Recently I had an opportunity to speak with Jim DiCesare of CFS Clinical in preparation for an upcoming conference. As Vice President, General Manager and father of 3, Jim’s schedule is extremely tight so I was grateful he was able to make the time to connect. If you haven’t met Jim, he transitioned from Merck to CFS Clinical several years ago and has developed a unique perspective on both the challenges and opportunities sponsors face in the clinical study start-up and clinical trial process. On a personal note, Jim is one of the warmest and most humble thought leaders I’ve met in the industry….so when he claims to play a mean air guitar, I’m picturing Jimi Hendrix.
How did your work at Merck prepare you for your role at CFS Clinical?
CFS Clinical is a growing organization and in my six and a half years here I've had to wear many hats. Typically when you work at a larger organization you have a more narrow focus, which can make it more difficult to transition to a smaller company like CFS Clinical. However, in my case I was fortunate to work for a new organization within Merck that was small and therefore required me to do many varied tasks. I did a lot of clinical trial financial and budget management, procurement of commercial vendors supporting our research activities, negotiation of clinical trial agreements with sites, investigator payment processing, and much more. My experience at Merck exposed me to the business side of clinical research and I was fortunate to have the opportunity to be a key player in these different facets of the process. The broad-based experience I gained during my time at Merck really had me well prepared to make the transition to CFS Clinical. From the get-go I was asked to build out a new division that focused on the business and financial management aspects of clinical research.
Any advice you’d give to others looking to make a similar transition?
Do it! Wait, let me clarify that . . . If you want to make an impact and are comfortable taking on a high degree of accountability, then this kind of transition will be a great move for you. I've never been happier in my work career and that's largely due to two key factors --- the overall culture of our organization (which is set at the top by our President, Greg Seminack) and the fact that I know I'm having an impact on the industry. Essentially, we're speeding up the study start-up process and helping companies achieve their study goals-- all of which are vital to the industry.
Don’t get me wrong, there's a certain element of risk when you join a smaller organization. I would advise anyone thinking of making this kind of transition to do their homework. Understand the company’s strategic plan over the next 3-5 years and evaluate the company culture to help determine if it's a good fit for you.
Clinical Trials have been conducted for decades. Why has the study start up process not yet been mastered?
It's pretty amazing that we work in such an innovative industry that can discover all kinds of treatments to improve the quality of life for patients. However, mastering the art of getting all the regulatory documents and contracts completed efficiently and on time is always challenging. In my opinion, it comes down to focus . . . or, better put, lack of focus. When companies have the opportunity to invest in technology, much of the focus is on improving their CTMS, EDC, IVRS, or e-TMF systems. These are all crucial to achieving success in clinical research, but they take up so much of the effort and investment dollars that there's nothing left for technologies focused on automating the study start-up process. Consequently, organizations are left to manage this process in a very decentralized manner, using spreadsheets or stand-alone databases to track start-up activities. A huge opportunity to significantly improve the study start-up process is being missed because all of this valuable site information is static and non-searchable. Therefore, organizations are left doing it the same way they have for years --- e-mailing boilerplate templates to sites even though they've already modified and commented on those same templates numerous times and requesting things like medical licenses and CVs even though we have these documents in house...somewhere.
What is encouraging though is that we're starting to see the focus shift into study start-up and there're numerous organizations starting to provide technology and service solutions that automate many of the manual steps. The overall perception is that getting one patient enrolled at one site so that you can achieve your targeted "First Patient In Date" is not good enough and does not translate into overall study success. I think this will be a key area of focus for the industry-wide TransCelerate initiative as they look to revamp and improve much of the clinical trial process. I'm excited at the changes taking place in study start-up and look to be an active contributor in improving the process.
Aside from drug approval, what do you see as the best measure of clinical trial success?
I would define a successful clinical trial as one that achieves the desired outcome described in the protocol on time and within budget. Many trials have significant delays and budget overruns, which ultimately affects when these medicines get into the hands of patients. On the budget side, there's a finite amount of R&D dollars to spend. If additional dollars are funneled to a study because of poor planning, or inefficient processes, there are other programs that could be delayed or cancelled. If you're able to deliver the results anticipated and do it within the timeframe and budget allocated, then you have just had a successful clinical trial.
If you had a super power that would allow you to change one thing in the clinical trial process, what would it be?
Hmmm . . . great question! If I could eliminate one thing, it would be the paper! For all the technology that we have brought to bear on the clinical trial process, we're still generating tons of paper and have been very slow to embrace processes and technologies that would eliminate paper (i.e. electronic signatures come to mind). I’d like to see us move to virtual regulatory packages and digitized Clinical Trial Agreements that don't require multiple hard copies and wet ink signatures. We have done a nice job of eliminating paper when it comes to Case Report Forms and paper patient diaries, and we're comfortable with physicians electronically signing eCRFs within an EDC system. However, we still need to broaden that to all of the other processes where a significant amount of paper is still being generated.
What are some of the new challenges your clients have been faced with in the wake of Healthcare Reform?
I think if you ask any company in our industry this question, they would answer it very similarly . . . The Physicians Payments Sunshine Provisions (aka Sunshine Act) is the biggest challenge coming out of Healthcare Reform. The requirement to track payments back to the individual physicians pose some unique challenges on the R&D side of the organization. In clinical research, we typically pay the employer of the physician and that payee data resides in an Accounts Payable system. The actual physician information associated with that payment typically sits in a Clinical Trial Management System which is in no way integrated with the A/P system. The Sunshine Act requires both pieces of information to be linked and reported, meaning organizations are then left to go through a manual process of making the appropriate association between the actual payment data and the physician information.
In addition, the Sunshine Act requires the reporting of certain physician investment information that is similar to what is required by the Financial Disclosure requirements mandated by the FDA in 21CFR Part 54. This results in companies struggling with how to approach the collection of this information in a more holistic way to satisfy both requirements without being redundant and overburdening the investigator sites.
If you were to change careers, what other profession would you be interested in pursuing?
If I could be anything I wanted, I’d go in an entirely different direction and be a musician. I love to sing and I play a mean air guitar!
On a personal note, what is the best book you’ve read this year?
I’m a single dad with 3 young boys who are involved in a lot of different activities, so reading is something that I do not get much time to enjoy. I'm an audiobook fan, though, and like to read self-improvement books. I recently read David Allen’s Getting Things Done and am looking forward to putting into practice his methodology for managing all of the information that comes flying at us these days both personally and professionally.
Want to Hear More From Jim?
You can meet Jim “Hendrix” DiCesare at CBI’s Clinical Study Start Up one day Seminar on July 16th in Philadelphia as part of the 5th Forum on Clinical Trial Budgeting and Project Management on the 17th and 18th. Feel free to register for the one-day seminar or join us for the full three-day experience and learn in-depth techniques and strategies to improve forecasting, manage costs and maintain timelines.
James M. DiCesare
Vice President and General Manager, Contract & Regulatory Services, CFS Clinical (CFS)
Mr. DiCesare leads a highly skilled and experienced team of individuals who are responsible for delivering study startup services to clinical trial sponsors and CROs. This includes both the collection, review, processing and tracking of essential site regulatory documents as well as the negotiation of Clinical Trial Agreements and investigator grant budgets. Mr. DiCesare has been with CFS since 2006 when he joined the organization as Director of the Pharmaceutical Services Group.
Prior to joining CFS, Mr. DiCesare spent 14 years in the financial services and pharmaceutical industries. Most recently, he spent more than 9 years at Merck & Co., Inc., providing clinical trial financial management and commercial outsourcing services in support of the Clinical Development Programs Department. He held positions of increasing responsibility while at Merck, culminating in the position of Senior Manager of Financial Operations. Prior to Merck, Mr. DiCesare spent 5 years in the financial services industry where he held various senior-level positions within the internal audit departments of Harleysville National Corporation and PNC Bank Corporation.
Mr. DiCesare has a B.S. in Accounting from Kutztown University in Kutztown,PA.