Regulatory

  1. Genentech Masters Breakthrough Therapy Designation
    6/7/2017

    Genentech has garnered 15 Breakthrough Therapy Designations for its medicines since 2013, which is more than any other company. Jeffrey Siegel, senior group medical director for Genentech, believes this success reflects the company’s focus on developing new approaches to address unmet medical needs.

  2. The Importance Of Harmonizing Tariff Classification For Clinical Trial Supplies
    5/26/2017

    Trade tariffs can significantly impact the cost of importing and exporting investigational products and ancillary supplies for clinical trials. As such, it is important that companies consider harmonized tariff classification to ensure no money is left on the table.

  3. Beyond The FDA Guidance: Practical Considerations For Quality Agreements
    5/19/2017

    Many sponsors, particularly small to midsize organizations, opt to use their CMO’s boilerplate quality agreement. These agreements in many cases are compliant with the standards, but they usually lack many of the practical details to ensure an effective relationship with clear expectations.

  4. Building A Productive Relationship With The FDA: Beyond The Science
    5/17/2017

    At the end of the day (or several years), sponsors and the FDA ideally work collaboratively during the drug development process, having a shared public health goal of making safe, effective, and high-quality drugs available to the American public as quickly as possible.

  5. Enforcement & Regulatory Responses To The Pharmacy Benefit Manager Debate
    5/16/2017

    The first part of this article introduced pharmacy benefit managers (PBMs) and their business model and explored the monopolization concerns in this market. The focus now turns to state and federal actions regarding PBMs.

  6. Biopharma IPR Trends
    5/9/2017

    It has been almost five years since post-grant proceedings, including inter partes reviews (IPR), were implemented under the America Invents Act as an alternative to patent litigation for challenging granted patents. Taking place before the Patent Trial and Appeal Board (PTAB) at the U.S. Patent and Trademark Office, these proceedings quickly gained the reputation of being patent “death squads,” because they resulted in surprisingly high rates of patent cancellation and therefore became a complement to most patent litigations.

  7. What Can We Learn From 2016 FDA & MHRA Drug GMP Inspection Observations?
    5/2/2017

    This article presents the most recent GMP inspection data from CDER and MHRA (Medicines and Healthcare Products Regulatory Agency).  The CDER data and the MHRA data come from GMP inspections conducted in 2016.

  8. Impact Of International Trade Regulations
    4/26/2017

    The significant number of national and international trade regulations are challenging for the development of logistics strategies for global clinical research. Identifying the similarities, differences and obstacles pharmaceutical companies face while importing and exporting medicinal products for clinical trials creates an opportunity to streamline the process, remove barriers, and improve efficiency.

  9. CMS’ Coverage Gap Is A Significant Challenge For Biosimilars
    4/26/2017

    Today it is hard to read anything about specialty drugs without a mention of the potential cost savings offered by biosimilars. Estimates of their potential savings vary – on the high end, some estimates suggest a savings of $66 billion by 2024.1 While stakeholders from patients to physicians, payers, and policymakers would like to realize the full potential of biosimilars in the United States, the challenge that remains is ensuring that reimbursement incentives are adequate to ensure their uptake and long-term utilization.

  10. Trump’s Deregulatory Agenda: What It Could Mean For Biopharma & Medtech
    4/20/2017

    Within just a few days of taking office, President Trump launched his deregulatory agenda, and he has now issued several executive orders that build on each other. This article analyzes the executive orders and the Office of Management and Budget’s implementation guidance to agencies — and offers insights on their implications for the FDA and innovators.