04.19.21 How To Navigate Compliance With FDA s 21 CFR Part 11
CUE Biopharma CEO Dan Passeri, JD joins the
Business of Biotech to discuss the development of their Immuno-STAT platform for the selective targeting and alteration of T cells. Passeri shares how the CUE-100 series of candidates in its pipeline are being developed to address a scourge of HPV-related head, neck, and other cancers. Listen now and subscribe so you never miss an episode.
Featured Editorial
By Kyle Neuman, SAFE Identity
21 CFR Part 11, the FDA s regulation on electronic records and electronic signatures, causes sleepless nights for many quality control experts and directors of regulatory compliance at CROs and pharma companies. How can you ensure compliance with this regulation?
04.07.21 AI Speeds Patient Recruitment At Health Quest
On this episode of
Business of Biotech, Nevan Charles Elam, J.D., founder of Rezolute Bio, shares the company s rationale for pursuing congenital hyperinsulinism and diabetic macular edema therapeutics by leveraging monoclonal antibodies (mAbs) and discusses the company s approach to process development and manufacturing. Listen now and subscribe so you never miss an episode.
Featured Editorial
By Ed Miseta, chief editor, Clinical Leader
Artificial intelligence (AI) has the potential to disrupt and revolutionize many aspects of clinical trials. One area in which it is already making an impact is patient recruitment. Mining electronic medical records (EMRs) for patients meeting inclusion and exclusion criteria can be tedious and time-consuming work but is a chore that seems ideal for an AI solution.
02.17.21 Why Did Veeva Become A Public Benefit Corporation?
With the spread of SARS-CoV-2 (COVID-19) intensifying, scientists, together with pharmaceutical companies, are reinventing the approach of how to bring life-saving drugs to market. Attend this webinar to learn more about bringing life-saving drugs to market faster without impacting product quality, safety, or efficacy and the impacts and comparisons of classic platforms vs. new-generation platforms. And more!
By Ed Miseta, chief editor, Clinical Leader
On February 1, 2021, Veeva Systems officially became a Public Benefit Corporation (PBC). With this move, it becomes the first technology company supporting life sciences to transition to a PBC and it is also the first publicly traded corporation in any industry to make that move. How will the designation benefit the company?
01.28.21 When Pharmaceutical Automation Projects Fail: Averting Disaster Through Risk Assessment
With the spread of SARS-CoV-2 (COVID-19) intensifying, scientists, together with pharmaceutical companies, are reinventing the approach of how to bring life-saving drugs to market. Attend this webinar to learn more about bringing life-saving drugs to market faster without impacting product quality, safety, or efficacy and the impacts and comparisons of classic platforms vs. new-generation platforms. And more!
By Tim Sandle, Ph.D., Bio Products Laboratory Ltd.
Automation does not always result in success, and poor automation can be as damaging to the pharmaceutical organization as no automation at all. This article addresses what happens when automation goes wrong and how mistakes can be avoided by adopting a risk-centric approach.
12.15.20 Cleaning Process Development: Time To Clean Studies & The Cleaning Assurance Level For Pharmaceutical Products
ISR’s Health Panel includes managers, directors, executives, and subject matter experts in clinical development and drug manufacturing who work at pharma companies, service provider companies, and research sites. Members are paid for their time (a 15-minute survey may be $40, whereas a 45-minute phone interview may be $150) and they get to choose which research opportunities to participate in. Apply here.
Featured Editorial
By Ruijin Song and Andrew Walsh, Center for Pharmaceutical Cleaning Innovation (CPCI)
A simple time-to-clean study can provide a rapid and efficient way to evaluate the behavior of a product during cleaning and obtain a reasonable estimate of the actual amount of time needed to achieve acceptable cleaning.