Phase 1 clinical program planning is complicated these days with added pressure to get maximum study data and move quickly to Phase 2 or partner the clinical asset.  Whatever the plan, it makes good sense to utilize study designs and processes that save time and cost while avoiding expensive delays through identification of unseen compound safety risks typically not found until the end of Phase 2 or later. 

The presenters will review the following specific study components which can be highly beneficial in terms of time and cost savings when included in a Phase 1/ First-in-Man clinical studies: 

  1. Metabolites in Safety Testing (MIST) in SAD/ MAD studies.
  2. Concentration QT modeling (cQT modeling) in SAD studies.
  3. Time and cost-effective Dose Selection strategy for SAD studies, bridging preclinical data to First-in-Man and beyond.

An insightful overview for anyone new to Phase 1 clinical study operations and useful information for those who have not run an early clinical program in some time.

Featured Speakers

Dr. Philip R. Tiller

Senior Director
Frontage Laboratories, Inc.

Dr. Tiller obtained his Ph.D. from the Imperial College of Science, Technology and Medicine, London. He has more than 25 years’ experience working in the Pharmaceutical industry at Glaxo in England, at Merck in the US, at RMI Laboratories, and now at Frontage. His focus has been the application of high-resolution mass spectrometry (HRMS) to metabolite Identification. He co-chaired the team that crafted Merck response to the 2008 MIST guidance and has been a part of more than 100 MIST studies.

Dr. Frank Lee

Executive Medical Director
Frontage Laboratories, Inc.

Dr. Lee is the Executive Medical Director at Frontage. He has over 14 years of early stage drug development, serving as Principal Investigator/Sub-Investigator on over 150 clinical trials including first in human, bioequivalence, absolute bioavailability, dose escalation, drug-drug interaction, and adaptive design studies. These trials encompassed a variety of therapeutic areas including cardiovascular, endocrine/metabolic, oncology, infectious disease, and neurology. He is a Certified Principal Investigator (CPI) through the Association of Clinical Research Professionals (ACRP), with a M.D. Degree from New York Medical College and a BA degree in Biology from Brown University.

Dr. Ken Yin

Director of Clinical Pharmacology
Frontage Laboratories, Inc.

At Frontage Clinical Services Dr. Yin supports the clinical pharmacology sections of Phase 1 & 2 clinical studies and has extensive experience in the characterization of pharmacokinetics and pharmacodynamics of small molecules and biotherapeutics. He has designed and reviewed all types of clinical pharmacology studies and often addresses regulatory bodies (FDA, EMA or CFDA) with review questions. Dr. Yin has expertise in bridging preclinical pharmacokinetic and toxicokinetic NOAEL data to predict the dose and exposure in First-in Man/ SAD/MAD studies using allometric scaling method to speed up early development.

Prior to joining Frontage Clinical Services, work in academia followed by posts at Novartis and GlaxoSmithKline where he contributed to the preclinical and clinical development of several products receiving FDA approval.