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The Road to the Clinic for Small Molecule
September 15, 2016 @ 12:00 pm - 3:30 pm
Do you have a solid plan to achieve CTA acceptance? Filing a small molecule Clinical Trial Application (CTA) 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 a CTA. Whether your goal is to develop a pipeline through commercial launch or partner as early as possible, submitting a CTA 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 CTA approval, and we want you to be ready.
The presentations will highlight the following:
- Janssen Research & Development – Overview
- 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, CTA requirements, and Pre-CTA meetings
|12:00 PM | Registration Opens, Lunch, and Networking|
|12:30 PM | Janssen Research & Development – Overview|
|1:00 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
|1:30 PM | Chemistry, Manufacturing and Controls Strategies|
|– Optimizing manufacture of your Active Pharmaceutical Ingredient (API)
– Drug product formulations for FIH
|2:00 PM | Clinical Pharmacology|
|– Designing FIH trials
– Understanding PK/PD
– Biomarkers of safety and efficacy
|2:30 PM | Regulatory Overview|
|– Data requirements: CMC, safety, clinical plan
– Pre-CTA meetings
– Regulatory strategy
|3:00 PM | Discussion and Q&A|
|3:30 PM | Program Close|
Jennifer Hamilton | Sr. Director, New Ventures, Johnson & Johnson Innovation read bio»
Michael Kelley | Sr. Scientific Director, Preclinical Development & Safety, Janssen R&D read bio»
Mark Krook | Sr. Scientific Director, Portfolio Management, Janssen R&D read bio»
Kenneth Turner | Sr. Scientific Director, Quantitative Sciences, Janssen R&D read bio»
Stefan Ochalski | Sr. Director, Global Regulatory Leader, Janssen R&D read bio»
About Janssen BioTherapeutics:
Janssen BioTherapeutics (JBIO), is a family of scientists, innovators and committed partners that are changing the way molecules become medicines by asking and answering the simple, liberating question “what if?”
We are the biotherapeutics innovation engine of Janssen R&D, with the spirit and energy of a biotech start up and the proven track record of delivering therapies that treat millions. We are Janssen. We collaborate with the world for the health of everyone in it.
Click to connect: makethejbioconnection.com.
FREE | McMaster University Employees, Students, and Faculty
CA$ 40 | General Public
CA$ 30 | Other Student/Academic
CA$ 55 | At the door
McMaster Innovation Park
175 Longwood Road South, Room 1A-D
Jennifer Hamilton, Ph.D. | Senior Director, New Ventures, Johnson & Johnson Innovation, Canada
Jennifer Hamilton is the New Ventures Lead in Canada for the Johnson & Johnson Innovation. Based in Vancouver, British Columbia, she is responsible for identifying emerging healthcare technologies and business opportunities involving pharmaceutical, device, biomaterial, health IT and consumer innovations in Canada. Prior to joining J&J in 2010 she spent 17 years in venture capital as Venture Partner at UK-based Nomura Phase4 Ventures and as Investment Director with Rothschild Asset Management which managed two global publicly traded funds. Jennifer has a Ph.D. (Experimental Pathology/Lipid Metabolism) from the University of British Columbia.
Michael Kelley, V.M.D., Ph.D. | Sr. Scientific Director, Preclinical Development & Safety, Janssen R&D
Mike received his BA and VMD degrees from the University of Pennsylvania, and his Ph.D. in toxicology from Texas A&M University. Following post-doctoral research in drug metabolism at the Roche Institute of Molecular Biology, he joined Rorer Group (now part of Sanofi) in 1987 as a toxicologist in the Drug Safety Division. Mike joined R.W. Johnson Pharmaceutical Research Institute in 2000 as a Director/Preclinical Development Leader. 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 preclinical projects in the Oncology, Cardiovascular and Metabolism therapeutic areas as well as the Janssen Established Products portfolio. Mike 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.
Mark Krook, Ph.D. | Sr. Scientific Director, Portfolio Management, 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 Senior Scientific Director, Portfolio Management 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, 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.