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RRD Network

William G. Kramer, PhD (Pharmacokinetics)

As a drug development consultant, Dr. Kramer draws on over 30 years of experience in the pharmaceutical industry and conducting academic research to work with client companies in the development of research strategies to minimize the time for completion of clinical trials and FDA approval. An expert in clinical pharmacology, pharmacokinetics, and pharmacodynamics, Dr. Kramer assists client companies in program design, protocol preparation, study implementation, and the analysis and interpretation of results. Dr. Kramer has prepared pharmacokinetic sections of INDs, NDAs, ANDAs, BLAs, and submissions to European regulatory agencies. He has presented at all levels of FDA meetings, including Advisory Committee Meetings, and has published extensively on the pharmacokinetics/dynamics of drugs in adult and pediatric populations.

Prior to forming Kramer Consulting LLC, Dr. Kramer was a Senior Consultant at Quintiles Consulting and before that served as Director, Clinical Research, and Head, Pharmacokinetics and Bioanalytics, at Boehringer Mannheim, where he created and maintained the pharmacokinetic plan for all drug projects in the US. Other positions in which Dr. Kramer worked include serving in the Department of Drug Metabolism and Pharmacokinetics at Schering-Plough Corporation, and he spent ten years teaching and conducting clinical pharmacokinetic research at the University of Houston College of Pharmacy. Dr. Kramer received a PhD in Pharmaceutics at Ohio State University, Columbus, OH, and a BS in Pharmacy from the University of Pittsburgh.

Sandra Morseth, PhD (Toxicology)

Dr. Morseth received her PhD in 1984 from Washington State University in Experimental Psychology. She joined Hazleton Labs (now Covance) that year and served as a study director for developmental and reproductive studies until joining the FDA in 1990. While at the FDA, she worked at both CDER and CBER as a pharmacology/toxicology reviewer. She was a member of several inter-center committees including serving as chair of the FDA (CDER/CBER) Developmental and Reproductive Toxicity Committee where she both advised other reviewers and participated in the ICH guideline development process. After leaving FDA she again joined Covance as the Associate Director of Toxicology with responsibility for the scientific direction of small animal and developmental and reproductive toxicology. She left there in 1998 to join Quintiles where she joined the interdisciplinary consulting group and served as a preclinical consultant providing scientific and regulatory advice to companies developing pharmaceutical products in the US, Europe, and Asia. Since then she has continued to serve as a consultant, first for Milestone Biomedical Associates (a division of CRL), and now as an independent consultant specializing in the science and strategy of preclinical drug development. She is a longtime member of the Teratology Society, the Society of Toxicology, and the American College of Toxicology.

Kathryn Zunich, MD (Immunology, Regulatory, General Clinical Development)

Dr. Zunich is a board certified physician in Internal Medicine with subspecialty training in Allergy and Immunology. She has over 18 years’ experience in the pharmaceutical industry and more than 25 years’ overall experience in clinical trials and drug development. She assists clients in the strategic planning and implementation of development programs with an emphasis on clinical and regulatory support. Dr. Zunich is a founding member of Iasis Partners, LLC, a drug development consultancy.

Prior to founding Iasis Partners, Dr. Zunich was an independent medical consultant to the pharmaceutical industry and has also held senior positions at Syntex Research in Palo Alto, California and Univax Biologics in Rockville, Maryland. During that time, she played significant leadership roles in five successful NDAs, having key roles in the development of drugs such as mycophenolate mofetil (CellCept) for the prevention of acute rejection in solid organ transplantation, and biologics such as anti-Rho(D) (WinRho) for the treatment of immune thrombocytopenia. She has also made major contributions to the strategic planning and implementation of numerous INDs. Prior to joining industry, Dr. Zunich served as a Program Officer at the National Institute of Allergy and Infectious Diseases of the National Institutes of Health in Bethesda, Maryland, where she conducted clinical trials in HIV infection and associated complications. She also served as NIAID Section Chief in Transplantation and in Asthma, during which time she oversaw a portfolio of grants in allergy, immunology, and transplantation.

Dr. Zunich received her B.A. in Natural Science from Fordham University, her M.D. degree from Upstate Medical University of the State University of New York at Syracuse, and her internship and residency training in Internal Medicine and Primary Care at St. Vincent’s Hospital and Medical Center of New York. She subsequently completed a post-doctoral fellowship in Allergy and Immunology at National Jewish Health (formerly National Jewish Center for Immunology and Respiratory Medicine) in Denver, Colorado where she began her early work as an investigator in clinical trials and drug development. She is author or co-author of a number of peer-reviewed publications including original research and review articles.

Cynthia McCormick, MD (CNS, Regulatory, General Clinical Development)

Dr. McCormick is a private clinical and regulatory consultant to government and pharmaceutical companies who are developing products for CNS disorders. Dr. McCormick served as Medical Reviewer in the Division of Neuropharmacological Drug Products at the FDA for five years. During this time she was the lead reviewer for all neuropathic pain and antiepileptic drug product INDs and NDAs.  She was the primary reviewer for drugs such as gabapentin, tiagabine, topiramate, vigabatrin, and a large number of sNDAs.  She was then promoted to Director of the Division of Anesthetic, Critical Care and Addiction Drug Products at the FDA in 1996 where she served until 2002.

During that time, she oversaw the review and approval of anesthetic agents, drugs targeted for the treatment of pain and addiction, and initiated strategies to ensure that a standardized approach to the development of drugs for pain was undertaken.  She held positions sequentially on the FDA’s pediatric drug development, labeling and exclusivity implementation committees during her tenure at FDA. Prior to her FDA experience, Dr. McCormick served as a Medical Officer in the NINDS Antiepileptic Drug Development Program that spearheaded the development of new therapies for the treatment of epilepsy; and more recently she held the position of Deputy Director of Extramural Research for the National Institute of Neurological Disorders and Stroke, NIH.  She also played a key role in the implementation of the National Vaccine Injury Compensation Program as Chief Medical Officer and Deputy Director.

She preceded her career in the Federal Government with the clinical practice of Pediatric Neurology.  Dr. McCormick is a graduate of Bryn Mawr College and the Medical College of Pennsylvania.  She received her postgraduate residency training at the University of Michigan, Department of Pediatrics and the University of Pennsylvania, Department of Neurology.

John (Jack) McCormick, MD (Regulatory, Orphan Drug Products)

Dr. McCormick is an independent medical and regulatory consultant with expertise in ophthalmology, pediatrics, and the development of orphan drug products. Dr. McCormick worked at the FDA for over 20 years, most recently as the Deputy Director of the Office of Orphan Product Development (OOPD). During his time at the FDA, Dr. McCormick was responsible for insuring that applications for orphan designation were consistent with OOPD precedent and met appropriate review standards. Additional duties included representing the OOPD Director in meetings with patient groups, industry, and other FDA divisions. He was also responsible for advising companies developing orphan products on the quality of their development plans.

While at FDA, Dr. McCormick also served as a Medical Reviewer at the Center for Drug Evaluation and Research (CDER) Division of Anti-infective Drug Products and at the Center for Biologic Evaluation and Research (CBER) Division of Antiviral Drug Products. As a Medical Officer at CDER and CBER, he reviewed INDs and NDAs for ophthalmic products and AIDS-related products, including those for pediatric indications. He preceded his career in the Federal Government with private practice at the Duluth Clinic in Duluth, Minnesota.

Prior to that, he held academic appointments as Clinical Assistant Professor of Ophthalmology at the University of Minnesota-Duluth, and before that as Instructor in Surgery and Pediatrics at the Medical College of Pennsylvania. Dr. McCormick is a graduate of Pennsylvania Military College. After completing his Bachelor’s degree, Dr. McCormick served in the US Army Medical Service Corps as a 1st Lieutenant. He subsequently completed pre-medical education at the University of Michigan and graduated from Temple University School of Medicine. He received his postgraduate residency training at the University of Michigan Medical Center in the Department of Pediatrics and Communicable Diseases, and in the Department of Ophthalmology.