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 2017San Francisco 2017

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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. Sup., Technical Dev. | 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. Sup., Technical Dev. | Biogen
    Jaeseung Kim, Sr. Dir., CMC and R&D | Qurient Co. Ltd.
    Dennis Knox, Sr. Mgr., Quality | Elusys Therapeutics
    Paul Maffuid, EVP, Research & Development | MabVax Therapeutics
    John Newsam, CEO | Tioga Research, Inc.
    David Hennings, Sr. Dir., Head, CMC | Cortexyme (Moderator)

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
    George Badescu, VP, Scientific Affairs | Abzena
    Paul Maffuid, EVP, Research & Development | MabVax Therapeutics
    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
    Xiaohu Deng, Sr. Dir., Head, CMC | Kura Oncology, Inc.
    Ray Kaczmarek, VP, Commercial Mfg. & Supply Ops. | Pacira Pharmaceuticals, Inc.
    Oliver Stauffer, CEO | Packaging Technologies & Inspection
    Susan Dexter, Managing Director | Latham Biopharm Group (Moderator)

4:00 pm

Networking Reception

 

6:00 pm

Day One Concludes

 

Wednesday 08/23/17

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 1 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 (former FDA counsel)| Backfield PLLC
    Francie Barron, VP, Biology & Regulatory Affairs | Nanomedical Diagnostics, Inc.
    Ben Littler, Sr. Dir., Process Chemistry | Vertex Pharmaceuticals
    Ajay Madan, VP, Development | Crinetics Pharmaceuticals (Moderator)

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 (former FDA counsel) | Backfield PLLC
    Doug Jolly, EVP, Research & Pharmaceutical Dev. | Tocagen, Inc.
    Barbara Unger, President | Unger Consulting; Co-Lead | Rx-360 Data Integrity Group
    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 Biopharm Group (Moderator)

2:15 pm

Networking Refreshment Break

3:00 pm

Spotlight Leadership Company: Pfizer Global Supply

25-year veteran of Pfizer, and former US Air Force captain Thomas Wilson, sits down with chief editor Louis Garguilo to talk about Wilson's experiences in drug development and manufacturing outsourcing, and offer some best practices, advice and actionable information for drug owners, and service providers alike.

 

  • Panelists:
    Thomas P. Wilson, VP, Contract Manufacturing Operations | Pfizer Global Supply
    Louis Garguilo, Conference Chair and Chief Editor | Outsourced Pharma (Moderator)

3:50 pm

Conference Chair Closing Remarks

4:00 pm

Conference Concludes

* Agenda and panelists subject to change.

 

San Francisco 2017 Agenda

Transference In Drug Development and Manufacturing Outsourcing

Tuesday 10/17/17

8:00 am

Registration and Exhibit Hall open, Networking Breakfast

9:00 am

Welcome / Conference Chair Opening Remarks

9:15 am

Data integrity meets knowledge transfer

Data integrity is mission critical. But project success also relies on turning your data into a “knowledge transfer” with your outsourcing partners. We’ll discuss the best ways to both ensure data accuracy, and ensure you are transferring useful knowledge to and from all your partners.

 

10:15 am

Networking Refreshment Break

11:00 am

The geography of outsourcing: How important is your project’s location?

How critical is physical location to the success of your project? Does proximity outweigh purpose, or geography mean as much as specific capabilities? We’ll outline all the variables (e.g., distance, country, equipment, platforms, capacity, and capabilities) you must consider to select the best location of your next project and outsourcing partner.

 

12:00 pm

Networking Lunch

 

1:15 pm

Aligning motivations for sponsor and supplier innovation

Even small “i” innovations at your service providers can lead to big outcomes. So how do you align motivations for innovation through your supply chain? We’ll discuss what actually motivates providers to innovate, and how to ensure that matches up with your needs and goals.

 

2:15 pm

Networking Refreshment Break

3:00 pm

Spotlight technology: Outsourcing assistance for cell and gene therapies

When science advances through new therapies and companies, how do external partners expand capabilities, or new service providers emerge? Is there a supporting cast of outsourcing companies for the development of new cell- and gene-based therapies? We’ll hear from sponsors what they need, where to get it, and equally important, what not to expect.

 

4:00 pm

Networking Reception

 

6:00 pm

Day One Concludes

 

Wednesday 10/18/17

8:00 am

Exhibit Hall Opens, Networking Breakfast

9:00 am

Conference Chair Day Two Opening Remarks

9:15 am

Teaming up for regulatory advancements

The process to drug approval and manufacturing compliance should feel like a three-way partnership for advancing common goals. Are you effectively teaming up with your external partners to work with regulatory authorities to make this happen? We’ll provide real-world case studies on how drug sponsors, service providers, and regulators can successfully operate together.

 

10:15 am

Networking Refreshment Break

11:00 am

Your workforce: Challenges in hiring new and skilled employees

In any industry, finding and maintaining new and skilled employees is a major factor in operational continuity and business advancement. In this session, biopharma experts will take up our industry’s current and specific workforce challenges, and provide some implemented and potential solutions to overcome them.

 

12:00 pm

Networking Lunch

1:15 pm

Putting it together: Evaluating your provider network

It’s not enough to measure service providers in isolation. How effective are partners within the entire continuum of your project development and manufacturing network? We’ll learn best practices, including a matrix-based approach to evaluation, and reasons why traditional partner benchmarking can be sending you the wrong signals

 

2:15 pm

Networking Refreshment Break

3:00 pm

Spotlight Leadership Company: Achaogen

Members of Achaogen will provide insight and advice on the successful outsourcing of various activities and functions. And they’ll take your questions on how they’ve achieved such success to date.

 

3:50 pm

Conference Chair Closing Remarks

4:00 pm

Conference Concludes

* Agenda and panelists subject to change.