Cell and Gene Regulatory

  1. CMS Restructured The CAR-T DRG – What It Means For Manufacturers & 4 Strategies Forward 9/17/2021

    In August 2021, the Centers for Medicare and Medicaid Services (CMS) expanded the chimeric antigen receptor T-cell (CAR-T) diagnosis-related group (DRG). While industry generally views this change as a positive development, significant uncertainties remain as to the specific immunotherapies included and how payment will change over time. To prepare, you should adjust your launch strategies.

  2. 5 Misconceptions About Data Integrity In Pharmaceutical And Device Development & Operations 9/15/2021

    Data integrity (DI) issues in pharma and medical devices have always been there, but in my experience as a consultant, these issues have increased in frequency more recently, thus moving them to the forefront. In this article, I explain five misconceptions about data integrity in our industry.

  3. Beginner’s Guide To Minimal Risk Research 9/14/2021

    This blog aims to provide a beginner’s overview to the regulatory concept of “minimal risk,” and which regulatory flexibilities research might be eligible for.

  4. Your Full-Spectrum Gene Therapy Partner 9/13/2021

    Work with us from start to finish of your product or partner with us at any stage of your project – preclinical through commercial scale.

  5. The Andelyn Difference 9/13/2021

    For this innovative biotech organization, the patient always comes first. Inspired by two young gene therapy pioneers, we are a combination of the names of the children who participated in the momentous Phase I clinical trials at Nationwide Children’s Hospital.

  6. Understanding The 5 Elements Of cGMP 9/13/2021

    The elements of cGMP outline safety procedures for every basic part of the production process – defining what needs to be done to keep products safe, to operate machinery properly, to validate processes, and to maintain consistent procedures.

  7. Stop Managing Paper In A Data-Driven World 9/3/2021

    Many life sciences companies have implemented manufacturing information systems as part of their automated manufacturing initiatives aimed at increasing product quality and lowering manufacturing costs however, paper production records and a hyper-focus on compliance remain a reality for many emerging and mid-market companies. This paper explores how companies that shift from paper to data-driven intelligence are able to better leverage manufacturing data to improve the reliability of their quality metrics and support their regulatory compliance and business improvement efforts.

  8. The Next Generation Of the Number One Enterprise Quality Management System (QMS) 9/2/2021

    MasterControl has been delivering quality excellence for over 25 years. We continue to improve our quality management solution to meet the needs of highly regulated industries - like life sciences - as they embrace new levels of digitization and automation and require quality management practices that are more dynamic, connected and scalable.

  9. What Is An IND And Why Do I Need One? 8/30/2021

    This infographic explores the purpose of the IND, their types, the format, what the FDA really cares about, and how the applications are approved by the FDA.

  10. Referencing A Listed Drug For The 505(b)(2) Pathway 8/27/2021

    Section 505(b)(2) of the Food, Drug, and Cosmetic Act describes a 505(b)(2) new drug application (NDA) as an application where at least some of the information required for approval comes from studies not conducted by or for the applicant and for which the applicant has not obtained a right of reference.