LSL Web-Exclusive Content

  1. Alternative Fact: Site Identification Is Not Critical To Clinical Trial Efficiency

    On the surface this may seem to have some validity, as sponsors and CROs often lack a transparent, evidence-based strategy for this task. Instead, they frequently rely on archaic paper-based or spreadsheet methods to identify sites across the globe with a reasonable chance of enrolling the contracted number of patients on schedule, and the ability to generate quality data.

  2. Survey Says: Pharma Perspectives On Implementation & Impact Of Recent Regulatory Guidances

    Over the past 10 years, both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have issued new and revised regulations and guidances in an attempt to define, clarify, and modernize their requirements. Ideally, these documents would have aided industry in developing new products that take advantage of new technologies, given budget and personnel limitations in both the regulatory agencies and industry. And in fact, many of these documents have proposed or emphasized radical changes in strategy and operations, but unfortunately such changes are often met with skepticism and concern by industry.

  3. Novartis And The Arrival Of The Continuous Manufacturing Facility

    The journey to implementation of the disruptive technology of continuous manufacturing began in 2005, according to Markus Krumme of Novartis, with a single question on a slide presented to Novartis development and manufacturing executives. “Why don’t we have facilities that can continuously produce materials?” then-CEO Daniel Vasella asked.

  4. Launching A New Drug In A Maturing Market — Lessons Learned From Recent COPD Entrants

    Chronic obstructive pulmonary disease (COPD), a global growth market worth well over $15 billion in the U.S. and EU5 in 2016, has long represented a lucrative opportunity for drug manufacturers. However, the proliferation of treatments and increasing number of generics have begun to limit the potential for emerging therapies. A review of the successes and stumbles of the newest class of drugs (LABA/LAMA fixed-dose combinations) illustrates broader lessons manufacturers should consider when launching into a rapidly maturing market.

  5. Drug Pricing: 2017’s Challenge Confronting Biopharma

    Although just a part of total healthcare costs, drug prices have certainly attracted a lot of comments from politicians and mentions in the press. If the issue was limited to being primarily a talking point exploited by politicians to generate populist support, it might be one thing; however, the politicians’ commentary is giving voice to a more significant concern among the public.

  6. FDA’s New Quality Agreement Guidance — What It Says (And What It Fails To Say)

    In November 2016, the FDA issued new guidance for industry titled Contract Manufacturing Arrangements for Drugs: Quality Agreements. This guidance is timely, given the rise of the virtual biotech company in the development landscape. Most development programs now include the support of at least one contract service provider (CSP) for services that vary from early development contract research to commercial manufacturing and analytical support.

  7. Three Experiences Power A Non-Profit’s Business Approach

    Jennifer Dent is all business. At a nonprofit organization. She thinks that's exactly how it’s supposed to be. She also shares the enthusiasm of a humanitarian on a mission. Reviewing three experiences in the career of Dent, president of BIO Ventures for Global Health (BVGH), one might think none of this should be the case.

  8. Why Pharma Is Seeking A New Type Of BD Leader

    Early last year I had a call with the Global Head of Business Development and APAC (Asia Pacific) Regional Head of Human Resources at a major biotech group. Once initial pleasantries were exchanged the first words from this executive were “Rob, we’re looking to hire a scout ASAP to lead business development in Asia.”

  9. Mobile Apps: A Look At Their Use In The Precommercial Phase

    In the precommercial phase, companies invest significant time and money to recruit patients and collect real-world data as well as uncover gaps in current therapies and emerging or anticipated public health needs. That’s why pharmaceutical companies are proactively evaluating and deploying mobile apps to accomplish these goals more quickly, efficiently, and effectively.  You can ping someone and get their attention immediately – faster than eliciting a response from an email. This type of engagement is also more conducive to a variety of lifestyles than any other medium.

  10. A Prescription For Change: Navigating Tax Reform In 2017

    Proposed changes to the tax code could have a pervasive impact on Pharma’s business strategy.