Bill has expertise in clinical development, regulatory NDA –BLA - ANDA – IND – IDE – PMA – 510K FDA - OPDP submissions, strategies and approvals; commercialization, marketing and management of products and technologies for the Biotech, Medical Device, Allied Health and Pharmaceutical Industries. He has diverse product experience spanning all major medical specialties, delivery methods, and innovative health care practices. Along with extensive management experience of all phases of the FDA processes, he also has experience with European (ISO/GCP/GMP), Canadian and Japanese regulatory environments, and with IBC AHA and JCAHO regulatory affairs processes. Bill has worked with GCP auditing & CRO assessments / evaluations, Medical Monitoring, Pharmacovigilance Monitoring & Data Mining Analysis & Processing and Risk Management Planning & Reviews.
Bill is a current committee member of PRC, IRB, DSMB, Federal Grant & IBC (various)
EXPERIENCE:
Capital City Technical Consulting, Inc., Washington, D.C.
CSO/Medical Director
CELSION Corporation, Columbia, Maryland
Vice President, Clinical & Medical Affairs
Vaccinogen (formerly INTRACEL) Corporation, Frederick, Maryland
Vice President, Clinical & Medical Affairs
Quintiles MTC, Inc., Arlington, Virginia / Rockville, Maryland
Senior Director, U.S. Clinical Operations - Medical Device Division
Director, Medical Affairs
PPD Development, Inc. (formerly PPD/Pharmaco, Inc.), Wilmington, North Carolina
Medical Director
Nastech Pharmaceutical Co., Inc., Hauppague, New York
Director, Medical Affairs & Clinical Development
ISG Technologies, Inc., Toronto, Canada
Director, Clinical Development & Medical Affairs
The AVMD Group (Audio Visual Medical Marketing, Inc.), New York, New York
Vice President, Medical Affairs
Klemtner Advertising, Inc. (Division of Saatchi & Saatchi Advertising Worldwide), New York, New York
Medical Director
Bill Gannon is a Clinical Consultant at Proxima Clinical Research, Inc. Proxima is a contract research organization focused on assisting emerging pharmaceutical and medical device companies in clinical product development. He is an MD and has an MBA in Health Care Administration / Marketing.
Mr. Gannon is part of the following IRB, DSMB, IBC, Clinical Advisory Boards, Professional Organizations & Affiliation:
CSSi - Medical & Clinical Advisory Board 2014- Present
NIAID/NIH/DHHS – HIV-AIDS Research Review Committee 2013-Present
OTSUKA Pharmaceuticals America, Inc. – PRC (DDMAC Clearance/OPDP) 2007- 2015
DMID/NIAID/NIH - DSMB – Vaccine Committee 2010- 2020
BCAN (Bladder Cancer Advocacy Network) – Advisory Board Consultant 2007- 2018
AREAS Corporation - IBC 2006-2012
Intercell, Inc. (Kendle - CRO) - IRB 2010-2011
TOTAL IRB 2009-10
AVI Inc. - DSMB 2008-09
Great Lakes IRB 2007-10
Aspen Publishing, Inc.; Frederick, MD – Editorial Advisory Board Member 2001-03
EER Medical Systems; Chantilly, VA– Clinical Consultant 2001-03
SMA Medical Corporation; Irvine, CA– Clinical Advisory Board Member 2000-02
The Health Exchange, Inc.; Stamford, CT– Clinical Advisory Board Member 2000-02
Mr. Gannon is part of the following Board of Directors:
RARE DISEASE REPORT – Advisory Board Member 2015 - 2020
CUREMARK, LLC – Advisor to Board of Directors 2008 – Present
PROTALEX, Inc. – Consultant to Board of Directors 2009 - 2016
APTHERA, Inc. – Member – Board of Directors 2005-2011
CYTIMMUNE SCIENCES, Inc. - Consultant to Board of Directors 2005- 2010
Mr. Gannon is part of the following Research & Professional Organizations & Affiliations:
Foundation for Sickle Cell Research – Chairman – Board of Directors 2013 to 2014
AdvaMed (Advance Medical technology Association) 2010 to Present
Mautner Project – Member – Board of Directors 2005 to 2012
Drug Information Association 2000 to Present
Regulatory Affairs Professional Society (RAPS) 2000 to Present
ACRP/American Academy of Pharmaceutical Physicians & Investigators 1992 to Present
Vice President, Public Relations Committee, Membership Committee 1994 to 1997
American Association of Pharmaceutical Scientists 1994 to 1997
Associates of Clinical Pharmacology 1995 to 1999
American College of Healthcare Executives
Mr. Gannon has contributed to the following peer-reviewed publications:
A Specific Pancreatic Insufficiency in Children With Autism Spectrum Disorder; Pearson, D.; 20 authors; Gannon, W.E.; British Journal of Medicine. Q4 - 2017
PTRX-100 in Combination with Methotrexate in Patients with Active Rheumatoid Arthritis: A Phase 1b Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Safety Study: Bernton, E; Gannon, W.E; Kramer, W; Krantz, E., American Journal of Rheumatology. Q3 – 2013
The Value of EDC in Early Stage Clinical Trials. Gannon, W.E., Life Science Leader. Q1 - 2012.
Phase I & Pharmacokinetic Studies of CYT-6091, a Novel PEGlyated Colloidal Gold-rh TNF Nanomedicine. Tamarkin, L.; Gannon, W.E. et al., Clinical Cancer Research, January 2011.
Expanded Market Opportunities Using Nasal Drug Delivery: A Case Study. Gannon, W.E., AAPS Journal, December 1995.
Nasal Vitamin B12: Intranasal Versus Intramuscular Serum. Vitamin B12 Profile in the Treatment of Vitamin B12 Deficiency Anemia. Romeo, V.D.; Sileno, A.P.; Gannon, W.E., AAPS Journal, October 1994.
The Viewing Wand – A New System for 3-Dimensional CT – Correlated Interoperative Localization. Leggett, B.L.; Greenberg, M.M.; Gannon, W.E.; Dekel, D.; Gabe, C.J., Current Surgery, December 1991.
Mr. Gannon has presented at the following conferences:
Final Results from a Phase I Clinical Trial Evaluating the Safety, Immunogenicity and Ant-Tumor Activity of SNS-301 in Men with Biochemically Relapsed Prostate Cancer: Nordquist, L, 6 authors; Gannon, W.E.; Presentation – ESMO. October 2018
Panelist – Medical Cannabis Clinical Trial Symposium – Philadelphia, PS, December 2017
Panelist – Optimizing Clinical Development for Early Phase Oncology Programs – Harvard – Boston, MA 2017
Meeting Leader – BCAN (Bladder Cancer Advocacy Network) Annual Meeting – Snowmass, CO, August 2013
Co-Author - A Phase 1 Randomized, Double-blind, Placebo-controlled Multiple-dose Study of Intravenous Staphylococcal Protein A in Patients with Active Rheumatoid Arthritis on Methotrexate: Pharmacokinetics, Safety, and Tolerability – American College of Rheumatology Annual Meeting – Washington, DC, November 2012
Meeting Leader – BCAN (Bladder Cancer Advocacy Network) Annual Meeting – Stowe, VT, August 2012
Speaker - The Value of EDC in Early Stage Clinical Trials. Gannon, W.E., AAPS Annual Mtg Presentation. October 2011
Meeting Leader – BCAN (Bladder Cancer Advocacy Network) Annual Meeting – SanDiego, CA, August 2011
Meeting Leader – BCAN (Bladder Cancer Advocacy Network) Annual Meeting – Traverse City, MI, August 2010
Medical Leader – Investigator’s Meeting – Phase I Trial in Vaccine Therapy Treatment of Rheumatoid Arthritis – Protalex, Inc. - George, South Africa – May 2010
Meeting Leader – BCAN (Bladder Cancer Advocacy Network) Annual Meeting – Jackson Hole, WY, August 2009
Medical Leader – Investigator’s Meeting – Phase III Clinical Trial for Autism - Curemark, Inc, Rye, NY, November 2008
Speaker – “The Role of Industry in Funding Clinical Trials in/for Academic Cooperative Groups” – Children’s Cause for Childhood Cancer Advocacy Annual Meeting – New York City, NY – October 2008
Medical Leader – Investigator’s Meeting – Phase II Clinical Trials in Nanotechnology in Oncology – CytImmune Sciences, Inc., June 2008
Speaker – “The Role of Industry in Funding Clinical Trials in/for Academic Cooperative Groups” – BCAN (Bladder Cancer Advocacy Network) Annual Meeting - Washington, DC, September 2007
Panelist - Oncology Clinical Trial Summit – Arlington, VA, September 2007
Emerging Novel Technologies in Bladder Cancer: 2nd Annual JHU Bladder Cancer Think Tank, Cape Cod, MA, August 2007
Emerging Novel Technologies in Cancer Therapies: Partnerships with CRO’s, Orlando, FL, March 2007
Focused Microwave Phased Array for Targeted Treatment of Primary Breast Tumors: ESHO 2003, Munich, Germany, June 2003
Thermodynamic Therapy for the Treatment of Cancer: ESHO 2003, Munich, Germany, June 2003
Phase II Clinical Studies of FMPA for Primary Breast Cancer – Progress Report: ESHO 2003, Munich, Germany, June 2003
Web Based Clinical Trials: Where are We Today and Where Are We Headed
Web Based Clinical Trials Conference: New Orleans, LA, March 2001, Boston, MA, October 2001
Autologous Vaccine Therapy – Panel Discussion
ASCO Annual Meeting, New Orleans, LA, April 2000
Third Annual Medical Device Industry Conference: Legislative Update ’98
San Francisco, CA, March 1998
Intranasal Drug Delivery: Commercial Advantages
AAPS Conference, Miami, FL, November 1995
Innovative Drug Development ’95: Company Overviews
Technologies and Opportunities Communitech Conference, New York, NY, May 1995
CAS in Neurosurgery – Overview and Clinical Applications
Stereo tactic Conference UCLA, Los Angeles, CA, August 1992
CAS Systems and Its Applications to FESS
First International Congress for Advance FESS, Vienna, Austria, July 1992
Minimally Invasive Surgery – CAS in Neurosurgery
Biomedical Business Institute, San Diego, CA, May 1992
3-D Imagery: A Role in Radiology Today
Radiology Society of North America, Chicago, IL, December 1991
Impact of Computer Technologies on the Department of Surgery
Northeast Hospital Conference, Baltimore, MD, April 1989
Chymotrypsin: Evidence of a Novel Pancreatic Insufficiency in Children with ASD?: IMFAR Annual Mtg. May 2017
Results of a Phase I Clinical Trial of CYT-6091: A PEGylated Colloidal Gold-TNF Nanomedicine: ASCO Annual Mtg. June 2010
Preliminary Results of a Phase I Clinical Trial of CYT-6091: A PEGylated Colloidal Gold-TNF Nanomedicine: ASCO Annual Mtg. June 2007
Phase II Clinical Studies with FMPA for Primary Breast Cancer – Progress Update: ASBS Annual Mtg., Miami, FL, and February 2003
New Drug Delivery Approach for the Treatment of Prostate Cancer: CaP Cure Annual Mtg.: Washington, DC. September, 2002
Ongoing Phase II Clinical Studies of Focused Microwave Phased Array (FMPA) Thermotherapy for Primary Breast Cancer: American Society of Breast Surgeons (ASBS) Annual Conference: Miami, FL, March, 2002
