MARK LANE1, RAMI SCHARF2
1. Vice President of Development Consulting and Scientific Affairs, PharmaLex, Mannheim, Germany
2. Senior Director Development Consulting and Scientific Affairs, PharmaLex, Mannheim, Germany

Abstract

Competition, complex new science and regulatory changes have been compounded by economic tightening. In 2023 and beyond, smaller biopharma companies in particular will need to rethink their strategies to attract investors, carefully plan how and with whom they outsource and ensure they understand the finer nuances of the regulations when they seek to globalize. Mark Lane and Rami Scharf of PharmaLex describe the challenges ahead.

The demands on life sciences companies are constantly intensifying. Resource constraints – whether workforce or the need to cut costs or streamline processes – different global regulatory requirements and the need to stay on top of technology advances create an increasingly complex environment for the industry.

Pressure to move faster and operate more efficiently is coming from all sides – from the regulators, from innovation by competitors and from investors. There are many exciting developments in the pipeline, but there are also many considerations to balance if companies are to succeed. As industry looks for new breakthroughs and opportunities, there are several key trends that will need to be top of mind in 2023.

ATTRACTING INVESTORS WITH SMART DRUG DEVELOPMENT
For small innovator companies, getting funding for a therapeutic or diagnostic target is proving difficult. Indeed, the current fundraising climate is among the most challenging in recent memory. While attracting investors has long been an issue, a tougher economic environment combined with heightened competition in novel areas of science and ...