Dr. Michael Kurman has been in the healthcare field for 28 years, first as a physician-investigator, later as a pharmaceutical executive and now as a consultant to the healthcare, pharmaceutical and biotech industries.

Examples of some projects completed by Michael Kurman Consulting, LLC include:

  • Advised the European subsidiary of a Japanese pharmaceutical company in organizational structure for its Clinical Research Division
  • Trained a newly assembled pharmaceutical sales force at the time of launch of a new breast cancer drug
  • Assisted several privately held biotech companies in the raising of venture capital
  • Assisted a small pharmaceutical company with clinical developmental and regulatory strategy, and presenting the company’s position at a pre-NDA meeting at the FDA
  • Assisted a hospital placed on clinical hold by the FDA in re-organizing their IRB and clinical research departments
  • Designed the U.S. clinical development plan for a growth factor inhibitor sponsored by a Japanese pharmaceutical company and leading an expert panel to discuss the development plan
  • Designed the global clinical development plan for an agent for the treatment of bone metastases for a European pharmaceutical company
  • Designed the Phase 1 studies for a novel chemotherapy agent sponsored by a major U.S. pharmaceutical and healthcare company
  • Wrote the business plan for a privately held medical informatics and data-management company concentrating in the oncology area
  • Assisted a company in its due diligence in anticipation of purchasing a CRO
  • Designed and managed the Phase 1 program of a novel cancer immunotherapeutic for a privately held biotech company
  • Designed the clinical trials for a Phase 4 program for a major global pharmaceutical company in anticipation of the launch of a novel oncology product
  • Advised a medical education company in their efforts to obtain certification to provide continuing education credit
  • Performed medical and clinical due diligence for the US subsidiary of a European pharmaceutical company attempting to licensing in several oncology products
  • Wroate the Integrated Summary of Safety for NDA and participating in pre-NDA meeting for agent for metastatic bone disease
  • Served as medical monitor for clinical trials of a breast cancer diagnostic product
  • Served on the Medical Advisory Board of a medical education company
  • Assisted a major biotech company in analysis of safety data from a Phase 1 study of new proteasome inhibitor
  • Developed several Phase 4 studies for a global pharmaceutical company for a recently launched growth-factor inhibitor drug
  • Assisted a pharmacogenomics company with licensing strategy and due diligence
  • Advised a venture capital company regarding due diligence and investments in biotechnology
  • Advised a biotechnology company with a unique anti-cancer platform on development and regulatory strategy
  • Assisted a major European pharmaceutical company in development of a new chemotherapy product for colorectal cancer
  • Assessed the clinical development plan for a biotechnology company with a vascular targeting agent
  • Assisted a Canadian pharmaceutical company with preparation and submission of a US IND for a novel anti-cancer drug
  • Assisted the same Canadian pharmaceutical company in raising venture capital
  • Assisted a major global pharmaceutical company with the development of an agent for the treatment of bone metastases, including authoring two Phase 3 pivotal protocols, serving as a clinical advisor in an end of Phase 2 meeting at FDA and participating in a special protocol assessment
  • Assisted a small natural products company in the development of a new cytotoxic derived from plant biomass
  • Assisted a small pharmaceutical company with a clinical development plan for a unique anti-anginal product
  • Assisted a US pharmaceutical company (study design, database design, data analysis) with a Phase IV trial of a calcium channel blocker used during angioplasty
  • Authored the Phase 1 protocol and the clinical portion of the IND and served as the clinical representative during the pre-IND meeting with the FDA for a novel monoclonal antibody targeting a growth factor receptor of a major international pharmaceutical company
  • Authored the Phase 1 protocol, the investigator’s brochure and the clinical portion of the IND for a novel anti-mitotic agent and led the pre-IND teleconference for a small pharmaceutical company
  • Authored the Phase 3 clinical development plan for a novel agent that induces heat shock protein 90 for a small pharmaceutical company
  • Authored a global clinical development plan for a vascular disrupting agent for an Australian company
  • Authored a clinical development plan for a gene-therapy product for the treatment of ovarian cancer
  • Authored a global clinical development plan for 2 products with unique mechanisms of action for a Canadian pharmaceutical company
  • Assisted a European pharmaceutical company with their pediatric investigational plan for the EMA
  • Leading the development effort for a radiation protection agent for patients with head and neck cancer
  • Assisted the US subsidiary of a Japanese pharmaceutical company in performing medical due diligence for several oncology drug in-licensing opportunities
  • Assisting a Japanese-based global pharmaceutical company in the development of several compounds for a variety of malignancies
  • Performed due diligence for the US subsidiary of a major Japanese pharmaceutical company on the successful in-licensing of a novel compound for the treatment of Hodgkin’s Disease
  • Assisted a marketing/communications company making a presentation to a major US biotechnology company with strategic and medical focus for an advertising campaign for a monoclonal antibody used in the treatment of non-Hodgkin’s lymphoma; presented at the pitch to the client