Speakers: Sandhya Mandlekar, Genentech; Ben Maldonato, Revolution Medicines; Jian Luo, Genentech; Jay Tibbitts, Surrozen; Thomas Pillow, Genentech; Paulina Jakubiak-Fort, Genentech; Ramesh Palaparthy, Gilead; Kapil Gadkar, Genentech; Chee Ng, NewGround Pharmaceutical Consulting
Organizers: Amrita Kamath, Genentech; Sandhya Mandlekar, Genentech; Vittal Shivva, Genentech
Date: 2024-09-10
Time: 8:45-16:30 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: (18)Aliri Bioanalysis; Biomere; BioTether Sciences; Cellentia, Inc; Charles River; CP Lab Safety; Croda; Curia; Discovery Life Sciences; Emery Pharma; Eurofins Viracor BioPharma; Meadowhawk Biolabs; Medicilon; PharmaBlock; Quantall LLC; Resolian; Syngene; Worldwide clinical trials
Registration: http://www.PBSS.org
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. Some of these advancements extend beyond traditional small molecules and antibodies to encompass exciting areas like bispecific antibodies, ADCs and gene therapies. Even within the small molecule realm, covalent binders, biased agonists and pan-inhibitors 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.

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. 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. Jian Luo, Senior Director, Pharmacology. He was with Carmot Therapeutics before the recent Roche acquisition. Jian's research interest has been mostly in the metabolic diseases field. He has gained extensive drug discovery and development experience from both small and large biotech/pharmaceutical companies for the last 30 years.