Sunil Agnihotri, Ph.D.
Axsome Therapeutics
Sunil Agnihotri, Ph.D., is a pharmaceutical R&D leader with more than 20 years of diverse experience in research, development and manufacturing of soild oral and injectable drug products. Sunil has a Ph.D. in pharmaceutical sciences with post-doctoral research experience in advanced drug delivery systems. His key strengths are formulation development, analytical methods, scale-up, manufacturing and authoring CMC sections for regulatory filings.
Currently, Sunil is a director of CMC at Axsome Therapeutics, where he is responsible for guiding all the CMC activities for the drug product development. Before joining Axsome, Sunil was director of product development at Dechra. At Dechra, Sunil was responsible for development of several key products and helping the team to navigate regulatory requirements from CVM to successfully obtain approvals and commercial launch. Sunil is passionate about solving challenging technical and regulatory issues encountered during the drug product development, manufacturing and approval process.
He has been fortunate in his R&D career to embrace several technical and leadership positions with increasing responsibilities at Banner Life Sciences, Frontage Labs, Lupin Pharma and Sun Pharma.
He lives in Portland, Maine, with his wife and two young boys. He likes to hike and travel with his family.
Rob Hunter, Ph.D.
One Medicine Consulting
Seminar instructor Rob Hunter has 20 years of veterinary and human drug development experience with NASA, Pfizer, Elanco, Parnell and Provetica. He has contributed to the approvals for Revolution®, Dectomax®, Aviax®, Doxidyl™, A180®, tylosin, Micotil®, Ovugel®, Kexxtone®, ractopamine, Experior™, Posilac® and Pulmotil®, with others currently in development or under regulatory review.
Hunter is an internationally recognized subject matter expert on pharmacokinetics, antimicrobial PK/PD, interspecies allometry, drug metabolism, bioequivalence and tissue residues/human food safety, along with corresponding bioanalytical support.
Hunter has served on and chaired several AHI committees and represented the U.S. veterinary pharmaceutical industry on the VICH bioequivalence expert committee. He has represented various companies at CVM/FDA, EMA/CVMP, APVMA, VDD (Canada), NVQRS/QIA (South Korea), Thailand FDA, NVAL (Japan), Ministry of Agriculture (Vietnam), and IVDC (China) regarding specific products, issues, and/or policies. He is the current president of the American Academy of Veterinary Pharmacology and Therapeutics.
David Longstaff, Ph.D.
U.S. Food and Drug Administration
David Longstaff, Ph.D., received his B.Sc. (hons) in Microbiology and Genetics from the University of Aberdeen in Scotland, and M.S. and Ph.D. in Microbiology from The Ohio State University.
Longstaff joined the Office of New Animal Drug Evaluation in the Center for Veterinary Medicine at the U.S. Food and Drug Administration in 2008 as a reviewer in the Division of Manufacturing Technologies. After 8 years reviewing the chemistry, manufacturing and controls sections for all dosage forms and species, he transitioned to a team leader position in the Division of Generic Animal Drugs, where his focus is the use of in vitro data in support of bioequivalence.
Kara George Rosenker, Ph.D.
U.S. Food and Drug Administration
Kara M. George Rosenker, Ph.D., received her B.S. in Chemistry from Juniata College in Huntingdon, Pennsylvania, and a Ph.D. in Organic Chemistry from the University of Pittsburgh.
Currently, Rosenker is a chemist in the Division of Manufacturing Technologies in the Office of New Animal Drug Evaluation at the Center for Veterinary Medicine at U.S. Food and Drug Administration. As a chemist, she is responsible for the review of the chemistry, manufacturing and controls information for generic oral dosage forms.
During her 6 years at CVM, Rosenker also has focused specifically on the dissolution of immediate release oral dosage forms, as well as the control of impurities in drug substance and drug products.