Guest Columns

1. Design Thinking: A Shared Methodology Between Sponsor And CMO To Benefit Patients 9/15/2020

   Collaborative efforts made by the sponsor and the CMO, coupled with a well-defined process grounded in design thinking, can lead to improved patient compliance.

2. One-Stop Shop Or Best of Breed? 3 CDMO Selection Case Studies 9/8/2020

   Following last week’s editorial by chief editor, Louis Garguilo, Ray Sison, xCell Strategic Consulting, has prepared three case studies and a detailed analysis of the best-of-breed and one-stop-shop outsourcing models. Learn to define a strategy that best fits your product requirements and aligns with your corporate objectives.

3. Dos And Don’ts Of Virtual Factory Acceptance Testing In Life Sciences 9/3/2020

   Performing virtual FATs (vFATs) can be a helpful solution in these new and uncertain times, though it does come with added risk. Without having the team on-site, remote FATs present a higher possibility for equipment to be shipped without meeting the end user’s requirements and functional specifications.

4. Incorporating Privacy By Design & Security By Design Into Medtech Development 9/2/2020

   Medical device companies need to act now to demonstrate their products' cyber resilience and privacy capabilities, not simply to address the myriad of compliance and data privacy regulations but also to establish patient and caregiver confidence in their products.

5. An Update On 2020 U.S. Biosimilars Regulation & Litigation 9/1/2020

    

   The biosimilar market and regulatory and legal landscape remained dynamic throughout the first half of 2020. Ongoing activity indicates that the remainder of 2020 should bring more interesting developments.

    

6. Strategic Outsourcing For Virtual Companies — Lessons Learned In The Trenches 8/31/2020

   A virtual company advancing a drug candidate into product development faces a deluge of challenges. The reality is you do need the assistance of pharmaceutical scientists and advice from industry professionals to help you navigate the twists and turns in the road.

7. Making FMEA More Robust With HACCP 8/27/2020

   Risk priority number scores and criticality analysis are frequently used to quantify risks for users, designs, and processes. However, these traditional failure mode and effects analysis (FMEA) techniques often fail to fully document risks associated with contamination. To complement FMEA, consider borrowing a risk-management technique from the food industry.

8. How Storyboarding Can Bring Clarity To Regulatory Inspection Readiness & Facilitation 8/25/2020

   Developing storyboards for regulatory inspection readiness and facilitation is a growing trend, yet the tool is shrouded in mystery for many pharma industry professionals. (Downloadable storyboard template included.)

9. Janssen v. Celltrion Federal Circuit Judgment: What Biosimilar Makers Need To Know 8/25/2020

   The Federal Circuit recently issued Rule 36 judgments in two separate BPCIA cases: Genentech v. Amgen and Janssen v. Celltrion. This two-part article series explores some of the unanswered questions raised in these two cases. In Part 1, Genentech v. Amgen was discussed. Here, Part 2 delves into the remaining questions following Janssen v. Celltrion.

10. Risk Mitigation For Homecare Devices: 4 Tips For Anticipating The Unanticipated 8/24/2020

    With the surge in home healthcare these days, designers must approach risk very differently than when devices were being designed solely for use by clinical personnel. This rise in home healthcare is driving the need for increased risk scrutiny for several reasons.