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FORUM: New Advances in Combination Products
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Combination products are defined as a product comprised of a medical device and/or a drug and/or a biologic and/or companion diagnostics. Given product diversity, it takes cross-functional talent to bring novel therapeutics into clinical practice.

When: Wed Oct 30, 2018
5:30-8:30 PM
Where: Regis College, Fine Arts Center
235 Wellesley St
Weston, Massachusetts  02493
United States
Contact: Bill Munger

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Oct 30 MDG Forum - New Advances in Combination Products
Addressing the Unmet Need
to Develop Drug Delivery
Innovation Strategies in
Preclinical Drug Discovery
& Development
Combination products are defined as a product comprised of a medical device and/or a drug
and/or a biologic and/or companion diagnostics.
Given product diversity, it takes cross-functional talent to bring novel therapeutics into clinical practice.
Program Description  
Numerous combination product examples can be cited which generally fall into several categories:
  • Prefilled drug delivery systems
  • Medicated devices
  • Co-labeled (e.g. companion diagnostics)
The objective of this session is to present a point of view on combination products covering topics that include:
  • The opportunity
  • The range of therapies under investigation
  • The challenges associated with their
  • delivery-targeting and binding.
  • Drug delivery platforms and controls
  • Measuring post administration
  • pharmacokinetics
  • Thoughts on regulatory pathways
  • Engaging in pre-clinical settings
  • Business model considerations
Combination products are changing the traditional rules of drug delivery system innovation prompting the need for the concurrent development of a therapeutic and its delivery system.

Early engineering engagement with the scientific and clinical community in the preclinical setting is becoming increasingly important to sort through drug delivery system tradeoffs that ensure drug safety and efficacy.

Advances in molecular biology, biotechnology, regenerative medicine, and material sciences heighten the importance of addressing drug delivery system innovation earlier in the discovery process.

As more becomes known about a therapeutic's mechanism of action, dosing, and safety profile, the integration of clinical and engineering functions becomes paramount to vet multiple factors including:
  • The bioavailability, efficacy, and safety profile of the therapeutic
  • Routes of drug administration-injectable, implantable, oral, inhalation, transdermal, otic, topical etc.
  • Flow control, temperature control, and pressure control
  • Materials and transport phenomena 
Oct 30, 5:30 - 8:30 PM
Regis College Fine Arts Center
Weston, MA
MDG Boston Earlybird Forum Fees
   Member/Alliance Partner - $30   
   Non-member - $45 
   Student (member) - $10
   Student (non-member) - $15 
Gold Member - No Charge
Event Sponsorship - $500
   (contact Hank Allard for details 


Event Sponsors
Premier Sponsors

Who Should Attend: 
  • Scientists, clinicians, and translational science professionals investigating drug delivery combination product platforms
  • Engineering professionals looking to engage with Life Sciences counterparts
  • Sales executives seeking to advance sales campaigns in pharmaceutical R&D settings
  • Entrepreneurial and venture interested in drug delivery innovation opportunities
Our Distinguished Panel
Alex Yi, MD, PhD     
Director, Translational Medicine
Cardiovascular and Metabolism,
Novartis Institutes for BioMedical Research
Anthony F. Coston PhD, MBA, PMP 
Head of Medical Devices,
The Charles Stark Draper Laboratory Inc.
Steve Bowman, PhD     
Device Program Lead,
Bill Boardman      
Managing Director,
The StratOps Group
Panel Bios     
Alex Yi, MD, PhD     
Director, Translational Medicine Cardiovascular and Metabolism, Novartis Institutes for BioMedical Research
"Emerging Therapies and Unmet Drug Delivery Innovation Needs"
Dr. Yi is an accomplished cardiologist and distinguished researcher engaged in the development of novel therapies addressing cardiovascular disease. Alex also serves as Novartis' translational medicine expert responsible for taking early stage compounds from the lab to clinical proof-of-concept and bridging to late-stage development.

Alex completed his undergraduate work at MIT and received his MD and PhD degrees from the University of California, San Francisco-School of Medicine. He completed his residency at New York Presbyterian Hospital and trained in cardiovascular diseases at Massachusetts General Hospital.

Dr. Yi also conducted research as a Research Fellow at the Massachusetts General Hospital Cardiovascular Research Center and an Instructor of Medicine at Harvard Medical School.

Anthony F. Coston PhD, MBA, PMP
Head of Medical Devices, The Charles Stark Draper Laboratory Inc.
"Advanced Drug Delivery Platforms"
Anthony Coston is the Head of Medical Devices at Draper where he oversees the Medical Device Business within Draper's Commercial Division. His daily New Business Development (NBD) activities involve determining how to leverage internal technologies and capabilities and deploy them against significant unmet needs within the Medical Device Marketplace through collaborations and partnerships with Commercial companies.

Anthony's portfolio of available technologies and capabilities includes Neurotechnology, Mental Health, Diagnostics & Therapeutics, Data Analytics, and Image Processing.

Anthony holds a degree in Electrical Engineering from the University of Delaware, a in Biomedical Engineering from Penn State University, a PhD in Biomedical Engineering from Rutgers University and MBA from MIT's Sloan School of Management.

Steve Bowman, PhD
Device Program Lead, Shire
"Integrating with the Pharmaceutical Drug Delivery Innovation Team"  
Steve was the first leader of Shire's Device Center of Excellence, a group formed in recognition of the increasing importance of devices and combination products to Shire's continued growth.  
Steve is currently the Device Program Lead for two high-value rare disease products (Natpar/Natpara and Gattex/Revestive), responsible for all new global device development activities. Prior to joining Shire Steve was the Sr. Director of Sports Medicine R&D for Smith & Nephew, responsible for all global development of surgical implants and instruments for arthroscopic knee, shoulder and hip repair. He started his career at Johnson & Johnson, with multiple roles of increasing responsibility in R&D, Biologics Manufacturing, Project Management and Alliance Management.  
Steve earned a BS in Mechanical Engineering from Columbia University, a PhD in Medical Engineering and Medical Physics from the Harvard - MIT Program of Health Sciences and Technology.

Bill Boardman - MODERATOR
Managing Director, The StratOps Group
"Thinking Through and Acting on the Go-to-Market Playbook"  
Bill specializes in strategy development, market positioning, and the Go to Market execution for the commercialization of emerging technologies. He brings 25 years of operations and business development experience supporting Fortune 1,000 companies and emerging companies through critical stages of turn-around, rapid growth, and transformation.  
Bill has directed client engagements across multiple industries. His health care work has addressed multiple modalities that have included diabetes, orthopedics, imaging, and critical care to HCIT and IoT Platforms.  
Bill formerly was a part of Arthur D. Little's Technology and Innovation Management team, a Senior Manager with Ernst & Young, and held program management roles within Honeywell Aerospace.
David Buzzeo - CO-CHAMPION
Global Category Manager, Shire
Dave is senior level Global Sourcing and Procurement professional with experience in different industries including life science (Millipore), medical devices (Medtronic and Haemonetics), and now Pharmaceuticals (Shire). He has worked at these innovative large companies as well as early stage startups. David holds a BSME (WPI) and MSME (UConn) as well as an MBA (Babson College). Dave is also the Co-Chair for MDG Boston Programming.
Fees -  (Light dinner included)
Fee Category Early Registration
(By Oct 23)
Week Prior
(Oct 23-Oct 30)

At the Door
(Oct 30) 
Member/Alliance Partner: $30 $35 $45
Non-Member: $45 $55 $65
Student Member $10 $12 $15    
Student Non-member w/ a valid ID $15 $18 $20 
Gold Member No Charge No Charge  No Charge 
Event Sponsor - $500 -  (contact Hank Allard for details -
About MDG Boston
The Medical Development Group (MDG Boston) is a community of individuals professionally committed to the Medical Device and other Medical Technology Industry segments united by the belief that innovation and advances in technology lead to substantial improvements in health care. MDG pursues this mission through the organization of educational programs and forums: the facilitation of cross-disciplinary dialogue and collaboration; the creation of venues for networking and information sharing for current and aspiring professionals, clinicians, and entrepreneurs; and the development of alliances with complementary organizations.

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