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

Nov 17 2015https://www.eventbrite.com/e/from-chemical-to-drug-the-path-to-a-small-molecule-...

JLABS BOSTON EVENT 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


Partners:
This event is presented in partnership with MassTERi, the UMMS Office of Innovation and Business Development, and the UMass Center for Clinical and Translational Science.

   




Agenda:

11:30 AM | 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



Speakers
Michelle Browner | Platform Innovation & Partnership Management, Johnson & Johnson Innovation read bio»
Mark Kao | Scientific Director, 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»
Bethany Paxson | Sr. Director, Global Regulatory Affairs, Janssen R&D read bio»


Fees:
Free | UMass Employees, Students, and Faculty
$35  | General Public
$20  | Student/Academic
$45  | At the door


Location:
University of Massachusetts Medical School
55 Lake Ave North
Worcester, MA


Speakers' Biographies:

Michelle Browner Michelle Browner, Ph. D. | Platform Innovation & Partnership Management, Johnson & Johnson Innovation
Michelle is Senior Director of Platform Innovation and Partnership Management at Johnson & Johnson Innovation, Boston. Previously, Michelle was CEO of Enlight Biosciences, a unique entrepreneurial partnership with major pharmaceutical companies and leading academic researchers, focused on building companies based on breakthrough innovations for drug discovery and development. Michelle had a distinguished career at Roche Pharmaceuticals, where she was the Global Head of Emerging Science and Technologies in Pharma Partnering, Basel, Switzerland from 2010 to 2011. She served as the Global Head of Pharma Research Strategy, responsible for creating and implementing a strategic plan for the global research organization, from 2007-2010. Michelle joined Roche in 1993, rising to the position of Vice President of Discovery Technologies in Palo Alto, California. She contributed to drug discovery projects in the disease areas of inflammation and virology, advancing more than a dozen compounds to clinical trials, with several progressing towards commercial development. She led the way in implementing cutting edge technologies for lead discovery of small and large molecules; including establishing structure-based drug discovery, high-throughput crystallography and fragment-based screening. Michelle earned her PhD in Cell Biology from Baylor College of Medicine after graduating with high honors in Biology from Kenyon College. She has an international scientific reputation in drug discovery and structural biology with over 45 publications.



Mark Kao Mark Kao, Ph.D. | Scientific Director, Janssen R&D
Mark is currently a Scientific Director at Jansen Pharmaceutical Research and Development (JRD) responsible for safety evaluation of drug candidates and marketed pharmaceutical products. Before joining JRD he also worked at Wyeth and Bayer with similar responsibilities. He graduated from North Carolina State University with a Ph.D in Toxicology. Prior to joining Industry he also conducted research at NIH and Cornell University to understand toxicity mechanisms. He frequently gives lectures on the topic of strategy and preclinical study requirements for pharmaceutical drug development. Recently, he has been involved in developing treatments for rare and neglected tropical diseases.



Mark Krook 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 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.



Bethany Paxson Bethany Paxson | Sr. Director, Global Regulatory Affairs, Janssen R&D
Bethany obtained her BS in Chemistry in 1989. She started her career at Cephalon, Inc. (now Teva) and spent 4 years doing peptide synthesis focused on neurological diseases (ALS, AD). While still at Cephalon, Bethany transitioned to Regulatory Affairs. Since Cephalon, she has worked at 3 other PHARMA companies, including Centocor/Janssen (J&J) which she joined in 2001. She has over 20 years of global regulatory experience with both large and small molecules across multiple therapeutic areas such as Oncology, CNS, and Immunology. During her time in regulatory, Bethany has had regulatory responsibility for products targeting colon cancer, breast cancer, obesity, schizophrenia, ALS, Alzheimer's disease, narcolepsy, Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Crohn's Disease, Ulcerative Colitis, Asthma, COPD, IPF, and Psoriasis. Since joining J&J, Bethany has held positions of increasing responsibility, first within the Centocor GRA organization and then in Janssen Global Regulatory Affairs as part of the Immunology Therapeutic Area. Bethany is a Senior Director performing the role of Global Regulatory Liaison (GRL). As GRL, she has overall responsibility and accountability for developing and implementing global regulatory strategies for Immunology compounds in development. Her current responsibilities include both large and small molecules and span all stages of development from pre-NME to marketed products. Bethany also supervises a group of 7 regulatory professionals within the Immunology TA.


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