From Chemical to Drug - The Path to a Small Molecule IND
Texas Medical Center , John P. McGovern Campus , Houston , TX 77021
February 17, 2016 from 12:00 PM to 15:30 PM (CST)
$10 - $35
From Chemical to Drug - The Path to a Small Molecule IND
Best Practices When Filing Small Molecule Investigational New Drug Applications
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 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
- 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
|11:00 AM |||Registration, Lunch, and Networking|
|11:30 AM |||Janssen Research & Development -Your partner of choice|
|12:00 PM |||Preclinical Development Strategies|
|- Designing drugable molecules with appropriate kinetics and metabolism
- Preclinical toxicology evaluations before and during GLP toxicology
- Considerations for typical First-in-Human (FIH) Program
|12:30 PM |||Chemistry, Manufacturing and Controls Strategies|
|- Optimizing manufacture of your Active Pharmaceutical Ingredient (API)
- Drug product formulations for FIH
|1:00 PM |||Clinical Pharmacology|
|- Designing FIH trials
- Understanding PK/PD
- Biomarkers of safety and efficacy
|1:30 PM |||Regulatory - Overview|
|- Data requirements: CMC, safety, clinical plan FIH trials
- Pre-IND meetings
- Regulatory Strategy
|2:00 PM |||Discussion and Q&A|
|2:30 PM |||Program Close|
Speakers: Janssen Pharmaceutical Companies of Johnson and Johnson
Anders Brunmark | External Innovation, Discovery Sciences, Janssen R&D read bio»
Michael Kelley | Sr. Scientific Director, Preclinical Development & Safety, Janssen R&D read bio»
Mark Krook | Head, Global Portfolio Management - Small Molecules, Janssen R&D read bio»
Kenneth Turner | Sr. Scientific Director, Quantitative Sciences Therapeutic Area Leader, Cardiovascular & Metabolism, Janssen R&D read bio»
Stefan Ochalski | Sr. Director, Global Regulatory Leader, Janssen R&D read bio»
$35 | General Public
$20 | Student/Academic
$45 | At the door
Texas Medical Center
John P. McGovern Campus
2450 Holcombe Blvd, Suite X
Houston, TX 77021
Please park in the self parking areas of the McGovern Campus. Grab a Token at the gate and bring it to the event space. We encourage carpooling and using the TMC shuttles.
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 technologies team at the La Jolla, California R&D site, comprising DMPK, PharmSci/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.
Michael Kelley, V.M.D., Ph.D. | Sr. Scientific Director, Preclinical Development & Safety, Janssen R&D
Mike is currently Senior Scientific Director/Head of Preclinical Projects & Submissions at the Janssen R&D site in Spring House, PA. As part of this role, he is responsible for a portfolio of discovery and development projects in the Oncology, Cardiovascular and Metabolism therapeutic areas. Mike is also the Janssen R&D preclinical scientific liaison to the Johnson & Johnson Boston Innovation Center. Mike has more than 25 years of preclinical experience working for small and large biopharmaceutical companies. He is a full member of the Society of Toxicology, Past-President of the Mid-Atlantic Chapter of the Society of Toxicology, and a Diplomate of the American Board of Toxicology. Mike received his BA and V.M.D. degrees from the University of Pennsylvania, and his Ph.D. in toxicology from Texas A&M University.
Connect with Mike:
Mark Krook, Ph.D. | Head, Global Portfolio Management - Small Molecules, Janssen R&D
Mark has over 29 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 where he is currently a Head, Global Portfolio Management - Small Molecules, leading a group of CMC Leaders with responsibility for CMC activities across the entire 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.
Kenneth Turner, Ph.D. | Sr. Scientific Director, Quantitative Sciences Therapeutic Area Leader, Cardiovascular & Metabolism, Janssen R&D
Ken received his BA degree in Chemistry and his Ph.D. degree in Pharmaceutics from the University of North Carolina at Chapel Hill. After graduating, he accepted a position in the Drug Metabolism and Pharmacokinetics Department of Novartis Pharmaceuticals in 1997 and performed toxicokinetic analysis, preclinical PK/PD modeling, and allometric scaling to support the transition of compounds from preclinical to clinical development. Ken joined the Metabolism and Pharmacokinetics Department of Bristol-Myers Squibb in 1999, and provided PK/PD support for compounds in nonclinical development and directed Clinical Pharmacology programs in late development. In 2001, he became an Exploratory Clinical Research Team Leader for Endocrine/Aging and Lipids Disorders programs, and led teams responsible for progressing compounds through the Discovery, First in Human, and Proof of Concept stages of development. Under his leadership, these teams implemented PK/PD modeling & simulation and utilized appropriate safety and efficacy biomarkers to optimize the design and efficiency of clinical trials. Ken joined Janssen in 2005 and led the Clinical Pharmacology program for the antibiotic doripenem through successful registration. He became the Clinical Pharmacology Therapeutic Area Head for the Cardiovascular & Metabolism and Immunology Therapeutic Areas in 2009, and is currently serving as the Quantitative Sciences Therapeutic Area Leader for the Cardiovascular & Metabolism Therapeutic Area.
Stefan Ochalski, Ph.D., MBA | Senior Director-Global Regulatory Leader, Janssen R&D
Stefan Ochalski, Senior Director-Global Regulatory Leader, has been with Janssen R&D (JRD), a Johnson & Johnson company, since 2006 when he joined the regulatory organization as Director, North American Regulatory Liaison. Prior to joining JRD, Stefan worked in the areas of nonclinical pharmacology and in regulatory affairs on assignments of increasing responsibility, including with over the counter and imaging drugs, as well as supporting regulatory strategies in various therapeutic areas globally. His experience includes facilitating pediatric initiatives with FDA and EMA, as well as, providing regulatory strategy for a US FDA Advisory Committee meeting. In addition to his regulatory affairs responsibilities Stefan has been involved with the Board of Editors for RAPS Focus and has been a presenter and lecturer for PERI and DIA. After graduating from Rutgers University with a BS degree in animal science, Stefan attended Monmouth University where he obtained his MBA. Stefan's Ph.D. degree is in Organizational Management and Leadership.