YourEncore Insights - Life Sciences

Holiday Wish-Lists and Watch-Outs From Regulatory Leaders

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

 

 

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Topics: Pharmaceutical Industry, Regulatory, FDA, Pharmcast

Billion Dollar Bets: Lessons on Innovation from a BMS Chief Scientific Officer, Dr. Elliott Sigal

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.

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Topics: Pharmaceutical Industry, Pharmcast

The Pharmcast: 9 Biotech Valuation Killers

Posted by Jim Combs on 11/17/16 8:00 AM

 

This week in the Pharmcast, we discuss "9 Biotech Valuation Killers" with Dr. Brian Daniels, the former SVP of Global Development for Bristol-Myers Squibb and now Venture Partner with 5AM Ventures, and Dr. Don Therasse, former VP of Global Patient Safety and Medical Affairs for Eli Lilly & Company.  

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Topics: Pharmcast

The Pharmcast: Leading the Bristol-Myers Squibb Transformation (Part 2)

Posted by Jim Combs on 11/10/16 8:00 AM

 

A continuation of our maiden voyage of the Pharmcast, we talk with a trio of former Bristol-Myers Squibb executives, who developed and delivered BMS’ “String of Pearls” strategy, that delivered first-class medicines to patients and positioned BMS as a clear leader in the immuno-oncology space.

In part 2 of the roundtable, we start off with John Celentano, who was responsible for delivering a large organizational transformation to fund reinvestment in their innovation pipeline.

With the "string of pearls" strategy in place, it was time to figure out how BMS was going to pay for their acquisitions, and continue to fund the development of new products.

Knowing they needed to fundamentally change how they ran the business, the BMS board set out with something they referred to as "the productivity transformative initiaitive."

After restructuring the way the company ran, by shrinking the company and increasing productivity, the board members of BMS set their sites on investing in innovative products and technologies - primarily biologics. At the time, only about 6-7% of major drus were biologics. But, the BMS executives estimated that in the future, the biologic market would near 25%.

In what was, at the time, a make-or-break decision, the BMS executives made a leap-of-faith, $2.3 billion acquisition of a small company called "Medarex," a company that focused on immuno-oncology medicines.

Despite originally being heavily criticized by leaders in the oncology field for the alliance, BMS was well on their way to becoming a leader in the immuno-oncology space. 

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Topics: Pharmcast

The Pharmcast: Leading the Bristol-Myers Squibb Transformation (Part 1)

Posted by Jim Combs on 11/9/16 2:25 PM

 

We are pleased to announce that YourEncore has officially joined the podcasting ranks with the launch of the YourEncore Pharmcast, your weekly dose of wisdom from top life science minds.   Each week we will speak with top industry experts in our network or beyond about hot industry topics, leadership, and the path to success. 

For our maiden voyage of the Pharmcast, we talk with a trio of former Bristol-Myers Squibb executives, who developed and delivered BMS’ “String of Pearls” strategy that delivered first-class medicines to patients and positioned BMS as a clear leader in the immuno-oncology space.

What follows is a tremendous case study on leadership, portfolio decisions, organizational transformation, and most importantly, developing life-changing medicine for patients.

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Topics: 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

Considering Biosimilars – 3 Key Areas to Assess in Your Strategy

Posted by David Wierz on 10/13/16 9:22 AM

Innovators simply cannot afford to ignore biosimilars. These products have the potential to create significant clinical and financial advantages for both patients and payers.

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Topics: Biosimilars

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.

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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. 

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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: 

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Topics: Pharmaceutical Industry, FDA, Drug Pricing