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TRx Drug Development Boot Camp

DATE/TIME: Every Monday from Jan 29 – March 26, 2018, 4:00pm – 6:00 PM (Tuesday Session on Feb 20 and March 20)

LOCATION: 622 W 168th St., PH building, 10th floor, room 405 A/B 
(Location Tues Feb.20 and Tues Mar. 20- 701 W 168th st, corner of 168th and Ft.Washington Ave, room LL1-103)

COURSE OUTLINE: The TRx Boot Camp is an 8- session course designed to give academic investigators an overview of early development aspects of therapeutic design and commercialization.  The lecture series will provide an overview of the drug development process with a special focus on resources available.
Upon completion of the boot camp, attendees will be able to position their therapeutic discoveries for future commercial value.
Boot camp attendance is mandatory for investigator teams that have submitted pre-proposals and are interested in submitting a full proposal for the TRx Resource Pilot Award but open to all Columbia faculty, staff, and students. 

COURSE SCHEDULE:

Date 

Topic

Presenter

Session I  January 29

“Kick Off Session & Drug
Development”
Team Introductions

Bruce Conway, PhD
Program Director, Robertson
Therapeutic Fund at Rockefeller
University

Session II February 5

Team Introductions
“Who is my Target Customer” Unmet clinical need, competitive landscape and stakeholder discovery

Harvey Homan, PhD, MBA
HDH Associates International
Jumpstart NJ Angel Network

Session III  February 12

“What Does My Target
Product Look Like” Target
Product Profile development

Randall Kaye, MD 
Global Head of Medical Affairs, SSI Strategy

Session IV
February 20
(TUESDAY)
Joint with BiomedX
Room: Hammer
Health Sciences
Building, LL1-103

“How do I Protect My Innovation” Patenting and licensing discussion with Columbia’s licensing office

Jeffrey Sears, PhD, JD
Office of General Counsel
Ron Katz, PhD, MBA
Columbia Technology Ventures


Session V
 February 26

“What are the right Pre-
Clinical Studies and What Resources are available at Columbia?” A review of IND enabling studies and Columbia’s core facilitates

Stephanie Oestreich
EVP, Head BRIDGEs
Partnerships NA- Evotec
 
Brian Walsh

Serge Cremers, PhD, PharmD
Columbia University

Session VI
 March 5

“How do I Approach the FDA” IND and Clinical trial design, led by Columbia’s
Clinical Trials Office

Helen Kim, PharmD
Executive Director, Columbia
Clinical Trials Office
 
Jane Cho, MS, MPH
Manager of Regulatory Science,
Columbia Clinical Trials Office

Session VII
March 12

“How do I Fund My Studies” A Panel discussion with industry and NIH representatives, led by SPA.

Nader Halim, PhD
Senior Director, Pfizer CTI

Alexis Desrichard, PhD
BMS, II-ON

Moderator: Rudi Odeh-
Ramadan, PharmD
Vice President for Research
Administration, Columbia
Sponsored Projects
Administration

Session VIII 
March 20
(TUESDAY)
Joint with BiomedX
Room: Hammer
Health Sciences
Building, LL1-103

“How to Pitch my
Innovation” Pitch crafting
techniques

Joint with BiomedX

Session IX 
March 26

“Closing Session”

 

Additional Resources: Dropbox Link
CONFIDENTIALITY: We ask all participants to read and adhere to the following Confidentiality Statement:
“As a participant in this course, I understand that my fellow participants may wish to pursue patent protection for their course projects and that confidentiality is often essential for doing so. In order, to promote a free exchange of information among participants, I shall treat all communications on course projects that I receive from participants during the time period of the course as confidential. I shall not disclose these communications to any third party, except for that which is already known or rightfully obtained by me prior to its disclosure to me by the participants or other advisors.”

 

Time: 4-5:30p
Location: Irving Institute, PH 10-405

2017 TRx Boot Camp

Date

Topic

Presenter

Video

Session I
January 23

Market Research & Competitive Analysis

Lorraine Marchand, MBA
Centricity Health

 Link

Session II
January 30

Intellectual Property, Licensing, and Sponsored Research

Teresa Chen, PhD, JD Columbia Office of General Counsel
Ron Katz, PhD, MBA Columbia Technology Ventures

Link

Session III
February 6

Developing a Target Product Profile

Randall Kaye, MD
SSI Strategy

 Link

Session IV
February 13

Experimental Design with Translational Perspective

Anton Simeonov, PhD NCATS,NIH

 Link

Session V
February 27

Working with the FDA

Dilcia Granville, PhD
US FDA

 Link