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Joseph V. Pergolizzi, Jr., M.D.

Objective

An experienced, results-oriented C-Level leader who has leveraged his significant medical, regulatory and business expertise to build a strong track record of success within the health care industry.  Extensive start-up experience with a proven track record of success. My success had been a direct result of my desire to achieve greatness and my passion to develop new entities.

Work Experience

Native Cardiovascular Inc., Naples, FL2015-2017
Co-Founder and Chief Executive Officer
Native Cardiovascular Inc. (Native) is a privately owned medical device company founded in 2013 in Delaware. US operations are based in Naples, FL. Native designs and manufactures medical devices for the management of atrial fibrillation. The first product is intended to be 510K FDA-cleared medical device and is used to help patients with acute post-operative atrial fibrillation. Native aims to provide cutting edge research and innovative technology to the medical community and its patients.
Responsibilities include serving as strategic leader of the company and direct the Executive Management team to establish long and short-range goals, strategies, plans and policies; reporting to the Board of Directors, providing leadership to position the company at the forefront of the industry; developing plans and strategies to increase business and achieve company’s research and regulatory goals while advancing the company’s mission and objectives and to promote revenue, profitability and growth as an organization; oversees company operations in order to insure production efficiency, quality, service and cost-effective management of resources. P&L accountability; negotiating with vendors; developing relationships with insurers and key opinion leaders in the industry; creating partnerships with pharma or other device companies; assisting in raising capital at appropriate valuations to enable the company to meet sales, growth and future commercial objectives; motivating and lead high-performance management team; providing mentoring as a cornerstone to the management team performance; ensuring to reward and discipline employees, address complaints and resolve problems and representing the company to any media and official events.
I bring over 15+ years’ experience in driving biotech companies; a positive track records with startup companies, corporate mergers and acquisitions; experience and recent positive track record of overseeing and executing a pharmaceutical and medical device companies in accordance with FDA 501K, PMA and 505(b)2 and other applicable regulatory standards.

Life Science Equity Partners, LLC., Palo Alto, CA2013-2015
General Partner
Over 15 years of experience in biomedical research, development and finance. Joined LSEP in 2013 as a General Partner, and specializes in funding clinical stage pharmaceuticals as well as mid-level life science companies. Has financed and served on the board of four companies which received successfully commercialized products and was an early investor and board member of these companies. As a consultant, actively contributed to at least 5 blockbuster drugs, 20 NCEs and numerous 505(b)(2) compounds, medical devices, and consumer health products resulting in excess of $15 billion in global sales. Currently is a steering committee member of the Food and Drug Administration’s Safe Use Initiative and Adjunct Faculty at Johns Hopkins University School of Medicine.

Umbria Pharmaceuticals LLC., Naples, FL2010-2014
Chief Executive Officer and Chief Medical Officer
Reporting to the Board of Directors, providing leadership to position the company at the forefront of the industry. Develop the strategic plan to advance the company’s mission and objectives and to promote revenue, profitability and growth as an organization. Oversees company operations in order to insure production efficiency, quality, service and cost-effective management of resources. P&L accountability. Represents the company to any media and official events.
CMO responsibilities include: global strategic direction of Medical Affairs for the company, ensuring alignment with objectives and plans of the organization. Direct oversight and leadership responsibility related to Medical Affairs activities in support of the commercial organizations, and serve as the Company’s ultimate authority on medical affairs issues, clinical research, drug safety and pharmacovigilence. Represents the company with regulatory and legislative agencies, globally addressing the scientific and medical/health aspects of the company’s product portfolio. Acts as the primary spokesperson for the company with key opinion leaders at scientific conferences and advisory boards. Oversees the development and implementation of risk mitigation strategies to ensure the safe and appropriate use of Umbria pharmaceutical products.

Tigris Pharmaceuticals Inc., Bonita Springs, FL2010-2011
Chief Medical Officer
As the Chief Medical Officer this position established the global strategic direction of Medical Affairs for the company, ensuring alignment with objectives and plans of the organization. The CMO served as the Company’s ultimate authority on medical affairs issues, drug discovery, clinical research, drug safety and pharmacovigilence. The CMO represented the company with regulatory and legislative agencies, globally addressing the scientific and medical/health aspects of the company’s product pipeline. The CMO acted as the primary spokesperson for the company with key opinion leaders at scientific conferences and advisory boards. The CMO oversaw the development and implementation of risk mitigation strategies to ensure the safe and appropriate use of Tigris pharmaceutical future products.

NEMA Research Incorporated, Naples, FL1997-present
Founder and Chief Operating Officer
Global business corporate lead with direct responsibilities for turn-key clinical trial management and implementation (Phase I-IV ) including but not limited to: Medical Affairs, SMO activities, budgets and contracting, single to multi-center trial selection and management, protocol concept and regulatory representation, medical information services and support, publications, CSR, IIS, ISE, Pharmacovigilance, commercial trial support for product Market Aligned Planning (MAP), FDA regulatory consulting including sponsor representation (sNDA, NDA, 505(b) 2, 510K) and sponsor- corporate interface.

CreoMed Incorporated, Naples, FL2004-2013
Founder and Chief Executive Officer
CreoMed Inc. is a Consumer Healthcare Pharmaceutical Company located in Naples, FL. Executive business lead overseeing all corporate matters including but not limited to: Corporate strategy and governance, R&D, issue and risk management, turn-key product commercialization including marketing, advertising and sales strategies and tactics, new product licensing, manufacturing / CMC and fulfillment issues, QA/QC, regulatory issues, medical and scientific affairs, financial issues, corporate communications, compliance, partnership/ alliance management, import/ export issues and legal matters.
The company had licensed two major products lines (8 products) from Europe and internally developed one line. The company’s lead product is an FDA OTC monograph topical analgesic called OxyRub that is licensed to a Helen of Troy.

Naples Anesthesia and Pain Associates Naples, FL2001-present
Founder and Senior Partner
A Concierge, Comprehensive Perioperative Consultation Company specializing in Clinical Anesthesia / Pain Management, preoperative consulting, clinical trials investigation services, and pharmaceutical consulting. Responsibilities include KOL services to medical device and pharmaceutical companies, acting as Principal Investigator on research projects, teaching responsibilities, publications, and perioperative and pain medicine consultation.

International Medical Solutions Inc., Baltimore, MD2000-2004
Founder and CEO- Former
Medical Education Company responsibilities included: KOL management, monitoring advisory boards, concept to implementation of move than 50 CME and brand promotional programs, medical publications and presentations, creation enduring materials, and grant creation and management.

AirScript Inc, Washington, DC1999-2004
Founder & CEO- Former
Electronic Prescribing Company (ERx) exclusive partner with Sprint PCS collaborated with eLiily on development of a closed loop e-prescribing system. Executive managerial responsibilities from concept up thru development of ERx system Beta testing using the Sprint PCS G3 system.

The Johns Hopkins University School of Medicine, Baltimore, MD1997-2000
Director of Business Development and Financial and Affairs
Johns Hopkins University Clinical Trials Unit
Directly responsible for front line interfacing with Industry on all aspects of clinical trials and managing the GSK Partners in Development Program. Internal and external leadership position, established master clinical contracts between JHU and Industry. Matched JHU human capital resources with Industry’s Market Aligned Plan (MAP) product life cycle needs.

Academic Appointments

Johns Hopkins University School of Medicine2000-present
Adjunct Assistant Professor (part-time)
Department of Medicine
1830 E. Monument Street
Baltimore, MD 21205
jpjmd@jhu.edu

Georgetown University Medical School2009-2011
Adjunct Faculty
Department of Anesthesiology
3800 Reservoir Road, NW
Washington, DC 20007
pergolij@georgetown.edu

Temple University School of Medicine2012-2014
Adjunct Associate Professor
Department of Pharmacology
3307 N. Broad Street,
Philadelphia, PA 19140

Education

M.D., 1996, Ross University School of Medicine, Dominica, W.I., Medicine, Highest Honors, clinical clerkships completed thru Johns Hopkins University and University of Maryland affiliated programs.

BS, 1989, Chemistry: Physical Chemistry Applied & Experimental, St. Johns, Queens, NY. Honors
Included Dean’s List, ACS Certification, Roger Bacon Honor Society.

Clinical Training

Clinical Research Fellowship, 1996, The Johns Hopkins University School of Medicine, Department Of Medicine, Division of Endocrinology and Metabolism, Baltimore, M.D.

Medical Internship, 1997, Greater Baltimore Medical Center, Baltimore, M.D.

Anesthesia Residency, 2000, Georgetown University/ NIH Medical Center, Washington, D.C. Chief Resident, with sub-specialty training in pain medicine, obstetric, pediatric, and transplant Anesthesia.

Professional Awards

American College of Physician’s, 1997, Second Place in the Clinical Vignette Poster Division at the 15thAnnual Maryland Associates Meeting.

International Executive Who’s Who, 1997

American Medical Association, 2002-2008, Physician’s Recognition Award with Commendation

Charles Fazio Award, 2008, Outstanding Alumni Volunteer Georgetown University

Patients’ Choice Award, 2010

Compassionate Doctor Recognition, 2010

Who’s Who in Medicine, 2011

Who’s Who in Healthcare, 2011

Patients’ Choice Award, 2010

Directorships/Steering Committees

Board of Directors, Association of Chronic Pain Patients, TX, USA 2010-2014

Board of Directors, Georgetown Club of Naples, FL, USA 2005-2013

Board of Directors, Always Healthcare, FL, USA 2010-present

Steering Committee, Food and Drug Administration, Safe Use Initiative 2010-present

Steering Committee, EFIC- Change Pain Pan-European Initiative 2009-present

External Referee, The Netherlands Organization for Health Research and Development – National Pain Committee 2011-2014

Consultant, National Institutes of Health (NIH), Centre of Pain Excellence U.S. National Pain Education Initiative (Ad-hoc) 2012-Present

Department of Veteran Affairs- Advisory Committee Special Government Employee. HSR&D Scientific Merit Reviewer 2014-Present

Publications

Raffa RB, Pergolizzi JV Jr. Is Morphine Medicine’s Biggest Misnomer? (July/August). Ann Pharmacother. 2012 Jul 3. [Epub ahead of print]

Angeletti C, Guetti C, Papola R, Petrucci E, Ursini ML, Ciccozzi A, Masi F, Russo MR, Squarcione S, Paladini A, Pergolizzi J, Taylor R Jr, Varrassi G, Marinangeli F.  Pain after earthquake. Scand J Trauma Resusc Emerg Med. 2012 Jun 29; 20(1):43. [Epub ahead of print]

Pergolizzi JV, Raffa RB, Pergolizzi JS, Taylor R. Non-Analgesic Effects of Opioids: Factors Relevant to Opioid Abuse and Abuse-Deterrent Formulations. Curr Pharm Des. 2012 Jun 28. [Epub ahead of print]

Pergolizzi JV Jr, Raffa RB, Taylor R Jr, Rodriguez G, Nalamachu S, Langley P.  A Review of Duloxetine 60 mg Once-Daily Dosing for the Management of Diabetic Peripheral Neuropathic Pain, Fibromyalgia, and Chronic Musculoskeletal Pain Due to Chronic Osteoarthritis Pain and Low Back Pain.  Pain Pract. 2012 Jun 21. Doi: 10.1111/j.1533-2500.2012.00578.x. [Epub ahead of print]

Pergolizzi JV Jr, Gharibo C, Passik S, Labhsetwar S, Taylor R Jr, Pergolizzi JS, Müller-Schwefe G.   Dynamic risk factors in the misuse of opioid analgesics.  J Psychosom Res. 2012 Jun; 72(6):443-51. Epub 2012 Apr 5.

 

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