Panel Discussion on Pharma and Chemical Supply Chain

Keywords: chemical, pharmaceutical supply chain, supply chain

In this January-February issue we have foreseen a Panel discussion on the Pharma Supply Chain involving Companies working on different steps. Personalised medicines, gene therapy, Quality by Design (QbD), Process Analytical Technology (PAT) and continuous manufacturing are for sure hot topics to discuss on. An important overview has been given on the key success factors, market trends, technology Innovations and the ever-changing Regulation landscape. An overview of the take home messages from this Panel can be found in Dr. Michael Quirmbach’s article at the beginning of this Panel (pag. 25).

The following players have joined this initiative:

Scott Martin, President, Fine Chemistry Services - Albemarle

How do you address the increasing needs of Biotech and Pharma companies towards integrated supply solutions?

We at Albemarle’s FCS have the benefit of offering our customers the ability to back integrate to the RSMs for our new APIs. This allows our South Haven cGMP site to seamlessly coordinate and quickly resolve issues with our Tyrone site on quality, scheduling changes , tighter impurity specs , etc at any scale. A significant number of our custom products have achieved fast track status. Having one supplier of both the API and the RSMs allows quicker resolutions, close alignment and partnership with our customers which leads to the successful scale up of these challenging APIs.

Which are the key success factors of a successful CDMO in today’s environment?

Quality. You must have a pristine FDA compliance record to start. We are continuing to add more analytical capability to meet the more stringent guidelines. Then talent and experience moving these fast track APIs through regulatory steps in close alignment customer’s technical and regulatory teams.

Which trends do you see from Biotech vs Pharma companies in their request for services and products – where is the industry heading? Single Services and multiple providers vs fully integrated providers?

We see it being a combination of multiple integration, as the needs of the program require. The speed to market success requires a dedicated team that can execute and change course quickly should the development program require it. We find this success comes most frequently with teams that are agile and aligned with our customer’s goals. This can be lost in an environment that has become overly layered.

How important is the US market to your business, and where do you see changes and challenges in the next 5 years in the US market?

We are a US based integrated supplier, therefore it’s very important. The challenge will always be the attraction of what seems to be lower costs from offshore. We believe the market for small molecule scale up and product launch will continue to be robust. The drivers to success will be high quality, excellent regulatory record, and experience in scale up of multiple APIs to the market. Therefore we are not too concerned with the offshore CDMO offerings.

Which technology trends do you see in the next 5 years and how will your company deal with them, is continuous manufacturing one of those trends?

There is a good deal of focus and attention given to continuous manufacturing in the Pharma space. Continuous manufacturing has its applications. One must remember that this will require the building of a dedicated unit for this product. That will require time to pilot, design, construct and then validate the new equipment. We have not seen the opportunity to apply this technology to a multipurpose API process development to commercial environment that will not adversely impact the speed to market for our customers.

Many of the APIs have very targeted indications (specific target areas within oncology for example) that may limit the total annual demand to 1000 kgs or so. Working with a proven CDMO and practicing batch manufacturing allows the advantage of operating through the different scales needed from Phase 1 through launch quickly in proven equipment. That equipment can be campaigned to produce other APIs which results in lower capital cost vs a dedicated designed continuous plant that will be down a good deal during the different Phases (that assumes the market size was known when the plant was designed). If anything we are adding smaller scale capacity to service our biotech customers to offer them the flexibility needed.

We will continue to monitor the development of this technology and will be ready to invest if a project warrants its use.

Compared to other markets, US generic products are still more expensive, will this change in the next future?

Off shore competition for US generic API suppliers is very concerning and may even challenge the availability US production. We see no change and may exit some of our generics. With the number of regulatory issues at multiple off shore producers and shortages thereby created of those APIs, you would reason that domestic supply would be valued. Only time will tell.

Gareth Jenkins, CSO - Arcinova

What are the key success factors of a successful CDMO in today’s environment?

Success is really all about problem solving, being able to help people with the challenging drug compounds that have been discovered and working out the best routes to get them through clinical development phases. Given that new drug compounds are now more likely to be complex entities, it is up to the CDMO community to solve the corresponding formulation challenges in the same or less time than they have done in the past.

Which trends do you see from Biotech vs Pharma companies in their request for services and products - where is the industry heading? Single services and multiple providers vs fully integrated providers?

Biotech companies have long used outsourcing as a strategy for developing their new medicines and a variety of CDMOs, CMOs and CROs exist to serve this need. Pharma companies have tended to be more tactical in their outsourcing, using it to supplement their in-house capabilities. The service providers have responded to both drivers towards outsourcing with examples focused on either drug substance or drug product services. Alternatively, some service providers looked at developing multiple services within stages of the clinical development.

How important is the US market to your business, and where do you see changes and challenges in the next 5 years in the US market?

The US market is a very important and well-funded market. We are now seeing more US-based companies taking their drugs all the way through clinical development to market approval. Orphan drug designation has been very successful in encouraging new medicines for small markets that were previously considered to be uneconomic. This trend towards smaller, more targeted drugs will continue especially with the advance of personalised medicines. Agile CDMOs like Arcinova are well placed to meet the challenge of developing and manufacturing highly complex medicines, using science and technology to intensify and accelerate pharmaceutical development.

What will be key issues shaping the pharmaceutical industry in the next 3 - 5 years?

In the longer term, the trend for personalised medicines targeting smaller patient populations is going to present both an opportunity and a challenge in pharmaceutical drug development. Over the shorter term, due to the increasing pressure from the payers of medicines, we will also see a shift towards outcomes-based payments, where payment arrangements are linked to the outcome of a course of medicines. This will be enabled by advances in diagnostics and the use of machine learning to define the manufacturing requirements for drug products.

Which technology trends do you see in the next 5 years and how will your company deal with them, is continuous manufacturing one of those trends?

We think that technology is going to revolutionise both drug substance and drug product manufacture.

These technologies include continuous, digital and automated manufacturing, along with better modelling to define a most effective overall manufacturing process. We also predict the use of synthetic biology will begin to provide much shorter routes to highly complex drugs starting from simple building blocks. Where a chemical route may be over 20 steps, a synthetic biology approach could reduce this to under 10.

Which markets will gain more importance for your company in the next 5 years?

Asia is a very dynamic market. Japan has always been strong, with a number of global pharmaceutical companies. China is expanding and offers great growth potential and so will rise in importance over the longer term.

Where can you add value in the pharmaceutical supply chain?

We have a unique multi-disciplinary and multi-dimensional approach to pharmaceutical development.

Our Alnwick Research Centre offers a combination of drug substance process development, formulation development, drug product manufacture and state-of-the-art bioanalysis. Our clients value this extensive and highly integrated pharmaceutical development platform and our ability to rapidly develop, make and test new pharmaceutical clinical candidates. We are helping them to improve patient care through our transformational technology and integrated solutions.

Hendrik Baumann, CEO - Arevipharma

Personalized medicine, biotechnology, gene therapy and the rise of emerging markets are already influencing the pharmaceutical landscape. How will your company deal with these changes? Which are the area’s you are planning to add to your future service portfolio?

We are continuously checking our portfolio, filling the pipeline with new projects and make sure that we have the lowest possible production costs. Beside this we have a long term investment program and based on market requirements we invest in selected technologies.

Which are the key success factors of a successful CDMO in today’s environment?

Arevipharma is focussing on CMO business and it is of importance to have excellent service in combination with attractive production costs and high quality of the product.

This discussion is being held for long time, without significant change of the competitive landscape. Most of the big pharma companies like to have one single service provider which can do everything, means they like “one stop shopping”. A look to the todays market shows that more than 500 companies worldwide are active as CMO’s, CDMO’s or simple API’s suppliers. All working in the field of pharmaceutical and fine chemicals business. The market is constantly growing but we have never seen a real consolidation and the market share of the largest companies is below 3% in fine chemical manufacturing. Each company is more or less unique, has special technology, services, costs and locations.

To offer all technologies, services etc. under one roof is nearly impossible and that’s the reason why we did not see any consolidation in the market and therefore we do not believe that fully integrated providers will be more successful than specialised companies, on long term prospective.

How important is the US market to your business, and where do you see changes and challenges in the next 5 years in the US market?

Due to the nature of our business we have a small market share in the USA. However, we are focussing on selective CMO projects and few generic API’s. If the influence of the government to the health insurance system will further increase, we expect the same price erosion as we see in Europe.

How important are face-to-face meetings with your customers and suppliers and events for your business?

Still extremely important. We have tried several times video conferences, skype meetings etc. This work for routine business but not for intimate project discussions. DCAT for example is the best venue for meeting all US and some European customers. We like the style “hotel exhibition” as it saves a lot of costs in comparison to CPhI or other large exhibitions and the value for money is unbeatable.

What will be key issues shaping the pharmaceutical industry in the next 3-5 years?

Less NCE’s, constant price pressure from government and health insurance and last but not least the trend to individualised medicine.

Will the industry be able to meet a new innovation level in 2019? (talking about the FDA approval of NCE’s)

The most of the major diseases are treatable with good and affordable medicines. Innovation potential is in the field of antibody medicines and digitalisation.

Which technology trends do you see in the next 5 years and how will your company deal with them, is continuous manufacturing one of those trends?

We see projects with lower volumes will increase due to more individualised approaches in the medicinal chemistry and due to the fact that individualised medicine will become more important. Beside this, continuous manufacturing is a very interesting trend and might gain market share. But not every reaction can be performed and therefore we see it more as an “add on” to the current technology portfolio.

Beyond the USA, which growing markets do you see in the next 5 years?

China and India will be hot markets in the future. Our company has started projects with customers to launch generic API’s formulations in China for example. Beside this, Vietnam will play an interesting role in the future, Malaysia and Philippines as well.

Which roles play Quality by Design (QbD) and Process Analytical Technology (PAT) in your compliance system, what are the next trends in compliance?

We cannot ignore such initiatives and have to follow whenever possible. Finally everybody must be aware that the full implementation of QbD and/or PAT will influence the production costs dramatically. The question is: Who is paying for the cost increase.

How can US and European competitors stay in the market and remain profitable in a general context of growing emerging markets and strong competition from Asian providers?

Constant level of investment in people and technology. Keeping the plant state-of-the-art and have the costs under control.

Jason Moss, Director, Drug Substance Contract Manufacturing - BioMarin Pharmaceutical

Which are the key success factors of a successful CDMO in today’s environment?

A successful CDMO should appreciate the ever-increasing regulatory scrutiny placed on sponsors and be a partner – not a vendor – to help sponsors meet and exceed these requirements. It’s also vital that CDMOs don’t hew to a ‘standard’ approach to interactions with sponsors, as everyone brings a different approach to CMC. Beyond meeting the expectations of regulatory authorities, there’s no one right way to manage a program on strategic and tactical levels. CDMOs – and sponsors – need to learn from each other and work together in order to bring novel products to patients quickly, safely, and cost-effectively.

Every sponsor takes a different approach but I see limited value in the one-stop-shop model. One of the often-touted benefits is that it’s easier to have a single contract than multiple for DS and DP manufacturing activities, as well as one point of contact. However, contractual terms are often completely different for these areas, particularly with respect to proprietary DP strategies, so the argument based on contractual simplicity often doesn’t apply. Also, DS and DP business and manufacturing units are usually completely separated within a parent company. With all of these caveats, I advocate finding the right CDMOs for the individual elements of a program, which also mitigates the risk of having your entire program under the control of a single external party. Besides, if a CDMO is acquired and spins off a business unit – which happens very frequently these days – you’re back in the normal situation of having different CDMOs manage different aspects of a program.

How important are face-to-face meetings with your customers and suppliers and events for your business?

Vital. T-cons and screen-sharing are our bread and butter but there’s nothing that can replace the human interactions. These are what build long-lasting trust between sponsors and CDMOs; without them it’s very easy for commentary on the phone to be mis- or over-interpreted and lead to misunderstandings during a program.

How can US and European competitors stay in the market and remain profitable in a general context of growing emerging markets and strong competition from Asian providers?

Compliance, transparency, communication, and stability. There will always be a less-expensive option in China or India but increasing regulatory expectations on starting materials and intermediates will continue to give high quality US and European manufacturers an opportunity to add value and mitigate risk.

Fabio Silvestri, Head of Product Strategy and Planning - Bormioli Pharma

How do you address the increasing needs of Biotech and Pharma companies towards integrated supply solutions?

We are addressing these needs radically changing our innovation model, strongly reducing boundaries between the company and the surrounding environment, and promoting a more open, distributed approach, involving clients, end users, start-ups and incubators.

Through the creation of a broader, more permeable and transparent environment we can quickly intercept new and upcoming needs and provide the solutions the market is seeking.

To do that, it is necessary to change our culture, opening our doors to customers, making them see what we do and how we do it. The idea is to create an ecosystem, where different actors can play to reach their own goal taking advantage to what every single player can put.

This change in perspective requires stronger internal processes, so that we may stay aligned to the standards pharma market requires.

Personalized medicine, biotechnology, gene therapy and the rise of emerging markets are already influencing the pharmaceutical landscape. How will your company deal with these changes? Which are the areas you are planning to add to your future service portfolio?

All these topics are radically changing the pharma landscape, even though in different ways. Putting the end users, i.e. the patients, at center stage is the key to have an all-around vision on the industry, enabling us to react quickly to the market ’s requests.

A strong innovation culture and a more agile organization helps the company to perceive these changes as a considerable opportunity to grow, enabling us to monitor trends – both in the pharma industry and globally – to come up with new, unconventional solutions to meet medical and business needs.

As a key player in the pharma packaging industry, we strongly believe that our industry’s future will be more and more focused on the integration between manufacturing and services, thus offering a complete customer experience.

What will be key issues shaping the pharmaceutical industry in the next 3-5 years?

The global pharma industry is forecasted to evolve at an increasingly fast pace. As a pharma packaging manufacturer, we monitor the macro-trends behind these changes, focusing on five main drivers. First of all, the demographic one. The pharma industry will be asked to deal with increasingly aging population, as well as growth in oncology, chronic illnesses, and global pandemic risks.

Second, the technology trends, including digital and connectivity as a disruptor allowing personalized medicines. Third, the trends being defined by consumers, such as a growing awareness on health and prevention, pushing the pharma industry towards new go-to-market models.

Moreover, economic and social trends are also strongly influencing the future of the industry, fostering changes in value drivers, commoditization of mature technologies and a new focus on sustainability.

In the next 3-5 years, the main issue for the whole pharma supply chain will be the cascading of these trends. Every single player inside the supply chain is now asked to actively face these challenges, addressing them with concrete solutions.

What technology trends do you see in the dosage form area?

The pharma market is looking for packaging technologies able to support personalized medicine and patients adherence. From a packaging perspective, we see a great potential in the dual chamber technology for oral drug reconstitution. A dual chamber system is normally composed of a plastic bottle storing the solvent, and a cap storing the powder. This allows to reconstitute oral drugs on the go, directly in the packaging, following a simple and guided procedure.

Compared to traditional reconstitution processes, dual chamber systems allow a high formulation versatility: for example, pharma companies are able to choose which solvent storing in the bottle, offering alternatives to water. Moreover, the high level of protection guaranteed to active ingredients inside the cap adds flexibility to the formulation. That is why pharma companies can take into consideration also highly sensitive active ingredients, otherwise difficult to include into their drugs.

Sandra Cernick, Chief Commercial Officer - Callery

How do you address the increasing needs of Biotech and Pharma companies towards integrated supply solutions?

Globalization has brought many benefits to the manufacturing sector along with some challenges. New chemical entities are often developed in western countries before being moved east for large-scale manufacturing. Having the capability, resources and regulatory capabilities to supply quality products to meet manufacturing needs, regardless of scale or manufacturing location is important to our customers and part of who we are.

How important is the US market to your business, and where do you see changes and challenges in the next 5 years in the US market?

The US market remains an important sector with respect to innovation and early adoption of our technology in the APIs of tomorrow. The surge of smaller virtual firms and their transition from a make-to-license to a make-to-market business model will require additional resources and a shift in our customer interaction model to remain competitive and feed our project pipeline.

How important are face-to-face meetings with your customers and suppliers and events for your business?

While the frequency of face-to-face meetings will likely remain flat to slightly declining, their importance will increase dramatically.

While technology and social media routes to communication remain important for new business development, interpersonal interaction will be crucial to cement trust in an environment growingly concerned about reducing supply chain risk and minimizing the industries effect on the environment and society. This is evident in the China EHS shutdowns and the increased regulations in response to the opioid crisis.

What will be key issues shaping the pharmaceutical industry in the next 3-5 years?

The Virtual Pharma business model is not burdened by the layers of bureaucracy found in Big Pharma. Virtual Pharma firms that focus on bringing their clinical candidates to market rather than license will be more efficient and effectively shorten the timeline for developmental projects. This will be advantageous for fine chemical and other upstream contributors to API manufacturing.

While 2018 was a banner year for New Drug approvals, increased focus on preventive treatment, personalize medicine and gene therapy (CRISPER) could reduce the overall patient population. US government pressure on pricing and increased scrutiny from the FDA on the prescription of opioids will reduce the “cash cow” of many large-scale producers potentially causing them to divest less profitable generics. This could cause a shortage in drugs for pain relief.

Beyond the USA, which growing markets do you see in the next 5 years?

The expectation is that Asian markets, particularly China and India will continue to play a major role in the pharmaceutical value chain. Both countries are working through various regulatory challenges which have impacted the short-term business environment; however, there is little doubt that the challenges will be overcome and opportunities for additional growth will develop as a result.

How can US and European competitors stay in the market and remain profitable in a general context of growing emerging markets and strong competition from Asian providers?

When faced with a less than competitive labor rate and potentially less favorable shipment route to the customer, western fine chemical firms will have to exhibit a more sustainable business atmosphere including both internal (financial and safety records) and external factors (environmental record and social reputation) to remain competitive with emerging markets. The western supplier needs to exemplify the trusted responsible partner motif.

COMPANY PROFILE

Callery, A Strong Partner in Boranes and Alkali Metal Alkoxides

Callery is the world’s leading expert in boranes, alkali metal alkoxides and HMDS bases headquartered in Evans City, Pennsylvania where it was founded more than 75 years ago by Mine Safety Appliances. The plant was founded for the primary purpose of producing potassium-based products for emergency breathing devices used in the mining industry and borane-based propellants for the US government to support its military. Later, in 2002, the site was acquired by German-based BASF Group where it served as the global headquarters for the Specialty Inorganic Chemicals Division. Recently, in 2017, the site spun off as Callery, LLC after being purchased by Edgewater Capital Partners. Today, Callery produces over 50 different products which enable chemistries used in the production of active pharmaceutical ingredients, agrochemicals, fine chemicals for liquid crystal displays (LCD), and organic light emitting diodes (OLED).
In addition, Callery’s products are used in the process to produce olefins, organometallic chemicals, synthetic styrene-butadiene rubber (sSBR) for tires, specialty coatings and surface treatment, wastewater treatment, and low energy surface adhesives (LESA).

The Callery team is dedicated to remaining a safe, secure and customer-centric organization. The site operations are engineered to support the production, packaging, and shipping of highly energetic, air sensitive and pyrophoric compounds. With a 100% Customer audit success rate, over four years without an OSHA reportable incident or injury, and >90% on-time delivery rating, Callery is the proven, committed and above all, preferred partner in the chemical manufacturing industry.

Callery, LLC
1424 Mars-Evans City Rd,
Evans City, PA 16033 USA
P: +1.724.538.1200
E: info@callery.com
www.callery.com

Elise Mous, Director Sales & Marketing / Business Development - Capua BioServices

Andrea Conforto, Business Development Director CDMO - Olon

How do you address the increasing needs of Biotech and Pharma companies towards integrated supply solutions?

Olon Group is growing in the direction of providing integrated solutions in the supply of APIs for the Pharma industry. The recent acquisition of Capua BioServices S.p.A is a perfect example of strengthening and broadening of integrated supply solutions. This expansion provides access to high quality lab, pilot and commercial-scale manufacturing know-how and capabilities to further support the growing demand for microbial manufacturing capabilities in the market. These capabilities will be added to the already existing range of services of strain improvement and development, process development and manufacturing of API, HPC, food ingredients and generally speaking “biotech products” available at Olon as microbial fermentation CDMO.

Which are the key success factors of a successful CDMO in today’s environment?

The long experience at Olon is the result of the merger of knowledge coming from different companies. Olon can combine industrial capabilities, developed during a long and successful history, together with the skills of our scientists and technical global teams. Furthermore, our group company Olon Ricerca Bioscience located in Ohio together with an integrated multisite project management are the factors which elevate Olon to the top CDMO service provider. The ongoing integration of Capua BioServices with Olon already now results in the establishment of the largest microbial CDMO in Europe with a total of 4500 m3 of fermentation capacity. However, capacity as such is not a sole key success factor. In the end, the skilled people, their dedication and the flexibility of the mindset, the equipment set-up and the processes in place form the key to being a successful CDMO.

We recognize that in the last few years there is an increasing trend to outsource products to fully integrated service providers in order to simplify the supply chain. In this respect Olon has done in the last few years some strategic acquisition (i.e Olon Ricerca Bioscience in 2017) in order to be able to support customers from early clinical stage up to commercial API production.

Biotech and Pharma companies are moving to very specific therapeutic areas, focusing their R&D activities on niche markets, orphan drugs and biological. Immuno-oncology and personalized medicines are considered the TOP emerging industry trends while regulatory constraints and price pressure represent continuous challenges. In this scenario a partner like Olon can be an excellent support to the development and production, providing an integrated solution from the early phase to commercial stage. The good mix of technologies and the recent acquisitions have enhanced our capabilities without changing the backbone of the company which stays focused on APIs and Intermediates

How important is the US market to your business, and where do you see changes and challenges in the next 5 years in the US market?

The US market is key for the CDMO strategy for both Olon and Capua BioServices. Together, about 45% of the total business comes from the US or from partners which are targeting a US market. The R&D vocation of the country makes the US the driver of our CDMO activities without forgetting other key areas like the EU, Japan and China.

How important are face-to-face meetings with your customers and suppliers and events for your business?

Outsourcing decisions are often associated to complex challenges and business cases. Such decisions are typically not made by one single person and not taken overnight. Having face to face meetings at different levels of influence and expertise is of the utmost importance to build a sound personal, yet business-oriented relation as a basis to jointly manage risks and rewards along the way. In the end, people still buy from people; regardless of the complexity.

Which technology trends do you see in the next 5 years and how will your company deal with them, is continuous manufacturing one of those trends?

The Pharma industry is changing fast and several trends & technologies will impact the market in the following years, such as: targeted therapies (including biologics), discoveries in the microbiome (the link between pharma and food) and the need for improved efficiency & productivity (for both chemical and biological processes). To address the latter technology trend, Olon is significantly investing in continuous manufacturing technology in collaboration with strategic partners and Universities. The trend towards personalized medicine will call for multiple smaller, yet targeted solutions and in order to address this, a variety of equipment set-up’s at different sizes are needed. Flexibility will be key. This is why are convinced that the general trend towards outsourcing will also remain for the next 5 years.

Beyond the USA, which growing markets do you see in the next 5 years?

The biological research is giving new energy to the EU opening up new opportunities but also countries like China are expected to growth fast especially due to the high investment rate on research and new technologies. The scientific background is improving a lot and we expect it will bring China to the top for innovation.

Which roles play Quality by Design (QbD) and Process Analytical Technology (PAT) in your compliance system, what are the next trends in compliance?

We have been using QbD and PAT for a few years for some of our processes, mainly for those steps in which the use of this approach gives a real advantage. For example, in the case of complex system in which fully understanding of the effects of parameters, in some cases playing a combined role, is fundamental to guarantee the quality of the product.

We are using this approach also to have more flexibility in the fine-tuning of the process in the standard production slightly changing the process parameters within the design space.

We think that the full knowledge of the process and the clear understanding of the role of each parameter will allow the Company to avoid in the future the Process Validation in case of demonstration of the absence of any critical parameter with the same level of control of the final quality of the product.

How can US and European competitors stay in the market and remain profitable in a general context of growing emerging markets and strong competition from Asian providers?

The EU and the US have a long history in the Pharma business and the growing regulatory activities, which are considered a constrain from many players, has to be seen as an opportunity for companies which have a strong quality background like Olon. Our RA knowledge has been built thanks to our presence in the generic fields where these activities are a mandatory support provided to our customer.

In the past the EU has been the driver for a sustainable industry and for sure moving in this direction will play a key role for the future of the Pharmaceutical activities.

Denis Angioletti, Chief Commercial Officer - Cerbios-Pharma

How do you address the increasing needs of Biotech and Pharma companies towards integrated supply solutions?

It is a need of our clients to get suppliers which have the resources, technologies and expertise to partner with them for more than one single service. As an API manufacturer, you can consider either integrating downstream to the final dosage form or expand your service from early stage development until the commercial manufacturing of the API.

Many companies address this need by making acquisitions to obtain what they were missing. We, at Cerbios, are continuously investing to expand our resources and technologies and can offer to our clients a complete service from their early development phases up to the commercial supplies. The big advantage comes when we have an excellent team and Program Management System which lead to a lean development work that save time and costs while moving ahead with the development program.

Which are the key success factors of a successful CDMO in today’s environment?

Communication, Flexibility, Reliability, Management commitment and consistent application of Best Practices.

I don’t believe that it all stands in one only way of doing, that the trend to integrated providers totally excludes the others. It is also a matter of being excellent in what you do.

Therefore, while we all know that extending our offer to multiple services is a need of the industry, being recognized as a specialist and leader for a specific technology or service is still rewarded.

How important is the US market to your business, and where do you see changes and challenges in the next 5 years in the US market?

The US market is one of our primary markets and it is still the largest for innovator business. For a CDMO it is essential to follow the evolution in the business models of the big players, as well as to understand the role of the new startups.

Which technology trends do you see in the next 5 years and how will your company deal with them, is continuous manufacturing one of those trends?

Surely continuous manufacturing is an attractive field where Cerbios has already acquired experience and where further investments are foreseen to reinforce its position. It is a versatile tool box to offer to our customers. Its application for the manufacturing of highly potent drugs is quite interesting to us; for that we filed a patent and we keep investing resources to further expand our know-how.

Beyond the USA, which growing markets do you see in the next 5 years?

Definitively the Asian markets are growing, with China first, but not only. That is shifting the balance of the industry and each player, primarily us as an API and CDMO supplier, shall refocus itself to get the opportunities where they are.

Which roles play Quality by Design (QbD) and Process Analytical Technology (PAT) in your compliance system, what are the next trends in compliance?

They are essential. QbD is one of the driving tools for us to get an efficient development work, on time and in quality. Analytical Technology is the key, since the bar in quality is getting up and up, even more in our case where we are focused on HPAI, ADCs and innovative APIs.

How can US and European competitors stay in the market and remain profitable in a general context of growing emerging markets and strong competition from Asian providers?

I’d see this from a different perspective. When we are talking about high value and technology products, like in our case, it is no longer about the equation Asia means cheaper; it is about who makes it better either it is in Europe, US or Asia. So, there are strong companies in Asia as well as there are in Europe and USA and anyone has its chances to be the partner of choice.

Christopher Verbicky, Managing Director - Curve Consultants

Which are the key success factors of a successful CDMO in today’s environment?

I believe that customer service remains the key differentiator for CDMOs. CDMOs stand out in this industry by having the ability to rapidly respond and meet their clients’ needs while maintaining quality standards. Operating in concert with their customers despite having multiple organizations with competing priorities is the hallmark of customer-centred CDMOs.

As consolidation grows the number of CDMOs offering integrated services increases, we may be getting closer to an ideal CDMO. Historically, I have not seen fully integrated services work optimally. The unique needs of most projects challenge a single organization’s capabilities and even when they exist, competing demands are a factor. CDMOs need to minimize downtime for their capabilities, so there is always a push to keep active. Managing the balance of client access and downtime is central to making an integrated offering work.

How important are face-to-face meetings with your customers and suppliers and events for your business?

Digital communications are commonplace and lead to perceptions of improved efficiency. Face-to-face meetings seem less important, which is far from the truth. No better form of communication exists than face-to-face conversation. We’ve all toiled to perfect an email when a phone call would convey the message better. Focusing on electronic communications and underutilizing of face-to-face communication fails to develop strong, trusting relationships. We fail to recognized that strong relationships enable companies to adapt together to overcome challenges.

What technology trends do you see in the dosage form area?

Historically injectable dosage forms were disfavoured. Administration by injection has become necessary as products that lack bioavailability and stability for oral administration are developed. Recent trends show nasal, sublingual, and transdermal administrations preferred as technologies improve.

Injectables are an area with a high growth rate, but also with an increasing complexity from a regulatory point of view - e.g. medical device products – how do you address these challenges?

Aseptic manufacturing is in the spot light recently, which is driven by >90% of drugs on the shortage list and the preponderance of products produced by compounding laboratories are injectables.

As new capacity comes online, we see more often isolator technology employed to increase control of aseptic manufacturing. These micro-environments are chemically sanitized and have better control of contamination than traditional cleanrooms. Aseptic technique is important, but the impact of failures is considerably reduced when operating in an isolator.

The development of generic products has become highly complex and very competitive, where do you see the challenges in the US market in the next 5 years?

There is more social and political pressure in the industry than ever before. Free-market economics have ruled for decades, driving price-points down and products off the market. This works when the product is not life-enabling or life-sustaining. When selecting an economical product vs. cutting-edge technology, it is easy to understand why one costs more. However, when an MS patient must select between a 40-year old product and one approved in the past year after successful comparator studies demonstrate superior efficacy, it is harder to deny access based upon cost. These social questions challenge the healthcare industry every day.

In which area is your company involved?

We offer a range of services spanning the pharmaceutical sciences, business, and project management. We have worked in the CDMO space nearly all our careers and developed extensive experience. We are driven to help others solve problems and draw tremendous satisfaction from applying our experience in that effort.

Where can you add value in the pharmaceutical supply chain? Management consulting, technology consulting, regulatory & compliance, product development, human resources, IP & patent consulting

Our expertise lies in product development and lifecycle management. Getting products to regulatory submission involves understanding of science, regulatory, and business to develop an effective strategy. This involves building a development plan around strong regulatory strategy and pulling together the right partners to execute. This where we are at our best.

What is important to provide good consulting?

Know your client. Just like in the CDMO space, responsiveness and communication is key. Establishing strong relationships translates to operational efficiency. Our partners fall in a range from knowing what they need to do but lacking capacity to not knowing how to develop a plan from an idea. The most important part of consulting is to know where in this range you are operating and cater to your clients’ needs.

How can you stay informed and involved in the very dynamic landscape of the pharmaceutical industry?

Keeping up with regulatory changes and pharma news is key, but talking with our clients to understand their challenges is the best way to stay informed.

Vance Lyon, Senior Director - DavosPharma

How do you address the increasing needs of Biotech and Pharma companies towards integrated supply solutions?

DavosPharma is meeting with customers across the industry all the time and we are learning their ever increasing requirements and requests. Through our network of suppliers, as well as our growing knowledge of the capabilities of these and other suppliers, we have assembled a world-class network of vetted companies which can meet the expanding needs of Biotech and Pharma companies. With our model, it is not necessary for one company to meet all the customers’ requests – Davos is able to assemble and package the studies, focusing the strengths of each of the individual suppliers, while Davos manages the overall work, moving material as needed to specific sites and assembling the data.
As Davos is bringing multiple projects to our suppliers, we have increased leverage with them to provide the same service to biotechs which a supplier would bring to a multi-national customer.

Which are the key success factors of a successful CDMO in today’s environment?

The keys for successful CDMOs are the same as they are for organizations throughout the marketplace. The organization should have the technical competence to successfully complete the requested task. The customer cannot be in a position where they learn part-way through the work that the CDMO does not have the necessary experience, capabilities and capacity to undertake the work. Beyond this, complete and transparent communication is critical. It is critical for the pharma company and the CDMO to both clearly understand the work at hand, the timeline and for the CDMO to provide regular updates, address any problem points and troublesome issues which might arise. Finally, the CDMO needs to be able to provide comprehensive and thorough documentation and final reports for the work undertaken.

How important are face-to-face meetings with your customers and suppliers and events for your business?

Face-to-face meetings are critical for the successful kick off for a project. These types of meetings are also important for securing business as this builds relationships, and leads to better understanding of the requests and the ways to address the issue. In general, trade shows serve as a way to provide a general overview of our business for new customers, while it serves as an important tool for continuing and building relationships and identifying new opportunities.

What will be key issues shaping the pharmaceutical industry in the next 3-5 years?

As scientists and clinicians develop new and more effective drugs, such as CAR-T treatments, the industry is faced with rising costs, while payers are faced with a mandate from government and insured people for more affordable care. Bringing these two together successfully will be an increasing challenge. Additionally, the issue of quality at manufacturing plants inspected by the FDA will remain important for the US and elsewhere.

Which technology trends do you see in the next 5 years and how will your company deal with them, is continuous manufacturing one of those trends?

Manufacturers are moving towards a more complete offering for their customers. This often includes options for highly potent manufacturing and handling, more complete control over the final API particle’s properties, including such processes as micronization and spray drying, and continuous manufacturing. Many suppliers are now incorporating continuous manufacturing studies in their lab studies. All these trends will continue to be more important to pharmaceutical customers in the coming years.

What is the role of an agent/trader in the today’s global pharmaceutical industry (generics, contract manufacturing)?

Davos’ role is to meet with our customers and, with them, identify ways in which we can assist through our suppliers. Our main role, once the project is in place, is to maintain communications between all parties. It is our responsibility to keep communications flowing smoothly so that everyone’s expectations are met. We work with the parties to clearly outline the project deliverables and timelines. Unlike agents, we stay involved in projects from beginning to end, keeping projects on time and addressing any concerns as they arise. Our best source of growth are our current customers and their recommendations.

Where can you add value to the pharmaceutical supply chain for your principals and for your customers?

From the experience which we have gained with our suppliers, we are able to leverage their best resources to meet the customers’ needs. Our suppliers are often smaller, more agile companies, able to move quickly, starting projects sooner and being able to react quicker to technical requests. Communication is necessary to alert the customer to any issues which might slow the project, or that require input. Davos facilitates this communication, bringing projects more quickly to a successful and satisfactory conclusion.

In which area is your company involved?

DavosPharma serves the pharmaceutical industry, both biotechs and multi-nationals. We assist our customers with any and all services from early discovery, through development to full commercial manufacturing. We have developed IND-enabling programs which provide the biotech with a completed CMC section for their IND. This effort includes the necessary testing, development and manufacturing – both API and formulated drug product – as well as consultants to assemble the information and write and prepare the documentation.

Andreas Meudt, Vice President and Head of Exclusive Synthesis - Evonik

Which are the key success factors of a successful CMO in today’s environment?

For a CMO to be considered as a partner for an API, HPAPI or intermediate project, it is imperative that they have the necessary global scale, expertise and flexibility. Companies also want to partner with CMOs that have a reliable track record in the production of comparable products at consistent quality levels. In particular, there is a strong preference for Western-based manufacturing sites to reduce supply continuity risks.

Most of all however, CMO selection is coming down to which prospective partner has the right combination of advanced technologies to manage the production of a complex compound with more than a dozen process steps. Having established a market-leading portfolio including HPAPI, continuous processing, highly pure PEGs and mPEGs and microbial fermentation, we can bring together multiple advanced technologies to address specific customer requirements.

While some CMOs are trying to market an end-to-end approach, pharmaceutical customers of Evonik have indicated that what they desire most from a preferred partner is a selection of best-in-class services that strongly complement their project requirements. Following a $41 million expansion of advanced technologies across our global network of sites, we are well positioned to address the current and emerging requirements of customers with high-value projects.

In Hanau, Germany, we recently introduced a new modular continuous processing pilot plant, a small-scale plant for the custom synthesis of highly pure PEGs and mPEGs, and a suite for the small-scale production of HPAPI and ultra-HPAPI. We have also expanded the asset footprint of our Tippecanoe site in the U.S. In addition to being the world’s largest HPAPI manufacturer, we are now able to run several small, medium or large HPAPI projects in parallel down to an exposure level (OEL) of 5 ng/m³. A new downstream processing pilot plant in Slovakia also further expands our worldwide network to support microbial fermentation projects from strain development through to commercial manufacturing for pharma and for other applications such as food ingredients.

What will be key issues shaping the pharmaceutical industry in the next 3-5 years?

As small molecules continue to increase in complexity and require specific process steps for production, it will become more important for CMOs to maintain a leadership role across several highly specialized technology areas.

In parallel, pharmaceutical companies will continue to reduce risk by selecting partners with trusted U.S. and European sites, and by signing contracts that guarantee long-term continuity of supply for periods of ten years or more. Many top pharmaceutical companies are also strengthening their relationships with CMOs that have business practices that complement their own sustainability goals.

Which technology trends do you see in the next 5 years and how will your company deal with them, is continuous manufacturing one of those trends?

The number of small molecules in clinical development that are based upon highly specialized chemical compounds that require a combination of continuous processing and other highly differentiated technologies continues to grow rapidly. Evonik is leveraging more than five decades of experience in the development and application of continuous processes, with two-thirds of our own products by volume made in this way. Our reputation as the continuous processing experts is helping us secure customer projects where support is required from process development to customized production.

Another substance area where demand is growing for advanced technologies is enantiopure compounds, where customers are selecting Evonik based upon our combination of chemo-catalysis, enzymatic chemistry, fermentation and chiral pool chemistry expertise. Demand for projects based upon nucleoside chemistry is also growing, where our strengths across technologies including carbohydrate chemistry and heterocyclic chemistry puts us in a strong position to serve customers. Beyond the pharmaceutical market, we are also securing contracts with advanced food and material companies that require our advanced commercial capabilities in microbial fermentation.

How can US and European competitors stay in the market and remain profitable in a general context of growing emerging markets and strong competition from Asian providers?

Recent quality and regulatory issues has led many pharmaceutical companies to transfer their outsourcing partnering relationships to financially stable CMOs in Europe and the U.S. Today, most new high-value projects are almost exclusively being outsourced to CMOs that have a strong network of Western-based sites. The fact that our Tippecanoe facility in the U.S. has now recorded six consecutive FDA inspections without a Form 483 is an indication of how we can provide customers with peace-of-mind.

COMPANY PROFILE

A global CMO leader and preferred partner

Evonik is one of the world’s leading specialty chemical companies. The Evonik business line Health Care serves more than 1,000 pharmaceutical, medical device and nutraceutical companies worldwide. Evonik is one of the world’s largest CMOs for API, HPAPI and intermediates, with the ability to leverage decades of chemistry, biotechnology and process engineering expertise for large or complex small molecule projects. A team of more than 800 chemistry and process engineering experts are available worldwide to support process development and optimization. A global network of manufacturing sites across the U.S., Europe and Asia deliver quality consistency and supply continuity at virtually any clinical or commercial scale. A broad selection of advanced technologies can be brought together to address specific project requirements.

Offered services:

API, HPAPI and intermediate production
Continuous processing
Highly pure PEGs and mPEGs
Microbial fermentation
Catalysis
Biocatalysis
Chiral chemistry
Polymer API
Organometallic chemistry
Cryogenic chemistry
Carbohydrate chemistry
Nucleoside chemistry

Website: www.evonik.com/exclusive-synthesis
Email: healthcare@evonik.com
Employees: 34,000 worldwide
Year of foundation: 2007
Headquarter country: Germany

Gregor Kawaletz, Vice President Global Sales and Marketing - IDT Biologika

It is a strong tendency in the industry to use novel technologies to bid different diseases. IDT has a great scientific background and therefore it focusses on gene therapies and fill/finish capacities.

Which are the key success factors of a successful CDMO in today’s environment?

Especially for mid-tier companies it is important to focus on own strength. This means in IDT language, Innovation by special technologies which allow for acceleration of projects to market. This is key for all clients.

Some CDMO companies call themselves “peace of mind” or “turnkey solution” provider. In relation to a project this makes sense. However for these companies it is a challenge to offer interdisciplinary services by different technologies on a high quality level.

How important is the US market to your business, and where do you see changes and challenges in the next 5 years in the US market?

USA is for sure the most important market globally. The challenges in the coming years will be to get access to the US market especially for Non-US companies. Another topic is also innovation of new products which bring the breakthrough for different diseases instead just improvement.

What will be key issues shaping the pharmaceutical industry in the next 3-5 years?

Costs and prices for new products will be a challenge.
On the one hand we have a population getting older which need more medication, on the other hand we have higher prices for modern products. This brings new challenges in terms of how to finance.

The other point will be patent protection. Knowing that the population still with a low income in the emerging markets with similar diseases as in the post-industrial developed countries is growing and knowing that the patent protected products are usually more efficient for the health, it might be difficult to decrease prices for those markets.

Which technology trends do you see in the next 5 years and how will your company deal with them, is continuous manufacturing one of those trends?

In the market it is a strong tendency visible to invest in biologics as a real alternative to the conventional products with a breakthrough potency. The majority of our clients do not invest in small molecules any longer but in biologics.

Beyond the USA, which growing markets do you see in the next 5 years?

In the next years beyond US further countries will play a more and more important role, especially Asia. This is due to growing population and better living conditions, higher income and dynamic scientific environment with a lot of innovation.

How can US and European competitors stay in the market and remain profitable in a general context of growing emerging markets and strong competition from Asian providers?

US and European supplier have a good chance to be successful on the market. One element is innovation for new products and high quality of the products offered. Furthermore the markets will grow so all suppliers will find own clients.

What technology trends do you see in the dosage form area?

In the biologic world there are two fields which will become more and more important and one of those is self-administration which might be by an auto-injector or safety device. This will reduce health care costs.

Which markets will gain more importance for your company in the next 5 years?

As Mentioned before Asia will rather short notice play a more important role, while Africa will be long terms also of interest.

Stefano Togni, BD&Licensing Director – CDMO - Indena

Which are the key success factors of a successful CDMO in today’s environment?

There are probably two key success factors for a CDMO, once the fundamental requirements (in terms of quality and solidity) are met. One is the human factor: it is not enough to have a very nice piece of equipment, if you miss a skilled, well trained and passionate resource to take care of it. The other is being able to continuously invest in new specialized technologies, anticipating somehow the market demands: this was Indena’s approach and the rationale behind the investment done in the last two years (further expansion of spray drying from organic solvents, an additional GMP kilolab for ultrapotent APIs and the creation of a new GMP pilot plant).

I’m not so confident in fully integrated solutions, generally speaking. On the one hand it makes sense to broaden the offer of services to facilitate the partner (for example, adding API pre-formulation capabilities, like spray drying in the presence of excipients; or a downstream integration for Highly Potent compounds, so that the manufacturing process of the finished dosage form is streamlined). But on the other hand, it is important to maintain the focus on the core competencies, especially for highly specialized novel therapies. It is important to avoid becoming a jack of all trades, but a master of none.

How important is the US market to your business, and where do you see changes and challenges in the next 5 years in the US market?

The US market is by far the most important one for Indena, not only in terms of absolute value of single projects but also as far as the innovation rate is concerned. It is common for us to interact both with very innovative start-ups with brilliant ideas and with large, more structured corporations. In the US market, traditionally we have been involved since the early phases of oncology drugs which have become then blockbusters, following the projects since the very early stages and assisting to the parallel transformation of the originating companies – from early stage biotech to large corporations. On the other hand, the generic market seems to be under a strong price pressure: historical US generic players have been forced out of the market, or have been acquired – several companies in the generic space are now producing finished drug products abroad and importing them to US; some generic companies, despite having achieved a successful FDA registration, decide not to launch for economic reasons; and this can bring to peculiar situations of shortage, which are detrimental to patients. There are still opportunities with niche generics or when technical barriers exist.

How important are face-to-face meetings with your customers and suppliers and events for your business?

Face to face meetings are the basis of our business. In a world which is becoming more and more digital, the human interaction (and the trust you gain in the partner through this personal interaction) is fundamental. Then periodical follow-ups and project management can be done by email or videoconference; but when taking critical decisions or for early stage contacts, it is very important to meet. This is an approach shared and required also by our customers. Emails and digital interactions are a necessary tool, but need to coexist with the real world interaction.

What will be key issues shaping the pharmaceutical industry in the next 3-5 years?

We are seeing the emergence of complex molecules targeting very niche and specialized segments (like orphan diseases). There are not so many companies willing to embark in a full process validation and commercial GMP manufacturing of APIs whose yearly requirement is in the range of tens or hundreds of grams. Especially if they have invested in large scale unspecialized reactor capacity. Moving toward a personalized medicine approach may require more targeted molecules, based on patient’s own specificity – hence with lower volumes and a high flexibility in terms of manufacturing.

Which technology trends do you see in the next 5 years and how will your company deal with them, is continuous manufacturing one of those trends?

As Indena we have expanded our technological offer by contiguity and improved flexibility. In other words, we have expanded the range of HIPO we can handle (now dealing with HPAPIs with 20 ng/m3 OEL), installed a medium scale spray dryer (to complement the large scale equipment), opened a new GMP pilot pharmaceutical plant to intercept early stage projects or commercial productions requiring high flexibility/intermediate scale.

Beyond the USA, which growing markets do you see in the next 5 years?

Europe and Japan are following US in terms of growth and innovation. Most likely, several innovative products will come from South Korean companies, as they are targeting now the global market.

How can US and European competitors stay in the market and remain profitable in a general context of growing emerging markets and strong competition from Asian providers?

The data integrity issue with some Asian providers seems still far to be solved. Furthermore there is the tightening of environmental policies in countries like China, which on the one hand has forced the abrupt interruption of some plants, on the other hand is reducing the economic advantage of outsourcing to China, if we all play with the same (or at least similar) rules. US and European providers are hence in a favourable condition, compared to some years ago, receiving increased demands. Especially for innovative molecules and highly complex ones, the Asian option seems to be less appealing than some time ago; EU and US suppliers needs to remain quality oriented, innovative and specialized. As far as Italy is concerned, the pharmaceutical manufacturing industry is doing particularly well: having surpassed Germany already in 2017, it is now the most important country in EU in terms of value of pharmaceutical productions. The quality of the Italian production has been the clue of the success, as it attracted many new investments and boosted Italy’s exports.

Kevin Hennessy, Global New Business Director - Johnson Matthey

How important is the US market to your business, and where do you see changes and challenges in the next 5 years in the US market?

The US market is hugely influential and currently makes up more than 50% of JM’s overall business. A key challenge we expect in the next five years is additional scrutiny around quality and regulatory compliance. Additionally, the US market is very competitive and requires us to identify and select the products that will succeed in this particular market in order to avoid the unnecessary waste of capital resources.

How important are face-to-face meetings with your customers and suppliers and events for your business?

We strongly believe the best relationships in business are those that are maintained through face-to-face interactions and we feel this form is critical for our business. We see great benefit from presenting and attending the industry’s largest trade-shows and events, not only to generate new opportunities, but also to build on the previous years’ successes. We see great value and returns on our investments.

What will be key issues shaping the pharmaceutical industry in the next 3-5 years?

We see the emergence of new markets and several of the new trends in Pharma as being key drivers that will shape the industry in the coming years. The demand to develop therapies involving both small and large molecules will only continue to rise, highlighting an area where JM can play a key role in all stages along the drug and API development pipeline.

Additionally, we are seeing increased demand for generic drugs in China, which has opened up the industry and created greater international competition. Finally, changes to drug pricing policies in the US will also have a significant impact on the industry and it will be important for companies to positively react to the increasing competition.

The development of generic products has become highly complex and very competitive, where do you see the challenges in the US market in the next 5 years?

Increasing the speed to market while providing a high-quality and cost-effective service are all key factors that are essential to succeeding in the US market and indeed other global marketplaces. Another critical factor is maintaining efficient supply chains to ensure rapid and uninterrupted drug development. We believe the most successful companies will be those with quick reactivity to changing market conditions.

How is your company differentiating against other generic competitors?

We pride ourselves on offering a diverse portfolio of products that are right for the treatment at hand. In addition, JM has a flexible business model that allows us to influence market shifts and respond rapidly to market volatility. JM also works to backwards integrate the suppliers that are essential for our API development, this aids in our ability to maintain flexibility.

Stefan Schmidinger, Chief Marketing Officer - Kemiex

What is the role of an agent/trader in the today’s global pharmaceutical industry (generics, contract manufacturing)?

KEMIEX is the future of exchanging generic raw materials between buyers and sellers on the global spot market. It uses a business model and technology that has been used in other industries for years, but customized in a way that it meets strict regulatory requirements in pharma, vet and food industries. It is substantially more efficient, charges lower intermediation fees and offers additional benefits such as identity protection and instant access to a large and quality-approved network of counterparties. A traditional agent or voice broker typically searches products for buyers through a human network of suppliers against payment of a substantial commission. Traders also buy ingredients on stock, offer in-depth product advice and generally take more responsibility in the supply chain.

Where can you add value to the pharmaceutical supply chain for your principals and for your customers?

Highest added value is for buyers in opportunistic situations, where raw materials cannot be accessed directly, or for non-strategic products where efficiency matters most. Especially in small to mid-sized procurement teams, or labs and CMOs where purchasing might not be an established function. Another benefit are market and pricing insights that help to take better purchasing decisions. This is partly possible thanks to our unprecedented partnership with Dutch credit insurance ATRADIUS which offers financial insights and new insurance solutions exclusively to our members.

What are the challenges for your business in times of internet, datarooms, clouds and emerging markets?

KEMIEX is the first online trading network and platform that takes advantage of all these trends, to offer global buyers and sellers of raw materials a safe, efficient and convenient trading experience. We are very aware that the Pharmaceutical and Chemical industries are rapidly going digital and are committed to contribute in that transition with our solution.

In which area is your company involved?

KEMIEX is a premium trade network enabling safe and efficient trade through its pioneering online trading platform for buyers and sellers in pharma, but also in veterinary, and human and animal nutrition industries.

We carefully select the companies that enter into Kemiex through our Onboarding and Monitoring process, to ensure that only reliable companies are part of our network. This allows companies to become instantly connected to a global network of reliable counterparties that are compliant with latest regulations and quality controls, facilitating safe trade execution. Additionally, Kemiex helps companies to reduce transaction lead times, achieve more competitive prices and stay in full control of their trading activity from A to Z.

Detlef Behrens, Owner - Life Science Consulting

Which are the key success factors of a successful CDMO in today’s environment?

The general topics like quality and regulatory track record need to be seen as basic requirement. One of the key focus areas in CMO selection process is nowadays the reliability of supply. CMOs need to establish in a partnership with their clients a robust and reliable supply chain preventing any interruptions.

There is a contrary trend available. For simple conventional products the trend is towards fully integrated suppliers as this concept will take complexity out of the supply chain. For newer very complex products the likelihood of finding a supplier with the expertise in all required fields is very challenging and supply chains often involve various specialized services providers to manage the complexity of such projects.

How important are face-to-face meetings with your customers and suppliers and events for your business?

Face-to-face meetings and direct interaction between customers and suppliers are still one of the most important drivers for trust building and are an important part of the decision process.

Which technology trends do you see in the next 5 years and how will your company deal with them, is continuous manufacturing one of those trends?

Key trends will be the combined drug product/device combinations and the handling of insoluble substances. Continuous manufacturing for drug substances and drug product is a hot topic as it will at one hand support to establish a robust, flexible and safe process and will help to manage costs in a tough pricing environment.

Which roles play Quality by Design (QbD) and Process Analytical Technology (PAT) in your compliance system, what are the next trends in compliance?

With all the constant global issues in compliance all systems supporting a good compliance track record are at the focus of the industry. Processes like QbD and PAT supporting companies to develop safe and robust processes for their products. Smaller CMOs often missing the required skill sets here and struggling to provide the necessary support to their customers.

How can US and European competitors stay in the market and remain profitable in a general context of growing emerging markets and strong competition from Asian providers?

Over the last couple of years regulatory, quality and EHS track records getting high on pharma companies agenda. Whilst I’m a strong believer that location doesn’t mean a negative track record there is still a negative perception out on suppliers from China and India. To stay successful as a service provider you need to guarantee a good track record on the above mentioned topics. In this context US and European suppliers need to be way more focused on efficiency and high automation to overcome the disadvantage of higher labour costs.

What technology trends do you see in the dosage form area?

Beside of the obvious shift away from large batches towards small niche products the key technology focus areas are still injectable products – and here more and more linked to devices for application – and as well technologies to manage hardly soluble substances in various dosage forms. This would mean for CMOs to ideally offer access to certain tech platform or devices as an additional service.

How does your company differentiate within the highly competitive dosage form business?

Differentiation in highly competitive markets is coming via technology differentiation and value proposition to customers. Also finding a technology differentiation in competitive markets is a challenge it can be reached via niche technologies, rare batch sizes or specific technology platforms. Value proposition is over and above this and can be supplier driven or project driven and should help to answer why a specific CMO will be selected.

Where can you add value in the pharmaceutical supply chain? Management consulting, technology consulting, regulatory & compliance, product development, human resources, IP & patent consulting

By knowing CMO sales and as well procurement of CMO services a wholistic supply chain concept can be established reflecting the needs of customers and the requirements of CMOs. With the given expertise we can act as a mediator between customers and CMOs to support them in a better understanding.

What is important to provide good consulting?

Key is to understand customer requirements and to translate these into actions and solutions which can be executed. Mainly smaller companies require consultancy support without having the capacity and financial options to establish complex process and solutions.
Good consulting should offer here practical and manageable solutions.

Jean-Marie Rosset, Sales & marketing VP Global - Minakem

How do you address the increasing needs of Biotech and Pharma companies towards integrated supply solutions?

In the frame of our network both in Europe and the US, we are able to cover demands for building blocks, advanced intermediates /raw materials and APIs throughout the entire product life cycle and across various technologies. We are able to supply gram demand to hundreds of tons, non GMP – GMP. Minakem is also developing and manufacturing highly potent compounds from gram to 20 – 50 kg batch size as well as toxins for ADCs in a dedicated site with high containment capabilities.

Which are the key success factors of a successful CDMO in today’s environment?

A key success factor of a successful CDMO is its ability and flexibility to quickly respond to unexpected demand from customers. For example, a development program may suddenly require the allocation of large number of scientists, equipment and capacities.

Furthermore, it is very important for a CDMO to be fully committed to all its projects and customers. We at Minakem strive to continuously work on improving costs and efficiency by implementing new ideas, process improvements and outsourcing strategies.

Also, a CDMO must continuously implement and invest in new technologies and be able to offer all supporting activities (analytical, solid state characterization, safety, quality by design and quality assurance) as molecules and API development continue to become more complex. This is achieved by constant communication and open dialog at various levels with customers is critical with certainly more efforts to put on new customers.

Regulatory and SHE environment aspects are further increasing in complexity and this trend does not seem to stop. A hot topic these days is on the registered starting materials (RSMs). Regulations are also increasing on downstream intermediates: some starting materials considered few years ago as basic raw materials are now considered as intermediates and a grey zone remains. Some historical suppliers of these chemicals are therefore not suitable anymore and new alternative suppliers need to be identified and qualified. Closure of several chemical plants in China over the last 2 years also does not help. Potency of some intermediates and APIs impurities (genotoxic or not) are also hot subjects these days. Minakem with its different assets in Europe and the US can respond to these challenges by being fully back integrated when required.

How important is the US market to your business, and where do you see changes and challenges in the next 5 years in the US market?

The US market is of course a very important market for Minakem. Over the last decade, the US market has been very active with new innovating companies being created constantly, raising a lot of capital and developing fast. This creates a number of opportunities for CDMOs who serve a wide range of technologies and manufacturing capacities such as Minakem. At the same time, there is a high amount of M&A activity among large pharma which can be seen as a challenge as much an as opportunity for CDMOs already engaged by the acquired company as it is uncertain of the strategy that the larger pharma will employ.

Further challenges are to carry on building/adding capacities, accessing new technologies and keeping the quality requirements to respond to the increased demand of customers. For this, Minakem is committed to its CAPEX investment plan while considering further investing opportunities in the US.

How important are face-to-face meetings with your customers and suppliers and events for your business?

Relationship with the customer is key. Face to Face meetings are definitely very important with our customers as much as with our suppliers and this will never replace a conference calls or e-mails. Regular meetings, at customer facilities and on our sites, presence at major events and tradeshows, scientific presentations, publications, articles… are all necessary to meet with existing and new contacts and gain visibility as well as to be updated on the current industry trends. We also encourage our scientists to join the commercial team for some specific events and meetings.

Which technology trends do you see in the next 5 years and how will your company deal with them, is continuous manufacturing one of those trends?

Flow Chemistry has been a hot topic for a couple of years now. Minakem has invested in that area based on the long experience in flow processes within the Minafin group. Our aim is to combine flow chemistry with other emerging technologies, such as organic electrochemistry and photocatalysis. On the analytical side, there is an increasing demand on the structural elucidation and tracking of impurities; therefore, our Analytical group is constantly growing with the addition of improved technology and devices required by the higher expectations of the industry.

Beyond the USA, which growing markets do you see in the next 5 years?

The Business for Exclusive Synthesis is definitely very active in the USA, where the innovative pharma sector is booming and the pipeline of new drug candidates is large. Nevertheless, Japan and Europe markets are also very important, and for Europe the proximity is also a key player in the development of new customers.

Which roles play Quality by Design (QbD) and Process Analytical Technology (PAT) in your compliance system, what are the next trends in compliance?

QbD is integrated in our process development and scale-up activities management. It aims at increasing process understanding for process control and process improvement as well. Minakem is offering QbD risk assessment and study of processes using FMEA. We are also developing Design of Experiments, for example, to help defining the Critical Process Parameters which affect the Critical Quality Attributes. This enables us to enhance the performance, process reliability, robustness as well as impurity and quality control. We see PAT more as an additional tool in the toolbox of process control than a revolution. It often delivers its highest value in continuous processes.

Nevertheless, as regulators continue to push for greater compliance and manufacturing quality standards, QbD and PAT are increasingly important for CDMOs. We recognize this need and continuously strengthen our PAT capabilities to ensure that our products are made to the highest possible standards.

How can US and European competitors stay in the market and remain profitable in a general context of growing emerging markets and strong competition from Asian providers?

Competition from emerging markets is real, but their previous cost structure advantage has definitely become weaker following the increase demand in quality of the market as well as SHE requirements from the local authorities. Customers are looking for reliable and transparent CDMOs with high quality standards, so there is definitely a big role to be played by Europeans and North Americans.

A good way to keep profitability is to constantly invest, innovate, adapt and anticipate the needs of customers.

COMPANY PROFILE

MINAKEM is a fully integrated development and commercial manufacturer
for pharmaceutical companies

Custom development (process development and optimization)
Custom manufacturing
API manufacturing (Innovators, Generics and Highly Potent)
Production of key intermediates and building blocks

All development and manufacturing activities are supported by highly skilled R&D technical centers and strong state-of-the-art analytical services, including solid form and QbD laboratories.

MINAKEM’s talented team also ensures high-quality services in Quality Assurance, Regulatory Affairs, Safety, Health and Environment (SHE).

MINAKEM is a technology-driven company with expertise in complex multi-step synthesis, pressure chemistry, chiral synthesis, halogenation chemistry, steroid chemistry and “prazole” chemistry…

Minakem has operations in 3 different development and manufacturing sites, which are all approved by the U.S. FDA and local health agencies:

Beuvry-la-Forêt, France: R&D Center, pilot/launch plant and GMP manufacturing
Dunkirk, France: large scale API manufacturing site
Louvain-la-Neuve, Belgium: containment facility

Strong synergies within MINAKEM offer its customers the flexibility, responsiveness and cost-effectiveness paired with the strong technical know-how to create significant added value within our customers’ supply chains.

Minakem is an affiliate of the Minafin Group and as such has access to all technologies, resources, and capabilities to respond to its client’s needs, especially with Minascent technologies(Leuna, Germany), and Pennakem (Memphis, TN, USA).

www.minakem.com
Rue Fond Jean Pâques 8
1435 Mont St Guibert
Belgium

Judy Zhu, General Manager - Nanjing Dorra Pharmaceutical Technology

Which are the key success factors of a successful CDMO in today’s environment?

Apart from the so-called “hard factors” like manufacturing capacity, regulatory track record, financial strength, a broad technology toolbox, the difference among providers is made by what I call “soft factors”. We consider each CDMO project as a partnership. The objective is to enable our client to become successful with his product. Open and reliable communication is key, and for this, we form a project management team dedicated to our client’s project. Collaborating with Chinese providers involves different languages and different company cultures. To overcome communication gaps and to avoid misunderstandings, we are working with experienced advisors who have the experience of European and US CDMOs and on the other hand are able to understand our mindset. Dorra is proud to have a proven history of close and strategic collaboration with a number of renowned European CDMOs, and we have become first tier partner. It is therefore logical that we are working on increasing our activities in CDMO with Western partners.

Today, Chinese authorities, in particular environmental, have increased their scrutiny. Dorra has already and proactively invested in sustainable waste management and our sites are fully compliant. We are now dealing with the compliance of our suppliers, as the availability of raw materials which we are using to manufacture the products for our Western partners, can compromise the entire supply chain. For Western CDMOs it is therefore important to work with the right partner able to faces these challenges and to maintain the continuity of the supply chain. This is where we are investing a lot of our efforts, and so far with success.

How important is the US market to your business, and where do you see changes and challenges in the next 5 years in the US market?

The US market is the most important one at global level. Dorra has become a well-established and qualified partner of many European CDMO’s, and it is therefore logical as a next step that we engage in the US market. Moreover, our fine chemical manufacturing sites are already US FDA inspected. Our presence and visibility will increase in the near future attending several important events such as DCAT, CPhI, Chemspec and Chemoutsourcing USA.

How important are face-to-face meetings with your customers and suppliers and events for your business?

Even in the age of social media, IT and virtual reality, personal relationships between technical people, commercial people and top management are still essential. Many issues can be resolved and discussed by face to face meetings at best, of course, language skills are important. For Chinese, this means mainly English skills, but interesting jobs will also become available for people in Western Economies with Chinese (Mandarin) language skills.

But still, emerging business relationships start with personal meetings. This means that at least our travelling budgets will not be reduced because of enhanced virtual reality.

What will be key issues shaping the pharmaceutical industry in the next 3-5 years?

Harmonization of compliance levels, in particular with emerging markets, for quality, health, safety and environment.

Industry 4.0: automation, smart IT solutions in R&D and production;

Growth of biotech and genetic technologies, new treatments for ageing populations, also in emerging markets;

Shift of technology lead to China;

Will the industry be able to meet a new innovation level in 2019? (talking about the FDA approval of NCE’s)

In the pharma industry, innovation is a continuous activity, although sometimes slow in some areas; new forms of treatments are being applied using gene editing technologies, diagnostics become more accurate and drugs more specific, for example in the treatment of cancer.

In manufacturing, the pharma industry still needs to close-up with other sectors. For example, most small molecules are still produced by batch processes. Where more efficient and economic, continuous manufacturing steps will take over, process analytical technologies with real time, in situ or online measurement will render processes more accurate and safe.

So far, leader countries in manufacturing technologies have been the USA, Japan, Europe and South Korea to some extent. We expect that China will increase its role, as technology leadership is a declared objective of the actual 5-year plan, and because the government is investing heavily in new technologies.

Which technology trends do you see in the next 5 years and how will your company deal with them, is continuous manufacturing one of those trends?

Continuous processes are for sure a part of the trends in technologies, and Dorra is already applying microfluidics and continuous methods at R&D level. It is our objective to transfer continuous manufacturing into our plants in the years to come.

Our R&D Center in Taizhou (Zhejiang Province) is already operating a fully automated pilot plant, where we can efficiently and accurately run trial batches. We have started to transfer automation into our manufacturing plants, thus following Industry 4.0.

We are also evaluating other new technologies to become a leader in modern CDMO at global level.

Beyond the USA, which growing markets do you see in the next 5 years?

Mostly, emerging markets will see strong growth, China in the first line, India, countries in the Asian Pacific Rim. There are two ways, being part of the supply chain for US, European and Japanese customers, and manufacturing for domestic demand. In emerging markets, drugs need to become accessible for each patient at affordable prices.

This will need new, innovative approaches, for example for high volume products, which can again become a competitive advantage for the export business. For advanced technologies such as genetic therapies and biotech, the USA, Europe and Japan will keep the lead, but China and India closing up.

In CDMO, with more harmonization in global compliance, and the efforts of single players like Dorra, Chinese providers will see growth, although some are actually facing compliance issues. But China will remain an important provider within the global Supply Chain.

How can US and European competitors stay in the market and remain profitable in a general context of growing emerging markets and strong competition from Asian providers?

The question is not whether you are a US, European, Japanese or Chinese competitor. Rather it is the ability to deliver products at high quality level, remaining cost competitive. On the long run, each competitor needs to be innovative. In CDMO, as already explained earlier, the so-called “Soft Factors” are important differentiators such as reliability, trust, open collaboration and customer orientation.

Bill Grubb, Vice President, Global Business Development and Chief Innovation Officer - Noramco

Which are the key success factors of a successful CDMO in today’s environment?

Being responsive. Do not commit to something that you cannot deliver. Truly listen to the stated as well as unspoken customer requirements and use your expertise and experience to suggest ways to avoid a pitfall.

How important is the US market to your business, and where do you see changes and challenges in the next 5 years in the US market?

Historically and today the US market is key to our business. In the next five years we see an increasing importance for the Canadian and European markets related to Cannabinoid APIs and Clinical Programs.

How important are face-to-face meetings with your customers and suppliers and events for your business?

Meeting with a customer face-to-face to establish requirements and communicate progress is critical. So much information is conveyed through non-verbal communication regardless of native language or culture.
Additionally conveying complex concepts on a white-board in real-time is hyper-efficient compared to other.

What will be key issues shaping the pharmaceutical industry in the next 3-5 years?

Cost pressures from payers in all major markets will continue to drive all aspects of the supply chain to look for lower cost and more efficient ways to develop, manufacture, and deliver pharmaceuticals.

Beyond the USA, which growing markets do you see in the next 5 years?

The Canadian and European markets are key and critical for the Cannabinoid therapies and programs and well as an increasing focus on addiction treatment and abuse prevention globally.

How can US and European competitors stay in the market and remain profitable in a general context of growing emerging markets and strong competition from Asian providers?

To remain competitive clients and providers need to have an open dialog about development and manufacturing costs that include a total cost concept, not just a low unit cost. If a low unit cost or low development cost results in rejects, recalls, or development delays is it really “lower total cost”? The cliché “You get what you pay for frequently applies!”

COMPANY PROFILE

Noramco, headquartered in Wilmington, Delaware, is a global leader in the production of controlled substances.
The company offers cannabinoids and APIs for use in abuse deterrence, attention deficit disorder, pain management, and addiction management. We realize our success through a keen focus on commercial and operational excellence as well as continuing strategic growth. Our global footprint includes Athens, GA, Wilmington, DE and Neuhausen, Switzerland.

Specialists in controlled substance development and manufacturing, Noramco is a partner to the pharmaceutical industry:

Focusing on high-purity controlled substances
Leveraging intellectual property to devise the most efficient routes to APIs
Providing analytical data, chemical and physical properties, stability studies and regulatory assistance
Formulation friendly particle size grades and extended technical packages
Delivering DEA-compliant security and production capacity, from kilos to multi-ton supply
Supporting world-class supply security of controlled-substances, from schedule I to schedule III

Jim Mish
President & CEO
www.noramco.com

Stuart Needleman, Chief Commercial Officer - Piramal Pharma Solutions

How do you address the increasing needs of Biotech and Pharma companies towards integrated supply solutions?

Piramal Pharma Solutions, as an integrated Contract Development and Manufacturing Organization (CDMO) offers services across the entire spectrum of the drug life cycle. Our development sites are forward integrated with our commercial manufacturing sites thereby allowing us to take a molecule through clinical development and all the way to the market. We specialize in the areas of Clinical Trial Supply Management with expertise in streamlining the clinical trial packaging and supply process. Our expertise in drug development and manufacturing has resulted in over 70 successful integrated projects between discovery, drug substance, drug product and Antibody Drug Conjugation (ADC). Our sites with accreditation from US FDA, European MHRA/MPA & PMDA Japan among others offer seamlessly blend operations that address the needs of our Biotech and Pharmaceutical customers.

Which are the key success factors of a successful CDMO in today’s environment?

Pharmaceutical firms look to partner with CDMOs that exhibit a good track record – financial stability, quality, delivery and execution. With the increasing complexity of pharmaceutical industry, a CDMO’s success also depends on its ability to make flexible development model and strategies that suit a customer requirement. Piramal is a company that sees its customers’ success as the only way to nurture our own growth.

What will be key issues shaping the pharmaceutical industry in the next 3-5 years?

According to a recent report (1), the worldwide prescription drug sales are forecasted to grow at a robust 6.4% (CAGR) through 2024 to reach $1.2 trillion. With the increase in drug sales the key issues shaping the industry include ageing global population, demand for targeted and personalized medicines and fast growing therapeutic areas like oncology. The consolidation of the pharmaceutical companies in the US and its complexities is one of the crucial factors. On the other hand, with the possibility of a no-deal Brexit, the businesses need to understand what they need to prepare for. We remain optimistic that the final decision will take into consideration that our customers have business continuity and get their products on time/in full.

How important are face-to-face meetings with your customers and suppliers and events for your business?

Customer centricity continues to be our primary differentiator and our overarching approach is extremely clear: we must concentrate our efforts on meeting customers’ needs. Face-to-face meetings with the customer not only promotes healthy business but also sets out the intent of doing well and doing good that helps in strengthening our relationship. Our partners always rate us high for accessibility to senior management. Our team attends various tradeshows and conferences round the year where we engage with customers regarding on-going projects and understand their new requirements.

We organize supplier meets every year where we align expectations and business outlook with our key suppliers. We are here to make our customers succeed by getting medicines to patients rapidly and cost effectively.

Beyond the USA, which growing markets do you see in the next 5 years?

Piramal has a versatile, fully integrated network of development and manufacturing sites across North America, Europe, and Asia. The US is one of our fastest growing markets while we also serve a growing number of customers in countries of Europe, Asia Pacific and Latin America. Pharmerging markets like India, China, Brazil, South Africa, Australia, Taiwan and New-Zealand are witnessing a steady growth.

What technology trends do you see in the dosage form area?

Organizations pursue strategies to extend adult to paediatric dosage forms like minitablets, dispersible tablets for life cycle extension of existing molecule which offer added 6 months exclusivity. Variability and toxicity of the new NCE’s is minimized by upgrading technology from the monolithic controlled release dosage to multi-particulate system (i.e. pellets in tablets/capsules). Most NCE’s pose challenge of poor aqueous solubility hindering drug absorption, so solubilisation techniques viz. using spray drying, hot melt extrusion, nanonization, modulating pH microenvironment, use of surfactants in dosage form etc. are being utilized in the dosage form design. The technological revolution of moving from traditional one-size-fits-all to personalized medicines using - solid dosage pens, 3D printing is being discussed frequently in large pharmaceutical forums.

How does your company differentiate within the highly competitive dosage form business?

Our USFDA and UK MHRA accredited manufacturing sites in Morpeth, UK and Pithampur, India offer a wide spectrum of manufacturing options for oral solids. We manufacture a wide range of oral solids ranging from conventional tablets, modified release formulations, press coated tablets, hard gelatine capsules etc. We specialize in hormonal formulations that are manufactured in a dedicated and segregated suite at our Morpeth site. In addition, our site in Ahmedabad, India is a centre of excellence for development of solid orals having developed over 200 formulations including complex formulations. This site is forward integrated with our commercial sites for tech transfer.

Sources

Evaluate Pharma^® - World Preview 2018, Outlook to 2024

Robert Hagopian, Director, Business Development - PolyPeptide Group

We are pleased to announce that the PolyPeptide Group is committed to serving the personalized medicine market. PolyPeptide has completed the necessary investments in equipment and infrastructure for this particular field and is in the process of completing several contracts with Biotech companies that are leading this field.

How important is the US market to your business, and where do you see changes and challenges in the next 5 years in the US market?

The US market has been growing steadily for the past several years. We anticipate the trend to continue in 2019. It is difficult to predict the future as this would depend on the general economic health of the US and global market.

How important are face-to-face meetings with your customers and suppliers and events for your business?

While email is today’s predominant approach to communication, it does not substitute the overall efficiency of an “old fashioned” one on one call, or a face to face meeting with a client or a supplier. Meeting the client is essential in building a sustainable longer term relationship.

Beyond the USA, which growing markets do you see in the next 5 years?

As a global organization, PolyPeptide anticipates growth for our products in the Japanese and other South Eastern Asian countries.

How can US and European competitors stay in the market and remain profitable in a general context of growing emerging markets and strong competition from Asian providers?

At PolyPeptide our goal is to build strong and sustainable relationships with our existing and new clients. We aim at doing so by providing a consistently high quality product, and by relentlessly improving our production efficiency so we may maintain our costs low and offer value to our clients.

Which markets will gain more importance for your company in the next 5 years?

PolyPeptide anticipates the personalized medicine market to become a more important part of our ongoing business.

Richard Sidwell, Vice President and Chief Scientific Officer - Recro Gainesville

Which are the key success factors of a successful CDMO in today’s environment?

The number one key to success for a CDMO remains the ability to establish a good working relationship with their clients. Businesses have different cultures and styles, and a clash of communication style or expectations could have a negative impact on your project. Free exchange of information and ideas is crucial to the success of any team. When the project team spans different companies, as in a sponsor-CDMO relationship, any inter-company tension undermines that free exchange, and creates risk of misunderstanding and violated expectations. CDMOs must take ownership of this process to make the relationship work smoothly. This means being flexible, quick, open, and clear in interactions with clients. It also means working hard to listen carefully and seek to understand and accommodate both the client’s real needs and their preferred ways of working, even when they may not be clearly articulated.

How important is the US market to your business, and where do you see changes and challenges in the next 5 years in the US market?

The US market remains extremely important to our business. The main challenges continue to be the balance between being thorough and being fast. This is particularly true in relation to ex-US competitors, as the industry sponsors seek the right amount of speed, cost, and compliance at each phase of development.

How important are face-to-face meetings with your customers and suppliers and events for your business?

The importance of face-to-face meetings depends heavily on the type of project. Face-to-face meetings with suppliers of off-the-shelf materials, consumables, or equipment may not be necessary. Once projects begin to involve a significant amount of input from both sides, for example, in formulation development, clinical supply or regulatory strategy, face-to-face meetings become extremely valuable. Not only do these meetings help establish rapport within the team, they provide a better communication bandwidth, allowing deeper and more efficient understanding that is crucial to complex planning and decision-making. The recent advances in easy-to-use and high quality videoconferencing have dramatically closed the gap between teleconferences and being in-person. Video is now a viable alternative to “being there” for many more meetings.

What will be key issues shaping the pharmaceutical industry in the next 3-5 years?

Key issues shaping the pharmaceutical industry in the next 3-5 years, as always, are economic conditions, regulatory expectations, and the continued political focus on the cost of pharmaceuticals in the US. Money availability for investment in new products is still strong, but many people are beginning to be concerned that a recession, while not imminent, is on the horizon.

At the same time, the industry is caught between political pressure to lower prices, and regulatory pressure to invest even more time and effort in thorough development.

Over time, these forces will drive companies to seek increased efficiency through automation, and to keep capital investment at arms-length whenever possible. In the short term, this should mean continued growth in outsourcing both development and manufacturing.

What technology trends do you see in the dosage form area?

The main technology trends I see right now would be automation (especially laboratory and data automation), bioavailability enhancement, and solubility enhancement. Modified-release, high potency, abuse-deterrent, and fixed-dose combination products also see continued interest.

Continuous manufacturing and material handling automation, while rapidly advancing in other industries, seem to be longer term trends for the pharmaceutical industry. Continuous manufacturing technology will eventually also drive further use of process analytical technology (PAT). For now, the start-up cost and time, and perceived lack of flexibility of the current continuous manufacturing technology is still hindering wide adoption.

Which markets will gain more importance for your company in the next 5 years?

I expect that in terms of global markets there will not be a major shift over the next 5 years. Instead the shift will be more and more towards outsourcing opportunities from small, early phase, pharmaceutical companies.

How does your company differentiate within the highly competitive dosage form business?

Recro Gainesville is an uncommon blend of start-to-finish capabilities within the small to mid-sized CDMO market. We are small enough to give concierge level attention to our clients, but we also provide services from preformulation, formulation and analytical development all the way to fully cGMP commercial manufacturing.

COMPANY PROFILE

Recro Gainesville is a Georgia-based CDMO providing solid dosage form product development, clinical and commercial manufacturing, packaging, and logistics services to the global pharmaceutical market. Specializing in extended release solid dose and DEA controlled substances, Recro has the experts to deliver clients’ most complex pharmaceutical development and manufacturing projects.

Recro Gainesville demonstrates continued growth, most recently adding a 24,000 square foot facility near its existing 97,000 square foot contract pharmaceutical development and manufacturing plant in Gainesville, GA. In addition to increasing capacity for development through Phase IIb clinical trial material (CTM) manufacturing, the space offers a specialized footprint for commercial manufacturing of high-potency compounds. The newly added square footage allows for early feasibility studies, enabling clients to determine the leading formulation candidates at laboratory scale and subsequently scale-up to GMP manufacturing of CTMs.

The Recro Gainesville team prides itself on being pioneers in the development of extended release technology. Recro is one of the few CDMOs capable of taking delayed release, sustained release, or combination release products from development though commercialization and also leverages in-house experts to offer regulatory guidance and consultation – hence, nurturing a “Start with Recro. Stay with Recro” approach with clients. Furthermore, Recro supports continued product innovation through reformulation, extending patent protection and expanding revenue opportunities for its clients.

Recro Gainesville is a wholly owned subsidiary of Recro Pharma, Inc. For more information about Recro’s flexible CDMO solutions, visit www.recrogainesville.com.

Recro Gainesville
1300 Gould Drive, Gainesville, GA 30504
Phone: 770-534-8239
BusinessDevelopment@recroCDMO.com
www.recrogainesville.com

Stuart Levy, Principal - SGL Chemistry Consulting

How do you address the increasing needs of Biotech and Pharma companies towards integrated supply solutions?

As a technical strategic consultant providing expertise to entrepreneurial startup companies, a multi-pronged approach is needed. Even in early development, at least some raw and starting materials are not available in sufficient quantities, if at all, as catalog items, and they need to be custom-produced. Sources of materials need to be identified and secured in the short-term. Longer term, an assessment needs to be made, regarding the API manufacturing route. Which steps will be conserved and remain as-is, in mid to late-stage development? The final steps of an API manufacturing process tend to remain fixed, and the earlier steps are more likely to be modified. This determines the strategy for the supply chain, beyond early clinical API supply.

Which are the key success factors of a successful CDMO in today’s environment?

1) Flexibility – ability to serve evolving and changing needs of programs that come from entrepreneurial pharmaceutical companies. This includes accommodation of aggressive timelines, changes in priorities, focus, and volume, the involvement of new partners, licensees and purchasers of the asset that has been placed with the vendor.
2) Breadth of services – API manufacturers stay competitive by offering services that customers need, such as those that facilitate and support the transition to drug product development and manufacturing, e.g., solid state chemistry and preformulation activities. The ability to develop and produce multiple potential forms of a small molecule API (e.g., salts, cocrystals, and amorphous dispersions) reduces the need to seek multiple providers. 3) Focus – This argues for balance and against being spread too thin in the quest to expand offerings to customers. Vendors need to continue to stress core competencies and assure that they remain predominant performers in what they are known to do well. Any services added need to be offered and performed in this spirit and at this high level, without compromising and/or diluting existing areas of excellence, for which a given vendor has established their reputation.

How important is the US market to your business, and where do you see changes and challenges in the next 5 years in the US market?

The US market is 100% of my current business. I see challenges to vendors in the US market over the next 5 years as follows: 1) Vendors in Asia that are expanding their offerings and attempting to be one-stop CMC shops, 2) Cost and timeline pressures due to competition from Asian vendors that undercut US costs and timelines (without necessarily providing the same quality of results or strength of performance), 3) Consolidation – less competition, increasing prices, less leverage for small company customers, less nimbleness and flexibility.

How important are face-to-face meetings with your customers and suppliers and events for your business?

Face to face meetings are critical – things are discussed and shared that would not be addressed via email, tcons or on the telephone. There is a crucial personal dimension to the relationships between sponsors and vendors that is only forged and deepened in in-person meetings.

Which technology trends do you see in the next 5 years and how will your company deal with them, is continuous manufacturing one of those trends?

Continuing trends are increased use of continuous manufacturing and flow chemistry in chemical development and API manufacturing, increased use of DoE to solve development and manufacturing problems in both batch and continuous operating modes, continued integration of low-cost equipment fabrication, PAT/real-time process analysis and control, statistical analysis of experiments and manufacturing campaigns – data rich PR&D and manufacturing, which will accelerate development timelines.

Beyond the USA, which growing markets do you see in the next 5 years?

China, India, South America

How can US and European competitors stay in the market and remain profitable in a general context of growing emerging markets and strong competition from Asian providers?

Continue to do work that has high quality and value; expand offerings to accommodate customer needs without diluting existing core capabilities; Maintain a track record of consistent success and performance for customers.

Injectables are an area with a high growth rate, but also with an increasing complexity from a regulatory point of view – e.g. medical device products – how do you address these challenges?

Increase in the use of solid amorphous dispersions and other solubility-enhancing technologies to produce nanoparticulate suspensions, DP intermediates for poorly soluble and/or permeable small molecule drug candidates; use of bulk non-aqueous organic liquid based oral formulations – gel caps, soft gels, etc; Use of in silico methods to address increasing number of small molecule drug candidates that are poorly soluble and/or poorly permeable.

What is the role of an agent/trader in the today’s global pharmaceutical industry (generics, contract manufacturing)?

Valuable agents have exclusive arrangements with portfolio companies that are “under the radar,” and that provide transparent, equitable partnership opportunities with their customers.

Where can you add value to the pharmaceutical supply chain for your principals and for your customers?

Leading R&D to find innovative, economical solutions to bottlenecks in supply; role in development of practical, scalable processes for raw and starting materials, as well as APIs; Continually monitor the vendor landscape to make sure I can continue to excel at matching my clients’ needs with the most appropriate, capable vendors.

What are the challenges for your business in times of internet, datarooms, clouds and emerging markets?

Datarooms are still not yet sufficiently functional or navigable – the data is still fragmented and poorly organized, or not available. Need better control over access, editing, population, updating, etc. That said, datarooms are the solution for large documents, to ensure security of information and data, and controlling access to project information.

In which area is your company involved?

Technical/strategic chemistry and CMC consulting, vendor evaluation, selection, engagement and management, technical problem solving, CMC plans and strategies, technical, quality and regulatory risk management, due diligence evaluations for in-licensing opportunities, expert witnessing for chemical process patent infringement cases.

What is important to provide good consulting?

Transparency, timeliness, responsiveness, good listening to client and understanding of client’s needs, ability to persuade, presentation of multiple strategic options from which clients choose, from POV of risk management.

How can you stay informed and involved in the very dynamic landscape of the pharmaceutical industry?

Maintain regular contact with network of vendors operating in my areas of specialty, stay in touch with peers, attend trade shows and relevant symposia, and continue to do meaningful, challenging work in my field.

Pedro Couto Rosado, Director Business Development - SK biotek

How do you address the increasing needs of Biotech and Pharma companies towards integrated supply solutions?

We do see Pharma, particularly Biotechs aspiring to work with innovative and highly-qualified CDMOs offering integrated services from chemistry to formulation development and ultimately reliable manufacturing.
Aligned with this trend:
- SK biotek in Swords, Ireland, is developing its capabilities in Particle Engineering and Solid State Science to enable full support to pre-formulation studies.
- The SK group holding company is actively evaluating options to potentially add drug product development and manufacturing capabilities at a global level.

Personalized medicines will further promote the fast growing diversity of small volume drugs. Such is observed at the record number of NMEs approved by FDA in 2018 (59), the weight of orphan indications (60%) and lastly the increasing potency of drugs.
“On request” supplies based on short campaigns will become the norm, which together with fast emerging new markets will drive the need of a challenging totally new paradigm: mobility of GMP manufacturing units.
For such scenario, SK biotek is extremely well positioned with its extensive experience of +20 years in multipurpose continuous manufacturing, with both a powerful in-house engineering capability and an highly reliable GMP operation.

Which are the key success factors of a successful CDMO in today’s environment?

The current environment of fast growing challenges at development of NMEs, additionally drives in our view the need for new relationship models between Pharma – small and large – and CDMOs.
The traditional “fee for service” is hardly the best solution to handle increasing business risks. And more importantly, it stifles innovation power!
To unlock such value both parties will require a far greater relationship intimacy incentivised by models where risks and benefits are shared (e.g. sharing equity or assets, success and penalty fees, royalties, etc.)

Which trends do you see from Biotech vs. Pharma companies in their request for services and products – where is the industry heading? Single Services and multiple providers vs fully integrated providers?

Reliable integrated CDMOs is naturally of interest to Biotechs. But also of increasing of value to large Pharma as these focus progressively on efficiently discovering and marketing new molecules and treatments.
Pharma will look for agile and fully reliable integrated CDMOs continuously assuring access to the latest scientific and know-how.
CDMOs will in future probably also support toxicological and clinical trials, taking Pharma’s lead molecules through all process and formulation development up to commercial manufacturing of the final dosage form.

What will be key issues shaping the pharmaceutical industry in the next 3-5 years?

Growing Economic Development and Demographics:
- Successful populated emerging countries will increase global access to medicines and ageing population worldwide will further drive the growth;
New Chemical Entities are increasingly becoming more targeted:
- Complexity and potency of molecules will be multiplied fostering innovative and agile manufacturing technologies;
Compliance:
- The regulatory bar will continue to raise and will determine increased cost challenges to assure compliance. Same will occur with Sustainability requirements.

Which technology trends do you see in the next 5 years and how will your company deal with them, is continuous manufacturing one of those trends?

To address growing trends, both SK biotek in Ireland and in Korea, as well as the recently joined sister company Ampac Fine Chemicals in USA, are able to offer – today - the best of:
- Safe manufacturing – under continuous monitoring - of high potent compounds down to OEL of
10ng/m³;
- cGMP compliant continuous manufacturing of challenging and/or large volume compounds, particularly benefiting from SK biotek’s leading role in this technology for over 20 years;

Which roles play Quality by Design (QbD) and Process Analytical Technology (PAT) in your compliance system, what are the next trends in compliance?

Both QbD and PAT have a crucial role in SK biotek’s value proposition to ultimately achieve optimal manufacturing processes based on increased understanding science and technology.
PAT is - and will be - of particular increasing relevance at SK biotek to support efficient development of well controlled continuous manufacturing processes.

How can US and European competitors stay in the market and remain profitable in a general context of growing emerging markets and strong competition from Asian providers?

As mentioned earlier, key for continuing success will be establishing intimate and mutually beneficial relationships between CDMOs and Pharma.
This includes the very fast growing need for full alignment with Sustainability goals of the United Nations as this will become a key requirement to operate any Industry in our planet.

COMPANY PROFILE

SK biotek (CDMO) specializes in the manufacture of cGMP API and Intermediate via Advanced Synthesis, Continuous Processing and HPAPI for global pharmaceutical companies.

Our state-of-the-art facility in Swords, Dublin has been the launch and manufacturing site for some of the world’s leading therapeutics for >50 years. With exceptional technical capabilities and extensive experience in custom development from clinical phases to commercial launch and scale-up for products.

We offer multi-scale plants (grams–100skgs) capable of handling material with OEL ≤1 µg/m³. Swords hosts a fully integrated facility capable of handling material with OEL ≤10ng/m³for highly potent compounds. This integrated facility combines manufacturing plants, R&D and QC laboratories within the same building. With a strong safety compliance policy and adherence to high-quality standards, Swords is a renowned supplier of HPAPIs.

AMPAC Fine Chemicals (AFC) became an SK Company in 2018, expanding manufacturing footprint to the US. SK biotek and AFC are subsidiaries of the Korean conglomerate SK.

AFC is a custom manufacturer of APIs and Intermediates for >75 years, specializing in process development, scale-up, and cGMP compliant production from kilos to multi-ton.

Combined the companies have >1000m³ of capacity globally. This creates substantial market synergies by combining highly complementary assets and expertise, further enabling us to provide the highest-quality services to our customers.

Our plants in Korea are a leading supplier of late phase and commercial pharmaceutical materials using continuous processing. Continuous Flow Processing has many advantages over traditional batch processing. It is not just greener, highly efficient, cost effective and regulatory supported; also has the capability to achieve low and high temperature, hazardous, high-pressure and catalytic reactions.

SK commits to work with you and stand over your product as if it were our own.

Pedro Couto Rosado
Director Business Development
SK biotek
eMail: pedro.coutorosado@sk.com

Dix Weaver, President - Weavchem LLC

Which are the key success factors of a successful CDMO in today’s environment?

While CDMO’s bring needed manufacturing capacity to smaller “virtual” biotech with few or no internal assets, and the CDMO’s can help larger innovators manage capital investment risks for the uncertainty of launch, it is even more critical for CDMO’s to bring innovative solutions to the customer during development and launch. This includes state-of-the art technologies for DS and DP development and support for regulatory submissions. The client and CDMO must have clear expectations for the business arrangement, either sharing the risk of development costs and the rewards of a successful product, or the expectation that the client will pay the full cost of the CDMO’s services.

The apparent limited CDMO capacity for development and manufacturing of large molecules, along with new, specialized technologies, results in contractual arrangements in which the client faces longer lead times to get a slot in the CDMOs’ development and manufacturing resources. This leads to higher fees for postponement and cancellation of the commitments for these slots than those typical of small molecules. Relationships, communication, and transparency are critical. Integration is improving, but not yet optimized.

How important are face-to-face meetings with your customers and suppliers and events for your business?

Electronic tools like videoconferencing, WebEx, Skype, emails, etc., assist everyone trying “do more with less”. But try to remember your first important meeting with a customer or client. Exchanging business cards, small talk about your “life outside work” and sharing the challenges in our jobs start the relationship. Time and travel constraints limit these opportunities, but when there are critical topics to discuss, nothing replaces the face-to-face time with those important to our success. It’s easy to hide off screen and not discuss difficult topics, but the time and handshake leave both parties feeling much better than clicking a button to end a call.

What will be key issues shaping the pharmaceutical industry in the next 3-5 years?

The challenge of providing affordable healthcare globally for unmet clinical needs rises exponentially as complex innovative medicines are developed. Many therapies address smaller populations of patients, while some offering hope for large populations (i.e. Alzheimer’s) will challenge global health care reimbursement resources. Innovators must be rewarded so they continue addressing these challenges.

How can US and European competitors stay in the market and remain profitable in a general context of growing emerging markets and strong competition from Asian providers?

We must balance our sourcing strategies with the pressure on costs and speed during development. Emerging country CDMO’s with “limitless” capacity and people may offer access to more resources faster. While exchange rates for Western CDMO’s have improved, there likely will always be some cost advantage for the emerging CDMO’s. However, when the total cost and effort in managing the development and manufacturing process is considered, the balance shifts back towards the West, especially for smaller biotech companies with limited resources. Often a geographic mix of CDMO’s will help minimize the risk and cost to your pipeline, allowing you to leverage the advantages of global CDMO’s.

For commercial supply, a similar global approach can allow you to balance cost, capacity, currency, and other factors for a secure supply chain.

What is the role of an agent/trader in the today’s global pharmaceutical industry (generics, contract manufacturing)?

In the “early days” procurement might provide “grocery lists” of chemicals to traders/ agents who sourced materials, conducted diligence, negotiated pricing (with varying transparently), arranged logistics and payments, and managed communications. Buyers would store boxes of company brochures to “profile” the capabilities. Few pharma companies saw the value for developing procurement careers to maintain these internal skills.

Today, CDMO profiles are on the Web. Sourcing databases and websites are available. CDMO’s in non-English speaking countries have salespeople fluent in English and experience in Western business practices. Still you may need “feet on the ground” in distant countries for: diligence, negotiations, pre-payment, export, currency exchange, and logistics. Today’s agent/trader/consultant can add value in most facets of the supply chain, allowing internal procurement to focus on supply risk.

Where can you add value to the pharmaceutical supply chain for your principals and for your customers?

Many biotech companies are focused on the chemistry (CMC), clinical, and regulatory aspects of getting their products to market quickly. Some in pharma can’t justify full time procurement as supply chain needs vary throughout the life cycle. On an “as needed” basis, the agent/trader/consultant can step in with extensive experience and connections on a global basis to help with supplier selection, negotiation, logistics, contracts, and communications. Quite often, due to a lack of experience or time, the wrong people in pharma organizations negotiate and contract with CDMO’s, only to find that risks and legal issues were created. The impartial assistance of an external supply chain expert can allow others to focus on their areas of expertise and prevent long-term risks and unnecessary costs.

What is important to provide good consulting?

While it seems easy to do a quick Web search, connect with a CDMO, and commit (often without a proper agreement), it is more difficult and time consuming to fix the resulting problems when the product or service is delayed, costs changed, or the quality wasn’t right. An experienced consultant will have dealt with nearly every imaginable scenario and can proactively follow a proven process for on-time and on-spec deliverables. Having expansive connection with top global CDMO’s brings credibility to the client and a lower risk supply chain throughout the life cycle.

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Panel Discussion on Pharma and Chemical Supply Chain

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