Contributing Editors

  1. How To Evaluate & Manage Safety Risks In Biopharma 5/2/2022

    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).

  2. Small Molecule Drug Discovery: Can AI Do It All? 4/27/2022

    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.

  3. FDA Releases Draft Guidance On CMC For Individualized ASO Therapies 4/26/2022

    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.

  4. 3 Keys To A Fit-For-Purpose Compliance Strategy In Decentralized Pharma 4/25/2022

    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.

  5. Technical Due Diligence Considerations For Multi-Site Biopharma Acquisitions 4/14/2022

    Part 1 of this 2-part article series shared considerations for standalone biopharma manufacturing facility acquisitions. This article, Part 2, shares considerations for multi-site acquisitions when the seller is manufacturing part or all its products in-house.

  6. Rare Diseases’ Cost Burden On Patients 4/13/2022

    95% of rare diseases do not have approved treatments or therapies. Patients often bear the brunt of costs directly and indirectly. By understanding the cost drivers that a lack of available treatments poses for rare disease patients, pharma companies can identify unmet needs. Drug developers can improve the cost burden using 3 strategies.

  7. Biopharma Patents: Satisfying Descriptions For Claimed Ranges 4/11/2022

    In pharma patents, ranges are often recited in patent claims to broaden the scope of the claim coverage. Claims may also include a temperature range or pH range used in making a drug. This article shares the key takeaway for industry from a recently decided court case.

  8. Tech Due Diligence: Acquiring A Biopharma Manufacturing Facility 4/8/2022

    As a consultant, this author has been approached on several occasions to perform on-site technical due diligence for facilities that his clients were considering to acquire. In this article, he shares the considerations you should keep in mind when acquiring a stand-alone biopharma manufacturing facility.

  9. A Better Path For CMO Relationships As The Pandemic Continues 4/6/2022

    In this article, we discuss how drug sponsors and service providers can better work together to continue down the path of outsourcing success that has been highlighted during the pandemic.

  10. FDA Issues Guidance On Initiation Of Voluntary Recalls 4/5/2022

    This guidance supports the requirements of 21 CFR Part 7 Enforcement Policy for drugs, medical devices, and biological products, and is being issued consistent with FDA's good guidance practices regulation. You may submit comments regarding this guidance to the agency at any time.