Emerging Pharma: Aligning Regulators, Investors and Suppliers to Assure Successful Drug Development
with Networking Reception
Date/Time: Wednesday, March 20, 2019 - 3:30 PM to 5:15 PM
Location: InterContinental Barclay - Grand Ballroom
Sponsored by Alcami Corporation
This program is designed to assist emerging bio/pharma companies and their development partners to resolve key factors that influence the nature, pace, and cost of product development. It brings together professionals with a variety of experiences and perspectives on drug development decision-making.
Managing Changing CMC Regulatory Requirements from Pre-IND to NDA Approval
This session will help emerging bio/pharma executives determine the optimal amount of information to provide to the US Food and Drug Administration or other regulatory health authorities for initiating clinical trials. It will address how to balance providing sufficient preclinical and chemistry, manufacturing and controls (CMC) data to support the start of Phase I testing against the need to ensure flexibility for continued process and formulation improvements throughout clinical development and commercialization. Executives will provide actual company experiences to offer perspective on these issues, which can be particularly challenging for companies developing novel drug candidates.
- Abizer Harianawala, PhD, Senior Director, Product Development and Technical Operations, TARIS Biomedical
- Ken Shultis, Managing Partner, Rondaxe
- Drew Barlow, MPH, Vice President, Regulatory Affairs, Syner-G Pharma Consulting, LLC
How Investors and Other Parties Impact Drug-Development Decisions
Emerging Pharma executives and their manufacturing and supply partners (e.g., CDMOs and CMOs) will gain insight on the expectations of investors, pharmaceutical company partners, and other stakeholders on the issues impacting drug development. A panel of pharmaceutical executives, a venture capitalist, and development consultant will address these all-important questions:
- How are the objectives of investors and funding partners aligned with those of Emerging Pharma companies?
- What are key regulatory and scientific issues, in drug development, including those relating to manufacturing supply, which may impact investor decisions?
- How can Emerging Pharma companies manage investors’ expectations surrounding cost and time?
- Robert Knowles, Senior Director, Worldwide Business Development, Pfizer Inc.
- Jesse Shefferman, CEO, ArTara Therapeutics
- Cameron Wheeler, Partner, Private Transactions Team, Deerfield Management
- Tom Ransohoff, Vice President and Principal Consultant, BioProcess Technology Consultants
Following the presentations, all registered attendees are invited to a Post-Program Networking Reception.
- Time: 5:15 PM - 6:15 PM
- Room: InterContinental Barclay, Grand Ballroom
Who Should Attend?
This program has been developed to assist emerging pharmaceutical companies in making the all-important decisions for developing and implementing a successful development and launch strategy. The program and reception is open to, and complimentary for, qualifying non-member emerging pharmaceutical companies. Please request to attend below and further information/confirmation will be sent to you via email.
Note: Emerging pharmaceutical companies refer to innovator pharmaceutical companies that operate largely as clinical-stage pharmaceutical/biopharmaceutical companies with no or very limited commercial drugs.
Member companies are also encouraged to urge those qualifying non-member emerging pharma companies which they know of or might be currently working with to apply for the complimentary registration.
Pricing and Registration:
The DCAT organization is pleased to offer timely and topical education sessions during DCAT Week. Compared to similar programs found in the industry’s marketplace, our program fees are deeply discounted for employees of our Registered Member Companies. Please check with your DCAT delegate to ensure your company’s membership before registering or call DCAT at 1-609-208-1888.
- DCAT Member Company Price: $69.00
- Emerging Pharma Company Price: Complimentary
- Non-Member Price: Sorry, no non-member guests who do not fit the outlined criteria
- Doors open at 3:00 PM for refreshments & networking
- There is no break during this program
- Beginning March 1, the attendee list for this program will be added to the DCAT Week Mobile App (note: the list will be updated weekly through DCAT Week)
Online registration for this event has closed. To register onsite during DCAT Week, please visit the DCAT Office located at InterContinental Barclay, Rockefeller Room.