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: TBA

10:15 am

Networking Refreshment Break

11:00 am

Is your CMO listening? Different breeds and different needs at sponsors

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: TBA

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: TBA

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: TBA

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: TBA

10:15 am

Networking Refreshment Break

11:00 am

You can't outsource data integrity

Ensuring data integrity is codified in regulatory guidance … and expressed in the high 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: TBA

12:00 pm

Networking Lunch

1:15 pm

New methods for qualifying CDMOs 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: TBA

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.