William Brodbeck, Ph.D.

**** ******** ***, ******, **** 44236

• Cell: 216-***-**** • Home: 330-***-**** • Email: abnjvy@r.postjobfree.com

Medical device product experience with demonstrated expertise in research and development, product

development, quality systems and regulatory affairs.

Industry Experience and Achievements

Brodbeck Consulting Group, LLC (2008 – Present)

Senior Consultant

o Assisted medical device companies with ISO 13485:2003 and 21 CFR 820 compliant Quality

System establishment

o Provided guidance in all phases of medical device product development

o Assisted in defining and implementing pre-market regulatory strategies

o Prepared pre-510(k) packages and 510(k) submissions

o Aided companies in the remediation of FDA initiated Form 483 and warning letters

o Aided in the preparation, initiation and execution of pre-clinical GLP animal studies

o Provided guidance in the preparation of clinical trials

o Provided histologic analytical services to medical device companies

ProEd Communications, Inc (2008)

Associate Medical Director

o Responsible for the planning and composition of manuscripts and presentations for the

pharmaceutical industry

ICON Interventional Systems, Inc. (2003- 2007)

Vice President, Research and Development

o Performed proof of concept studies leading to the Company’s initial round of funding for the

development of a drug-eluting coronary stent, including determination of the polymer/drug

combination that delivered the appropriate drug release kinetics, cell culture studies, and initial large

animal studies

o Planned and executed in vitro, in vivo and ex vivo studies to fulfill all product verification

requirements, including GLP compliant and non-GLP studies

o Responsible for overseeing and performing in-house studies in accordance with applicable standards

o Acted as Sponsor Representative, responsible for overseeing and participating in studies at contract

lab facilities

o Planned and performed feasibility testing on new product concepts and improvements to existing

products

o Served as Project Leader for a cross-functional team composed of individuals from Research and

Development (Scientists and Engineers), Quality Assurance, Regulatory, Manufacturing and

Marketing.

o Written and executed in vivo safety protocols reviewed and accepted by the Food and Drug

Administration

o Planned and maintained project budgets ($3-5 M), schedules and milestones

o Obtained Small Business Innovation Research grants to support product development

o Prepared CE certification application/ Technical File/ Device Dossier, and assisted in preparation of

IDE filing

o Key member of Company panel during Federal Agency meetings

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William Brodbeck, Ph.D.

5794 Bradford Way, Hudson, Ohio 44236

• Cell: 216-***-**** • Home: 330-***-**** • Email: abnjvy@r.postjobfree.com

o Highly involved with Company Intellectual Property portfolio including patent searches and

writing, resulting in nine published patents

o Recruited and directed a team of scientists and engineers resulting in three to five direct reports

including two Ph.D. level employees

o Appointed Head of Quality Assurance

o Coordinated activities leading to ISO 13485:2003 certification

Responsible for organizing and executing external audits leading to the approval of critical suppliers

o

o Responsible for coordinating Design Review Meetings at various stages of product development

o Involved with discussions with Clinical personnel in preparation of Clinical Trials, submission of

Investigators' Brochures and Design Inputs

Research Experience

Case Western Reserve University

Research Associate/ Post-doctoral Fellow

Advisor: James M. Anderson, M.D., Ph.D.

Biomaterial biocompatibility focus (Pathology)

o Responsible for leading team investigations involving implantable medical devices

o Experience in various molecular and cellular biology methods including RT-PCR, ELISA, and flow

cytometry

Graduate Research

Case Western Reserve University

Advisor: M. Edward Medof, M.D., Ph.D.

Complement inhibition focus (Immunology)

Professional Societies

NIH/NHLBI K-08 grant review committee 2006 – present

Society for Biomaterials 2006 – 2008

American Heart Association (AHA) 2005 – 2008

American Society for Quality (ASQ) 2006 – 2007

ASTM F04 Committee 2005 – 2007

American Association for the Advancement of Science (AAAS) 2001– 2004

Grant Support

Principle Investigator: W. G. Brodbeck, “Biomaterial Surface Control of FBGC Activation/Apoptosis”, NIH,

2000 – 2002.

Principle Investigator: W.G. Brodbeck. Triazolopyrimidine Coated Endovascular Stent. SBIR Phase I*,

2005-2006. Phase II submitted

Education

Ph.D. Molecular and Cellular Basis of Disease - Case Western Reserve University, Cleveland, Ohio

B.S. Biology, Chemistry Minor - Wilkes University, Wilkes-Barre, Pennsylvania

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William Brodbeck, Ph.D.

5794 Bradford Way, Hudson, Ohio 44236

• Cell: 216-***-**** • Home: 330-***-**** • Email: abnjvy@r.postjobfree.com

**Publications and References are available Upon Request

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