Life Science Leader Blogs

  1. The Folly Of Burying Great Insight
    12/21/2015

    Last week I posted “Why The Wall Street Journal’s U.S. Drug Price Comparison Misses The Mark,” a criticism of health and science deputy bureau chief Jeanne Whalen’s Dec. 1, 2015 article titled, “U.S. Drug Prices Dwarf Other Nations.” What bothered me about this article was that I felt it skewed the facts, sensationalized the issue, and seemed intent on stirring up controversy.

  2. FDA/CMS Summit Demonstrates Need For Innovative Hiring Solutions
    12/17/2015

    When Janet Woodcock, M.D., kicked of this year’s FDA/CMS Summit for biopharmaceutical executives, the FDA’s director for the Center for Drug Evaluation & Research (CDER) did so by recapping what was achieved in 2015, as well as sharing her lengthy list of priorities for the coming year. According to Woodcock, the challenge to successful implementation of various priorities is analogous to keeping an airplane flying while at the same time trying to fix or improve whatever isn’t working. And though she and her team have done admirably in piloting the organization for the past several years, I wonder how long they can continue to do so. For despite CDER’s significant accomplishments last year (e.g., first biosimilar approval), one priority that hasn’t moved — at all — is the organization’s glaring need for staffing. From a PowerPoint released at the conclusion of last year’s summit, at the bottom of slide four you see a 2015 front burner priority listing of “Improve staffing” that notes over 600 vacancies at CDER.. One year later, Woodcock stated that CDER still has 600 vacancies – (see slide 10 of this year’s presentation)! Now, one could argue that CDER, like most organizations, probably had its share of routine turnover. Perhaps the agency hired more than 600 people last year. But at an organization that employs approximately 3,200 civilians, 600 vacancies represents trying to fly and fix the CDER plane with about 20 percent less staff than you need. Constant pressure in other industries to do more with less has been shown to increase employee burnout. If the CDER employee hiring needle hasn’t moved at all in 12 months (probably longer), perhaps it is time to start asking about what needs to change, because the current approach isn’t working, and employee burnout could further exacerbate the problem.

  3. Why The Wall Street Journal’s U.S. Drug Price Comparison Misses The Mark
    12/11/2015

    In the December 1, 2015 edition of the Wall Street Journal there is an article titled, “U.S. Drug Prices Dwarf Other Nations.” The author, health and science deputy bureau chief Jeanne Whalen, begins by pointing out that Norway, an oil producer with one of the richest economies in the world, is an expensive place to live. To support her claim she highlights Norway’s cost of a Big Mac ($5.65) and a gallon of gasoline ($6). But she also notes that prescription drugs are far cheaper in Norway than in the U.S. According to Whalen, The Wall Street Journal did a comparison of the drug pricing for Medicare Part B versus the health systems of Norway, England, and Ontario. Her conclusion, “Throughout the developed world, branded prescription drugs are generally cheaper than in the U.S.” While she may be right in her assessment, I still find it wrong what she and the Journal are doing, and here’s why.

  4. There’s More To January Than Just the JPM Conference
    12/8/2015

    One of the biggest biopharmaceutical industry events, the 34th Annual JP Morgan Healthcare Conference, is right around the corner, January 11-14. And while the event is famous for overrunning San Francisco with neckties, as well as blowing up Twitter with its hashtag #JPM2016, there are a number of other worthwhile events also taking place. For example, just down the street is the 8th Annual Biotech Showcase #BTS2016. In fact, last year my colleague Wayne Koberstein and I had the opportunity to attend BTS, and it was very fruitful; it resulted in one of my favorite articles from 2015, “So You Want To Start Your Own Biotech?” However, as JPM attracts so many biopharma folks to the area in a very short period of time, it can be easy to overlook other very worthwhile opportunities, such as Life Science Nation’s Redefining Early Stage Investments (RESI) conference.  

  5. Startups & Outsourcing — Opposite Poles or Virtual Partners?
    12/2/2015

    Let’s face it, finding the money often captures all but a few crumbs of the typical startup CEO’s attention. Laser-sharp illustrations in the company’s dog-and-pony show may present its scientific platform with convincing clarity and purpose, but traditionally, investment conferences have not been a place where the dollar-hungry startup talks about the infrastructure it must build or hire to turn its science into a medical product.

  6. ISPE Meeting Provides Emotional Rollercoaster
    11/13/2015

    Stepping out of my hotel room on the last day of the 2015 International Society of Pharmaceutical Engineering (ISPE) annual meeting in Philadelphia (November 8 – 11), I reach down and pick up the USA Today that is blocking my egress. Flipping through the newspaper the headline “Allen Always Aimed High” catches my eye. As writer Nicole Auerbach relates how Duke University basketball standout Grayson Allen strived to achieve his childhood dream, I am struck by the similarity between the story and this year’s ISPE annual meeting. “I had so much joy,” recalls Allen of the sensation experienced the first time he successfully slam dunked a basketball on a 10 foot hoop — a goal that took years of persistent practice to finally achieve. It is important to remember that biopharma executives and engineers are not immune to deeply experiencing human emotions (e.g., joy, sorrow). And while attendees of ISPE were certainly treated to high-caliber networking and educational opportunities at this year’s show, they were also provided a strong dose of emotional reality to fuel their passionate pursuit of excellence. Like Duke’s Allen, to achieve beyond your expectations, sometimes it is important to be reminded of why it is you do what you do.

  7. Reliving the Past, Shaping the Future of Cancer Therapy
    10/6/2015

    A news item on AZ’s new “crowdsourcing” approach to cancer-drug treatment. The report uncritically hailed the program as a veritable revolution in cancer therapy that could yield greatly improved results from combinations of traditional chemotherapeutics and, presumably, other approved drugs with different modalities such as molecular-pathway targeting.

  8. How Can You Provide Healthcare Value In A Patient-Centric Era?
    10/1/2015

    Patients have become more empowered, better informed, and more financially invested in their health and well-being than ever before. As a result, we have seen the healthcare landscape evolve toward a patient-centric delivery model.

  9. Does Being Disruptively Innovative Translate Into Being More Patient-Centric?
    9/25/2015

    Everyone has experienced poor customer service in one form or another. Say you want to call a company with a question or a complaint about a product. You’re likely to be informed by an automated voice that, “Due to the high volume of calls we are currently experiencing, your anticipated wait time will be X minutes.  For faster and more convenient customer service, please visit our website at www.wedon’tcaretospeaktoyou.com.

  10. The Value Of Biopharma Headhunters — A Comprehensive Executive Resource
    9/10/2015

    During a conversation with Pascale Witz, leader of Sanofi’s newly created global divisions and strategic development organization, the former GE executive commented on the value of headhunters (recruiters) in being able to do more than fill talent gaps.