Regulatory Affairs Editorial

  1. How To Conduct Better GCP Audits (Even When You Feel Like An Impostor)
    8/22/2019

    How many of us drive to work every day? How many of us know the route so instinctively that we no longer think about where we have to go? It’s easy, right?

  2. Rebiotix Works With Regulators To Define A New Clinical Pathway
    8/14/2019

    Rebiotix, a Ferring company, hopes to revolutionize the treatment of debilitating diseases by harnessing the power of the human microbiome. The company is developing their proprietary MRT drug platform, which uses a defined manufacturing process and quality control parameters to assess the impact of human-derived microbiota therapies on patient health and disease.

  3. GenSight Uses Gene Therapies To Target Neurodegenerative Diseases
    8/1/2019

    GenSight Biologics believes it is on the cutting edge of ophthalmology, gene therapy, and drug development. The company is focused on finding treatments for patients with neurodegenerative diseases and is developing products that are a combination of gene therapy, its mitochondrial targeting sequence technology, and optogenetics.

  4. 3 Surefire Approaches To SOP Harmonization
    7/25/2019

    We seem to be buried in standard operating procedures (SOPs). So how the heck are companies supposed to make the SOP mountain smaller through harmonization?

  5. A Tactical Approach To Risk Management At The System-Level
    7/10/2019

    Many biotechnology/pharmaceutical organizations are in the early stages of developing their risk management process. For the most part, we tend to see this process developing at the clinical trial level. The struggle with implementing these practices solely at the trial level is that it quickly becomes inconsistent and obsolete. Study teams are taking the time to assess risk as it applies to their trial, but the information gained is seldom shared cross-functionally or upward through an organization. It is more of a “going through the motions” type practice — which is then filed away, never to be utilized again.

  6. 4 Key Ingredients Of A Robust Risk Management Framework
    5/16/2019

    It is certainly no surprise that risk management continues to hold the spotlight as a hot topic within the biotechnology/pharmaceutical industry. With the increased focus by regulatory authorities on an organization’s ability to identify, mitigate, and control risks, the industry remains in a state of growth, developing and evolving practices to ensure proper alignment with industry best practices and regulators’ expectations. Many organizations are finding it difficult to establish and embed risk management practices, as doing so requires a paradigm shift from a traditional risk-averse industry culture.

  7. 3 Powerful Writing Tips that Will Significantly Improve Your Clinical SOPs
    4/18/2019

    In addition to my career as a pharma industry consultant, I’m a writer. While I don’t claim to be the next Ernest Hemingway, I do consider myself a decent writer. I’ve put in the 10,000 hours of writing Malcolm Gladwell told us it takes to be an expert in his 2008 book, Outliers: The Story of Success. I’ve always had a passion for writing. At 24, I made a serious commitment to become a real “writer.”

  8. New FDA Guidance Answers Questions On RBM Use
    3/27/2019

    In August 2013, the FDA produced guidance on Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring. In March 2019, the agency produced an eight-page question-and-answer draft guidance seeking to provide additional insights and facilitate sponsors’ implementation of RBM.

  9. Follow The Leader: Why Clinical Development Must Transition From Pharma-Led To Patient-Led
    3/12/2019

    “Patient-led drug development” has matured in recent years from an industry buzzword to a maxim practiced in pockets of pharma organizations each day. Yet, much more can be learned by looking through the patient lens, deeply considering their needs, and focusing on their quality of life. In recent years, companies have galvanized their efforts to develop additional methods for gathering patient input, to redesign clinical programs that improve patient experiences, and to track surrogate measures of “patient-centricity” at key stages.

  10. FDA Form 1572 And Non-U.S. Clinical Trials: To Complete Or Not To Complete?
    2/28/2019

    As Bob Dylan sang many years ago, “For the times they are a-changin,”1 could be the motto of drug development. Regulations, requirements, and enforcement practices have changed, and industry professionals strive to maintain awareness in order to be compliant. As the number of clinical trial site locations outside of the U.S. has increased — driven by untapped populations, faster recruitment, and lower costs,2 — the challenges have added up. Regionally, the required or anticipated documentation and enforcement of those requirements has changed over time. One document that has recently garnered attention is the FDA Form 15723 and specifically its use by non-U.S. investigators.