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MICHAEL MILES WESS 3711 MEDICAL DR., STE. 834 SAN ANTONIO, TX 78229 +1.210.375.5557 (HOME) +1.210.827.8372 (MOBILE) mwessmd@mac.com

EDUCATION

MPH, Johns Hopkins University, Bloomberg School of Public Health Baltimore, Maryland

MD, University of Chicago, Pritzker School of Medicine Chicago, Illinois

MBA, University of Chicago, Booth School of Business Chicago, Illinois

BA, Boston University, College of Liberal Arts Boston, Massachusetts

PROFESSIONAL EXPERIENCE

Jul-2013 to present			Wess Consulting, PLLC – San Antonio, Texas President and CEO Worked as consultant to several companies- reviewed phase 2 through 4 clinical trial data and wrote the safety sections of various documents including REMS and PSURs. Assisted clients in developing clinical development programs in various therapeutic areas.

2006 to Jun-2013			Genzyme, a Sanofi Company – San Antonio, Texas Medical Director and Global Safety Officer, Global Pharmacovigilance & Epidemiology Global Safety Officer for biopharmaceutical (small molecule and biologics), vaccine and medical device development programs (phases 1-4 and non-clinical). Medical Director, Global Patient Safety and Risk Management (GPS&RM)- responsible for mentoring and training of new GPS&RM physicians. As Global Safety Officer, continuously assess the overall risk-benefit profile and maintain updated CCDS, USPI, SPC and local labels for several drugs, biologics and devices. Provide medical review and regulatory support for assessment of clinical trial, literature and post-marketing AEs, SAEs, UADEs and SUSARs in various regulatory regions including the US, EU, Japan, Canada, Mexico, Brazil, Norway, Indonesia, Philippines, Thailand, Egypt, Argentina, Chile, Uruguay, South Africa, Columbia, Turkey, China, Russia, Ukraine, Switzerland, Serbia, Belarus, Iceland, Israel, Australia, New Zealand, South Korea and India. Participate in life cycle management of approved products (including directing clinical development of new indications). Represent company at meetings with global regulatory authorities. Provided input into the design of drug development programs (phases 1-4). Write sections of clinical trial protocols, CSRs, IBs, ISSs, ASRs and PSURs. Developed and implemented company-wide training program regarding specific safety topic of QTc assessment (ICH E14 and ICH S7B) and hepatotoxicity as critical issues in drug/biologic development. Supervise electronic filing of individual case safety reports according to ICH E2B guidelines. Assumed primary responsibility for the design and conduct (monitoring) of 2 “Thorough QT Studies (TQT Studies)” according to ICH E14 guidelines. Performed scheduled and ad hoc analysis of company safety database and public databases for safety signals using a variety of data mining techniques including MGPS, PRR and BCPNN. Authored EU-RMP, Canadian RMP, RiskMAP and draft REMS for several drugs/biologics. Re-wrote several USPIs according to PLR SPL format. Participated in submission of 2 NDAs, 2 BLAs, 1 sBLA, 1 510(k) and 2 PMAs. Therapeutic areas include: cardiovascular disorders, oncology, transplant (both solid organ and hematopoietic), genetic disorders of metabolism, GvHD, neurology and lipid disorders. Broadened experience in general safety issues and periodic regulatory submissions for a wide spectrum of products (i.e. - drugs, biologics, vaccines and devices) across therapeutic areas and throughout the world.

2005 to 2006						Wess Consulting, PLLC – Houston, Texas Principal and Founder Worked as consultant to several companies- reviewed phase 2 through 4 clinical trial data and wrote the safety and efficacy sections of CSRs, ASRs and PSURs. Assisted clients in developing clinical programs for drugs, biologics and medical devices in various therapeutic areas. Developed successful filing strategies for 2 drugs, 1 biologic and 1 medical device (i.e., 2 NDAs, 1 BLA and 1 PMA). Co-founder, editor and chief medical writer for a consumer healthcare website.

2001 to 2005			 		 Amarin Pharmaceuticals – Mill Valley, California Vice President, Scientific, Medical and Regulatory Affairs Responsible for Pharmacovigilance, Medical Information, Medical Affairs and Regulatory Affairs for a growing pharmaceutical company. Specialized in neurology and pain management, although company’s portfolio of products also included therapeutic areas of allergy/immunology, cardiology, oncology, endocrinology, gastroenterology, and neuroimmunology. Directed phase 2 to 4 clinical programs for Huntington’s Disease, Parkinson’s Disease and Pain Management including design of clinical trials, writing of protocols and running day-to-day drug safety and regulatory activities. Collaborated with corporate partners in submission of NDAs, including one compound with Orphan Drug designation. Developed Drug Safety and Medical Information Department from their beginning- major responsibilities included writing SOPs, developing the drug safety database/ and recruiting personnel. Developed SOPs relating to cGCP, cGLP and cGMP compliance, including SOPs relating to ICH guidelines. Collaborated with Sales and Marketing Department to support sales force, reviewed/developed promotional materials and interacted with various regulatory agencies, such as DDMAC. Developed training and educational materials for sales force and for healthcare practitioners. Evaluated compounds for in-licensing on the basis of safety, efficacy and market potential. Participated in development of overall business strategic plan for company. Performed CBA and CEA for on-going drug development programs and made “go/no-go” decisions based on results. Managed budgets of over $20 million/year. 2000 to 2001			Texas Biotechnology Corporation (TBC) – Houston, Texas Medical Director Served as Project Medical Officer for phase 1 to 4 clinical trials of endothelin antagonists, direct thrombin inhibitor and selectin antagonists. Therapeutic areas included: pulmonary hypertension; essential hypertension; renovascular hypertension (renal artery stenosis); prostate cancer; congestive heart failure; cardiac arrhythmias; coronary artery disease including use of PTCA; asthma; immunology; solid organ transplant; and treatment/prevention of GvHD. Served as: Clinical Team Leader for the selective endothelin antagonist program; Medical Monitor for the non-selective endothelin antagonist program; Medical Monitor for the PTCA and Stroke phase 4 trials of thrombin inhibitor; and Medical Monitor for the selectin antagonist program. Founded and managed company’s Drug Safety Unit that was responsible for safety reporting for phase 1 to 3 clinical trials of 12 investigational compounds. Successfully filed an sNDA and IND in the US and an IND in Canada. Wrote and implemented all SOPs for Drug Safety and for Post-Marketing Safety Surveillance including installation of global safety database using an Oracle-based system. Participated in face-to-face meetings with global regulatory authorities. Presented research findings at the Seventh International Conference on Endothelin (ET-7) in Edinburgh, Scotland.

1996 to 2000						Quintiles, Inc. - Arlington, Virginia Director, Medical Affairs (11/96 – 5/98) Senior Director, Drug Safety (5/98 – 1/99) Senior Director, Medical and Scientific Affairs, Cardiovascular Therapeutics (1/99 – 3/00) Senior Clinical Consultant, Regulatory Affairs (1/00 – 7/00) Participated in clinical trials (phase 1 to 4) of new drugs, biologics and medical devices. Medical Monitor for international clinical trials which were in a variety of therapeutic areas including: cardiology, dermatology, general internal medicine, infectious disease, neurology, pain management, erectile dysfunction, vascular surgery, hepatic transplant and rheumatology. Served as Project Medical Officer in 4 large cardiovascular trials of drugs/devices involving over 100,000 patients worldwide (indications: acute coronary syndromes, PTCA/restenosis, aortic dissection, and hypertension). Medical Monitor for other trials across therapeutic areas including AIDS, community-acquired pneumonia, epilepsy, osteoarthritis, migraine headache, Alzheimer’s disease, and type II diabetes. Served as echocardiography consultant (focused on heart failure incidence during thiazolidinedione trials) and ECG core reading lab. Identified safety signals (liver function test abnormalities, QTc prolongation) during clinical trials. Participated in Investigator Meetings including protocol presentation. Participated in business development including bids, proposals and budgets. Supervised Medical Writing Department, Medical Affairs Department, Drug Safety Unit and Medical Monitors. Developed and grew Drug Safety Unit in Washington, DC area. Served as Drug Safety expert for law firm involved in a high-profile lawsuit regarding cardiac effects of a diet drug therapy. Prepared and supervised filing of SAEs, PSURs, UADEs and IND safety alerts for approximately 75 clinical trials resulting in over 500,000 patient-years of medical monitoring and safety surveillance experience. Participated in filing of 3 INDs, 7 NDAs, 1 ANDA, 3 sNDAs, 2 IDEs, 4 BLAs, 1 PLA and 1 PMA. Received President’s Award for outstanding achievement as Senior Director. Participated in development of first prototypes for MedDRA. Managed budgets over $200 million.

1995 1996				Corning Besselaar, Inc. (Covance) - Princeton, New Jersey Associate Medical Director, Clinical Research Participated in national and international clinical trials (phase 1-3) of new drugs, biologics and medical devices involving over 15,000 patients. Wrote protocols for clinical trials and reviewed study reports and 2 NDAs. Principal author of 2 CSRs, 3 clinical trial protocols, 2 ISSs and 1 ISE. Reviewed and supervised reporting of SAEs to the FDA and global regulatory authorities. Participated in business development and Investigator Meetings. Investigated use of the Internet for registration of clinical trials.

1993 1995				Georgetown/NIH/Washington VA - Washington, DC Fellow, Cardiovascular Diseases Trained in invasive and non-invasive cardiovascular techniques at 3 institutions (Georgetown University Hospital, National Institutes of Health [NIH] and Washington National Veteran’s Administration Hospital [VA]). Worked in ICU/CCU, inpatient and outpatient settings. Gained experience in: diagnostic left and right heart catheterization; PTCA; intravascular ultrasound; echocardiography (including stress echocardiography); exercise treadmill testing; Holter monitoring, ECG interpretation; and non-invasive imaging (including cardiac CT, MRI and PET).

1992 1993	Hospital of the University of Pennsylvania (HUP)- Philadelphia, Pennsylvania Attending Physician, Emergency Medicine Responsible for supervision and instruction of housestaff in a busy urban emergency room with a Level I trauma center. Gained extensive experience in field of emergency medicine (achieved Board Eligible status) with a special emphasis on trauma, anesthesia/critical care and obstetrics/gynecology.

1992 1993	 Hospital of the University of Pennsylvania (HUP) - Philadelphia, Pennsylvania Clinician-Educator Fellow, Department of General Internal Medicine Responsible for direct patient care in Penn General Internal Medicine Clinic. Developed curriculum and taught housestaff for both in-patient and out-patient clinical education modules. Invited by ABIM to assist in writing questions for the ABIM Internal Medicine Board Certification exam. Attending Physician at Philadelphia VA Internal Medicine Clinic and as a Medical Consult Attending and Ward Attending Physician for inpatient services at HUP.

1989 1992	Hospital of the University of Pennsylvania (HUP) - Philadelphia, Pennsylvania Intern and Resident, General Internal Medicine Responsible for direct patient care in an academic medical center, and formal teaching of housestaff and students in primary care medicine. Performed clinical outcomes research.

1988 1989					Ernst & Whinney (Ernst & Young) - Chicago, Illinois Intern, Management Consulting Responsible for conducting labor economics analysis of nursing shortage. Performed strategic planning analyses for hospitals. Established risk management plans for safety issues.

1987 1988					   American Medical Association - Chicago, Illinois Policy Analyst Responsible for conducting research in medical quality assurance and medical economics.

1985						  National Institutes of Health - Bethesda, Maryland Research Fellow Investigated stress-mediated modification of benzodiazepine receptor. Utilized high-throughput screening of various chemical libraries and identified potential drug candidates.

1984		         Argonne National Laboratory/US Department of Energy - Argonne, Illinois Research Intern Responsible for rational design of agents for PET imaging, including both non-clinical and clinical research of investigational agents.

1981 1984				   Massachusetts General Hospital - Boston, Massachusetts Clinical Chemist Responsible for biochemical analysis of patient specimens. Acquired advanced experience in a variety of quantitative and qualitative clinical chemical techniques.

1982 1983				   Brigham and Women’s Hospital - Boston, Massachusetts Research Analyst Responsible for performing clinical neurophysiologic research.

CERTIFICATIONS/LICENSURE

•	Certified in Public Health (CPH), National Board of Public Health Examiners •	Internal Medicine, Diplomate of the American Board of Internal Medicine •	Advanced Trauma Life Support (ATLS), Advanced Cardiac Life Support (ACLS) •	Board Certified, Internal Medicine •	Granted medical license in the District of Columbia and Commonwealth of Pennsylvania

PROFESSIONAL MEMBERSHIPS

•	Academy of Pharmaceutical Physicians and Investigators •	American College of Physicians •	American Medical Association •	American Public Health Association (APHA) •	Amnesty International (AI) •	Drug Information Association (DIA, Clinical Safety and Pharmacovigilance Committee) •	Drug Safety Executive Council (DSEC) •	EBSCO Publishing Medical Advisory Board •	Médecins Sans Frontières •	International Society for Pharmacoepidemiology (ISPE) •	International Society for Pharmacoeconomic and Outcomes Research (ISPOR) •	Physicians for Human Rights (PHR)

THESIS TOPICS

Johns Hopkins University, Bloomberg School of Public Health, MPH Thesis “An Examination of Biostatistical Approaches to Safety Signal Evaluation in Phase 1 Clinical Trials: Implications for Public Health”

University of Chicago, Booth School of Business, MBA Thesis “A Prediction of the Relative Diffusion of New Technologies: MRI versus PET”

Boston University, Departments of Chemistry and Biology, BA with Distinction Thesis “An Analysis of Brain Myelin Proteolipid Protein: Implications for Clinical Research”

RECENT COURSEWORK (Coursera)

2012 “Computing for Data Analysis”				Johns Hopkins University “Computational Methods for Data Analysis”			University of Washington

2013 “Drug Discovery, Development & Commercialization” 	University of California, San Diego “Cryptography I”						Stanford University “Vaccine Trials: Methods and Best Practices”		Johns Hopkins University “Computer Networks”					University of Washington “Computational Molecular Evolution”			Technical University of Denmark “Nanotechnology”						Rice University

PRESENTATIONS AND PEER-REVIEWED PUBLICATIONS

Wess M. Is There a Link Between the Chernobyl Accident and the Current Global Incidence Rate of CLL? A Geospatial Analysis. Drug Information Journal, October, 2013 (submitted).

Wess M. De-risking Drug Candidates in Early Clinical Development. Webinars sponsored by the Drug Safety Executive Council on 07-MAY-2009, 01-APR-2010 and 02-AUG-2010.

Kantarjian H, Jeha S, Gandhi V, Wess M and Faderl S. Clofarabine (Clolar®): Past, Present, and Future. Leukemia and Lymphoma, October, 2007; 48(10): 1922-30.

Wess M. New Therapeutics in Parkinson’s Disease: Zelapar®. Presented at the International Conference on Parkinson’s Disease, March, 2004 in Beijing, China.

Wess M and Scott D. The Pharmacodynamics of Zelapar®: Confirmation of MAO-B Selectivity. Presented at American Society of Experimental Neurotherapeutics Meeting, December, 2003 and published in NeuroRx, 2003.

Nausieda P, Stern M, Hubble J, Silver D, Wess M, and Watts R. Pergolide (Permax®) Monotherapy Titration in Parkinson’s Disease. Presented at the 7th International Conference on Parkinson’s Disease and Movement Disorders, November, 2002 and published in Movement Disorders, 2002.

Wess M, Mather J, and Davidson T. Effects of TBC3711, A Novel Endothelin A Antagonist, on the Hemodynamics of Normal Healthy Males. Presented at the 7th International Conference on Endothelin (ET-7) held September, 2001 in Edinburgh, Scotland.

Schwartz S, Wess M, Labrca R, Skolnick P, and Paul S. Acute Stress Enhances Activity of the GABA Receptor Gated Chloride Ion Channel in Brain. Brain Research, 411: 151-55, 1987.

Gatley S, Wess M, Govoni P, Katz J, and Friedman A. Deuterioglucose: Alteration of Biodistribution by an Isotope Effect. Journal of Nuclear Medicine, 27:388-94, 1986.

Wilkins D, Hallet M, and Wess M. Audiogenic Startle Reflex of Man and Its Relationship to Startle Syndrome. Brain, 1009:561-73, 1986.

Wess M and Fisher M. Evoked Motor Response Duration: Differences in Aging between Males and Females. Muscle and Nerve, 7:577-78, 1985.

ABBREVIATIONS USED IN THIS CV

ANDA		Abbreviated New Drug Application ASR		annual study report BCPNN	Bayesian confidence propagation neural network BLA		Biologics License Application cGCP		current Good Clinical Practice cGLP		current Good Laboratory Practice cGMP		current Good Manufacturing Practice CBA		cost-benefit analysis CCDS		company core data sheet CEA		cost-effectiveness analysis CHMP		Committee for Medicinal Products for Human Use CSR		clinical study report DDMAC	Division of Drug Marketing, Advertising and Communication (FDA) EU-RMP	European Union-Risk Management Plan GvHD		graft-versus-host disease GPS&RM	Global Patient Safety & Risk Management ICH	International Conference on Harmonisation IDE		Investigational Device Exemption IND		Investigational New Drug ISE		Integrated Summary of Efficacy ISS		Integrated Summary of Safety MedDRA	Medical Dictionary for Regulatory Activities MGPS		multi-item gamma Poisson Shrinker PADER	Periodic Adverse Drug Experience Report PLA		Product License Application PLR		Physicians’ Labeling Rule PMA		Pre-Market Approval (application) PRR		proportional reporting ratio PSUR		Periodic Safety Update Report REMS		Risk Evaluation and Mitigation Strategy RiskMAP	Risk Minimization Action Plan SAE		serious adverse event sBLA		supplemental Biologics License Application sNDA		supplemental New Drug Application SPL		Structured Product Labeling (FDA) SUSAR	suspected unexpected serious adverse reaction (EMA) UADE		unanticipated adverse device effect

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