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 in
ternational 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 clinic
al 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, analyz
ed, and reported on oncology Phase I, II, III, IIIb in thousands of patients enr
olled in hundreds of investigative sites. Significant oncology programs have bee
n performed for major pharmaceutical companies and leading biotechnology compani
es.
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 f
or resistant/refractory multiple myeloma.
Responsibilities included design of clinical trials,clinical operations,NDA subm
ission 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 clini
cal programs for multiple indications including prostate cancer,colorectal cance
r,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 o
f 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 Co
rporation
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, pr
oduct licensing, product development, pharmacovigilance.
Oncology drugs and biologics development. Nonclinical safety and efficacy progra
ms. Design and manage Phase I-Phase IV clinical trials for pancreatic, colorecta
l, prostate, breast, lung malignancies. Cytotoxic drugs and moleculary targeted
oncology drugs including angiogenesis inhibitors,
Receptor tyrosine kinase inhibitors, apoptosis inducers, inhibitors of metastasi
s, Pharmacogenomics and proteomics. Gene therapy. Excellent FDA contacts.
Medical Safety & Pharmacovigilance: Monitor and provide medical evaluation for a
dverse 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 clinic
al trials for CNS therapeutics, infectious diseases including HIV, cardiovascula
r, endocrinology, oncology, rheumatology. Extensive
experience in pharmacokinetics.
Quality Assurance: QA consulting responsible for compliance with Good Clinical P
ractices, Good Manufacturing Practices and Good Laboratory Practices.
Marketing: Design and execute Phase IV clinical trials for national and internat
ional 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, regu
latory and business direction of all Phase I, Phase II, Phase III and Phase IV c
linical trials at New Britain General Hospital, a 350 bed acute care hospital wi
th over 250 physicians on the Medical Staff. The Hospital is a major teaching ho
spital affiliated with the University of Connecticut School of Medicine. The Cli
nical Research Center, at the present time, is responsible for a total of over 1
00 state of the art clinical trials in Oncology, Cardiology, Neurology, Endocrin
ology, 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, psychiat
ry 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 Clinica
l Practices, Good Manufacturing Practices and Good Laboratory Practices.
Corporate Partnering: Structuring and negotiating domestic and international str
ategic alliances. Research and development agreements. Product license agreement
s. Distribution agreements. Separate entity joint ventures.
Marketing: Design and execute Phase III and Phase IV clinical trials for nationa
l 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 lead
ing biotechnology companies and major pharmaceutical companies. Consultation inc
ludes quality of life and pharmaco-economic evaluation
* Charged with clinical development of novel biologic for multiple sclerosis in
cluding Phase II and Phase III trials.Leadership
Responsibility for NDA submission which was approved by the
FDA for Copaxone.Organized panel of KOLs.
Projects included:
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 Clinica
l Practices, Good Manufacturing Practices and Good Laboratory Practices.
Central Nervous System: Design and execute Phase I, Phase II and Phase III clini
cal trials for Alzheimer's disease, Parkinson's disease, stroke, dementia, depre
ssion, Amyotrophic Lateral Sclerosis and Multiple Sclerosis. Clinical trials inc
luded significant populations of elderly patients.
Gerontology: Design Phase 1, Phase II and Phase III clinical trials with signifi
cant population of elderly patients.
Oncology: Design Phase I, Phase II and Phase III Clinical trials for breast, ova
rian, colon, prostate, as well as melanoma and Kaposi's sarcoma.
Gene Therapy: Design Phase I and Phase II clinical trials for gene
therapy of human cancers employing modifications of tumors, antisense oligodeoxy
nucleotides, suicide genes, stem cell modification and lymphocyte modification.
Rheumatology: Phase III clinical programs for rheumatoid arthritis and osteoarth
ritis.
Infectious Disease: AIDS - Design and execution of Phase I Trial to evaluate nov
el HIV-1 protease inhibitor. Influenza A and B - Design and execute Phase II Tri
al to evaluate efficacy and safety of novel inhaled and intranasal therapeutic f
or treatment and prevention of influenza.
Septic Shock - Design and execution of Phase II and Phase III studies to evaluat
e novel tumor necrosis factor receptor blockers.
Surgical Infections - Design and execute Phase III clinical trials for complicat
ed intra-abdominal infections, prophylaxis of colo-rectal surgeries and pelvic i
nfections with a novel antibiotic.
Projects also included Phase I, II and III clinical trials for asthma.
GENZYME
Clinical Research Group-Full Service CRO
Vice President of Product Development and Medical Director
London,La Jolla,Boston and New Jersey
November 1989 - March 1994
All business units reported to me including: Regulatory Affairs; Biostatistics;
New Product Development; Clinical Trials Design and Monitoring - Phase I, Phase
II, Phase III, and Phase IV; Medical Writing,
finance and marketing. Provide consultation to leading biotechnology companies a
nd the major pharmaceutical companies.
Projects included:
International Regulatory Affairs: Responsible for regulatory submission in the U
.S., Europe and Japan.
Central Nervous System: Design and execute Phase I, Phase II and Phase III clini
cal trials for Alzheimer's disease, Parkinson's disease, stroke, dementia, depre
ssion, Amyotrophic Lateral Sclerosis and Multiple Sclerosis. Clinical trials inc
luded significant populations of elderly patients.
Gerontology: Design Phase 1, Phase II and Phase III clinical trials with signifi
cant population of elderly patients.
Oncology: In preparation for filing Product License applications, design Clinica
l Development Programs for ex vivo therapies with monospecific
and bispecific monoclonal antibodies. Experience in designing clinical developme
nt programs involving autologous and allogenic bone marrow transplantation with
both positive selection therapeutic strategies (CD34+) and negative selection. (
Purging with monoclonal antibodies specific for tumor cells.)
Hematology: In preparation for filing appropriate Product License Applications,
design clinical development programs for antithrombin III and Von Willebrands fa
ctor.
Infectious Disease: Design Clinical Development Programs and evaluate novel ther
apies for AIDS, Septic Shock and Lyme Disease.
Rheumatology: Design and execute Clinical Development Program for osteoarthritis
, rheumatoid arthritis and systemic Lupus Erythematosus.
Blood Bank: Design and execute a Clinical Development Program for novel blood su
bstitute and for a novel family of solutions for cryopreservation of blood compo
nents.
Immunotherapy: Evaluate a novel autologous vaccine for human colorectal carcinom
a. Evaluate novel therapeutic strategies for Interleukins, Growth Factors and Ce
ll Adhesion Molecules.
 SCICOR-COVANCE CENTRAL LABS
Vice President of Professional Services
2643 Rand Road
Indianapolis, IN 46241 July 1988 - October 1989
Accepted Genzyme Position when Corning bought Scicor.
Corporate Objectives:Scicor does clinical testing for the forty major pharmaceut
ical companies in collaboration with over two thousand physician-investigator si
tes at major medical centers, universities and clinics.
Responsibilities:
Medical, scientific and administrative direction of all sections of the Clinical
Laboratory including Immunology, Hematology, Microbiology, Urinalysis and Radio
immunoassay. The Clinical Laboratory was staffed by 80 health care professionals
.
Medical, scientific and administrative direction of the Technical Administration
Department. This department was responsible for Clinical Project Design, establ
ishing disease specific reference ranges for all clinical tests, statistical ana
lysis of test results and the integrity of the medical and scientific database.
Medical and scientific consultant to the forty major pharmaceutical companies ad
vising on design of clinical trials, selection of clinical tests, statistical an
alysis of clinical results. Scicor is now doing clinical testing for over three
hundred clinical trials including Phase I, Phase II, Phase III and Phase IV.
The clinical trials include the evaluation of new therapeutics in the discipline
s of Infectious Diseases, Virology, AIDS, Rheumatology, Diabetes, Hyperlipidemia
, Hematology, Cardiovascular and Neurology.
Accomplishments:
Profits increased over five hundred percent (500%) in the past twelve months as
business volume increased over three hundred percent (300%).
Successfully managed both the Clinical Laboratory and the Department of Technica
l Administration during three hundred per-cent (300%) growth. Designed and imple
mented management structure for all laboratory sections. Recruited key health ca
re professionals, formulated the budget for the Clinical Laboratory and Technica
l Administration on a quarterly basis owing to explosive growth rate.
Managed New Test Development Program. Ensured compliance with all federal, state
and local regulations. Had the leadership responsibility for preparing the Clin
ical Laboratory for inspections by the college of American Pathology, CLIA and t
he FDA. Inspections were also conducted by the pharmaceutical companies. Under m
y direction, all inspections went well and let to accreditation by all appropria
te agencies.
OCHSNER CLINIC 7/85-6/88
Medical Director and Attending Physician
Clinical Immunology Laboratories
New Orleans,La
*
Rheumatology: Responsible for all clinical immunology profiles. Clinical researc
h to improve treatment of patients with severe rheumatoid arthritis and SLE by i
mmune monitoring and monoclonal antibodies. AIDS: Responsible for state-of-the-a
rt lymphocyte subset analysis for all AIDS patients at Ochsner.
Oncology: Responsible for immunophenotyping all leukemias and lymphomas. Clinica
l research with B cell activation monoclonals. DNA laser flow cytometry to monit
or patients with bladder carcinoma, breast carcinoma, colon carcinoma and prosta
te carcinoma.
Transplantation: Clinical research to develop state of the art immune monitoring
with monoclonal antibodies and laser flow cytometry for heart, liver and renal
transplantation.
Immunohematology: Immunoelectrophoresis workups. Immunofixation. Share responsib
ility for HLA, Serology Laboratories and Blood Bank Hemotherapy including therap
eutic aphaeresis.
Assistant Professor, Department of Microbiology and Immunology
Tulane Medical Center
New Orleans, LA 1976 - 1981
NIH and American Cancer Society Grants. Honors for excellence in teaching.
Medical and scientific responsibility in Infectious Diseases and Virology.
EDUCATION AND Immunohematology Post Graduate Fellow July 1984 - June 1985
TRAINING Tulane Medical Center, New Orleans, Louisiana
Resident in Clinical Pathology July 1983 - June 1984
Tulane Medical Center, New Orleans, Louisiana
M.D. - M.D., Ph.D. Program June 1981 - May 1983
University of Miami School of Medicine, Miami, Florida
Visiting Scientist and Postdoctoral Fellow
Fox Chase Center for Cancer and Medical Sciences
University of Pennsylvania School of Medicine
Philadelphia, PA 1971 - 1975
Clinical Research in oncogenic tumor viruses and carcinogenesis.
Fellow of Leukemia Society of America
Ph.D. Biochemistry September 1968 - May 1972
Boston College, Boston, Massachusetts
National Science Foundation Predoctoral Fellow
A.B. Biology September 1964 - August 1967
Boston University, Boston Massachusetts
CERTIFICATION: Board Certified in Clinical Pathology, American Board of Patholog
y, 1989
LICENSURE: Diplomate, National Board of Medical Examiners, July 1, 1984
Connecticut Medical Licensure, 1994
MEMBERSHIPS: Regulatory Affairs Professional Society
Connecticut State Medical Society
New Haven County Medical Association
American Academy of Pharmaceutical Physicians
American College of Physician Executives
SELECTED PUBLICATIONS AND ABSTRACTS
1. Springgate, C.F., Cartwright, T, .Belt, R., Redfern, C., Stuart, K. (2001)Pha
se II Study of GBC-590 in Patients with Relapsing or Refractory Colorectal Cance
r Abstract. American Society of Clinical Oncology
2. Springgate, C.F. (1993) Prognostic Quantitative Pathologic Features in Ovaria
n Tumors and Adoptive Immunotherapy, Proceedings of the European Multicenter Ova
rian Tumor Symposium, Invited Address.
3. Garner, R.J. Springgate, C.F. and Hoyt, T. (1989) Immune Monitoring of Blood
in Heart Transplant Recipients: Application of Flow Cytometry, Seminars in Diagn
ostic Pathology, 6, 83.
4. Springgate, C., Hussey, J. and Hoyt, D. (1988) Immune Monitoring Transplant P
atients with Monoclonal Antibodies and Flow Cytometry, American Society for Hist
ocompatibility and Immunogenetics, Invited Review.
5. Tseng, C.K., Springgate, C. et al (1988) Identification of a Novel Human B Ce
ll Activation Antigen Involved in B Cell Growth Factor Dependent Proliferation,
J.of Immunology, 140:2305.
6. Springgate, C. et al (1988) A Unique Lymphocyte Subset is Significantly Incre
ased in Active Rheumatoid Arthritis but not in Polymyalgia Rheumatica, Abstract,
American Rheumatism Association Meeting.
7. Springgate, C. et al (1988) Increased Helper Inducer T Cells in Polymyalgia R
heumatica, Abstract, American Rheumatism Association Meeting.
8. Rosenberg, S., Blaiss, M. and Springgate, C. (1988) Emerging Therapies for Au
toimmune Disease such as Systemic Lupus Erythematosus, Modern Medicine, 56: 44-4
7.
9. Rosenberg, S., Blaiss, M. and Springgate, C. (1988) New Therapies for Diabete
s Mellitus, Modern Medicine, 56:42-45.
10. Blaiss, M. and Springgate, C. (1988) Human Immune System Response to Allerge
ns, Modern Medicine, 56:52-55.
11. Tseng, C., Springgate, C. et al (1987) Development and Characterization of a
Human B Cell that Responds to B Cell Growth Factor but not Interleukin II, J.of
Immunology, 138: 2552.
13. Springgate, C., Flaum, M. and Cooper, E. (1987) The Therapeutic Potential of
the Interleukins, Modern Medicine, 55:44-46.
14. Springgate, C. Flaum, M. and Cooper, E. (1987) The Promise of Interferon in
the Treatment of Common Diseases, Modern Medicine, 55:44-46.
15. Cooper, E., Flaum, M, and Springgate, C. (1987) The Functions of T Cells in
Managing Arthritis, Allergens and Infections, Modern Medicine, 55:24-26.
16. Cooper, E., Flaum, M. and Springgate, C. (1987) Macrophages: Controllers of
the Human Immune System, Modern Medicine, 55:40-43.