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Past Events: San Francisco 2016

November 1-2, 2016
Hyatt Regency San Francisco Airport

 

Produced by Life Science Leader, Biocom
Supported by Outsourced Pharma, Rondaxe, ISR Reports

 

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San Francisco 2016
San Francisco 2016

  • Sponsors

     

    Bio-Rad
    Dottikon
    Fisher Scientific
    Solvias
    Tepnel Pharma Services

    Exhibiting sponsors:
    Alcami
    Almac Group
    Althea CMO
    Amatsigroup
    AMRI
    Ash Stevens
    Avara Pharmaceutical Services
    Avista Pharma Solutions
    Axcellerate Pharma, LLC
    B. Braun
    Berkshire Sterile Manufacturing
    Boehringer Ingelheim Biopharmaceuticals GmbH
    Cambrex
    Capsugel
    Catalent Pharma Solutions
    CMC Biologics
    CordenPharma
    Cytovance Biologics
    DavosPharma
    EAG Laboratories
    Emergent BioSolutions
    Eurofins Advantar Laboratories, Inc.
    Fareva
    Fermion Oy and Orion Corporation
    Flamma S.p.A.
    FUJIFILM Diosynth Biotechnologies
    Hetero USA
    Hovione
    IDBS
    Lifecore Biomedical
    Lonza
    Metrics Contract Services
    Paragon Bioservices
    PCAS
    PCI Pharma Services
    PCI Synthesis
    Pfanstiehl, Inc.
    Pfizer CentreOne
    Pharmasol Corporation
    Ricerca Biosciences
    Rondaxe
    Science Exchange
    Sherpa Clinical Packaging
    Siegfried USA, LLC.
    Solid Form Solutions
    SynConnection
    Tepnel Pharma Services
    Therapure Biopharma
    Toxikon Corporation
    Triclinic Labs
    Unither Pharmaceuticals
    Wacker
    XiltriX
    Yourway Transport

     

  • Speakers

     

    Achaogen | Tina Larson, VP Technical Operations
    ADC Therapeutics | Michael Mulkerrin, VP, Head of CMC
    Althea | David Enloe, President & CEO
    Amgen | Margaret Faul, Executive Director
    Amgen | Alekhya Gummaregula, Senior Project Manager - CMC Lifecycle Management
    Amgen | Rod MacLea, Director Supply Chain
    Anthera | Umar Hayat, Sr. Dir. Pharmaceutical Development, Manufacturing & Supply Chain
    Biotechnology Innovation Organization (BIO) | John McSherry, 2017 Program Committee
    Dermira | Sriram Naganathan, Senior Director Chemical Development
    FibroGen | Mike Thompson, Senior Director, Chemical Development
    FLAG Therapeutics | Frank Sorgi, President & CEO
    Hercules Technology Growth Capital | Himani Bhalla, Principal
    IDBS | Scott Weiss, VP Product Strategy
    Intarcia Therapeutics | Prem Ramiya, ED API Synthesis & Formulation Development
    Launch Pad Central | Sheila Babnis, Innovator In Residence, Advisory Board
    Medivation | Thomas Templeman, SVP Pharmaceutical Operations
    MyoKardia, Inc. | Louis Sehl, Executive Dir. Manufacturing & Technical Operations
    OutsourcedPharma.com | Louis Garguilo, Chief Editor
    Pfizer | Bernie Huyghe, Senior Director
    Pfizer | Judy Chou, VP Pharmaceutical Operations
    Pharmatech Associates | Bikash Chatterjee, President & CSO
    Pharmatek Laboratories | Timothy Scott, President
    Rondaxe | Ken Shultis, CEO
    Science Exchange, Y Combinator | Elizabeth Iorns, Co-Founder and CEO, Part-time Partner
    Skyland Analytics | Joe Rothman, VP Compliance & Services
    Triclinic Labs | Shawn Comella, CEO
    Tunnell Consulting | Julia O'Neill, Principal
    Unither Pharmaceuticals | Kevin Haehl, General Manager North America
    Verizon | Thomas Villa, Head of Enterprise Product Management
    XenoPort | Sami Karaborni, VP Development Operations

     

  • Agenda

Drug development and manufacturing outsourcing in an era of technology

 

Tuesday 11/1/16

 

7:00 am

Registration Opens

8:00 am

Exhibit Hall Opens, Networking Breakfast

9:00 am

Welcome / Conference Chair Opening Remarks

9:15 am

Pharma’s invitation to “innovation partners” in the outsourced supply chain

Defining “innovation” in outsourcing of drug development and manufacturing
Pharma/Bio discuss their ideal technology and innovation partners in drug development and manufacturing
What new technology service providers are entering the supply chain?
How can CMOs become more innovative – or are they actually already?

 

  • Panelists:
    Bernie Huyghe, Sr. Director | Pfizer
    Tina Larson, VP Technical Operations | Achaogen
    Rod MacLea, Director Supply Chain | Amgen
    David Enloe, President and CEO | Althea CMO
    Louis Garguilo, Chief Editor | Outsourced Pharma (Moderator)

10:15 am

Networking Refreshment Break

11:00 am

A view from afar: Silicon Valley on drug development and manufacturing

Technology companies provide analysis – visions and solutions – for improving aspects of the outsourced drug development and manufacturing continuum
Examples of how the technologies of today are already serving the bio/pharma industry
Questions from Tech companies for the bio/pharma industry

 

  • Panelists:
    Thomas Villa, Head of Enterprise Product Management | Verizon
    Elizabeth Iorns, Founder and CEO, Part-time Partner | Science Exchange, Y Combinator
    Himani Bhalla, Principal | Hercules Technology Growth Capital
    Scott Weiss, VP Product Strategy | IDBS
    Louis Garguilo, Chief Editor | Outsourced Pharma (Moderator)

12:00 pm

Networking Lunch

Sponsored by Bio-Rad

 

1:15 pm

Bridging cultures: Sponsors, CMOs, Tech … and Millennials

How can all parties learn the same language, bridge cultural chasms, and bring an innovation revolution to bio/pharma’s external development and manufacturing industry
Outsourcing renewed: Some ideas from younger members of our industry

 

  • Panelists:
    Alekhya Gummaregula, Sr. Project Manager - CMC Lifecycle Management | Amgen
    Prem Ramiya, ED API Synthesis & Formulation Development | Intarcia Therapeutics
    Sheila Babnis, Innovator In Residence, Advisory Board | Launch Pad Central
    Joe Rothman, VP Compliance & Services | Skyland Analytics
    Louis Garguilo, Chief Editor | Outsourced Pharma (Moderator)

2:15 pm

Networking Refreshment Break

3:00 pm

Short stories on outsourcing innovation

Panelists and the audience provide and discuss their real-world examples of sponsors and providers teaming up to advance drug development and manufacturing - be sure to have your OP Events app open!

 

  • Panelists:
    Judy Chou, VP Pharmaceutical Operations | Pfizer
    Michael Mulkerrin, VP, Head of CMC | ADC Therapeutics
    Shawn Comella, CEO | Triclinic Labs
    Louis Garguilo, Chief Editor | Outsourced Pharma (Moderator)

4:00 pm

Networking Reception

Sponsored by Fisher Scientific

 

6:00 pm

Day One Concludes

 

Wednesday 11/2/16

 

7:00 am

Registration Opens

8:00 am

Exhibit Hall Opens, Networking Breakfast

9:15 am

Data deluge: Has the tech disruption started?

Creating higher “Supply Chain Visibility”
Can we learn to manage supply chain data and optimization from other industries?
How does more data help optimize innovation in the supply chain

 

  • Panelists:
    Margaret Faul, Executive Director | Amgen
    Sriram Naganathan, Sr. Director Chemical Development | Dermira
    Louis Sehl, Executive Dir. Manufacturing & Technical Operations | MyoKardia, Inc.
    Ken Shultis, CEO | Rondaxe
    John McSherry, 2017 Program Committee | Biotechnology Innovation Organization (BIO) (Moderator)

10:15 am

Networking Refreshment Break

11:00 am

Quality and the FDA in an era of tech transformation

The FDA and the idea of “innovation” in drug development and manufacturing
Do we hide behind “compliance” and “regulatory bodies”?
What do the Quality professionals have to say on advancing innovation?

 

  • Panelists:
    Thomas Templeman, SVP Pharmaceutical Operations | Medivation
    Mike Thompson, Sr. Director, Chemical Development | FibroGen
    Bikash Chatterjee, President & CSO | Pharmatech Associates
    Shawn Comella, CEO | Triclinic Labs
    Julia O'Neill, Principal | Tunnell Consulting (Moderator)

12:00 pm

Networking Lunch

Sponsored by Tepnel Pharma Services

 

1:15 pm

We’ve already been innovative: Continuous manufacturing, single-use equipment, new development platforms

A look at some of the innovations already in our supply chain
Whose idea was it? Where did the innovation and new technology come from? Is there a model for replication?

 

  • Panelists:
    Judy Chou, VP Pharmaceutical Operations | Pfizer
    Umar Hayat, Sr. Dir. Pharmaceutical Development, Manufacturing & Supply Chain | Anthera
    Sami Karaborni, VP Development Operations | XenoPort
    Kevin Haehl, General Manager North America | Unither Pharmaceuticals
    Timothy Scott, President | Pharmatek Laboratories (Moderator)

2:15 pm

Networking Refreshment Break

3:00 pm

Future shock: Our age of outsourcing enters the era of technology

An open discussion on what we can strive for in the next three years to create more supplier innovation
How can sponsors incentivize all their service providers in the supply chain to adopt a culture of innovation?
What role – or anchor – will regulations play?

 

  • Panelists:
    Bernie Huyghe, Sr. Director | Pfizer
    Michael Mulkerrin, VP, Head of CMC | ADC Therapeutics
    Frank Sorgi, President & CEO | FLAG Therapeutics
    Timothy Scott, President | Pharmatek Laboratories
    John McSherry, 2017 Program Committee | Biotechnology Innovation Organization (BIO) (Moderator)

4:00 pm

Conference Concludes