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San Diego 2017

August 22 -23, 2017 | Hyatt Regency La Jolla


Sponsors

Fermion OY, Orion Group

Life Science Leader

Life Science Training Institute

Procos USA

   

Exhibitors

Adesis, Inc.

Advinus Therapeutics

Albemarle

Alcami Corporation

Althea CMO

Avara Pharmaceutical Services\

Avista Pharma Solutions

Berkshire Sterile Manufacturing

Cambrex Corporation

CordenPharma

DavosPharma

Dottikon ES America

Dupont Protection Solutions

 

EAG Laboratories

Emergent Biosolutions

FAREVA

Full Spectrum Analytics

JRF Global

Korber Medipak Systems NA Inc.

Metrics Contract Services

Mikart, Inc

Olon Ricerca Bioscience LLC

PCI Pharma Services

Pharmatech Associates

Piramal Pharma

Solutions

Quotient Clinical

Rondaxe

Sherpa Clinical Packaging

Siegfried USA, LLC

Scientist

STA Pharmaceutical, A WuXi AppTec Company

SynConnection

Triclinic Labs

Unither Manufacturing LLC

Yourway Transport


Agenda

Tuesday 8/22/17

Registration and Exhibit Hall open, Networking Breakfast

8:00AM

Welcome & Conference Chair Opening Remarks

9:00AM

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

9:15AM

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?

  • 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)

Networking Refreshment Break

10:15AM

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

11:00AM

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?

  • 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)

Networking Lunch

12:00PM

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

1:15PM

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.

  • 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)

Networking Refreshment Break

2:15PM

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

3:00 pm

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.

  • 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)

Networking Reception

4:00PM

Day One Concludes

6:00PM


Wednesday, 8/23/17

Exhibit Hall Opens, Networking Breakfast

8:00AM

Conference Chair Day Two Opening Remarks

9:00AM

Regulatory dynamics for innovation: Safety first, please

9:15AM

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.

  • Katlin Backfield, Attorney at Law & Consultant (former FDA counsel)| Backfield PLLC
  • Francie Barron, VP, Biology & Regulatory Affairs | Nanomedical Diagnostics, Inc.
  • Dennis Hester, VP, Product Development & Head, CMC | Mirati Therapeutics
  • Ben Littler, Sr. Dir., Process Chemistry | Vertex Pharmaceuticals
  • Ajay Madan, VP, Development | Crinetics Pharmaceuticals (Moderator)

Networking Refreshment Break

10:15AM

You can't outsource data integrity

11:00AM

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.

  • 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)

Networking Lunch

12:00PM

New methods for qualifying your service providers and benchmarking performance

1:15PM

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.

  • 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)

Networking Refreshment Break

2:15PM

Spotlight Leadership Company: Pfizer Global Supply

3:00 pm

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.

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

Conference Chair Closing Remarks

3:50PM

Conference Concludes

4:00PM

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