Expert Details
Pharmaceutical Licensing Partnerships and Intellectual Property Disputes
ID: 731634
New Jersey, USA
Pharmaceutical who has over 25 years of experience in partnerships and licensing and clinical trials. Involved in all aspects of business partnerships: identification, evaluation, due diligence, negotiations, clinical trials contract drafting and alliance management. Experience in the following therapeutic/technical areas: arthritis, cardiovascular, oncology, virology, urology, type II diabetes and anti-infectives. Extensive Clinical Development Management experience and negotiations with Clinical Sites regarding Intellectual Property Ownership. Patent on Chronic Obstructive Pulmonary Disease drug.
Expert Witness for litigation or arbitration disputes regarding pharmaceutical, and biotechnology companies; Universities, Venture Capital and Entrepreneurs in the following areas:
• Patents and Partnerships.
• Licensing Agreements (Royalty and Milestone Payment Transactions)
• Clinical Trial Management
• Product Promotions and Marketing
• Resolution of Intellectual Property Ownership
Education
| Year | Degree | Subject | Institution |
|---|---|---|---|
| Year: 1972 | Degree: MBA | Subject: Finance | Institution: New York University |
Work History
| Years | Employer | Title | Department |
|---|---|---|---|
| Years: 2015 to 2015 | Employer: Shinoghi Pharmaceuticals- | Title: Clinical Operations | Department: |
Responsibilities:Organized and reviewed Request for Proposal Agreements for CROs and translated those into Master Service agreements.Clinical Site agreement drafting and negotiations Member of Clinical Development team. |
|||
| Years | Employer | Title | Department |
| Years: 2013 to 2015 | Employer: Drais Pharmaceuticals | Title: Clinical Management | Department: |
Responsibilities:Drafted and reviewed legal agreements-Allocating Intellectual Property RightsMaster Service, Confidentiality, Vendor, Clinical Site, Consultant, European Representative and Privacy Agreements. Estimated budgets for two programs involving a urological and gastro-intestinal drug. Solicitude 16 CRO’s to determine response to Clinical Specification Proposal. Reviewed and edited trial protocol and protocol synopsis. Participated in clinical team meetings. Global responsibilities. Reviewed and negotiated all legal agreements: Vendor CRO, CDA and Clinical Trial Agreements, Various Site Agreements. Domestic and International Experience. |
|||
| Years | Employer | Title | Department |
| Years: 2012 to 2013 | Employer: Merck Research Laboratories | Title: Clinical Management | Department: |
Responsibilities:Research budgets and contract review. Member of Clinical development team.Negotiations with CROs regarding clinical research costs. Contract review with vendors such as translation services, central laboratories, electronic recoding companies and all vendors associated with development projects. Budgets and invoice review and approval. Developed financial benchmarks for clinical grant budgets. Projects exceeded $150 million in both domestic and overseas markets. |
|||
| Years | Employer | Title | Department |
| Years: 2006 to 2012 | Employer: MicroDose Therapeutx | Title: VP | Department: Business Development |
Responsibilities:MicroDose Therapeutx (venture backed drug Delivery Company merged with Teva). He completed the largest partnerships in the Company’s history by licensing basic technology to Merck and Novartis and Gilead Sciences. These partnerships required joint product development and sharing intellectual property. Out-licensed a viral therapy to Gilead Sciences, the leading global virology company. In licensed, nascent technology to telephonically relay data from the patient to physician and a preclinical therapy for a gastrointestinal disease. |
|||
| Years | Employer | Title | Department |
| Years: 2002 to 2005 | Employer: Odyssy Pharmaceticals | Title: Sr Director | Department: Business Development |
Responsibilities:Odyssey Pharmaceuticals (a $100 mm subsidiary of foreign generic company which merged with Teva) He completed a partnership and a joint product development program for a urology product which established this small company as a major specialty pharmaceutical company. |
|||
| Years | Employer | Title | Department |
| Years: 1999 to 2002 | Employer: Hoffmann La Roche | Title: Director | Department: Business development |
Responsibilities:Director of Global Business Development: He identified, analyzed and negotiated pharmaceutical licensing, copromotion and acquisition opportunities. Assessed technology in several therapeutic areas. Instrumental in building the Oncology business through the acquisition of Kytril ($350mm in sales) and identifying and evaluating the license of Tarceva, a novel oncology compound with sales over $2 billion Out licensing and planning responsibilities. Generic partnering strategies. |
|||
| Years | Employer | Title | Department |
| Years: 1994 to 1999 | Employer: Sanofi-Aventis | Title: Assosiate Director | Department: Licensing-Business Development |
Responsibilities:for this US subsidiary of a $20 billion French pharmaceutical company,He identified, analyzed and negotiated pharmaceutical licensing and acquisition opportunities. Assessed technology in several therapeutic areas: cardiovascular, oncology, CNS and anti-inflammatory. Interfaced with market research, research and development and foreign parent to forecast and value transactions. Provided analysis of deal structure and conducted negotiations. Concluded a co-promotion agreement for a cardiovascular drug which was the first such agreement for the US operation and contributed $5mm in profits. Proposed and negotiated the license an ant-inflammatory drug which contributed $70mm in sales. Completed the acquisition of Bock Pharmacal, which provided a US infrastructure and US sales force. |
|||
| Years | Employer | Title | Department |
| Years: 1991 to 1994 | Employer: American Cyanamid /Lederle Pharmaceuticals | Title: Manager, Corporate Planning and Development | Department: |
Responsibilities:(merged with American Home in 1995) Evaluated pharmaceutical licensing, venture capital and acquisition candidates. Instrumental in the evaluation of the partial acquisition of Immunex (a biotechnology company) for $800 million. This complex acquisition involved the merger of the domestic oncology business and a cash consideration to achieve control of Immunex. Evaluated licensing transactions in the cardiovascular and anti-infective areas. |
|||
Government Experience
| Years | Agency | Role | Description |
|---|---|---|---|
| Years: 2011 to 2011 | Agency: Department of Defense | Role: Secured $1mm grant | Description: Licensed drug delivery technology to the DOD and resolved joint intellectual ownership issues. |
International Experience
| Years | Country / Region | Summary |
|---|---|---|
| Years: 1999 to 2003 | Country / Region: Switzerland | Summary: Worked for Swiss based pharmaceutical company. |
| Years: 1994 to 1999 | Country / Region: France | Summary: Worked for Paris based pharmaceutical company |
Career Accomplishments
| Associations / Societies |
|---|
| Licensing Executive Society |
| Awards / Recognition |
|---|
| Received award for one of the best Journal articles: Negotiating Pharmaceutical Licenses” Les Nouvelles 9/09 |
| Publications and Patents Summary |
|---|
| Publications: 3 Patent Application (sole inventor) for a novel drug to treat Chronic Obstructive Pulmonary Disease. |
Additional Experience
| Expert Witness Experience |
|---|
| None |
| Training / Seminars |
|---|
| Speeches at international health care conferences: “Valuing Products in New Market Areas: A Business Development Perspective” “Successful Pharmaceutical Acquisitions of Biotechnology Companies” “Off Loading Risk-Out-licensing as a Business Development Function” |
| Vendor Selection |
|---|
| He has great experience with contacting patent law firms, multiple pharmaceutical and medical device companies. |
| Marketing Experience |
|---|
| Published various article in industry journals: “In-Licensing Discontinued Pharmaceutical Products: finding the Rembrandt in the Attic.” and “Negotiating Pharmaceutical Licenses” Les Nouvelles 1/06; 9/09. |
| Other Relevant Experience |
|---|
| Patent Application (sole inventor) for a novel drug to treat Chronic Obstructive Pulmonary Disease. Now being developed by a multi-national pharmaceutical company. |