Growing your NPC Presented by Allan Krehbiel Nonprofit

Growing your NPC Presented by Allan Krehbiel Nonprofit Program Office VHA Office of Research and Development U. S. Department of Veterans Affairs

Why The NPC’s Need To Grow ◦ Some top level VA managers may view the NPCs as risky and small in the context of VA’s $168. 8 billion budget ◦ Many of the NPCs are well-heeled, but many are struggling ◦ Some NPCs are undercapitalized because they have relied too much on the lean overheads allowed by Federal funders

Why The NPC’s Need To Grow ◦ Retention of key NPC personnel depends largely upon organizational resources and prospects for growth ◦ The more revenues and resources the NPCs can muster, the better able they will be to support VA research and education while also developing their own organizations

Before Growth, Basic Organization • Basic organization should come first, assure that: ◦ Operations fully comply with VHA Handbook 1200. 17 ◦ Internal controls are effective ◦ Staff is trained ◦ Board oversight is in place (4 meetings a year) ◦ A strategic plan has been developed (list of a few key obtainable objectives over the next 3 to 5 years)

Options for growth ◦ Federal funds administration, NIH, DOD, CDMRP, etc. ◦ Private grant administration, American Heart Association, etc. ◦ Public and institutional fund-raising ◦ Clinical trials and the administration of CRADAs These are not options: ◦ Operating a business in competition with private enterprise ◦ Becoming a landlord to VA or private businesses

Federal Funds Administration ◦ Federal funds administration, NIH, DOD, CDMRP, is presently our largest source of revenues at 69% and growing ◦ 65 of the 84 NPCs administer some Federal funds ◦ NIH and Do. D budgets are not growing much ◦ Federal grants are increasingly competitive ◦ Only about 10% of NIH grant proposals are awarded

Federal Funds Administration ◦ Federal grants require careful, costly administration ◦ Federal funders allow very lean overheads for administration ◦ Some NPCs have eroded their capital because they have relied too heavily on Federal funds administration ◦ A few affiliated universities insist on managing all NIH awards ◦ CDMRP (Do. D) is an especially good opportunity for us

Private Grants ◦ Grants from the American Heart Association, American Diabetes Association, and many others continue to be very important to the NPCs and should not be overlooked ◦ Presently they account for approximately 10% of revenues ◦ Overheads granted are typically lean ◦ Still a good opportunity for most NPCs

Public and Institutional Fund. Raising ◦ Very competitive, especially public fund-raising ◦ Now less than 1% of NPC revenues ◦ Usually requires a significant change in focus for the NPC ◦ May require relatively large investments of time and money ◦ Board membership will probably need to be augmented

Public and Institutional Fund. Raising ◦ A few NPCs have had very limited success to date ◦ Outside the NPCs, charitable bequests are growing rapidly ◦ Seeking bequests is probably worthwhile ◦ It does pay to raise your NPC’s profile in both the VAMC and the community

Clinical Trials ◦ The primary objective of clinical trials is to improve Veterans’ health care and give the Veterans FREEDOM OF CHOICE ◦ Also to give the brightest and best clinicians an opportunity to conduct research and advance medical science, making their careers at VA more satisfying and retaining them for VA ◦ More clinical trials administration will bolster the NPCs, their revenues and resources, and in some cases, help repair deficient net worth financial positions ◦ Half of the NPCs derive more than half of their revenues from the administration of clinical trials and they account for approximately 20% of total revenues

Clinical Trials ◦ It is possible to realize a net gain after administrative costs on some clinical trials ◦ The trend by CRO’s and other sponsors is to minimize participation at any one site to minimize the risk of failure ◦ You may need to start small and work your way up to broader participation as your track record of success becomes better and better

The Clinical Trials Industry ◦ The industry consists of pharmaceutical companies, biotechnology firms, medical device manufacturers, and contract research organizations (CRO’s) ◦ CRO’s are rapidly growing, now at $38 billion and expected to reach $64 billion by 2020 (72% of the industry) ◦ VA only does about $39 million annually in clinical trials, down from $71 million ten years ago. ◦ Because we are the largest health care system in the U. S. and because we have many unique advantages, this is an exceptional growth opportunity for VA.

Industry Problems ◦ Cost to discover a new drug and bring it to market is 10 -15 years and $1. 3 billion ◦ New drug development is excessively costly, a lot of time, effort, and money is wasted ◦ More than 70% of physician investigator CT sites are under-performing or non-performing ◦ More than 80% fail to enroll subjects on time ◦ 30% fail to enroll even a single subject (Turner, A Concise Guide to Clinical Trials)

Industry Problems ◦ 80% of subjects who complete the trial do so at only 20% of the sites. ◦ 70% of physician investigators who take part in their first clinical trial do not wish to participate in another trial ◦ VA’s completion track record is much, much better than that of the rest of the industry (Turner, A Concise Guide to Clinical Trials)

VA Advantages ◦ Largest health care provider in the U. S. , eight million patients ◦ Long, deep experience with clinical trials ◦ Well-staffed, equipped and organized at many VAMCs ◦ Multi-site trials are possible where needed ◦ Excellent, universal electronic medical record ◦ Stable, long-term patient populations ◦ Veteran study subjects are disciplined and inclined to serve others

VA Advantages ◦ Central Office of Research and Development (ORD) to provide overall direction ◦ ORD Communications Department for outreach to industry ◦ Office of Research Oversight to ensure human subject protection compliance ◦ Local VAMC Research Service offices and ACOS/R’s to direct actual on-site research work ◦ New simplified CRADA agreements, IP provisions deleted ◦ Dedicated STAR team and availability of master CRADA agreements ◦ Long-established NPCs fully capable of properly administering CT agreements (CRADAs)

What We Can Do To Grow Clinical Trials ◦ Reach out to the pharmaceutical companies, biotechnology firms, medical device developers, and contract research organization to let them know you are ready to serve them ◦ Make every effort to expedite the approval of new studies ◦ At some high-volume locations, have IRB and R&D Committee meetings more frequently ◦ Follow instructions for CRADAs from the STAR team very closely ◦ Encourage sponsors with recurring CT needs to execute master CRADAs ◦ Accept studies that have a high likelihood for rapid and complete study subject recruitment

What Can Be Done To Grow Clinical Trials ◦ Do not accept studies that compete with other studies at your location ◦ Support programs to both recruit and retain study subjects ◦ Ensure that there is adequate dedicated space for examining study subjects ◦ Arrange for the storing and shipping of biological samples if required

What Can Be Done To Grow Clinical Trials ◦ Arrange for a dedicated work space for sponsors’ Study Monitors while they are working on-site at your VAMC ◦ Provide experienced Clinical Trials Coordinators (CTC’s) to manage the day to day work flow and the required study documentation ◦ Sponsor SRA and other training for the CTC’s ◦ Arrange for participation of qualified biostatisticians where needed ◦ Include the ACOS/R’s and NPC Executive Directors in the VAMC’s hiring process for all new professional personnel ◦ Have an annual Research Day honoring Veterans and study subjects

� THINK GREEN! � GROW YOUR NPC!