Upcoming program agendas

Participants have described our sessions as “electric.” High energy comes from the earnest (and yes, sometimes heated, but always civil) discussions. We dive into everything from new FDA regulations and tech-transfer best practices, to the competition between outsourcing in the East and West … and the very future of the industry.

See what we have planned for our upcoming programs!

San Diego 2017Other agendas

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San Diego 2017 Agenda

An Early Start on Drug Development and Manufacturing Outsourcing

Tuesday 8/22/17

8:00 am

Registration and Exhibit Hall open, Networking Breakfast

9:00 am

Welcome / Conference Chair Opening Remarks

9:15 am

The fast and slow of tech transfer: Success in the balance

Sponsors often focus tech transfer on cost cutting and speed, minimizing engineering or pilot runs. This makes it difficult for CMOs to demonstrate robust process control, let alone think about new technology or innovation. Is there a happy median?

 

  • Panelists:
    Dan Gage, Sr. Scientist | Biogen
    Antonio Garrido-Montalban, Executive Director | STA Pharmaceutical, A WuXi AppTec Company
    Ben Littler, Sr. Dir., Process Chemistry | Vertex Pharmaceuticals
    John Newsam, CEO | Tioga Research, Inc.
    Scott Zook, VP, CMC Development | Neurocrine Biosciences, Inc.
    Rachael Atlee, Regional Dir., ExM Sterile Tech-Ops | Merck (Moderator)

10:15 am

Networking Refreshment Break

11:00 am

Is your CMO listening? Different breeds and different needs of sponsor companies

Tips on effectively communicating your organization’s specific needs to your CMO, and strategies for helping your CMO be more responsive. Are you asking too much? Or are you settling for too little?

 

  • Panelists:
    Dan Gage, Sr. Scientist | Biogen
    Dennis Knox, Sr. Mgr., Quality | Elusys Therapeutics
    Paul Maffuid, EVP, Research & Development | MabVax Therapeutics
    John Newsam, CEO | Tioga Research, Inc.

12:00 pm

Networking Lunch

 

1:15 pm

Antibody-drug conjugates: ADCs as an innovation model for outsourcing

Pfizer presents on the ins-and-outs of outsourcing a complicated and disruptive innovation like antibody-drug conjugates (ADCs), followed by a discussion of how ADCs can serve as a model for managing outsourcing and implementing innovations.

 

  • Panelists:
    Firelli Alonso, Sr. Dir., Biotherapeutics & Vaccines Outsourcing | Pfizer
    Paul Maffuid, EVP, Research & Development | MabVax Therapeutics
    Brian Mendelsohn, Principal Scientist | Astellas
    Mitchell Rosner, Principal Consultant | Quality Consulting Associates (Moderator)

2:15 pm

Networking Refreshment Break

3:00 pm

Spotlight Technology: Yes, you need to take the pulse of packaging now

Think it’s too early to think ahead to your potential drug’s primary packaging? Think again. Panelists provide real experiences on why innovations in packaging can impact your upstream development activities, and even selection of CMOs. It pays to plan ahead.

 

  • Panelists:
    Mark Butchko, Sr. Dir., QA, Product R&D | Eli Lilly and Company
    Ray Kaczmarek, VP, Commercial Mfg. & Supply Ops. | Pacira Pharmaceuticals, Inc.
    Oliver Stauffer, CEO | Packaging Technologies & Inspection
    Susan Dexter, Managing Director | Latham Biopharma (Moderator)

4:00 pm

Networking Reception

 

6:00 pm

Day One Concludes

 

Wednesday 08/23/17

7:00 am

Registration Opens

8:00 am

Exhibit Hall Opens, Networking Breakfast

9:00 am

Conference Chair Day Two Opening Remarks

9:15 am

Regulatory dynamics for innovation: Safety first, please

Often innovation enters drug development at phase one study. Yet sponsors prioritize innovation by cost and time savings. The FDA welcomes innovation, but is concerned the industry is losing sight of “safety first.” We’ll discuss this dynamic from all angles.

 

  • Panelists:
    Katlin Backfield, Attorney at Law & Consultant | Backfield PLLC
    Francie Barron, VP, Biology & Regulatory Affairs | Nanomedical Diagnostics, Inc.
    Bernie Huyghe, Sr. Director | Pfizer
    Ben Littler, Sr. Dir., Process Chemistry | Vertex Pharmaceuticals

10:15 am

Networking Refreshment Break

11:00 am

You can't outsource data integrity

Ensuring the integrity of all your data is codified in regulatory guidance … and negatively expressed in the proportion of FDA citations related to data. Don’t be next. This session provides practical steps for your struggles with managing data in an outsourced environment.

 

  • Panelists:
    Rachael Atlee, Regional Dir., ExM Sterile Tech-Ops | Merck
    Katlin Backfield, Attorney at Law & Consultant | Backfield PLLC
    Brian James, SVP, Operations | Rondaxe (Moderator)

12:00 pm

Networking Lunch

1:15 pm

New methods for qualifying your service providers, and benchmarking performance

Your drug programs are reliant on new technologies and platforms, and advancing outsourcing relationships. So how can today’s drug developers qualify and then accurately benchmark the performance of service providers? Here’s a look at some updated methodologies for better outsourcing outcomes.

 

  • Panelists:
    Antonio Garrido-Montalban, Executive Director | STA Pharmaceutical, A WuXi AppTec Company
    Ray Kaczmarek, VP, Commercial Mfg. & Supply Ops. | Pacira Pharmaceuticals, Inc.
    Peter Lee, Vice President | NovMetaPharma
    Sylvie Sakata, Senior Director, External Research Solutions | Pfizer
    Susan Dexter, Managing Director | Latham Biopharma (Moderator)

2:15 pm

Networking Refreshment Break

3:00 pm

Spotlight Leadership Company

More info coming soon

 

  • Panelists: TBA

4:00 pm

Conference Chair Closing Remarks

4:15 pm

Conference Concludes

* Agenda and panelists subject to change.

Other 2017 Programs

Looking for more information on our education programs? View agendas from our previous seven programs.

San Francisco

Tuesday 10/17/17 & Wednesday 10/18/17

Program details to be announced by Q3 2017.