Industry Insights

51. Risk Management Planning: Be Prepared When Disaster Strikes 4/1/2025

    Few life sciences companies are ready for a disaster, particularly a cyber one. Key factors include an integrated approach to cyber preparedness and risk planning, a dedicated team, and more.

52. Are You Considering Serialization Processes When Choosing Your CDMO Or 3PL? 10/16/2024

    When choosing your trading partner (CDMO or 3PL), an important element that can be overlooked is serialization and DSCSA compliance. Ensuring these partners can meet requirements is critical.

53. FDA's 2021 Focus Areas Of Regulatory Science: 5 Trends To Watch 3/19/2021

    Examine key elements from the report “Advancing Regulatory Science at FDA: FARS” that provide meaningful regulatory insight on new and emerging approaches to drug development and governance.

54. FDA Priority Voucher Program Submissions Window Opens On New Website 7/29/2025

    The Commissioner's National Priority Voucher program is accepting applications. Experts predict brisk competition since the agency is only awarding five vouchers for now.

55. Tracking 4 Payload Trends In Drug Delivery Development 1/22/2024

    Amid new research and development in nanocarriers, market attention has shifted toward payloads and enhancing compatibility. This discussion explores the latest trends and includes a research database.

56. AI And Blockchain Will Take Center Stage At DIA 2019 5/30/2019

    A Q&A with Sudip Parikh, PhD, senior VP and managing director, DIA Americas

57. EU MDR Implementation Challenges: Harmonized Standards, Common Specifications, And Risk Management Changes 10/22/2018

    Harmonized standards need to be reviewed and revised to reflect requirement changes under the MDR and IVDR. The creation of Common Specifications, as well as changes to ISO 14971, further complicate the transition for med device manufacturers.

58. The Business Case for Healthcare Compliance Programs for Emerging Companies 6/9/2023

    For emerging drug and medical device companies on a tight budget, an effective healthcare compliance program can actually save precious resources by establishing better oversight, controls, and monitoring of the company’s quality, R&D, clinical, and market access activities. Such a program should be implemented in pre-commercial stages and will prepare you for the regulated future ahead. 

59. How Novartis Developed An Agile Approach To Rapid Study Startup 9/13/2018

    Over the last four years, the U.S. Medical Operations group of Novartis Oncology — in collaboration with internal clinical partners — has been transforming the study startup process for Novartis-sponsored studies.

60. The 8 Key Takeaways For FDA Inspections In The Food And Drug Omnibus Reform Act 2/7/2023

    With President Biden’s signature, the Food and Drug Omnibus Reform Act of 2022 (FDORA), part of the larger Consolidated Appropriations Act of 2023, became law on Dec. 29, 2022. FDORA expands and modifies the inspection authority of the FDA in several key areas, including alternative tools to inspection, mutual recognition agreements, bioresearch monitoring, and more.