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Past Events: San Francisco 2017

October 17-18, 2017
Hyatt Regency San Francisco Airport

San Francisco 2017
San Francisco 2017

  • Sponsors

     

    DPT Laboratories
    Skyland Analytics
    Symbiosis Pharmaceutical Services
    PharmaAssist Analytical Laboratory
    Pfizer CentreOne
    Life Science Leader
    Life Science Training Institute



  • Exhibitors:

    Adesis, Inc.
    Albemarle
    Alcami Corporation
    Althea CMO
    AMPAC Analytical Lab
    Aphena Pharmaceutical Solutions
    Avara Pharmaceutical Services
    Avista Pharma Solutions
    B. Braun Medical OEM
    Berkshire Sterile Manufacturing
    BioDuro
    Boehringer Ingelheim
    Cambrex Corporation
    Boston Institute of Biotechnology LLC
    Cambrex Corporation
    CMC Biologics
    Cytovance Biologics
    DavosPharma
    Dottikon ES America
    Eurofins Alphora
    FAREVA
    Flamma S.p.A.
    FUJIFILM Diosynth Biotechnologies
    Full Spectrum Analytics
    Jubilant Chemsys
    LI-COR Biosciences
    Metrics Contract Services
    Multipharma Inc.
    Olon Ricerca Bioscience LLC
    PCI Pharma Services
    PCI Synthesis
    Pharmatech Associates
    Piramal Pharma Solutions
    Quotient Clinical
    Recro Gainesville
    Rondaxe
    SafeBridge Consultants, Inc.
    Scientist
    Sherpa Clinical Packaging
    SHL Group
    Siegfried USA, LLC
    SMC, Ltd.
    Therapure Biopharma
    Triclinic Labs
    Unither Manufacturing LLC
    Yourway Transport
    Rondaxe
    Sherpa Clinical Packaging
    Siegfried USA, LLC
    Scientist
    STA Pharmaceutical, A WuXi AppTec Company
    SynConnection
    Triclinic Labs
    Unither Manufacturing LLC
    Yourway Transport

     

  • Speakers

     

    Achaogen | Tina Larson, VP, Technical Operations
    Achaogen | Amelia Milani, Senior Director, Supply Chain
    Achaogen | JIm Kirchner, Senior Director, CMC
    Achaogen | Kirin Jamison, Director, Antibody Process Development
    ADC Therapeutics | Mike Mulkerrin, Head, CMC
    Aequor, Inc. | Marilyn Bruno, CEO
    Amunix Pharmaceuticals | Ulrich Ernst, SVP, Manufacturing & Quality Ops.
    Assembly Biosciences | Jennifer Troia, SVP, HR & Organization Dev.
    Boehringer Ingelheim | Jens Vogel, President & CEO, BI Fremont Inc.
    Cell Design Labs | Peter Emtage, SVP, Research
    Cyathlon Bioscience | Jason Carstens, Principal Consultant
    Dermira | Sriram Naganathan, Sr. Dir., Chemical Development
    FDA | Jane M. Kreis, Traning Officer
    FibroGen | Wayne Frost, VP, Regulatory Affairs
    Hayat Pharmaceuticals Consulting | Umar Hayat, Principal
    Jaguar Animal Health | David Upchurch, VP, Supply Chain
    Juno Therapeutics | Mary Mallaney, Senior Engineer
    KO Pharma R&D| Sami Karabomi, Co-Founder
    Nuredis | Thomas W. Sun, VP, Nonclinical Development
    Outsourced Pharma | Louis Garguilo, Conference Chair & Chief Editor
    PCT Cell Therapy Services (Hitachi Group) | Catherine McIntyre, Sr. Dir., Global MSAT
    Pfizer | Ali Javadian, Dir., Biotherapeutics & Vaccines Outsourcing
    PharmAssist | Jeff Evans, CEO, President
    Pharmatech Associates | Bikash Chatterjee, President & CSO
    Regulatory Pathfinders | Federico Goodsaid, Principal (former FDA official)
    Rondaxe Pharma | Dave Perritt, Vice President
    Universal Cells | Bryan Steadman, Chief Technology Officer
    Validant | John McShane, Managing Partner
    Valley Fever Solutions | David Larwood, CEO & President
    Versartis | Vinita Kumar, VP, QA & QC
    Wallowitz Associates | Sue Wallowitz, President

 

  • 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.

     

    • Panelists:
      Jane M. Kreis, Training Officer | FDA
      Vinita Kumar, VP QA / QC | Versartis, Inc.
      Michael Mulkerrin, Head of CMC | ADC Therapeutics
      Sue Wollowitz, President | Wollowitz Associates (Moderator)

    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.

    • Panelists:
      Marilyn Bruno, CEO | Aequor, Inc.
      Michael Mulkerrin, Head of CMC | ADC Therapeutics
      Sriram Naganathan, Senior Director, Chemical Development | Dermira
      Thomas W. Sun, VP, Nonclinical Development | Nuredis
      Jens Vogel, President & CEO, BI Fremont Inc | Boehringer Ingelheim
      John McShane, Managing Partner | Validant (Moderator)

    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.

    • Panelists:
      David Larwood, CEO & President | Valley Fever Solutions
      Sriram Naganathan, Senior Director, Chemical Development | Demira
      David Upchurch, VP, Supply Chain | Jaguar Animal Health
      Jens Vogel, President & CEO, BI Fremont Inc | Boehringer Ingelheim
      Sami Karaborni, Co-founder | KO Pharma R&D (Moderator)

    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.

    • Panelists:
      Jason Carstens, Principal Consultant | Cyathlon Bioscience
      Peter Emtage, SVP, Research | Cell Design Labs
      Ali Javadian, Director, Biotherapeutics & Vaccines Outsourcing | Pfizer
      Mary Mallaney, Senior Engineer | Juno Therapeutics
      Catherine McIntyre, Sr. Dir., Global Manuf. Support | PCT Cell Therapy Services (Hitachi Group)
      Bryan Steadman, Chief Technology Officer | Universal Cells (Moderator)

    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.

    • Panelists:
      Wayne Frost, VP, Regulatory Affairs | FibroGen
      Federico Goodsaid, Principal | Regulatory Pathfinders (former FDA official )
      Umar Hayat, Principal | Hayat Pharmaceuticals Consulting
      Vinita Kumar, VP QA / QC | Versartis, Inc.
      Bikash Chatterjee, President | Pharmatech Associates (Moderator)

    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.

    • Panelists:
      Jeff Evans, CEO | PharmAssist
      Wayne Frost, VP, Regulatory Affairs | FibroGen
      Mary Mallaney, Senior Engineer | Juno Therapeutics
      Jennifer Troia, SVP, HR & Organizational Development | Assembly Biosciences.
      Dave Perritt, Vice President | Rondaxe (Moderator)

    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

    • Panelists:
      Ulrich Ernst, SVP, Tech Operations | Amunix Pharmaceuticals
      Ali Javadian, Director, Biotherapeutics & Vaccines Outsourcing | Pfizer
      Thomas W. Sun, VP, Nonclinical Development | Nuredis
      David Upchurch, VP, Supply Chain | Jaguar Animal Health
      John McShane, Managing Partner | Validant (Moderator)

    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.

    • Panelists:
      Tina Larson, VP Technical Operations | Achaogen
      Kirin Jamison, Director, Antibody Process Development | Achaogen
      Jim Kirchner, Senior Director CMC | Achaogen
      Amelia Milani, Senior Director Supply Chain | Achaogen
      Louis Garguilo, Conference Chair and Chief Editor | Outsourced Pharma (Moderator)

    3:50 pm

    Conference Chair Closing Remarks

     

    4:00 pm

    Conference Concludes