Advisors
Science, Research & Clinical
|
Nicholas M. Dean, PhD
|
|
Dr. Dean is a leader in the field of oligonucleotide therapeutics, with an emphasis on pharmacology and serves as an Independent Consultant in the Biotech industry. He founded Excaliard Pharmaceuticals in 2006 – an RNAi company focused on developing antisense-based drugs to treat skin scarring, and which was later acquired by Pfizer in 2011. Prior to this, Dr. Dean was vice president of Functional Genomics and Oncology at Isis Pharmaceuticals, where he also served as managing director of Isis Singapore. He originally joined Isis Pharmaceuticals in 1991 and served in various roles in the molecular pharmacology department until 2000, at which time he became executive director and vice president, Functional Genomics for Isis Pharmaceuticals. He is a member of the editorial board of Antisense & Nucleic Acid Research and Drug Discovery Today: Technologies. He served as a Member of Scientific Advisory Board at Galena Biopharma, Inc., since March 2007 and Arcturus Therapeutics since May 2013. He has also served as member of the Scientific Advisory Board of RXi Pharmaceuticals Corp. Dr. Dean has published over 120 scientific articles, and has over 50 issued patents. Dr. Dean received his Bachelor of Science degree from the University of Wales. He completed his PhD at the Welsh National School of Medicine (Cardiff) in 1984 before conducting post-doctoral research at the National Institutes of Health and the University of Hawaii.
David Ward, PhD
Dr. Ward is a prominent research scientist with significant expertise in virology, molecular genetics, cytogenetics and biotechnology. He is author on over 300 manuscripts and has been issued more than 40 patents while faculty at Yale University. Over 20 of his patents are still in use in the clinical diagnostic and therapeutic areas, including non-isotopic nuclei acid labeling techniques, single and multiparametric fluorescence in situ hybridization (FISH) in cancer diagnostics, the Abbott Urovision™ test for bladder cancer and the LabCorp 6-plex protein blood test for detection of ovarian cancer, molecular cytogenetics (M-FISH or spectral karyotyping [SKY]) and prenatal diagnosis of Down Syndrome and other disorders with chromosomal abnormalities. Dr. Ward was elected to the National Academy of Sciences of the United States in 1998.
|
Thomas S. Kupper, MD
|
|
Dr. Kupper is the Thomas B. Fitzpatrick Professor of Dermatology at Harvard Medical School, Chairman of Dermatology at Brigham And Women's Hospital. He has served as Director of the Harvard Skin Disease Research Center (HSDRC) since its initial funding in 1994 and is the co-leader of the Cutaneous Oncology/Melanoma Program in the Dana Farber/Harvard Cancer Center. His research has focused on epidermal and T cell cytokines, adhesion molecules, dendritic cells and T cell homing, and the interface between acquired and innate immunity in the skin. He initiated several transgenic approaches to the study of skin immunopathophysiology. His current research focus also includes cutaneous oncology, with active translational research programs in cutaneous T cell lymphoma, dendritic cell immunobiology, and vaccine therapy.
|
Joseph F. Merola, MD
|
|
Dr. Merola is Assistant Professor of Dermatology at Harvard Medical School and the Director of Clinical Trials and Co-Director of the Center for Skin and Related Musculoskeletal Diseases at Brigham And Women's Hospital. He was trained in Dermatology, Internal Medicine and Rheumatology with clinical and research interests at the interface of these specialties. Dr. Merola focuses on autoimmunity in two major disease state areas: psoriasis/psoriatic arthritis and connective tissue disorders (e.g., cutaneous and systemic lupus erythematosus, dermatomyositis, systemic sclerosis).
Product Development, FORMULATION, Manufacturing & Control (CMC)
Gregory E. Hardee, PhD
Dr. Hardee is a Senior Pharmaceutical Consultant providing strategic and creative advice on pharmaceutical development issues ranging from novel drug delivery to expedient development. He has held positions of responsibility in the Pharmaceutical and Biotechnology Industry throughout my career. As a 30-year industry veteran, he has accumulated considerable experience in the areas of strategic, inventive, technical and regulatory issues. He has successfully developed all types of NCEs, dosage forms and unique delivery systems, with expertise in Formulation Research, Drug Product Development, CMC, and Quality issues and providing guidance from preclinical research through registration, approval and manufacturing for market.
Strategic & Regulatory Counsel, FDA Liaison (IND, CTA, and NDA)
Elizabeth Gordon, PhD
Dr. Gordon is responsible for developing, directing and implementing the global regulatory strategy, objectives, policies and programs pertaining to the development of drug and biological products. Dr. Gordon acts as a liaison with regulatory health authorities (FDA and other global authorities). Technical areas of expertise include: preparation and/or evaluation of pre-clinical and clinical data; quality/chemistry, manufacturing, and controls information; and pharmacology and toxicology data submitted to the health authorities to support the safe and effective use of drug and biological products specified by Investigational New Drug (IND), Clinical Trial Application (CTA), and New Drug Application (NDA) requirements. Dr. Gordon has in-depth knowledge of FDA programs to facilitate and expedite development of new drugs.
