Regulatory Articles. App Notes, Case Studies. & White Papers

51. bluebird Bio's Scott Cleve On New Therapies, New Regulatory Approaches 10/4/2021

    bluebird bio's Scott Cleve sat down with The Business of Biotech podcast to talk about shifting regulatory standards and how pharmas can adapt how they engage with regulators.

52. How Fulcrum Therapeutics Protects Its Data 4/20/2021

    Maintaining GxP compliance, creating a secure environment for collaboration, and ensuring there is a single source of truth are becoming more and more of a hassle. Read how Fulcrum has turned to technology to help automate many of these processes in order to streamline collaboration with third-parties and the organization of data into a single repository.

53. Current Data Privacy Regulations Impacting The Life Sciences Industry 4/20/2021

    The GDPR is a significant advancement of consumer data protection rights. The European member states agreed to a set of principles that would penalize organizations that don’t safeguard personal identifying information (PII). If your team or clinical trial operates in the EU, California, S Korea, Australia, or a dozen other countries, your data could be subject to strict privacy laws. Violating GDPR, PIPA, APP, or CCPA, among others, have serious consequences for your program. Learn how to mitigate risk and keep on the right side of regulators.

54. Q&A: Achieving BLA Success Using A Structured Approach 1/19/2021

    Drs. Jason Osman and John McGuire from Lonza Pharma & Biotech answer attendee questions from a recent webinar about Lonza’s structured approach to developing a CMC strategy.

55. Best Practices Guide To Data Privacy In Clinical Trials 1/6/2021

    As life sciences companies grow, so do the regulatory compliance requirements. These responsibilities extend beyond conventional health-related frameworks and into the realm of data privacy as well.

56. 3 Ways To Survive The Shifts In Life Sciences 1/6/2021

    Over the past 20 years, the life sciences industry has undergone massive changes, and new software and partners have emerged. There are three key ways that business can serve the dynamic needs of modern drug development.

57. 3 Ways To Mitigate Data Manipulation Risk In Drug Development 1/6/2021

    A critical output of the drug development process, besides the compound itself, is data. We highlight specific actions to mitigate your organization’s risk of data manipulation and three key steps in tackling this problem.

58. Why Life Sciences Needs The Science Of Security 1/6/2021

    Given the complexities that arise when securing data in drug development and developing software that facilitates common workflows, ensuring best-of-breed security simultaneously is the key to success.

59. Success At Speed: Best Practices To Accelerate Vaccine Development 12/18/2020

    This collection of articles documents each step in the vaccine development journey and how technology and partnerships make the difference in getting medicines to patients when they need them most.

60. Surviving The Paperwork: Why Seamless Submissions And Good Compliance Envelopes Matter 12/10/2020

    Are you finding it increasingly challenging to manage your organization’s regulatory submission process? The entire process of developing a drug from preclinical research to marketing takes approximately 12 to 18 years and can cost billions of dollars before a drug is even approved. Learn how the advantages of a good ‘compliance envelope’ can far outweigh its costs by making companies operationally more effective, with a positive impact on the top line.