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PDA New England Chapter Dinner Event: Advancing from Clinical to Commercial - The Commercialization Roadmap

May 16 - May 16, 2018 |
May 16, 2018 |
Hyatt Regency Cambridge | Cambridge, MA
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with Todd Applebaum and James Blackwell

General Meeting format

Sponsors can begin setting up at 4:45 pm
Registration/cocktails/social hour with sponsors: 5:30 - 6:30 pm
Dinner starts approximately 6:30 pm
Introductions and presentations begin at approx. 7:00 pm

Location: Hyatt Regency Cambridge
575 Memorial Drive
Cambridge, MA 02139

Speakers and Presentations

Planning and Mobilizing for Commercial Launch
Presented by: Todd Applebaum

Todd Applebaum has a 20-year track record in business strategy, manufacturing, operations and supply chain management, working with life science companies across the pharmaceutical, biologics, regenerative medicines, and medical device sectors. Prior to founding Converge, Todd was VP of Tech Ops at Ovascience, Inc, a developer of cell therapy treatments for fertility, where he led Manufacturing, Quality, Supply Chain, and Tech Services as the company transitioned from research to commercial. He also served as VP of Research for the Healthcare and Life Science industries at Gartner, Inc., was co-Founder of Maxiom Consulting Group, and worked in operations at Deloitte Consulting. Todd holds a BS IE and a MBA from Carnegie Mellon University.

A commercial launch will establish your company's ability to execute commercially, and, in the process transform your organization from a focus on Research and Clinical Development to a focus on Physicians and Patients; from a science and technology company to an integrated pharmaceutical company. Launch impacts every aspect of the company: new operations and functional areas, new business processes, new responsibilities, new (and enhanced) IT infrastructure, growing workforce. Plan for and manage uncertainties, characterize uncertainty, create multiple budgeting scenarios. This presentation will touch on these challenges and techniques used to plan and mobilize for commercial launch.

CMC Activities for Commercialization: PAI, QMS, and BLA/NDA
Presented by: James Blackwell

Dr. Blackwell is a leading industry consultant with broad experience from process development to commercial operations. His broad CMC product experience includes major therapeutic classes. Clients include virtual start-ups to multi-national pharma companies. His regulatory experience includes INDs, PAIs, DMFs and leading NDA CMC submissions. He was involved with third party Consent Decree monitoring, organizational mentoring and quality system remediation. He has led or actively participated in more than forty due diligence projects on products, technologies and companies. Dr. Blackwell was on the formative management team and led Mfg. and Technical Operations for Shore Therapeutics and has been VP Manufacturing for SpineOvations.

The major CMC activities for commercialization are: preparing one's regulatory submission; preparing for your pre-approval inspection; and switching your quality system from a clinical focus to being able to handle commercial responsibilities. For successful outcomes, some guiding principles include: start early in the product lifecycle with the end in mind; KISS (keep it simple stupid); communicate, communicate, communicate; and resource with skilled and experienced talent, both internal and external, including expert project managers. Practical insights from the trenches will be provided from both challenged and world class organizations.

Meeting Hosts

Henry Brush
Director, Drug Product Manufacturing
Zafgen, Inc.

Sunil Anklekar
Associate Director, Drug Product and API Manufacturing
Lantheus Medical Imaging, Inc.

Registration

PDA Members: $90
PDA Student Members: $10
PDA Retired Members: $10
Unemployed Members: $10
Non-Members: $110

Not yet a member of PDA?
Join today and attend this meeting for free! Email Katie Ruiz once you have completed your membership purchase to be registered at no charge for this event.

Register online by 12:00 Noon, Friday, May 11th

Late registrations will be accepted after noon on May 11th on a space-available basis.

Late Registration is $130 for all.

For late registration contact Events@ne-pda.org. Late registration payment will be accepted at the door. You can now pay for late registration with your credit card.

NEPDA Upcoming events

September 12th, 2018 Dinner Meeting
September 26th, ISPE show at Gillette Stadium in Foxboro
November 14th, 2018 Dinner Meeting

 

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