With decades of experience in academics, industry, and consulting in a wide range of therapeutic areas, Endpoint LLC can provide authoritative, comprehensive advice to multinationals, biotech start-ups, charitable medical foundations, governmental bodies, and biotech investors.

Strategic Drug & Device Development

Details

  • evaluate the medical and commercial potential of products in preclinical or early clinical development
  • formulate comprehensive clinical development plans to the highest medical, scientific, and ethical standards
  • position products for optimal marketing through a carefully integrated Phase I through IV clinical trials program
  • optimize go/no-go decision points during product development
  • help emerging companies articulate a comprehensive approach to product development customized to their compound or device, planned indication, and specific corporate needs
  • interact with regulatory agencies to gain endorsement of the clinical trial program and planned regulatory submission
  • assist with strategic planning of FDA advisory committee presentations

Clinical Trial Design & implementation

Details

  • design state-of-the-art clinical trials to optimally achieve key goals at each stage of a product’s development
  • optimize outcome measures that are most appropriate for both the product and the target patient population
  • provide strategic review of draft protocols
  • assure that clinical studies will meet the requirements of regulatory agencies and institutional review boards (“ethics committees”) worldwide
  • act as the medical monitor for emerging companies: supervise CRAs and provide help with the evaluation and processing of adverse events
  • help supervise the CRO carrying out a client’s clinical activities

Due Diligence for Acquirers & Investors

Details

  • predict the outcome of pivotal clinical trials based on publicly available information
  • predict the likelihood of FDA approval of NDA submissions
  • write interpretive critiques of key manuscripts, reports, document and competitor data
  • evaluate opportunities in and perform due diligence of early-stage investment opportunities

Partnering & Strategic Alliances

Details

  • suggest partnering strategies for emerging companies
  • evaluate and help negotiate in- and out-licensing opportunities
  • coordinate activities between companies co-developing a product
  • help clients develop a package for presentation to investors or potential aquirers

Educational & Academic

Details

  • produce authoritative overviews of medical conditions and their current therapy in areas relevant to a company’s portfolio
  • identify and help select opinion leaders in North America and Europe
  • assemble and/or chair expert advisory panels
  • educate company staff in various aspects of strategic drug or device development