CMC Strategies for Initial IND and Phase 1 Clinical Trials, AND Recent Regulatory Experiences

 also known as

Same Strategy, Same Agency, Different Outcomes

Speaker: David Houck PhD,

President, Chief Regulatory and CMC Consultant at Pharmakey LLC.

Dr. David Houck is the President of Pharmakey, LLC and an accomplished chemist and drug developer with over 25 years of experience in the pharmaceutical and biotechnology industries. Dr. Houck assists companies with formulation development, manufacture, and  testing of their therapeutic candidates for preclinical and clinical studies. Dr. Houck has held Director and VP roles in biotechnology companies focused on development of products from preclinical through clinical proof of concept.  For example, Dr. Houck recently advanced a selectively immunosuppressive cyclosporine from preclinical to phase 2 study for the treatment of HCV infections.  In addition, Dr. Houck has manufacturing and regulatory experience with small molecules and biotechnology products, including recombinant proteins and DNA molecules.  Therapeutic areas have spanned anti-infective, hemostasis, immunosuppression, cancer, cardiovascular, and CNS.  He has written over 200 regulatory submissions, and has frequent interaction with CDER and CBER (7 FDA meetings in 2009). During his industrial career Dr. Houck has contributed to the advancement of numerous drug leads and a couple marketed pharmaceuticals at Merck, Sterling Winthrop (Sanofi), OSI Pharmaceuticals, Phytera, and Scynexis. 

B.S. summa cum laude in Biology from Alma College in Alma, MI , an M.S. in Biochemistry from Purdue University in West Lafayette, IN , and a Ph.D. in Chemistry from Ohio State University, Columbus Ohio (Ph.D. funded by Merck & Co).   Dr. Houck has authored/co-authored over 30 articles/chapters, and holds twelve patents.  

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