$1,885 – $5,675

4th Technology Transfer for Biologics (EXL)

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Location

Location

Wyndham Boston Beacon Hill

5 Blossom Street

Boston, MA 02114

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Refund Policy

Refund Policy

No Refunds

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Event description

Description

DESCRIPTION

ExL’s 4th Technology Transfer for Biologics conference is the only educational event in the U.S. to focus on the project, facility, and partnership management skills needed to maintain biologics quality at every step of process transfer and scale-up. No other event covers this subject in as much depth.

This year’s show features an all-new lineup of case studies to help you guarantee the reliability of your supply chain to U.S. and emerging markets, while also accelerating late-stage biologics development and exploring advancements in single-use technologies and commercialization software.

AGENDA

DAY ONE

Monday, October 16, 2017

-8:00AM – 9:00AM

Registration and Continental Breakfast

-9:00AM – 9:15AM

Introduction From Conference Chairperson

-9:15AM – 10:30AM

IN-DEPTH WORKSHOP: Improve the Design of Your Tech Transfers to Eliminate Risks and Accelerate Project Timelines

John Herberger, Chief of Staff, New Product Introductions (API), AMGEN

-10:30AM – 11:00AM

Networking Break

-11:00AM – 12:15PM

Workshop Resumes

-12:15PM – 1:15PM

Luncheon

MAINTAIN QUALITY CONTROL DURING EVERY STEP

-1:15PM – 2:00PM

Ensure Quality of Biologics During Upstream Engineering

Seth Kitchener, Associate Director, Cell Line and Upstream Process Engineering, IMMUNOGEN

-2:00PM – 2:45PM

CASE STUDY: An Overview of Quality by Design (QbD) for Technology Transfers

Emily Xiao, Scientist, BRD Formulation and Stability Platform, SANOFI PASTEUR

-2:45PM – 3:15PM

Networking Break

-3:15PM – 4:00PM

Key Considerations for Safeguarding Biologics During Technical Transfers

Adnan Sabir, QA Associate Director, KOWA PHARMACEUTICALS

-4:00PM – 5:00PM

Transform Development and Manufacturing Paradigms in Drug Product Operations Using Predictive Models

Suresh Nulu, Senior Engineer II, BIOGEN

-5:00PM – 5:00PM

Day One Concludes


Day Two

Tuesday, October 17, 2017

-8:00AM – 9:00AM

Continental Breakfast

-9:00AM – 9:15AM

Chairperson’s Recap of Day One

EFFECTIVE LICENSING, OUTSOURCING, AND PARTNERING

-9:15AM – 10:00AM

CASE STUDY: Improve Biopharmaceutical Licensing to Advance Global Public Health

Steven Ferguson, Special Advisor, NIH OFFICE OF TECHNOLOGY TRANSFER

-10:00AM – 10:45AM

Analyze Hot Topics in Outsourcing, Technology Transfers, and Supply Chains

Pankaj Paranjpe, Director of Biologics Manufacturing-Drug Product, CELGENE
Adam Elhofy, CSO, ESSENTIAL PHARMACEUTICALS
Kumar Dhanasekharan, Senior Director and Head, Biologics Process and Analytical Development, AMICUS THERAPEUTICS

-10:45AM – 11:15AM

Networking Break

-11:15AM – 12:00PM

Considerations for Partnering With CMOs, CDMOs, and Contract Laboratories for Late State Product Development and Future Commercial Manufacturing

Nick Vrolijk, Vice President, Manufacturing Operations, CELLDEX THERAPEUTICS

-12:00PM – 12:45PM

Gain Control of Your Production Timeline for Advanced Development and Manufacturing

Ping Yin, Scientist II, VERTEX PHARMACEUTICALS

-12:45PM – 1:45PM

Luncheon

-1:45PM – 2:30PM

Best Practices to Identify Risks and Streamline Management of Your Technology Transfers

Jose Caraballo, Director, Global Quality Assurance, Biotech, BAYER

-2:30PM – 3:15PM

A Call for Further Guidance on Quality by Design and Process Analytical Technology

Adnan Sabir, QA Associate Director, KOWA PHARMACEUTICALS
Kumar Dhanasekharan, Senior Director and Head, Biologics Process and Analytical Development, AMICUS THERAPEUTICS

-3:15PM – 3:30PM

Chairperson’s Closing Remarks

-3:30PM – 3:30PM

Conference Concludes


FACULTY

Jose Caraballo
Director, Global Quality Assurance, Biotech, BAYER


Kumar Dhanasekharan
Senior Director and Head, Biologics Process and Analytical Development, AMICUS THERAPEUTICS

Adam Elhofy
CSO, ESSENTIAL PHARMACEUTICALS

Steven Ferguson
Special Advisor, NIH OFFICE OF TECHNOLOGY TRANSFER

John Herberger
Chief of Staff, New Product Introductions (API), AMGEN

view speaker profile

Seth Kitchener
Associate Director, Cell Line and Upstream Process Engineering, IMMUNOGEN

Suresh Nulu
Senior Engineer II, BIOGEN

Pankaj Paranjpe
Director of Biologics Manufacturing-Drug Product, CELGENE

Adnan Sabir
QA Associate Director, KOWA PHARMACEUTICALS

Nick Vrolijk
Vice President, Manufacturing Operations, CELLDEX THERAPEUTICS

Emily Xiao
Scientist, BRD Formulation & Stability Platform, SANOFI PASTEUR


Ping Yin
Scientist II, VERTEX PHARMACEUTICALS


SPONSORS


ProPharma Group



PARTNERS


Association of Clinical Research Professionals (ACRP)

Big3Bio

MEDtube

PharmaLeaders

pharmaphorum.com

PharmaVOICE

PM360

Technology Networks

Technology Networks is an internationally recognised publisher that provides access to the latest scientific news, products, research, videos and posters. Our global community is made up of over 300,000 researchers and scientific professionals from the life science, drug discover and analytical arenas.

Website: http://www.TechnologyNetworks.com


Please contact the event manager Marilyn below for the following:
- Discounts for registering 5 or more participants.
- If you company requires a price quotation.
Event Manager Contact: marilyn.b.turner(at)nyeventslist.com
You can also contact us if you require a visa invitation letter, after ticket purchase.
We can also provide a certificate of completion for this event if required.

NO REFUNDS ALLOWED ON REGISTRATIONS
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Date and Time

Location

Wyndham Boston Beacon Hill

5 Blossom Street

Boston, MA 02114

View Map

Refund Policy

No Refunds

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