YourEncore Insights - Life Sciences

Bioethics in Biopharma: Lessons on Safety, Big Data and Bioethics from Dr. Don Therasse  (Ep. 7 on The Pharmcast)

Posted by Jim Combs on 1/5/17 12:26 PM

This week on The Pharmcast, we talk with Dr. Don Therasse, former VP of Global Patient Safety for Eli Lilly & Company, and current Strategic Advisor for YourEncore.

With over 26 years of experience working with Lilly, Therasse held a diverse set of roles ranging from clinical research physician, to medical director, to medical affairs leader, and finally to patient safety leader.  Beyond drug safety, Don Therasse is a thought leader in bioethics and is credited with building Lilly's internal bioethics group.

In our conversation with Dr. Therasse, we explore experiencing a major patient safety event, building a bioethics program, the promise (and limitations) of big data in patient safety, and success formulas for transitioning into new departments within a large biopharma company. 

If you have topics you would like YourEncore to explore on future episodes of The Pharmcast, please email Pharmcast@yourencore.com with feedback or suggestions.

Read More

Topics: Pharmaceutical Industry, Quality & Safety, Pharmcast

From Big Pharma to Biotech C-Suite: Industry and Career Insights from Dr. June Almenoff (Ep. 6 on The Pharmcast)

Posted by Jim Combs on 12/15/16 10:40 AM

This week on The Pharmcast, we talk with Dr. June Almenoff, former President, Chief Medical Officer and Board Member of a biotech, which was recently acquired in 2014 by Actavis for $1.2 billion.

With an M.D. and Ph.D., Dr. Almenoff began her career as a faculty member at Duke University before landing a position at GlaxoSmithKline (GSK) in their medical R&D division and scientific licensing.  However, after 13 years at GSK,  a new opportunity presented itself in 2010 when Dr. Almenoff was invited to head up a small biopharma company as President & CMO, which she would soon lead into a $1.2 billion acquisition.

Almenoff helped the company successfully progress its Irritable Bowel Syndrome drug from Phase 2 through the FDA submission, which the FDA approved in 2015 on its first review cycle.

Everyone talks about learning from failure, but from our discussion with Dr. Almenoff, we learn from success.  I asked Dr. Almenoff about her keys to success, drug development trends, and the lessons she's learned across her 'big pharma' and biotech career.

Read More

Topics: Pharmaceutical Industry, 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

 

Read More

Topics: Pharmaceutical Industry, Regulatory, FDA, Pharmcast

Billion Dollar Bets: Lessons on Innovation from a BMS Chief Scientific Officer, Dr. Elliott Sigal (Ep. 4 on The Pharmcast)

Posted by Jim Combs on 12/1/16 8:00 AM

 

Each week in The Pharmcast, we talk with top industry experts from our network or beyond about hot industry topics, leadership, and the path to success. This week in The Pharmcast, we catch up with Dr. Elliott Sigal, the former Chief Scientific Officer of Bristol-Myers Squibb.

In 2012, Dr. Sigal was called by Scrip Pharma Intelligence "The Best R&D Chief in Pharma," largely for helping deliver BMS' "String of Pearls" strategy that helped position BMS as a major player in the immuno-oncology space.

As referenced in both Episode 1 and Episode 2 of The Pharmcast,  Dr. Sigal, through internal development and making sizable asset acquisitions, developed a pipeline of first-in-class medicines that helped transform the company, the industry, and most importantly, the lives of hundreds of thousands if not millions – of patients. 

When asked what his "secret sauce" to success was, he said it was not just one thing, but the culmination of many things.  Below are the three of the things Dr. Sigal attributed to his success.

Read More

Topics: Pharmaceutical Industry, Pharmcast

Pharm-ers Almanac 2016: The Butterfly Effect

Posted by Tim Franson, MD on 9/27/16 8:30 AM

There is a saying, coined by the late Edward Lorenz, an early pioneer of the chaos theory, that “the flap of a butterfly’s wings in Brazil can set off a tornado in Texas.” This observation is known as the butterfly effect: the concept that small changes can have large downstream effects.

Read More

Topics: Pharmaceutical Industry, Regulatory, Medical Device

Are You Ready for EU MDR?

Posted by Minnie Baylor-Henry on 9/15/16 12:47 PM

Back in 2010 when European regulators announced plans to overhaul legislation on how the European Union oversees medical devices, the industry knew that it would take time for changes to take effect. With the EU reaching agreement on the regulation, it appears that the final Medical Device Regulation (EU MDR) may take effect as early as January 2017. 

Read More

Topics: Life Sciences, Pharmaceutical Industry, Regulatory, Medical Device

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: 

Read More

Topics: Pharmaceutical Industry, FDA, Drug Pricing

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.

Read More

Topics: Pharmaceutical Industry, Regulatory, FDA

If Brexit, Whither EMA?

Posted by Peter J. Pitts on 7/14/16 9:00 AM


If Brexit, whither EMA?

Will Great Britain become like Norway and Iceland, attending committees such as the CHMP, where their views and votes are not of the same standing as those of members of the EU, or choose to follow a different route? There’s a lot at stake for the future of the MHRA and the British public health.

But what about the impact of removing MHRA expertise from EMA?

Read More

Topics: Pharmaceutical Industry, Regulatory

Alternative Regulatory Pathways for Rare Disease: Breaking the ICE

Posted by Tim Franson, MD on 4/25/16 10:30 AM

There is a heightened sense of urgency by all stakeholders to accelerate development of therapies for rare disease.  The FDA shares this urgency, but it also must protect the public safety and follow the well-defined laws and regulations governing the process.

The challenge (or opportunity) is to develop creative approaches, which accelerate access and stay within the regulatory boundaries – or find ways to shape the boundaries.  Intermediate Clinical Endpoints, or ICE, could represent one such approach. 

I sat down with Dr. Joe Lamendola on April 7th to discuss this approach, and you can listen/watch the full converation below

Read More

Topics: Pharmaceutical Industry, Regulatory, Rare Disease