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Past Events: Boston 2017

April 26-27, 2017
Boston Park Plaza

 

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

 

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Boston 2017
Boston 2017

  • Sponsors

     

    Capsugel
    Fermion OY, Orion Group
    Life Science Training Institute
    LuinaBio Pty Ltd.
    Pfizer CentreOne
    Solvias
    Sterling Pharma Solutions, Ltd.
    Symbiosis Pharmaceutical Services



  • Exhibiting sponsors:

    Adesis, Inc.
    Albemarle
    Alcami Corporation
    Almac
    Althea CMO
    AMRI
    Ascendia Pharmaceuticals
    Ash Stevens
    Avara Pharmaceutical Services
    Avista Pharma Solutions
    B. Braun Medical OEM
    Berkshire Sterile Manufacturing
    BioDuro
    Cambrex Corporation
    Cardinal Health
    Capsugel
    CMC Biologics
    CordenPharma
    Corning
    Cytovance Biologics
    Dottikon ES America, Inc.
    Emergent Biosolutions
    Eurogentec S.A.
    Fareva
    FUJIFILM Diosynth Biotechnologies
    Genovior Biotech Corp.
    Halo Pharmaceutical, Inc.
    Korber Medipak 
    LSNE
    Masy BioServices
    Metrics Contract Services
    Paragon Bioservices
    Patheon
    PCI Pharma Services
    PCI Synthesis
    PharmAssist Analytical Laboratory
    Pharmatech Associates
    Quotient Clinical
    Ricerca
    Richter-Helm BioLogics
    Rondaxe
    SafeBridge Consultants, Inc.
    SGS Life Sciences
    Sharp Packaging Solutions
    Sherpa Clinical Packaging
    Solid Form Solutions
    SynConnection
    Tepnel Pharma Services
    Triclinic Labs
    Unither Pharmaceuticals
    UPM Pharmaceuticals
    Vetter
    Wacker Biotech GmbH
    WuXi AppTec

     

  • Speakers

     

    Agios Pharmaceuticals | Bob Sheroff, SVP, Technical Operations
    AMAG Pharmaceuticals | James Lucie, Associate Director
    Amgen | Thao Nguyen, Project Manager, Global Operations CMCi
    Berkshire Sterile Manufacturing | Shawn Kinney, CEO
    Biogen | Tobias Blackburn, Supervisor, Technical Development
    Biogen | Evan Guggenheim, Sr. Manager, Technical Development
    Biogen | Thomas Holmes, Sr. Dir., Global External Manufacturing
    Biogen | Clive Patience, VP, Asset Development & Program Management
    Biogen | Patrick Soares, Sr. Director, External Manufacturing
    Boston Institute of Biotechnology | Peng Jiao, CEO
    Boston Institute of Biotechnology | Jared Kaufman, Associate Scientist
    Bristol-Myers Squibb | Keirnan LaMarche, Senior Research Investigator
    CMC Turnkey Solutions | Barbara Berglund, COO
    Cytovance | Naomi Seresinhe, VP, Program Management
    Eli Lilly and Company | Mark Butchko, Sr. Dir., QA - Development
    Fortress Biotechnology | George Avgerinos, SVP, Biologics Operations
    Freedom Bioscience Partners | Brian Scanlan, Managing Partner
    Genentech | Todd Mabe, Head, Biologics, Drug Substance
    Johnson & Johnson | Milan Shah, Head, Publishing, Global Capabilities IDAR
    Latham Biopharma | Susan Dexter, Managing Director
    MedImmune
    | Steve Cook, Head, Global Biologic Supply Chain Ops.
    Merck | Anand Ekambaram, Executive Director, Global Technical Operations
    Merck | Pamela Rizos, Associate Director, Regulatory Affairs
    Merck | Kurt Wolf, Director
    Metrics Contract Services | Charles Waldroup, Director, Project Management
    Outsourced Pharma | Louis Garguilo, Conference Chair & Chief Editor
    Patheon | Franco Negron, President, Drug Product Services
    Rondaxe | Brian James, SVP, Operations
    Sanofi Genzyme | Piet Houwen, Head, Contract Manufacturing Operations
    Snapdragon Chemistry | Matthew Bio, President and CEO
    Sunovion Pharmaceuticals | Vince Kosewski, VP, Supply Chain Operations
    Tunnell Consulting | Julia O'Neill, Principal
    Vertex Pharmaceuticals | Michelle Bailey, Assoc. Dir., Validation Continuous Manufacturing
    Xenetic Biosciences | Henry Hoppe, VP, Drug Development

 

  • Agenda


    A summit on modern-day drug development and manufacturing outsourcing

     

    Wednesday 4/26/17

     

    8:00 am

    Registration and Exhibit Hall open, Networking Breakfast

    9:00 am

    Welcome / Conference Chair Opening Remarks

    9:15 am

    Learning to fly: How to support incremental innovative solutions

    New drug delivery platforms and devices, digital solutions and knowledge management systems, evolving immunotherapies, changes in the design and operation of facilities, evolving and developing CMO skillsets: incremental innovations like these need to be supported throughout your supply chain. Here’s a discussion on how to break down “innovation” into practical applications and best practices for drug developers and service providers.

     

    • Panelists:
      Todd Mabe, Director, Drug Substance Quality | Merck
      Piet Houwen, Head, Contract Manufacturing Operations | Sanofi Genzyme
      Evan Guggenheim, Sr. Mgr., Technical Development | Biogen
      Thomas Holmes, Senior Director, Global External Manufacturing | Biogen
      Shawn Kinney, CEO | Berkshire Sterile Manufacturing
      Barbara Berglund, COO | CMC Turnkey Solutions (Moderator)

    10:15 am

    Networking Refreshment Break

    Sponsored by Capsugel

    11:00 am

    Buyer’s or seller’s market? The truth about capacity and your supply chain needs

    Everyone seems concerned about capacity – for large and “the right kind of” small molecule. Today, you can’t just determine how much drug substance or product you need, and contact a CMO. You need to understand where and how much capacity is available for your specific projects, and when to start planning to secure it. This panel will dive into best practices on forecasting and managing capacity and strategies for working with CMOs.

     

    • Panelists:
      Vince Kosewski, VP, Supply Chain Operations | Sunovion Pharmaceuticals
      Bob Sheroff, SVP, Technical Operations | Agios Pharmaceuticals
      Steve Cook, Head, Global Biologic Supply Chain Ops | MedImmune
      Anand Ekambaram, Executive Director, Global Technical Operations | Merck
      Franco Negron, President, Drug Product Services | Patheon
      Brian Scanlan, Managing Partner | Freedom Bioscience Partners (Moderator)

    12:00 pm

    Networking Lunch

    Sponsored by Fermion

     

    1:15 pm

    Project Managers from the frontlines: Avoiding the worst battles

    Ever wonder what’s really happening during the management of your outsourced drug development and manufacturing projects? A panel of professionals from the frontlines of managing a variety of projects and service-provider relationships will complete this sentence for you: We could shorten timelines, improve reliability, and save you money if we could only ______________.

     

    • Panelists:
      Milan Shah, Head, Publishing, Global Capabilities IDAR | Johnson & Johnson
      Pamela Rizos, Associate Director, Regulatory Affairs | Merck
      James Lucie, Associate Director | AMAG Pharmaceuticals
      Charles Waldroup, Director, Project Management | Metrics Contract Services
      Naomi Seresinhe, VP, Program Management | Cytovance
      Thao Nguyen, Project Manager Global Operations CMCi | Amgen
      Barbara Berglund, COO | CMC Turnkey Solutions (Moderator)

    2:15 pm

    Networking Refreshment Break

    3:00 pm

    Spotlight technology: Continuous manufacturing and its broadest impacts

    A detailed look at where we are, and what you might be missing regarding the full potential and impacts of continuous manufacturing on your entire approach to developing new medicines. Learn how your supplier network, and web of decision-making, is going to change.

     

    • Panelists:
      Keirnan LaMarche, Senior Research Investigator 1 | Bristol-Myers Squibb
      Michelle Bailey, Assoc. Dir., Validation Continuous Manufacturing | Vertex Pharmaceuticals
      Matthew Bio, President and CEO | Snapdragon Chemistry
      Susan Dexter, Managing Director | Latham Biopharma (Moderator)

    4:00 pm

    Networking Reception

    Sponsored by Pfizer Centre One

     

    6:00 pm

    Day One Concludes

     

    Thursday 04/27/17

    7:00 am

    Registration Opens

    8:00 am

    Exhibit Hall Opens, Networking Breakfast

    9:15 am

    FDA, regulatory, and quality dynamics for innovative outsourcing

    The FDA – and our entire system for drug approval – should feel more like a partner for the advancement of innovation and technology. Instead of using the FDA as a reason not to innovate, we’ll present some cues for working supportively. Topics will include moving from Quality to Integrated Risk Management, and how drug owners can team up with outsourcing partners.

     

    • Panelists:
      Henry Hoppe, VP, Drug Development | Xenetic Bioscience
      Mark A. Butchko, Ph.D., Senior Director – QA, Product Research & Development | Eli Lilly and Company
      Peng Jiao, CEO | Boston Institute of Biotechnology
      Julia O’Neill, Principal | Tunnell Consulting (Moderator)

    10:15 am

    Networking Refreshment Break

    11:00 am

    Winning workforce: A new generation in the supply chain

    Look around your company (or in the mirror). Is there a successful changing of the guard? How can you benefit from – and make our outsourcing industry attractive to – the best of a new generation? They learn differently; they may actually be better at working with – or at – supply chain partners. We’ll get perspectives from younger members of our industry, and those of you trying to hire and mentor them.

     

    • Panelists:
      Evan Guggenheim, Senior Manager, Technical Development | Biogen
      Tobias Blackburn, Supervisor, Technical Development | Biogen
      Pamela Rizos, Associate Director, Regulatory Affairs | Merck
      Kurt Wolf, Director, Externalization | Merck
      Peng Jiao, CEO | Boston Institute of Biotechnology
      Jared Kaufman, Associate Scientist | Boston Institute of Biotechnology
      Julia O'Neill, Principal | Tunnell Consulting (Moderator)

    12:00 pm

    Networking Lunch

    1:15 pm

    Costs and price pressures rise ... best efforts not withstanding

    Smarter procurement procedures, streamlined supply chains, improved partnerships … despite these efforts and some good results, our costs to develop and manufacture drugs still seems to go up, while the pressure to reduce drug prices rises. Your CEO – and society – is looking for maximum efficiency from all parts of your business. This panel helps you to take a hard look at the structural, systematic and other financial inputs into your outsourcing.

     

    • Panelists:
      Vince Kosewski, VP, Supply Chain Operations | Sunovion Pharmaceuticals
      George Avgerinos, Sr. VP, Operations | Fortress Biotechnology
      Susan Dexter, Managing Director | Latham Biopharm
      Anand Ekambaram, Executive Director, Global Technical Operations | Merck
      Brian James, SVP Operations | Rondaxe Pharma (Moderator)

    2:15 pm

    Networking Refreshment Break

    3:00 pm

    Manufacturing Strategy: How Biogen positions outsourcing & partnering as a foundational element of its network

    Hear from leaders within Biogen’s Pharmaceutical Operations & Technology organization on how to develop a comprehensive strategic framework to develop, manufacture, and deliver biopharmaceutical products that create value for patients, employees, and shareholders. Key themes in the discussion will include: How to evaluate what is strategic, core and commodity; key factors in selecting CMO’s / partners; role of sourcing procurement; redundancy & risk factors; strategic relationship management principles and key resourcing considerations.

     

    • Panelists:
      Thomas Holmes, Sr. Director, Global External Manufacturing | Biogen
      Clive Patience, VP, Asset Development & Program Management | Biogen
      Patrick Soares, Sr. Director, External Manufacturing | Biogen
      Louis Garguilo, Chief Editor & Conference Chair | Outsourced Pharma (Moderator)

    4:00 pm

    Conference Concludes