Columbia University

Technology Ventures

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

June 14, 2017
Speaker: 
Eric Schaeffer, Mike Kelley, Daniel Schaufelberger, Dolly Parasrampuria, Kathy Tsokas
Irving Cancer Research Center
1130 St. Nicholas Avenue
New York, NY
10032
12:00pm

Event Partners: 
        

 

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



Agenda: 

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


Speakers 
Eric Schaeffer | Janssen R&D read bio» 
Mike Kelley | Sr. Scientific Director, Preclinical Development & Safety Janssen R&D read bio» 
Daniel Schaufelberger | Sr. Scientific Director, Portfolio Management, Janssen R&D read bio» 
Dolly Parasrampuria | Scientific Director, Janssen R&D read bio» 
Kathy Tsokas | Sr. Director, Global Regulatory Affairs, Janssen R&D read bio» 


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

Location:
Irving Cancer Research Center
Florence Irving Auditorium, 1st Floor
1130 St. Nicholas Avenue
New York, NY 10032 

Speakers' Biographies: 
Eric Schaeffer, Ph.D. | Senior Director, Neuroscience External Innovation, Janssen R&D 
Eric Schaeffer has more than 20 years of experience in the pharmaceutical industry, and has delivered multiple drug candidates to the clinic in both large and small company environments. Eric has an extensive background in the biology and pharmacology of CNS disorders including Alzheimer's disease, major depressive disorder, bipolar disorder and schizophrenia. In his current role at Janssen Eric is responsible for establishing and managing external partnerships in the areas of Mood Disorders and Alzheimer's disease. Previous roles held by Eric include Senior Director of Neuroscience Discovery at Pfizer where he was responsible for leading preclinical pharmacology, Director of Neuropharmacology at CHDI where he was responsible for initiating and managing biotech and academic partnerships focused on Huntington's disease and Director of Clinical Biomarkers at Bristol-Myers Squibb where he was responsible for developing the translational strategies for early clinical programs in the areas of schizophrenia, depression and neuromuscular diseases. Eric received his PhD from the Albert Einstein College of Medicine, and did postdoctoral work at MIT and Rockefeller University prior to initiating a career in the pharmaceutical industry. 
Connect with Eric: 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 


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 


Dolly Parasrampuria | Scientific Director, Janssen R&D 
Dr. Parasrampuria has over 18 years of drug development experience in both large pharma and biotech industry. During this time, she has been the lead clinical pharmacologist for numerous global New Drug Application (NDA) submissions leading to approvals, for both small molecules and biologicals. Dolly has also contributed to numerous Investigational New Drug (IND) applications and first-in-human trials for a wide range of therapeutic areas. Most recently, Dolly was involved in the clinical development and global filings resulting in approval of edoxaban, a direct FXa inhibitor. Dolly has a bachelor's (BPharm Hons) and MPhil degrees in Pharmacy from BITS, Pilani (India), and PhD in Pharmaceutical Chemistry from the University of California, San Francisco (UCSF). Currently, Dolly is a Scientific Director in the Global Clinical Pharmacology group at Janssen supporting oncology drug development. 
Connect with Dolly: Connect on LinkedIn


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