Past Event

4th Technology Transfer for Biologics (EXL)

16–17 October 2017
5 Blossom Street Boston, MA 02114, United States
 

4th Technology Transfer for Biologics (EXL)


Mon, Oct 16, 2017, 8:00 AM –
Tue, Oct 17, 2017, 5:00 PM EDT


Wyndham Boston Beacon Hill
5 Blossom Street
Boston, MA 02114
United States


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


SPONSORS
ProPharma Group - sponsors 4th Technology Transfer for Biologics


PARTNERS


Association of Clinical Research Professionals (ACRP)

ACRP supports clinical research professionals through membership, a broad array of training and development tools, and certification. Founded in 1976, ACRP is a Washington, DC-based nonprofit organization with more than 13,000 members who work in clinical research in more than 70 countries. ACRP’s vision is that clinical research is performed ethically, responsibly, and professionally everywhere in the world. ACRP’s mission is to promote excellence in clinical research.

Website: https://www.acrpnet.org/
Big3Bio

Big3Bio is the leading aggregator service for the top three life science hubs in the world: Boston, San Diego, and the San Francisco Bay Area. Big3Bio’s newsletters and additional channels provide complete, daily coverage of the news, events, jobs, and developments in these regions to the industry’s top professionals and executives. Subscribe to the Big3Bio newsletters at www.big3bio.com.

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