Clinical Guest Contributors
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Effective Medical Communications During CGT Clinical Trials
9/27/2022
Medical communications help crystalize the nuances of cell and gene therapies for patients and healthcare providers. For a successful cell or gene therapy launch, you'll need to draw attention to stakeholders early in clinical trials to effectively inform them of the value of the therapy in development. This article shares key tips for an effective strategy.
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How To Take Full Advantage Of RWD Without Jeopardizing Privacy Laws
9/26/2022
Biopharma companies need personally identifiable information to aggregate and analyze valuable real-world data. However, in many countries, these details are protected by data privacy laws. The EU's EHDS regulation helps clarify the situation in Europe, but other regulatory authorities will also need to clarify and articulate their positions.
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6 Best Practices For Biopharma Talent Management In 2023
9/23/2022
The Great Resignation. Inflation and the rising cost of goods and services are compelling workers in a variety of industries to seek higher salaries. This is being acutely felt in the life sciences industry. We need to revolutionize how we're approaching talent management in pharma and biopharma in order to succeed in this environment.
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Overcoming 4 Challenges In Orphan Disease Clinical Trials
9/22/2022
Developing innovative treatments for patients with orphan and rare diseases offers substantial challenges. This article shares the author's tips for recruiting from small patient populations, collaborating with the FDA, choosing to work with a CRO or not, and determining a patient-centric approach.
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Nonprofit Org Sees A New Way To Train CTA Talent
9/20/2022
Training the next generation of life sciences talent is a challenge that MassBioEd, a Massachusetts-based non-profit 501(c)(3) organization with a mission to build a sustainable life sciences workforce in the region, is working to solve. It recently created two apprenticeship programs, one of which is for clinical trial associates.
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Using RWE In Clinical Trials: Challenges & Opportunities
9/19/2022
What are real-world data (RWD) and real-world evidence (RWE), and how can we overcome the challenges of integrating them into clinical trials to produce better outcomes?
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Collaborating With Academia For Drug Discovery Targeting Immune-Mediated Diseases
9/16/2022
Last year, Janssen Biotech and the University of Oxford established a collaboration to understand pathogenic pathways driving immune-mediated inflammatory diseases. They have been creating a cellular map of expressed genes and proteins. This article shares what the collaboration has accomplished so far.
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The 5 Principles To Guide The Future Of Randomized Clinical Trials
9/15/2022
While a range of guidelines for clinical trials exists, the Good Clinical Trials Collaborative was established in 2020 to outline what “good” looks like for randomized clinical trials. The guidance is not a manual describing who, what, where, or how, but is a compass that helps users explore why a particular approach will achieve the right outcome for a robust trial.
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EU Reg. 536/2014’s Expiry Label Requirement Forces Us Backward, Not Forward
9/14/2022
In a world shifting toward advanced technology, the new EU Regulation No. 536/2014's Annex VI is forcing us back into the paper age; specifically, the new requirement to print the expiry date on the primary container label, not just the external carton label. This article describes what is now required, how we got here, and how we can move the industry forward.
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Biomarker Testing: A Key Component To Advancing Precision Medicine
9/13/2022
Biomarker testing isn’t always the standard of care for many people living with cancer today. Providers and patients need to be better educated about biomarker testing, we need a consistent standard of care across oncology institutions, and we need to advocate for equitable access to biomarker testing.