University of Maryland, National Institute of Standards and Technology to Host First National Summit on Biosimilars

Biomanufacturing Summit 2014

The University of Maryland and the National Institute for Standards and Technology (NIST) will host the first national symposium to discuss biosimilar therapeutics on June 13, 2014, at the Institute for Bioscience and Biotechnology Research in Rockville, Md.

The event, “Emerging Strategies for the Production and Characterization of Biosimilars,” kicks off the first annual UMD/NIST Biomanufacturing Technology Summit, which pulls together company, government and academic thought leaders from around the world each year to discuss strategies, trends and issues in biotechnology products and manufacturing.

“The University of Maryland and NIST are proud to host this conference on one of the most important topics facing the biotechnology industry today,” said Ben Woodard, Director of the Biotechnology Research and Education Program at UMD, co-organizer of the symposium. “Biosimilars present a unique challenge: while they could mean more affordable drugs for consumers, they also require unique standards and regulations to ensure their efficacy and safety. We are pleased to bring together thought leaders from biopharmaceutical companies, academe, and standards and regulations officials all to the same table to discuss strategies for producing these therapeutics.”

The Emerging Strategies for the Production and Characterization of Biosimilars symposium features morning sessions on the Bioanalytical Characterization of Biosimilars. Speakers include:

  • Dr. Michael J. Tarlov, Division Chief, Biomolecular Measurement, NIST
  • Dr. William E. Bentley, Robert E. Fischell Distinguished Professor and Chair, Department of Bioengineering, University of Maryland, College Park

The symposium’s afternoon sessions cover Biopharmaceutical Industry Perspectives of Biosimilar Characterization. Speakers include:

  • Dr. Patrick Liu, Global Head of Bioanalytical Sciences and Technologies, Teva Pharmaceutical Industries Ltd.
  • Dr. Alistair Kippen, Director, Analytical Biotechnology, MedImmune (AZ)
  • Dr. Jennifer Liu, Director of Analytical Sciences, Biosimilars Process Development, Amgen Inc.

Both the morning and afternoon sessions will feature panel discussions following individual presentations.

Biosimilars, also called follow-on biologics, are structurally similar versions of commercial therapeutics that tests show are sufficiently similar both architecturally and clinically. The promise is cheaper therapeutics for consumers after an initial drug’s patent expires.

But biosimilars are biologics, or drugs created using biological processes (not chemically synthesized), and they are more complex to manufacture. Even small changes to the way they are made can change the drug’s safety and efficacy, which presents a unique challenge to standards and regulation agencies such as NIST and the Food and Drug Administration.

The FDA gained the authority to approve biosimilars as part of the Patient Protection and Affordable Care Act in 2010, but none have yet been approved.

This summit brings together, for the first time in the region, biopharmaceutical companies, academe, and government standards and regulation officials to discuss the potential and challenges of biosimilars.

For more information and to register for the 2014 Biomanufacturing Summit: Emerging Strategies for the Production and Characterization of Biosimilars, visit: http://ter.ps/biosummit

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