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Medical Device and Biotechnology FDA Regulatory and Intellectual Property Expert

Technical Consultant #2273


Expertise

  • Intellectual property (IP) and regulatory strategy.
  • FDA regulation of novel products such as wearable medical devices, and electronic cigarettes.
  • Patent protection of drugs, medical devices, dietary supplements, and tobacco products.
  • Patent landscaping and freedom-to-operate analyses.
  • Consultation with and representation before U.S. Food and Drug Administration (FDA).
  • IP and regulation surrounding novel technologies such as RNAi, gene editing, and synthetic biology.
  • In vitro diagnostic medical device and consumer personal care products.

Experience

Undisclosed Company, General Counsel and Chief Scientific Officer, 2008 - Present

  • Professional in vitro diagnostic medical device and consumer personal care products.
  • Advise CEO and other senior management on all issues of material importance to company.
  • Oversee and direct entire research and development program.
  • Devise and implement IP and regulatory strategy.
  • Oversee and direct all patent prosecution and litigation.
  • Work closely with research and development team to capture novel technologies in patents and as co-inventor.
  • Ensure compliance with all FDA and other relevant regulatory regimes.
  • Design and oversee all clinical studies.
  • Review all draft marketing materials and labeling for compliance.

Undisclosed Law Firm, Lexington, KY, Of Counsel, 2015 - Present

  • Intellectual property and business law.
  • Prepare and prosecute patent applications on novel chemical and other technologies.
  • Conduct research for intellectual property and business litigation.
  • Draft and edit portions of court filings.

Undisclosed Company, Executive Vice President; Member, Board of Directors, 2012 - Present

  • Novel plant extracts used for consumer products such as electronic cigarette liquid ("e-liquid").
  • Advise CEO and other Board members on all issues of material importance to company.
  • Oversee and direct entire research and development programs.
  • Devise and implement IP and regulatory strategy.
  • Oversee and direct all patent prosecution.
  • Ensure compliance with all FDA and other relevant regulatory regimes.
  • Design and oversee all nonclinical studies.

InterLink Biotechnologies, Princeton, NJ, Consultant, 2012 - Present

  • Advanced biotechnologies including RNAi, gene editing, and synthetic biology.
  • Conduct patent landscaping and strategic freedom-to-operate analyses.

Foresight Science & Technology, Hopkinton, MA, Senior Consultant, 2005 - Present

  • Advanced technologies including biotechnology and medical device technologies.
  • Conduct market analyses to determine optional commercial fit of early-stage technologies.

Middleton Reutlinger, Louisville, KY, Of Counsel, 2011 - 2015

  • Intellectual property and (FDA) regulatory law.
  • Prepared FDA filings in compliance with Tobacco Control Act.
  • Prepared and prosecuted patent applications on novel (esp. tobacco) biotechnologies.
  • Prepared and prosecuted patent applications on novel chemical technologies.

Cogent Solutions Group, Lexington, KY, Chief Scientific Officer and General Counsel, 2006 - 2008

  • Dietary supplements based on hyaluronic acid.
  • Advised CEO on all issues of material importance to company.
  • Oversaw and directed entire research and development program.
  • Oversaw and directed all patent prosecution and litigation.
  • Designed and oversaw all clinical studies.
  • Reviewed all draft marketing materials and labeling for compliance.

Stockwell & Smedley. Lexington, KY, Of Counsel, 2005 - 2006

  • Intellectual property and regulatory law.
  • Drafted filings for trademark, unfair competition, trade secret, patent and copyright litigation.
  • Represented clients before courts and administrative agencies and in settlement negotiations.

Humana, Louisville, KY, Consultant, 2005 - 2006

  • Health benefits industry.
  • Drafted standard operating procedures for intellectual property development.
  • Advised on patent prosecution and related matters.
  • Conducted training of principal investigators in Innovation Center.

Blairex Laboratories, Columbus, IN, Director of Regulatory Affairs, 2004 - 2005

  • Pharmaceutical, medical device and consumer products industry.
  • Oversaw all efforts to maintain FDA regulatory compliance.
  • Drafted and implemented standard operating procedures.
  • Prepared and submitted required FDA annual reports.
  • Signed off on all product (e.g., Simply Saline®, Blairex's flagship product) releases.
  • Conducted compliance training of employees.
  • Audited contract manufacturers.

Commonwealth Industries, Louisville, KY, Intellectual Property Counsel, 2003 - 2004

  • Venture Initiatives team concerning IP position of novel technologies under development and/or targeted for possible acquisition.
  • Oversaw all patent and trademark prosecutions.
  • Reviewed all draft marketing materials for compliance.

Murty Pharmaceuticals, Lexington, KY Chief Patent Counsel, 2003 - 2004

  • Prepared and prosecuted pharmaceutical patent applications.
  • Worked closely with research and development team to evaluate freedom-to-operate issues impacting proposed Abbreviated New Drug Application (ANDA) projects under Hatch-Waxman Act.

ApoImmune, Louisville, KY, Senior Scientist and Co-Founder, 2001 - 2003

  • Biotechnology and biologicals (autologous transplantation) industry.
  • Principal Investigator on NIH grant for novel treatment for graft-versus-host disease.
  • Drafted grant applications resulting in initial $750,000 of non-diluting funding.
  • Drafted and oversaw prosecution of patent applications.

Stoll, Keenon & ParkLexington, KY, Of Counsel, 2001 - 2003

  • Intellectual property law.
  • Prepared and prosecuted patent applications in chemical and pharmaceutical arts.

Audax, Leitchfield, KY, Scientist, 1997 - 2001

  • Pharmaceutical, medical food and dietary supplement industry.
  • Prepared and prosecuted patent applications.
  • Troubleshot formulation and manufacturing issues with Epulor® medical food product.

Honors & Publications


Credentials

  • RAC, Regulatory Affairs Certificate, Regulatory Affairs Certification Board
  • Post doctorate Biochemistry, University of Kentucky, Lexington, KY
  • Post doctorate Biochemistry, University of Texas Southwestern Medical Center, Dallas, TX

License

  • Registered Patent Attorney - U.S. Patent and Trademark Office
  • Admitted to state Supreme Court and federal District Court

Languages

  • English (native speaker)
  • Portuguese (fluent reading and basic speaking proficiency)
  • Spanish (fluent reading and basic speaking proficiency)
  • French (fluent reading and basic speaking proficiency)

Academic and Professional Affiliations

  • Food and Drug Law Institute
  • Licensing Executives Society

Awards

  • Robert A. Welch Foundation Fellow

Publications and Patents

  • 10 peer-reviewed publications
  • 2 pending PCT patent applications

Education

  • J.D. Law, University of Kentucky, Lexington, KY
  • Ph.D. Biochemistry, University of North Texas, Denton, TX
  • M.S. Anatomical Sciences & Neurobiology, University of Louisville, Louisville, KY
  • A.B History, Harvard College, Cambridge, MA
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