Increase In FDA Inspections + Whistleblower Complaints = Heightened Compliance Scrutiny
We are seeing a significant increase in manufacturing facility inspections by the FDA and other health authorities globally. We are also seeing an uptick in whistleblower complaints. Why? And how can you navigate it? This article examines the issue.
Next-Gen Nanobodies With MoonLake's Jorge Santos Da Silva, Ph.D.
Approved therapies for inflammation have fallen short for patients, says Moonlake Immunotherapeutics CEO Jorge Santos Da Silva, Ph.D. What's the problem, and why does he think his camelid-derived nanobody candidates are poised to outperform big-pharma standards from the likes of UCB and Novartis? Find out on the Business of Biotech.
Lessons From The Bone Therapeutics/Medsenic Merger
On the surface, the merger of Medsenic and Bone Therapeutics doesn't look obviously synergistic. But Francois Rieger, Ph.D., CEO of the resulting company BioSenic, says that on the scientific level, it's a perfect union. And the veteran biotech founder says the business should always follow the science.
The Potential Of RNA Exon Editing With Ascidian Therapeutics' Romesh Subramanian, Ph.D.
Cell & Gene: The Podcast Host, Erin Harris, welcomes Romesh Subramanian, Ph.D., CEO of Ascidian Therapeutics, a Boston-based biotech focused on rewriting RNA to the pod. During the episode, Subramanian defines RNA exon editing, and they discuss the differences between RNA exon editing and gene editing. With current programs in ophthalmology, neurological and neuromuscular disorders, as well as rare diseases, Subramanian explains the overwhelming potential of RNA exon editing.
TCRs In Personalized Oncology With BlueSphere Bio's Keir Loiacono
BlueSphere Bio CEO Keir Loiacono, Esq., works with a sense of urgency inspired by his own cancer journey. Business of Biotech toured Bluesphere's state-of-the-art facility, then sat down with Loiacono to learn his story and discuss the company's vision for the future of personalized, adoptive T-cell therapy.
Dispelling 4 Common Myths Of Data Quality Governance
Achieving robust data quality governance doesn't need to be an unwieldy prospect. Here, we dispel the four common myths of data quality governance and share the three phases of a good data quality governance program.
ICH Guideline Q9(R1) On QRM, Part 2: Subjectivity & Supply Continuity
The long-awaited revision to ICH’s harmonized tripartite guidance on Quality Risk Management, Q9(R1), was adopted on January 18. This article focuses on the guidance's new topics of subjectivity and the role of QRM in addressing product availability risks.
BoB@JPM: Self-Replicating RNA With Elixirgen's Akihiro Ko
Elixirgen Therapeutics CEO Akihiro Ko discusses a unique, temperature-controlled in-vivo gene expression technology designed to address common cell therapy administration challenges and unwanted, off-target immungenicity effects, shares progress on the company's ex-vivo candidate for telomere biology disorders, and more.
Automating Processes To Scale CGT Manufacturing With PA Consulting's Paolo Siciliano
When it comes to manufacturing, many cell and gene therapy companies struggle to automate the diverse processes needed to scale manufacturing. London-based PA Consulting's Associate Partner, Paolo Siciliano, talks to Cell & Gene: The Podcast's Erin Harris about how lean, small biotechs with limited resources and limited funds can strive for automation success. They also discuss what cell and gene therapy companies should do today to address tomorrow’s scalability challenges and what the long-term effects on the business may be from such upfront work.
ICH Guideline Q9(R1) On QRM, Part 1: Formality & Risk-based Decisions
The long-awaited revision to ICH’s harmonized tripartite guidance on Quality Risk Management (QRM), Q9(R1), was adopted on Jan. 18, 2023. While the primary principles of QRM in this new version remain consistent with the original 2005 document, the revised guidance has four new subsections. This article examines the topics of formality and risk-based decisions.