LSL Web-Exclusive Content

  1. Big Pharma: From Siloed To Streamlined

    For decades, large pharmaceutical companies operated in a fairly standardized manner, including their organizational structure. Big Pharma’s structure, generally, was the result of traditional corporate design formed over years of growth and expansion. As companies became larger, their decision-making procedures and other business processes also expanded.

  2. Biosimilars In Hospital Settings: What You Need To Know

    A few months ago, Biosimilar Development published an interview with Dave Picard, VP of biosimilars and injectables for AmerisourceBergen, who shared his predictions on how biosimilars will fit into hospital distribution models. Based on the popularity of that article, we decided to reach out to another leading U.S. drug wholesaler for their perspective on the topic. In this Q&A, Chadi Nabhan, M.D., VP and chief medical officer of Specialty Solutions at Cardinal Health, discusses biosimilar uptake at the hospital level — and how biosimilar companies should be planning their distribution strategies.

  3. Beyond The FDA Guidance: Practical Considerations For Quality Agreements

    Much has been written in recent months about the FDA’s final guidance for industry, Contract Manufacturing Arrangement for Drugs:  Quality Agreements, issued in November 2016.  Recently, a thorough assessment of the guidance requirements and gaps was published on this website. (See FDA's New Quality Agreement Guidance — What It Says (And What It Fails To Say) and Examining FDA's New Quality Agreement Guidance.)

  4. Building A Productive Relationship With FDA: Beyond The Science

    Whether your relationship with the FDA starts with pre-IND feedback or simply with an IND submission itself, these early interactions will likely form the basis for a long (and hopefully happy) marriage.  After all, this liaison could very well last beyond submission and initial approval of a marketing application to include additional trials relevant to the drug’s development and labeling.  As there is no manual available for building an effective and collegial relationship with the FDA, this article offers helpful tips to assist sponsors in establishing and maintaining this critical union.

  5. What Would Steve Jobs Tell The Pharma/Biotech Industry?

    Whether you’re a fan of Steve Jobs and his products or not, two things are undeniable: He was very successful and very different. Now you can relax; this short article will not provide a blow-by-blow account of the man and his methods. “What would Steve Jobs tell the pharma/biotech industry?” is just a metaphor to encourage our industry to radically change — not by reinventing the wheel, but by copying the success of others.

  6. Engaging A Life Science Consultant: Common Pitfalls & Best Practices

    This article summarizes insights gleaned from interviews with multiple consultants, each of whom has at least 25 years’ experience in the life sciences space — and from conversations with the life science companies who hire such consultants to ensure that their systems meet the product quality attribute/specification requirements mandated by their respective regulators.

  7. Is Marking Individual Doses The Future Of Anticounterfeiting?

    The last in our five-part series examining the current state of the counterfeit medicines problem. Previous stories looked at efforts to quantify the crime, examined the issue from the perspective of the industry giant Pfizer, described how an international coalition is fighting the crime, and highlighted the latest programs aimed at teaching the public how to safely shop for medicines online.

  8. Insights Regarding The Oral Arguments In Amgen Inc. v. Sandoz Inc.

    Amgen Inc. v. Sandoz Inc., is a multibillion-dollar dispute for Big Pharma companies around patent issues. Here's some expert commentary from intellectual property law firm Wolf Greenfield & Sacks, P.C.

  9. Cancer Breakthroughs: A Look to The Past Can Be A Look To The Future

    Medical breakthroughs in the treatment of cancer have arrived at an accelerated pace. Seemingly each day, a new “next-generation” technology makes headline news, or a CEO touts a treatment as a game changer. While many of these will miss, others will succeed and undoubtedly make a difference in the lives of thousands of patients and their families.

  10. What Can We Learn From 2016 FDA & MHRA Drug GMP Inspection Observations?

    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.