Siuta Consulting, Inc.
Pharmaceutical Licensing Consultants

 

 

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Gerald J Siuta, Ph.D.
Services Provided
License Opportunities
Areas of Interest
Industrial Clients
Academic Clients
Notable Achievements
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14 Georgetown Oval

New City, NY 10956

Tel: 845-634-4491

Fax: 845-634-7639

 

 

Notable Achievements

License Deals:

On behalf of The Global Alliance for TB Drug Development, Inc. (TB Alliance), negotiated an agreement with Bayer Healthcare AG (Bayer)  for a global clinical trial program to study the potential of moxifloxacin to shorten the standard 6-month treatment of tuberculosis (TB).

  • In 2006, the Licensing Executives Society (LES) Industry/University and Government Laboratory Transactions Sector presented TB Alliance and Bayer with its Deals of Distinction Award.  This Award recognizes worthy transactions involving licensing and transfer of intellectual property that promote creative and innovative solutions to business issues.

  • The TB Alliance-Bayer deal was also one of six finalists for the Scrip 2006 Best Partnership Alliance Award.  Scrip Awards are designed to recognize new standards of excellence and celebrate the very best achievements that reflect cutting-edge science and the intellectually exciting and socially rewarding nature of the industry.  The Award focuses on deals that require strong strategic input from both partners, are mutually beneficial, hold promise to address an unmet medical need and demonstrate strategic potential as well as an innovative business model.

Exclusively out-licensed a novel disulfone bis-phosphonate reagent to incorporate a disulfone and/or a disulfone phosphate moiety into potential phosphate dependent enzyme inhibitors.  Using this reagent, several novel compounds were synthesized and found to be inhibitors of HIV integrase.

Obtained over $650,000 from a major pharmaceutical company for sponsored research on Parkinson's disease under a two year Option Agreement that included provisions for a university client to receive an additional $2.8 million from a license execution fee and milestone payments upon exercise of the option.

Negotiated terms of a worldwide exclusive License Agreement with a major multi-national company that provided a university client with more than $4.5 million in license fees and royalty income.

Out-licensed a university discovered niche cardiovascular compound to a U.S. based start-up pharmaceutical development company.

Re-negotiated an exclusive License Agreement with a start-up company on behalf of a university client that more than doubled the university’s initial equity position in the company in lieu of future royalties on net sales of a specific potential product.

Assisted an academic client with negotiation of a License Agreement with a start-up company that originated from the university.

Reviewed a draft License Agreement and offered expert advice to a university client.

Technology Identification:

Located a library of small molecule compounds at a major pharmaceutical company and negotiated a Screening Agreement for an industrial client to evaluate selected compounds for potential utility in a novel therapeutic area.

Located novel synthetic organic chemistry process technologies at U.S. universities with the potential to enable a U.S. based bulk drug manufacturer to improve the synthetic procedure and significantly reduce the cost of preparation of several generic drugs.

Identified novel microencapsulation technologies at several academic laboratories and research institutes that resulted in an industrial client entering into Confidentiality Agreements and receiving written research proposals from six different investigators.

New Product Identification

Identified a compound for the treatment of atopic dermatitis in Phase II clinical trials at a small start-up company for an industrial client with a large franchise in skin care products.

Identified several compounds with a specific mechanism of action that were in late stage clinical trials at major pharmaceutical companies, determined the availability for license in a patentably distinct therapeutic area and then arranged for introductory meetings with a start-up pharmaceutical company client.

Identified a novel compound in Phase I clinical trials that was available for licensing and co-development by an industrial client.  Arranged for the client to visit the company's research facilities and receive a scientific presentation with an outline of potential licensing terms.

Portfolio Evaluation:

Evaluated novel cardiovascular technology and provided a university client with a detailed written report describing potential commercialization strategies.

Reviewed biological data on a series of novel compounds and provided a university client with several potential commercial options.

Reviewed various technologies and prepared more than 50 detailed Evaluation Reports for an academic client.

Analyzed marketing data from a business plan for a university client that was in the process of starting a company based upon novel university discovered technology.

Reviewed Invention Disclosures and rendered a licensing opinion for several other university clients.

Expert Witness:

Served as an Expert Witness, was deposed and testified at trial for the defendant in a patent infringement lawsuit of a currently marketed medical product.

Served as an Expert Witness, was deposed and testified on behalf of the defendant at an arbitration in a contract dispute relating to a medical technology.

Served as an Expert Witness for the defendant in a successful defense of a currently marketed medical product against a patent infringement lawsuit.

Provided expert advice for the defendant in a patent infringement lawsuit with regard to basic licensing practices including license fees and reasonable royalty rates on net sales.

Provided expert advice to the plaintiff in a contract dispute that was settled out of court in favor of the plaintiff.