Development of biopharmaceuticals: How challenges can be smartly addressed or even transformed into opportunities and value creation?

Euromeeting DIA, Hamburg, 6 – 8 April 2016

Dr Diane Seimetz, Co-Founder of Biopharma Excellence, chaired the session “challenges & opportunities in the clinical development of biopharmaceuticals” at the DIA Euromeeting in April 2016.

Biopharmaceuticals already account for about half of the drugs now in the biopharmaceutical R&D pipeline, with that share expected to grow. Compared to small molecules biopharmaceuticals are more demanding to develop. Due to complexity of the manufacturing process, the cost of goods are substantially higher.

Regulatory requirements as well as expectations of health technology assessment bodies have increased, resulting in a prolonged time to market and shorter in-patent sales.

Therefore it is important to have tools in hand to accelerate the development, handle challenges effectively and to benefit from the changing regulatory environment.

Based on real life examples Dr Diane Seimetz discussed challenges faced in early and late stage clinical development, during the authorization phase and life cycle management. Clear recommendations were provided how challenges can be effectively addressed, prevented or even transformed into opportunities and value creation. The regulatory initiatives PRIME (priority medicines) and adaptive pathways are important to foster product development and accelerate time to market.

Dr Nikolai Brun, Vice President Drug Development, Serodus, Norway was providing the industry perspective on today’s challenges and opportunities in biopharmaceutical development. Based on a presented case study of a monoclonal antibody he outlined important differences between the EU and US system at the time of development, approval and for reimbursement. These differences stimulate discussions and call for changes.

Dr Jan Mueller-Berghaus, co-opted member of the CHMP, provided the agency perspective on the future paradigm of an integrated clinical development for biopharmaceuticals including answers to the question: What will be expected for approval and beyond? The concept of adaptive pathways will allow agencies to address uncertainties such as related to efficacy and effectiveness in much more proactive and phased approach. The PRIME initiative aims to enhance early dialogue of involved stakeholder to accelerate assessment of priority medicines.