Business Management Experience:
January 2002 – 2004
Responsible for global development of pharmaceuticals, biologics and drug-coated medical devices and key functional areas. Oversight of the direction, planning, execution of clinical trials/research (Phase I to Phase IV), budget approval and regulatory submission in cardiovascular (drug and drug coated devices), renal, anesthesia, pain, immunosciences and inflammation therapeutic areas. Additionally, responsible for the direction, planning, execution and budget approval of the Global Quality Assurance, Global Medical Sciences and Global Medical Affairs functional areas. Member of four person leadership team which drove major corporate reorganization resulting in the formation of the Global Pharmaceutical Research and Development organization.
Jan 1998 to Jan 2002
Responsible for developing business strategy for critical care, cardiovascular, inflammation and bio-products therapeutic areas, identification of disease state targets with high value un-met needs, development and prioritization of critical care/cardiovascular/inflammation portfolio, and business development for acquisition and out-licensing of molecules. Managed complex joint collaborations with corporate partners. Executive sponsor and scientific leadership for pulmonary/critical care anti-inflammatory small molecule programs, antimicrobial program, XIGRIS, and academic scientific discovery (joint Lilly-Harvard) program.
Member clinical research committee which reviews and approves all clinical trials in all therapeutic areas and reviews/approves molecule/program advancement at each development phase. Designated Eli Lilly spokesperson for Investor Relations for critical care/inflammation portfolio. Frequent invited speaker at national/international scientific meetings. Global Product Team Leader responsible for all aspects of XIGRIS product development. Global clinical development plans, budget development and management, clinical trial design and execution, global registration strategy, international regulatory interactions, plans and execution, global marketing strategy, plans and execution, manufacturing and CM&C plans, discovery and clinical science to support regulatory and product label claims, FDA meetings, publications, statistical analysis and data analysis.
Key Biopharmaceutical Accomplishments:
20 years experience in Clinical Research Trials and Phase I to Phase IV drug development.
Proven track record of:
• Scientifically championing selected molecules, successfully guiding them through the pre-clinical and clinical drug development process, and achieving regulatory approval (US and International).
• Building international network of collaborators, effective interactions with professional organizations, thought leaders and regulatory organizations (US and International).
• Managing complex joint collaborations with corporate and academic partners.
• Issued patents from both US (4) and European (2) patent offices with 5 patents pending
• Co-founding biopharmaceutical company (Incyte).
• Full development and FDA and ROW regulatory approval of XIGRIS (LLY)
• (recombinant human activated protein C, drotrecogin alfa (activated)) for the treatment of severe sepsis. This is the first and only molecule (biologic or small molecule) to receive regulatory approval for the treatment of severe sepsis in the world.
• Assisted ONO Pharmaceuticals to achieve Japanese Regulatory approval of ELASPOL (neutrophil elastase inhibitor, sivelestat sodium hydrate) for treatment of ARDS/ALI This is the first and only molecule to receive regulatory approval for the treatment of acute lung injury (ALI) in the world.
• Development and FDA approval of HUMIRA (ABT)
• (anti-tumor necrosis factor human monoclonal antibody, D2E7, adalimumab) for treatment of rheumatoid arthritis. This is the first fully human monoclonal antibody to receive regulatory approval in the world
Medical and Academic Experience
Head, Section of Critical Care Medicine
the Cleveland Clinic Foundation
1992-1997
Associate Professor and Chief
Division of Critical Care Medicine
Case Western Reserve University, School of Medicine
University Hospitals of Cleveland
1986-1992
Prior to joining the biopharmaceutical industry fulltime, Dr. Fisher’s academic career was as Professor and Head, Section of Critical Care Medicine at the Cleveland Clinic Foundation and served as an international thought leader in sepsis by biopharmaceutical companies to direct the development of their molecules (recombinant proteins, soluble receptors, receptor antagonists, monoclonal antibodies, vaccines and small molecules). He designed, conducted and executed over 20 clinical trials Phase I to Phase III/IIIb as Principal Investigator.
EDUCATION:
San Diego State University - 1964-69
Michigan State University – 1969-1973
B.S. Michigan State University - 1971
M.D. Michigan State University - 1973
MEDICAL LICENSURE:
California A26183
Ohio 35-05-3751
DEA BF179275
Certifications:
Diplomate, American Board of Internal Medicine (ABIM)
June 16, 1976, Certificate #058566
Diplomate, Critical Care Medicine (ABIM)
November 10, 1987, Certificate #058566
Diplomate, American Board of Emergency Medicine (ABEM)
May 7, 1990, Certificate #11828
Board Eligible, Pulmonary Medicine (ABIM)
ACLS Instructor
ATLS Instructor
SIGNIFICANT AWARDS:
Alpha Omega Alpha Medical Honorary Society
Gamma of Michigan
Distinguished Faculty Teacher Award
The Cleveland Clinic Foundation - 1997
Robert Symon Award for High Altitude Flight and Research
The Outstanding Alumni Award "in recognition of outstanding contributions to society and the medical profession"
Michigan State University, College of Human Medicine, 1995
Distinguished Alumus of the University
Michigan State University, May 1997
Patents issued:
Method of treating viral hemorrhagic fever with activated protein C
US # 6, 270, 764 (7 Aug 2001)
EP # 1131091
Methods for treating sepsis
US# 6,344,197 (5 Feb 2002)
Method for treating heparin-induced thrombocytopenia
US# 6, 743.426 (1 Jun 2004)
Methods for treating viral hemorrhagic fever
US # 6767539
Methods for treating thrombocytopenic purpura and hemolytic uremic syndrome
EP # 1137423
Patents Pending:
Method of treating thrombocytopenic purpura and hemolytic uremic syndrome
USPA# 20040087643 (6 May 2004)
Formulations and methods for treating hypercoagulable states
USPA# 20030211969 (13 Nov 2003) and Europe
Methods for treating vascular occlusive disorders and acquired hypercoagulable states by administering a combination of APC and PC Zymogen
Pending US and Europe
Method for treating heparin induced thrombocytopenia (HIT) with Protein C
Pending Europe
Prosthesis having varied concentration of beneficial agent (pharmaceutical agent attached to medical device)
Pending US and Europe
SCIENTIFIC & ADVISORY BOARDS:
Critical Care Medicine Fellowship Site Surveyor-ACGME
Infectious Disease and Critical Care Scientific Advisory Board CENTOCOR
American College of Chest Physicians & Society of Critical Care Medicine
Joint Consensus Conference on Sepsis
ALI/ARDS American-European Consensus Conference
American Thoracic Society-European Society of Intensive Care Medicine Joint Consensus on ALI/ARDS
Society of Critical Care Medicine Task Force on Guidelines
Scientific Advisory Board - Incyte
Scientific Advisory Board – Univax
Scientific Advisory Board – Centocor
Scientific Advisory Board - Celltech
Scientific Advisory Board - Somatogen
Scientific Advisory Board - Synergen
Scientific Advisory Board – Immunex
Scientific Advisory Board – Knoll
Scientific Advisory Board – Eli Lilly
Red Cross Foundation Central Laboratory Blood Transfusion Service, Swiss Red Cross
Military Service:
Lieutenant Colonel
United States Army Reserve
United States Army Special Operations Command
Ft. Bragg, North Carolina
Security Clearance: Top Secret/SCI
Military Awards:
3 Bronze Star Medals with V device (for valor)
Joint Service Commendation Medal
3 Army Commendation Medal
Joint Service Achievement Medal
Army Achievement Medal
2 National Defense Service Medals
Global War on Terrorism Expeditionary Medal
Global War on Terrorism Service Medal
Armed Forces Service Medal
Humanitarian Service Medal
Armed Forces Reserve Medal with M (mobilization) and # 2
Army Service Ribbon
Reserve Components Overseas Training Ribbon with # 4
NATO Medal Former Republic of Yugoslavia (FRY)
Joint Meritorious Unit Award with OLC
Army Parachutist Badge
Parachutist Badge from Cote d’Ivoire (Ivory Coast)
Former wartime service shoulder sleeve insignia (SSI) combat patch
CAPOC, 82nd ABN, 3rd Army
Publications:
Author or co-author of over 75 publications and over 80 abstracts in many areas of medicine and drug research and science (list available upon request).
Grants:
1985
"Methylprednisolone Sodium Succinate in Severe Sepsis and Septic Shock –Multi-Center Study"
UPJOHN
Principal Investigator
1985
“Portable Fluidic High Frequency Jet Ventilator”
NATIONAL INSTITUTE OF HEALTH
CO-Investigator
1985
“Establishment of Animal Preparation of Toxic Shock Syndrome: Effect of Toxic
Shock Syndrome Toxin-1 (TSST-1) on Hemodynamics and Lung Fluid Balance”
DEANS RESEARCH GRANT
Principal Investigator
1987
“HA-1A Human Monoclonal Antibody in Patients with Severe Gram-Negative Sepsis”
CENTOCOR
Principal Investigator and Project Coordinator (12 Centers)
1989
“Prospective, Randomized Double-Blind Multicenter Trial of HA-1A Human
Monoclonal Antibody in Patients with Severe Gram-Negative Sepsis”
CENTOCOR
Principal Investigator and Project Coordinator (24 Centers)
1990
“Murine Monoclonal Anti-TNF Antibody in Patients with Sepsis Syndrome”
CELLTECH
Principal Investigator and Project Coordinator (20 Centers)
1991
“IL-1ra Human Recombinant Interleukin-1 Receptor Antagonist Study-Phase II”
SYNERGEN
Principal Investigator and Project Coordinator (12 Centers)
1991
“Randomized Study of Safety and Immunogenicity of Tetravalent Group B
Streptococcus (GBS) Vaccine in Normal Healthy Volunteers” UNIVAXBIOLOGICS
Principal Investigator and Project Coordinator
1992
“Anti-TNF F(ab’)2 Murine Monoclonal Antibody in Patients with Sepsis Syndrome”
KNOLL PHARMACEUTICALS
Principal Investigator and Project Coordinator (8 Centers)
1993
“Phase II Multicenter Trial to Evaluate the Safety and Efficacy of Recombinant
Human TNF Receptor Fusion Protein (rhu TNFR:Fc) in Sepsis Syndrome”
IMMUNEX
Principal Investigator and Project Coordinator (12 Centers)
1993
Recombinant Human Interleukin-1 Receptor Antagonist in the Treatment of Patients with Sepsis Syndrome (Phase III)
SYNERGEN
Principal Investigator and Project Coordinator (70 Centers)
1994
“A Study to Evaluate the Safety and Efficacy of Human Recombinant Interleukin-1 Receptor Antagonist (IL-1ra) Increasing Survival in Patients with Severe Sepsis,
A Randomized, Double-blind, Placebo-controlled Multicenter Trial” (Phase III)
SYNERGEN
Principal Investigator and Project Coordinator (82 Centers)
1995
“Adult Respiratory Distress Syndrome Clinical Treatment Network” NATIONAL INSTITUTES OF HEALTH
NHLBI – HA-94-05 1995-2002
Co-Principal Investigator
1996
Double-Blind, Placebo-Controlled Study of E5531 Lipid A Antagonist in Patients with Severe Sepsis (Phase II)
EISAI
Principal Investigator
1996
Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a Single dose of Ro-2081 TNF Fusion Protein in the Treatment of Severe Sepsis and Early Septic Shock (Phase III)
HOFFMAN-LAROCHE
Principal Investigator
1996
Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter Study of the Safety and Efficacy of Intravenous Taurolidine in Septic Patients (Phase III)
WALLACE LABORITORIES
Principal Investigator
1996
Phase 2 Study to Determine the Safety, Pharmacokinetics, and Effective Dose Range and Dosing Duration For Recombinant Activated Protein C (rAPC) in Severe Sepsis (Phase II)
LILLY RESEARCH LABORATORY
Principal Investigator
