BIOPHARMA CONSULTING SERVICES - Key Persons
Anne Trench brings more than 20 years of hands-on experience in clinical research operations and medical writing to BioPharma Consulting with whom she has worked for the last three years. Anne has helped small companies select and manage contract research organizations in the successful execution of clinical trials. During her career, she has managed the preparation of the clinical portions of INDs, NDAs, BLAs, and FDA Advisory Board presentations. Anne has assisted clients with development of core clinical standard operating procedures, protocols, and clinical project budgets. Before joining BioPharma, Anne was Senior Director of Clinical Administration at Immunex and a Director at Berlex Laboratories, where she played key roles in the development of the first biologic to be licensed for multiple sclerosis and in a breakthrough biologic therapy for rheumatoid arthritis. Anne also has experience working with biologics and small molecules for oncology and other indications.
From 2002 to present, Dr. Serdar has served as a consultant at early stage biotechnology companies. In this role, Dr. Serdar applied his expertise to assist biotechnology companies with a variety of services, ranging from basic research to regulatory filings. Prior to that, he worked at Amgen for over 15 years in Basic Research, Product Development, and Clinical Affairs. While at Amgen, his drug development experience included four biologics and he worked in the areas of oncology, inflammatory diseases and tissue regeneration. His responsibilities included coordination research, regulatory, manufacturing, CROs and clinical staff in the management of multicenter trials and multiple projects. He received his Doctorate in Microbiology from the University of Texas at Austin. He has three issued patents and has authored 28 publications.
Dave Boyden has been in the biopharmaceutical industry for 25 years and has a broad functional background including research, venture capital, sales and marketing. Mr. Boyden obtained a degree in Molecular Biology from UC San Diego and spent five years as a research scientist at Syntro, an early-stage biotech company. He then received an M.B.A. from the Anderson School at UCLA and worked at 3i Ventures, a biotech venture capital firm. Mr. Boyden then spent 14 years at Amgen in a number of senior Sales and Marketing positions, including Senior Brand Director responsible for EPOGEN®, the world's largest biotech product, and the launch of Aranesp™. He was also Global Commercial Leader for Aranesp™ and was involved in the development of important new indications such as CHF. Mr. Boyden has extensive reimbursement, channel, and national account experience and has worked in a number of therapeutic areas, including oncology, infectious disease, cardiology and nephrology. He formed Mirador Strategies in 2005.
Dr. Brent Blumenstein is a biostatistician and clinical trialist with special focus on the architecture and conduct of multisite clinical trials. He was trained at Emory University, and has been on the faculties of Emory University, University of Washington, Fred Hutchinson Cancer Research Center, Northwestern University, and Duke University. While an academician he focused on multisite clinical trials sponsored by the National Cancer Institute. He also has extensive experience as a consultant working on clinical trials done in support of product registration, including both drugs and devices. His particular areas of statistical expertise include clinical trial design, survival analysis, general statistical modeling, and evaluation of diagnostics and markers. His particular areas of clinical expertise include cancer, surgical interventions, diagnostic markers, prognostic markers, medical devices, and cardiovascular disease. In 2002 Dr. Blumenstein formed Trial Architecture Consulting (www.TriArcConsulting.com). He also serves as an FDA panelist.
Dr. David Liebowitz has preclinical and clinical development experience in Oncology, Infectious Diseases (Virology), Inflammation and Metabolic Disorders using protein, small molecule and vaccine therapeutic modalities. In addition to his work with BioPharma Consulting Services, Dr. Liebowitz is also the Chief Scientific and Medical Officer for Vivaldi Biosciences, an influenza vaccine and therapeutics biotechnology company. Prior to that, he was Executive Vice President and Chief Scientific Officer at Galileo Pharmaceuticals, a small molecule drug discovery and development company, focused on Inflammation and Metabolic Disorders. He also served as co-CEO of Galileo for a short period of time. Prior to joining Galileo, Dr. Liebowitz was at Amgen, where he served as the Director of Research responsible for all Oncology drug discovery and development programs at the Amgen Washington research site. He also managed external development collaborations and licensing activities. Dr. Liebowitz joined Amgen through their acquisition of Immunex. He was recruited to Immunex as a Medical Director (Oncology) in Clinical Development. Later he moved within the Immunex organization to start a new research therapeutic area in Oncology.
Prior to joining Immunex, he was an Associate Investigator in the Abramson Cancer Institute at the University of Pennsylvania, where he served as Director of their Immunotherapy and Cellular Therapy Programs targeting cancer and chronic viral diseases. Dr. Liebowitz was an early recipient of a grant from the Bill and Melinda Gates foundation. He began his academic career as an Assistant Professor of Medicine and Virology at the University of Chicago, and was the Director of the Bone Marrow Transplantation Program.
Dr. Liebowitz has B.S. and M.S. degrees in Biology from Emory University, an M.D. with Honors and a Ph.D. in Molecular Genetics and Cell Biology, both from the University of Chicago.
Dr. Ellen Cheung has over 15 years of experience with the Biotechnology and Pharmaceutical Industry. Her areas of expertise are in preclinical pharmacokinetics/pharmacodynamics analysis and modeling; and in bioanalytics and biomarker development and validation. She has had the responsibilities for preclinical development and/or clinical pharmacology on project teams that had successfully brought six products to market while at Amgen and at Bayer Corporation.
Dr. Cheung received her doctoral training in Medicinal/Pharmaceutical Chemistry at the University of California, San Francisco, and post-doctoral training in the Laboratory of Pharmacology and in the Laboratory of Molecular Biophysics at the National Institute of Environmental Health Sciences. She has worked at Amgen during its earlier days and contributed to the establishment and growth of the Department of Pharmacokinetics and Drug Metabolism. She was the first group leader for Amgen's Biomathematical Modeling Team. She was Director of Preclinical Development at Bayer Corp and most recently Senior Director of Preclinical Research at InterMune, prior to devoting all of her time to consulting. Among her client list are small start-ups and mid-size biopharmaceutical companies.
For the past eight years Dr. Paul Fredlund has worked in clinical drug development designing and monitoring clinical trials in erectile dysfunction, diabetes, sepsis, Chron's Disease, Non-Hodgkin's Lymphoma and lung cancer. He has extensive experience drafting clinical study reports, preparing regulatory documents and evaluating potential in-licensing opportunities. He has a special interest in clinical drug safety (pharmacovigilance) and has served on several drug safety monitoring committees.
In 2000 he joined ICOS Corporation and as Director; Clinical Research was actively involved in the clinical development and the successful worldwide registration of Cialis (tadalafil) for erectile dysfunction. In 2003/2004 Dr Fredlund was the Co-director of the Lilly/ICOS U.S. Affiliate Cialis™ Product Development Team responsible for the commercialization of Cialis and the design and implementation of Phase 4 Cialis clinical trials.
Dr Fredlund graduated from Harvard College and Harvard Medical School. He completed his training with a residency in internal medicine at Harvard Medical School's Peter Bent Brigham Hospital and a clinical fellowship in endocrinology and metabolism at the National Institutes of Health. He is board certified in internal medicine and endocrinology and has been a Clinical Professor of Medicine at the University of Washington School of Medicine.
Dr. Richard Stead has more than 20 years of experience in the biotechnology and pharmaceutical industry directing clinical trials, in- and out- licensing efforts, as well as preclinical research and development at Amgen and Immunex. Since 2002, he has worked as an independent consultant to biotechnology and pharmaceutical companies as well as investors in several therapeutic areas. He focuses on clinical and regulatory strategy for therapeutic product development as well as operational issues in executing clinical development programs.
In 1988, Dr. Stead was recruited to Amgen as its first physician. He played significant roles in the clinical development, FDA approval and commercialization of Amgen's first two products, Epogen® and Neupogen®. In 1999, he joined Immunex as Vice President of Clinical Research and Development with responsibilities for both pipeline and marketed products for Oncology and Neurology. He negotiated the approval and post-marketing commitments for the approval of Novantrone® in multiple sclerosis with the FDA.
Dr. Stead graduated from the University of Wisconsin and Stanford University School of Medicine. He completed his medical training at the Brigham and Women's Hospital and Harvard Medical School and a second post-doctoral fellowship at the National Cancer Institute.
Job Titles:
- Network
- President of Posada & Associates, Inc
James Posada Ph.D., MBA is the President of Posada & Associates, Inc., a life sciences consulting firm. Dr. Posada works primarily with early-stage private biotechnology companies; partnering with founders and investors to design and execute the most appropriate business strategy, partnering transactions, and market positioning; taking into
Larry Johnson brings more than 30 years' experience to bear in helping to expedite the development of biotechnology-derived pharmaceutical products from product identification to marketing approval. He has worked with both biological and drug products in the US and internationally, and he has played key roles in obtaining regulatory approvals for innovative and medically-significant therapeutics.
Larry has lectured at industry meetings and commercial gatherings, and he has served as instructor or director in numerous regulatory training venues. He is highly regarded as a hands-on, results-oriented resource, and he has consultative experience with more than 35 firms at every stage of product development.
Larry's educational background includes a B.S. degree from Whitman College, Walla Walla, Washington, an M.S. degree in Health Services Administration from the Rochester Institute of Technology, and a certificate in Gerontology from the University of Washington, Seattle.
Molly brings over 20 years of experience in epidemiological and clinical research. This was through positions at academic institutions (University of Washington and George Washington University Biostatistics Center), the FDA, in the pharmaceutical industry (Amgen, and Biogen Idec) and as part of a major contract research organization (Westat). Molly's principal areas of interest are clinical team management, study design, development plans, and literature reviews.
An accomplished pharmaceutical regulatory affairs professional, Nancy Kercher is highly experienced in the pharmaceutical/ biotechnology industry working with CBER, CDER and OGD. Her areas of expertise include but are not limited to asthma, oncology, rheumatology, cardiology, neurology, psychiatry and immunology. In 2002 Ms. Kercher created and is President of Strategic Biotechnology Consultants, a consulting service for drug development teams and management to ensure the optimal development plan is being pursued with the FDA. Her services outline, interpret and clarify FDA requirements, ensuring quality submissions to the FDA which result in reduced review times and accelerate time to market. Prior to starting her own company, Ms. Kercher worked for Immunex, Abbott Laboratories and Upjohn (Chugai-Upjohn).
Dr. Noonan has more than 25 years of diverse (from bench-level to senior management) experience in the Pharmaceutical Industry. As VP of Clinical Pharmacology at a full service CRO, he assisted sponsors in the development of numerous preclinical and clinical programs. As VP of Pharmacokinetics and Regulatory Affairs at Mylan Pharmaceuticals he was responsible for the completion of several INDs, one NDA (Cystagon®) and more than 20 ANDAs. Dr. Noonan has a broad and extensive background in clinical pharmacology including practical experience in the areas of Phase 1 (including 2a) clinical trial design and conduct, protocol development, pharmacokinetics, pharmacodynamics, biopharmaceutics, drug delivery, drug metabolism and assay development. As President of PK Noonan & Associates, LLC, Dr. Noonan provides pharmacokinetic, clinical pharmacology and regulatory advice/services to the Pharmaceutical Industry.
Prior to joining BioPharma Consulting Services, Dr. Weiden worked for biotechnology firms involved in developing chemotherapeutic agents and cellular immunotherapy of cancer. During the previous 20 years, Dr. Weiden was a member of the Section of Hematology-Oncology at Virginia Mason Medical Center in Seattle, WA. In addition to a full clinical practice in this tertiary medical center, Dr. Weiden served as Principal Investigator of the Community Clinical Oncology Program (CCOP) where he gained experience in cooperative group trials and as the Principal Investigator responsible for the design and conduct of phase 1/2 trials involving radiolabeled monoclonal antibodies. Dr. Weiden also served as Medical Director of the Cancer Clinical Research Unit and as a member of the Ethics Committee and the Research Advisory Committee, each of which provided unique exposure to different aspects of clinical research.
From 1971 to 1980, Dr. Weiden was a member of the Division of Medical Oncology, University of Washington and Fred Hutchinson Cancer Research Center, where he was involved in studies of stem cell transplantation and tumor immunotherapy. Dr. Weiden's training includes Harvard College and Medical School and the National Cancer Institute, Bethesda, Maryland. He has published over 240 articles dealing with clinical and preclinical aspects of oncology, hematology, radiolabeled monoclonal antibody therapy and stem cell transplantation.
A former senior consultant at Milestone, Dr. Wilson continues her consulting career as VP and Chief Scientific Officer at Aclairo. Prior to consulting, Dr. Wilson was a pharmacology/toxicology reviewer 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.
Theresa L. Gerrard, Ph.D..has both FDA and industry experience and has been president of TLG Consulting Inc. for the past ten years. She assists pharmaceutical and biotechnology companies in product development and regulatory strategy from early development through phase 4. She aids clients in an understanding of the FDA review process, CMC issues for proteins, and review of clinical submissions to the FDA., Dr. Gerrard was with the FDA for 11 years and was the Director of the Division of Cytokine Biology (now the Division of Protein Therapeutics). In this capacity she worked with many manufacturers in the review of IND and license applications for a variety of protein therapeutics. Prior to establishing TLG Consulting Inc., she was Director of Development for Amgen in Boulder, Colorado where she oversaw the product development of several products.