Expert Details

Expert in Biopharmaceuticals

Expert ID: 735302 California, USA

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Biopharmaceutical researcher and executive with 26 years of industry experience in all components and phases of drug development. Expertise in diverse therapeutic areas, with technical proficiency in formulation and API development, and interpretation of clinical data and research findings.

Education

Year Degree Subject Institution
Year: Degree: PhD Subject: Cellular & Molecular Physiology Institution: Yale University

Work History

Years Employer Title Department Responsibilities
Years: 2017 to Present Employer: Undisclosed Title: Chief Operations Officer Department: Responsibilities: A targeting chronic pain and neurodegeneration via a novel mechanism of action. Responsible for management of all day-to-day operations, including clinical, CMC, toxicology, safety pharmacology, DMPK, and project management. Extensive engagement with investors and the Board of Directors. Support ongoing grant applications, technology licenses and intellectual property prosecutions.
Years: 2015 to Present Employer: Undisclosed Title: Adviser and Mentor Department: Responsibilities: Advise and mentor start-up biopharmaceutical companies focused on indications that have included urinary tract infections, pain, cancer, chronic gastrointestinal inflammatory diseases, and sickle cell disease. Includes being an Adviser for the California Life Sciences Association Fellows All-Star Team program.
Years: 2014 to Present Employer: Undisclosed Title: Intellectual Property and Litigation Expert Department: Responsibilities: Prepare, draft and defend expert reports on in/validity and patent infringement cases based on expertise in formulation development, clinical pharmacology, pharmacokinetics and drug development.
Years: 2015 to 2017 Employer: Title: Senior Vice President of Development Department: Responsibilities: Led all aspects of development of a locally acting anti-proliferative/anti-viral compound for cervical, anal and oral neoplasias. Led non-clinical evaluation of the molecule and formulations, which included in-house and consultant toxicologists. Worked closely with KOLs to iteratively improve the Target Product Profile and collaboratively helped design the clinical program. Led interactions with two FDA divisions and served as primary author on regulatory submissions (e.g., pre-IND Briefing Documents for two indications). Conceived of and supervised development of topical formulation to be used in proof-of-concept clinical studies. Directly managed all CMC activities, ranging from API supply and process development, to GMP production of clinical trial material. Key contributor to exploration of additional indications for clinical candidate and other proprietary compounds. Responsible for development and management of Project Plans for each indication. Responsible for all budgets and forecasts relating to CMC and nonclinical activities. Contributed to patent applications on novel compounds and formulations. Interacted extensively with investors and the Board of Directors. Key player in raising Series C VC financing ($22M).
Years: 2015 to 2015 Employer: Title: Consultant and Enreprenuer Department: Responsibilities: Provided scientific evaluations for portfolio prioritization and valuations, and licensing deal analyses, for biopharmaceutical companies. Helped develop and edited VC pitch decks. Developed proposals for matching technologies and products available for out-licensing. Attempted to license several assets to start own company.
Years: 2013 to 2014 Employer: Title: Senior Vice President of Product Development Department: Responsibilities: Led all aspects of drug and medical device development related to urological, dermatological, and undisclosed rare disease indications. Led and managed clinical, regulatory affairs, discovery and formulation research, nonclinical, and CMC. Designed and managed nonclinical studies, in conjunction with global partner (Galderma). For urology clinical studies, supervised completion of one study, and then developed protocol, guided clinical operations, updated Investigator’s Brochure, trained Investigators, and selected Medical Monitor for a multi-site Phase-2 clinical study. For the urology portfolio, evaluated patient needs and market potential to inform the Target Product Profile, and in conjunction with marketing colleagues, developed sales projections. Key determiner of regulatory strategy and lead face-to-face meetings and teleconferences with multiple FDA divisions. Led multiple interactions with Division of Bone, Reproductive and Urological Products, and drafted and prosecuted Orphan Drug and Fast Track designation applications to support urology product candidate. Drafted, reviewed and edited 510(k) and CE Mark submissions for dermatology products. Managed regulatory affairs attorneys and consultants. Contributed to patent applications for formulations to support urology portfolio, and was a key player in overall intellectual property strategy. Maintained close relationships with corporate partners and participated in developing new partners for urology, dermatology, and undisclosed product candidates. Led research into new targets and indications for proprietary compounds and topical formulations. Managed those responsible for relationships with API and product manufacturers. Engaged in high-level negotiations with manufacturers and CROs. Participated in investor briefings both at corporate offices and at investor hubs. Provided scientific interface and credibility with investors. Drafted and reviewed press releases. Supervised QA managers to insure compliance with GMP, GLP and ISO standards for drug candidates and medical devices. Liaised with KOLs and researchers in a variety of indications.
Years: 2012 to 2013 Employer: Title: Founder Department: Responsibilities: Expert's company aspired to develop several different products, the most advanced of which were novel injectable or oral medicines for the acute management of congenital bleeding disorders, and pain. The lead series of compounds were prodrugs of FDA-approved drugs indicated for either bleeding or pain management. Other opportunities explored included a photodynamic therapy for the management of chronic pain and itch, and attempts to license languishing drug candidates (e.g., for chronic kidney disease). Conceived of and led all aspects of the various technologies, from conception and intellectual property filings to supervision of medicinal chemistry and formulation development.

Years: 2012 to 2013 Employer: Title: Consultant Department: Responsibilities: Continued to advise and assist NeurogesX with a range of activities, including patent prosecution and sale of corporate assets. Assisted emerging biopharmaceutical companies with a wide range of drug development activities, ranging from discovery research and nonclinical study management to corporate presentations and documents for investors. Advised on the design and placement of nonclinical and clinical studies at CROs. Supervised development of bioanalytical assays. Worked with API suppliers and CROs to manufacture and characterize drug substances. Wrote, reviewed and edited study reports and publications. Interacted with thought and key opinion leaders in CNS fields ranging from pain to amyotrophic lateral sclerosis.
Years: 2001 to 2011 Employer: Title: Senior Vice President Department: Responsibilities: .
Years: 2000 to 2001 Employer: Title: Vice President, Nonclinical Research & Development Department: Responsibilities: Product Development & Support: Instrumental role in transformation of treatment concept into the topical medicine Qutenza® (www.qutenza.com) marketed in over 31 countries by Acorda Therapeutics and Astellas Pharma. Supervised or participated in design and implementation of all NDA- and MAA-supporting pharmacology, toxicology, safety pharmacology and ADME studies. Supervised bioanalytical method development and both clinical and non-clinical plasma sample analyses at CROs. Directly responsible for all aspects of product profile and prototype formulation development. Selected CROs to develop topical patch and liquid formulations, and proprietary adjuncts. Identified and selected API manufacturer. Supervised or participated in later-stage CMC activities. Drafted Qutenza Development Report for regulatory filings. Reviewed and participated in the writing of all regulatory submissions. Developed a thorough knowledge of FDA regulations and international regulatory requirements. Represented nonclinical functions in presentations and discussions with US FDA and EU (UK, Sweden, Germany, Portugal & Hungary) regulatory agencies. Provided input to preparation for Advisory Committee meeting on Qutenza Supplemental NDA. Played key role in strategy concerning product collaborations, launch, commercialization and life cycle management. Drafted and maintained functional area budgets and timelines. Led design of first Phase 1 clinical study of Qutenza and active control, and published resulting data. Participated in training of NGSX Medical Science Liaisons and sales force. Wrote and edited key documents for corporate and product web sites or supplied to sales force and MSLs. Identified thought leaders for conference presentations. Assisted with compilation of materials to be used for Continuing Medical Education. Initiated and maintained relationships with key opinion leaders.
Science & Research: Scientific leader for NGSX. Served as spokesperson regarding mechanism and site of action of Qutenza (NGX-4010) and capsaicin. Authored or contributed to publications on capsaicin, TRPV1 receptors and Qutenza. Conceived of next-generation TRPV1 agonist-based product and lead development of NGX-1998 (now designated NP-1998 by Averitas) into successful Phase 2 proofof-concept clinical study. Supervised or participated in design and implementation of pharmacology and toxicology studies to support Qutenza and second-generation TRPV1 agonist products. Led exploratory research into novel analgesics and developed pipeline strategy. Conceived of and initiated exploratory research into multiple projects, including those for acetaminophen and opioid prodrugs. Led nonclinical evaluation of novel analgesics. Led and supervised research activities at international CROs. In conjunction with Morrison & Foerster, participated in drafting and prosecution of patent applications for novel capsaicin formulations, capsaicin prodrugs and prodrugs of other analgesics. Identified and evaluated in-licensing candidates. Generated product ideas. Maintained close ties to the neurology and pain research communities. Invited speaker and chairperson at pain meetings.
Corporate: One of 3 founding employees. Co-wrote and delivered investor presentations which raised Series A funding. Contributed to raising Series B, C1 and C2 venture capital financings (~$86 MM). Participated in all aspects of biopharmaceutical company management. Contributed to IPO process (May 2007; NGSX) through editing and writing sections of S-1 and underwriter and analyst briefings. Participated in reviewing major SEC filings. Delivered numerous presentations to Board, investors, research analysts and potential corporate partners. Contributed significantly to Ex-US partnership with Astellas. Served as scientific expert at Qutenza booths at scientific meets for both NGSX and Astellas. Planned strategy for NGSX patent estate. Traveled to US PTO for face-to-face prosecution of patent applications.
Years: 1999 to 2000 Employer: Title: Research Manager Department: Departments of CNS Research & Analgesia Responsibilities: .
Years: 1995 to 1998 Employer: Title: Research Scientist II Department: Department of Analgesia Responsibilities: .
Years: 1991 to 1995 Employer: Title: Research Scientist I Department: Department of Neuroscience Responsibilities: .
Years: 1991 to 1991 Employer: Title: Associate Research Scientist Department: Department of Neuroscience Responsibilities: Project Leadership: Led Palo Alto-based Project Team responsible for preclinical, Phase 1 and Phase 2a development of a novel pain therapeutic; Project Team activities included design and implementation of clinical studies, preparation of cGMP drug formulation, toxicology and pharmacokinetic studies to support regulatory filings and continued pharmacological characterization of the compound. After transfer of project to Roche Global Development, served as the pharmacologist on International Project Team, thus responsible for composition and review of many global presentations and documents. Participated in meetings with FDA and EU regulatory authorities.
Supervisory: Managed and mentored a large group of physiologists and cell biologists responsible for in vitro assays that supported drug discovery programs in analgesia, CNS and GI disorders and urology. Established research priorities and coordinated all activities. Communicated assay results throughout the organization. Monitored compliance with internal SOPs, intellectual property requirements and FDA regulatory guidelines.
Science & Research: Participated in research in Alzheimer’s disease, depression, anxiety, schizophrenia, stroke, pain, inflammation, GI and urogenital therapy areas. Generated many ideas for novel drug targets in neurology, pain and urology therapeutic areas. Received Roche Bioscience Innovator’s Award for proposal of mechanism of action underlying RO1138452. Liaised with business development organization regarding scientific evaluation of product concepts and in-licensing opportunities. Educated chemists regarding molecular targets and bioassays for many projects.

Career Accomplishments

Associations / Societies
Selected memberships: Drug Information Association, American Urology Association, Society for Neuroscience, International Society for the Study of Pain, American Pain Society Chairman, Yale Neuroscience Retreat Committee Brookdale Institute Fellow Columbia University Presidential Fellow Magne Cum Laude, Phi Beta Kappa Mullen Foundation Fellow
Awards / Recognition
Innovator’s Award, Roche Pharmaceuticals
Publications and Patents Summary
Patents: 26
Selected Patent Applications: 4
Publications: 38

Additional Experience

Expert Witness Experience
Expert witness work: patent infringement, trade secrets, Infringement and invalidity analyses; deposition,

Fields of Expertise

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