Citeline Podcasts

On this week's Medtech Insight podcast: cybersecurity and US FDA warning letter headaches for St. Jude; a conversation with AdvaMed CEO Scott Whitaker; a profile of device-maker InVivo Therapeutics, which is looking to leverage 2tst Century Cures provisions; a verdict was reached in a Kimberly-Clark fraud suit; comments roll in on the Diagnostic Accuracy and Innovation Act in the US; and more.

In this Medtech Insight podcast, Xavier University's Marla Philips explains why the school is teaming up with IBM Watson Health to launch a Center for Artificial Intelligence. "Our mission is to provide artificial intelligence solutions. We will have free and open access for anyone to use so they can implement those solutions across the pharma and device industries, and FDA itself," she says.

Three months after the official launch of the Oncology Center for Excellence, applications for cancer products are now being reviewed by OCE medical teams. OCE Director Richard Pazdur provides more details on the process and procedures of the newly established center in a podcast interview.

Cowen & Co.'s Washington Strategist Chris Krueger and Prevision Policy's Ramsey Baghdadi talk about the initial strategy behind the House AHCA bill, whether it will be revisited, the impact on user fee legislation and whether there is room for drug pricing in the upcoming legislative period.

On this week's podcast, we checked in on Q1 2017 trends that we have spotted in Medtech Insight's online data trackers for venture funding, M&A and global product approvals.

The Rose Sheet’s editorial team discusses key news and developments over the past month, including cosmetics industry stakeholders’ efforts to tack cosmetics reform provisions onto pending US user-fee reauthorization legislation, continued tension in the EU regarding animal-testing policy under the Cosmetics Regulation and REACH, and dietary supplement firms’ ongoing struggle to comply with Good Manufacturing Practices requirements to FDA’s satisfaction.

On this week's podcast, we discuss the bad data news that has come in recent weeks for Abbott Labs' Absorb BVS bioresorbable scaffold; the latest user-fee reauthorization hearing on Capitol Hill; our recent interview with outgoing AdvaMed chair Vince Forlenza; and recent deep-dives into compliance and IP challenges facing the digital medtech space.

CARB-X Executive Director Kevin Outterson and BARDA Acting Deputy Director Joe Larsen describe the work of the accelerator, which announced the first eleven projects in its Powered by CARB-X portfolio March 30.

The Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator, or CARB-X, announced the first eleven projects in its Powered by CARB-X portfolio March 30. Details on each of the initial projects are here: http://www.carb-x.org/portfolio; they include three projects on new classes of antibiotics and four projects on non-traditional products, such as immunotherapy or antibody-drug candidates.

We talked to Executive Director Kevin Outterson narrowing down applicants from the wide interest and upcoming additions to the portfolio. Then BARDA Deputy Director Joe Larsen discussed the beginning of CARB-X, how it fits with other work by BARDA and how the accelerator could also make private investment attractive again in this space. Both emphasized the continued need for pull incentives, such as wildcard patent exclusivity or market entry rewards.

Vince Forlenza, recently retired chair of AdvaMed's board, says for the most part the issues facing the new chair and the medical device lobby group in general are the same: repealing the 2.3 percent medical device excise tax and passing the device user fee reauthorization.

This is Compliance 360°, an eight-part podcast series from Medtech Insight on US FDA compliance and enforcement issues. In this eighth and final installment, former US FDA investigations branch director Ricki Chase explains how the role of the patient influences FDA's enforcement strategy.