Developing Competitive Biologics Products Necessitates Combining Formulation Design, Process Development, and Device Integration

Nandini Kashyap of Cambridge Healthtech Institute recently spoke with Dr. Yatin Gokarn of Sanofi about Developing Competitive Biologics and where the industry is headed in coming years. Dr. Gokarn is the keynote speaker at the 5th Annual Overcoming Formulation Challenges for Biopharmaceutical Development which is taking place from August 21-22, 2017 in Boston, MA where he will be delivering his talk on “Developing Competitive Biologics Products Necessitates Combining Formulation Design, Process Development, and Device Integration”. This conference is being organized as part of the 9th Annual The Bioprocessing Summit which runs from August 21-25, 2017 in Boston, MA.

KEYNOTE PRESENTATION:

Yatin_Gokarn Yatin Gokarn, Ph.D., Head, Global Pharmaceutical Development Biologics, Sanofi Genzyme

There is an increasing need for designing and developing competitive biologics drug products in biotherapeutics marketplace when many new modalities and new product formats are making their way to market and many promising leads continue to fill the research and development pipelines. A competitive patient-centric product necessitates a holistic product development strategy that takes into consideration formulation design, process development, analytics and device integration.

1. Can you tell us about yourself and about your role?

I recently joined Sanofi as Head of Global Pharmaceutical Development Biologics responsible for end-to-end Drug Product development of the Sanofi biologics portfolio. It is an exciting time at Sanofi where we are leveraging our global footprint and recent successes in the Biologics area to continue building a world-class end-to-end, integrated biologics organization - from DNA to dosage form. We collaborate with our Research organization to enable the selection of candidates with optimal ‘drugability’ properties, employ ‘speed to clinic’ platforms, and then develop commercially competitive dosage forms by collaborating with our device development, commercial & manufacturing organizations.

2. What are some current big trends in biologics research & development and commercialization?

One of the key trends particularly for biologics is that there will continued focus on developing patient-centric dosage forms to enhance patient convenience and compliance, which necessitates a holistic, and integrated product development strategy. Another important focus area is increasing the speed of CMC development as well as reducing cost-of-goods of the Biologics products we produce.

3. Where is the biologic market and R&D headed in next 5 years?

I believe antibody based therapeutics will continue to grow and continue to be established a dominant modality for treating disease. Multi-specific and other novel formats are fast emerging to exploit simultaneous targeting of multiple disease pathways with a single agent. Other exciting emerging/re-emerging areas are that of cell-based and gene therapies

4. What are the major challenges in bringing new biologics to market and what is your advice to people working in this area?

Developing high quality products & implementable innovative technologies are critical for success in CMC development. A focus on applied science & technology and collaboration to enhance product quality, increase speed, and reduce cost-of-goods – better, faster, cheaper! is essential. Have a collaborative and translational science mindset,

5. Why have you chosen to speak at the 5th Annual Overcoming Formulation Challenges for Biopharmaceutical Development conference? What are you looking forward to at this conference?

Bioprocessing summit is a unique, high-quality conference that is focused on highlighting innovative science, and CMC challenges/trends in our biopharmaceutical industry. I have been part of the Bioprocessing Summit in preceding years either as a speaker or as an attendee. I always learn something new and novel at this conference.