Industry Insights

31. Dispelling 4 Common Myths Of Data Quality Governance 3/9/2023

    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.

32. Emerging Partnership Trends In Oligo-Based Medicines 11/6/2024

    The oligonucleotides sector is quickly evolving and seeing more industry partnerships than ever before. We caught up with DeciBio's Carl Schoellhammer and Phillip Leclair for their analysis.

33. Getting Genomic Medicines Ready For Prime Time 2/5/2024

    Explore the benefits of building a manufacturing process early, how research into LNPs in nucleic acid therapeutics will contribute to the development of future drugs, and more.

34. 10 Things To Know Before Writing An FDA 483 Response Letter 7/6/2022

    Learn why time is of the essence when crafting a FDA response letter and remediation plan as well as the best practices for responding.

35. Guidelines For mRNA Drug Product Manufacturing And Quality Control 9/15/2023

    The lightning fast rise of mRNA raised the need for manufacturing standards and consensus on product quality attributes and test methods. This article provides perspective and insight on PQAs for mRNA vaccines and other mRNA-based products.

36. FDA Seeks Public Comment On Quality Metrics Reporting Program 3/17/2022

    The FDA recently announced it is soliciting comments on changes to its previously proposed Quality Metrics Reporting Program. This article shares which primary metrics the FDA intends to collect data on as well as the FDA's questions for input. The comment period ends June 7, 2022.

37. Combination Product QMS Requirements For The EU Market 6/30/2023

    Pharma companies are now building the capability to manufacture combination products in-house to increase flexibility and reduce dependency on third parties. This article shares key considerations for companies implementing a medical device QMS with regard to EU requirements.

38. A Biosimilar Manufacturer's Sword & Shield Against Doctrine Of Equivalents Claims 10/23/2018

    While biosimilar manufacturers face many unique challenges in patent litigation, one of the most common is an infringement action brought under the doctrine of equivalents (DOE). DOE is a principle where a party sues for infringing on the general spirit of the patent, rather than on the specific content of its claims.

39. Developing An Effective Lipid Nanoparticle Formulation Process For Small Molecule And Biologicals Delivery 3/1/2022

    Lipid nanoparticles (LNPs) are a versatile formulation technology used by drug development teams to deliver a variety of small/large molecules, peptides, and biologicals.

40. Best Practices For Designing And Running Clinical Trials For Patients With Rare Diseases 5/25/2021

    As an industry, we are constantly searching for ways to improve the drug development process – particularly in the rare disease space. One way to improve on running your rare disease clinical trial is to foster collaborative partnerships with patient advocacy organizations and to stay connected to patients throughout the trial. Here's how to do that.