Alfred W. Alberts, DSc (Honorary) - Drug Discovery
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Directed programs in the areas of atherosclerosis, diabetes and obesity. Responsible
for the discovery and development of MERCK’s lovastatin and simvastatin. Also, involved
in the discovery of natural products and combinatorial chemicals.
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David Clark, M.S. - GMP Compliance Specialist
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Areas of expertise include Drug and Device Good Manufacturing Practices (GMPs),
Quality Assurance, Quality Control, environmental compliance, Hazardous waste regulations,
and ISO 9000. Formerly at Advanced Polymer Systems.
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Cori Gorman, Ph.D. - Gene Therapy and Therapeutics
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Dr. Cori Gorman, who is a partner in the firm DNA Bridges, Inc., is a recognized
expert in the biotechnology industry having 16 years experience in this field as
a research scientist and administrator. Her experience in strategic planning includes
work in genomics, functional genomics and microarray screening; vaccine development,
including DNA vaccines; tools for gene targeting and persistent gene expression;
cancer; cell biology and neurobiology. She has an outstanding record of achievement
in basic research and drug development applications in diverse areas including gene
therapy, gene expression, and transfer, hormone processing, cell biology, protein
transport, and the humanization and production of recombination of proteins. Two
projects have resulted in marketed therapeutics and four projects have therapeutics
currently in clinical trials. Dr. Gorman has worked for such industry leaders as
Genentech while also being experienced in all aspects of a start-up company. She
has a strong publication (over 13,000 citations and 6 classic citations) and presentation
record. Dr. Gorman developed the CAT assay in 1980 as a postdoctoral fellow in the
LMB/NCI. This assay was developed as a sensitive determiner of gene expression and
was the industry standard for over more than fifteen years.
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Colleen Dragular Johnson, MS. - Toxicology
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Brings over 10 years of experience in the area of toxicology. Holds a M.S. in Toxicology
from University of Arizona as well as Board Certification (D.A.B.T.). Specializes
in the development nonclinical toxicology testing programs for new drugs. Prepares
toxicology summaries for drug and medical device submissions, develops protocols,
monitors toxicology programs, interacts with FDA, conducts due diligence audits.
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Gilbert Lam, Ph.D. - Pharmacokinetics
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He brings 18 years of experience in the area of bioanalysis, pharmacokinetics and
drug metabolism for pharmaceutical development. He held positions as Director of
Preclinical ADME at DuPont Merck Pharmaceuticals and Executive Director of Preclinical
Safety and Drug Disposition at CoCensys and currently the President and CEO of MicroConstants,
a full service bioanalytical company specialized in HPLC/MS analysis.
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Joseph G. Lombardino, Ph.D. - Drug Discovery
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Spent 41 years at PFIZER CENTRAL RESEARCH where he discovered Feldene, the first
once-a-day treatment of arthritis. Formed and headed the Department of Development
Planning which established matrix teams and project management techniques to the
drug development process. Most recently, was Senior Director of Operations Planning
at PFIZER CENTRAL RESEARCH. Has published 64 scientific papers including 2 books
and holds 56 patents.
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Andrew R. McCullough. M.D. - Urology
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Dr. Andrew R. Mccullough is Assistant Professor of Clinical Urology and Director
of Male Sexual Health and Fertility in the Urology Department at the New York University
Medical Center.
In 1974 he completed his undergraduate work in natural sciences at the Johns Hopkins
University in Baltimore and in 1978 his medical school training at the University
of Maryland School of Medicine in Baltimore. After his surgical internship at the
University of Florida Shands Teaching Hospital, he returned to the Johns Hopkins
University for his urology training. In 1981 he completed a one year fellowship
in uro-oncology and in 1983 completed his urology residency, under the tutelage
of Patrick C. Walsh at Brady Urological Institute of the Johns Hopkins University
Hospital. He joined the clinical faculty at Johns Hopkins as clinical instructor
in 1983.
In 1984 he moved to New Haven and joined the clinical urology faculty at the Yale
School of Medicine as clinical instructor. In addition to his teaching responsibilities
to the medical students and urology residents at Yale University he also engaged
in a busy practice of general urology in New Haven.
In 1994 he joined Dr. Herbert Lepor, Dr. Ellen Shapiro and Dr. Christopher Dixon
to help restructure the Urology Department and residency program at New York University
Medical Center. Since 1994 he has subspecialized in malesexual health and fertility
tapping into 10 years of general urologic practice. He holds hospital appointments
at the NYU-Mount Sinai Medical Center and the Manhattan Veterans Admistration Hospital.
He has studied with Dr. Tom Lue in San Francisco and collaborating with his wife,
Dr. Joanna Fine, a psychiatrist and clinical instructor in the Department of Psychiatry
at NYU, he seeks to provide a comprehensive approach at the diagnosis and treatment
of male sexual dysfunction. He has lectured and presented papers nationally and
internationally both in the areas of male sexual health and fertility and frequently
donates his time to lecture at local RESOLVE and American Infertility Institute
support group meetings to educate infertile couples.
He has been principle investigator in numerous clinical trials in erectile dysfunction
including the pivotal sildenafil trials. Currently he is conducting ED trials with
Bayer, TAP, Liliy-ICOS and Pfizer as well as investigator initiated collaborative
projects with the departments of psychiatry and reproductive endocrinology..
Dr. McCullough is board certified in Adult and Pediatric Urology and has served
as a high level advisor and expert to many companies including Pfizer, Bayer, Bristol
Meyers Squibb, Vivus, Schering-Plough, Smith Kline Beecham, and TAP. He is a fellow
of the American College of Surgeons, member of the Society for Male Reproduction,
American Society of Andrology, American Urological Association, Society of Sex Therapy
and Research and the Society for the Study of Male Reproduction.
Areas of active research include the study of post radical prostatectomy erectile
dysfunction, female sexual dysfunction, the effect of sperm cryo-preservation of
post IVF-ICSI miscarriage rates, and the impact of aging on human seminal parameters.
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Alvin J. Melveger, Ph.D. - Analytical Chemistry
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Analytical methods development including validations, stability studies and process/product
trouble shooting. Formerly at Ethicon, Inc.
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Otto H. Mills Jr., Ph.D.- Dermatology
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Otto Mills joined the University of Pennsylvania's Graduate Group on Molecular Biology
in 1965 and the Department of Dermatology, School of Medicine in 1967. His first
appointment at The University of Medicine and Dentistry of New Jersey, Robert Wood
Johnson Medical School was in 1984, where he is a member of the Division of Dermatology.
He has authored or co-authored over two hundred publications and lectured by invitation
at universities and medical meetings in the United States, Europe and Asia.
Dr. Mills has served as Chair of Dermatologic and Allergic Diseases, American Society
of Clinical Pharmacology and Therapeutics, and he is a Fellow of the American College
of Clinical Pharmacology. His other memberships include: Sigma Xi (University of
Pennsylvania), the American Federation for Medical Research, the Society for Investigative
Dermatology and the American Academy of Dermatology.
Among the awards he has received for original research are those from the American
Academy of Dermatology (1970, 1981, 1985), the College of Physicians of Philadelphia
(1971), the Medical Society of New Jersey (1975), the American Medical Association
(1975), and the Southern Medical Association (1971).
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Terry F. Plasse, M.D. - Medical Oncology
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Pharmaceutical development management from preclinical through phase IV testing
with both biologics and drugs. Extensive interaction with FDA from IND through product
approval. Expertise in the area of medical oncology. Formerly at Rhone-Poulenc Rorer
and Interferon Sciences.
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David W. Pratt, M.S. - Marketing
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Specializes in marketing, market research, product launches, medical education.
Strong scientific and marketing background allows David to work with both traditional
and biotech products.
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Frederick E. Reno, Ph.D. - Toxicology
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Holds a Ph.D. in Toxicology from Utah State University. Specializes in FDA interactions
and strategies, preparations of IND, IDE, PMA and NDA toxicology sections. Manages
entire nonclinical toxicology programs including program design, protocol preparation,
placement and execution of nonclinical studies, preparation of study reports and
their inclusion into regulatory submissions. Formerly Vice President of the Life
Sciences at Hazelton Laboratories.
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Howard Rubin, M.A. - Product and Process Development
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Research and development executive with more than thirty years of consumer and professional
pharmaceutical and cosmetic product development experience. Formerly at Johnson
& Johnson, Block Drug, Warner-Lambert, Hoffman-LaRoche & Bristol-Myers.
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Janet L. Wolfe, Ph.D. - Pharmaceutical Chemistry
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After completing a Ph.D. in Pharmaceutical Chemistry from the University of Kansas,
Dr. Wolfe was awarded a post doctoral fellowship at the National Institutes of Health
Clinical Center Pharmaceutical Development Section where she was involved in developing
NIH-generated compounds for use in clinical trials. Following her stay at NIH, Dr.
Wolfe was appointed Assistant Professor at the University of Tennessee, where she
expanded her expertise in pharmaceutical analysis, pharmaceutical preformulation
and formulation. Following Tennessee, she founded Wolfe Laboratories Inc. (www.wolfelabs.com),
a contract research organization providing research and development services to
the pharmaceutical and biotechnology industries.
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