The outsourcing industry continues to gain a bigger share of the dollars spent on preclinical, clinical, and post approval functions. To accurately quantify the size of various segments of the outsourcing market, this report acknowledges that task is next to impossible.
The nonprofit ACRES operates in the public interest, taking a multi-stakeholder approach, forming a true alliance united behind the goal of collaboratively building a system for the clinical research process, based in principles of Accountable Research™.
How do you take pharma, and other biomedical R&D, as well as CROS, which for years have operated as separate entities, and get them to come together and create standards and an accreditation process to benefit the entire industry, indeed, the entire enterprise of a complex of multiple stakeholders, including regulators and the public?
Selecting a CRO partner is never a simple process. If you are outsourcing a specific aspect of your study, you still need to evaluate a CROs’ expertise and bandwidth to perform the work in order to select the one that best suits your needs. With many pharma and biopharma companies moving toward strategic partnering agreements, the ante has been upped, making selection of the right partner even more critical. Still, some basic selection criteria have not changed over the years.
Craig Wozniak, Head, Americas Clinical Operations for GSK, is no stranger to risk-based monitoring. He has spoken on the topic on numerous occasions and has been involved with the risk-based monitoring initiative for TransCelerate since its inception. Recently he moderated a panel discussion on RBM: The Site Effect After Year One at the 2014 Site Solutions Summit sponsored by the Society for Clinical Research Sites (SCRS).
“At last year’s conference we talked about evolving monitoring practices, which has now become known as risk-based monitoring,” notes Wozniak. “SCRS has been active and produced some articles from that discussion, and now, a year later, we are looking to see where everything currently stands.”
As the head of clinical innovation for Eli Lilly and Company, Jeff Kasher, Ph.D. likes to spend time thinking about different parts of the clinical business and how they can be improved. Speaking during the Dirty Laundry session at the 2014 Disruptive Innovations conference, he noted a recent experiment where he toyed with the idea of eliminating central labs from the clinical trial process.
Kasher’s experience in trials led him to believe the labs were expensive and an area where the company invested a significant amount of money. The process of going through a central lab can also be incredibly slow, thereby slowing the pace of the entire trial. “When a patient comes in for an initial visit, I oftentimes will need a lab value before I can proceed to the next step,” he says. “If I cannot get an immediate turnaround on the data, as a consequence I may have to schedule another visit with the patient. So in terms of the patient perspective, as well as the time and cost of central labs, I started to question how I could get rid of them.”
Success stories are great, but sometimes you can learn more from your endeavors that do not go as planned. In this article Craig Lipset, head of clinical innovation at Pfizer tells of a recruitment challenge that did not meet expectations. Was the effort a failure? Only if you neglect to look at what did work and learn from it. After all, if you don't have any negative outcomes, you aren't trying hard enough.
When he decided to start a CRO four years ago, Renold Capocasale, founder and CEO of FlowMetric, decided talent and expertise would be the best way to differentiate his company from competitors. A former pharma employee himself, Capocasale immediately set out to hire scientists with a background in pharma. He uses the background of those employees to sell clients on the topics of quality and timeliness, something near and dear to their hearts. The company is already profitable, and recently opened a second office in Milan, Italy.
I recently spoke with him on what sponsors should look for when selecting a CRO partner.
Bringing together five large pharmaceutical companies for any endeavor can be a challenge. However, the potential for creating a common golden record of 50,000 sites, over 7,300 protocols, and 180,000 investigators, will definitely get their attention. The Investigator Databank has been able to do just that.
Via the Investigator Databank, five major pharmaceutical companies (Janssen, Lilly, Merck, Pfizer, and Novartis) have agreed to share their investigator information with each other. DrugDev, a family of technology solutions that bring together investigators, sponsors, and CROs, is the hosting partner for the Investigator Databank.
With more than 30 years of experience in the pharmaceutical industry, Tom Pike, CEO of Quintiles, has seen many positive changes occur. Speaking at the Oracle Industry Connect conference earlier this year, Pike opted to delve into that experience and share some of the progress he has seen.
Between 1987 and 2007, the risk of death from heart attack has fallen between 50 and 60%. We have seen a quarter-billion children get vaccinated, which has likely saved around four million lives. Even the mortality rate from HIV has been reduced by about 93% due to drugs developed over the last 30 years.