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Boston 2018 Agenda

Thriving In An Expanded Outsourced Drug Development and Manufacturing Model

Monday 5/14/18

8:00 am

Registration and Exhibit Hall open, Networking Breakfast

9:00 am

Welcome / Conference Chair Opening Remarks

9:15 am

Help! The 7 Critical Areas Where Sponsors Need More Support

Executives at sponsor companies explore their seven most critical support needs for drug development and manufacturing. Learn how a lack of support in each area impacts their plans, and join a discussion on how sponsors and CDMOs can work together to solve each challenge.

  • Panelists:
    Mark Butchko, Sr. Dir., Quality Assurance | Eli Lilly and Company
    Sachin Chandran, Director, Pharmaceutical Sciences | Catabasis Pharmaceuticals
    Thomas Hazel, SVP, Research | Neuralstem
    Greg Zarbis-Papastoitsis, VP Process & Manufacturing | Compass Therapeutics
    Julia O'Neill, Principal | Tunnell Consulting (Moderator)

10:15 am

Networking Refreshment Break

11:00 am

How To Survive – And Even Benefit From – Your CDMO’s M&A

Your CDMO is being acquired or merging: How do you ensure your projects and company continue to receive the attention they deserve? Sponsors with firsthand experience detail specific steps you can – and should – take to ensure you don’t get lost in the M&A shuffle.

  • Panelists:
    Vince Ammoscato, VP, Site Head | Piramal Pharma Solutions
    David Brown, VP, Tech Ops | Alcresta Pharmaceuticals
    Brian Scanlan, Managing Partner | Freedom Bioscience Partners
    Lisa Wyman, Head, Quality | Mersana Therapeutics
    Mark Butcko, Sr. Dir., Quality Assurance - Development | Eli Lilly And Company (Moderator)

12:00 pm

Networking Lunch

 

1:15 pm

New Business Models With CDMOs Include Better Pricing

Today’s more creative sponsor-CDMO business models now include improved pricing strategies. Can these enlightened models and strategies work for you and your service provider? Here are some answers from three real-life case studies.

 

  • Panelists:
    Christine Carberry, COO | Keryx Biopharmaceuticals
    Hugh Wight, Vice President, Technical Operations | Allena Pharmaceuticals
    Patricia Seymour, Sr. Consultant | BioProcess Technology Consultants (Moderator)

2:15 pm

Networking Refreshment Break

3:00 pm

Spotlight Technology: Lowering Risk To Your Physical Supply Chain

Will your shipments of raw materials or finished goods get stolen, diverted, counterfeited … or simply disappear? Our experienced panelists present on the state of our physical supply, how to evaluate security risk in key areas of your supply chain, and lead you in a discussion of security technologies. Big or small, all biopharma companies should attend this session.

 

  • Panelists:
    Carl J. Accettura, Vice President and General Manager | PharmoRx Therapeutics
    Mike Long, Sr. Dir., Consulting Services & Principal Consultant | Concordia ValSource
    Chirag V. Shah, Director, Global Product Security | Sanofi
    Lee Spach, Director, Global Product & Supply Chain Security | Biogen
    Ron Guido, President | Lifecare Services (Moderator)

4:00 pm

Networking Reception

 

6:00 pm

Day One Concludes

 

Tuesday 5/15/2018

8:00 am

Exhibit Hall Opens, Networking Breakfast

9:00 am

Conference Chair Day Two Opening Remarks

9:15 am

How Small Sponsors Can Compete For Attention At Their CDMOs

Start-ups, virtuals, biotechs and smaller pharma compete with bigger sponsors for capabilities, capacity, better pricing … and just to maintain a service provider’s full attention. Some break through, while others feel marginalized. Our experienced professionals will offer strategies to help, and also discuss your experiences.

 

  • Panelists:
    Vincent Kosewski, SVP, Manufacturing & Supply Chain Management | Kala Pharmaceuticals
    Jim Nolan, Head, CMC Operations | Kyn Therapeutics
    Michael Markey, CMC Director | Radius Health, Inc.
    Thomas Holmes, Sr. Dir., Global External Manufacturing | Biogen
    Brian James, SVP Operations | Rondaxe Pharma (Moderator)

10:15 am

Networking Refreshment Break

11:00 am

Does Your Risk Management Plan Satisfy The FDA and SEC?

Regulatory scrutiny of your outsourcing activities isn’t limited to the FDA. The SEC is paying more attention to how you manage and disclose operational risks. Any drug developer receiving funding needs to listen to this panel discuss risk management and disclosure, best practices for data integrity and IP protection, and supply and quality agreements.

 

  • Panelists:
    Paula Katz, Director, Manufacturing Quality Guidane & Policy Staff | FDA
    Robert Di Scipio, CEO | Skyland Analytics, Inc.
    John Lee, SVP, Pharmaceutical Development | Decibel Therapeutics

12:00 pm

Networking Lunch

1:15 pm

Aspects & Considerations For Dealing With Challenging CDMO Relationships

Shire will lead this discussion with a mini case-study about “inheriting" a CDMO relationship when it obtained a new product, and the resulting challenges with change control, deviation management, and regulatory implications that might end in difficulties if not handled correctly. We’ll get advice from all our panelists — and answer your questions — on dealing with the more challenging outsourcing relationships sponsors may face today.

 

  • Panelists:
    Barbara Glantschnig, VP, Quality | Shire
    Suzanne Murray, VP, Quality | Agios Pharmaceuticals
    Bill Pasek, EVP & Chief Commercial Officer | Avara Pharmaceutical Solutions
    Scott Willett, VP Biopharmaceutical Development | Promedior
    Brian Clark, Principal | GMP Operations Consulting, LLC (Moderator)

2:15 pm

Networking Refreshment Break

3:00 pm

Spotlight Leadership Company: Mersana Therapeutics

The President & CEO, CSO, and SVP of CMC for Mersana Therapeutics — an exciting Boston-area biotech reliant on strategic partnering — will provide best practices, advice, and real experiences in the art of outsourcing drug development and manufacturing.

 

  • Panelists:
    Anna Protopapas, President and CEO | Mersana Therapeutics
    Timothy Lowinger, Chief Scientific Officer | Mersana Therapeutics
    Tom Wagler, Executive Director, Drug Substance Development
    Michael Kaufman, SVP, CMC | Mersana Therapeutics
    Louis Garguilo, Conference Chair and Chief Editor | Outsourced Pharma (Moderator)

3:50 pm

Conference Chair Closing Remarks

4:00 pm

Conference Concludes



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