2nd Technology Transfer for Biologics

Start

Mon, 5 Oct 2015, 08:00

End

Tue, 6 Oct 2015, 09:00

WebSite

http://exlevents.com/2nd-technology-transfer-for-biologics

Venue:

Once you have established biologic efficacy and safety in early clinical material, your company’s real challenges are only beginning. Replicating the synthesis and bioanalysis of your biologic at different settings and among licensing or manufacturing partners introduces the risk of facility-based errors. And in order to commercialize your biologic, production volumes must be upscaled so intensely that new problems not encountered at smaller clinical volumes may severely hinder your timelines.

ExL Events’ 2nd annual Technology Transfer for Biologics conference recognizes that every instance of technology transfer succeeds or fails based on transparency of communications and the skill of the project manager. Exclusive case studies from industry leaders can help you guarantee biologic quality and accelerate to commercial stages after method transfer. No other event focuses so specifically on the essential skill sets required for team-based biologics quality assurance during and after method transfer!

Exhibit

Symposia

Workshops

Organiser

Sponsor

Programme Highlights

Leverage Analytical Technology Platforms to Accelerate Product and Process Development and to Mitigate Risks Associated with Technical Transfer
Modify Pipelines to Adjust to New Molecules
CASE STUDY: The Upstream Perspective for Technology Transfer of Novel Molecules
CASE STUDY: Special Considerations for Downstream Novel Molecule Tech Transfer
Plan for Technology Transfer and Scale-Up of a Biosimilar Cell Culture Manufacturing Process
Clarify Techniques to Accommodate Higher Densities and Titers for Uptream-to-Downstream Transfers and Upscaling

Top Five Reasons to Attend

In-depth examination of the proper tech transfer methods for antibody-drug conjugates, biosimilars, and other new molecules
Case studies illustrating how to maintain product purity during upscaling
Analysis of the best approaches for rapid technology transfer acceleration
Review of the ideal skill sets and leadership styles of tech transfer project managers
Detailed discussion of the equipment standardization exercises and process models that safeguard biologics quality

Who Should Attend

Pharmaceutical, biotech and medical device professionals responsible for:

Technology Transfers
Method Development/Method Transfers
Technical Operations
Technical Science
Bioprocessing
Manufacturing/Biomanufacturing
Process Development
Quality Control/Quality Assurance

Upscaling
Facilities
CMC
Biologics Outsourcing
Biologics Strategy
Process Sciences
Upstream
Vendor Management/Supply Chain

This event may also be of interest to:

CROs
CMOs
Aseptic Fill-Finish Vendors
Quality Control Specialists
Cell Culture Suppliers/Managers

Central Labs
Regulatory Consultants
Supply Chain Facilitators
Lab Hardware Designers
Facility Designers

Registration Details

Click here to Register.

Pricing

STANDARD RATE — Register after August 21, 2015

	Price
Conference Only	$2,095

ONSITE RATE

	Price
Conference Only	$2,195

*Includes Sales Tax and Service Fees

GROUP DISCOUNT PROGRAMS:

*Offers may not be combined. Early Bird rates do not apply.*

SAVE 25%
For every three simultaneous registrations from your company, you will receive a fourth complimentary registration to the program (must register four). A savings of 25% per person.

SAVE 15%
Can only send three? You can still save 15% off of every registration. To find out more on how you can take advantage of these group discounts, please call 212-400-6240.

TERMS AND CONDITIONS:

By registering for an ExL Events, Inc. (“ExL”) event, you agree to the following set of terms and conditions listed below:

REGISTRATION FEE:

The fee includes the conference‚ all program materials‚ and designated continental breakfasts‚ lunches and refreshments.

PAYMENT:

Make checks payable to ExL Events, Inc. and write C623 on your check. You may also use Visa, MasterCard, Discover or American Express. Payments must be received in full by the conference date. Any discount applied cannot be combined with any other offer and must be paid in full at the time of order. Parties must be employed by the same organization and register simultaneously to realize group discount pricing options.

**Please Note: There will be an administrative charge of $300 to substitute, exchange and/or replace attendance badges with a colleague within five business days of any ExL conference.**

CANCELLATION AND REFUND POLICY:

If you cancel your registration for an upcoming ExL event, the following policies apply, derived from the Start Date of the event:

Four weeks or more: A full refund (minus a $295 processing fee) or a voucher to another ExL event valid for 12 months from the voucher issue date.
Less than four weeks: A voucher to another ExL event valid for 12 months from the voucher issue date.
Five days or less: A voucher (minus a $395 processing and documentation fee) to another ExL event valid for 12 months from the voucher issue date.

To receive a refund or voucher, please email [email protected] or fax your request to 888-221-6750.

Main Conference Day 1

MONDAY, OCTOBER 5, 2015: DAY ONE

8:00AM – 8:45AM	Registration and Continental Breakfast
8:45AM – 9:00AM	Chairperson’s Opening Remarks Brandon Christensen,*Manager, Biopharmaceutical Tech Transfer and Manufacturing Support,MEDIMMUNE*

NEW MOLECULES AND NEW ENVIRONMENTS FOR TECH TRANSFER

9:00AM – 9:45AM	Leverage Analytical Technology Platforms to Accelerate Product and Process Development and to Mitigate Risks Associated with Technical Transfer Hemant Kumar,*Senior Director, Quality,GENZYME*
9:45AM – 10:30AM	Modify Pipelines to Adjust to New Molecules Vincent Turula,*Director, Biotherapeutics Outsourcing Management,PFIZER*
10:30AM – 11:00AM	Networking Break
11:00AM – 11:45AM	CASE STUDY: The Upstream Perspective for Technology Transfer of Novel Molecules Mark Meyers,*Manager, R&D,MEDIMMUNE*
11:45AM – 12:30PM	CASE STUDY: Special Considerations for Downstream Novel Molecule Tech Transfer Brandon Christensen,*Manager, Biopharmaceutical Tech Transfer and Manufacturing Support,MEDIMMUNE*
12:30PM – 1:30PM	Luncheon
1:30PM – 2:15PM	Plan for Technology Transfer and Scale-Up of a Biosimilar Cell Culture Manufacturing Process Brett Belongia,*Associate Director, Biologics Development,MOMENTA*
2:15PM – 3:00PM	Clarification Techniques to Accommodate Higher Densities and Titers for Uptream-to-Downstream Transfers and Upscaling Blanca Lain,*Senior Scientist II, Process and Manufacturing Sciences,ELEVEN BIOTHERAPEUTICS*
3:00PM – 3:30PM	Networking Break

PARTNERSHIPS, PROJECT MANAGEMENT AND PREPARATION FOR TECH TRANSFER

3:30PM – 4:15PM	Build Modeling Tool Kits to Facilitate Process Adaptation and Technology Transfer Zheng Huang,*Senior Manager, Global Manufacturing Science and Technology,GENZYME*
4:15PM – 5:00PM	Emphasize Communication and Transparency in Project Manager Skill Sets John Bowers,*Senior Principal Scientist, Biopharmaceutical Engineering,MERCK*
5:00PM – 5:00PM	End of Day One

Main Conference Day 2

TUESDAY, OCTOBER 6, 2015: DAY TWO
8:00AM – 8:45AM	Registration and Continental Breakfast
8:45AM – 9:00AM	Chairperson’s Recap of Day One Brandon Christensen,*Manager, Biopharmaceutical Tech Transfer and Manufacturing Support,MEDIMMUNE*
9:00AM – 9:45AM	Process Fit To Plant Impact on Process Development Life Cycle Management, Equipment Standardization and CMC Success Amos Tsai,*Principal Scientist,JOHNSON & JOHNSON*
9:45AM – 10:30AM	Ensure Early QA Involvement and the Use of Quality Improvement Tools to Increase the Likelihood of Tech Transfer Success Amnon Eylath,*Senior Director, Quality Assurance,GENZYME*
10:30AM – 11:00AM	Networking Break
11:00AM – 11:45AM	Balance the Risks, Specializations and Standardizations Required to Execute an 8-Week Tech Transfer Tracy Ahrens,*Tech Transfer Leader,BIOGEN*
11:45AM – 12:30PM	Build a Decision Tree that Optimizes Flexibility and Speed in Technology Transfer Fauad Hasan,*Director, CMC Teams,ALLERGAN*
12:30PM – 1:30PM	Luncheon
1:30PM – 2:15PM	Advance from Legacy Product Standards to Next-Generation Processes Gene Mehr,*Senior Engineer II,BIOGEN*
2:15PM – 3:00PM	Build a Sense of Investment in Team Members to Avoid Information Slowdowns Venkat Koganti,*Associate Director, Formulation and Process Development,CELSION CORPORATION* Jenna Carlson,*Senior Technical Manager,GENENTECH*
3:00PM – 3:00PM	End of Conference