I work with biotech companies to assist them in all legal issues during difficult start-up phases. Currently, I am the acting General Counsel for Crowpierce Technologies, LLC, I was a Senior Consultant in Legal and Business Development to CEPI (Collaboration for Epidemic Preparedness Innovations) on the development and regulation of novel vaccines for use in potential epidemics. became Interim General Counsel at Adjuvant Capital during their start-up phase. I was an equity partner… Show more I work with biotech companies to assist them in all legal issues during difficult start-up phases. Currently, I am the acting General Counsel for Crowpierce Technologies, LLC, I was a Senior Consultant in Legal and Business Development to CEPI (Collaboration for Epidemic Preparedness Innovations) on the development and regulation of novel vaccines for use in potential epidemics. became Interim General Counsel at Adjuvant Capital during their start-up phase. I was an equity partner at Bird & Bird, Ltd. in London, and relocated to the U.S. after the death of a family member to become the CEO of a significant family business with three corporations and four trusts, which I have spent 5 years managing and winding up. Simultaneously, I served as subject matter expert, articulating the emergence of case law and its impact on biosimilar drug development, licensing, and distribution for investment banks and for biotech companies. I have since developed a successful business in working for various biotech companies, particularly start-ups. As GC at Triskel, and as an equity partner at Bird & Bird and director at Wragge & Co, I have significant experience developing pharma/biotech products through market authorisation, including biosimilars, small molecules, vaccines, medical devices (including in vitro medical devices), gene therapies, monoclonal antibodies, and orphan medicinal products. Show less

Drafted, negotiated and finalized agreements with several of CEPI's coalition partners. Worked on all legal and business development issues for the organisation in its nascent phase.

One of the leaders responsible for Bird & Bird’s IP Group-Life Sciences practice in London, including 6 partners and 15 attorneys. Bird & Bird is an international law firm with over 1,100 lawyers in 27 countries known especially for its expertise in strategic commercial issues, particularly IP law and regulatory affairs.• Advised client boards of directors and C-suite executives on go or no-go decisions on potential purchases and acquisitions of biotech products and projects, with a… Show more One of the leaders responsible for Bird & Bird’s IP Group-Life Sciences practice in London, including 6 partners and 15 attorneys. Bird & Bird is an international law firm with over 1,100 lawyers in 27 countries known especially for its expertise in strategic commercial issues, particularly IP law and regulatory affairs.• Advised client boards of directors and C-suite executives on go or no-go decisions on potential purchases and acquisitions of biotech products and projects, with a special emphasis on cross-border authorizations.• Created and implemented a successful strategy for approval of orphan drug designations, including pegylated recombinant human growth hormone and morphogenic bone protein. Obtained FDA and EMA approval.• Wrote numerous papers and made a number of presentations on drug development, approval, and licensing.• Managed the clinical trial and regulatory strategy for a gene therapy targeting adolescents resistant to triplicate HIV treatment. Obtained national and EU approval for research studies.• Led notified body applications to successfully gain medical device (including IVD) approvals in the EU. Also successfully negotiated with competitors that had improperly appropriated/infringed on approvals. • Advised a client on strategy for making effective presentations to the Oncologic Drugs Advisory Committee of the FDA. Also obtained favorable amendment to the USP monograph. Show less

Director serving as one of the firm’s key advisors on pharmaceutical licensing and pharmaceutical and IP litigation. Wragge & Co. (since 2014, Wragge Lawrence Graham & Co) was a UK-headquartered international law firm that specialized in IP licensing.• Developed and implemented a plan to build an effective regulatory process for approval and distribution of drugs, medical devices, and complementary medicines in Abu Dhabi. Also drafted regulatory statutes.• Advised clients on… Show more Director serving as one of the firm’s key advisors on pharmaceutical licensing and pharmaceutical and IP litigation. Wragge & Co. (since 2014, Wragge Lawrence Graham & Co) was a UK-headquartered international law firm that specialized in IP licensing.• Developed and implemented a plan to build an effective regulatory process for approval and distribution of drugs, medical devices, and complementary medicines in Abu Dhabi. Also drafted regulatory statutes.• Advised clients on strategies to handle the special challenges related to products containing porcine trypsin to ensure that people had access to drugs that were effective but that also met religious standards in countries in the Middle East.• Counseled global food companies on how to ethically produce and market food additives. Show less

Project manager and attorney responsible for the development of an inactivated trivalent polio vaccine based on the Sabin strain for use in the post-eradication era.

Served simultaneously as Chief Legal Officer and Chief of Staff, with responsibility for strategic planning, financial oversight, contract management, client relations, and legal affairs. Triskel is a pharmaceutical consultancy that advises clients on drug approval, regulation, and distribution.

Attorney and regulatory affairs officer responsible for drug approval for WHO’s vaccine programs.