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

  • Pharma’s Battle To Stamp Out Transparency Laws
    Pharma’s Battle To Stamp Out Transparency Laws

    States are moving to control rising drug prices, and pharma is fighting back.

  • What’s Next In Patient Engagement?
    What’s Next In Patient Engagement?

    Patients have an irrefutable role in shaping the care they need. We have come a long way since the days when the idea of involving patients in healthcare product development was controversial, if not unheard of. In recent years, the healthcare ecosystem, and the role patients play in it, has evolved in a promising direction, leading to a much deeper understanding of the impact the patient voice can and should have in healthcare.

  • Writing Bulletproof SOPs: Best Practices For Life Sciences Companies
    Writing Bulletproof SOPs: Best Practices For Life Sciences Companies

    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.

  • 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.

  • Market Access Impediments: Where Should Biosimilars Go From Here?
    Market Access Impediments: Where Should Biosimilars Go From Here?

    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).

  • 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.

More web-exclusive editorial

 EVENTS

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)
Price:  $299 - Includes Bonus Handouts!
Right to Try Legislation: Impact on Industry, Health Authorities, and Patients June 28 - 28, 2018
1pm-2:30pm EDT, Online Training)
Duration:  90-Minutes
Price:  $299 - Includes Bonus Handouts!
Electronic Informed Consent (eIC): How The FDA/OHRP Final Guidance Affects You July 11 - 11, 2018
1pm-2:30pm EDT, Online Training)
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
More events....

JUNE 2018 DIGITAL EDITION

THE 2018 BIOPHARMA MANUFACTURING EBOOK

 

2018 CMO & CRO AWARDS EDITIONS

   

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