YourEncore Insights - Life Sciences

Working with the FDA: Developing a Regulatory Strategy That Works (Ep. 14 of The Pharmcast)

Posted by Jim Combs on 3/2/17 4:00 PM

On this week's episode of The Pharmcast, we explore the key elements of an effective regulatory strategy and how to drive value to patient and shareholders by working with the FDA. We also cover common ways agency decisions can destroy value if not done properly.

Dr. Tim Franson and Dr. Joe Lamendola recently gave a presentation to a group of private equity and venture capital funds to outline the importance of regulatory strategy for small biopharma companies.

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Topics: Regulatory, FDA, Pharmcast

Riding the Policy Roller Coaster in 2017: A Policy Update with Dr. Tim Franson (Ep. 13 of The Pharmcast)

Posted by Jim Combs on 2/16/17 8:30 AM

We are at a time of great change and transition in the FDA. The sitting FDA chief stepped down, just when the 21st Century Cures Act passed into law; PDUFA 6 is up for renewal this year; and the new administration has signaled hiring freezes for government agencies, including the FDA.

While many of the policy and leadership changes in 2017 may not appear to make a day-to-day impact on drug developers at first, these changes can in fact have a profound impact. 

To help us understand how 21st Century Cures, PDUFA 6, and leadership changes can affect your development plans, we sit down with Dr. Tim Franson, who is not only YourEncore's Chief Medical Officer, but also Chairman of the Board  for The Critical Path Institute, the Immediate Past-President for the USP, and a key contributor to the last few PDUFAs.

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Topics: Regulatory, FDA, Pharmcast, policy, pdufa

NDA Mistakes to Avoid: An Interview with Dr. Joseph Lamendola (Ep. 12 on The Pharmcast)

Posted by Jim Combs on 2/13/17 9:00 AM

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Topics: FDA, Pharmcast, NDA

FDA 483 Responses: Avoiding Common Pitfalls and Deficiencies (Ep. 8 on The Pharmcast)

Posted by Jim Combs on 1/12/17 8:00 AM

This week on The Pharmcast, we explore best practices and common pitfalls in FDA 483 Responses. 

In 2015, there were an average of 175 inspections and 10 warning letters issued per month by the Center for Devices and Radiological Health alone.  Regulatory inspections and 483 findings are a part of being a life sciences company.  However, how companies respond can have a major impact on patient safety and business performance.

To share best practices, we held a special presentation with two of our top medical device experts, Victor Chance and Judy Meritz, to outline what they’ve learned over the course of their 20+ year careers in the medical devices industry.

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Topics: Medical Device, Med Dev, FDA, Supply Chain, Pharmcast

Holiday Wish-Lists and Watch-Outs From Regulatory Leaders (Ep. 5 on The Pharmcast)

Posted by Jim Combs on 12/8/16 9:56 AM

 

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Topics: Pharmaceutical Industry, Regulatory, FDA, Pharmcast

Navigating Drug-Device Combination Product Approval

Posted by Judith Meritz, J.D. on 11/3/16 11:11 AM

 

The popularity of drug-device combination products has been soaring. These products — which comprise combinations of drugs, biologics and devices — had sales reaching $22 billion in 2014, and the market is expected to grow to $31 billion by 2019.1

However, growth in this sector is threatened by a lack of alignment within the FDA, which is slow to approve drug-device combination products.  For those considering developing a combination product, I thought it helpful to provide an FDA primer to help people navigate the approval process and understand where the challenges are.    

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Topics: Medical Device, FDA, Combination Products

Drug Pricing – What’s the Answer to High Cost Off-Patent Medicines?

Posted by Jim Combs on 9/13/16 11:00 AM

In the wake of the Turing, Valeant, and Mylan EpiPen pricing controversies, YourEncore Insights coordinated a conversation with two top experts to discuss potential solutions to some drug pricing dilemmas.  I interviewed Peter J. Pitts, former FDA Associate Commissioner and President of the Center for Medicine in the Public Interest, and Dr. Tim Franson, YourEncore’s Chief Medical Officer and former VP of Global Regulatory Affairs for Eli Lilly and Company.

The transcript is provided below: 

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Topics: Pharmaceutical Industry, FDA, Drug Pricing

FDA 483 Response: Four Tips to Avoid a Warning Letter

Posted by Victor Chance and Judith Meritz on 8/25/16 12:05 PM

The receipt of a 483 at the conclusion of a facility inspection notifies a company of conditions the FDA believes are in violation of the Food, Drug & Cosmetic Act. If 483s are not properly addressed, the FDA can take further enforcement action to protect the public health – including issuing Warning Letters. Warning Letters not only indicate potential risks to patients, but also bring unwanted publicity, erode patient trust, and potentially restrict the approval of future products significantly impacting revenue. Therefore, companies must know how to mount a competent response.

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Topics: Quality & Safety, Medical Device, FDA

Embracing Satan's PDUFA

Posted by Peter J. Pitts on 8/19/16 8:00 AM

Monday’s public meeting on the FDA’s PDUFA VI Commitment Letter was a love-fest (mostly) – but as Theresa Mullin, Director of CDER’s Office of Strategic Programs, wisely noted, “the devil is in the details." Indeed.

The meeting was in three panels: Pre-Market Review and Post-Market Safety, Regulatory Decision Tools, and Administrative Enhancements.

A few highlights and comments.

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Topics: Pharmaceutical Industry, Regulatory, FDA

Real World Evidence: Times They Are a (Slowly) Changin'

Posted by Peter J. Pitts on 8/2/16 8:50 AM

Per the FDA’s PDUFA VI "commitment letter," the agency will face some real world deadlines to advance the use of real world evidence. But, since we’re dealing with the real world, let’s get real – guidance is unlikely until the end of 2022 at the earliest. (That's the timeline agreed to via the PDUFA VI negotiations.)

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Topics: FDA