weekly biotechnology news wrap up

June 9, 2017

June 9, 2017

This week’s headlines include: Novartis, IBM Watson Health team up for breast cancer project, Drug Prices Become Target for FDA as Chief Expands Purview, F-star, Merck Agree Up to €1B Deal to Develop Five Bispecific Anticancer Antibodies, User fee Reauthorization Bill Advances in the House, NICE backs Keytruda for first and second-line use, and Cancer Drug Proves to Be Effective Against Multiple Tumors


Headlines:

“Novartis, IBM Watson Health team up for breast cancer project,” Reuters

“Novartis has agreed to work with IBM Watson Health to explore ways to use patient data and advanced analysis to glean insights on the likely outcomes of breast cancer treatments, the Swiss drugmaker said on Monday…”

“Drug Prices Become Target for FDA as Chief Expands Purview,” Bloomberg

“The head of the U.S. Food and Drug Administration is considering using the agency’s powers to bring more price competition to the market for generic drugs, targeting high-priced products by prioritizing the approval of additional competing treatments…”

“F-star, Merck Agree Up to €1B Deal to Develop Five Bispecific Anticancer Antibodies,” Genetic Engineering News

“U.K.-based F-star and Germany’s Merck established a potentially €1 billion (approximately $1.13 billion) strategic collaboration to develop and commercialize five of F-star’s bispecific immuno-oncology antibodies (mAb2™). The deal includes F-star’s lead preclinical asset FS118, which targets lymphocyte activation gene 3 (LAG-3) and programmed death-ligand 1 (PD-L1), plus four additional bispecific antibodies selected by Merck from F-star’s platform…”

“User fee Reauthorization Bill Advances in the House,” Regulatory Focus

“The House Energy and Commerce Committee on Wednesday voted unanimously (54-0) to advance its bill to reauthorize the US Food and Drug Administration’s (FDA) user fee programs for prescription and generic drugs, biosimilars and medical devices to the full House…”

“NICE backs Keytruda for first and second-line use,” PharmaTimes

“MSD’s Keytruda has now become the first and only immunotherapy to be recommended by the National Institute for Health and Care Excellence as a first and second line treatment for specific populations of patients with lung cancer…”

“Cancer Drug Proves to Be Effective Against Multiple Tumors,” The New York Times

“The 86 cancer patients were a disparate group, with tumors of the pancreas, prostate, uterus or bone. One woman had a cancer so rare there were no tested treatments. She was told to get her affairs in order. Still, these patients had a few things in common. All had advanced disease that had resisted every standard treatment. All carried genetic mutations that disrupted the ability of cells to fix damaged DNA. And all were enrolled in a trial of a drug that helps the immune system attack tumors…”

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Webinars:

Continuous Bioprocessing Technology and Regulatory Considerations

Wednesday, June 14, 2017, 01:00 PM EDT

SUMMARY

Many industries have adopted a one-piece flow approach (continuous manufacturing) to leverage the core reductions in inventory, increased operational flexibility, and greater product consistency and quality that it delivers. However, biopharmaceutical manufacturers have been slow to put continuous processing theory into practice due to the highly-regulated nature of the industry.

On June 14th at 1pm EDT, Peter Levison, PhD will moderate as Mani Krishnan, PhD and Marc Bisschops, PhD examine the evolution of interest in continuous bioprocessing, the advances being made in today’s market, and how the regulatory authorities are responding. Mani will also offer insight into the technological challenges of implementing continuous bioprocesses, and potential regulatory questions surrounding batch definition, bioburden control, virus clearance, scale-up/down, defect perturbation, design space, etc.; he will also propose effective mitigation strategies for a successful transition to continuous bioprocessing.

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SUMMARY

Continuous multi-column chromatography (MCC) has been gaining increasing interest as an enabling bioprocessing technique that allows for increases in specific productivity (g/L/hr) and operating binding capacity (g mAb/L sorbent) over traditional batch solutions. With recent advances, users have reported an increase in cost savings stemming from reduced resin volumes, lower buffer consumption, and increased resin usage.

Mark Pagkaliwangan presents on July 18th at 1PM EDT, with David Johnson moderating, as they discuss MCC solution advances with processes utilizing two columns or more. They will explore how the total number of columns used in a process can affect performance, and how titer and flowrate can be optimized with more columns for greater efficiency and productivity.

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Cell Culture Events:

Cell Culture & Cell Therapy: Bioprocessing Conference – June 26-27, 2017, Philadelphia

MarketsandMarkets put together a unique platform to establish the reproducible and robust manufacturing processes for the production of stable cell culture and therapeutic cells. At the Cell Culture & Cell Therapy: Bioprocessing Conference scheduled to be held in Philadelphia, USA on 26 – 27 June 2017, leading experts in the industry will be gathered to discuss strategies, technologies and innovations in the area of bioprocessing of cell culture and cell-gene therapies.