Lazarex Cancer Foundation's IMPACT program and the Cancer Moonshot Summit

As part of the June 2016 Cancer Moonshot Summit, Lazarex Cancer Foundation’s (LCF) President Dana Dornsife addressed Vice President Biden, Cancer Task Force Executive Director Greg Simon, Cancer Moonshot Summit attendees and over 18,000 viewers via a live stream broadcast. In 10 minutes she delivered a powerful message on behalf of the 1.7 million people who will be diagnosed with cancer and the 600,000 who will die from cancer this year alone. That’s 4,620 new cases and 1,630 deaths every day.

Dana introduced the Lazarex IMPACT (Improving Patient Access to Clinical Trials) program and asked for a change at the federal policy level that would cost nothing but would lift the financial burden of clinical trial participation from the shoulders of cancer patients, provide equitable access to potentially lifesaving breakthrough treatments, and increase trial enrollment and retention. You can watch Dana’s recorded presentation here at 14.00 minutes: http://bit.ly/292ZJFh

Lazarex Cancer Foundation is a publicly funded 501(c)(3) nonprofit based in Danville, CA. EIN#20-2562494

Here is Dana’s message:

I am here today to bring this all full circle. To shift our focus for a few moments to cancer patients, on the challenges of actually converting benchside progress to viable bedside therapies for them. To concentrate on patients, stricken with cancer, who involuntarily fuel this industry with opportunity, to supply new products and technologies to meet an ever growing demand for treatments and cures that are synonymous with life.

So, what are Moonshot and translational science really all about? People. People afflicted with cancer who deserve equitable access to medical breakthroughs in technology that could save their lives. Yet all too often, we leave humanity out of the scientific and medical equations. All of this is extraordinarily important, but if we miss the ultimate target – actually translating knowledge into application for the benefit of cancer patients – what have we gained? If we celebrate success in the lab and fail to deliver new technologies to patients – who have we served?

How can we fix the misalignment between cancer patients who desperately want to benefit from medical breakthroughs in technology in their quest for life and the 1,000’s of clinical trials that desperately depend on patient participation to succeed? We have (2) simple requests of Vice President Biden, Greg Simon and the Moonshot Initiative that will cost Moonshot NOTHING but will bring transformational and sustainable change to clinical trial enrollment, retention and minority participation, provide equitable access and transfer technology to market faster. Our requests are:

• To support the creation of FDA regulatory language that lifts the veil of inducement from industry and addresses the barriers to clinical trial participation.
• To endorse our IMPACT program as a component of Moonshot, and, for continuity, by the NCI in their efforts going forward.

For 10 years, LCF has focused on removing the barriers to clinical trial participation for advanced stage patients. We have provided clinical trial navigation services and financial assistance to thousands of patients and their travel companions based on financial need – achieving equitable access to the treatment opportunities clinical trials can provide. Lack of knowledge, financial constraints, support network interruption, historical, cultural and language issues and socioeconomic factors are individual barriers to clinical trial participation. In combination, they create an impenetrable wall.

“We work so hard at the bench side and spend billions of dollars there and yet, incredibly, almost 50% of trials fail to meet their completion targets due to lack of enrollment.”

It’s no secret that barriers to cancer clinical trial enrollment exist… 5% of eligible patients participate and of those who do, less than 5% are from minority communities. Only 6% of doctors suggest clinical trials to their patients. Most patients go to their graves never having known that clinical trials were an option. 11% of clinical trials never enroll a single patient. 37% are grossly under enrolled. Financial burden is the primary reason patients cite for not participating in a clinical trial. We work so hard at the bench side and spend billions of dollars there and yet, incredibly, almost 50% of trials fail to meet their completion targets due to lack of enrollment. We must take the burden of participation off the shoulders of patients if we need more to participate and increase the rate and number of treatments that currently trickle through from bench to bedside.

The services we provide at Lazarex are noble and in great demand but they are not sustainable. Lazarex is pleased to announce the creation of IMPACT - Improving Patient Access to Clinical Trials. IMPACT provides a sustainable solution to removing the barriers to clinical trial enrollment, retention, and minority participation. It brings together the significant resources of academic institutions, medical facilities and professionals, policy makers, industry, public health entities and community organizations nationwide, to leverage their academic, medical, socioeconomic, policy, research, ethnic, racial and geographic assets. The deliverable from this 3 year pilot program is to create a replicable, “boots on the ground” action plan, bringing significant and sustainable change to the status quo of clinical trial enrollment, retention, minority participation, completion, and translational science - providing equitable and timely patient access to cancer discovery.

IMPACT has 4 primary areas of focus:

1. Improving patient engagement and participation at the research and clinical trial level
2. Focusing on patient navigation at the community level, including the most at risk patients
3. Increasing education and community outreach efforts about clinical trials and early detection at the patient, social service and medical professional levels and
4. Providing data management; administration, evaluation and statistical analysis of tracked data points

Moonshot, the NCI and IMPACT have crossover interests in several areas: advancing the understanding of cancer, healthcare delivery, equitable access to care and removing barriers. With this crossover, we have mission alignment and the potential to achieve true collaborative progress.

But – the collaboration doesn’t stop with Moonshot, the NCI and IMPACT. A coordinated effort amongst all stakeholders is required to meet this challenge and achieve sustainable change. Through IMPACT, we are engaging with all stakeholders: Academic, medical, industry, physicians, caregivers, insurers, policy makers and regulatory bodies, social welfare programs, community organizations and most importantly – PATIENTS!

The simple, no cost solutions to Moonshot of language and endorsement will produce HUGE return on human investment. We must have language that acknowledges ancillary cost as a primary barrier to patient participation in oncology clinical trials, clearly identifies allowable expenses for reimbursement to patients, and methodology of reimbursement, and definitively and unquestionably sets apart reimbursement from inducement. This will encourage industry financial support for identified patient ancillary costs for clinical trial participation.

Again, with no cost to Moonshot, with FDA language in place, endorsement of IMPACT by Moonshot and the NCI, we can succeed in securing the support of industry for the IMPACT program.

These are the faces of cancer. Speaking from the patient perspective, collaboratively we have the opportunity to check the “mission accomplished” box. Our IMPACT partners represent the best in cancer care, research, academia, public health and policy. This is a no cost opportunity to resolve a historical and multilateral problem with a unilateral solution.

“Vice President Biden and Mr. Simon, please, don’t let 433 words of proposed language stand in the way of the pursuit of life for advanced stage patients through clinical trials and the arrival of new treatments to them...”

– a tank of gas per week for a single Mom whose 8 year old little girl Nevaeh has been supported by Lazarex and traveling between Sacramento and San Francisco to her trial for more than half of her life; airfare and lodging for JR, a Stage IV melanoma patient, who has achieved remission through participation in 3 clinical trials; or for Mike, a sarcoma patient, who against all odds has stable disease after 5 years and 2 trials, and recently has a predicted life expectancy of 10 more. Both JR and Mike are presenting at the Howard University Summit today.

In closing, I hope I have helped to sharpen your perspective on the human side of Moonshot and what is possible but also on what is morally and ethically right. In the time I have been addressing you, 32 people have been newly diagnosed with cancer and sadly 12 have passed from it – we can fix this! Thank you for your time, attention, and desire to do the right thing.