Expert Details

Expert in Biotechnology Product Reviews, Biologics, Drugs & Medical Devices, FDA Litigation, Vaccines, etc.

Expert ID: 722432 Virginia, USA

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Over 18 years experience with legal, scientific, business and regulatory issues affecting the research, development and commercialization of biomedical and information security products. Recognized expertise in strategy development, audit and due diligence, outsourcing, and FDA regulatory matters, including consulting for many of the world’s leading medical technology companies. Direct responsibility in leading or guiding project teams, resulting in numerous INDs/IDEs and marketing approvals for biologics, drugs and medical devices/IVDs, including responsibility for strategy development and document drafting of CMC, clinical and other sections.

Experience with innovative products, including preparing some of the first commercially sponsored applications for clinical testing of gene therapy and xenotransplantation, and extensive work with monoclonal antibodies, cytokines, small molecules, blood substitutes, biodevices, contraceptives, implants, radio-ablation, fibrin sealants, drug delivery systems, diagnostics, cell and gene therapies, chemical & biological warfare defense agents, molecular and DNA based diagnostics, fusion toxins and software based products. Broad experience in technical and regulatory matters, including work as a reviewer at the FDA’s Center for Biologics Evaluation and Research.

At FDA, he was responsible for biotechnology product reviews, including recombinant and natural vaccines, blood substitutes, and recombinant products. He has conducted original research and development, and is the inventor on six pending patents in gene therapy, grid computing/bioinformatics, encryption and information security.

Expert was an attorney in the FDA/Life Science's practices for a former employer's firm. He also has experience in academic and corporate positions, including as a reviewer at the FDA's Center for Biologics Evaluation and Research.

He was on the Law Review, and published an article on the limits to FDA's medical device jurisdiction and was a Scholar of the Food & Drug Law Institute.

He possesses more than eight years of bench-top experience in institutional university and corporate laboratories researching leading edge biomedical technologies.

He provides extensive consulting and due diligence services to life sciences companies and investors and services providers, including regulatory compliance, clinical and non-clinical testing, outsourcing consulting and management, advisory and business development.

Expert may consult nationally and internationally, and is also local to the following cities: Baltimore, Maryland - Frederick, Maryland - Gaithersburg, Maryland - Bowie, Maryland - Richmond, Virginia - Alexandria, Virginia - Lancaster, Pennsylvania

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Education

Year Degree Subject Institution
Year: 1993 Degree: JD Subject: Law Institution: George Washington University
Year: 1990 Degree: MS Subject: Applied Molecular Biology Institution: University of Maryland, Baltimore
Year: 1980 Degree: BA Subject: Biochemistry and Molecular Biology Institution: University of Maryland, Baltimore
Year: 1986 Degree: CHinese Proficiency Certificate Subject: Chinese Institution: Bejing University, Teachers Campus

Work History

Years Employer Title Department Responsibilities
Years: 2000 to Present Employer: Undisclosed Title: Founder & President Department: Responsibilities: Establish consulting practice focusing on integrated due diligence and consulting for biologics, blood products, pharmaceuticals, medical devices and diagnostics, research tools and bioinformatics. Performed extensive work on product development in gene therapy molecular diagnostics, recombinant hormones, blood products and vaccines, including production, outsourcing and supply chain managements, compliance and approval strategies and matters. Retained as an expert witness in matters involving FDA regulation, licensing and related matters.
Years: 2003 to 2007 Employer: MonoGen Inc. Title: Vice-President Department: RA/QA Responsibilities: Responsible for developing, and implementing and assuring regulatory compliance, planning and budgeting. Areas of responsibility: manufacturing Quality Systems, vendor management, and product engineering; design and execution of FDA, UL and international approvals for Class I-III medical devices, including the design, execution and analysis of US and international clinical and non-clinical studies, and the development and review of validation studies for product design and manufacturing; providing regulatory and technical due diligence for technology acquisitions and company financings. Designed and executed 11,000 woman multinational study that was the basis for FDA PMA approval of new cervical cancer diagnostic product, including all related contracts.
Years: 1999 to 2000 Employer: IATROS Bio/Pharma Inc. Title: Sr. VP Chief Counsel/Deputy Director Department: EER Medical Systems Responsibilities: Co-led spinout of government only CRO focused on regulatory services into a venture development company and commercial sector CRO. Introduced over $4 million in venture equity funding and established $500,000 in convertible debt funding. Established successful technology acquisition and licensing program, and created and recruited commercial CRO management. Provided advanced regulatory advice and support on DoD projects including vaccines, skin protectants, therapeutics and diagnostics including manufacturing/GMP, clinical and pre-clinical, IND and NDA/PMA/BLA preparation. Helped prepare complex multi-year project bids to NIAID for over $60 million worth of competitive awards that were either awarded or reached final pre-award stage. Negotiated the successful reacquisition of company principal assets by majority shareholder and the settlement of a multi-jurisdiction litigation with original claims exceeding one million dollars.
Years: 1998 to 1999 Employer: George Washington University, National Law School Title: Professorial Lecturer in Law Department: Law Responsibilities: Taught graduate level seminar class in Technology Transfer and Licensing
Years: 1993 to 1998 Employer: Heller Ehrman White & McAuliffe Fenwick & West LLP Title: Attorney/Regulatory & Technical Expert Department: Responsibilities: Counsel biopharmaceutical, medical device and medical informatics clients on FDA, licensing, outsourcing and other legal and regulatory matters. Emphasis on novel regulatory and product development issues requiring sophisticated approaches with strong integration of scientific and commercial factors. Develop and implement regulatory, outsourcing and licensing strategies. Draft, edit and evaluate submissions to regulatory agencies, including: INDs, BLAs, NDAs, 510(k)s/PMAs, DMFs, PMNs, Orphan Product Applications, labeling and advertising materials, responses to compliance actions, SEC and other securities filings. Negotiate regulatory decisions with FDA and other agencies, and prepare client public and advisory panel presentations. Conduct audits and training for GMP, GCP and GLP compliance, and for securities and acquisitions related due diligence. Negotiate and draft complex outsourcing, R&D, clinical study, manufacturing, supply, and intellectual property licensing agreements. Assist in litigation matters, including drafting of motions and briefs and formulation of litigation strategy.
Years: 1991 to 1992 Employer: Baker & Hostetler Title: Regulatory & Technical Expert Department: Responsibilities: Assisted in advising clients on scientific and regulatory issues regarding biologics, drugs and devices. Developed and recommended regulatory and scientific strategies. Plan, manage and execute interactions between clients and regulatory agencies, including FDA, EPA, & USDA. Helped negotiate and draft licensing, manufacturing, outsourcing and research agreements.
Years: 1989 to 1990 Employer: FDA/CBER Title: Biochemist/Reviewer Department: Biologics IND Responsibilities: Evaluated IND/DMF and PLA submissions describing the manufacturing and testing of vaccines and other products. Prepared draft guidance document on the testing and manufacturing of HTLV-1&2 IVDs. Created database program used for tracking all CBER AIDS related clinical trials. Division Commentator at the BioEast '91, Washington, D.C.
Years: 1988 to 1989 Employer: Digene Diagnostics, Inc. Title: Scientist Department: Responsibilities: Researched novel methods for diagnosing diseases with proprietary DNA products and designed, tested and evaluated medical devices and scientific apparatus.

Career Accomplishments

Associations / Societies
Bar Memberships: Maryland, District of Columbia.

American Society of Quality, American Society of Cytopathology (scientist member), Regulatory Affairs Professional Society, Clinical Laboratory Standards Institute.
Current, Institute for One World Health Scientific Advisory Board; Quackwatch.com, Legal Advisory Board
Prior: Pharmaceutical Outsourcing Managers Association, GeneTox Corporation; Vitro Diagnostics, Inc. (Scientific Advisory Board), Proteus (Scientific Advisory Board), NetImmune Technologies Inc
Professional Appointments
Editorial Board Member:
JOURNAL OF BIOPROCESSING,
Bio/Pharmaceutical Outsourcing Report,
VALIDATION TIMES,
JOURNAL OF GXP COMPLIANCE.
Medical / Professional
University of Iowa, Summer Scholars Training Program Summer 1982.
Researched cardiovascular physiology. Nat’l Acad. of Science National Talent Search Finalist
Publications and Patents Summary
Over twenty publications in the field.
He is the inventor on six pending patents in gene therapy, vaccines, bioinformatics and information security.

Language Skills

Language Proficiency
Chinese Studied Chinese language and culture in accelerated immersion program.

Fields of Expertise

antimicrobial medical device, biocompatibility testing, bioinformatics, bioinstrumentation, biologic (product), biologic sterilization, biomedical application, biomedical device, biomedical diagnostic instrumentation, biomedical engineering, biomedical instrumentation, bioprocess engineering, Current Good Manufacturing Practice, drug development, drug regulation, drug validation, electronic medical device, Food and Drug Administration compliance, FDA medical device regulation, Food and Drug Administration National Drug Code, Food and Drug Administration new drug code, Food and Drug Administration regulation, Food and Drug Administration validation, gastrointestinal drug, gelatin capsule, generic drug manufacturing, Good Laboratory Practice, Good Manufacturing Practice, gynecologic drug development, investigational drug procedures, investigational medical device exemption regulation, medical device auditing, medical device hazard analysis, medical device inspection, medical device premarket approval, medical device reliability testing, medical device reporting, Medical Device Reporting regulation, medical device safety, cytopathology, settlement, intellectual property licensing, 21 CFR Part 11, active pharmaceutical ingredient, medical device evaluation, bioethics, European sourcing, Far East sourcing, outsourcing, Department of Health and Social Security standard, food biotechnology, clinical measurement, medical device coating material, medical device corrosion, cannula, FDA food labeling regulation, medical oxygen concentrator, inhaler, medical filter, bionics, biomechanical engineering, in vitro diagnostics Food and Drug Administration code, injectable pharmaceutical product, pharmaceutical capsule, tablet manufacturing, medical device clinical research, hemostat, electrocautery instrument, dilator, FDA limulus amebocyte lysate test regulation, 510(k) document, Food and Drug Administration cosmetic regulation, disinfectant Food and Drug Administration regulation, Food and Drug Administration CFR-21 part 175, electrosurgical instrumentation, alcohol-level instrumentation, disposable medical device, Food and Drug Administration drug packaging regulation, Food and Drug Administration food packaging regulation, stent, medical device irradiation sterilization, Food and Drug Administration food regulation, medical device manufacturing quality control, medical device manufacturing, medical device design, international food statute, Food and Drug Administration, biologic cellular component, medical instrument, biomedical instrument, bioengineering, drug, surgical instrument, artificial cardiac pacemaker, medical device, investigational drug, implantable device, food regulation, dosage form, bulk pharmaceutical chemical manufacturing, biomedical chemical sensor, biomechanics

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