CHIEF MEDICAL OFFICER & VICE PRESIDENT
GLOBAL DRUGS,BIOLOGICS,IMMUNOLOGY
ONCOLOGY,DRUG SAFETY,PHARMACOVIGILANCE
CMO & VP with extensive successful experience in directing
biotech drug and biologics development and managing CRO's.
have directed non-clinical programs, Phase I, II, III, IV clinical trials,
Biostatistics, Regulatory Affairs. Therapeutic areas include Oncology,
CNS, GI, Respiratory, HIV & Infectious Disease, Immunology,
Anti-Inflammatory, Endocrinology, Critical Care, Allergy.
Twenty years HIV clinical development experience-Phase I,
Phase II,Phase III,Phase IV clinical trials-Global experience.
Translational Medicine experience includes preclinical studies and
novel Proof of Concept Phase I & Phase II Clinical Trials
employing biomarkers, genomics, proteomics, metabolomics,
novel patient selection criteria. Therapeutic areas include
inflammation, respiratory, oncology. Consultant to major
pharmaceutical companies and leading biotech companies.
Immunology experience includes translational medicine and clinical
Development programs for major pharma and biotechs :
Pfizer,Bayer,Merck,Astra Zeneca,Glaxo,Eli Lilly,Amgen,
Smith Kline,multiple early stage biotechs.
PFIZER CENTRAL RESEARCH-9/06-CURRENT
Consultant-Global Drugs & Biologics Development
Groton,CT and New York City
25-40
Immunology,Oncology,CNS,Infectious Disease
Multiple early stage biotechs-oncology,autoimmune.
BEARDSWORTH CONSULTING GROUP-4/03 -7/06
Medical Director Oncology & Immunology
A Full Service CRO
70 Church Street
Flemington, NJ 08822
Anti-Inflammatory Drugs and Biologics Development
Phase I,II and III programs in asthma, rheumatoid arthritis,
inflammatory bowel disease, multiple sclerosis, allergy, sepsis.
drugs and biologics include monoclonal antibodies, integrin
inhibitors, TNF inhibitors, p38 inhibitors, cytokine and interleukin
inhibitors. Vaccine clinical research and development
.
* Charged with leading international clinical development
Teams for oral dual integrin inhibitors for multiple sclerosis
Asthma,rheumatoid arthritis,Crohn's Disease and IBD.
Led Phase I,IIa and IIb clinical trials.Organized ScientificAdvisory Board of
international experts in each therapeutic area.Phase III trials now being
enrolled.
Clients were major pharmaceutical companies.Led clinical development teams with
up to 75 multiple disciplinary clinical development professionals.
* Initiated and led clinical development teams in Phase II and Phase III
clinical trials for rheumatoid arthritis with anti CD20 monoclonal antibody.Phase
III clinical trials are in progress.
Clinical Oncology Drugs and Biologics Development
Beardsworth has designed, managed, monitored, produced accurate datasets,
analyzed, and reported on oncology Phase I, II, III, IIIb in thousands of
patients enrolled in hundreds of investigative sites. Significant oncology
programs have been performed for major pharmaceutical companies and leading
biotechnology companies.
Solid tumors: brain, breast, esophagus, head and neck, lung, melanoma,
ovary, prostate, renal cell. Hematologic malignancies: acute myelogenous
leukemia, chronic lymphocytic leukemia, hairy cell leukemia, multiple
myeloma, non-hodgkins lymphoma. Drugs and biologics have
included: monoclonal antibodies, antisense, proteasome inhibitors,
angiogenesis inhibitors, anti-metabolite, and cytotoxics.
* Charged with Phase I,Phase II and Phase III clinical development of Velcade
for resistant/refractory multiple myeloma.
Responsibilities included design of clinical trials,clinical operations,NDA
submission which was approved by FDA.Led clinical and regulatory teams with up to
80 multiple disciplinary professionals.
GLYCOGENESYS,INC 2/1999-4/2003
Chief Medical Officer Oncology & Immunology
31 St James
Boston,MA 02116
Responsible for preclinical and clinical development of novel
Anti-inflammatory drugs and biologics for rheumatoid arthritis,
IBD,multiple sclerosis and asthma.
Key responsibilities also include design of Phase I ,II & III
oncology clinical trials for GCS-100 - a novel therapeutic that induces
programmed cell death by selectively depolarizing the mitochondria of
cancer cells as well as mediating a Bcl-2 pathway induced apoptosis
of cancer cells. Responsible for establishing successful strategy for drug
development of GCS-100 and all submissions and interactions with
the FDA. Key role in successful joint venture funding with a
major pharmaceutical company. Entrepreneurial spirit, excellent
communication skills, people management and project management.
Responsible for clinical operations..
* Charged with preclinical and clinical development of a first
In class novel galectin 3 inhibitor in oncology and immunology.
Multiple Phase I and Phase II clinical trials with KOLs including
Prostate cancer,colorectal cancer and pancreatic cancer. Created Phase III
clinical programs for multiple indications including prostate cancer,colorectal
cancer,pancreatic cancer and breast cancer.Led clinical development teams with up
to 70 multidisciplinary professionals.
* Initiated preclinical and clinical development of novel galectin 3 inhibitor
in auto immune disease including rheumatoid arthritis and asthma.
* Discovered new clinical indication for novel galectin 3 inhibitor-cirrhosis
of the liver.Organized world class development team and KOLs.Clinical development
in progress.
* Leadership role in all interactions with FDA.
* Leadership role in raising over 25 million USD from private investors
* Leadership role in establishing 50 million USD Joint Venture with the Elan
Corporation
SPRINGGATE ASSOCIATES 1998-Present
President and Medical Director Oncology & Immunology
1320 Little Meadow Road
Guilford, CT 06437
Consultants to the pharmaceutical and biotechnology industry on medical issues,
design of clinical trials, United States and international regulatory issues,
product licensing, product development, pharmacovigilance.
Oncology drugs and biologics development. Nonclinical safety and efficacy
programs. Design and manage Phase I-Phase IV clinical trials for pancreatic,
colorectal, prostate, breast, lung malignancies. Cytotoxic drugs and moleculary
targeted oncology drugs including angiogenesis inhibitors,
Receptor tyrosine kinase inhibitors, apoptosis inducers, inhibitors of
metastasis, Pharmacogenomics and proteomics. Gene therapy. Excellent FDA
contacts.
Medical Safety & Pharmacovigilance: Monitor and provide medical evaluation for
adverse events. Write safety expert reports and overall
safety evaluation for aggregate safety reports. Make recommendations
for labeling changes. Review documents relative to safety oversight.
Familiar with regulatory guidelines and references. Experienced in post
marketing pharmacovigilance. Deals with safety related issues using
Critical medical and regulatory analytical strategies to develop optimal
solutions.
International Regulatory Affairs: Responsible for regulatory submissions in the
U.S., Europe and Japan. Drugs, Biologics and Devices.
Clinical Pharmacology: Design and execute Phase I, Phase II and Phase III
clinical trials for CNS therapeutics, infectious diseases including HIV,
cardiovascular, endocrinology, oncology, rheumatology. Extensive
experience in pharmacokinetics.
Quality Assurance: QA consulting responsible for compliance with Good Clinical
Practices, Good Manufacturing Practices and Good Laboratory Practices.
Marketing: Design and execute Phase IV clinical trials for national and
international product launches for drugs, devices and biologics.
UNIVERSITY OF CONNECTICUT SCHOOL OF MEDICINE
Founder-Medical Director Oncology & Immunology
Clinical Research Center
New Britain General Hospital
Affiliated-University of Connecticut School of Medicine
100 Grand Street
New Britain, CT 06050 October 1995 - January 1998
Clinical Trials: Professional responsibilities include medical, scientific,
regulatory and business direction of all Phase I, Phase II, Phase III and Phase
IV clinical trials at New Britain General Hospital, a 350 bed acute care hospital
with over 250 physicians on the Medical Staff. The Hospital is a major teaching
hospital affiliated with the University of Connecticut School of Medicine. The
Clinical Research Center, at the present time, is responsible for a total of over
100 state of the art clinical trials in Oncology, Cardiology, Neurology,
Endocrinology, Infectious Diseases, OB/GYN, Pediatrics, Psychiatry, Nuclear
Medicine and Radiology.
Clinical Pharmacology: Design and execute Phase I clinical trials for infectious
diseases, cardiovascular, endocrinology, oncology, pulmonary medicine, psychiatry
and neurology.
International Regulatory Affairs: Responsible for regulatory submissions in the
U.S., Europe and Japan. Drugs, Biologics and Devices.
Quality Assurance: Managed QA group responsible for compliance with Good
Clinical Practices, Good Manufacturing Practices and Good Laboratory Practices.
Corporate Partnering: Structuring and negotiating domestic and international
strategic alliances. Research and development agreements. Product license
agreements. Distribution agreements. Separate entity joint ventures.
Marketing: Design and execute Phase III and Phase IV clinical trials for
national and international product launches for drugs, devices and biologies.
NATIONAL MEDICAL RESEARCH CORPORATION
Vice President Clinical and Regulatory Affairs
25 Main Street
Hartford, CT 06106 April 1994 - September 1995
Full service CRO where I had 125 muldisciplinary clinical development
Professionals reporting to me including MDs,Ph.D.s,CRAs.
Professional responsibilities include design and execution of Phase I, Phase II,
Phase III and Phase IV Clinical Trials. Provide regulatory consultation to
leading biotec |