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[In-Person] Translational PK/PD and Human Dose Projection for Antibodies/ADCs and Novel Therapeutic Modalities

Speakers: Sandhya Mandlekar, Genentech; Ben Maldonato, Revolution Medicines; Aline Bergesch Barth, Structure Therapeutics; Jay Tibbitts, Surrozen; Thomas Pillow, Genentech; Paulina Jakubiak-Fort, Genentech; Ramesh Palaparthy, Gilead; Kapil Gadkar, Genentech; Chee Ng, NewGround Pharmaceutical Consulting; Di Zhou, Amgen
Organizers: Amrita Kamath, Genentech; Sandhya Mandlekar, Genentech; Vittal Shivva, Genentech
Date: 2024-09-10
Time: 8:45-17:30 Pacific Time
Registration fee: Regular attendees: $295; Academic/Students/Postdocs/Out-of-Pocket: $45; Major Sponsorship: $3000; Vendor Show: $695, Happy Hour Sponsorship: $975; Lunch Sponsorship: $1250; On-site Registration: $500
Location: Crowne Plaza, Foster City, CA (San Francisco Bay Area)
Major Sponsor: (2)Allucent; Certara
Vendor show vendors registered to date: (7)Biomere; CP Lab Safety; Croda; Eurofins Viracor BioPharma; Meadowhawk Biolabs; Resolian; Worldwide clinical trials
Registration deadline:2024-09-09  (it will close sooner if the seating cap is reached)

About the Topic

The landscape of disease-treatment modalities has undergone a dramatic transformation in recent years. New therapeutic modalities, with innovative mechanisms of action, are revolutionizing patient care. These advancements extend beyond traditional small molecules and antibodies to encompass exciting areas like bispecific antibodies, ADCs, ASOs, siRNA, cell & gene therapies. Even within the small molecule realm, targeted protein degraders, molecular glues and covalent binders are pushing the boundaries of our understanding of pharmacokinetic (PK)/pharmacodynamic (PD) relationships. In addition to this, therapeutics that are intended for ocular and neuro delivery put forth challenges associated with delivering desired drug concentrations at the site of action. Translational PK/PD aspects for these emerging modalities present unique challenges and opportunities. The recommendation of an optimal First-In-Human (FIH) dose as well as the determination of "efficacious dose" – both cornerstones of drug development – is being re-evaluated. This workshop brings together a distinguished panel of experts working at the forefront of these modalities. They will share their insights and experiences in navigating translational PK/PD considerations and projecting human doses for these groundbreaking therapies. 

Time  Topic Topic
8:45 - 9:00 am PBSS Welcome Shichang Miao, PhD, President, PBSS
9:00 - 9:15 am Workshop Introduction Vittal Shivva, PhD, Sr. Principal Scientist, Genentech
Session 1:  Novel small molecules and large molecules (AM) Moderator: Amrita Kamath, PhD, Executive Director & Distinguished Scientist, Genentech
9:15 - 9:45 am Targeted Covalent Inhibitors in Oncology: A Comprehensive Integrated Clinical Pharmacology Analysis versus Reversible Inhibitors Sandhya Mandlekar, PhD, Distinguished Scientist, Genentech
9:45 - 10:15 am Translational Modeling of RMC-6236, an Investigational RAS(ON) Multi-Selective Inhibitor, to Inform Clinical Dose Exploration and RP2D Selection Ben Maldonato, PhD, Sr. Scientist, Revolution Medicines
10:15 - 10:45 am TBD Aline Bergesch Barth, PhD, Structure Therapeutics
10:45 - 10:55 am Major Sponsor Presentation Certara
10:55 - 11:15 am Break and Vendor Show -
11:15 - 11:45 am Translation of Therapeutic Protein PKPD: Putting 30 Years of Progress Into Practice Jay Tibbitts, DVM, PhD, VP, Nonclinical Development, Surrozen
11:45 - 12:15 pm Antibody-Drug Conjugates (ADCs): Past, Present and Future Thomas Pillow, PhD, Distinguished Scientist, Genentech
12:15 - 1:15 pm Lunch Break Sponsored by Biomere
Session 2:  Novel large molecules (PM) Moderator: Sandhya Mandlekar, PhD, Distinguished Scientist, Genentech
1:15 - 1:45 pm Advancing Retinal Therapeutics: Optimizing PK/PD, Biodistribution, and Dosage for Improved Patient Outcomes Paulina Jakubiak-Fort, PhD, Principal Scientist, Genentech
1:45 - 2:15 pm PK/PD Considerations for the Development of Novel Modalities in Virology Ramesh Palaparthy, PhD, Executive Director, Gilead
2:15 - 2:45 pm Drug Delivery to the CNS for Novel Biotherapeutics Kapil Gadkar, PhD, Senior Director, Genentech
2:45 - 2:55 pm Major Sponsor Presentation Allucent
2:55 - 3:15 pm Break and Vendor Show -
3:15 - 3:45 pm Gene Expression Efficiency Factor for Human Dose Projection of Viral-mediated in-vivo Gene Therapy Chee Ng, PharmD, NewGround Pharmaceutical Consulting
3:45 - 4:15 pm Advancing Clinical Pharmacology, Modeling and Simulations for Optimal Dose Selection and Development of CAR-T Cell Therapies Di Zhou, PhD, Sr. Principal Scientist, Amgen
4:15 - 4:45 pm Panel Discussion All Speakers
4:45 - 5:45 pm Happy Hour Sponsor (TBD)

About the Speakers

Dr. Sandhya Mandlekar has been a Distinguished Scientist in Clinical Pharmacology at Genentech since 2020. She is an expert in pharmacokinetics, pharmacodynamics, and drug disposition with 20+ years of prior industry experience co-leading drug optimization teams through clinical candidate nomination. She was a Director at Bristol-Myers Squibb in Bangalore, India between 2007-2019 overseeing a multi-disciplinary team of PKDM, Bioanalytical Research, and Investigative Toxicology.

Dr. Ben Maldonato is a Senior Scientist in the Department of Non-clinical Development and Clinical Pharmacology at Revolution Medicines, Inc. where he builds internal translational modeling capabilities and interacts with both discovery and clinical stage projects as a DMPK project representative.  Before joining Revolution Medicines, he supported in-house bioanalysis at Rigel Pharmaceuticals.  He obtained his PhD in Medicinal Chemistry from the University of Washington, where he worked in the Totah lab.

Dr. Aline Bergesch Barth, VP, Head of Clinical Pharmacology and Pharmacometrics, Structure Therapeutics

Dr. Jay Tibbitts is Head of Nonclinical Development at Surrozen, Inc. Prior to this he led Nonclinical PKPD organizations at Abbvie, UCB, and Genentech. Jay has dedicated much of his career to the quantitative pharmacology and development of both small and large molecule drugs across multiple indications; and has contributed to the filing of more than 20 INDs and several BLA filings.

 Dr. Thomas Pillow received his PhD from Stanford University in organic chemistry under the direction of Professor Paul Wender. Upon graduation, he moved to Genentech in 2009 where he is currently a distinguished scientist in the discovery chemistry department leading Genentech’s effort on the discovery of new antibody-drug conjugates. He is the inventor of 3 ADCs that have advanced to human clinical trials.

Dr. Paulina Jakubiak-Fort is a Principal Scientist in the Preclinical and Translational PK/PD Department within Development Sciences at Genentech. She applies preclinical animal and in silico models to guide the design, delivery, and development of novel therapeutics in ophthalmology. In her role, she focuses on approaches to translate preclinical PK/PD to support first-in-human dose selection. She is actively contributing to the development of new long-acting ocular drug delivery systems and technologies with a patient-centric view.

 Dr. Ramesh Palaparthy is a distinguished drug developer and seasoned scientist with over 23 years of expertise in Clinical Pharmacology and Pharmacometrics. He earned his PhD in PK/PD from the University of Illinois at Chicago and his BPharm from BITS, Pilani. Fueled by a passion for innovation and enhancing patient outcomes, Dr. Palaparthy is a master in optimizing dosing strategies for personalized patient care. His extensive experience in drug development encompasses top-tier pharmaceutical and biotech organizations, where he has pioneered MIDD strategies for diverse drug modalities across numerous therapeutic areas. A prolific researcher, he has contributed over 70 abstracts and publications to prestigious peer-reviewed journals and conferences. Dr. Palaparthy is also a respected mentor and leader, guiding the next generation of Clinical Pharmacology researchers and drug developers.

Dr. Kapil Gadkar is currently a Distinguished Scientist, Senior Director, and the Head of the Modeling and Simulation Group in the Department of Preclinical and Translational Pharmacokinetics at Genentech. Kapil Gadkar earned his PhD in Chemical Engineering from UC-Santa Barbara. He has spent 20+ years developing and applying mathematical models to support drug development. Dr. Gadkar has been working at Genentech from 2011-2019 and then 2023 onwards, where he and his team have worked in a wide range of therapeutic areas including Immunology, Oncology, Ophthalmology, Cardiovascular disease, and Neuroscience. Between 2019 and 2023, Dr. Gadkar was at Denali Therapeutics where he supported the discovery and development of drug therapeutics towards defeating neurodegeneration. Dr. Gadkar also has a keen interest in teaching and takes every opportunity to lecture in topics related to Modeling and Simulation in Drug Development to undergraduate and graduate students in short courses and workshops. 

Dr. Chee Ng is currently working as the managing director of NewGround Pharmaceutical Consulting LLC.  Previously, he was faculty in the Children Hospital of Philadelphia/ University of Pennsylvania and the University of Kentucky.  He also worked as research scientist in the Genentech and Bristol-Myers Squibb.  Dr. Ng has authored over 120 peer-reviewed research articles, book chapters, patents, and conference communications related to pharmacometric, clinical pharmacology and drug development.   Dr. Ng received his B.S. in pharmacy from the State University of New York at Buffalo, Doctor of Pharmacy (with High Honor) from the University of Illinois at Chicago and a PhD in Pharmaceutical Science from the University of North Carolina at Chapel Hill.  He also completed a Clinical PK/PD Fellowship, GlaxoSmithKline/University of North Carolina at Chapel Hill and is an elected Fellow of American College of Clinical Pharmacology.

Dr. Di Zhou is an accomplished clinical pharmacologist with over a decade of experience in both the pharmaceutical industry and regulatory agency. Currently serving as the Senior Principal Scientist in the Department of Clinical Pharmacology, Modeling and Simulations (CPMS) at Amgen, Di specializes in clinical pharmacology, modeling and simulations within the field of immuno-oncology. His work encompasses leading global clinical pharmacology initiatives for cutting-edge modalities such as Bi-specific T-cell engagers and CAR-T cell therapies, contributing to the development of therapeutic proteins for both hematologic malignancies and solid tumors.

Prior to joining Amgen, Di served as a Senior Clinical Pharmacology Reviewer in the Office of Clinical Pharmacology (OCP) at the FDA, where he provided regulatory guidance on drug development strategies in psychiatry. He was the primary clinical pharmacology reviewer for over 100 Investigational New Drugs (INDs) and four New Molecular Entity New Drug Applications (NME NDAs).

Di received his PhD in Pharmaceutical Sciences from the University of Florida. During his PhD, he also completed a two-year fellowship in the Division of Pharmacometrics at the FDA focusing on PK/PD modeling for inhalation drugs and disease progression modeling. He has authored ~20 peer-reviewed articles and scientific abstracts in the fields of clinical pharmacology, pharmacometrics, and medicinal chemistry.

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2024-10-10, [In-Person] Regulatory Global Submission: Strategies and Best Practices for FDA, EMA and PMDA
2024-10-25, [Free Online Workshop] Unleashing the Power of Real-World Evidence / Data (RWE/RWD) to Facilitate Drug Discovery, Development, and Beyond
2024-11-01, [In-Person] Clinical Pharmacology Studies on Hepatic and Renal Impairments for NDA Filing: Strategies, Design, Conduct, Analysis and Regulatory Aspects
2024-11-13, [Free Online Workshop] Career Transition for Research Scientists: Business Development & BioPartnering
2024-11-15, [In-Person] Bioanalysis for Biologics and Cell/Gene Therapy Products: Refining Established Approaches for New Complex Therapeutics
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