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 Expert  722432

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

Available for your Consulting and Expert Witness Needs

Virginia (VA)
Education Work History Career AccomplishmentsPublicationsConsulting Services Expert Witness

Summary of Expertise: Listed with other top experts in: 
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.


antimicrobial medical device


biocompatibility testing






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

Show Secondary and Basic Areas of Expertise
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;  and Lancaster, Pennsylvania.

Often requested
with this expert:

Professional QA & Regulatory Compliance for Medical...
FDA Compliance, Project Management, New Product...
International and Domestic Medical Devices, Sales/...
Product Development, Product Safety, Regulatory Compliance,...

Year   Degree   Subject   Institution   Honors
1993   JD   Law   George Washington University   Highest Honors, Order of th Coif, Law Review, Vincent Klienfield/FDLI Scholarship
1990   MS   Applied Molecular Biology   University of Maryland, Baltimore   Summa cum laude, Molecular & Cell Biology Scholarship
1980   BA   Biochemistry and Molecular Biology   University of Maryland, Baltimore   Genral Honors
1986   CHinese Proficiency Certificate   Chinese   Bejing University, Teachers Campus  

Work History:
Years   Employer   Department   Title   Responsibilities

2000 to


(Undisclosed Consulting Company)



Founder & President


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.

2003 to 2007


MonoGen Inc.






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.

1999 to 2000


IATROS Bio/Pharma Inc.


EER Medical Systems


Sr. VP Chief Counsel/Deputy Director


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.

1998 to 1999


George Washington University, National Law School




Professorial Lecturer in Law


Taught graduate level seminar class in Technology Transfer and Licensing

1993 to 1998


Heller Ehrman White & McAuliffe Fenwick & West LLP



Attorney/Regulatory & Technical Expert


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.

1991 to 1992


Baker & Hostetler



Regulatory & Technical Expert


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.

1989 to 1990




Biologics IND




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.

1988 to 1989


Digene Diagnostics, Inc.





Researched novel methods for diagnosing diseases with proprietary DNA products and designed, tested and evaluated medical devices and scientific apparatus.

Career Accomplishments:

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 Internships

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.

Selected Publications and Publishers  
 - Bio/Pharmaceutical Outsourcing Reports  
 - ChemTech 38  
 - J. Inst. Valid. Tech  

Consulting Services:
Recent Client Requests:
  • Expert for consulting on Quality Assurance Assessment.
  • Expert for consulting on FDA's upcoming opinion on Ipsen's Dysport for both cervical dystonia and cosmetic use.
  • Expert in ethylene oxide for consulting on syringe sterilization.
Click the green button above to contact Expert for a free initial screening call regarding your expert consulting needs.  Expert is available for consulting to corporate, legal and government clients.  Remember, your initial screening call to speak with Expert is free.

Expert Witness:
Expert Witness Experience Summary:
FDA regulation of manufacturing of biologics products, including contract, shared and other cooperative manufacturing pertaining to inter-party rights over product with annual US sales >$1 billion (testifying witness, drafting of expert reports/responses, underwent deposition, supported counsel in discovery/briefing, and trial assessment).

GMP requirements for production of active biopharmaceutical ingredient (consulting witness, discovery/affidavit guidance, provided and managed of other expert witnesses: settlement before depositions or testimony).

FDA regulatory authority over personal care product as a medical device (consulting and testifying witness, provided expert report, discovery/affidavit guidance, underwent deposition: settled post-depositions).

FDA requirements, approval timelines, and expected development activities for the development of vaccines (consulting witness, discovery/affidavit guidance: settlement before depositions or testimony).

FDA regulations and policies pertaining to pharmaceutical intermediates (consulting witness, discovery/affidavit guidance, provided and managed of other expert witnesses: settlement before depositions or testimony).

Law Firm Professional Malpractice in obtaining FDA approval for Class III implantable medical device (consulting and testifying witness, discovery/affidavit guidance: settlement before depositions or testimony).

Recent Litigation Client Requests:
  • Biomedical engineer expert witness for consulting on Use of pre-filled diluent syringes in the Autoject device by an MS patient. The syringe broke when using the Autoject and caused injuries to our client.
  • FDA expert witness for consulting on an atypical antipsychotic..
  • FDA expert witnesses for consulting on FDA medical device and supply chain/distribution.
  • Expert witness in FDA investigational medical devices for consulting on pulmonary vein isolation ablation catheters, mapping systems and navigational devices.
Click the green button above to contact Expert for a free initial screening call regarding expert testimony, litigation consulting and support, forensic services, or any related expert witness services.  A few litigation needs include product liability, personal injury, economic loss, intellectual property (patent, trademark, trade secret, copyright), and insurance matters.  Remember, your initial screening call to speak with Expert is free.

Language Skills:
Foreign Language   Description
Chinese   Studied Chinese language and culture in accelerated immersion program.


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