Medical Device and Biotechnology FDA Regulatory and Intellectual Property Expert

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