CENK ÜNDEY
Head of Data and Digital, Pharmaceutical Technical Development Genentech, Roche, South San Francisco

Abstract

Digital innovation is a critical enabler for advancing a molecule in the pipeline to make it into a product. Right way of capturing data by using FAIR principles is one of the key requirements to ensure seamless data flow and enable other advanced applications such as machine learning and computational modeling across the value chain. These then enable speed to patients, efficiency in operations with increased productivity and support robust design. We are also focusing on establishing the digital mindset across our organization. We have provided examples using machine learning and computational modeling taking technical development to the next level using digital innovation.

ON THE CONVERGENCE OF BIOTECH AND TECHNOLOGY REVOLUTIONS
Since the discovery and introduction of first biopharmaceuticals in late 70s to early 80s, the biopharmaceutical industry has come a long way with many life-changing medicines available to patients. From insulin to recombinant proteins, then to monoclonal antibodies as dominant modalities, we are seeing more cell and gene therapies and other novel modalities coming to the mainstream. While the various modalities are being advanced, in parallel we also see advances in different and more intensified with reduced manufacturing footprint biopharmaceutical manufacturing/processing formats such as single-use technologies and continuous manufacturing. Of these developments, we have been experiencing the proliferation of data generation during the technical development and manufacturing of medicines. In the world of technology, we have witnessed the Industry 4.0 revolution (with 5th revolution is around the corner). This involved connected cyber and physical systems, a boom in industrial internet of things and sensory networks towards enabling Smart Manufacturing concepts harnessing the power of artificial ...