CLINICAL

N. Jean Warner, M.D. has more than 20 years of experience in pharmaceutical research management, having led both large multinational drug development organizations and cross-functional project teams. Dr. Warner has designed and executed programs in all aspects of drug development, from lead validation through Phase IV. She has filed INDs for over 30 pharmaceutical and biotechnology compounds, has participated in the filing and prosecution of 8 successful NDAs for 6 different compounds and has presented three compounds to the FDA Advisory Committee. In addition, she has presented to the Canadian, UK, French and Australian regulatory authorities and has prepared consultants for presentations to a number of other regulatory agencies, including the EMEA and German authorities. Dr. Warner has served as President and CEO of PPGx, a joint venture pharmacogenomics company, was Vice President of Clinical Research and of Safety, Surveillance and Reporting at Syntex and held a number of senior positions at Khepri, Arris and Axys Pharmaceuticals. Previously, Dr. Warner was at Merck, Sharp and Dohme Research Laboratories, where she was involved in designing and executing the clinical programs and filing NDAs for a number of compounds, including enalapril, lisinopril, lovastatin and simvastatin. She began her research career at Columbia University where she won the American College of Cardiology Young Investigator of the Year Award for her work on the interaction of digoxin and quinidine. Dr. Warner is board certified in Internal Medicine and Cardiovascular Disease.

Coleman Gross, M.D. has been involved in biomedical research for over 14 years. His experience includes all stages of research from bench experimentation, in vitro animal studies and clinical trials. He has conducted research and development within the biopharmaceutical industry as well as in academic medical centers, and independent research institutes. Dr. Gross is the principal of AVIYA Clinical Research and Development. Prior to founding AVIYA he was the Director of Clinical Affairs at Calyx Therapeutics where he was responsible for all aspects of clinical development. From 1998 to 2000 he was Assistant Professor of Medicine at UCSF/San Francisco VA Medical Center and prior to that was a faculty member at Stanford University. Within the biopharmaceutical industry, Dr. Gross has led multidisciplinary teams and has been responsible for the development of numerous clinical drug candidates. He has overseen clinical candidate optimization, qualification and selection of a number of drugs entered into clinical development in several therapeutic areas. He has played a central role in non-clinical safety assessments for many drugs including ones successfully entered into clinical trials. Dr. Gross has produced IND submissions and other regulatory submissions in multiple therapeutic areas. Dr. Gross has considerable experience in clinical development strategy including development planning, clinical trial design, and protocol development. Dr. Gross received a bachelor’s degree from the University of California Berkeley and an M.D. from the University of Southern California. Dr. Gross completed an internal medicine residence at UCLA and a fellowship in endocrinology at Stanford. He is board certified in internal medicine, diabetes, endocrinology and metabolism and he is Assistant Clinical Professor at UCSF. He has published many papers in the field of endocrinology. He maintains an active practice in endocrinology.

Heather Burt is a clinical operations consultant with more 20 years of experience in the industry, ranging from academic research to pharmaceutical, biotechnology and contract research organizations. At Forbes Medi-Tech, she was the Associate Director, Clinical Research where she managed internal and external stakeholders in the completion of a cardiovascular trial and developed company policies and procedures for clinical research activities. Ms. Burt spent over 4 years at Inex Pharmaceuticals where she held a number of positions, including Associate Director of Clinical Research, Senior Manager of Clinical Research and Senior Manager of Data Management and Statistics. She managed internal and external teams in the completion of several oncology trials and was the clinical lead in the submission of Inex’s first New Drug Application. Ms. Burt has also managed international solid organ transplant trials and registries. She holds an Honors Degree in Respiratory Therapy and is a Certified Clinical Research Associate


REGULATORY

Bonnie Horner has more than 25 years of experience in regulatory affairs in the pharmaceutical industry. She held a variety of positions in the Regulatory Affairs Department of Syntex, in both the American and European offices. Ms. Horner spent 4 years as Director of the European Regulatory Affairs Department for Syntex, and 11 years in the U.S. Regulatory Group. At the time Syntex was acquired by Roche, she was Executive Director of Corporate Regulatory Affairs. Since then, Ms. Horner has held the positions of Senior Director of Regulatory Affairs at Neurex Corporation and Vice President of Regulatory Affairs at ICON Clinical Research. She began consulting work in 1997, and is now an independent regulatory consultant. Ms. Horner has worked with a number of small companies in the early stages of product development. Ms. Horner holds an M.A. in organic chemistry from Rice University and a B.S. in chemistry from Texas Tech University.

Caryn Peterson has over 24 years of pharmaceutical industry experience, including management positions in research and development, operations, and regulatory affairs. Most recently, Ms. Peterson served as Vice President of Regulatory Affairs and Compliance at FeRx, where she was a key participant in executive management with extensive responsibility in the strategic operations for the company. In this position, her responsibilities included the development and subsequent execution of a global non-clinical, clinical and regulatory strategy for FeRx’s lead compound and platform drug-delivery technology. Ms. Peterson joined FeRx in 1997 following 8 years at Amylin Pharmaceuticals, where she held managerial positions in both Pharmaceutical Development and Regulatory Affairs. Prior to joining Amylin Pharmaceuticals, she held scientific positions in the Therapeutics and Diagnostics Divisions at Hybritech Incorporated for 9 years. Ms. Peterson has authored several research publications and is a co-inventor on multiple patents.

^top


TOXICOLOGY

Jeri El-Hage, Ph.D. is a Regulatory Toxicologist, Senior Consultant at Aclairo Pharmaceutical Development Group. Previously, Dr. El-Hage held leadership positions in the Center for Drug Evaluation and Research at FDA including 6 years as supervisory pharmacologist in the Division of Metabolism and Endocrinology Products (DMEP), and 2 years as the Associate Director of Pharm/Tox for the Office of Drug Evaluation I. Her career in CDER also included 8 years as a pharmacology/toxicology reviewer in DMEP and 4 years as a reviewer in the Division of Reproductive and Urology Products. Dr. El-Hage's most recent special projects and committee work within the FDA included: Carcinogenicity Assessment Committee member; Pharmacokinetics / Toxicokinetics Subcommittee, co-chair; and recognized expert on the preclinical development and toxicity of Peroxisome Proliferator-Activated Receptor (PPAR) Agonists. Dr. El-Hage has extensive preclinical experience with drugs indicated for diabetes, obesity, and dyslipidemia and peptide and protein hormone biologics. Dr. El-Hage holds a Ph.D. in Physiology & Biophysics, Howard University College of Medicine, Washington, DC and a B.S. in Biological Sciences from State University of New York at Brockport, New York.

Brian C. Rogers, Ph.D., D.A.B.T., M.B.A is a co-founder of Pacific BioDevelopment, LLC and serves as Founding Partner and Vice President of Toxicology. He has nearly 20 years of industrial toxicology experience primarily in biotechnology and pharmaceuticals, including five years at Genentech. During this time he has extensively interacted with the FDA and authored over 40 IND and several NDA and BLA nonclinical sections on behalf of clients. He holds a Ph.D. in Toxicology from the University of North Carolina, Chapel Hill, NC and a B.S. in Environmental Toxicology, University of California, Davis, CA (UCD). He is a Diplomate of the American Board of Toxicology (since 1993) and also holds an MBA from and was an adjunct professor at the UCD School of Management.

Susan Wilson, D.V.M., Ph.D. is Vice President and Chief Scientific Officer at Aclairo Pharmaceutical Development Group. Previously she served as a senior consultant at Milestone Development Services. Prior to consulting, Dr. Wilson was a pharmacology/toxicology reviewer at the FDA’s Center for Drug Evaluation and Research (CDER) in the Division of Anti-inflammatory, Analgesic, and Ophthalmic Drug Products and the Division of Medical Imaging and Radiopharmaceutical Drug Products. While at the FDA, she served as co-chair of the Immunotoxicology Working Group, provided consultation to the review divisions at FDA on issues of immunotoxicology, and served on the InterAgency Coordinating Committee for the Validation of Alternative Methods subcommittees for Immunotoxicology and Ophthalmic Drugs. In addition, Dr. Wilson has approximately 10 years of veterinary medicine practice experience. As a consultant, Dr. Wilson has developed toxicology plans, provided regulatory strategies to facilitate drug development, prepared regulatory submissions, participated in FDA meetings, conducted due diligence, and participated on several expert panels. Her areas of expertise include immunotoxicology and issues related to endocrine, anti-inflammatory and ophthalmic drug products, large molecular weight products, as well as imaging agents. Dr. Wilson holds a D.V.M. from University of Georgia College of Veterinary Medicine and a Ph.D. in Pharmacology & Toxicology from Medical College of Virginia.

^top


CMC/FORMULATION DEVELOPMENT

Barbara Laidlaw, Ph.D. serves as a consultant to pharmaceutical and biopharmaceutical companies engaged in early to late stage product development and provides advice and leadership in the areas of pharmaceutical development and CMC functions. Dr. Laidlaw specializes in formulation development, process development and analytical characterization of a variety of dosage forms, including novel drug delivery approaches. Prior to forming her consulting firm, Dr. Laidlaw was employed at Durect Corporation, Alza Corporation and Syntex Corporation serving in a number of roles involved in developing implantable, biodegradable controlled release systems, controlled and immediate release oral dosage forms, injections and other delivery systems. Dr. Laidlaw received a Ph.D. in Physical Pharmacy from Purdue University, West Lafayette, IN and a B.S in Pharmacy from the University of Iowa, Iowa City, IA.

^top


STATISTICS

Alice Tinker is a consulting biostatistician in the pharmaceutical, biotechnology, and medical device industries. She has devoted over 25 years to the biostatistics associated with the conduct and analysis of clinical trials. In her role as a consultant Ms. Tinker has emphasized problem identification and characterization as well as definition and formulation of unique efficacy measures. Her work for diverse US and international companies, in various stages of product development, has included clinical trial protocol and CRF development, sample size calculations, statistical analyses and consultation, design of tables, figures, and listings, and statistical content for integrated study reports. As a senior biostatistician at Syntex Research she provided the primary statistical support for three NDA approvals, including statistical strategy, design, and analysis of clinical safety/efficacy studies. She established statistical study procedures and data analysis templates, which became corporate standards; and she managed statistical and data management efforts for a biotechnology joint venture. Also at Syntex, Ms. Tinker accepted an overseas assignment to support an urgent EEC drug submission. She has provided long-term ongoing statistical support for molecular biology research efforts at Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill. Ms. Tinker holds BS and MS degrees in statistics from Stanford University.

^top


QA/QC

Carl Wilson is a consultant with expertise in pharmaceutical and biopharmaceutical Quality Assurance and Quality Control systems to meet Current Good Manufacturing Practices (cGMP) and Good Laboratory Practices (GLP) requirements, as well as pharmaceutical validation requirements, both process and systems. He has hosted workshops on GMPs for APIs and ICH Stability programs for several years throughout the U.S. and Asia. Mr. Wilson previously held QA/QC positions at Invitrogen, Cytel Corporation and Validation Systems and earned his B.A. and M.A. degrees in Microbiology at California State University, Fullerton, Fullerton, CA.

^top


Project Management

Christine Mangan is a clinical research, regulatory compliance and project management consultant for biotech, pharmaceutical, and contract research organizations. Ms. Mangan has worked in the industry for more than 25 years. At Connective Therapeutics she was the Sr. Manager, Clinical Research where she developed company standards for clinical research and GCRP compliance and implemented policies and procedures to support clinical trials. As Project Team Leader, she was responsible for project plans, timeline management, and cross-function coordination of scleroderma, multiple sclerosis, and rheumatoid arthritis programs. During 13 year at Syntex, Ms. Mangan held a number of positions including Clinical Trials Expert on the Mycophenolate Mofetil Clinical Program Team where she participated in the development of the Clinical Functional Plan for the prevention of renal transplant rejection indication, developed the NDA timeline for all clinical activities, and managed the performance of Study Management Teams. Other positions at Syntex included Manager of Clinical Research Administration, Manager of Bioresearch Compliance, and Sr. Clinical Research Associate. She has been an independent consultant since 1996. Ms. Mangan has a B.S. in Medical Technology and an M.B.A.

^top


Intellectual Property

Jeffrey B. Prince, Ph.D. has over 15 years experience managing intellectual property in the pharmaceutical and biotechnology industries. Dr. Prince was formerly Senior Director of Intellectual Property at Calyx Therapeutics, where he developed an extensive patent portfolio on the company’s small molecule and peptide-based therapeutics. Previously he served as Director of Intellectual Property and Technical Communications at InnoGenex, and prior to that was Manager of Intellectual Property and Marketing Communications at its parent BioGenex Laboratories, a leader in the development of cell-based diagnostic systems for the histopathology market. Dr. Prince was a MacArthur Foundation Fellow in the Division of Infectious Diseases, Stanford University School of Medicine and a Senior Research Associate in the Department of Immunology and Infectious Diseases, Palo Alto Medical Foundation. The recipient of a P.H.S. National Research Service Award from the National Institutes of Health, Dr. Prince earned his Ph.D. in Biochemistry at the University of Massachusetts, Amherst and a B.A. in Chemistry at Hofstra University.

^top