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Forum: Pathways to Market: The Changing Paradigms of Commercialization
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In this Forum we will explore a number of shifts that challenge the conventional wisdoms of commercialization. Real World Evidence and Health Economics Data are increasingly important components of successful product commercialization. The paradigms of seeking clearance first in the US or outside the US are shifting. Medical Payer Requirements are considered sooner in the product lifecycle.

 Export to Your Calendar 6/4/2018
When: Mon June 4, 2018
5:30-8:30 PM
Where: Regis College, Fine Arts Center
235 Wellesley St
Weston, Massachusetts  02493
United States
Contact: Bill Munger
617-620-4161


Online registration is available until: 6/4/2018
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June 4 MDG Forum
Pathways to Market
The Changing Paradigms of Commercialization
 
Real World Evidence and Health Economics Data are increasingly important components of successful product commercialization.

The paradigms of seeking clearance first in the US or outside the US are shifting.

Medical Payer Requirements are considered sooner in the product lifecycle.


Key Topics:  
In this Forum we will explore a number of shifts that challenge the conventional wisdoms of commercialization.

What is Real World Evidence? What are the differences between real-world evidence and real-world data? How and when should real-world evidence be used in submissions to the FDA?

How has the Landscape Changed in terms of seeking clearance first inside the US vs outside the US? What does it mean to your company?

When should you start to consider Payer Coverage Requirements and the level of evidence you will need for payer adoption? Is the clinical trial too soon?

How has the need for Health Economics Data changed from both a clearance and payer adoption perspective?

These are just some of the important questions our panel of industry experts will discuss in their talks and the Q&A session that follows.

 
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FORUM GRAPHIC 6-4-18  
Monday 
June 4, 5:30 - 8:30 PM
Regis College Fine Arts Center
Weston, MA

  

EARLY BIRD DISCOUNT FEES
   Member/Alliance Partner - $30 
   Non-member - $45 
   Student Member - $10
   Student Non-Member - $15
    
   Event Sponsorship - $500
   (contact Hank Allard for details -hallard@mdgboston.org) 

 
Event Sponsor 

 

RIGHT SUBMISSION  

 

 
You Should Attend If You Are: 
  • Entrepreneurs seeking to understand the rapidly changing pathways to commercialization
  • Professionals in the life science industry who want to understand the increasing importance of Health Economics on Commercialization
  • Anyone considering using Real World Evidence with the FDA
  • R&D engineers and scientists entrusted with developing life science products.
Our Distinguished Panel
AMOROSI CARPINELLA DRUES   MUNRO
Stacey L Amorosi, BA, MA 
Director, Health Economics Center of Excellence 
Wanda Carpinella 
Vice President,
Regulatory Affairs, BBA
 
Michael Drues, MS, PhD 
President of Vascular Sciences  
Kristofer Munroe, JD  
General Counsel and
Director of Market Access
   
FORUM MODERATOR
 

Panel Bios     
 
Stacey L Amorosi, BA, MA 
Director, Health Economics Center of Excellence
Stacey has designed and executed global health economic strategies across diverse therapeutic areas to measure, promote, and defend the value of Boston Scientific's innovative technologies. Stacey was instrumental in developing the economic modelling platform to evaluate the value of innovation in cardiac stents.

More recently, she developed the global budget impact and cost effectiveness models for Watchman that have been used to support reimbursement dossiers around the world. Stacey's research initiatives have resulted in numerous scientific abstracts and publications. Stacey serves as the Director of Boston Scientific's Health Economics Center of Excellence.

In this capacity, Stacey is responsible for driving alignment on clinical, health economic, and outcomes data requirements to secure market access around the world. She also oversees development of global health economic evidence generation strategies for all key technologies and health care solutions. Stacey has a BA and MA in economics and is a member of (ISPOR) and (HTAi).

Wanda Carpinella
Vice President, Regulatory Affairs, BBA
In her role, Wanda leads the experienced regulatory team at BBA guiding clients through innovative regulatory strategies to obtain regulatory clearance or approval in complex global markets.

Prior to joining BBA, Wanda held numerous regulatory roles at AngioDynamics, Navilyst Medical and Boston Scientific. With over twenty years of experience in Regulatory Affairs in the Medical Device Industry, Wanda brings a wealth of knowledge about U.S, EU and International Quality System and Design Control Regulations.

Wanda is the author of numerous U.S., Canadian, EU and other International regulatory submissions with years of experience interacting and negotiating directly with regulatory agencies. Her therapeutic areas of regulatory experience include Cardiology, Urology, Gynecology, Neurology, Peripheral Vascular, Venous Access and Oncology. Wanda has a BS from Northeastern University.

Michael Drues, MS, PhD
President of Vascular Sciences
Dr. Drues has worked for and consulted with leading medical device, pharmaceutical and biotechnology companies ranging in size from start-ups to Fortune 100 companies. He also works on a regular basis for the U.S. Food and Drug Administration (FDA), Health Canada, the US and European Patent Offices, the Centers for Medicare and Medicaid Services (CMS) and other regulatory and governmental agencies around the world.

Dr. Drues is an internationally recognized expert and featured keynote speaker on cutting- edge medical technologies and regulatory affairs. He conducts seminars and short-courses for medical device, pharmaceutical and biotechnology companies.

He is an Adjunct Professor of Regulatory Affairs, Medicine and Biomedical Engineering at several universities and medical schools. Michael regularly teaches graduate courses in Regulatory Affairs and Clinical Trials, Clinical Trial Design, Medical Device Regulatory Affairs and Product Development, Combination Products and Pathophysiology.

Kristofer Munroe, JD - MODERATOR
General Counsel and Director of Market Access
With over fifteen years of experience in advocacy, Kristofer provides expertise in the design, training for, and implementation of compliance programs. His background in consumer issues provides practical insight into the healthcare system. Additionally, he has direct experience interacting with HHS OIG on behalf of his clients.

Kristofer has been engaged in advocacy through his work and as a volunteer serving on various non-profit boards and committees to advocate for consumers and patients. As an attorney he has represented healthcare consulting companies, providers, and medical device manufacturers.

He began his career in the life science industry as a patient advocate and has since worked in the legal realm for the past 10 years as a consumer and health care attorney at his own firm and as general counsel to Argenta Advisors, Inc. Kristofer is a member of Medical Development Group and the American Bar Association's Health Lawyers Section.

Agenda
5:30 - 6:15PM Arrival, Networking & Dinner
6:15 - 6:30PM Announcements and Introductions
6:30 - 8:00PM Speakers and Q&A
8:00 - 8:30PM More networking

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