SANDEEP NEMA, PhD, is Executive Director, Biotherapeutics Pharmaceutical Sciences at Pfizer where he is responsible for all pre-proof of concept biologics projects from discovery up to Phase 3. Sandeep earned a PhD in 1992 and since then has been involved with the development of small molecule, vaccine, protein, and cell and gene therapy drugs via parenteral delivery first at Mallinckrodt Medical and then at Pfizer (Searle, Pharmacia). He has been lead formulator for four launched products. Dr. Nema is a Certified Regulatory Affairs Professional and is active in AAPS and PDA, where he regularly teaches courses and organizes symposiums. He is an adjunct professor at the University of Tennessee. In addition, he has served as a Steering Committee Member for the Handbook of Pharmaceutical Excipients.

JOHN D. LUDWIG, PhD, is Senior Vice President, Medicinal Sciences, Worldwide Research and Development at Pfizer, where he is responsible for medicine design, biomedicine design, pharmaceutical sciences, and global clinical supply. Ludwig earned a BS in pharmacy and a PhD in pharmaceutics at the University of Tennessee, Memphis and has held numerous research and development positions at Burroughs Wellcome Co, Searle Inc., Pharmacia Inc., and Pfizer Inc. Dr. Ludwig is active in the American Association of Pharmaceutical Scientists (AAPS) and the Parenteral Drug Association (PDA) Training and Research Institute. He has contributed to the development of three professional training courses and serves regularly as a course instructor at PDA.