Biotechnology Industry Expert: Pharmaceuticals, Drug Development and Drug Therapy; Oncology, Arthritis and Immune Diseases

Technical Consultant #2054


Expertise

  • Deep understanding of pharmaceutical and biotech industries acquired over 33 years.
  • Oncology, infectious diseases, arthritis and other inflammatory and immune diseases, respiratory disorders and acute and chronic pain.
  • Small molecules, including radiopharmaceuticals, for therapeutic and diagnostic/imaging applications.
  • Pre- and post-IND drug development experience, including translational medicine.
  • Technology platform enhancement and innovation (in-house and in-licensed).
  • Significant business development and strategic planning experience.
  • Extensive management/HR-related experience in large and small company settings.

Experience

Undisclosed Company, Present

President and Chief Drug Development Consultant

  • Administrate day-to-day operations and oversees business development.
  • As Chief Consultant on drug development, actively consults for clients to progress programs from pre-IND through NDA submission.
  • Oversees outsourcing activities on clients' behalf.
  • Strategic and regulatory consulting.

Novelos Therapeutics, Inc., Newton, MA, 2005 - 2013

Senior Vice President of Research and Development (Oncology drug development), 2011 - 2013

  • Cancer-targeted, small molecule radiotherapeutic and diagnostic (PET imaging) agents.
  • Cancer-targeted, small molecule optical imaging agents for diagnostic and surgical applications.
  • As Company officer and member of executive management and strategic planning team:
  • Responsible for all operations and staff management at our 16,000 sq. ft. research and radiopharmaceutical manufacturing facility in Madison, Wisconsin.
  • Led expansion of portfolio under active development from one to three drug candidates in one year.
  • Grew technical staff from 7 to 20 representing medical physics, synthetic and analytical chemistry, biology, radiopharmaceutical manufacturing, regulatory affairs, quality control and quality assurance.
  • Successful at building and nurturing a cohesive team environment, even while managing remotely (~1/3 time in Madison).
  • Responsible for management of external non-clinical contract research.
  • Together with technology founder and CSO established network of pre-clinical and clinical academic collaborators to broaden the application of our drug candidates in oncology indications resulting in twelve presentations at U.S. and international scientific meetings and multiple submissions to peer-reviewed journals under review.
  • Key member of team responsible for designing and executing Phase 1 and 2 clinical trials.
  • Oversaw successful submission of an IND for a cancer-targeted PET imaging agent.
  • Contributor to development and execution of clinical and regulatory strategies and conduct of FDA interactions (meetings, written responses).
  • Together with CEO and CFO, responsible for corporate fundraising efforts including numerous roadshows, and due diligence processes resulting in raising an additional $25 million in total.
  • Responsible for scientific communication with investment bank analysts.
  • Responsible for co-managing the company's intellectual property portfolio.

Vice President of Research and Development, 2005 - 2011

  • Company officer and member of executive management team, responsible for all scientific efforts of the company.
  • Established network of pre-clinical and clinical academic collaborators to better understand the mechanism of action underlying Novelos' oxidative glutathione-based technology platform, resulting in six peer-reviewed publications and twelve presentations at U.S. and international scientific meetings.
  • Key member of team responsible for designing and successfully executing a 900 patient Phase 3 clinical trial in non-small cell lung cancer across 100 clinical sites in U.S. and Europe.
  • Oversaw successful submission of an Investigational New Drug (IND) application for an anti-hepatitis C agent, writing most of it.
  • Responsible for management of external non-clinical contract research.
  • Contributor to development and execution of clinical and regulatory strategies and conduct of FDA interactions (meetings, written responses).
  • Together with CEO and CFO, responsible for corporate fundraising efforts including numerous roadshows, and due diligence processes resulting in raising $27 million in total and a successful transition from a private entity to a public one.
  • Responsible for scientific communication with investment bank analysts.
  • Together with the CEO and CFO responsible for business development efforts that resulted in successful out-licensing of regional rights to two products to two different entities. Vetting/due diligence on numerous in-licensing opportunities.
  • Responsible for co-managing the company's intellectual property portfolio.

Abbott Bioresearch Center (ABC), Abbott Laboratories, Worcester, MA, 2004 - 2005

Associate Director, Translational Medicine

  • Key player in the establishment of a new Translational Medicine Department with the mission of increasing clinical development success by driving the identification and establishment of Mechanism of Action (MOA) and/or efficacy-related biomarker endpoints.
  • Biomarker endpoints are established and validated during drug discovery phase and then translated into early clinical studies, providing evidence for successful molecular targeting of drugs in man and/or prediction of efficacious human dose levels via pharmacodynamics and pharmacokinetic analyses.
  • Organized and led cross-disciplinary, cross-project Biomarker Team consisting of scientists to identify MOA/efficacy-related biomarkers for each program in the drug discovery portfolio with the requirement that biomarker assays be implementable in early clinical studies.
  • Worked with individual discovery project teams to ensure exploitation of clinically feasible MOA/efficacy-related biomarkers/assays as a requirement for clinical candidate nomination.
  • Drove efforts to acquire and apply state-of-the-art platform technologies to biomarker identification and quantitation within ABC (e.g. protein TOF-MS).

ALS Therapy Development Institute, (ALSTDI), Cambridge, MA, 2002 - 2004

  • ALSTDI, a neurodegenerative disease drug discovery and development company.
  • As an independent research institute operating in the context of a unique, non-profit business model that at that time, raised over $15 million in 3 years.
  • With funded research programs and that greatly facilitated research and development interactions with academic and for-profit entities to drive and accelerate identification and development of new treatments for Amyotrophic Lateral Sclerosis (ALS, or Lou Gehrig's Disease).

Chief Operating Officer and Head, Research and Development, 2002 - 2004

  • Led a novel translational research program aimed at accelerating the pace of discovery and development of effective treatments for ALS, a devastating orphan neurodegenerative disease.
  • Research and development team includes 25 laboratory and bioinformatics researchers, focused on evaluating near-patient drugs that act on mechanisms/pathways involved in the progression of neurodegenerative diseases and identifying biomarkers for pre-clinical and clinical applications.
  • The program combines in-house research with an extensive network of academic and corporate collaborations and partnerships (over 30 established in past 12 months) to span the full range of molecular, cellular and animal level studies required to advance promising therapies.
  • In-house research includes the largest scale in vivo drug testing program in the ALS field.
  • To date, two potential new treatments, acting via novel molecular mechanisms with respect to neurodegenerative diseases, have been identified in this program and are expected to enter clinical trials in ALS patients.
  • Oversaw the creation of high-level Clinical and Scientific Advisory Boards to optimize and facilitate the research and development program and to enhance the visibility and credibility of the foundation.
  • Other significant non-research responsibilities include all business development efforts, significant involvement in fundraising, strategic and financial planning and human resources, and oversight of a 20,000 sq. ft. lab/office facility.

Phytera, Inc., Worcester, MA, Vice President of Research, 1994 - 2002

  • An infectious disease and oncology drug discovery and development company.

Research

  • Built and led a multidisciplinary research team of over 60 scientists (including 17 Ph.D.s), spanning plant biology, systematics and physiology, biochemistry, cell biology, microbiology, mammalian physiology, molecular biology (plant, microbial and eukaryotic), high-throughput screening, natural product chemistry (separative and analytical), synthetic chemistry (including combinatorial chemistry) and informatics.
  • Successfully integrated and managed this research team across four sites in three countries (U.S., U.K. and Denmark).
  • Built a complete natural-product based drug discovery engine (infectious disease focus).
  • Identified and patented numerous chemically and biologically novel lead compounds/series and subsequent conducted SAR programs to optimize activity and druggability.
  • Nominated multiple development candidates from this pool of leads, including a structurally and mechanistically novel in vivo active broad spectrum anti-fungal compound.
  • Integrated key external experimental resources (academic and CROs) to facilitate internal research and development programs.
  • Evolved and improved Phytera's platform technologies and IP base [viz natural chemical diversity access and optimization, novel screening methods (e.g. MDR pump knockout-based screens) and functional genomic methods to identify and characterize new and commercially significant plant genes.
  • Led scientific due diligence in the acquisition of two companies and of in-licensed products (a pre-clinical stage anti-viral candidate and a Phase II clinical-stage development oncology candidate).
  • Marshaled critical scientific advisors in each major scientific discipline represented by the teams' research efforts.

Business and Corporate Development

  • Played a key role in identifying, evaluating, securing and shepherding each of our eight corporate partnerships (revenue generating and joint venture/shared rights business models) and multiple academic technology licensing collaborations to further exploit Phytera's technology platform.
  • Drug discovery partnerships with large pharma/biotech companies (Eli Lilly, Chiron) and several smaller biotech companies in the U.S., Europe and Japan spanning numerous therapeutic areas and resulting in the generation of many novel lead compounds, multiple patents and several SAR programs.
  • Non-pharmaceutical oriented partnerships were crafted with large (Unilever/personal care products) and small (Lynx/plant functional genomics) companies.
  • Technologies capable of providing research tools and targets were identified and successfully in-licensed/accessed from numerous U.S. and European universities and other institutions; University of Maryland, Tufts University, the University of Massachusetts, the University of Cincinnati, Stanford University, the University of California, Harvard University/Beth Israel Deaconess Hospital, Sheffield University, Virginia Commonwealth University, Universite Catholique de Louvain, Centre Hospitalier Universitaire Vaudois/Lausanne University, Woods Hole Oceanographic Institution, and the Public Health Research Institute, SUNY.
  • Strongly involved in all financing initiatives since joining the company.
  • Key member of senior management team charged with development and execution of business and technical strategies.

Pfizer Inc. , Central Research Groton, CT, 1961 - 1994

Director, Exploratory Development Planning, Pfizer Inc.

  • Department head, responsible for coordinating and facilitating IND submission and early clinical studies (Phase I through Phase IIa) for the portfolio of sanctioned development candidates generated across all therapeutic areas by Pfizer's Central Research Division in Groton, Connecticut.
  • Grew and managed a group of 10 scientists and 2 administrative support staff who worked closely with over 25 Exploratory Development Candidate Management Teams.
  • Each of these highly visible, cross-disciplinary teams was comprised of roughly 12 representatives from drug discovery (chemistry and biology), pharmacokinetics/metabolism, toxicology, process chemistry, pharmaceutics, clinical studies and regulatory affairs.
  • Regular interactions with marketing representatives also occurred on these teams.

Assistant Director, Department of Immunology and Infectious Diseases, 1987 - 1983

  • Responsible for all discovery research in the areas of inflammatory disorders and respiratory diseases.
  • Key areas of research effort included cell adhesion and chemotaxis, cytokines, lipid mediators, degradative enzymes, cartilage metabolism and points of biochemical regulation of cell function (e.g. phosphodiesterases, protein kinases).
  • Doubled size of group to 13 Ph.D.s and 38 technical staff (BS/MS).
  • Direct reports included two managers (of Inflammatory Diseases and of Respiratory Diseases), the supervisor of our core EM/histology unit and three technicians (who independently operated an analytical support lab for the section).
  • Successfully introduced a variety of mechanistically novel agents into development (including clinical studies).
  • Major involvement with an advanced clinical candidate (tenidap) entailing integration of Central Research efforts (preclinical and clinical) with medical and marketing functions of our domestic and international operating divisions. This compound ultimately reached registration in Europe.
  • Chaired two Early Candidate Development Management Committees for IND-track candidates and sat as a member of a third.
  • Ensured that group established and exploited an extensive network of outside scientific collaborators, consultants and grantees.

Manager, Neurosciences Section, 1985 - 1987

  • Responsible for the majority of the neuroscience discovery biology research at Pfizer, including established programs in pain and psychosis/schizophrenia and creation of new approaches in anxiety and senile dementia and stroke.
  • Group comprised of 5 Ph.D.s and 11 technical staff.
  • Research laid foundation for several development candidate programs.
  • Gained direct experience with elements of pre-clinical and clinical development (e.g. animal PK and safety studies; human Phase I studies).

Project Leader, Neurosciences Section, 1983 - 1985

Research Scientist, Department of Metabolic Diseases and General Pharmacology, 1981 - 1983

  • Conceived of and executed novel approaches to drug discovery based on intervention with neuropeptide physiology, with a particular emphasis on analgetic drug discovery.
  • Techniques employed ranged from biochemistry (receptor binding, enzyme purification/assay, second messenger production) to whole animal physiology.
  • Multiple SAR programs were conducted around lead compound series.

Honors & Publications

Academic and Professional Affiliations

  • Senior and Staff Fellow for
  • National Institutes of Health, National Institute of Arthritis, Metabolism and Digestive Diseases, Clinical Hematology Branch, Bethesda, MD.
  • National Institutes of Health, National Institute of Child Health and Human Development, Reproduction Research Branch, Bethesda, MD.
  • Doctoral Research: A Study of Structure-Function Relationships in the Outer Membrane of Escherichia coli J5.

Publications and Patents

  • Author and Co-Author of over 50 publications, abstracts (59), lectures and invited presentations, (15).
  • 1 U.S. patent.
  • 1 World patent.

Education

  • Ph.D. Microbiology (Biochemistry), University of Notre Dame, Notre Dame, IN
  • B.A. Biology (with Honors), Oberlin College, Oberlin, OH
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