Summary
Overview
Work History
Education
Skills
Certification
Awards
Publications
Developed market leading products that changed the practice of medicine
Timeline
Generic

KEVIN SKINNER VMD

Newburyport,MA

Summary

Accomplished preclinical and clinical director with over 25 years of experience in medical technology and pharmaceutical start-ups and established firms. Medical and technical expert able to realize new business opportunities. Recognized for enabling direct reports to reach their full potential.

Overview

26
26
years of professional experience
1
1
Certification

Work History

Biocompatibility Subject Matter Expert

Medtronic
01.2022 - Current
  • EU MDR experience with expertise in technical documentation
  • Proven track record of EU MDR and other regulatory approvals
  • Expertise in 30-Day Notices and RTRs, Design Dossiers, and Technical Files
  • Experience in assembling facts from various areas, analyzing data, and providing informed recommendations
  • EU MDR remediation of dental, orthopedic, neurovascular and cardiac implantable devices

Biocompatibility Subject Matter Expert

ZimmerBiomet
01.2021 - Current
  • EU MDR experience with expertise in technical documentation
  • Proven track record of EU MDR and other regulatory approvals
  • Expertise in 30-Day Notices and RTRs, Design Dossiers, and Technical Files
  • Experience in assembling facts from various areas, analyzing data, and providing informed recommendations
  • EU MDR remediation of dental, orthopedic, neurovascular and cardiac implantable devices

Senior Consultant Research and Development

ARC MEDICAL DEVICES
01.2019 - Current
  • Determine the optimal global strategy and designs for clinical, post-market and registration trials, including clinical and economic outcomes, based on the requirements of patients, surgeons, hospitals, regulators, payers, companies interested in acquiring ARC or distributing ARC’s products, and any other relevant stakeholders.
  • Assist our VP Regulatory to initiate the regulatory process for clinical trials in four territories for our first-in-human clinical trial and at least three additional trials.
  • Initiate clinical trials:
  • Plan, design (including study protocols, investigators, key opinion leaders, clinical trial CROs), implement and initiate our first-in-human clinical trial including enrolling and treating the initial subjects and then run this trial through to completion.
  • Plan, design (including study protocols, investigators, key opinion leaders, clinical trial CROs), implement and initiate our second-in-human clinical trial including enrolling and treating the initial subjects – then run this trial through to completion.
  • Ensure maximum reimbursement and adoption of ARC’s products
  • Obtaining strong safety, effectiveness and economic data.
  • Providing a compelling clinical value proposition and clear healthcare economics.
  • Obtaining endorsement from KOLs.
  • Developing surgeon champions in relevant hospital committees; and
  • Working with marketing to develop and provide the most effective message to patients, payers, hospital administrators, surgeons, researchers, companies interested in acquisition or distribution, and any other relevant stakeholders.
  • Ensure compliance with all applicable regulatory standards related to global clinical trials and interactions with surgeons.
  • Directed the preclinical program which included ISO 10993 testing and proof of concept studies and regulatory submissions
  • Support the development of harmonized business process and procedures for execution and compliance with EU MDR.
  • Strong understanding and experience of good design, ISO 9001and ISO 13485

Consultant Regulatory Affairs

Velico Medical
01.2020 - 01.2021
  • Directs the development of the content and format for regulatory submissions, technical files, (technical documentation). Interacts with regulatory authorities regarding company’s filings.
  • Reviews and stays abreast of new regulatory developments within the US and global markets and assesses their impact on business.
  • Develops, implements, and reviews current policies and practices issued by Federal and international regulatory agencies.
  • Interpret FDA guidelines and regulations, anticipate federal regulatory concerns; integrate regulatory requirements into development programs, providing a sound regulatory footing.
  • Communicate recommendations for regulatory strategies including regulatory pathways, compliance test requirements, substantial change notifications.
  • Submit and review change controls to determine the level of change and consequent submission requirements
  • Analyze the input of cumulative product changes to current product submissions
  • Serve as regulatory affairs representative on product development teams.
  • Participate in risk management reviews and provide guidance to team on risk management process to maintain compliance with current standards
  • Review labeling (including IFU), publications and promotional material
  • Evaluates and approves contents of technical reports to ensure compliance with quality system and international regulations. Reviews document change notices
  • Serve as management representative or back-up for the company to the Notified Body
  • Participate in audits of suppliers, notified bodies, regulatory agencies, Competent Authorities.
  • Help prepare responses to non-conformances raised during quality system audits.
  • Maintain current essential requirements documents for EU and TGA
  • Assist with development and maintenance of complaints systems including providing support of QA

Director of Preclinical & Clinical Operations

ACTAMAX SURGICAL MATERIALS
01.2010 - 01.2018
  • Company Overview: (DuPont/DSM joint venture)
  • Hired as principal to cultivate joint venture to develop surgical materials, achieving proof of concept and clinical trial in less than 2 years.
  • Manage $8M annual budget and advise DuPont’s chief scientific officer, president, and board members on technical issues, report study progress, and results.
  • Create clinical development plans, including project goals, budgets, and timelines to ensure studies are completed for regulatory filings.
  • Technical Leadership
  • Provide scientific expertise on study design and execution from inception through late stage development of all nonclinical and clinical R&D activities.
  • Present preclinical/clinical data to the FDA, international regulatory bodies, and scientific meetings.
  • Directed the ISO 10993 testing program with new materials being developed for medical devices
  • Recruit and supervise consultants and clinical research organizations (CROs) designing and conducting trials, verifying that all procedures and regulations are followed.
  • Collaborate with abdominal surgeons and academics to review technology and data to plan trials.
  • Manage Institutional Review Board (IRB) and complete IRB applications.
  • Author clinical operation sections of regulatory documents including protocols, Investigator Brochures (IBs), and investigational new device (IND) annual reports, among others.
  • Define nonclinical and clinical testing needs and design studies to meet needs in accordance with ICH testing guidelines, Good Laboratory Practices (GLP), and Good Clinical Practice (GCP).
  • Oversee nonclinical and clinical aspects of investigational device exemptions (IDE) and premarket approval application (PMA) submissions, guaranteeing high quality FDA applications.
  • Direct data analysis and interpretation from nonclinical and clinical studies and ensure accuracy.
  • Involved in the development laparoscopic delivery system
  • Strategic Planning
  • Deliver expert scientific advice to executives to evaluate business development and licensing activities for new products, therapies, and business opportunities, leading to proposals for alternative technology applications, including for orthopedic, cardiovascular, and other indications.
  • Devise strategic plans for site selection, contract negotiations, and patient recruitment programs for preclinical and clinical project teams investigating new devices.

Associate Director of Science, Biomaterials

GENZYME CORPORATION
01.2000 - 01.2010
  • Company Overview: ($2.82B biotechnology firm)
  • Technical Leadership
  • Directed all aspects of preclinical safety and efficacy studies leading to IDE/IND approvals.
  • Oversaw PMA/new drug applications (NDAs) for medical devices, drugs, and biologics to reduce postoperative adhesions, visco-supplementation for osteoarthritis (OA), and drug delivery for anti-arrhythmic restenosis, OA, oncology, and ophthalmic diseases.
  • Presented preclinical data, science publications, and abstracts at well-known clinical investigator meetings to university academics, clinicians, business executives, Ph.Ds., and others.
  • Formulated regulatory strategy for preclinical studies and wrote preclinical sections for regulatory applications and annual reports.
  • Conducted competitor market research and due diligence on adhesion barriers, drug delivery, and cell therapy, and reviewed packages to refine product development and investments.
  • Served as chairman of the Institutional Committee for the Use of Animals (IACUC).
  • Personnel Management
  • Led 4 research associates to conduct basic research in peritoneal healing and adhesion formation.
  • Supervised 6 mid- to senior-level staff, including Ph.Ds., M.D.s, B.A.s, and M.A.s.
  • Led and supported multidisciplinary development teams of senior engineers, biologists, chemists, regulatory executives, business development, and sales teams to facilitate marketing approval.
  • Project Management
  • Managed planning, implementation, budgeting, and schedules for studies of $425M/year products.
  • Directed CROs conducting studies on safety, toxicology, pharmacokinetic, and pharmacology for products in development, ensuring efficacy and accurate reporting.
  • Directed the ISO 10993 testing program with new materials being developed for medical devices
  • Oversaw the Kendall Square animal facility, ensuring it met NIH, USDA, and City of Cambridge guidelines for care of laboratory animals.
  • Planned and implemented animal facility expansion at the Framingham, Mass. facility.

Education

Residency - Equine Sports Medicine

Meadowlands Racetrack
Rutherford, NJ

Internship - Equine Reproduction Medicine

Griggs, O’Neal & Kidder
Lexington, KY

V.M.D. - Veterinary Medicine

University of Pennsylvania
Philadelphia, PA

B.S. - Chemistry

University of Delaware
Newark, DE

Skills

  • Preclinical and clinical research
  • SME on biocompatibility of medical devices-ISO 10993-20 Standards
  • In depth knowledge and experience with EU MDR
  • GLP and GCP expert knowledge
  • Technical leadership
  • Project management
  • Drug Delivery
  • Business strategy
  • Product development
  • Experience with ISO9001 and ISO13845
  • Laparoscopic equipment and instrument design
  • Product development Class II and III Medical Devices
  • Product development
  • Experience with ISO9001 and ISO13845
  • Laparoscopic equipment and instrument design
  • Product development Class II and III Medical Devices

Certification

Diplomate of the American Board of Toxicology-2010

Awards

Award-winning research paper, annual meeting, ASMR (1998), Research staff received 12 vice president awards: Vice president’s award, Genzyme (1992), Small Business Innovation Research Award/Grant (SBIR Phase I Grant, Tendon Adhesion Studies), Chesapeake Biological Laboratories (1986), NIH Short-Term Research Fellowship (1981)

Publications

  • Burns, J. W., Skinner, K., Colt, J., Sheidlin, A., Bronson, R., Yaacobi, Y., & Goldberg, E. P. (1995). Prevention of tissue injury and postsurgical adhesions by precoating tissues with hyaluronic acid solutions. Journal of Surgical Research, 59(6), 644-652.
  • Burns, J. W., Colt, M. J., Burgees, L. S., & Skinner, K. C. (1996). Preclinical evaluation of Seprafilm biore-sorbable membrane. The European journal of surgery. Supplement.=: Acta chirurgica. Supplement, (577), 40-48.
  • Jackson, J. K., Skinner, K. C., Burgess, L., Sun, T., Hunter, W. L., & Burt, H. M. (2002). Paclitaxel-loaded crosslinked hyaluronan acid films for the prevention of postsurgical adhesions. Pharmaceutical research, 19(4), 411-417.
  • Ghellai, A. M., Stucchi, A. F., Lynch, D. J., Skinner, K. C., Colt, M. J., & Becker, J. M. (2000). Role of a hyaluronate-based membrane in the prevention of peritonitis-induced adhesions. Journal of Gastrointestinal Surgery, 4(3), 310-315.

Developed market leading products that changed the practice of medicine

  • SepraFilm Adhesion Barrier (prevents post-operative adhesion formation) - regulatory submission was used by the FDA to draft guidelines for all adhesion prevention products.
  • SynVisc (treatment of osteoarthritis); Negotiated with FDA to designate device and FIH clinical
  • ViaSpan Organ Preservation Solution (used in transplantation medicine) - preservation time increased significantly, allowing more liver transplants and better matches for the donor recipient.

Timeline

Biocompatibility Subject Matter Expert

Medtronic
01.2022 - Current

Biocompatibility Subject Matter Expert

ZimmerBiomet
01.2021 - Current

Consultant Regulatory Affairs

Velico Medical
01.2020 - 01.2021

Senior Consultant Research and Development

ARC MEDICAL DEVICES
01.2019 - Current

Director of Preclinical & Clinical Operations

ACTAMAX SURGICAL MATERIALS
01.2010 - 01.2018

Associate Director of Science, Biomaterials

GENZYME CORPORATION
01.2000 - 01.2010

Residency - Equine Sports Medicine

Meadowlands Racetrack

Internship - Equine Reproduction Medicine

Griggs, O’Neal & Kidder

V.M.D. - Veterinary Medicine

University of Pennsylvania

B.S. - Chemistry

University of Delaware

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KEVIN SKINNER VMD