2016 ACCP Annual Meeting | Clinical Pharmacology as a Cornerstone for Development of Products Under the Animal Rule: Determining an Effective Dose in Humans

  • Registration Closed

Clinical Pharmacology as a Cornerstone for Development of Products Under the Animal Rule: Determining an Effective Dose in Humans

DISCOVERY TRACK

Offers both CME and CPE Credit
UAN #0238-0000-16-004-L01-P
ACPE – 3.5 CONTACT HOURS/APPLICATION-BASED

CO-CHAIRS:
Nitin Mehrotra, PhD, Team Leader, Div of Pharmacometrics, US Food & Drug Administration
Kimberly L. Bergman, PharmD, Lead Pharmacologist, US Food & Drug Administration

TARGET AUDIENCE:
The target audience includes clinical pharmacologists, pharmacometricians and translational medicine scientists from the pharmaceutical industry, academia and regulatory agencies who have an interest in applying and/or currently apply the principles of clinical pharmacology modeling and simulation in drug development of products under the Animal Rule.
GOALS AND OBJECTIVES:
Following completion of this activity, the learner will be able to:
1. Understand the drug development and approval process of products under the Animal Rule;
2. Analyze and understand the role of clinical pharmacology modeling and simulation in dose selection in humans for development of products under the Animal Rule;
3. Highlight the case studies where clinical pharmacology modeling and simulation played a significant role in drug development or regulatory decisions.

Outline
Introduction: Setting the Stage
Nitin Mehrotra, PhD, Team Leader, Div of Pharmacometrics, US Food & Drug Administration

The Animal Rule: Approval of New Drugs & Biological Products When Human Efficacy Studies Are Not Ethical or Feasible
Andrea M. Powell, PhD, Pharmacologist, Counter-terrorism & Emergency Coordination, US Food & Drug Administration

The Animal Rule: The Role of Clinical Pharmacology in Determining an Effective Dose in Humans
Kimberly L. Bergman, PharmD, Lead Pharmacologist, US Food & Drug Administration

Perspective on the Clinical Pharmacology Approach for Rational Choice of Drug & Dose in Product Development Under the Animal Rule: Example for Treating Patients Acutely Exposed to Myelosuppressive Doses of Radiation
Andrew T. Chow, PhD, Executive Director, Amgen Inc

The Use of Modeling & Simulation in the Raxibacumab Development Program
Alfred Corey, BS, Consultant, AC Pharmaco LLC

Application of Quantitative Clinical Pharmacology in Dose Selection for Products Developed Under the Animal Rule: Case Studies
Lian Ma, PhD, Pharmacometrics Reviewer, US Food & Drug Administration

Panel Discussion

Nitin Mehrotra, PhD

Dr. Mehrotra is a Team Leader in the Div of Pharmacometrics, Office of Clinical Pharmacology at the US Food & Drug Administration (FDA). He joined the FDA in 2007. In his current role at the FDA, Dr. Mehrotra works in the areas of oncology, metabolic and endocrinology, medical imaging, gastroenterology and inborn error products. His job profile includes applying clinical pharmacology & pharmacometric principles for regulatory decisions such as dose selection, evidence of effectiveness, trial design, etc. Prior to joining FDA, Dr. Mehrotra obtained his PhD degree from Birla Inst of Technology and Sciences, India. Following which, he worked as a post-doctoral fellow at the Univ of Tennessee Health Science Ctr focusing on application of pharmacometrics in drug development. Dr. Mehrotra is a strong proponent of the concept of 'rationale dose selection' and believes it to be pivotal for success of any drug development program. Dr. Mehrotra has experience in reviewing/assessing the adequacy of the applications that are submitted to the FDA for product development/approval under the Animal Rule. He has published several articles and has been invited to conferences to present on topics pertaining to application of pharmacometrics in drug development and regulatory decisions.

Andrea Powell, PhD

Dr. Powell is a pharmacologist on the Medical Countermeasures Team in US Food & Drug Administration's (FDA) Counter-Terrorism and Emergency Coordination Staff (CTECS) in the Office of the Center Director in FDA's Ctr for Drug Evaluation and Research (CDER). She facilitates the development of medical countermeasures for chemical, biological, radiological and nuclear agents by working on policy and guidance related to medical countermeasure development and the regulations commonly referred to as the Animal Rule [21 CFR 314.600-650 (for drugs), 21 CFR 601.90-95 (for biological products)] and frequently gives presentations on these topics. Dr. Powell was the lead writer for FDA's guidance Product Development Under the Animal Rule. She also works on the development of electronic data standards for Animal Rule-specific studies.

Dr. Powell received her doctorate in pharmacology from Cornell Univ Graduate School of Medical Sciences. Prior to joining CTECS in 2008, she had 21 years of regulatory experience in CDER as a pharmacology/toxicology reviewer of drugs to treat neurological conditions.

Kimberly L. Bergman, PharmD
Dr. Bergman is a Lead Clinical Pharmacologist in the Office of Clinical Pharmacology (OCP), Office of Translational Sciences (OTS), Ctr for Drug Evaluation and Research (CDER), US Food & Drug Administration (FDA). Dr. Bergman began her career with the FDA in 2004 and has served as a clinical pharmacology reviewer and/or team leader in the antiviral, anti-infective, counter-terrorism and ophthalmology therapeutic areas. Currently, she is a Team Leader in OCP's Labeling & Health Communication group. Dr. Bergman received a Bachelor of Science in Education at the Univ of Nebraska and her Doctor of Pharmacy degree at the Univ of Nebraska Medical Center (UNMC). Upon completion of a clinical pharmacy practice residency at UNMC, she completed a post-doctoral research fellowship in critical care and infectious diseases pharmacotherapy at UNMC. Prior to joining the FDA, Dr. Bergman was a pharmacokineticist/associate scientist at Quintiles Inc and Otsuka Pharmaceutical Co Ltd.

Andrew T Chow, PhD
Dr. Chow is currently serving as Executive Director in the Dept of Medical Sciences at Amgen Inc. where he is responsible for the scientific and regulatory leadership encompassing pharmacokinetics (PK), pharmacodynamics (PD) and pharmacometrics (PM) sub-specialty areas; to support innovative small molecule and biological product development, biosimilar product development, global product registration and product life-cycle management. Andrew served as Executive Director, Quantitative Pharmacology Group Head in the Dept of Pharmacokinetics & Drug Metabolism at Thousand Oaks from 2006 to 2013. In his tenure, he transformed the group to today's organization with integrated functional capacity in clinical pharmacokinetics, pharmacometrics and data management to meet the growing scientific and workload demands in drug development.

Prior to joining Amgen in 2006, Andrew worked for Johnson & Johnson (J&J) from 1990 where he held positions of progressively increasing responsibility. He helped established the model-based drug development capacity at J&J in late 90's. In 2001 Andrew served as the first Director and Global Head (US and EU) of the Department of Advanced PK/PD Modeling and Simulation until he left the company in 2006.

Andrew enjoys giving lectures and sharing his knowledge and experience with industry colleagues and students in the academia. He was Adjunct Associate Professor in the College of Pharmacy of Rutgers, the State Univ of New Jersey from 2001 to 2006. Andrew received his BS degree in Pharmaceutics, BS degree in Pharmacy, and PhD degree in Pharmaceutical Sciences from the State Univ of New York at Buffalo.


Alfred Corey, BS

Mr. Corey has over 36 years of experience in the pharmaceutical industry and has recently begun working as an independent consultant. He offers preclinical and clinical pharmacokinetic, pharmacodynamic and pharmacometric support services, with emphasis on providing strategic planning services throughout a compound's development life cycle.

Prior to founding his consulting business, Al has worked for a variety of large and small pharmaceutical companies:he started in 1980 at Norwich Eaton Pharmaceuticals, which was acquired by Proctor & Gamble Co. In 1997, he moved to Otsuka America Pharmaceutical Co Ltd, and from there joined Human Genome Sciences in 2002. Human Genome Sciences was acquired by GlaxoSmithKline in 2012, and Al then joined that company. After a 15 month stint with Parexel Intl, Al formed AC Pharmaco LLC (acpharmaco@gmail.com) in 2016.

During his career, Al worked on drugs from a variety of therapeutic areas, including the anti-infective, anti-inflammatory, oncology, cardiovascular, renal, antiviral, immunomodulatory and bioterrorism arenas. He has supported numerous IND, BLA and NDA filings and has contributed to ex-US regulatory filings. Al enjoys the challenges of using modeling to proactively guide the development of drugs from the early preclinical to post-marketing stages.

Lian Ma, PhD
Dr. Ma is a Pharmacometrics reviewer in the Div of Pharmacometrics at Office of Clinical Pharmacology (OCP), US Food & Drug Administration (FDA) since 2013. She works in the areas of Oncology, Metabolic and Endocrinology, Gastroenterology and Inborn error and Medical Imaging products, and is responsible for assessing the Pharmacometric analyses in the IND/NDA/BLA submissions. She has experience in the review of applications under the Animal Rule particularly from a perspective of applying quantitative clinical pharmacology in dose selection. She has also published articles and been invited to conference to present on topics pertaining to application of pharmacometrics in drug development and regulatory decisions. Lian serves as peer reviewer for several clinical pharmacology journals. She received her Bachelor's (2005) and Master's degree (2007) in Pharmaceutical Sciences from Peking Univ and earned a PhD in Pharmacokinetics (Minor in Statistics) from Oregon State Univ in 2013.

CPE 3.5 Contact Hours
UAN Number: 0238-0000-16-041-H01-P    Expires 9/25/2019

Application - Based Activity

imageACPE Accreditation Statement

The American College of Clinical Pharmacology is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education.

imageACCME Accreditation Statement

The American College of Clinical Pharmacology is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

Designation Statement

The American College of Clinical Pharmacology designates this live activity for 1 AMA PRA Category 1TM credit. Physicians should only claim credit commensurate with the extent of the participation in the activity.

In order to receive CE credit, the learner must score 75% or better on the online post-test and must complete an online evaluation.

Key:

Complete
Failed
Available
Locked
Webinar
Recorded 09/25/2016
Recorded 09/25/2016
SYMPOSIUM 1: Clinical Pharmacology as a Cornerstone for Development of Products Under the Animal Rule: Determining an Effective Dose in Humans
12 Questions  |  1 attempt  |  9/12 points to pass
12 Questions  |  1 attempt  |  9/12 points to pass
Evaluation - Clinical Pharmacology as a Cornerstone for Development of Products Under the Animal Rule: Determining an Effective Dose in Humans
8 Questions
Medical Certificate
Up to 3.50 medical credits available  |  Certificate available
Up to 3.50 medical credits available  |  Certificate available