Guest Columns

  1. Are Regulatory Agencies Prepared For A Rapidly Aging Population?
    12/10/2018

    Despite changing demographics in aging populations, regulatory guidance specific to drug development for geriatrics has been limited, with guidances dating back to the 1990s.

  2. Cybersecurity Among Biggest Challenges For Pharma Firms Incorporating Digital Health Technologies
    12/7/2018

    This is the second of two articles focusing on the issues that pharma companies face when moving into the digital health space. In the first installment, the development process, agency guidance, and the type of quality oversight needed for software incorporated into medical device and combination products were explored. This part focuses on the importance of cybersecurity and software maintenance, how time scales and methods of execution differ from those in traditional pharma, how agile software development works, and how to avoid potential pitfalls.

  3. Cardiac Stem Cell Controversy — 3 Important Lessons Learned
    12/6/2018

    Heart problems have touched many of our lives, or the lives of those we care about. Heart attacks and heart failure are leading killers in the U.S.,1 with limited treatment options available today. Typically, a heart attack is followed by significant heart muscle cell death, leaving the organ in a weakened state and the patient at risk of cardiovascular dysfunction and eventual heart failure. This leads to many of the deaths attributed to cardiovascular disease.

  4. Data Integrity, Startups, & Cloud Storage: Don’t Let This Happen To You!
    12/5/2018

    Data integrity is of paramount importance to ensure patient health and safety and to improve shareholder value, particularly for virtual companies. Startups finding themselves in the throes of managing complex drug development programs realize they may face great risk if they do not begin with the end in mind and integrate data integrity practices early on.

  5. Continued Process Verification And The Validation Of Informatics Systems For Pharmaceutical Processing
    12/3/2018

    This article, written by members of the BioPhorum Operations Group (BPOG) Continued Process Verification (CPV) Informatics team, summarizes their collective experience in validating the informatics components of their CPV programs, to shed light on common issues and provide recommendations and best practices.

  6. The Brexit Deal And Its Impact On The Pharmaceutical Industry
    11/30/2018

    According to trade groups, approximately 45 million packs of medicines leave the U.K. for Europe every month, and 37 million go in the opposite direction. In a year, that’s almost 1 billion packs of medicines. What those borders would look like after a Brexit deal would significantly impact major industries in the U.K. and EU economies.

  7. How To Pay For CAR T? Reimbursement Insights For Cell & Gene Therapy Developers
    11/29/2018

    While recent scientific breakthroughs for regenerative cell therapies are bringing great hope to patients and providers in desperate need of treatments and cures, they have created a major question mark for the healthcare system at large. How do you determine payment for something of enormously high value that has literally never existed before?

  8. Biopharma Quality Systems Need Revamp To Accommodate Digital Health Tech
    11/28/2018

    As biopharmaceutical companies develop and market more medical devices and combination products with digital health components, the FDA and industry experts caution about regulatory and business risks.

  9. Top 5 Ways To Get The Most Out Of A Supplier Audit
    11/27/2018

    Your outsourcing may come in the form of manufacturing of a sterile injectable, tablets, or topical dosage form or it may be GMP product release and stability testing. The product may need to be stored under controlled temperature and humidity conditions and then distributed to locations around the globe. The suppliers you choose to execute these critical operations are of paramount importance to your company’s success.

  10. Advanced Auditing Strategies To Detect Data Integrity Risks
    11/26/2018

    The growing reliance on increasingly sophisticated digital systems means that issues relating to data integrity are increasingly complex. As a result, auditing is more critical than ever.