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Workshop

[In-Person] Preclinical Development and IND Filing for Small Molecules: Nuts, Bolts and Best Practices


Speakers: Shaji Theodore, FDA; Griff Humphreys, Aranmore Pharma Consulting; Patricia White-Cipriano, consultant; Aarti Sawant, AstraZeneca; Dustin Smith, Merck; Nathalie Rioux, Certara; Jonathan Jackson, Pfizer; Marie Lemper, UCB; Drew Barlow, Syner-G BioPharma Group
Organizers: Rob Foti, Merck; Anshul Gupta, Editas Medicine
Date: 2024-06-25
Time: 8:45-17:00 Eastern Time
Registration fee: Regular attendees: $295; Academic/Students/Postdocs: $45; Out-of-Pocket: $45; Major Sponsorship: $3000; Vendor Show: $695, Happy Hour Sponsorship: $975; Lunch Sponsorship: $1250; On-site Registration: $500
Location: Merck Research lab, Boston
Major Sponsor: (2)Frontage Laboratories, Inc.; Resolian
Vendor show vendors registered to date: (13)Alturas Analytics; Beijing InnoModels Biotechnologies; BioAgilytix; BioDuro-Sundia; ChemPartner; Curia; Curia Global; Ellegaard BioResearch; Hypha Discovery Limited; Meadowhawk Biolabs; Q Squared; Veloxity Labs; WuXi AppTec
Registration: http://www.PBSS.org
Registration deadline:2024-06-24  (it will close sooner if the seating cap is reached)

About the Topic

Time EST Topic Speaker
8:00 – 8:40 am Registration and Coffee -
8:40 – 8:50 am Welcome Chandra Prakash, PhD, Senior Research Fellow, Agios Pharmaceuticals
8:50 – 9:00 am Workshop Objectives and Introduction Rob Foti, PhD, Senior Director, Merck;  Anshul Gupta, VP, Editas Medicine
9:00 – 9:40 am FDA Guidance on Preclinical IND Package Shaji Theodore, PhD, DABT, Senior Pharmacologist, FDA
9:40 –10:20 am Overview of Sections 2.6.2, 2.6.4 and 2.6.5 Griff Humphreys, PhD, Principal, Aranmore Pharma Consulting
10:20 – 10:40 am Break and Vendor show -
10:40 – 11:15 am Overview of Section 2.6.6 Patricia White-Cipriano, PhD, Independent Consultant, Nonclinical/Scientific/Regulatory Drug Development
11:15 – 11:25 am Sponsor Presentation Frontage Laboratories, Inc.
11:25 am – 12:00 pm Overview of Clinical section, CDP Aarti Sawant, PhD, Director, Clinical Pharmacology, AstraZeneca
12:00 – 1:00 pm Lunch Sponsor (Alturas Analytics)
1:00 – 1:35 pm In Vitro & In Vivo ADME Characterization Dustin Smith, PhD, Principal Scientist, Merck
1:35 – 2:10 pm Evaluation and Translation of Preclinial DDI Nathalie Rioux, PhD, VP, Early Drug Development, Certara
2:10 – 2:20 pm Sponsor Presentation Resolian
2:20 – 2:40 pm Break and Vendor Show -
2:40 – 3:15 pm Preclinical DILI Assessment Jonathan Jackson, PhD, DABT, Senior Principal Scientist, Discovery & Investigative Toxicology, Pfizer
3:15 – 3:50 pm IQ Consortium - Starting Dose Selection Marie Lemper, PharmD, PhD, DABT, ERT, Head of US Toxicology, UCB
3:50 – 4:25 pm Chemistry, Manufacturing, and Controls (CMC) Drew Barlow, MPH, SVP, Head of Regulatory Partnerships, Syner-G BioPharma Group
4:25 – 4:55 pm Panel Discussion Rob Foti, PhD, Senior Director, Merck; Anshul Gupta, VP, Editas Medicine
4:55 – 5:55 pm Happy Hour Sponsor (Veloxity Labs)

About the Speakers

Dr. Anshul Gupta is an experienced R&D leader and strategic drug hunter with a passion for team building and advancing drug development. With substantial expertise in integrating interdisciplinary knowledge, she supports discovery and development pipelines from lead discovery to early development. Her focus on pre-clinical and clinical ADME/PK/tox/DDI aspects has contributed to several successful CTA and IND submissions across multiple modalities. Currently serving as Vice President at Editas Medicine, Anshul's career includes pivotal roles at Generation Bio, Amgen, Alnylam Pharmaceuticals, and AstraZeneca across multiple therapeutic areas and modalities. She holds advanced degrees/training in Veterinary Sciences and DMPK, with a strong commitment to innovative problem-solving and regulatory excellence.

Dr. Shaji Theodore is a board-certified toxicologist (DABT) and a senior pharmacologist at the center for drug evaluation and research, FDA. Dr. Theodore holds a PhD in toxicology, masters in pharmacology and a degree in veterinary medicine. Before FDA, Dr. Theodore was an academic researcher investigating the molecular mechanisms of neurodegenerative disorders. Dr. Theodore collaborates with leadership within the FDA and with regulatory agencies outside the USA on regulatory issues concerned with drug safety. He is currently the co-chair of the immunotoxicology subcommittee, member of the pediatric subcommittee, nitrosamine working group, and novel excipient review program at FDA.

Dr. Griff Humphreys is currently principal with Aranmore Pharma Consulting.  Prior to that he spent 26 years at BMS in various leadership roles within the DMPK function.  He received his graduate training at the University of Virginia in chemistry and completed a post-doctoral fellowship at Vanderbilt University. His interests include predictive metabolism and toxicology models and other aspects of candidate optimization and characterization. He has co-authored over 130 refereed manuscripts and numerous reviews. Griff is a member of ISSX and ACS/TOXI and has served in leadership roles in both.  He was Meeting Chair for the 2019 Drug Metabolism GRC.

Dr. Patricia White-Cipriano, an industry scientist and medical writer, specializes in nonclinical and regulatory sciences. She started as a technician at a CRO after earning a B.S. from Western Michigan University. Then, she pursued pharmacology, focusing on neuroscience, at night while working at various companies in the Cambridge area as a junior toxicologist. She earned her PhD from Northeastern University. Patricia has since served in diverse roles as a consulting medical writer and regulatory strategist for around 20 small biotech companies over 7 years, filing regulatory documents like INDs/CTAs/NDAs. Patricia enjoys mentoring women in the biotech industry and is a mother to 4 girls.

Dr. Aarti Sawant is a Clinical Pharmacologist at AstraZeneca, supporting oncology and immunology programs from early development through approvals. With over 17 years of experience in drug discovery and development, she previously worked at Pfizer as a Clinical Pharmacologist in early clinical development and in the pharmacokinetics, dynamics, and metabolism department, across different therapeutic areas. Aarti has contributed to projects in oncology, inflammation, cardiometabolic, and neuroscience/pain. She is an adjunct faculty at the University of Arizona, R. K. Coit College of Pharmacy. Aarti earned her doctorate in natural products disposition from the University of Illinois/NIH Botanical Center. In her spare time, she serves on scientific societies, health boards, and mentorship panels.

Dr. Dustin Smith is a principal scientist at Merck Research Laboratories in Boston, Massachusetts. He earned his Ph.D. in Medicinal Chemistry from the University of Washington in Seattle. He has ~15 years of industry experience spanning both discovery and development as an ADME PI across multiple therapeutic areas. His expertise lies in drug metabolism, enzyme kinetics, drug-drug interactions, pharmacokinetics and pharmacokinetics/pharmacodynamics. He has been at Merck for 6 years working on projects spanning from early discovery to mid to late stage drug development focused on Oncology.

Dr. Nathalie Rioux, Vice President of Early Drug Development at Certara, earned her PhD in Pharmacy from Laval University, Quebec, focusing on lung cancer chemoprevention. With over 20 years in biotech, pharma, and CRO service, she has held key roles at Boehringher Ingelheim and Epizyme before establishing the DMPK, bioanalytical, and clinical pharmacology group at H3 Biomedicine. Now at Certara, Nathalie offers strategic consulting in discovery and nonclinical DMPK, clinical pharmacology, and regulatory sciences for various biotechnology companies. She also serves as a Core Team Member of the Center of Excellence in Drug Interaction Science, driving both strategic and tactical initiatives.

Dr. Jonathan P. Jackson, a board-certified toxicologist (DABT), holds a PhD in Molecular and Cellular Toxicology from North Carolina State University, working with the NIEHS under Drs. Goldstein and Negishi. Joining Pfizer in June 2019, he serves as the DSRD Discovery and Investigative Tox DILI subject matter expert. With 17 years in biotech and biopharmaceutical industries, he specializes in ADME-Tox, focusing on drug metabolism, transport, and molecular toxicology. Dr. Jackson’s expertise includes hepatic and intestinal in vitro models, particularly in drug-induced liver injury (DILI) and metabolic diseases. He has also explored drug-drug interactions, cell signaling, and gene regulation mechanisms to elucidate hepatic safety concerns.

Dr. Lemper, PharmD, PhD, DABT, ERT is currently the Head of the US Toxicology group at UCB (US) and acts as Nonclinical Safety Strategy lead for rare diseases. Prior to her current role she worked at UCB (Belgium) as a nonclinical safety lead providing scientific leadership and working on a broad range of projects in different therapeutic areas, modalities and stages of development. Before UCB, Dr. Lemper worked as a toxicologist at Genentech across multiple therapeutic areas. She is a past president of the Drug Discovery Specialty Section of SOT and has been an active member of several scientific societies.

Drew Barlow, MPH, joined Syner-G in 2015, bringing over 20 years of regulatory and quality management experience. His team supports filings from early-stage INDs/IMPDs to global marketing applications. Drew has led regulatory efforts in diverse pharmaceutical technologies like QbD, continuous processing, PAT, and 3D printing of drug products. Prior to Syner-G, he served at FDA’s ORA, Vertex Pharmaceuticals, Inc., and Alkermes plc. Drew was a commissioned officer of the US Public Health Service. He holds an undergraduate degree from Mount Saint Mary’s University and a Master of Public Health from the University of North Carolina Greensboro.


2024-06-25, For PBSS members outside Boston [Webcast from Boston-PBSS] Preclinical Development and IND Filing for Small Molecules: Nuts, Bolts and Best Practices
2024-09-12, [In-Person] Biomarkers Enabling Clinical Development and Accelerated Drug Approval
┬ęPharmaceutical & BioScience Society, International; Last Modified: 6/15/2024; Admin Logon
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