9:00

 

9:30

Registration/Welcome Coffee

 

Organizing Committee Welcome

 

 

Central Theme:

From the Promise of Raising Capital

to the Reality of Clinical Trials

 

 

Soheila Gharakhanian, Boston

Frederick E. Pierce II, FEP Capital Advisors, Cambridge

Shahin Gharakhanian, Boston

 10:00

Opening Address

(tbc)

Excellence in Biotechnology

Collaboration

French Official Representative
MA Official Representative
(BIO Organizing Committee)
10:30 2018 Personalities & Successes

Special Guest Opening Keynotes

1 – David MEEK, CEO Ipsen

Creating Trans-Atlantic Synergy: My Vision & Practice

2 – Keynote To be announced

Funding Innovation in the Boston Area:

2018 Panoramic Vision & 5-Year Perspective

11:30

US Roadmap I

Partnerships with Boston Clinical Investigators and Academic Opinion Leaders for Product Clinical Development

Is there a “Cambridge” model in product development?

Role of academic though leaders in Biotech

Relations with Clinical Trial Investigators

Biotech-Academic Collaboration

 

Session Chair & Opening Remarks

Professor Kenneth Kaitin, PhD, Director TCSDD: TUFTS Center for Study of Drug Development, Boston MA. 

Camilla “Cami” Graham, MD, BIDC Medical Center, Harvard Medical School & TREK Therapeutics, Boston/Cambridge MA
Joseph Merola, MD, Director of Clinical Trials and the Director of the Center for Skin and Related Musculoskeletal Diseases, BW Hospital, Harvard Medical School, Boston MA 
To be announced
Panel Discussion with Audience
12:45 Soheila Gharakhanian: Extended Acknowledgement of SPONSORS & Introduces Exhibit
Lunch & Networking
Sponsors Echibition
2:00 pm

US Roadmap II

What is Your Regulatory Strategy?

Need for a US Regulatory Strategy

FDA Update

FDA / EMA comparisons

Resources for regulatory operations

Panel Moderator McDermott Will & Emery

Mark De Rosch, former Senior Vice-President, Regulatory Affairs, Quality Assurance & CMC, AKEBIA Therapeutics, Cambridge MA 

Veleka Peeples-Dyer, Partner, Regulatory Affairs & FDA-regulated Products, McDermott, Will & Emery, Boston 

Panel discussion with audience
2:50 pm

US Roadmap III

US Entry Pitch

@ Summit Panel of Experts

To be confirmed

 

Panel of Experts will shortly introduce themselves

Based on pre-established criteria 5-8 companies will be selected by French or Boston life sciences hubs as well as the program committee.

Each CEO will pitch

Panel discussion will follow including « tips » & recommendations

Session Chair & Opening Remarks

 

 

 

Panel Moderator

Pravin R. Chaturverdi, Ph.D., Chairman of the Scientific Advisory Board for Napo Pharmaceuticals, CEO IndUS and Oceanyx Pharmaceuticals

 

Julius Steffen, Bionest Partners, New York

Panel Opening Address:

“From a French Idea to an American Success:

How Boston has been the perfect environment to establish and grow my Company”

 

Sebastien Christian, CEO OtoSense

 

To be announced
To be announced
To be announced
To be announced
To be announced
To be announced
 5:00 pm  SUMMIT Adjourns 
The Program is being developed – More Speakers and Information will be added soon