GUEST COLUMNISTS

• Navigating Claim Scope For Functionally Claimed Biological Compounds After Amgen v. Sanofi

  It can be difficult for broad biological compound claims to meet the two requirements in patent law that are used to “police” claim scope: the enablement requirement and the written description requirement. This article discusses the future of these types of patent claims after two Federal Circuit cases, Amgen v. Sanofi and Juno v. Kite.

• 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.

• Draft FDA Labeling Guidance Proposes More Clarity For Providers

  The FDA's draft guidance for prescription and biologic drugs updates a 2010 guidance and comes following the boom of activity in the biologics space.

• 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.

• 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.

• Strategic Procurement For Emerging Pharmas & Biotechs

  Emerging pharma and biotech companies depend significantly on suppliers, from initial discovery to clinical trials and regulatory approval. As a result, the sourcing and procurement function requires a strategic mindset aligned with business goals to drive an efficient purchasing process throughout the entire supply chain.

• Expanding Treatment Options With Oral Therapies For Immune-Mediated Inflammatory Diseases

  One of the greatest advancements in treating immune-mediated inflammatory diseases (IMIDs) has been the advent of targeted biologic injectable therapies that target cytokines. However, oral cytokine inhibitors hold significant promise as next-generation options, offering the potential for improved safety, durability, and adherence.

• Resistance Or Defiance? The FDA And The 11th Circuit Spar Over Statute On Orphan Drug Statutory Exclusivity

  Last September, the 11th Circuit Court of Appeals sided with a challenge to the FDA’s long-standing interpretation of the Orphan Drug Act by broadening the scope of orphan drug exclusivity under step one of the Chevron legal analysis. But the FDA has pushed back.