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Expert in Biotechnology & pharmaceuticals: drug development, due diligence, strategy, finance, market analysis
Available for your Consulting and Expert Witness Needs
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Summary of Expertise:
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Listed with other top experts in: |
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With an MD-PhD, clinical training, ten years of experience analyzing and investing in companies developing drugs, and over three years running a start-up company developing a biologic, Expert has seen the drug and biotechnology industries from many angles. As an investor, he focused on companies developing drugs and became a student of clinical trial design, interpretation of clinical data, and analysis of pharmaceutical end-markets using prescription trends, epidemiological data and survey research. Indeed, he has twice been invited to speak at the FDA on topics relating to drug development in the biotechnology industry. As a portfolio manager, Expert bore entirely the consequences of his due diligence process, as an incorrect assessment of the likelihood of various potential outcomes would result in losses for him and his investors. Expert founded and became CEO of EnzymeRx in order to gain practical operational experience in drug development, and was intimately involved in every aspect of the development of pegadricase for gout and tumor lysis syndrome. He directed IND-enabling preclinical studies, oversaw scale-up transfer of the manufacturing process to a contract manufacturer, wrote several phase 1 and 2 clinical trial protocols and two INDs, let all regulatory interactions with the FDA including pre-IND and type C meetings, and was the study director on two phase 1 trials. These experiences give Expert a unique perspective on drug development and companies developing drugs. He is particularly skilled at assessing drug candidates, understanding end-markets and developing target product profiles and the clinical development program needed to attain that profile, strategically planning a translational program, and understanding what investors and partners want and expect to see in evaluating a company or drug candidates.
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As a former sell-side and buy-side analyst and long-short portfolio manager, Expert has ten years of experience with biotechnology and pharmaceutical stocks, including more than seven years as an investor in those industries. As an analyst at JP Morgan and Citigroup, he developed an extensive financial modeling skill set, which included building not only detailed models of company financial statements, but market models of important drugs. He is familiar with a wide range of valuation techniques. As a portfolio manager, Expert focused on fundamental aspects of biotechnology and pharmaceutical stocks, with a particular interest in companies facing potentially transformative events, including release of phase 3 clinical data, FDA reviews and approval decisions, patent litigation and new product launches. He has seen a wide variety of capital-raising structures over his careers, and has participated in PIPEs, registered directs, IPOs and other types of offerings.
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As CEO of EnzymeRx, Expert was intimately involved with the development of a pegylated uricase for gout and tumor lysis syndrome. He developed a detailed knowledge of gout, its treatment and commercial markets, and has a network of key opinion leaders. Expert has written several clinical trial protocols for uricase in the treatment of gout, and was the study director on two phase 1 trials conducted in nearly 50 gout patients. He has extensive experience with the manufacture and preclinical and clinical testing of uricase, and a deep understanding of therapeutic agents being developed for gout.
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Show Secondary and Basic Areas of Expertise | Localities: Expert may consult nationally and internationally, and is also local to the following cities: New York, New York;
Yonkers, New York;
Newark, New Jersey;
Jersey City, New Jersey;
Paterson, New Jersey;
Elizabeth, New Jersey;
Bridgeport, Connecticut;
New Haven, Connecticut;
Hartford, Connecticut;
and Philadelphia, Pennsylvania.
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| Year |
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Degree |
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Subject |
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Institution |
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Honors |
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1996
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MD-PhD
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Medicine and Molecular Pharmacology
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Albert Einstein College of Medicine
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Alpha Omega Alpha
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1989
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BS
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Biology
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MIT
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Phi Beta Kappa, Sigma Xi
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| Years |
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Employer |
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Department |
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Title |
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Responsibilities |
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2008 to
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(Undisclosed)
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President And Managing Member
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Expert consults for biotechnology and pharmaceutical companies and investors in those companies.
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2008 to 2010
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EnzymeRx
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President And Chief Executive Officer
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Responsible for all aspects of the drug development program for pegadricase, a pegylated biologic.
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2005 to 2008
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Pequot Capital Management
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Vice President And Portfolio Manager
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Managed long-short portfolios of biotechnology and pharmaceuticals stocks.
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2003 to 2005
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Sands Point Partners
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Analyst
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Researched and selected biotechnology and pharmaceutical stocks for trading in healthcare hedge fund.
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2001 to 2003
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Citigroup Asset Management
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Research
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Vice President
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Researched and analyzed biotechnology and pharmaceutical stocks for long-only institutional money management platform.
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1998 to 2001
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JP Morgan
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Equity Research
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Vice President
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Sell-side large-cap pharmaceuticals analyst.
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1996 to 1998
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Hospital of the University of Pennsylvania
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Medicine and Dermatology
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Resident Physician
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Resident physician.
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Licenses/Certifications
Have held series 7 and 63 and medical license (none active).
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Professional Appointments
Has served on the board of Stemline, a private biotechnology company, and the boards of several not-for-profit institutions.
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| Publications: |
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Publications and Patents Summary
He has 20 published articles in the medical and scientific literature and has presented posters at the American Society of Hematology and the American College of Rheumatology annual meetings.
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| Selected Consulting Examples: |
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Evaluated a portfolio of oncology drugs being considered as a possible spin-out on behalf of a venture capital fund.
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Developed extensive materials, clinical development plan and data room on behalf of a biotechnology company seeking a partnership, and supported outlicensing process.
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Directed financing (venture capital) and partnering (biotechnology companies)efforts for a biotechnology company with a phase 1 drug.
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Analyzed prescriber surveys and prescription trends in the hepatitis C market in order to build a forecast for a hepatitis C drug.
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Analyzed phase 2 clinical data for an oncology drug that was being considered as a potential investment.
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Click the green button above to contact
Expert for a free initial screening call regarding your expert consulting needs.
Expert is available for consulting to corporate, legal and government clients.
Remember, your initial screening call to speak with
Expert is free.
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Expert Witness Experience Summary:
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Expert has served as an expert witness for the defendants in a pharmaceuticals securities class action; in this capacity he wrote expert and rebuttal reports and was deposed for his testimony. His expertise relates to the analyst and investor interpretation of clinical data and the performance of stocks during and after release of complex information relating to drugs and drug candidates. He has also provided background information to class action lawyers and the SEC in cases relating to disclosure or lack of disclosure of material information by biotechnology companies.
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Click the green button above to contact
Expert for a free initial screening call regarding expert testimony,
litigation consulting and support, forensic services, or any related expert witness services.
A few litigation needs include product liability, personal injury, economic loss, intellectual property
(patent, trademark, trade secret, copyright), and insurance matters. Remember, your initial screening
call to speak with
Expert is free.
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| International Experience: |
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Country / Region |
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Summary |
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2010 to 2011
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China
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He executed sale of a drug to 3SBio, a Chinese biotechnology company.
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Expert has a long, longitudinal and deep experience in the biotechnology and pharmaceuticals industries. As a close follower of the industry, he has studied drugs and candidate drugs in all commercially important therapeutic classes, has witnessed companies of all sizes successfully execute development strategies and, just as frequently, make disastrous mistakes. Expert has operational experience in running a biotechnology company and in translational drug development, having run multiple preclinical and clinical studies and led all interactions with the FDA.
Click the green button above to contact
Expert for a free initial screening call regarding your marketing research, industry research, and company
research needs. For research needs involving multiple experts or secondary research,
a Research Director can be assigned to coordinate the work into a custom report for you as a potentially quicker
and more cost effective alternative to doing this work yourself or hiring a boutique consultancy.
Remember, your initial screening call to speak with
Expert is free.
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| Additional Skills and Services: |
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Supplier and Vendor Location and Selection Expert has sourced preclinical and clinical CROs for GLP toxicology studies and clinical trials; he has also sourced contract manufacturers for development and production of a biologic.
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Other Skills and Services
He has had substantial experience analyzing intellectual property in an effort to assess patent robustness and potential infringement, and have drafted several patent applications. I have published 20 papers in the scientific and medical literature, presented data at national medical conferences, and designed corporate presentations and electronic data rooms.
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