[NYC session] From Chemical to Drug - The Path to a Small Molecule IND

Sep 21 2016https://www.eventbrite.com/e/nyc-session-from-chemical-to-drug-the-path-to-a-sma...

From Chemical to Drug - The Path to a Small Molecule IND
Best Practices When Filing Small Molecule Investigational New Drug Applications

Program Overview:
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

Event Partner:
This event is presented in partnership with Mount Sinai Innovation Partners.



12:00 PM | Registration, Lunch, and Networking
12:30 PM | Janssen Research & Development -Your partner of choice
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
- eCTD
- Pre-IND meetings
- Regulatory Strategy
3:00 PM | Discussion and Q&A
3:30 PM | Program Close

Renee DesJarlais | Scientific Director & Fellow, Discovery Sciences, Janssen R&D read bio»
Mike Kelley | Sr. Scientific Director, Preclinical Development & Safety, Janssen R&D read bio»
Mark Krook | Sr. Scientific Director, Portfolio Management, Janssen R&D read bio»
Stefan Ochalski | Sr. Director, Global Regulatory Leader, Janssen R&D read bio»
Liping Zhang | Sr. Scientific Director, Global Clinical Pharmacology, Janssen R&D read bio»

Free | Mt Sinai Employees, Students, and Faculty
$35 | General Public
$20 | Student/Academic
$45 | At the door

Icahn School of Medicine at Mount Sinai
Davis Auditorium - 2nd Floor
Hess Center for Science and Medicine
1470 Madison Avenue
New York, NY 10029

Speakers' Biographies:

Renee L. DesJarlais, Pharm.D. Ph.D. | Scientific Director & Fellow, Discovery Sciences, Janssen R&D
Renee is currently Scientific Director & Fellow heading the Computational Chemistry group at the Janssen R&D site in Spring House, PA. Renee holds and a Ph.D. in Pharmaceutical Chemistry and a Doctor of Pharmacy both from the University of California, San Francisco. She has over 20 years of experience applying computational methods to early discovery projects in both large pharma and biotech settings. Renee and her group are responsible for providing computational chemistry expertise to drug discovery teams in the Cardiovascular and Metabolism, Immunology, Neuroscience, and Oncology therapeutic areas. In addition to using standard ligand-based and structure-based computational tools, the group is actively exploring new methods to predict compound activity and analyze molecular data to drive the drug discovery process more efficiently.
Connect with Renee: Connect on LinkedIn

Michael Kelley, V.M.D., Ph.D. | Senior 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: Connect on LinkedIn

Mark Krook Mark Krook, Ph.D. | Senior 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.

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.

Liping Zhang, Ph.D, FCP | Senior Scientific Director, Global Clinical Pharmacology, Janssen R&D
Liping Zhang, Ph.D, FCP, is a Senior Scientific Director and lead the US Pharmacometrics Group in Global Clinical Pharmacology at Janssen R&D. Liping received her B.S. in Pharmacy from Beijing Medical University, M.S. in Pharmaceutical Sciences from University of Southern California, and Ph.D. in Biological and Medical Informatics from University of California San Francisco. Prior to joining Janssen in 2011, she was a Research Scientist at Eli Lilly and took various positions up to Director at Bristol-Myers Squibb. Liping's research has focused on advancing pharmacometric approaches to facilitate clinical drug development and approval in cardiovascular, metabolic, immunology, and oncology areas. Liping has over 40 peer-reviewed publications and abstracts and has been invited to speak in many conferences and workshops. Liping is an avid participant in serving the pharmacometrics community. Her recent leadership roles include chair of the American Conference in Pharmacometrics (2015), executive board member of International Society of Pharmacometrics, fellow and member of the Education Committee of American College of Clinical Pharmacology (ACCP), member of the Editorial Board of Journal of Clinical Pharmacology (JCP), Chair of the Population Pharmacokinetics and Pharmacodynamic Focus Group of American Association of Pharmaceutical Scientists (AAPS), and instructor of Clinical Pharmacokinetics, University of Indiana and Thomas Jefferson University.