ALSO IN THIS MONTH'S ISSUE

  • Republicans Forsake Fiscal Restraint And Market-Based Healthcare
    Republicans Forsake Fiscal Restraint And Market-Based Healthcare

    In an incredible show of profligacy, Republicans forsook any notion of fiscal conservatism by substantially increasing discretionary spending by over $2 trillion over the next decade, less than two months after cutting taxes by $1.5 trillion over that same time period.

  • 2018 Likely A Banner Year For IPOs
    2018 Likely A Banner Year For IPOs

    2018 will be a good year for IPOs and for financing. Rounds are larger and non-traditional investors are turning to life sciences.

  • How To Survive The Perilous Life Sciences Startup Climb
    How To Survive The Perilous Life Sciences Startup Climb

    According to Noubar Afeyan, founder and CEO of Flagship Pioneering, his company shouldn’t be pigeonholed as a VC firm. ““From day one, our intent was to innovate and create new companies.” 

  • The Art Of Leadership
    The Art Of Leadership

    Former Pfizer exec and current partner at VC firm Polaris Partners Amy Schulman talks about what it takes to lead a pharma startup.

  • Navigating The Turbulent Waters From Discovery To Clinical
    Navigating The Turbulent Waters From Discovery To Clinical

    “A partnering deal with a bigger pharma company would certainly help us through [the Phase 3] process,” explains Jeff Davidson, CEO of Keystone Nano, a company that develops nanoparticles that target solid tumors by going after cancer cells and leaving the normal cells intact.

More from this month's issue

BEYOND THE PRINTED PAGE

More beyond the printed page articles

WEB-EXCLUSIVE EDITORIAL

  • As Cancer Immune Therapies Advance, 4 Biomarker Trends To Watch
    As Cancer Immune Therapies Advance, 4 Biomarker Trends To Watch

    Despite progress, the current patient response rates and side effects associated with immunotherapies have created a sense of urgency to more accurately identify which patients would most benefit from a particular treatment option.

     

  • 3 Tips To Get The Best Bang For Your Mock Inspection Buck
    3 Tips To Get The Best Bang For Your Mock Inspection Buck

    Many sponsors and CROs conduct mock inspections to determine organizational inspection and audit readiness. Investing in a regulatory mock inspection demonstrates a serious commitment to patient safety, data integrity, and regulatory compliance. It is also a proactive strategy to safeguard financial health, particularly for startups and companies with sparse pipelines.

  • Take A Page From Amazon’s Playbook To Transform Clinical Trials
    Take A Page From Amazon’s Playbook To Transform Clinical Trials

    Since my first Amazon article, readers contacted me about Amazon-like transformations in clinical research. I never expected clinical research trends to emulate Amazon’s playbook.

  • Doctors And Researchers Attempt To Stop Right-To-Try Legislation
    Doctors And Researchers Attempt To Stop Right-To-Try Legislation

    A group of academics who work at the intersection of drug development and medical ethics are jumping into the kerfuffle over proposed Right To Try (RTT) legislation, noting they are deeply concerned about the ramifications of a federal RTT law for patients and families. In a letter to the leadership of the House of Representatives’ Energy and Commerce Committee health subcommittee, the group notes it has “strong opposition’ to the pending legislation.

  • Why You Should Engage With Regulatory Early In Product Development
    Why You Should Engage With Regulatory Early In Product Development

    The transition from research to product development is a bit more involved than simply adding “&D” to “R.” Involving regulatory affairs early in the development process facilitates definition and execution of the development pathway while considering both regulatory requirements and the company’s business needs.

  • Beyond Pricing: Can Biosimilars Compete On Value?
    Beyond Pricing: Can Biosimilars Compete On Value?

    In recent years, the growth in U.S. drug spending has become a hot-button issue. Data released in 2017 by the pharmacy benefit manager (PBM) Express Scripts illustrates which drugs account for the increased spending. In 2016, spend on so-called specialty drugs, a class that contains many biologics, grew by over 13 percent, while spend on traditional drugs actually declined by 1 percent. Five of the top 10 earning drug therapies in the U.S. in 2016 were biologics.

  • #MeToo & Time’s Up — Parallels To Reporting Of GMP Compliance Issues
    #MeToo & Time’s Up — Parallels To Reporting Of GMP Compliance Issues

    #MeToo and Time’s Up are spotlighting illegal, unethical, improper, and undesirable behaviors and showing that well-established people and businesses can be toppled by their actions. Illegal, unethical, improper, and undesirable behavior exists in the GMP world, too, and we’ve been warned as well.

  • Stop Ignoring Your Top Performers
    Stop Ignoring Your Top Performers

    Today’s healthcare leaders must carefully decide how to spend their time — and be clear about what will come off their plate. Unfortunately, even the best leaders may inadvertently take the wrong things off the priorities list.

More web-exclusive editorial

 EVENTS

Cell Therapy: Process Design Considerations To Support Commercialization February 27, 2018
1pm-2:30pm EST, Online Training)
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
FDA Regulations for Analytical Instrument Qualification and Validation: Comprehensive Best Practices March 1, 2018
1pm-2:30pm EST, Online Training)
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Authoring and Implementing Standard Operating Procedures (SOPs): Best Practices for Success March 6, 2018
1pm-2:30pm EST, Online Training)
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Clinical Study Requirements – Understanding Differences Between the US and EU March 7, 2018
1pm-2:30pm EST, Online Training)
Price:  $299 - Includes Bonus Handouts!
Quality Agreements & FDA – What You Must Know to Comply with the 2016 Final Guidance March 13, 2018
1pm-2:30pm EST, Online Training)
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
More events....

FEBRUARY 2018 DIGITAL EDITION

2017 CMO & CRO AWARDS EDITIONS

   

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