Upcoming program agendas

Participants have described our sessions as “electric.” High energy comes from the earnest (and yes, sometimes heated, but always civil) discussions. We dive into everything from new FDA regulations and tech-transfer best practices, to the competition between outsourcing in the East and West … and the very future of the industry.

See what we have planned for our upcoming programs!

Boston 2017 Other Programs

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Boston 2017 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, Head of Biologics, Drug Substance External Quality | Roche Genentech
    Piet Houwen, Head of Contract Manufacturing Operations | Sanofi Genzyme
    Evan Guggenheim, Sr. Mgr., Technical Development | Biogen
    Thomas Holmes, Senior Director for Global External Manufacturing | Biogen
    Shawn Kinney, CEO | Berkshire Sterile Manufacturing
    Barbara Berglund, COO | CMC Turnkey Solutions (Moderator)

10:15 am

Networking Refreshment Break

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 of Project Management | Metrics Contract Services
    Naomi Seresinhe, VP of 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
    Mathew 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’Neil, 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 Technology
    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
    BJ Hull, VP/GM | Emergent BioSolutions
    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 bio-pharmaceutical 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 for 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 Chair Closing Remarks

4:15 pm

Conference Concludes

* Agenda and panelists subject to change.

Other 2017 Programs

Looking for more information on our education programs? View agendas from our previous six programs.

San Diego

Tuesday 8/22/17 & Wednesday 8/23/17

Program details to be announced by Q2 2017.

 

San Francisco

Tuesday 10/17/17 & Wednesday 10/18/17

Program details to be announced by Q3 2017.