Principal
Richard
B. Stead, MD
Senior Consultant
Paul
L. Weiden, MD
Associates
Ellen
Cheung, Ph.D.
Paul
Fredlund, MD
Paul
Flyer, Ph.D.
Molly
Fischer, CRNP, MPH
Dr.
David Liebowitz
Cüneyt M. Serdar,
Ph.D
Anne Trench
Other Members of the BioPharma Consulting Services Network Include:
Brent
Blumenstein, Ph.D.
Dave
Boyden
Theresa
L. Gerrard, Ph.D.
Larry
Johnson
Nancy
Kercher
Patrick Noonan
Ph.D.
James
Posada, Ph.D., MBA
Susan Wilson D.V.M.,
Ph.D.
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.
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.
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.
www.pnwstat.com
email
Paul has over 25 years experience in the application of statistical
methods. This experience has been obtained while in senior positions
at the FDA, in the pharmaceutical industry (Amgen, Biogen Idec and ICOS)
and as part of a major contract research organization (Westat). Paul’s
primary areas of expertise are 1) developing statistical strategies for
product registration, 2) optimizing the use of complicated study findings
and 3) developing efficient implementation plans and processes for data
collection, processing and analysis (validation and CDISC)
www.pnwstat.com
email
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.
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.
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.
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.
www.TriArcConsulting.com
email
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.
www.miradorstrategies.com
email
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.
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.
http://biofinity.org
email
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.
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.
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
account the company’s assets, expertise, and intellectual property.
From 2004 Dr. Posada was the Senior Vice President of Business and Market
Development for GlycoFi, Inc., a biotechnology company spun out of Dartmouth
College. During his tenure at GlycoFi, Dr. Posada structured and negotiated
company transforming deals with Eli Lilly & Co.
and Merck & Co., ultimately leading to the 2006 sale of the company to Merck in the largest
all-cash transaction to date. Prior to GlycoFi, Dr. Posada was the Senior
Director of Business Development at Protein Design Labs, Inc. where he
was responsible for structuring and negotiating both in-licensing and
outlicensing transactions with pharmaceutical partners. From 1998-2002
Dr. Posada was with Eli Lilly & Company, serving on the management team of the therapeutic proteins division,
a 300 person biotech R&D component within Lilly. During that period Dr. Posada completed assignments
in New Product Planning and also worked closely with Lilly’s Corporate
Business Development team in the structuring and negotiation of several
key R&D collaborations and in-licensing transactions with biotech partners.
Dr. Posada is trained as a molecular biologist in cancer therapeutics,
working in the area of protein kinases and cell signaling. As a National
Institutes of Health post-doctoral Fellow at the Fred Hutchinson Cancer
Center, Dr. Posada cloned one of the first mitogenactivated protein (MAP)
kinases, and with colleagues at the University of Washington, worked
out the upstream activation pathway through MEK kinase; uncovering a
central signal transduction pathway critical in the control of cellular
proliferation. The MAP kinase pathway has since become the focus of numerous
drug discovery efforts, yielding several important therapeutic drug targets
and investigational drugs. From 1994-1998 Dr. Posada was a tenure track
faculty member at the University of Vermont School of Medicine where
he ran a basic research laboratory funded by the National Institutes
of Health, and National Science Foundation studying the mechanisms underlying
GPCR coupling to MAP kinase pathways. Dr. Posada is the author of over
two dozen peer reviewed publications in top-tier journals such as Science,
and the Journal of Biological Chemistry.
http://www.aclairo.com/
email
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.