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Past Events: San Diego 2015

August 25-26, 2015
Hyatt Regency La Jolla

 

Produced by Life Science Leader, Biocom
Platinum Sponsor Pfizer CentreSource
Supported by Outsourced Pharma, Life Science Training Institute, Rondaxe, Pharmatech Associates, Life Sciences Foundation, Big3Bio

 

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Conference at San Diego 2015
Registration desks at San Diego 2015

  • Sponsors

     

    AMRI
    Alphora Research
    Bend Research
    Cytovance Biologics
    inVentiv Health
    IriSys, LLC
    Pfizer CentreSource
    Sanofi CEPIA
    Thermo Scientific
    VWR International LLC

    Exhibiting sponsors:
    Advanced Bioscience Laboratories
    Advantar Laboratories, Inc.
    Althea
    Ash Stevens
    B. Braun
    Baxter BioPharma Solutions
    Biocom
    CMC Biologics
    DavosPharma
    Enterey Life Sciences Consulting
    Explora BioLabs
    Formex
    Fujifilm Diosynth Biotechnologies
    Glatt Pharmaceutical Services
    GVK Bio
    Hovione
    Integrated Project Management Company, Inc.
    LI-COR Biosciences
    Life Science Training Institute
    Lifecore Biomedical LLC
    Managed Laboratory Services
    Metrics, Inc.
    Occupational Services, Inc.
    Packaging Coordinators, Inc. (PCI)
    PfizerCentreSource
    PharmaCore, Inc.
    PharmaDirections, Inc.
    Pharmatech Associates
    Pharmatek
    Rho, Inc.
    Rondaxe
    Ropack
    SAFC
    Sherpa Clinical Packaging
    Solid Form Solutions
    Tergus Pharma
    Unanet
    UPS
    VWR

     

  • Speakers

     

    Agensys | Brian Mendelsohn, Leader of ADC Chemistry Group
    Althea | David Enloe, President and CEO
    Arcturus Therapeutics | Joseph Payne, President and CEO
    ArmaGen Inc. | James Callaway, President and CEO
    BalinBac Therapeutics | John Gregg, President and CEO
    Biotech CMQR Consulting | Suketu Desai, Principal & Founder
    Capricor Therapeutics | Denise McDade, VP of Quality
    CytRx | Carrie Helland, VP Project Management and Manufacturing
    Dauntless Pharmaceuticals | Olivier Laurent, VP Development
    FLAG Therapeutics | Frank Sorgi, President & CEO
    GenZum Life Sciences | Chris Achar, CEO
    Halozyme Therapeutics | Becky Tanamachi, Senior Director, Manufacturing
    HedgePath Pharmaceuticals | Nicholas Virca, President & CEO
    Inovio Pharmaceuticals | E.J. Brandreth, VP Quality
    MabVax Therapeutics | Paul Maffuid, VP Pharmaceutical Development and Operations
    Marlene García Swider, Regulatory Specialist
    Metrics Contract Services | John Ross, EVP
    Neurocrine Biosciences | Scott Zook, VP CMC Development
    Orexigen | Philip Roberts, VP Technical Operations
    Pacific BioVentures | Mark Wilson, Principal
    Pacira Pharmaceuticals | Ray Kaczmarek, VP Commercial Manufacturing & Supply Operations
    Pfizer | Sylvie Sakata, Sr. Director, External Research Solutions
    Pharmatech Associates | Bikash Chatterjee, President and CSO
    Pharmatek | Timothy Scott, President
    Polynoma | Pat Mallon, COO
    Retrophin | Nils Olsson, VP Chemistry, Manufacturing and Controls
    Rondaxe | Jeff Barker, Principal Consultant | Strategic CMC Consulting & Senior Advisor
    Sandoz | Michele Johnson, Director, Supplier Relationship Management
    Skyland Analytics | Robert Di Scipio, CEO
    Tergus Pharma | Vijendra Nalamothu, CEO
    Teva Pharmaceuticals | Gail Trimble, Director of Quality Assurance
    Tioga Research | John Newsam, CEO
    Tocagen | Doug Jolly, SVP R&D
    Tunnell Consulting | Julia O'Neill, Principal
    UPS | Robin Hooker, Director Healthcare Marketing
    ZZ Biotech | Kent Pryor, COO

     

  • Agenda

 

Tuesday 8/25/15

 

7:00 am

Registration opens
Exhibit hall opens

 

8:00 am

Networking breakfast

Sponsored by Pfizer CentreSource

 

9:15 am

A: A detailed investigation on the finances of outsourcing

  • David Enloe, President and CEO | Althea
  • Carrie Helland, VP Project Management and Manufacturing | CytRx
  • Pat Mallon, COO | Polynoma
  • Brian Mendelsohn, Leader of ADC Chemistry Group | Agensys
  • Kent Pryor, COO | ZZ Biotech
  • Moderated by Mark Wilson, Principal | Pacific BioVentures

 

B: Implement winning tech transfer strategies

  • Doug Jolly, SVP R&D | Tocagen
  • Paul Maffuid, VP Pharmaceutical Development and Operations | MabVax Therapeutics
  • Vijendra Nalamothu, CEO | Tergus Pharma
  • Philip Roberts, VP Technical Operations | Orexigen
  • Becky Tanamachi, Senior Director, Manufacturing | Halozyme Therapeutics
  • Moderated by Bikash Chatterjee, President and CSO | Pharmatech Associates

 

10:15 am

Networking refreshment break

Sponsored by AMIR & Bend Research

 

11:00 am

A: Don't get stuck – Building a scalable outsourced development model

  • Chris Achar, CEO | GenZum Life Sciences
  • Pat Mallon, COO | Polynoma
  • Becky Tanamachi, Senior Director, Manufacturing | Halozyme Therapeutics
  • Scott Zook, Vice President CMC Development | Neurocrine Biosciences
  • Moderated by John Ross, Executive Vice President | Metrics Contract Services

 

B: How do you know you're on target if you don't measure your CRO/CMO?

  • Michele Johnson, Director, Supplier Relationship Management | Sandoz
  • Denise McDade, VP of Quality | Capricor
  • Sylvie Sakata, Sr. Director, External Research Solutions West | Pfizer
  • Nicholas Virca, President & CEO | HedgePath Pharmaceuticals, Inc.
  • Moderated by John Newsam, CEO | Tioga Research

 

12:00 pm

Networking lunch

Sponsored by VWR

 

1:15 pm

Do you have a risky risk-mitigation strategy?

  • Jeff Barker, Principal Consultant, Strategic CMC Consulting & Senior Advisor | Rondax
  • James Callaway, President and CEO | ArmaGen Inc.
  • Carrie Helland, VP Project Management and Manufacturing | CytRx
  • Doug Jolly, SVP R&D | Tocagen
  • Timothy Scott, President | Pharmatek
  • Frank Sorgi, President & CEO | FLAG Therapeutics
  • Moderated by Bikash Chatterjee, President and CSO | Pharmatech Associates

 

2:15 pm

Networking refreshment break

Sponsored by Sanofi CEPIA

 

3:00 pm

What are the impacts of FDA quality initiatives on your relationship with your CROs/CMOs?

  • E.J. Brandreth, VP Quality | Inovio Pharmaceuticals
  • Suketu Desai, Principal & Founder | Biotech CMQR Consulting (formerly with Allergan)
  • Marlene García Swider, Regulatory Specialist
  • Julia O'Neill, Principal | Tunnell Consulting
  • Moderated by Timothy Scott, President | Pharmatek

 

4:00 pm

Networking reception

Sponsored by VWR

 

6:00 pm

Day one concludes

 

 

Wednesday 8/26/15

 

7:00 am

Registration opens
Exhibit hall opens

 

8:00 am

Networking breakfast

Sponsored by UPS

 

9:15 am

It's a global search to find the right CRO/CMO

  • David Enloe, President and CEO | Althea
  • John Gregg, President and CEO | BalinBac Therapeutics
  • Brian Mendelsohn, Leader of ADC Chemistry Group | Agensys
  • Nils Olsson, VP Chemistry, Manufacturing, and Controls | Retrophin
  • Nicholas Virca, President & CEO | HedgePath Pharmaceuticals, Inc.
  • Moderated by Jeff Barker, Principal Consultant, Strategic CMC Consulting & Senior Advisor | Rondaxe

 

10:15 am

Networking refreshment break

Sponsored by IriSys

 

11:00 am

Avoid conflict by eliminating these quality agreement mistakes

  • E.J. Brandreth, VP Quality | Inovio Pharmaceuticals
  • Bikash Chatterjee, President and CSO | Pharmatech Associates
  • Julia O'Neill, Principal | Tunnell Consulting
  • Gail Trimble, Director of Quality Assurance | Teva Pharmaceuticals
  • Moderated by Robert Di Scipio, CEO | Skyland Analytics

 

12:00 pm

Networking lunch

Sponsored by Thermo Scientific

 

1:15 pm

Don't let an outsourced supply chain put your business at risk

  • Ray Kaczmarek, VP Commercial Manufacturing & Supply Operations | Pacira Pharmaceuticals
  • Paul Maffuid, VP Pharmaceutical Development and Operations | MabVax Therapeutics
  • Nils Olsson, VP Chemistry, Manufacturing, and Controls | Retrophin
  • Joseph Payne, President and CEO | Arcturus Therapeutics
  • Philip Roberts, VP Technical Operations | Orexigen
  • Moderated by Robin Hooker, Director, Healthcare Marketing | UPS

 

2:15 pm

Networking refreshment break

Sponsored by Alphora Research, Inc.

 

3:00 pm

Protect yourself by building an outsourcing infrastructure

  • Suketu Desai, Principal & Founder | Biotech CMQR Consulting (formerly with Allergan)
  • Michele Johnson, Director, Supplier Relationship Management | Sandoz
  • Ray Kaczmarek, VP Commercial Manufacturing & Supply Operations | Pacira Pharmaceuticals
  • Olivier Laurent, VP Development | Dauntless Pharmaceuticals
  • Kent Pryor, COO | ZZ Biotech
  • Sylvie Sakata, Sr. Director, External Research Solutions West | Pfizer
  • Moderated by John Newsam, CEO | Tioga Research

 

4:00 pm

Conference concludes