[Irvine Session] From Chemical to Drug: The Path to a Small Molecule IND
[Irvine Session] From Chemical to Drug: The Path to a Small Molecule IND
The Cove @ UCI , 5141 California Ave , Irvine , CA 92617
September 19, 2017 from 14:30 PM to 19:00 PM (PDT)
$10 - $35
Do you have a solid plan to achieve IND acceptance? Filing an Investigational New Drug (IND) application might be the next step in advancing your company's early-stage drug development program. Johnson & Johnson Innovation, JLABS (JLABS) and Janssen Discovery Sciences invite you to an in-depth look into the process of filing an IND. Whether your goal is to develop a pipeline through commercial launch or partner as early as possible, submitting an IND is a critical early milestone for every biotech company. With big Pharma and VC firms competing for the most promising compounds, startups are expected to demonstrate a clear blueprint for IND approval, and we want you to be ready.
The presentations will highlight the following:
- Janssen Research & Development - your partner of choice
- Preclinical Development Strategies for pharmacokinetics, drug metabolism and toxicology
- Role of patient behavior in development of solutions
- Key CMC strategies to balance cost, time and quality risks
- Designing First-in-Human trials to highlight the qualities of your molecule
- Regulatory strategy, IND requirements, and Pre-IND meetings
Anders Brunmark, Ph.D. | External Innovation, Discovery Sciences, Janssen R&D read bio»
Jan de Jong | Scientific Director, Clinical Pharmacology, Janssen R&D read bio»
Mark Krook, Ph.D. | Head, Global Portfolio Management, Janssen R&D read bio»
Silvia Lee, | Associate Director, Global Regulatory Affairs, Janssen R&D read bio»
Sandra Snook | Sr. Director, Preclinical Development & Safety, Janssen R&D read bio»
|12:30 PM |||Registration, Lunch, and Networking|
|1:00 PM |||Janssen Research & Development -Your partner of choice|
|1:30 PM |||Preclinical Development Strategies|
|- Pharmacokinetics, distribution and metabolism in Discovery and Early Development – Picking the right molecule
- Preclinical toxicology evaluations before and during GLP toxicology
- Considerations for typical First-in-Human (FIH) Program
- Case study
|2:15 PM |||Chemistry, Manufacturing and Controls Strategies|
|- Optimizing manufacture of your Active Pharmaceutical Ingredient (API)
- Drug product formulations for FIH
|3:00 PM |||Break|
|3:15 PM |||Clinical Pharmacology|
|- Designing FIH trials
- Understanding pharmacokinetic/pharmacodynamic PK/PD
- Biomarkers of safety and efficacy
- Case study
|4:00 PM |||Regulatory - Satisfy Statutory Legal Requirements for Testing in Humans|
|- Regulatory Strategy
- Data requirements: CMC, safety, clinical plan
- Pre-IND meetings
- Case study
|4:45 PM |||Discussion and Q&A|
|5:00 PM |||Program Close|
$35 | General public
Free | UCI students/staff
$20 | Other student/academic
$35 | At the door
The Cove @ UCI
5141 California Ave.
Anders Brunmark, Ph.D. | External Innovation, Discovery Sciences, Janssen R&D
Anders Brunmark obtained his undergraduate in chemistry at University of Lund and completed his PhD on quinones and free radical biochemistry at University of Linköping, Sweden. He held a faculty position at this University between 1988 and 1992. He did postdoctoral work on immune recognition at the Department of Immunology at The Scripps Research Institute in La Jolla, CA between 1990 and 1994. Anders Brunmark joined J&J’s Pharmaceutical R&D organization in 1994 as group leader for protein expression and held a group leader position in Immunology Discovery 1999-2004. In 2004 Anders established an enabling technology team at the La Jolla, California R&D site, comprising DMPK, Pharm Sci/formulations, Genomics, Compound Logistics, and High Throughput Screening functions. In 2012 he took a job as Scientific Director in Integrated Systems Biology. Since 2014 he is Director in External Innovation in Janssen R&D Discovery Sciences with primary responsibility for Western US and Canada. He is an author on 48 papers, 3 book chapters, and inventor on 5 patents. Anders Brunmark’s research interests include development and application of new techniques for studying disease mechanisms and drug action both in vitro and in vivo.
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Jan de Jong, Ph.D. | Scientific Director, Clinical Pharmacology, Janssen R&D
Jan has over 20 years experience in drug development, with a focus on small molecule pharmacokinetics and metabolism. He is currently a Clinical Pharmacology Leader in the Global Clinical Pharmacology department. He holds a master’s degree in Pharmacochemistry from the Vrije Universiteit (VU) Amsterdam, the Netherlands, and a doctorate from the same university. Following a temporary Assistant Professorship at the VU, Jan joined the Drug Metabolism & Kinetics department at Organon, the Netherlands. He started at Janssen R&D in Belgium in 2000 as Head of Bioanalysis, and later relocated to the US where he joined the San Diego, CA site and became a preclinical project lead. He transitioned to clinical development to become the ClinPharm Oncology lead for ibrutinib, a first-in-class BTK inhibitor jointly developed and marketed with Pharmacyclics. He has worked on IND packages for several early development projects across various therapeutic areas.
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Mark Krook, Ph.D. | Head, Global Portfolio Management - Small Molecules, Janssen R&D
Mark has over 30 years of drug development experience in the pharmaceutical industry. He began his career at The Upjohn Company (eventually becoming Pfizer) as a process chemist working on API process development for clinical and commercial needs, eventually moving into the leadership of global, multi-site chemical process R&D organizations with responsibilities for both laboratory and pilot plant facilities. From there he transitioned to portfolio management, providing broad technical, strategic and governance oversight for cross-functional CMC activities within a diversified portfolio of development projects.
Mark joined Janssen in 2007 as the leader of the ChemPharm API Development group in the US. In 2010, he moved into the PDMS Portfolio Management function where he is currently leading a group of CMC Leaders with responsibility for CMC activities across the entire small molecule development spectrum (pre-clinical to life cycle management).
He earned a B.A. in Chemistry from the College of St. Thomas (now University of St. Thomas) and completed a Ph.D. in Organic Chemistry from the University of Notre Dame
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Silvia Lee, | Associate Director, Global Regulatory Affairs, Janssen R&D
Silvia has over 17 years of drug development experience in both small and large pharma. She began her career at Amgen as a pharmacologist setting up pre-clinical models for treatment of acute inflammatory diseases. She transitioned into Global Regulatory Affairs and was responsible for supporting early development programs for both large and small molecules. From there, Silvia moved into increasing Regulatory roles responsible for planning and preparing submissions for global regulatory filings (pre-IND/CTA through NDA/MAA approval). She has worked across therapeutic areas including metabolic diseases, neuroscience, immunology, neuroscience and oncology. In addition to Silvia’s Regulatory experience, she has worked in Quality Assurance. As a Quality Assurance Manager, she contributed to establishing and managing the Quality Assurance Program for a GLP clinical assay laboratory responsible for performing sample analysis (PK, biomarker, and immunogenicity). Silvia joined Janssen in 2011 as a Regulatory Leader and is currently responsible for providing strategic regulatory oversight to metabolic-related projects. She earned a B.S. in Pharmacology from Stony Brook University, NY and completed a M.S. in Regulatory Science from the University of Southern California.
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Sandra Snook | Sr. Director, Preclinical Development & Safety, Janssen R&D
Sandra has been supporting the preclinical development of small molecules for 25 years. She is a DVM and board certified Veterinary Pathologist and after a stint leading an academic research group at The University of Chicago, she moved to GD Searle/Pharmacia where she worked for 11 years supporting projects from late discovery through full development. In 2003 she took on the mission to form a nascent Preclinical Development & Safety group for Janssen’s La Jolla site. During her career, Sandra has worked across platforms including synthetic peptides, and small and large molecule pharmaceuticals. She has worked across therapeutic areas including infectious diseases, metabolic and cardiovascular diseases, immunology, neuroscience and oncology. Additionally, she has lead staff supporting toxicology and DMPK project support as well as laboratory animal medicine, investigative toxicology and molecular pathology. She and her team have extensive experience supporting innovative compound development from lead optimization through global registration; including managing the preclinical portion of external alliances and partnerships. Her team is frequently called upon to participate in critical due diligence reviews of potential licenses and acquisitions. For the last few years Sandra has also lead the Janssen Imbruvica preclinical development team 9a partnership with Pharmacyclics), one of the first drugs to successfully navigate the Breakthrough Drug designation at the FDA. Sandra received her AB degree from The University of Chicago, a DVM from Iowa State University and served as a post-doctoral fellow in Comparative Pathology at Harvard University. She served on the faculty of The University of Chicago where she had independent research funding (NIDA) and ran a comparative pathology diagnostic laboratory supporting the LAMS organization in addition to the Lincoln Park Zoo and Shedd Aquarium. Over the years Sandra has been active in both the ACVP and STP. She is an author on 26 papers and 33 posters/presentations.
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