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

61. Top 5 Risks That Can Compromise Your Life Sciences Data 12/10/2020

    Keeping the clinical trial data secure and compliant is paramount. Restricting access to only those that need it is an essential first step, but there is much more that needs to be done. To help you in your journey, we’ve created a list of five common ways that trial data puts us in jeopardy, and approaches you can take to avoid these risks.

62. Ditch The Checklist: Why Automation Is The Key To Content Compliance 12/10/2020

    Checklists work for things like house maintenance; you identify and fix the things that don’t meet building codes, and then you feel safe, and the building inspector is happy. Content, however, doesn’t operate like that. Some content is essentially stateless; because of collaboration or continuously changing data, content assets change. Identifying adherence to compliance controls, therefore, means it has to be evaluated continuously. Automated, continuous monitoring is imperative for companies that depend on their critical content to make business decisions and conduct operations.

63. Best Practices for 21 CFR Part 11 And GxP Validation For Electronic Records 12/7/2020

    Drug development has dramatically changed over the past ten years. A practice once dominated by pen-and-paper has since transitioned to computerized systems, cloud software, and artificial intelligence. This paper chronicles recent technological trends, specific challenges these trends pose for Quality & CSV teams, and best practices for tackling resulting compliance issues.

64. Remote Work Without VPN Helps Biopharmaceutical Company Keep Drug Development On Track 12/7/2020

    Travere Therapeutics is a San Diego, CA-based biopharmaceutical company that develops life-changing therapies for people living with rare diseases. When it transitioned to a primarily remote workforce in 2015, it needed to keep its work moving forward at the same speed. Accessing the cloud-share via VPN from one end of the country to another wasn’t just painfully slow, their people were losing connection, too. They needed a solution that would help keep drug development on track regardless of the location of each team.

65. Navigating Regulatory And Development Milestones 9/17/2020

    This article addresses how early-stage biotherapeutic companies can avoid common pitfalls as they navigate the funding and regulatory processes to bring novel therapeutics from research to market.

66. Gap Analysis Fundamentals To Maintain Forward Progress 9/16/2020

    Gap analysis—defined as the process of reviewing all the available information for a candidate product to assess current development status, identify potential gaps in information, and the subsequent steps required to develop a strategy to fill those gaps a fundamental and ongoing exercise. In a recent The Business Of Biotech podcast Dr. Valenzuela,  CEO at Andes Biotechnologies, was joined on the podcast by Cristian Hernández-Cuevas, COO at Andes. Their collective reflections and advice on gap analysis execution provides real-world guidance for the leaders of emerging biopharma organizations.

67. Embracing Biosimilars, They Are Here To Stay 10/10/2018

    The biosimilars market is suddenly booming, with established biopharma giants and nimble start-ups all clamoring for a piece of the action. But such steep competition means that only the wise will survive.

68. The Biomedicine Revolution 11/2/2017

    Personalized medicine has the untapped potential to unlock value for both patients and providers. However, biomanufacturers face major obstacles in drug development, such as increasing regulatory oversight, longer development times, and a growing public focus on drug pricing. This e-book outlines some of those struggles as well as highlights the successes of those working to advance the personalized medicine industry.

69. Autologous Cell Therapies At Crossroads With FDA: What To Do Now? 7/25/2017

    Regulatory controls on local collection and processing of autologous cells present a major challenge to clinics that want to provide individualized therapies. How can pharma overcome the hurdles?

70. A 15-Minute Guide To Clinical Trial Document Management And The eTMF 5/30/2013

    At the Drug Industry Association’s (DIA) annual meeting held in June 2012, the TMF Reference Model Working Group released TMF reference model 2.0, which included significant updates from the group’s 2010, 1.0 release.