Responsible for global development of pharmaceuticals, biologics and drug-coated medical devices. Oversight of the planning and 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, immuno-sciences and inflammation therapeutic areas. Responsible for the planning and execution of the Global Quality Assurance, Medical Sciences and Medical Affairs functional areas. Member of four person leadership team driving corporate reorganization that formed the Global Pharmaceutical Research and Development organization.
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.
Key Biopharmaceutical Accomplishments:
20 years experience in Clinical Research Trials and Phase I to Phase IV drug development.
• Championed selected molecules, successfully guiding them through the pre-clinical and clinical drug development process, and achieving regulatory approval (US and International).
• Managed complex joint collaborations with corporate and academic partners.
• Issued patents from both US (4) and European (2) patent offices with 5 patents pending
• 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 to receive regulatory approval for the treatment of severe sepsis .
• 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).
• 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.
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)
and executed over 20 clinical trials Phase I to Phase III/IIIb as Principal Investigator.
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
CERTFICATIONS:
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
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 Medals
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
