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Boston 2017

April 26-27, 2017 | Boston Park Plaza

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Produced by: Life Science Leader
Supported by: OutsourcedPharma.com, Rondaxe, ISR Reports


Sponsors

Capsugel

Fermion OY, Orion Group

Life Science Training Institute

LuinaBio Pty Ltd.

Pfizer CentreOne

Solvias 

Sterling Pharma Solutions, Ltd.

Symbiosis Pharmaceutical Services

 

Exhibitors

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


Agenda

Tuesday 4/26/17

Registration and Exhibit Hall open, Networking Breakfast

8:00AM

Welcome & Conference Chair Opening Remarks

9:00AM

Learning to fly: How to support incremental innovative solutions

9:15AM

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.

  • 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)

Networking Refreshment Break

10:15AM

Sponsored by Capsugel

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

11:00AM

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.

  • 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)

Networking Lunch

12:00PM

Sponsored by Fermion

Project Managers from the frontlines: Avoiding the worst battles

1:15PM

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 ______________.

  • 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)

Networking Refreshment Break

2:15PM

Spotlight technology: Continuous manufacturing and its broadest impacts

3:00 pm

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.

  • 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)

Networking Reception

4:00PM

Sponsored by Pfizer Centre One

Day One Concludes

6:00PM


Wednesday, 4/27/17

Exhibit Hall Opens, Networking Breakfast

8:00AM

Conference Chair Day Two Opening Remarks

9:00AM

FDA, regulatory, and quality dynamics for innovative outsourcing

9:15AM

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.

  • 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)

Networking Refreshment Break

10:15AM

Winning workforce: A new generation in the supply chain

11:00AM

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.

  • 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)

Networking Lunch

12:00PM

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

1:15PM

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.

  • 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)

Networking Refreshment Break

2:15PM

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

3:00 pm

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.

  • 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)

Conference Chair Closing Remarks

3:50PM

Conference Concludes

4:00PM

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