Expert Details
Pulmonary Hypertension Drugs, Nitric Oxide and Nitric Oxide Delivery Systems
ID: 731859
Florida, USA
Responsible for late stage development of several nitric oxide (NO) delivery platforms for various respiratory diseases. One of the principal scientific developers of Remodulin (treprostinil sodium) for the treatment of pulmonary arterial hypertension. Responsible for bringing the Company’s lead product, Tyvaso successfully through Phase III (primary endpoint met (p<0.0006) – FDA approved. A Key Contributor to the successful development and worldwide commercialization of Remodulin for the treatment of pulmonary arterial hypertension. Successfully set up and managed 5 concurrent development programs TRIUMPH, TRE-MDI, TRE-IPF, a Cell-Mediated Gene Therapy product and Beraprost SR. Solid experience in the development of novel drug/device delivery systems (inhalation, intravenous, and subcutaneous) for the pharmaceutical market. Key Contributor to successful launch of 3 new Companies (including 1 IPO). Led the rapid growth of Lung Rx, Inc. Developed and maintained very strong relationships with national and international thought leaders and professional organizations. Grew Remodulin revenue 40% annually while responsible for Sales and Marketing.
Expert was President of a consulting firm. During this period, he acted as a consultant to GeNO. During this time he was responsible for the following: Provide clinical research leadership, in planning, managing, and executing multiple combination product drug development programs. Develop, Implement, and Manage Toxicology Program. Evaluate partnering/licensing opportunities. Develop and Implement corporate strategy. Assist with Strategic Opportunity Assessment (identify high value, lower risk indications). Develop and execute Company Business Plan. Identify candidates for Scientific Advisory Board. Identify and assess additional product opportunities
Provide scientific consulting for the Pharmaceutical Industry. Subject matter expert in Pulmonary Arterial Hypertension
Education
| Year | Degree | Subject | Institution |
|---|---|---|---|
| Year: 1995 | Degree: PhD | Subject: Microbiology and Immunology | Institution: Duke University |
Work History
| Years | Employer | Title | Department |
|---|---|---|---|
| Years: 2009 to Present | Employer: Undisclosed | Title: Executive Vice President Global Clinical Affairs | Department: |
Responsibilities:Provide clinical research leadership, in planning, managing, and executing multiple combination product drug development programs. Develop, Implement, and Manage Toxicology Program. Evaluate partnering/licensing opportunities. Develop and Implement corporate strategy. Assist with Strategic Opportunity Assessment (identify high value, lower risk indications). Develop and execute Company Business Plan. Identify candidates for Scientific Advisory Board. Identify and assess additional product opportunities |
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| Years | Employer | Title | Department |
| Years: 1994 to 1997 | Employer: Lung Rx, Inc | Title: President and COO | Department: |
Responsibilities:Responsible for bringing the company’s lead product Viveta (Treprostinil Sodium for Inhalation) from preclinical testing through Phase III Development. Coauthored and reviewed regulatory documents for IND submissions to FDA and EMEA, prepared for and presented at FDA and EMEA meetings. Responsible for the product pipeline and the efficient development of new products. Worked closely with the business development and marketing departments at Lung Rx on clinical trial strategies, overall preparation of the market, and marketing/medical education initiatives. Worked closely with Key Opinion Leaders in the Pulmonary Hypertension community that Co Chaired the TRIUMPH (Treprostinil Sodium for Inhalation) Program Steering Committee.Provided vision for the Lung Rx organization, building strength and competence for the future, while at the same time having the judgment to prioritize programs/tasks, improve processes and meet timelines. Direct responsibility for a team of 12. Direct reports included Heads of Clinical, Regulatory, R and D and a Chief Medical Officer. Responsible for an annual budget of $10MM. With CEO, established a Scientific Advisory Board. |
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Career Accomplishments
| Associations / Societies |
|---|
| ATS Member, ISHLT Member, Drug Information Association, North Carolina RNA Society (Steering Committee Member), RNA Society |
| Awards / Recognition |
|---|
| National Register’sWho’sWho, United Therapeutics Certificate of Excellence (Key Contributor), Recipient of Lung Rx, Inc Excellence Awards, Recipient of (2) Cato Research, Ltd. President’s Excellence Awards, Duke University Program in Cell and Molecular Biology Fellowship |
| Publications and Patents Summary |
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| He is the co-inventor on five U.S. patents and published numerous articles in scientific journals. Expert has extensive experience in winning IND’s and NDA’s for drugs to address PH indications |