Lead Consultants

Minako Koga : Founder and President

Ms. Koga graduated from the Waseda University in 1992 with a degree in Human Science. She spent the next fifteen years working for a Japanese Pharmaceutical company (Daiichi Pharmaceutical Co., Ltd) in the area of drug development. She founded KM Pharmaceutical Consulting with Dr.Clarence-Smith in late 2006. With over 20 years of experience in clinical development and global project management, she has successfully implemented and managed over fourteen clinical trials in neurological, psychiatric and cardiovascular diseases, both in Japan and in the U.S. She has managed project budgets of up to $160 million. Her specialty is the interpretation of preclinical and clinical data and the project management from preclinical to clinical in drug and biologics development.

Experience / Strengths

  • Project Management (Clinical, Non-clinical, CMC)
  • Interpretation of Data
  • Patent Strategy
  • Clinical Operation
  • Languages: English, Japanese

Kathleen Clarence-Smith, M.D., Ph.D. : Cofounder

Dr. Kathleen Clarence-Smith MD, PhD, is an internationally-recognized neurologist whose career has been dedicated to developing new pharmaceuticals and shepherding them from early stages onto the market. She has worked in senior positions in large pharmaceutical companies (Sanofi; Roche; Otsuka) and more recently, she has founded, raised money and headed start-up pharmaceutical companies.

Dr. Clarence-Smith received her M.D. and Ph.D. in Neurosciences at the University of Tours (France) and completed a post-doctoral fellowship at Johns Hopkins University School of Medicine in the Department of Pharmacology and Experimental Therapeutics. Dr. Clarence-Smith is a board certified neurologist (Salpetriere; Paris; France). She is the Founder and a past President of the American Society of Experimental NeuroTherapeutics (ASENT) and is a member of several scientific societies. She is the author of more than 100 peer-reviewed papers.

Experience / Strengths

  • Neurologist
  • Drug Development Strategy
  • Patent Strategy
  • Translation Form Preclinial to Clinical
  • Languages: English, French, Italian

Thomas N. Chase, S.B., M.D.

Experience / Strengths

  • Neurologist
  • Design early stage clinical trials
  • Preclinical / Clinical data review
  • Languages: English

Dr. Thomas Chase has over 40 years experience in the discovery and clinical development of new drugs for CNS disease, first at the National Institutes of Health (NIH) and then as President and CEO of Hamilton Pharmaceuticals and of Chase Pharmaceuticals. He is a graduate of the Sloan School of Management at the Massachusetts Institute of Technology and of the School of Medicine at Yale University. He completed neurology residency training at Harvard Medical School and the Massachusetts General Hospital.

Dr. Chase then received postdoctoral training in basic and clinical neuropharmacology at the National Institute of Mental Health before transferring to the National Institute of Neurological Disorders and Stroke (NINDS). While at the NINDS, Dr. Chase served as Scientific Director, Intramural Director, Clinical Director and founding Chief of the Experimental Therapeutics Branch. He received both the Superior and the Distinguished Service Medals from the U.S. Public Health Service as well as awards from Yale University and the Johann Wolfgang Goethe Universitat of Frankfurt, the American Parkinson's Disease Association, National Parkinson Foundation, American Academy of Neurology, Movement Disorders Society, and the governments of Bolivia and Pakistan. Dr. Chase’s research focused on the pathogenesis and treatment of Parkinson's and Alzheimer's disease and related neurodegenerative disorders. He served as principal investigator on nearly 200 clinical trials, published 500 peer-reviewed papers and contributed to the development of several major drugs used in the treatment of these disorders.

In early 2005 Dr. Chase joined Hamilton Pharmaceuticals as CEO, president and a director, where he raised $11M in venture capital and advanced the development of its pioneering lead product. Upon Hamilton's acquisition by a publicly-traded pharmaceutical company in 2007, he founded the Chase Pharmaceuticals Corporation.

Martine Francis

Experience / Strengths

  • Clinical Operations
  • Languages: English

Ms. Francis joined KM in June 2007. She received a BA in Biology and Psychology from Norfolk State University in 1988 and MSc. in Project Management from the George Washington University in 2003. She has over 18 years of clinical development experience in the US, Europe and Asia. Ms. Francis has an extensive knowledge of the Code of Federal Regulations required for product development. She has worked for both Government and Industry and for both the Sponsor and CRO. Her vast experience is widespread across a variety of indications some of which include; Women’s Health, CNS, Infectious Disease, Blood Products, Oncology, and Gene Transfer. She has a comprehensive knowledge of the requirements for Global clinical development planning and conduct for drugs and biologics for Phase 1, 2, and 3 clinical studies. Her excellent communication skills have proven to be very effective while acting as liaison between clients and CROs, sites, vendors and the FDA to ensure well-conducted studies. Her formal Project Management training has been invaluable in the oversight of timelines and budgets. Ms. Francis is well respected and well connected within the industry.

Jen Feranil

Experience / Strengths

  • Project Management (Regulatory)
  • Regulatory Submissions
  • Orphan Diseases
  • Languages: English

Ms. Feranil has more than 17 years of experience in the development of drugs and biologics. She has extensive experience in the preparation and management of regulatory submissions to FDA and to Health Canada. Ms. Feranil’s experience with IND/NDA products includes neurology, psychiatry, oncology, ophthalmology, and dental products with a special interest in orphan (rare) diseases. Ms. Feranil is well versed in the Code of Federal Regulations and guidance documents. Ms. Feranil acts as the regulatory agent for various Sponsors and has been involved in numerous FDA-Sponsor meetings.

Ms. Feranil received a BA in Biology from the University of Virginia in 2000. Prior to joining KM in April 2008, Ms. Feranil worked at Prestwick Pharmaceuticals, Inc. for more than 7 years.