If you have been reading my posts you have undoubtedly seen a number of articles on failed launches and the challenges facing Alzheimer’s research and clinical trials. Since 2002, 99.6% of Alzheimer’s drug candidates have failed in clinical trails. Meanwhile the prevalence of Alzheimers continues to grow as our society ages. Every 67 seconds, someone in the US developed Alzheimer’s, it is the 6th leading cause of death in the US.
In 2014, the direct costs to American society of caring for those with Alzheimer’s will total an estimated $214 billion, including $150 billion in costs to Medicare and Medicaid. Despite these staggering figures, Alzheimer’s will cost an estimated $1.2 trillion (in today’s dollars) in 2050. In 2013, 15.5 million family and friends provided 17.7 billion hours of unpaid care to those with Alzheimer’s and other dementias – care valued at $220.2 billion, which is nearly eight times the total revenue of McDonald’s in 2012.
Alzheimers also poses a unique challenge to researchers. Currently a series of tests are needed to diagnose Alzheimer’s and distinguish it from other forms of dementia. Each form of dementia impacts the brain in different ways with different chemistry. It is estimated that 20% of Alzheimer’s patients are mis-diagnosed, and this bas had a devastating impact on the drug development process.
A few months ago I was introduced to Dawn Matthews, CEO of ADM Diagnostics. ADM Diagnostics is located in the IIT tech park and their imaging technology is poised to change the course in Alzheimer’s diagnosis and drug development.
ADM Diagnostics (ADMdx) is commercializing proprietary brain image analysis software to enable early, more accurate diagnosis of Alzheimer’s Disease and other brain disorders. By applying proprietary pattern recognition advances and a unique database of more than 6,000 brain images, we have been able to differentiate between various forms of dementia, predict rates of cognitive decline even in normal subjects, and detect drug effects on the brain. We are applying our technology in drug trials for pharma companies, and are developing software to aid in patient diagnosis in the clinical setting. Value for pharma is through earlier, more informed go/no-go decisions and in improved clinical trial success rates. Value in the diagnostic setting is
through earlier, more accurate diagnosis, patient prognosis, and appropriate treatment, particularly as new drugs become available. ADMdx is the first to take this holistic approach to creating a badly needed automated tool that incorporates advanced analysis technology, multiple sources of image data, the retrospective clinical outcomes of those patients, and the expertise of multiple leading centers in dementia evaluation and treatment.
ADMdx is based in Chicago, and began operations upon receiving a Small Business Innovation Research (SBIR) from the National Science Foundation in 2012. They have since been awarded additional SBIR grants, developed cutting edge image diagnostic software, achieved regulatory compliance necessary to provide image analysis for large clinical trials, and increased their customer base. ADMdx’s technology came from ADMdx’s parent companies, Abiant and Predictek, who merged their operations and capabilities to form ADMdx, and has since been developed further at ADMdx. Their VP and Chief Technology Officer, Dr. Miles Wernick, and Chief Science Officer, Dr. Stephen Strother, are leaders in advanced image pattern recognition and machine learning for medical imaging. They have a growing Scientific Advisory Board that includes several of the world’s leading clinical researchers in Alzheimer’s Disease and other dementias. And their internal team includes scientists, software engineers, and other functional experts who share a dedication to innovation, progress, and addressing the problem of dementia.
A major issue in Alzheimer’s Disease clinical trials has been that many of the patients tested did not actually have Alzheimer’s Disease. Including patients who do not have the targeted disease decreases the opportunity to detect treatment response. Using standard brain images, ADMdx’s dementia classification software can help to determine whether a patient actually has the form of dementia that is targeted. Another major issue is that patients enrolled in trials, even with the same diagnosis, vary widely in their disease severity and in the rate at which they will worsen. In multiple clinical trials, the placebo (untreated) group in study has included more patients who were less severe and would have declined at a slower rate than the patients who were treated, making it difficult or impossible to demonstrate treatment benefit. ADMdx’s disease progression software can use the same images to predict the severity of a patient and the likely rate of decline if untreated. This can allow comparisons to be made between similar patients, to increase the opportunity to detect of treatment effect.
WCN: Walk me through this, how are you able to work with clinical trials
WCN: This really addresses a lot of the problems facing Alzheimer’s drug development, I imagine that it would be essential to regular clinical trials but especially to adaptive trials.
Imaging, because of its objectivity and sensitivity to changes in the brain, can potentially provide an earlier indicator of drug effect than subjective cognitive tests, with fewer subjects. Some of our studies include an interim analysis point, which allows the pharma company to make decisions regarding trial continuation or the number of subjects required. Imaging may also be used to make interim decisions regarding which drug doses to bring forward for longer study.
To support doctors in diagnosing Alzheimer’s Disease, we will work directly with the clinicians who would use the software “portal” to our diagnostic support. Already, we have begun to collaborate with leading clinicians who can help to guide the design of our product and the information that it provides, so that it can be adopted and integrated into patient care. The clinical diagnostic pathway is different in that a different type of regulatory approval is required for products used in that setting, but the path we have taken for clinical trial compliance is consistent with those requirements. Also importantly, the clinical application must take into account how the doctor can make best use of our information, integrating it with other observations from clinical examination of the patient. For the
clinical application, we are also developing relationships focused toward distribution partnerships with large clinics, imaging equipment and software manufacturers, and other entities that can provide broad access to end users.
WCN: Alzheimer’s and dementia is such a prevalent and growing problem. I know I have had family members with Alzheimer’s, what got you interested in this area?
entrepreneurial mindset. You have had gone back and forth between corporate
and startups. What led to your decisions?
I began my career at Baxter Healthcare, a rather large organization, based on the belief, which was borne out, that one could learn important aspects of product development, regulatory approval, and management in an established company, and contribute within a stable and well capitalized environment. However, the strong appeal of being able to make a difference by addressing an underserved need, with an environment allowing and depending upon rapid progress, drew me to my first entrepreneurial startup. My subsequent experience at Motorola was in the context of a startup (biochips) as well, after which I had the opportunity to pursue my ideal as the leader of a growth company addressing brain disease. There is nothing more professionally exciting to me than to be able to create an environment where bright, dedicated, team-oriented individuals come together in an innovative, rapidly moving manner to create a socially and financially valuable solution that did not previously exist. While large companies provide strength in size and reach, entrepreneurial companies offer an unparalleled opportunity to direct energy into rapid, inventive progress, gaining the benefit of critical mass through partnering and growth.
you like to add anything else?