Industry Insights

  1. Blockchain’s Evolving Role In The Life Sciences Supply Chain

    The primary business case for blockchain in the pharmaceutical industry is its ability to serve as a “ledger of truth” when complex information needs to be shared with business partners across the supply chain, including those unique to life sciences, such as regulators, pharmacy benefit managers, and contract manufacturers.

  2. Should You Rotate Disinfectants? Industry Experts Weigh In

    Whether to rotate disinfectants has been debated in the pharmaceutical industry for years. This article discusses the concept of disinfectant rotation and the current mainstream industry practices.

  3. Will Biosimilars Trigger The Next Wave Of Blockbuster Biologics?

    In light of increased development and demand for biosimilars, as well as looming patent expiries, biologic developers are racing to release the next blockbuster biologic to replicate the success of past top-performers like Humira, and to prevent biosimilars from cannibalizing their market share.

  4. FY2017 FDA Drug Inspection Observations And Trends

    This article presents the most recent publication of GMP drug product inspection data from the FDA's Center for Drug Evaluation and Research (CDER), which addresses drug inspections conducted in FY2017. It looks at five years of data from the FDA, examines data from 2017, and evaluates five years’ worth of trends in GMP inspection enforcement.

  5. Principles of Technology Transfer

    In the context of contract drug development and manufacturing, transfer of technology is defined as “a logical procedure that controls the transfer of any process together with its documentation and professional expertise between development and manufacture or between manufacturing sites.” It is the systematic procedure that is followed to pass the documented knowledge and experience gained during development and or commercialization to an appropriate, responsible party.

  6. The Sunshine Act - It's Finally ‘Official’

    So now that the long wait is over for the final rule, where do you go from here? On February 8th, 2013 the final rule of the Physician Payment Sunshine Provision (PPSP aka "Sunshine Act") was released by The Centers for Medicare and Medicaid Services (CMS). By Kevin Williams

  7. Measuring The Impact Of Reforms On India’s Clinical Trial Environment

    The clinical trial environment in India has seen a downward trend since 2013, when the government approached the Supreme Court regarding the death of 2,644 volunteers during clinical trials over seven years.

  8. Latin America Offers Welcoming Entry Market Amid Tighter EU Regulations

    In the past, regulatory requirements that were laxer than U.S. rules made the EU almost a no-brainer as an entry market for many medtechs. However, the advent of the MDR and IVDR has tightened EU regulations and added implementation challenges. Are Latin American markets the answer?

  9. Will Biosimilars Solve The Insulin Cost-Conundrum In The U.S.?

    The debate on drug pricing is raising questions about why U.S. patients pay some of the highest fees in the world to access prescription medicines. Politicians are putting manufacturers of insulins under particular scrutiny.

  10. The Value Of Digital In Biopharma

    By working together across the biopharma industry, digital technology can be leveraged and data science can reengineer key elements of the drug manufacturing process to ease commercial scale-up.