Karen Brooks holds the title of senior director of clinical operations at Adare Pharmaceuticals, but the title may be misleading. With Adare being a growing specialty pharmaceutical company, Brooks is currently the entire clinical operations department. That means she wears many different hats, including operations, monitoring, management, recruitment, and retention. At the inaugural Clinical Leader Forum in Philadelphia, Brooks discussed her role in overseeing CROs.
SCORR Marketing, along with KNect365 Life Sciences, a global community of pharma stakeholders, has produced a report on the current status of patient centricity in clinical trials. The survey collected 208 responses from industry professionals in a variety of job functions and regions. The survey tried to determine if companies are taking patient preferences into consideration and, if so, how they are doing so.
One major challenge that still exists in clinical research is budget negotiations and payments to sites. Most would agree that trust and communication are vital to keeping those functions operating efficiently. The process put in place must also work for all stakeholders involved in the process.
If you have a trial you need to outsource to a CRO, how do you know what is the right price you should be paying for it? If you receive RFPs with a wide variation in quotes, how do you know which one is the most realistic? If the study is delayed for some reason, what extra costs will you incur? Those are questions that a panel of experts answered at the inaugural Clinical Leader Forum.
A new treatment for adult patients with ALS, also known as Lou Gehrig’s disease, is now available to patients in the U.S. Produced by Mitsubishi Tanabe Pharma America, Inc. (MTPA),RADICAVA is the first ALS treatment to be approved by the FDA in more than 20 years. While it will not reverse the effects of ALS, a recent clinical trial found it slowed the decline in physical function of patients by 33 percent.
In this Q&A, Sameer Tandon, head of strategic alliances and customer transactions in U.S. medical affairs for Novartis, shares some of the challenges of his job and what trends will shape the future of the medical affairs group. Tandon discusses real-world evidence, FDA, payers, working with CROs, procurement costs, and more.
Pharmaceutical companies, CROs, and software/application vendors with operations in the European Union (EU) may be at serious risk from the new EU General Data Protection Regulation (GDPR). Violations of the regulation, which is set to go into effect in 2018, can result in penalties of €20 million or 4 percent of worldwide revenue.
In August, the Senate passed, via unanimous consent, a bill that claims to improve access to experimental drugs for patients. While the Senate made numerous changes to the original Right-To-Try (RTT) bill, the New York University School of Medicine Working Group on Compassionate Use and Pre-Approval Access (CUPA), which came out against the bill advanced by the House, remains steadfast in its opposition to the legislation.
Consolidation continues in the CRO space, with the acquisition of Chiltern by LabCorp being just the latest example of top CROs expanding and increasing their breadth of offerings. As large CROs continue to acquire smaller competitors, can sponsor companies expect to benefit from this development?
Small and large pharma companies do not operate in the same manner. According to John Gainer, CSO of Diffusion Pharmaceuticals, those operational differences are critical when it comes to new treatments making it to patients. There is a common path whereby molecules in small companies make it to market, and Gainer believes there are problems with the model.
