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Past Events: San Diego 2017

August 22 -23, 2017
Hyatt Regency La Jolla

Boston 2017
Boston 2017

  • 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

     

  • Speakers

     

    Abzena | George Badescu, VP, Scientific Affairs
    Backfield PLLC | Katlin Backfield, Attorney at Law & Consultant (former FDA counsel)
    Biogen | Dan Gage, Senior Sup., Technical Dev.
    Cortexyme | David Hennings, Sr. Dir., Head, CMC
    Crinetics Pharmaceuticals | Ajay Madan, VP., Development
    Eli Lilly and Company | Mark Butchko, Sr. Dir., QA, Product Research & Dev.
    Elusys Therapeutics | Dennis Knox, Sr. Mgr., Quality
    Kura Oncology, Inc. | Xiaohu Deng, Sr. Dir., Head, CMC
    Latham Biopharm Group | Dennis Hester, VP, Product Development & Head, CMC
    MabVax Therapeutics | Paul Maffuid, EVP, Research and Dev.
    Merck | Susan Dexter, Managing Director
    Mirati Therapeutics | Rachael Atlee, Regional Dir., ExM Sterile Tech-Ops
    Nanomedical Diagnostics, Inc. | Francie Barron, VP, Biology & Regulatory Affairs
    Neurocrine Biosciences | Scott Zook, VP, CMC Dev.
    NovMetaPharma | Peter Lee, Vice President
    Outsourced Pharma | Louis Garguilo, Conference Chair & Chief Editor
    Pacira Pharmaceuticals, Inc. | Ray Kaczmarek, VP, Commercial Mfg. & Supply Ops.
    Packaging Technologies & Inspection | Oliver Stauffer, CEO
    Pfizer | Firelli Alonso, Sr. Dir., Biotherapeutics & Vaccines Outsourcing
    Pfizer | Sylvie Sakata, Sr. Dir., External Research Solutions
    Pfizer Global Supply | Thomas P. Wilson, VP, Contract Manufacturing Operations
    Quality Consulting Associates | Mitchell Rosner, Principal Consultant
    Qurient Co. Ltd. | Jaeseung Kim, Sr. Dir., CMC and R&D
    Rondaxe | Brian James, SVP, Operations
    Rx-360 Data Integrity Group | Barbara Unger, Co-Lead (President, Unger Consulting)
    STA Pharmaceutical, A WuXi AppTec Company | Antonio Garrido-Montalban, Executive Dir.
    Tioga Research, Inc. | John Newsam, CEO
    Tocagen, Inc. | Doug Jolly, EVP., Research & Pharmaceutical Dev.
    Vertex Pharmaceuticals | Ben Littler, Sr. Dir., Process Chemistry

 

  • 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.
      Dennis Hester, VP, Product Development & Head, CMC | Mirati Therapeutics
      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