Nate Edwards of Arya Consulting moderates a discussion with Elisabeth Gardiner of Tevard Biosciences and Donny Xu of the RTW Institute about the regulatory and manufacturing hurdles facing rare disease drug developers.
|Articles|May 15, 2017
- BioPharm International-05-15-2017
- Volume 2017 eBook
- Issue 1
Quality Metrics and CMO Agreement
FDA’s focus on the quality culture and its request for quality metrics may ensure a successful company-CMO relationship.
Advertisement
As Naheed Sayeed, Ajay Pazhayattil and Jena Spes of Apotex write, FDA’s guidances on quality agreements and quality metrics came at just the right time to address ongoing issues. Both guidances should benefit the industry, but, above all, the consumer, by establishing a framework for developing a culture of quality.
Articles in this issue
over 9 years ago
Customer Relationship Management in Contract Manufacturingover 9 years ago
Getting Biopharmaceutical Tech Transfer Right the First Timeover 9 years ago
CMOs Tackle New Challengesover 9 years ago
Gearing Up for Biosimilarsover 9 years ago
Insourcing vs Outsourcing: Choosing the Right Strategyover 9 years ago
Operations and Quality Oversight of CMOsAdvertisement
Related to this article
Rohit Tripathi, vice president of industry strategy, consumer packaged goods, and manufacturing at RELEX Solutions, explains where cold-chain planning still breaks down and why biopharma supply chain leaders should use AI to act on data sooner, with humans making the final call.
Alexion’s ravulizumab won accelerated approval to reduce proteinuria in adults with IgA nephropathy after the Phase 3 I CAN trial showed a 43.4% placebo-adjusted reduction at Week 34.
Rohit Tripathi, vice president of industry strategy, consumer packaged goods, and manufacturing at RELEX Solutions, explains what is driving biopharma reshoring, how USMCA uncertainty complicates sourcing for biologics, and where cold-chain visibility still breaks down.
Nuravax will test AV-1959R in a 160-adult phase 2 trial to see whether the amyloid vaccine can prevent Alzheimer disease before symptoms begin.
The FDA approved Roche's satralizumab (Enspryng), an IL-6 receptor-targeting monoclonal antibody, for adults with thyroid eye disease based on the Phase 3 SatraGO-1 and SatraGO-2 trials, giving patients the first at-home subcutaneous treatment option.
Advertisement
Advertisement
Trending on BioPharm International
1
Treasury Proposes Adding Biotech to Outbound Investment Restrictions Under COINS Act
2
FDA Approves On-Body Injector Induction for Skyrizi in Crohn's Disease
3
The BioPharm Brief: Gilead’s Oral IL-23R Bet, Roche’s Trispecific Deal, and Treasury’s Biotech Investment Proposal
4
Zymeworks Licenses DLL3-Targeted Trispecific T-Cell Engager ZW209 to Roche in Deal Worth Up to $813 Million
5