Partnering & Outsourcing Editorial

1. 6 Rules For Establishing Bulletproof CRO Governance 12/23/2019

   With the increase in strategic partnerships and alliances between pharmaceutical or biotech clinical study sponsors and contract research organizations (CROs) sweeping the clinical trials industry, study sponsors often see a need to establish formal structures to help guide these relationships. This, many times, will come in the form of a CRO governance structure. And, of course, the need is not only to establish CRO governance but also to make it effective. Although each organization and relationship is unique, there are a few critical rules that can greatly increase the chance that this governance will be effective. Before exploring these rules, let’s review some foundations of CRO governance.

2. Will Virtual Trials Mean The End Of CROs? 11/4/2019

   Virtual trials are growing in acceptance. The patient-centric aspect of these trials makes them easier to recruit and retain patients and accelerate timelines, while also providing patient data to researchers in real time. But will virtual trials also mean the end of CROs?

3. Rafael Pharmaceuticals Is Starving Cancer Cells 10/31/2019

   While many other oncology companies are focused on the development of targeted immuno-oncology therapies, Rafael Pharmaceuticals is working on a cancer metabolism drug that has the potential to revolutionize cancer treatment. Its primary objective is to produce anti-cancer agents that have minimal toxic effects on normal cells and tissues.

4. The 6 “Musts” Of Clinical Trial Contracting 10/17/2019

   Bella Sessoms has spent most of her career negotiating sponsor-CRO budgets and contracts. In her current position as director, contracts and outsourcing at Astellas Pharma, she leads a team of outsourcing managers who prepare vendor and site contracts. Below are the six efforts Sessoms believes you must undertake to make your contracting endeavor a success.

5. Marriage Pitfalls In Strategic Partnerships – And How To Avoid Them 10/11/2019

   Strategic partnerships have changed dramatically in the last 20 years. Regardless of your model, one thing is certain: All of them will have their own issues and challenges. What’s important is how you choose to address those outsourcing challenges when bumps in the relationship inevitably occur.

6. Regeneron Manages Clinical Costs In A Fast-Growing Organization 10/1/2019

   More complex oncology and rare disease trials are leading to a rise in the number of patients, sites, and clinical trial endpoints. All of that adds to an already challenging environment for biopharma companies struggling to understand where costs are increasing and what can be done to control them.

7. Report Projects Spending & Outsourcing To Drive CRO Market Growth 9/26/2019

   Earlier this year ISR Reports released its annual CRO Market Size Projections report. Overall, 2018 was a decent, but not spectacular, year for CROs. All the major/public CROs saw year-over-year revenue growth.

8. Idera Pharmaceuticals – A Patient Recruitment Success Story 9/24/2019

   Every company conducting clinical trials knows recruitment is a challenge. Slow recruitment can delay the start of a trial and, in some cases, cause them to be cancelled altogether. This is one factor that makes Idera Pharmaceuticals different. The company is months ahead on its patient recruitment goals.

9. Inspire Awards Honor The Industry’s Best 5/2/2019

   DIA’s Inspire Awards have grown every year that Barbara Lopez Kunz, global chief executive for DIA, has been with the organization. Kunz, who has been with DIA since 2013, notes it has become the place to be for attendees travelling to the annual meeting.

10. A Crash Course In CRO Partnership — 4 Strategies For A Healthy Relationship 3/14/2019

    You just wrapped up a productive meeting with the FDA. The FDA reviewer has agreed to your clinical strategy. Your leadership team is excited and cannot wait to launch the clinical trial.