Today's Pharmaceutical and Biotechnology Landscape:
Looking to Process Development and Manufacturing for Answers

Do you know what really drives your business? The answers may surprise you. In a Q&A format moderated by Deb Goldfarb, Vice President of Life Sciences at IDC, Dr. Justin Neway and Dr. G.K. Raju examine the changing pharmaceutical and biotechnology market, and explain how process development and manufacturing hold the answers to some of the industry’s leading challenges, including:

• Operating to new quality and efficiency standards
  • Pricing pressures
  • Generics
  • Expiring patents
• Deriving full value from existing manufacturing investments
• The effect of mergers on manufacturing operations
• The FDA’s Process Analytical Technology (PAT) initiative
• Addressing the barriers to executing compliance initiatives.

Click here to view the archived webinar!

About the Panelists:

Dr. Justin Neway, Ph.D., is the Executive Vice President and Chief Science Officer of Aegis Analytical Corporation, a company providing enterprise software and services for pharmaceutical and biotechnology companies.

Dr. Neway draws on over 20 years of experience in pharmaceutical and biotechnology manufacturing, and in the development and application of software solutions to quality compliance and operational efficiency in manufacturing. Dr. Neway was formerly the Director of Fermentation Development at Somatogen, a biotechnology manufacturer later acquired by Baxter, where he was the project leader for a collaborative project with Eli Lilly to develop a large-scale fermentation process and production facility for manufacturing recombinant hemoglobin. He also led a team effort to develop a computer and software system for retrospective analysis of manufacturing and process development data.

Dr. Neway holds both a B.Sc. in Microbiology and a M.Sc. in Biochemistry from the University of Calgary, along with a Ph.D. in Biochemistry from the University of Illinois.

Dr. G.K. Raju, Ph.D., is Chairman and CEO of Light Pharma Incorporated—a consulting and technology company focused on pharmaceutical manufacturing.

Dr. Raju has worked with or consulted for many brand name pharmaceutical companies. His expertise is in defining the strategic role of pharmaceutical development and manufacturing and enabling its performance within the pharmaceutical and biotechnology industry.

Dr. Raju is also Executive Director of the Pharmaceutical Manufacturing Initiative at MIT and Adjunct Professor of Industrial Pharmacy at Purdue University. He serves as the Executive Director of the Consortium for the Advancement of Manufacturing of Pharmaceuticals, and a member of the Process Analytical Technology (PAT) Subcommittee for the FDA Pharmaceutical Science Advisory Committee.

Dr. Raju obtained his M.S. in Chemical Engineering from MIT in 1989, his MS in Business Management from the MIT Sloan School of Management in 1994 and Ph.D. in Chemical Engineering from MIT in 1998.

About the Moderator:

Debra Goldfarb, Group VP for Life Sciences Research for IDC, specializes in high-performance and data intensive computing segments along with Bio-IT Infrastructure. She researches and analyzes traditional supercomputing technology and markets, as well as the impact and influence of these technologies on commercial markets. She has become a well-known industry spokesperson, visible at many conferences. In addition, Ms. Goldfarb is frequently quoted in both trade and business press. While at IDC, Ms. Goldfarb has focused on a broad array of areas, ranging from in-depth user studies on emerging technologies to government policy issues. She also consults regularly with systems vendors in strategic planning and product development issues. Ms. Goldfarb received her M.A. in political science from Tufts University in 1987, where she specialized in Chinese domestic studies.