GUEST COLUMNISTS

• Biopharma Partnerships: The Key To Filling The Life Sciences Innovation Gap

  The life sciences industry is facing a significant slowdown due to patent expirations. Many organizations have not established a robust enough pipeline to overcome the revenue to be lost. To bridge this innovation gap, pharma CEOs will need to expand their use of alliances, in tandem with bolt-on M&A, as a pipeline booster strategy.

• New ICH Q14 Guidance Applies QbD To Analytical Procedures

  ICH's new draft guidance (Q14) for Analytical Procedure Development describes an enhanced approach for method development, validation, and life cycle management employing elements of quality by design (QbD) and risk management tools. This article also explains the differences between this enhanced approach and the traditional approach.

• Make This Your New EU IDMP Implementation Strategy

  Just when the life sciences industry was as sure as it could be that EU Iteration 1 of ISO Identification of Medicinal Products (IDMP) implementation for centralized procedures in Europe was ready to go, the EMA announced a change of plan. Until further notice, the Digital Application Dataset Integration (DADI) user interface will be used to enable structured data submissions.

• Don’t Neglect This Drug Development Milestone: The Pre-IND Meeting

  The pre-IND meeting takes place when a sponsor presents their planned Phase 1 study design, including their proposed product development plan and regulatory strategy, to the FDA. Think of this as a necessary milestone for a quicker development timeline. This article shares best practices for preparing for the meeting as well as for the meeting itself.

• How To Evaluate & Manage Safety Risks In Biopharma

  Safety risks can be described and modelled as cause-and-effect relationships using system risk structures. This article structures risks beginning with a defined danger or threat so they can be effectively understood and then managed. Examples include wearing protective gloves (as a simple risk) and handling antibody-drug conjugates (as a complex risk).

• Small Molecule Drug Discovery: Can AI Do It All?

  The hope is that AI can solve the single most challenging problem at the heart of modern drug discovery: the reliable prediction of novel small molecule drugs that potently bind to a disease-causing protein and alter its function. This article discusses the challenges and how we can position ourselves to navigate them.

• FDA Releases Draft Guidance On CMC For Individualized ASO Therapies

  A new FDA guidance released in Dec. 2021 acknowledges the difficulties inherent in manufacturing individualized antisense oligonucleotide (ASO) treatments and offers researchers and manufacturers the opportunity to create policies and procedures that are more likely to be condoned by the FDA in an IND submission.

• 3 Keys To A Fit-For-Purpose Compliance Strategy In Decentralized Pharma

  Outsourcing and technology have morphed our industry into a new decentralized model. Now, each sponsor must carefully develop an ongoing compliance strategy considering its unique business model and its influence on the drug development journey. Strategies are needed to design QMS' that can expand and pivot in tandem with corporate and clinical development.