Gary H. Ward, Ph.D- Manufacturing & CMC
President of Ward Consulting, LLC, Dr. Ward provides state-of-the-art CMC expertise in the areas of analytical, bioanalytical, process and formulation development for both traditional compounds and biologics. Over the past 24 years, he has played key roles in successful product development efforts at 3M Company, Dura Pharmaceuticals, Élan, Chugai Biopharmaceuticals, CovX Research and Pfizer. Dr. Ward has been responsible for CMC efforts on complex biopharmaceutical APIs and drug products and has produced regulatory dossiers for numerous international new drug applications leading to several commercial products. Receiving his Ph.D. in Pharmaceutical Sciences from the University of Arizona, he is the author of over 60 papers and abstracts and the inventor on multiple patents in the areas of pharmaceutical pre-formulation, formulation and process development.
Advisors
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Marlene Modi, Ph.D- Preclinical Development & Clinical Pharmacology
Dr. Modi has more than 25 years of experience in the pharmaceutical industry. She has served as Vice President of Preclinical Development at Optherion, Inc. and Senior Director of Clinical Pharmacology at Eyetech Pharmaceuticals, Inc with responsibilities for assessing the pharmacology and toxicology of compounds in development. For the previous 15 years, Dr. Modi worked at Hoffmann-La Roche in key management positions, including Site Head and Director of Clinical Pharmacology. Dr. Modi has extensive expertise in the areas of preclinical and clinical development of large molecules (e.g., proteins, monoclonal antibodies, aptamers and pegylated compounds) and has facilitated the IND submission of more than 10 compounds within the last 5 years. She has played a key role in the submissions of NDAs/BLAs and sNDAs in the therapeutic areas of ophthalmology, virology, infectious disease, neurology, oncology, diabetes and asthma. Her areas of expertise include drug-drug interactions, pharmacokinetic-pharmacodynamic relationships, formulation development, and dose- and exposure-response relationships in special populations. She received a B.S. in Pharmacy from the University of Houston and a Ph.D. in Pharmaceutics from the State University of New York at Buffalo.
Steve Kradjian, RAC- Regulatory Affairs
Mr. Steven Kradjian is a veteran regulatory leader with more than 25 years of experience in biopharmaceutical regulatory affairs and development. Mr. Kradjian adds value to all stages of development ranging from product candidate selection through late stage clinical development with expertise in cellular and gene therapies, small molecules, recombinant proteins, monoclonal antibodies and combination products in a wide range of therapeutic areas, as well as development of investigational vaccines in populations at risk for infectious disease. He trained in regulatory affairs at Amgen while working on EPOGEN and other development programs, and later, as Executive Director of Regulatory and QA at Vical Inc., gained experience as product development team leader in the Phase 2 and Phase 3 settings. Since 2004, he has served as regulatory strategy advisor to Sponsors in the U.S., Europe, and Asia, and has successfully filed 27 IND/CTAs and managed numerous formal and informal meetings with regulatory agencies. Mr. Kradjian earned a Bachelor's degree in Chemistry from Occidental College and was Board certified in Regulatory Affairs in 2000 and completed the Executive Development program for Regulatory Professionals at the Kellogg School of Management.
Novel.