ALSO IN THIS MONTH'S ISSUE

  • Trump Unveils Drug Reforms: Rebates To PBMs At Risk
    Trump Unveils Drug Reforms: Rebates To PBMs At Risk

    After months of delay and suspense, in a Rose Garden ceremony, President Trump and HHS Secretary Alex Azar announced a comprehensive approach to prescription drugs, which they claimed would address major challenges.

  • Where Are The Most Valuable Lessons Learned?
    Where Are The Most Valuable Lessons Learned?

    I imagine George Yancopoulos, profiled on this month’s cover, to have gained some of his life’s wisdom in a similar fashion to most people — by trying new things.

  • Being A Multicultural Millennial Female In Pharma Manufacturing
    Being A Multicultural Millennial Female In Pharma Manufacturing

    Tawni Koutchesfahani, director of manufacturing strategy at Relypsa, says pharmaceutical manufacturing must diversify if it is to thrive. That means the recruitment and retention of more women and more millennials.

  • Biopharma Startups Take Advantage Of Open IPO Window
    Biopharma Startups Take Advantage Of Open IPO Window

    Biopharma startups are enjoying a window of opportunity for successful IPOs that opened in mid-2017. CEOs share their experiences of going public, what is fueling IPOs, and tips for others thinking about making this important next step.

  • Pfizer Executives Elaborate On Biosimilar Goals, Challenges
    Pfizer Executives Elaborate On Biosimilar Goals, Challenges

    It takes more to enter the biosimilar business than simply being a leading innovator in the biologics space. As several Pfizer experts shared, there are some integral transitions, both in mindset and in terms of practice, that need to occur to fully embrace biosimilars. 

More from this month's issue

BEYOND THE PRINTED PAGE

More beyond the printed page articles

WEB-EXCLUSIVE EDITORIAL

  • Why Slow Down? Lessons From A Burst Water Heater
    Why Slow Down? Lessons From A Burst Water Heater

    In slowing down long enough to be deliberate, thoughtful, and proactive in your approach, you lay the necessary foundation to go faster where it counts.

  • Recent Conference Reveals Growing Wave Of Biosimilar Social Responsibility
    Recent Conference Reveals Growing Wave Of Biosimilar Social Responsibility

    I’ve heard it said that innovation in the biosimilar world extends beyond the actual scientific and technical development of the product; innovation also applies to the act of changing and shaping regulations and perspectives. This year’s conference really emphasized the specific tasks being carried out by members of biosimilar companies, patient advocacy groups, payers, and research organizations to change and advance perspectives.

  • CRO Partnerships 101: What Sponsors Need To Know
    CRO Partnerships 101: What Sponsors Need To Know

    Much of the focus these days, especially after the release of ICH E6(R2), has been on how Sponsors can better monitor and oversee the performance of their CRO partners. This discussion, and resulting effort, around CRO oversight is worthwhile and useful, but too often it is narrowly focused on metrics. A holistic approach to successfully partnering with CROs is needed, starting with the initial assessment of outsourcing drivers all the way through to trial completion.

  • The Evolving Reimbursement Landscape — Considerations  For Clinical Trial Design
    The Evolving Reimbursement Landscape — Considerations For Clinical Trial Design

    Sponsor companies are increasingly examining ways to integrate the payer community’s point of view into clinical development activities, a trend that could improve the chances a drug will gain market access, achieve faster adoption once launched, and better meet patient needs. With payers increasingly demanding evidence of a drug’s value before they will cover a marketed product, demonstrating both better clinical and economic benefits of a treatment takes on greater significance.

  • 4 Keys To Choosing The Right Regulatory Consultant
    4 Keys To Choosing The Right Regulatory Consultant

    I spent the first two decades of my medical device career with startups and larger OEMs, working with or hiring consultants, as needed, for support. I then became a consultant for seven years, and I saw outsourced support from the other side. Now, I want to share some perspective on outsourced support. These important relationships can make or break your business.

  • Does Your Facility Have The Location And Amenities To Attract Top Talent?
    Does Your Facility Have The Location And Amenities To Attract Top Talent?

    To come out on top, some medical device companies are dedicating more attention to the workplace as a competitive differentiator. Investing in smart real estate and facilities strategies can pay dividends in helping companies win and retain the best talent. What’s working?

  • Unpacking The Latest Brexit Developments And Their Impact On Pharma
    Unpacking The Latest Brexit Developments And Their Impact On Pharma

    As the divorce date approaches for the U.K. and the EU, one would be forgiven for thinking there would be a plan in place to deal with an event that will have such a profound global impact on the pharma industry. However, manufacturers have to prepare for any possibly scenario, while continuing to wait for clarity.

  • What Does Patient-Centricity Really Mean — And Why Do We Need It?
    What Does Patient-Centricity Really Mean — And Why Do We Need It?

    The challenge to recruit and retain numbers of patients for Phase 3 industry-sponsored trials is not new to the industry. In fact, 48 percent of sites miss their enrollment targets and 80 percent of trials are delayed due to recruitment, but there are new opportunities to achieve recruitment goals while also minimizing dropout. 

More web-exclusive editorial

 EVENTS

Writing Effective 483 and Warning Letter Responses June 19 - 19, 2018
1pm-2:30pm EDT, Online Training)
Duration:  90-Minutes
Price:  $299 - Includes Bonus Handouts!
The Core Competencies of a World-Class Medical Affairs Team June 20 - 20, 2018
1pm-2:00pm EDT, Online Training)
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DCAT Sharp Sourcing 2018 June 26, 2018
New Brunswick, NJ)
Biocontainment For Manufacturing: Understanding The Risks, Guidance, and Design Requirements June 26 - 26, 2018
1pm-2:30pm EDT, Online Training)
Duration:  90-Minutes
Price:  $299 - Includes Bonus Handouts!
Electronic Data Integrity in a GxP Environment: Managing the Data Lifecycle for Compliance June 27 - 27, 2018
1pm-2:30pm EDT, Online Training)
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JUNE 2018 DIGITAL EDITION

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