From Chemical to Drug - The Path to a Small Molecule IND

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15/12/2014 09:00 15/12/2014 12:30 America/New_York From Chemical to Drug - The Path to a Small Molecule IND JLABS @LabCentral , 700 Main St , Cambridge , MA 02139 Johnson & Johnson Innovation, JLABS false DD/MM/YYYY

From Chemical to Drug - The Path to a Small Molecule IND

JLABS @LabCentral , 700 Main St , Cambridge , MA 02139

December 15, 2014 from 09:00 AM to 12:30 PM (EST)

$10 - $35

JLabs BOSTON EVENT From Chemical to Drug - The Path to a Small Molecule IND
Best Practices When Filing 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. JLabs, the Johnson & Johnson Innovation Centers 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


8:00 AM | Registration, Breakfast, and Networking
8:30 AM | Janssen Research & Development -Your partner of choice
8:45 AM | 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
9:15 AM | Chemistry, Manufacturing and Controls Strategies
  - Optimizing manufacture of your Active Pharmaceutical Ingredient (API)
- Drug product formulations for FIH
10:00 AM | Clinical Pharmacology
  - Designing FIH trials
- Understanding PK/PD
- Biomarkers of safety and efficacy
10:30 AM | From Chemical to Drug - The Path to a Small Molecule IND, Regulatory Aspects
  - Regulatory Strategy
- IND requirements
- Review and Actions
- Pre-IND meetings
11:00 AM | Discussion and Q&A
11:30 AM | Program Close

Speakers: Janssen Pharmaceutical Companies of Johnson and Johnson

$35 General Public
$20 Student/Academic
$45 Onsite

JLABS @LabCentral
700 Main St
Cambridge, MA 02139

Speakers Biographies:

Christopher Flores Christopher Flores, Ph.D. | Janssen R&D
Christopher M. Flores, Ph.D. is currently Global Head of External Innovation for Discovery Sciences at Janssen Research & Development. Chris originally joined Johnson & Johnson in 2002 as leader of the East Coast Analgesics Discovery Team, after which he successively became Head of Pain Discovery, Senior Director of External Innovation and Pain Franchise Strategy Leader for the Neuroscience Therapeutic Area, leading the advancement of several small-molecule analgesic candidates into and through Early Development. Before joining Johnson & Johnson, Chris was a P.R.A.T. Fellow at the National Institute of Neurological Disorders and Stroke and a tenured Associate Professor at the University of Texas Health Science Center at San Antonio in the departments of Pharmacology and Endodontics, wherein he was also Director of Research. He obtained his baccalaureate in Physiology from the University of California, Davis and his doctorate in Pharmacology from Georgetown University. He is the author of more than 75 original scientific articles and book chapters and inventor on 33 issued patents; in addition, he has served as Co-Chair of the PhRMA Predictive Models of Efficacy PISC Initiative and as a member of the editorial boards for Life Sciences, Molecular Interventions, the Pain Medicine Journal Club Journal and the Journal of Opioid Management.

Michael Kelley Michael Kelley, VMD, Ph.D. | 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 Mark Krook, Ph.D. | 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.

Donald Heald Donald Heald, Ph.D. | Janssen R&D
Don received his BS Degree in Biology from Gannon University and a MS (Pharmacology) and Ph.D. in Pharmaceutical Sciences from West Virginia University. Following a sabbatical at the Theoretical Mathematical Biology Department at the NIH National Cancer Institute, he joined the FDA as a Clinical Pharmacology (CP) Reviewer working in the Cardio-Renal Drug Division. While at the agency, he development and applied the first application of the electronic NDA (CANDA). Don then joined the CP group at The Upjohn Company and worked on anti-cancer and anti-aids compounds for three years before moving to Rorer (RPR) to lead the bioanalytical/methods development and build CP and Pop PK modeling groups. He led the Clinical Drug Disposition Department at RPR and was responsible for all CP activities for projects in full development. After 8 years he left R&D and moved into Medical Affairs at Rhone-Poulenc Rorer and worked with scientists at Case Western Reserve to develop novel 3D nuclear imaging techniques to determine lung and intranasal deposition of drugs. He joined Janssen in 2000 and was the Global Head of Clinical PK in CP and responsible for all clinical pharmacology activities in Early Development, Late Development and post marketed projects. Don is currently the Senior Scientific Director and Quantitative Science CP Therapeutic Area (TA) Head for Neurosciences and is responsible for all CP activities in this TA. He is currently serving on the scientific program committee for the American Society of Clinical Pharmacology and Therapeutics, leadership committee for IQ Clinical Pharmacology Technical Group and a member of the Academy of Molecular Imaging.

Katherine Tsokas Katherine Tsokas, J.D. | Janssen R&D
Katherine has 25 years of progressive global regulatory experience in small and large sized Pharma companies. She has worked on products at various stages of development, from early through to filing, approval and commercialization. Currently, Katherine provides strategic regulatory oversight to advanced therapy projects including cell therapies 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. Katherine is a member of the Alliance for Regenerative Medicine (ARM). She is the Chair for the ARM Regulatory Committee, and a member of the Reimbursement, and the Science and Technology Committees. Katherine 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.

Johnson & Johnson Innovation, JLABS

About Johnson & Johnson Innovation, JLABS 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 healthtech sectors. The JLABS flagship opened in 2012 in San Diego at Janssen's West Coast Research Center, and since then has grown to ten global locations including the Bay Area, Boston & Lowell, MA, Houston, Toronto, Beerse (Belgium), New York City, and with Shanghai opening in 2019. For more information please visit or follow @JLABS.

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