[Video] Breakthrough Status: Are You Ready?

In today's featured presentation from TIDES 2014, Jeffrey Baker, Ph.D., Deputy Director, Office of Biotechnology Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration talks about FDA SIA (Safety and Innovation Act). He presents a rundown of this act and talks about NDAs (Non-disclosure agreement), and BLAs (Biologics License Applications). Baker states that FDA SIA has made available a pathway for rapid approval of drugs critical to public health, however companies need to be prepared to manufacture and meet patient needs. Are you ready? For details, watch the presentation:



TIDES 2015 will take place May 3-6, 2015 in San Diego, California.  This year, Ravi S. Harapanhalli, Ph.D., Vice President, Technical, PAREXEL International and Former Branch Chief, Office of New Drug Quality Assessment, US FDA, will be on hand to present Progress in Advancement of RNAi Therapeutics.  For more information about this session and the rest of the program, download the agenda.  As a reader of this blog, when you register to join us and mention code XB15180BLOG, you can save 20% off standard rates.

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Approaching Quality of Biopharmaceutical Manufacturing at the Highest Level

In today's featured interview from Biopharmaceutical Development and Production Week 2014, Jeffrey C. Baker, Ph.D., Deputy Director, Office of Biotechnology Products (OBP), Center for Drug Evaluation and Research, U.S. FDA talks about the challenges in the bio processing industry, the systems based thinking facing the industry and knowledge management, He also looks at the challenges facing the industry, the future of regulation of continuous process validation, He also addresses how global supply chains can help the needs of the patients. Want to learn more?

Watch the interview here:


To hear more exclusive insights from biopharmaceutical production regulators, join us at the 2015 Biopharmaceutical Development and Production Week. It will take place March 30-April 2 in Huntington Beach, California. To receive updates on the program as they occur, sign up for email updates.

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Perspectives on Assessment, Assurance and Drug Quality: Part 2

In today's featured presentation from Biopharmaceutical Development and Production Week 2014, Jeffrey C. Baker, Ph.D., Deputy Director, Office of Biotechnology Products (OBP), Center for Drug Evaluation and Research, U.S. FDA talks about Abbreviated License Pathway for biological products- which rely on “highly similar” FDA product on existing knowledge about the safety, purity, and potency of the reference product. He mentions that as of February 28, 2014, CDER had 62 requests for an initial meeting and how FDASIA makes it criminal to stay silent about counterfeiting or safety related issues.Baker states that the FDA has a focus on quality expectation for clinical performance.

Want to know more? Watch the interview here:


Watch Part 1.

Biopharmaceutical Development and Production Week will take place March 30-April 2, 2015 in Huntington Beach, California.  To get the latest updates on the 2015 program, sign up for email updates.

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Perspectives on Assessment, Assurance and Drug Quality

In today's featured presentation from Biopharmceutical Development and Production Week 2014, Jeffrey C. Baker, Ph.D., Deputy Director, Office of Biotechnology Products (OBP), Center for Drug Evaluation and Research, U.S. FDA talks about the FDA’s work environment is of assurance, assessment, and assertion, the space of assertion that a company has, process validation (making an assertion and being an advocate, in a data driven way),and the many ways to look at quality by using different tools to evaluate it. Baker stated that he believes that design is about providing an experience.

Want to learn more? Watch the first part of the presentation here:


Biopharmaceutical Development and Production Week is will take place March 30-April 2. The agenda will feature more unique insights into the regulations of biopharmaceutical production so be sure to sign up to receive program updates for the 2015 agenda.

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Have You Seen Who is Speaking at BDP Week 2013?

IBC’s Biopharmaceutical Development & Production Week is a Fluid Representation of the Ever-Changing Biopharmaceutical Landscape! And these keynote presenters will share their insights:

Plenary Keynotes:

• - Jeffrey C. Baker, Ph.D., Deputy Director, Office of Biotechnology Products, CDER, U.S. FDA
• - Jonathan Coffman, Ph.D., Associate Research Fellow, Pfizer, Inc. Duncan Low, Ph.D., Scientific Executive Director, Process and Product Engineering, Amgen
• - Yongjick Kim, Ph.D., President, Manufacturing and Technical Operations, Celltrion, Korea
• - Drew Kelner, Ph.D., Executive Director, Global Analytical Sciences, Amgen

Session Keynotes:

• -  DC Characterization from Fred Jacobson, Ph.D., Principal Scientist, Genentech Inc., a member of the Roche Group Thomas
• - Promise of Biosimilars from Vanden Boom, Ph.D., Vice President, Global Biologics Research, Development and Manufacturing Operations, Hospira Inc..
• - Controlling Raw Materials form Rob Gronke, Ph.D, Senior Principal Scientiest, Biogen Idec
• - Integrating Analytics from Mary E.M. Cromwell, Ph.D., Director, Late Stage Pharmaceutical Development, Genentech, a member of the Roche Group
• - Bioproduction Innovation from Abhinav Shukla, Ph.D., Vice President, Process Development and Manufacturing, KBI Biopharma
• - Disruptive Purification Methods from Pete Gagnon, Senior Research Technology Specialist, Bioprocessing Technology Institute, Singapore
• - Drug Substance Fragmentation from E. Morrey Atkinson, Ph.D., Vice President, Process Sciences, Bristol-Myers Squibb

To find out more about these sessions and the rest of the agenda, download the brochure.

Biopharmaceutical Development and Production Week will take place February 25-April 1, 2013 in Huntington Beach, California. As a reader of this blog, when you register to join us and mention code BDP13JP, you’ll save 20% off the standard rate!* If you have any questions about the event, feel free to reach out to Jennifer Pereira.

*This does not apply if you've already registered to join us at BDP Week 2013

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