Scientific Advisors

Alfred W. Alberts, DSc (Honorary) - Drug Discovery

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.

David Clark, M.S. - GMP Compliance Specialist

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.

Cori Gorman, Ph.D. - Gene Therapy and Therapeutics

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.

Colleen Dragular Johnson, MS. - Toxicology

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.

Gilbert Lam, Ph.D. - Pharmacokinetics

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.

Joseph G. Lombardino, Ph.D. - Drug Discovery

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.

Andrew R. McCullough. M.D. - Urology

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.

Alvin J. Melveger, Ph.D. - Analytical Chemistry

Analytical methods development including validations, stability studies and process/product trouble shooting. Formerly at Ethicon, Inc.

Otto H. Mills Jr., Ph.D.- Dermatology

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).

Terry F. Plasse, M.D. - Medical Oncology

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.

David W. Pratt, M.S. - Marketing

Specializes in marketing, market research, product launches, medical education. Strong scientific and marketing background allows David to work with both traditional and biotech products.

Frederick E. Reno, Ph.D. - Toxicology

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.

Howard Rubin, M.A. - Product and Process Development

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.

Janet L. Wolfe, Ph.D. - Pharmaceutical Chemistry

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.