THEOREM THINK TANK BOSTON

Theorem Think Tank graphic

BOSTON  3/7/13

 

Thursday, March 7, 2013  |   3-7 p.m.
Boston Marriott Cambridge

Two Cambridge Center, 50 Broadway
Cambridge, Massachusetts

Sessions   |  Speakers   |   Register for this FREE event

 

If you’re in the drug or medical device industry and close to Boston, the THEOREM THINK TANK is a rare opportunity to gain important insights from some of Theorem’s top thinkers! Take us up on this chance to further your education and understanding of global drug and medical device development. Visit one, two or three sessions. Ask the questions you’ve always wanted to ask. Talk one-on-one with leading experts and get valuable advice on your own development programs.

 

Session TITLES AND TIMES

3 p.m.

web icon  Regulatory
"Strategic Regulatory Insight to Bring Your Device or Drug to Market in Record Time,” with Brian Bollwage, JD.

 

web icon  Patients
(KDH Systems for Patients)
"Electronic Patient Discovery With PatientLocateSM," with Dan Carnese.

4 p.m.

web icon  Therapeutics
"Patient Recruitment for Oncology Studies: Improving Your Probability for Success," with Connie Wierman.

 

web icon  CDISC
"BIMO (Summary Level Clinical Site Data for CDER's Inspection Planning) – What is it all about?" with Nate Freimark.

5 p.m.

web icon  Strategy
"Adaptive Clinical Trial Designs – Operational Considerations," with Mark Penniston.

 

web icon  Global
"Unraveling the Mystery of Delivery of Medical Device Trials in the Asia-Pacific," with D. Lee Spurgin, Jr., PhD,  and Nitin Jain.

6 p.m.

Networking

 
 

Theorem’s THINKERS
You’ll learn drug and medical device development information you can put into practice immediately!

 
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Brian Bollwage, JD
Vice President of Global Regulatory Affairs
With more than 30 years of experience in the health products industry, Brian Bollwage has provided regulatory counsel at i3 Research and with Johnson & Johnson, Pharmacia, Hoechst-Roussel and Bristol-Myers Squibb. He has managed the preparation, submission, research and associated FDA liaison activities for more than 150 INDs and 25 successful NDAs or BLAs.

 
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Dan Carnese
CEO, KDH Systems
Dan Carnese has more than 25 years of experience with Silicon Valley software ventures, including 12 years with start-ups delivering innovative products to health care providers and health insurance companies. Dan's experience spans a range of roles — encompassing engineering, marketing, sales, professional services and customer support — but his primary focus has been on new product development and delivery. He holds a Master of Science in electrical engineering and computer science from the Massachusetts Institute of Technology.

 
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Connie Wierman
Vice President, Biopharmaceutical Development
In a career spanning 25 years with more than half of it focused in oncology, Connie Wierman is one of the leading experts in oncology development programs. As vice president for clinical development, she led all oncology projects for INC Research and created the first medical science liaison (MSL) organization for ILEX (now Genzyme Corp.) to prepare the U.S. oncology market for launch of new products.

 
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Nate Freimark
Senior Director of the Biometrics Operations Standards Group
Nate Freimark has been heavily involved with the Clinical Data Interchange Standards Consortium (CDISC) since 2004 and, in particular, has been working to ensure clients meet the standards of the CDISC’s analysis data model (ADaM). From its inception, he has been a member of the ADaM leadership team, and has regularly provided public, private and FDA ADaM training courses. Working also as a lead programmer on numerous projects, Nate has extensive experience with a broad range of therapeutic areas including anti-infective, oncology and pain management studies.

 
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Mark Penniston
Senior Vice President and General Manager, Clinical Analytics
With more than 20 years of statistical experience, Mark Penniston has managed, analyzed and designed trials of every size and in all phases. He leads a team of global professionals in clinical data management, biometrics and medical writing and has presented, written for and hosted numerous technical conferences and serves on executive committees for technical service users groups.

 
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D. Lee Spurgin, Jr., PhD
Senior Vice President and General Manager, Medical Device and Diagnostic Development
With more than 22 years of industry experience, Dr. Lee Spurgin has been involved in more than 200 clinical trials with the majority of experience concentrated in the conduct of pivotal medical device programs. His experience in project execution spans 36 countries and his therapeutic experience includes asthma/allergy, cardiovascular disease, dermatology, endocrinology, HIV/AIDS, oncology and transplant (to include BMT).

 
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Nitin Jain
Vice President and General Manager for the Asia-Pacific Region
Nitin Jain held responsibilities in Asia-Pacific for both Covance and INC Research and was the director of international business and clinical research for Lal PathLabs, New Delhi. His responsibilities at Theorem include overall management of the Asia-Pacific operations and business development.

 
 

Smart THINKING
If you’re in the drug or medical device industry and close to Boston, the THEOREM THINK TANK is a rare opportunity to gain important insights from some of Theorem’s top thinkers. Take us up on this chance to further your education and understanding of global drug and medical device development. Visit one, two or three sessions. Ask the questions you’ve always wanted to ask. Talk one-on-one with leading experts and get valuable advice on your own development programs.

 

Attend this event for a chance to win 1 of 2 iPad minis.

Beverages and hors d'oeuvres served.

iPad minis

 

Register for this FREE event

 
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Please select one session per track (time).

3 p.m.

     Think Regulatory — “Strategic Regulatory Insight to Bring Your Device or Drug to Market in Record Time.”
 
Think Patients — (KDH Systems for Patients) "Electronic Patient Discovery With PatientLocateSM."

 

4 p.m.

     Think Therapeutics — “Patient Recruitment for Oncology Studies: Improving Your Probability for Success.”
 
Think CDISC — “BIMO (Summary Level Clinical Site Data for CDER’s Inspection Planning) – What is it all about?”

 

5 p.m.

     Think Strategy —“Adaptive Clinical Trial Designs – Operational Considerations.”
 
Think Global — “Unraveling the Mystery of Delivery of Medical Device Trials in Asia-Pacific.”