TS12B: PRACTICAL INTRODUCTION TO PKPD MODELING IN DRUG DISCOVERY AND DEVELOPMENT: BETTER, FASTER, CHEAPER

WEDNESDAY, JUNE 19 - THURSDAY, JUNE 20

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INSTRUCTORS:

Arijit Chakravarty, CEO, Fractal Therapeutics

Ryan Nolan, PhD, Vice President, Preclinical Development, Fractal Therapeutics

Model-based drug development (MBDD) has evolved into a set of practical techniques that dramatically reduce pharma R&D costs without sacrificing quality. Pharmacokinetic/Pharmacodynamic (PKPD) modeling lies at the heart of MBDD. Part 1 of the seminar will teach the concepts of MBDD and its application in drug R&D. Part 2 will provide an in-depth introduction to key concepts in PKPD modeling, and teach hands-on implementation of PKPD modeling on real and simulated datasets.

TOPICS TO BE DISCUSSED:

Part 1: Concepts of Model-Based Drug Development

• Principles of model-based drug development
• The design and interpretation of dose-response curves
• Dose schedule assessment for first-in-man trial design
• Using a validated model system to project efficacious doses
• Translational projections in the absence of a validated model system
• Safety projections: Identifying starting and maximum tolerated doses
• Challenges in therapeutic window assessment for large molecules
• Phase I single-agent trials in Oncology
• Non-Oncology Phase I trial design
• Using disease progress modeling to design better dose-ranging trials
• Dose-ranging assessment of efficacy and pharmacodynamic outcomes
• Using therapeutic window assessments to manage drug development risk
• Portfolio management for model-based drug design

Part 2: A Hands-On Introduction to PK/PD Modeling

• Compartmental PK modeling
• Turnover models
• Non-compartmental analysis
• Turnover modeling
• Dose vs. exposure
• Inter-species scaling
• Pharmacodynamic modeling
• Large molecule pharmacodynamics
• Systems modeling

INSTRUCTOR BIOGRAPHIES:

Arijit Chakravarty, CEO, Fractal Therapeutics

Before he founded Fractal Therapeutics, Arijit was the Director of the Modeling & Simulation (M&S) function at Takeda Pharmaceuticals International Co., Cambridge, MA. He has a PhD in Biochemistry from Dartmouth College, and a Bachelor's in Pharmacy and a Master's in Biological Science from the Birla Institute of Technology and Science, Pilani, India. Prior to his current role, Arijit has worked in other roles at Takeda (formerly Millennium), as a computational biologist, as a group leader and biomarker team leader in the in vivo pharmacology group, and in a translational group, where he led cell biology and pharmacology teams, and served as the discovery project leader for seven programs. He has contributed directly to around fifty drug discovery and development programs in multiple therapeutic areas, from target identification to discovery and early clinical development. Arijit has spoken at more than thirty conferences and invited seminars and published over thirty peer-reviewed articles and book chapters, and over fifty abstracts.

Ryan Nolan, PhD, Vice President, Preclinical Development, Fractal Therapeutics

Before his current role at Fractal Therapeutics, Ryan spent 13 years in the pharmaceutical industry across various large and small companies including Wyeth, Pfizer, Momenta, and Takeda. He has had numerous roles providing diverse experience, including bioprocess engineer, systems pharmacologist, and head of modeling and simulation groups. He has contributed directly to numerous drug discovery and development programs in multiple therapeutic areas, most extensively in immunology and oncology. He has a PhD in Chemical Engineering from Tufts University and a Bachelor's in Biomedical Engineering from Johns Hopkins University. Ryan has published several peer reviewed articles, a book chapter, and three patents.

Training Seminar Information

Each CHI Training Seminar offers 1.5 days of instruction with start and stop times for each day shown above and on the Event-at-a-Glance published in the onsite Program & Event Guide. Training Seminars will include morning and afternoon refreshment breaks, as applicable, and lunch will be provided to all registered attendees on the full day of the class.

Each person registered specifically for the Training Seminar will be provided with a hard copy handbook for the seminar in which they are registered. A limited number of additional handbooks will be available for other delegates who wish to attend the seminar, but after these have been distributed, no additional books will be available.

Though CHI encourages track hopping between conference programs, we ask that Training Seminars not be disturbed once they have begun. In the interest of maintaining the highest quality learning environment for Training Seminar attendees, and because seminars are conducted differently than conference programming, we ask that attendees commit to attending the entire program, and not engage in track hopping, as to not disturb the hands-on style instruction being offered to the other participants.