05.17.21 Are You Ready For The FDA s Data Effect Tsunami? 8 Steps To Prepare
State-of-the-art continuous manufacturing technologies are being developed and implemented to manufacture a wide variety of products. Several vendors offer development-scale to commercial-scale continuous downstream chromatography systems. When adopting continuous technology, it is critical to demonstrate that continuous downstream processes are comparable to batch-mode downstream processes and provide the supporting comparability data for technical and business decisions. Access the case study to learn more.
Featured Editorial
By Matt Collins, Cignyl, and John Giantsidis, CyberActa, Inc.
The FDA is moving forward with its Data Modernization Action Plan (DMAP), the next leg of the Technology Modernization Action Plan. Why is this a tsunami? Because you ll need to prepare yourself for the influx of questions, audits, observations, warning letters, and more! He
01.25.21 Research Report Shows Phase II/III Spending Will Increase
Continuing our Cell & Gene Series,
Business of Biotech features Dr. Bobby Gaspar, Orchard Therapeutics CEO, speaking on the challenges his company faces in the production of hematopoietic stem cells to treat neurometabolic disorders, primary immune deficiencies, and blood disorders. Listen now and subscribe so you never miss an episode.
Featured Editorial
Research firm Industry Standard Research recently published its
Phase II/III Study Trends and Market Outlook report. The goal of this report is to provide readers with a high-level view of the Phase 2 and 3 clinical development space to illustrate current market dynamics and inform strategic planning.
12.21.20 Lilly, Care Access Take COVID Trial Directly To Patients
Introducing WCG IRB We’re combining best-in-class capabilities to raise the bar for our industry. Building on our 52-year legacy of expertise and service, our five industry-leading IRBs are now WCG IRB one unified team protecting human research participants and delivering a seamless review experience. Together at the forefront of research we are reshaping the future of ethical review with our unified experience and revolutionary new submission platform. Empowering research and advancing health.
Featured Editorial
By Ed Miseta, chief editor, Clinical Leader
Eli Lilly and Company and Care Access Research have forged a unique partnership to develop and manage a first-of-its kind decentralized, mobile trial to safeguard the health of patients in nursing homes. Lilly and Care Access will take the trial directly to patients.