Expert Details
Biotechnology & Pharmaceuticals: Drug Development, Due Diligence, Strategy, Finance, Market Analysis
ID: 730470
New Jersey, USA
as a CEO of both private and public biotechnology companies, 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 twoclinical trials. As CEO of Employer, Expert has led the
phase 2 development of a novel cell therapy based on the ex vivo differentiation of mesenchymal stem cells, which are then
administered to ALS patients. This program has featured a multicenter. randomized, double blind, placebo control phase 2 trial.
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.
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.
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 underst
Evaluated a portfolio of oncology drugs being considered as a possible spin-out on behalf of a venture capital fund.Developed extensive materials, clinical development plan and data room on behalf of a biotechnology company seeking a partnership, and supported outlicensing process.Directed financing (venture capital) and partnering (biotechnology companies)efforts for a biotechnology company with a phase 1 drug.Analyzed prescriber surveys and prescription trends in the hepatitis C market in order to build a forecast for a hepatitis C drug.Analyzed phase 2 clinical data for an oncology drug that was being considered as a potential investment.
Education
| Year | Degree | Subject | Institution |
|---|---|---|---|
| Year: 1996 | Degree: MD-PhD | Subject: Medicine and Molecular Pharmacology | Institution: Albert Einstein College of Medicine |
| Year: 1989 | Degree: BS | Subject: Biology | Institution: MIT |
Work History
| Years | Employer | Title | Department |
|---|---|---|---|
| Years: 2014 to Present | Employer: Undisclosed | Title: Chief Executive Officer | Department: |
Responsibilities:Manages all corporate functions with a particular involvement in R&D, clinical development, finance and investor relations. |
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| Years | Employer | Title | Department |
| Years: 2008 to 2014 | Employer: Alchimia Partners | Title: President And Managing Member | Department: |
Responsibilities:Expert consults for biotechnology and pharmaceutical companies and investors in those companies. |
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| Years | Employer | Title | Department |
| Years: 2008 to 2010 | Employer: EnzymeRx | Title: President And Chief Executive Officer | Department: |
Responsibilities:Responsible for all aspects of the drug development program for pegadricase, a pegylated biologic. |
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| Years | Employer | Title | Department |
| Years: 2005 to 2008 | Employer: Pequot Capital Management | Title: Vice President And Portfolio Manager | Department: |
Responsibilities:Managed long-short portfolios of biotechnology and pharmaceuticals stocks. |
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| Years | Employer | Title | Department |
| Years: 2003 to 2005 | Employer: Sands Point Partners | Title: Analyst | Department: |
Responsibilities:Researched and selected biotechnology and pharmaceutical stocks for trading in healthcare hedge fund. |
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| Years | Employer | Title | Department |
| Years: 2001 to 2003 | Employer: Citigroup Asset Management | Title: Vice President | Department: Research |
Responsibilities:Researched and analyzed biotechnology and pharmaceutical stocks for long-only institutional money management platform. |
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| Years | Employer | Title | Department |
| Years: 1998 to 2001 | Employer: JP Morgan | Title: Vice President | Department: Equity Research |
Responsibilities:Sell-side large-cap pharmaceuticals analyst. |
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| Years | Employer | Title | Department |
| Years: 1996 to 1998 | Employer: Hospital of the University of Pennsylvania | Title: Resident Physician | Department: Medicine and Dermatology |
Responsibilities:Resident physician. |
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International Experience
| Years | Country / Region | Summary |
|---|---|---|
| Years: 2010 to 2011 | Country / Region: China | Summary: He executed sale of a drug to 3SBio, a Chinese biotechnology company. |
Career Accomplishments
| Licenses / Certifications |
|---|
| Have held series 7 and 63 and medical license (none active). |
| Professional Appointments |
|---|
| Has served on the board of Stemline, a private biotechnology company, and the boards of several not-for-profit institutions. |
| 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. |
Additional Experience
| Expert Witness Experience |
|---|
| 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. |
| Vendor 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. |
| Marketing Experience |
|---|
| 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. |
| Other Relevant Experience |
|---|
| 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. |
Fields of Expertise
biotechnology, biotechnology assessment, drug development, drug therapy, investigational drug procedures, new drug, pharmaceutical drug, pharmaceutical industry, pharmaceutical product development, pharmaceutical research and development, financial modeling, hedge fund, investment, gout, uricase, mesenchymal stem cell transplantation, pharmaceutical patent, equity, Hatch Waxman Act, stem cell transplantation, gout suppressant, anti-infective agent, antirheumatic agent, central nervous system agent, motor neuron disease, venture capital, stock option, due diligence, health care finance, legal litigation support, pharmaceutical science, securities valuation, clinical management, asset management, portfolio, securities fraud, initial public offering, protein drug, abbreviated new drug application, finance, biologic (product), antiarthritis drug, prescription drug, clinical study, generic drug, clinical trial design, allergy medication, uric acid, cytotoxic drug, drug clinical trial, antitumor drug, valuation, chemotherapeutic drug, stem cell, acne product, clinical research, pharmaceutical research, biotechnology market research, medical technology, technology evaluation, pharmaceutical analysis, management, Food and Drug Administration, market research, Food and Drug Administration regulation, drug regulation, drug, rheumatic disease, monoclonal antibody, modeling, investigational drug, genetics, dermatology, clinical trial, biology, anti-inflammatory drug