Dr Akshay Goel | Senior Vice President - R&D
Biological E Ltd | India

Dr Akshay Goel, Senior Vice President - R&D, Biological E Ltd

Dr. Goel is a passionate vaccinologist, and has been involved with process development, clinical and commercial manufacturing, and quality interface for commercialization of several vaccine candidates in both US and India over the past 22 years. Dr. Goel is passionate about rapid development and commercialization of high-quality affordable vaccines for global use.

Dr. Goel is currently leading the process development and clinical manufacturing activities for several pipeline vaccine products at Biological E. Hyderabad. Prior to joining the Biological E., Dr. Goel was the Chief Scientific Officer (CSO) at MSD Wellcome Trust Hilleman Labs in Delhi (2010-2012). This first of its kind JV has been setup by Merck and Company (a global US based pharmaceutical giant) and the Wellcome Trust (a UK based global charity).

Dr. Goel served as Director, new vaccines, Serum Institute of India (2005-2010). He had a leadership role in the development and launch of the Meningococcal A conjugate vaccine (MenAfriVac), a PATH funded project with a specific goal of eliminating epidemic meningitis as a public health problem in Sub-Saharan Africa through the development, testing, licensure, and widespread use of an affordable conjugate meningococcal vaccine. His portfolio at Serum also included technology transfer, process development, process validation, clinical and commercial manufacturing, NRA registration and WHO prequalification of Hib conjugate vaccine.

Before returning to India in 2005, Dr. Goel worked at Baxter and Pfizer in US. As a part of Pfizer Global Manufacturing in Kalamazoo MI (2003-2005), he successfully led the legacy process revalidation effort of approximately fifty products, which was the root cause of a US-FDA warning letter. As a part of the Baxter BioScience Vaccines Strategic Business Unit at Beltsville, MD (1996-2003), he was involved with the rapid development and launch of a Meningococcal C conjugate Vaccine.

Dr. Goel graduated with a B.Tech in Chemical Engineering from Indian Institute of Technology Kanpur in 1990. He completed his PhD in Biochemical Engineering from University of Pittsburgh (US) in 1995, and did a post-doctoral assignment at University of Maryland, Baltimore. He has over 30 publications. Dr. Goel also has a Bachelor’s degree in music (percussion) and enjoys fishing and gardening.

Appearances:



Conference Day 1 @ 14:20

Sustainability of Vaccines Industry: Coping with pricing pressures

India is supplying more than 60% of the vaccines procured by GAVI. Vaccines in the public market are older and mass manufactured. Due to the cost of production, new vaccines are not able to enter the market. Should local vaccine manufacturers focus on ensuring cheap production of old vaccines for the public market or should they develop new vaccines for their private market instead? This session will explore differences between public & private markets, together with strategies for navigating the public market.
  • Comparing the differences between public and private market in terms of development and production cost
  • Understanding the differences in demands for both markets
  • What are some challenges that are unique to the public market? (E.g. Price pressures from GAVI, WHO)
  • Explore strategies in overcoming these challenges to achieve a sustainable model

Conference Day 2 @ 14:10

Scaling up Vaccine Production: Process Validation

  • Demystifying process validation
  • Process validation deliverables
  • Application in vaccine industry: Post Approval change
  • Application in Pharma industry: Warning letter

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