Where can you hear FDA Perspectives this Fall?

At IBC’s 17th Annual Well Characterized Biologicals conference this October in Washington DC, you’ll meet and hear from multiple FDA regulators who provide you guidance to achieve success in your protein characterization and comparability efforts. We’ll help you understand all of the emerging regulatory/FDA guidances so that you can plan ahead and gain an advantage over your competitors

Hear FDA Perspective on Characterizing Biological Products

Gain an update on the US biosimilars program from Jeffrey Baker, Ph.D., Deputy Director of Biotechnology Products of CDER FDA. Obtain the latest updates on the emerging technical considerations to assure that your biosimilar products are safe and effective.

Hear regulatory considerations in the safety assessment of vaccine adjuvants and adjuvanted vaccines from Carmen Collazo-Custodio, Ph.D., Microbiologist and Primary Reviewer in the Division of Vaccines and Related Product Applications, CBER FDA. Regulatory considerations for the nonclinical and clinical safety evaluation of investigational vaccines containing novel adjuvants will be discussed.

Limit the amount of particulates in your protein therapeutics and ensure product consistency with Ewa Marszal, Ph.D., Chemist in the Hematology Division of CBER FDA's presentation on the recent advances in understanding the safety of particulate matter. Protein aggregates, testing methodologies and trends in setting standards are covered.

Be sure not to miss out on our featured FDA speaker, Alfred Del Grosso, Team Leader in Analytical Chemistry of CBER FDA's presentation on the top 10 list of analytical inadequacies in IND or BLA submissions. Hear his perspective on FDA expectation for analytical procedures and validations for drug products and drug substances.

Want to learn more? Download our agenda.

As a reader of this blog, you’ll receive 15% off the standard rate when using code XB13193BLOG to register. If you have questions about the event, contact Kate Devery (Kdevery@iirusa.com), or visit our webpage.

We look forward to seeing you October 21-23 in Washington, D.C!

Cheers,
The Well Characterized Biologicals Team

WCB Webpage
Follow us on Twitter
Connect with us on Linkedin

P.S. When you register for the 17th Annual Well Characterized Biologicals conference, you’ll also have access to all sessions for the Product and Process Variants & Impurities, one of our co-located events.

Share this article with your social network, just click below to share now!

Share |

Session Spotlight: Top 10 List of Analytical Inadequacies in IND or BLA Submissions

Procedures to support the identity, strength, quality, purity and potency of drug products and drug substances are an important component of new product applications reviewed by the FDA. Inadequacies commonly encountered in these submissions involve procedural details, system suitability tests, representative instrumental outputs, types of validation characteristics, linearity in sample matrix, verification of “compendial” procedures, robustness of critical assay parameters, accuracy calculations, precision and accuracy across intended range and factors in intermediate precision. So what exactly are the FDA expectations for analytical procedures and validations?

Session: Top 10 List of Analytical Inadequacies in IND or BLA Submissions
Speaker: Alred Del Grosso, Team Leader, Analytical Chemistry, CBER, US FDA

Join us for IBC's 17th Annual Well Characterized Biologicals as we highlight some of the errors and inadequacies FDA regulators have seen over the years in submissions. To learn more about our program, download the agenda.

As a reader of this blog, use code XB13193BLOG and save 15% off of the standard rate when you register. We look forward to seeing you October 21-23 in Washington, DC!

Share this article with your social network, just click below to share now!

Share |

Session Spotlight: Update on United States Biosimilars Program

Because of the recently defined regulatory pathways for biosimilars, there has been a huge rise in the number of biosimilar products in development.Thorough characterization of a biosimilar candidate in comparison with the reference product is the basis for a targeted clinical development program. FDA biosimilar guidelines suggest not only to analyze isolated quality attributes but also to focus on combinations of quality parameters. So what is the current status?

Session: FDA Perspective - Update on the United States Biosimilars Program

Speaker: Jeffrey C. Baker, Ph.D., Deputy Director, Office of Biotechnology Products (OBP), CDER, US FDA

Want to learn more about emerging technical considerations to assure safe and efficacious biosimilar products? Join us October 21-23 in Washington, DC for the 17th Annual Well Characterized Biologicals event.

To learn more, download our brochure. Register today for the leading industry conference to provide multiple, detailed case studies of the challenges, strategies and technologies involved in characterization and comparability of new biological molecules. We look forward to seeing you this fall!

As a reader of this blog, you'll receive 20% off the standard rate when you mention the discount code XB13193BLOG to register.

Share this article with your social network, just click below to share now!

Share |

Download the 17th Annual Well Charaterzied Biologicals today!

The 17th annual Well Characterized Biologicals conference program is now complete and we are extremely pleased with how the final agenda turned out. This event is consistently rated as one of IBC’s most in-depth and information-packed conferences, and this year is no exception.

Program Highlights:

 • 8 Confirmed FDA/Health Canada Speakers Provide Updates on Regulatory Guidance and Expectations For Your Molecules

• 19 Case Studies and 20 Unpublished Data Presentations You Can Apply in Your CMC Programs

• Increased Networking Opportunities to Build Valuable Contacts and Expand Your Network

 • Expanded Exhibit Hall and Best Poster Award

 • New co-located event: Product and Process Variants & Impurities – Gain Access to Any Session

Want to learn more? Download our brochure.

Register today for THE leading industry conference to provide multiple, detailed case studies of the challenges, strategies and technologies involved in characterization and comparability of new biological molecules. For more information visit out website. We look forward to seeing you October 21-23 in Washington, DC.

Share this article with your social network, just click below to share now!

Share |