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

    Speakers:
    Caly Chien, PhD | Scientific Director of Global Clinical Pharmacology, Janssen R&D
    Michael Kelley, VMD, PhD | Senior Scientific Director, Preclinical Development & Safety, Janssen R&D
    Melody Eble | Director, Regulatory Affairs, Janssen R&D
    Mark Krook, PhD | Head, Global Portfolio Management – Small Molecules, Janssen R&D

    Agenda:

  • 12:00 PM | Registration, Lunch, and Networking
  • 12:30 PM | Janssen Research & Development -Your partner of choice
  • 1:00 PM | Preclinical Development Strategies
  • 1:30 PM | Chemistry, Manufacturing and Controls Strategies
  • 2:00 PM | Discussion and Q&A, Coffee Break
  • 2:30 PM | Clinical Pharmacology
  • 3:00 PM | Regulatory – Overview
  • 3:30 PM | Discussion and Q&A
  • 4:00 PM | Networking
  • 5:00 PM | Program Close

    Speakers:

    Caly Chien, PhD | Scientific Director of Global Clinical Pharmacology, Janssen R&D

    As the current Scientific Director of Global Clinical Pharmacology for Janssen R&D, Caly Chien focuses on oncology drug development, late stage and post-marketing, with a focus in prostate cancer. Caly is also the Scientific Lead for the Clinical Pharmacology Development Programs for the abiraterone acetate and apalutamide (ARN-509). He has been with Johnson & Johnson for 10 years, starting his career with the company as the Associate Director of Clinical Pharmacology.

    Prior to joining Johnson & Johnson, Caly was with Bristol-Meyers Squibb as a Senior Research Investigator, focusing on early clinical drug development in virology, as well as Mylan Pharmaceuticals, where he researched the specialized in BA/BE to support generic drug development.

    He earned his B.S in Pharmacy from the University of Alberta and completed his PhD in Pharmacokinetics from The University of British Columbia.

    Michael Kelley, VMD, PhD | 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.

    Melody Eble | Director, Regulatory Affairs, Janssen R&D

    Over the course of her 30-year career in the pharmaceutical industry, Melody has contributed to small and large molecule oncology drug development, led a regulatory intelligence team, and provided Global Regulatory leadership for Janssen’s cell therapy/delivery system combination product.  Reflected her passion for learning and innovation, she is currently leading a Cross-Sector regulatory team focused on the introduction of Digital/Healthcare Technologies in Clinical Trials while she continues to coordinate J&J’s Cross-Sector Global Regulatory policy efforts in the Regenerative Medicine Advanced Therapies space.

    Melody completed her B.S. and Doctor of Pharmacy degrees at the State University of New York at Buffalo and completed an ASHP Accredited Post-Doctoral Residency in Oncology Pharmacy in San Antonio, Texas. 

    Mark Krook, PhD | Head, Global Portfolio Management – Small Molecules, Janssen R&D
    Mark has over 30 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 as the leader of the ChemPharm API Development group in the US. In 2010, he moved into the PDMS Portfolio Management function where he is currently leading a group of CMC Leaders with responsibility for CMC activities across the entire small molecule 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. 

Back to all