The Path to a Small Molecule IND

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16/05/2017 13:00 16/05/2017 16:30 America/Chicago The Path to a Small Molecule IND JLABS @ TMC , John P. McGovern Campus , Houston , TX 77021 JLABS @ TMC false DD/MM/YYYY

The Path to a Small Molecule IND

JLABS @ TMC , John P. McGovern Campus , Houston , TX 77021

May 16, 2017 from 13:00 PM to 16:30 PM (CST)

$10 - $35

Expert InsightFrom 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
- eCTD
- Pre-IND meetings
- Regulatory Strategy
2:00 PM | Discussion and Q&A
2:30 PM | Program Close


Michael Kelley | Sr. Scientific Director, Preclinical Development & Safety, Janssen R&D read bio»
Daniel Schaufelberger | Sr. Scientific Director, Portfolio Management, Janssen R&D read bio»
Katherine Tsokas | Sr. Director, Global Regulatory Affairs, Janssen R&D read bio»
Jan de Jong | Scientific Director Clinical Pharmacology, Janssen R&D read bio»

$35 | General Public
$20 | Student/Academic
$45 | At the door

John P. McGovern Campus
2450 Holcombe Blvd, Suite J
Houston, TX 77021

Parking Information:
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.

Speakers Biographies:

Michael Kelley Michael Kelley, V.M.D., Ph.D. | Senior Scientific Director, Preclinical Development & Safety, Janssen R&D
Michael 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 Michael: Connect on LinkedIn
Daniel S.
Daniel Schaufelberger, Ph.D. | Senior Scientific Director, Portfolio Management, Janssen R&D
Daniel Schaufelberger is currently a CMC Leader and Senior Scientific Director, Pharmaceutical Development & Manufacturing Sciences, at Janssen Research & Development L.L.C., a Johnson & Johnson company. He holds a degree in Pharmacy from the Eidgenössische Technische Hochschule (ETH) Zürich, Switzerland, and a doctorate from the University of Lausanne, Switzerland. He was a post-doctoral research fellow at the Cancer Research Institute, Department of Chemistry, Arizona State University, USA and worked as a Scientist in the field of anticancer natural products at the Frederick Cancer Research Facility, Frederick, MD, before joining the pharmaceutical industry. He held positions in Analytical Development at Sandoz Pharma AG, Basel and at the R. W. Johnson Pharmaceutical Research Institute in Schaffhausen, Switzerland and Raritan, NJ USA, before moving into pharmaceutical project management. He has been working on early and late stage development programs, across various therapeutic areas, including pediatric products. His work experience also includes joint development programs with several Japanese companies. Most recently, he led a team developing a new age-appropriate chewable tablet formulation of VERMOX™ (mebendazole), intended for donation to WHO for the treatment of intestinal worms, a neglected tropical disease affecting over 800 million children worldwide. He is currently a member of the Pediatric Center of Excellence at Johnson & Johnson and co-chair of the Pediatric Formulation Network. In his spare time, Daniel volunteers as Head of the ETH Zurich Alumni Organization in North America.

Connect with Daniel:  Connect on LinkedIn

Katherine Katherine Tsokas, J.D. | Regulatory Head, Regenerative Medicine & Advanced Therapy, Janssen R&D
Kathy Tsokas, J.D., is the Regulatory Head of Regenerative Medicine & Advanced Therapy leading project and influencing activities across Janssen Research & Development, and is the Director of the Johnson & Johnson Regenerative Medicine & Advanced Therapy Network a cross sector, cross functional network. Kathy has 26 years of global regulatory experience in both small and large sized Pharma companies. She has worked on products in various therapeutic areas and at all stages of development, from early through to filing, approval and commercialization. Kathy has been with J&J for 10 years. She has held several roles during this time including Global Regulatory Lead for the Research and Early Development (RED) units. Currently, her responsibilities include providing strategic regulatory oversight to advanced therapy projects in several therapeutic areas by ensuring regulatory strategies contribute to and support the development plans for the products and that all opportunities for collaboration internally and externally are utilized. Importantly, Kathy leads efforts internally and externally to enhance awareness and connectivity to influence the development of processes and regulatory pathways that enable the global development and commercialization of safe and effective advanced therapeutics. Kathy participates in discussions with global Health Authorities through internal project work and external collaborations. In addition, she represents Global Regulatory Affairs on the J&J First in Human Committee. Kathy is active with the Alliance for Regenerative Medicine (ARM). She is a member of the ARM: Regulatory Committee for which she chaired from 2011 through 2015; Government Affairs, and Science and Technology Committees. She is a frequent speaker at advanced therapy conferences and is a collaborator on planning programs in advanced therapy. Kathy received her Bachelor of Science Biology from Temple University, Juris Doctorate from Widener University Law School, and is admitted to the practice of law in Pennsylvania and New Jersey.
Connect with Katherine: Connect on LinkedIn 
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.
Connect with Jan: Connect on LinkedIn 


Johnson & Johnson Innovation, JLABS (JLABS) is a global network of open innovation ecosystems, enabling and empowering innovators to create and accelerate the delivery of life-saving, life-enhancing health and wellness solutions to patients around the world. JLABS achieves this by providing the optimal environment for emerging companies to catalyze growth and optimize their research and development by opening them to vital industry connections, delivering entrepreneurial programs and providing a capital-efficient, flexible platform where they can transform the scientific discoveries of today into the breakthrough healthcare solutions of tomorrow. At JLABS we value great ideas and are passionate about removing obstacles to success to help innovators unleash the potential of their early scientific discoveries. JLABS is a no-strings-attached model, which means entrepreneurs are free to develop their science while holding on to their intellectual property. JLABS is open to entrepreneurs across a broad healthcare spectrum including pharmaceutical, medical device, consumer and digital health sectors. The JLABS flagship opened in 2012 in San Diego at Janssen's West Coast Research Center, and since then has grown to eight locations including the Bay Area, Boston & Lowell, MA, Houston, Toronto and a ninth location, New York City, launching in 2018. For more information please visit

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