1. Dedicated to assisting the pharmaceutical and medical device industries to succeed in product registration and label expansion through programs with goals to maximize the possibility of success while minimizing risk.

    Every drug, biologic, or device program should have the ultimate "indication" clearly in focus throughout each step of the entire development program. We tailor our services, guided by this concept, specifically for every product.
    • Experience
      Clinical
      M.D.; clinical university practice >30 years
      (University of California, San Francisco;
      Peter Bent Brigham Hospital, Harvard
      )
      Academic
      • Professor Emeritus, University of California,
      San Francisco.
      • Prinicapal investigator with career-long
      competitive funding (NIH, DOD, industry) for
      many projects. See cv.
      Industry
      Novo Nordisk A/S (corporate headquarters,
      Denmark
      ): corporate VP and director of a major clinical research program;
      and executive scientific advisor (including evaluations for inlicensing or acquisition).
      Editorial
      experience as:
      • editor
      • editorial boards
      • extensive referee experience for many leading journals
      Consulting
      • Extensive consulting experience with many
      firms (small to very large) encompassing
      drugs, biologics, and devices
      • Regulatory agencies, interaction as
      - Industry representation
      - Industry program manager, including
      regulatory components (FDA and EMA)
      - Consultant to FDA
      • Consultant to DOD for drug/biologic/device
      development; and program review
      • Consultant to NIH for research evaluation;
      programmatic review
      Education/ Training
      • Albert Einstein College of Medicine, M.D.
      • Beth Israel Hospital (Harvard): internship
      • University of California, San Francisco:
      residency
      • Cardiovascular Research Institute, University of California, San Francisco: research fellowship
      Faculty Positions
      • Harvard Medical School
      • University of California, San Francisco Medical School
      Partners
      Every development program is unique, requiring specific experience and expertise. When requirements indicate that the program would benefit from additional expertise, we enlist collaborators with appropriate skills and knowledge, through an extensive network, either directly or as a recommendation.

       

    • Services
      We offer the following services commensurate with our experience and expertise
      Programmatic
      The key to a successful registration or label expansion is the design and implementation of cohesive laboratory and clinical development programs that are scientifically sound, and commercially viable. We offer guidance for entire programs, as well as the specific components: bench, pre-clinical, and clinical phases I, II, III, and IV programs.
      Regulatory
      Regulatory authorities in the U.S. (FDA) and Europe (EMA/CHMP) have been increasing their demands of sponsors. The most efficient method of easing the path to registration or product expansion is to have had a sound development program (see "Services: programmatic" and "Services: specific protocol design"). We have significant experience in working with these regulatory authorities and offer guidance in sponsor interactions; assistance with internal preparations for regulatory meetings; and when advisable, sponsor representation at meetings with regulatory authorities.
      Data Analysis & Interpretation
      The most important aspects of data analysis are to have had a scientifically sound program and protocols, with appropriate statistical analysis plans (SAPs). The programs, protocols, and SAPs are interactive, and not separate, discrete items. We offer an integrative approach to these, applying extensive experience in data analysis and interpretation.
      Evaluate Intra-Corporate Programs
      Streamline clinical development programs (and evaluate competing in-house programs) to improve efficiency and focus, to improve opportunities for success and reduce risk.
      Additional Experts
      Engage additional experts, as needed, for specific guidance, though an extensive network of partners and collaborators.
      Phase I-III: Specific Protocol Design
      This is an area of particular expertise with career-long experience and success. Each protocol is tailored to achieve maximal opportunity for registration (or expansion) for the desired indication, while minimizing programmatic and corporate risk.
      Phase IV (post-marketing): Program Concept & Design
      EMA and FDA are increasing Phase IV impositions. We endeavor to develop required focused programs to comply, while maximizing feasibility and minimizomg risk.
      Document Preparation & Editing
      Successful pharmaceutical development programs require not only appropriate scientific and clinical expertise, but also communication to all involved (internal and external scientists, experts, statisticians, regulatory, marketing) that accurately reflects the various programmatic aspects, and is understandable to each individual. We offer assistance, based on our substantial experience in scientific writing and editing, intra-corporate communication at all levels, and communications with regulatory agencies.
      Internal Education
      Productivity of those involved in a project might be improved by increased awareness and understanding of the various components involved. We offer assistance for internal education programs that can be tailored to specific expertise and the various stages of product development or life-cycle.
  2. Contact
    Our guidance and assistance is carefully tailored to each project. We encourage you to contact us for a discussion to determine whether our services fit your needs.