Guest Columns

  1. 5 Keys To Unlock The Full Potential Of Big Data In The Life Sciences
    6/20/2018

    The convergence of data and technologies provides an opportunity for companies to make a step change in innovation and performance. Those that successfully apply the strategies to all parts of the business will thrive in an increasingly complex sector.

  2. How Recent Regulatory And Payer Developments Will Impact U.S. Biosimilar Access
    6/19/2018

    Biosimilars were touted as a tool for payers to gain savings in specialty markets, but a recent survey by Avalere of the top 25 payers in the U.S. (about 189 million covered lives) using publicly available coverage policies found that biosimilars are commonly subject to step-through polices, including those that require the patient to “fail” first on a branded product, and only then will the payer cover a biosimilar of that same branded product (i.e., the biosimilar’s reference product). Policies like this may be why although the Congressional Budget Office (CBO) originally estimated a 10-year decrease in federal spending of $5.9 billion attributable to “follow on biologics”/biosimilars in 2009, it is estimated the actual savings have only been 8 percent of that amount (approximately $241 million). So what market access issues do biosimilars face in the U.S., and where could we go from here?

  3. Challenges Implementing New Advanced HFE testing Methods
    6/14/2018

    Part one of this series presented neuroscience-based HFE data capture methods that are beginning to penetrate HFE testing programs. This installment will discuss the challenges of utilizing advanced data capture systems in real world HFE testing programs.

  4. Writing Bulletproof SOPs: Best Practices For Life Sciences Companies
    6/13/2018

    Writing and enforcing standard operating procedures (SOPs) is a challenge. Poorly written SOPs are a common cause of deficiencies and observations cited in 483s and warning letters from the FDA.

  5. Market Access Impediments: Where Should Biosimilars Go From Here?
    6/12/2018

    Biosimilars were touted as a payer’s tool to gain savings in specialty markets, but a recent survey by Avalere of the top 25 payers in the U.S. (about 189 million covered lives) using publicly available coverage policies found that biosimilars are commonly subject to step through polices, including those that require the patient to “fail” first on a branded product, and only then will the payer cover a biosimilar of that same branded product (i.e., the biosimilar’s reference product). Policies like this may be why although the Congressional Budget Office (CBO) originally estimated a 10-year decrease in federal spending of $5.9 billion attributable to “follow on biologics”/biosimilars in 2009, it is estimated the actual savings have only been 8 percent of that amount (approximately $241 million).

  6. Integrating Risk Management Into Your QMS — An Essential Toolkit
    6/11/2018

    Probably the most significant concern for anyone responsible for implementing, deploying, and maintaining a quality management system is the integration of risk-based thinking. Risk-based thinking can and should be applied to the organization’s strategic and tactical planning processes.

  7. Closing The Loop For Bioelectronic Medicine
    6/11/2018

    To fully realize the potential of bioelectronic medicine, medical device developers will need to find ways to move beyond "set and forget" biostimulation devices to closed-loop systems that can provide more responsive and personalized treatments. 

  8. An Introduction To Liposome Processing For Drug Delivery
    6/8/2018

    Discovered in 1961, liposomes have been around for several decades as a drug delivery platform that has achieved varying levels of applications and popularity. With their biocompatibility and well-understood chemistry of encapsulation of a wide variety of APIs (active pharmaceutical ingredients), liposomes make it through the screening process for many potential products.

  9. The Hard Truth: Evidence — Not Marketing — Builds A Medtech Business
    6/7/2018

    In today’s high-stakes trade-off game, to be widely adopted, an advance must conclusively improve or extend human life while being cost-justified over the existing standard of care.

  10. 3 Good Reasons To Never Fall In Love With A Molecule
    6/6/2018

    In my 2016 book about drug development, Nesiritide,1 I used the admonishment, “Never fall in love with a molecule,” as a chapter heading. A few weeks ago, the editors of Clinical Leader asked me to expand a bit on that aphorism. That explains why I’m sitting at my desk channeling my inner Ann Landers and writing an advice column for the pharmaceutical industry. To be entirely fair, the phrase is not originally from me. In 2005, I heard it from Randall Kaye, M.D., my first boss in the industry. But it made a real impact.