JOHN EVANGELISTA 11 Cambridge Road Bedminster, NJ 07921jevangelista@optonline.net C: 908.295.4062

EXECUTIVE SUMMARY

Medical Affairs/MSL Professional with large, well-established network of leading physicians, surgeons, KOLs, thought leaders, and industry experts. Experienced in supporting Marketing, Pharmacovigilence, Regulatory, Quality, Business Development, compliance, KOL development and all aspects of clinical research. Exceptional medical expertise, clinical research/IRB compliance knowledge, business acumen, and understanding of U.S./European regulations and standards. Experienced in design, development, and oversight of clinical operations, clinical study protocols, quality, medical affairs, and regulatory functional areas, as well as all phases of Investigational Device Exemption (IDE), registries and post market surveillance studies. Proven record of accomplishment in strategizing, communicating, negotiating, and interacting with U.S. and international regulatory bodies. Skilled negotiator, able to influence perspectives across organizational levels and functional areas.

AREAS OF EXPERTISE

Clinical Research / Medical Affairs Management US / International Regulatory Compliance Emerging / Current Medical Technologies Product Development IDE, CE Mark, FDA Submissions Phase I, II, III, IV Studies / Registries Strategy Development / Execution Quality Assurance, FDA Inspections IRB Submission / Approval Contract Negotiation / Administration / Budgets Communication / Presentation M&A Due Diligence Medical Education/skills technique management KOL development

PROFESSIONAL EXPERIENCE

PACIRA PHARMACEUTICALS, SR. DIRECTOR MEDICAL AFFAIRS 2015 - PRESENT

Responsible for the scientific and medical practice expertise regarding the use of EXPAREL and its impact on patients and the health care system.

Supports and facilitates all Scientific Exchange in the area of responsibility Develops strategic alliances with both National and Regional thought leaders, cooperative groups,

research networks, guideline organizations and professional organizations and/or societies Directs a team of Medical Affairs Directors and Clinical and Education Specialists including on-going

training in scientific knowledge, presentation/communications, and corporate strategies and goals Supports Health Outcomes and Economic activities and leverages these, as well as other clinical data,

in the development and execution of all Advocacy and Market Development activities and programs as appropriate

Supports clinical studies/data collection initiatives (including Investigator Initiated Trials and Grants) to better establish the safety, efficacy and commercial viability of EXPAREL and any new products.

Establishes and Supervises HCP Education initiatives Contributes to the development of EXPAREL® Centers of Excellence and establish a strong network of

peer-to-peer educational forums. Implements systematic approaches to develop and maintain effective KOL relationships Identifies opportunities and creates a strategy for reaching key customers and potential customers

within a geographic area, in alignment with company goals; includes realigning resources as goals develop and change.

Represents Medical Affairs at scientific/medical symposia, industry councils, and internal meetings as requested

FIDIA PHARMA USA, EXECUTIVE DIRECTOR, MEDICAL AFFAIRS/MSL 2013 – 2015

Provide therapeutic area strategic and tactical direction for marketed products in the US, as well as to serve as liaison and ensure compliance with FDA regulations and reporting requirements.

Provide planning and leadership for the medical affairs/education function by ensuring development of appropriate structure, systems, competencies and third party support

JOHN EVANGELISTA jevangelista@optonline.net C: 908.295.4062

Provide input into various therapeutic areas, medical education, MSLs, advisory boards and thought leader development

Lead clinical research teams assuring compliance with Human Research/IRB regulations and procedures Develop the U.S. overall scientific communication and publication strategies in conjunction with KOLs in the

fields of rheumatology, orthopedics and pain management. Develop, review and approve safe, compliant clinical strategies, protocols and appropriate reports Manage the budget for Medical Affairs cost center and provide direction and oversight for the overall

therapeutic area budget Provide medical and scientific direction and review for global product development teams and pre and post

launch regulatory strategies, which may include label (PI), protocols, NDAs and supplemental NDAs, etc. As a senior therapeutic area expert, interact internally with senior commercial, medical and scientific

leaders to guide the overall activities of the specific compounds(s) and therapeutic area Provide strategic support for Fidia’s managed care activities Develop and maintain strong relationships externally through active participation in professional

associations (ACR, OARSI, AAOS), professional meetings and conferences, etc. to achieve the company’s strategic objectives

Serve as representative on Fidia’s Medical, Legal and Regulatory Committee Provide input to confidential new business development opportunities

COVANCE, ASSOCIATE DIRECTOR, REGIONAL CLINICAL QUALITY CONTROL FOR THE AMERICAS 2011 – 2013Lead a clinical quality control team established to ensure a common understanding of quality issues and execution of quality strategies.

Provide guidance to the general manager as to the quality status of their region and the actions required to support quality delivery for clinical trials

Assure compliance with IRB/GCP/ICH guidelines and regulations Conduct clinical quality control audits of targeted sites Prepare an annual quality control plan with the respective operational leads based on prior client and

Quality Assurance audits, regulatory inspections and the project specific operation plans Maintain, manage and coordinate the overall Quality Control (QC) plan for the region Ensure compliance with CAPAs, audit excellence, quality plan execution, QC metrics and quality

training and communication as required Assist with promotion of proactive quality culture

HISTOGENICS, MEDICAL AFFAIRS CONSULTANT 2011 -- 2012

Retained by regenerative medicine and tissue engineering company to assist with clinical research site selection. Successfully identified and engaged key opinion leaders to participate in clinical research studies for the company’s flagship product to treat articular cartilage derived pain and mobility.

BIOMET, Director, Medical Affairs / Director, Clinical Research & Tissue Compliance 2005 - 2011Recruited to lead Clinical Research/Tissue Compliance functions Promoted to Director of Medical Affairs and tasked with outsourcing Clinical Research. Developed and implemented medical education/skills courses. Direct 10-member data management/clinical research team, product development, projects, and physician training.

Manage post-marketing surveillance and validation studies to demonstrate product benefits and revenue potential, to uncover product issues, and to improve/accelerate next-generation product development.

Develop budgets and resource/staffing forecasts for Medical Affairs, Clinical Research, and Compliance activities, including contracted CROs for global studies.

Direct all facets of human tissue services, including regulatory matters and interaction with tissue partners. Cultivate and maintain relationships with key opinion leaders (KOLs) in orthopedics. Plan/oversee IDE clinical trials of new medical devices. Participate in pre-IDE/IDE meetings with FDA. Drove revenue/market share gains by implementing studies validating clinical/economic value of device. Develop and document protocols, ICFs, and IDEs, as well as IRB submissions. Author comprehensive Clinical Expert Reports for portfolio of 35 products for Regulatory Technical files.

analyze all literature, issues, adverse events, and revenue Recruit/select study investigators; set up investigational sites, negotiate contracts/budgets and monitor

studies; conduct investigator meetings and deliver training in GCP/regulatory issues for medical device trials.

JOHN EVANGELISTA jevangelista@optonline.net C: 908.295.4062

Respond to FDA inquires regarding IDE deficiencies; compile/prepare IDE annual progress reports.

ENCORIUM, Senior Clinical Quality Assurance Associate 2004 - 2005Recruited to join Clinical Research Organization (CRO); reported to Director of Quality Assurance (QA). Leveraged expertise in government regulations, GCP, ICH, and EU Directive to perform audits of investigator sites to ensure clinical trial compliance to protocols, as well as Encorium and sponsor SOPs. Retained by pharmaceutical firm to audit site in Canada; uncovered trend in medical records within 3

days eliminating the need to the continue audit; quick resolution resulted in substantial future business with client and additional revenue.

Provided QA reports to internal committees and sponsors. Wrote and implemented company SOPs, as well as IRB process. Trained staff on company procedures. Ensured consistency and accuracy of procedures by conducting audits of protocols. Validated systems and databases that were purchased through vendors and developed in-house. Performed IRB/IEC and database output audits. Provided ongoing GCP/ICH/EU education/training

PHARMREG CONSULTANTS, Principal / Senior Consultant 2002 - 2004Launched consultancy to provide QA, GCP/ICH/EU/SOP compliance, auditing, management, strategic planning, and marketing expertise. Developed solutions, negotiated strategic partnerships and leveraged relationships with KOLs to assist clients in developing education, training, research and promotional programs. Conducted audits in preparation for FDA, DOH, ISO inspections.Representative engagements: Center for Wound Healing - Division of Hyperbaric Therapy: Marketed/promoted hyperbaric wound

care; created highly cost-effective program and negotiated/won contracts to install hyperbaric therapy equipment in hospitals and provide patient services. Served as Medical Science Liaison.

Pfizer Pharmaceutical – Division of Global Quality Standards: Provided QA guidance for CNS and Anti-infective therapeutic organizations; conducted/managed QA audits of investigator sites, including pre-inspection preparation, GCP / ICH for FDA inspections of clinical research investigator sites.

NEW YORK TISSUE SERVICES, INC., Managing Director 1998 - 2002Started/led nationally recognized human bone bank. Ensured compliance with local, state and federal laws and regulations relating to tissue recovery, tissue distribution and HR administration. Conducted internal audits ahead of FDA, ISO and DOH inspections. Managed $2+ million budget. Established QA standards for procurement/distribution of allograft tissue for transplantation. Decreased discard rate from 15% to <3% and increased net yield/donor by improving screening methods. Cut operating costs 25% while increasing volume and revenue by creating efficiency improvements. Substantially increased tissue retrieval by negotiating contracts with 18 area hospitals. Led organization from startup through successful IPO in just 4 years.

Prior Experience includes:

GREATER METROPOLITAN BONE BANK, Executive DirectorGIFT OF LIFE ORGAN PROCUREMENT ORGANIZATION, INC., Transplant CoordinatorLUTHERAN MEDICAL CENTER, DEPT. OF PATHOLOGY, Pathology Research Assistant (PT)

ADDITIONAL EXPERIENCE

INSTITUTIONAL REVIEW BOARD (IRB) SOMERSET MEDICAL CENTER, Non-institutional Member 2002 - 2011Review/provide comments on proposed clinical research protocols, primarily on oncology research. Provide expertise in the informed consent process and implementation. Advocate for protection of human subjects in clinical research trials; provide guidance on compliance

with GCP / ICH and IRB standards.

EDUCATION & PROFESSIONAL DEVELOPMENT

Certificate, Bioethics & Medical Humanities, Columbia University College of Physicians & Surgeons, NY, NY, 1997Master of Public Health (MPH), Columbia University School of Public Health, NY, NY, 1991Doctor of Medicine (MD), University of CETEC School of Medicine, Dominican Republic, 1983Didactical Medical Training, University of Perugia School of Medicine, Perugia, ItalyLyceum Degree, University of Perugia School for Foreigners, Perugia Italy

JOHN EVANGELISTA jevangelista@optonline.net C: 908.295.4062

Bachelor of Science (BS), Health/Physical Education, Springfield College, Springfield, MA Certificate, Ethics and Regulation of Research with Human Subjects, New York UniversityCertificate, Medical Research Management, HIPAA–Complying with the Privacy Rule in ResearchClinical Research Management Training Program

MEMBERSHIPS

The New York Transplant Society American Association of Tissue Banks American College of Health Care Executives New York Citizens Committee on Health Care Decisions Metropolitan New York Ethics Committee Metropolitan Health Care Administrators Association

References Provided Upon Request