Our test works fairly simple. The patient gets an infusion of a radiolabeled chemo drug. 24h later, DNA is extracted from blood and a biopsy samples. We then determine via ultrasensitive Accelerator Mass Spectrometry the amount of drug that is bound to the DNA. The more drug is bound the better the therapy is killing the tumor. Based on the level of bound drug, the physician can make better treatment decisions. Out test takes the guesswork out of the picture.First, a patient sees his doctor. The hospital receives our assay kit, including the labeled drug, tissue and blood collection tubes. After then we receive the patients sample and send a detailed report back to the trending physician to make a superior treatment choice.
So initially we went out of the building (even though I was told there might be a zombie apocalypse out there right now) and interviewed people to confirm our hypotheses about value proposition and actual customers.
After talking to several physicians and patients, we found that we were on to something good and also got the ballpark right, but the devil was in the details. Fist we underestimated the role surgeons play in the decision making process for bladder cancer treatment. This finding came with a twist attached. We thought we understood how patients are treated in the real world, of course by following standard of care recommendations, but we found that in the recommended chemotherapy for bladder cancer patients is much under prescribed. This lead us to overthink our value propositions, that we thought were equally important, but actually that we could save lives strikes us as the most valuable of them all. In addition, we found that other thing were not as important then we thought, like the actual need to FDA approval for a diagnostic test.
With new and improved Ideas we went to talk to Key Opinion Leaders at UC Davis and UCLA and came up with a visual tool for Surgeonsto get them to tell us how our test need to perform in order to change their approach towards chemotherapy.
We used published patient data to model the outcome with or with out our test. As you can see here. In this model the red line represents the actual current outcome probability with a bladder cancer diagnosis. This line includes everyone, patients receiving chemo and patients that do not. Separating out the patients that do respond to chemotherapy leads only to a small difference in survival difference as shown in the blue line. But patient that are actually responding to chemotherapy have a much improved outcome, see the blue line. Currently only 10% of all eligible patients receive chemo, even they might response. Our test could change this behavior and could improve the overall survival by more the 14 years.
This class made us really go into the details of the value of our test. We believe that we largely nailed the right side of the canvas and have a very good product marked fit and a better understanding of our customer segments. On the other side we started validating the Key partners as well as activities we need to get our test launched, as soon as possible.
As everybody else, we were asked to assess our investment readiness level. Of course I would like to say we are a 9, but we have to see the reality in the eye. After taking this class and doing through all the additional slides Todd made us prepare and talk to so many experts, we judge our readiness level around 7 to 8, depending on how strict you define the boundaries.
Our test works fairly simple. The patient gets an infusion of a radiolabeled chemo drug. 24h later, DNA is extracted from blood and a biopsy samples. We then determine via ultrasensitive Accelerator Mass Spectrometry the amount of drug that is bound to the DNA. The more drug is bound the better the therapy is killing the tumor. Based on the level of bound drug, the physician can make better treatment decisions. Out test takes the guesswork out of the picture.
AMD needs to provide information for the reimbursement (clinical utility and feasibility).
Dx1 amd week10 class presentation
Accelerated Medical Diagnostics, Inc. George
D. Cimino, Paul T. Henderson, William Hope, Maike Zimmermann PlatinDx Diagnostic test to predict sensitivity towards platinum based chemotherapeutics Customers Interviews: 100
Market Opportunity Assessment Resegmented Market
Total Available Market (TAM): $5B Solid Cancers treated with Chemo Worldwide Served Available Market (SAM): $1B Cancers in the US Target Market (TM): $250M Bladder Cancer US TAM SAM TM
AMD activity before UCSF LLP
Idea To IPO AMD Formed 2008 SBIR P1 Business Plan v1 SBIR P2 Business Plan v2 2010 UCSF LLP 2012 IND/IRB Approvals (lung, bladder) 2014 IND/IRB Approvals (breast) 1st Patient Microdosed LLP program led to a focus on bladder cancer
Out of the Building Learning
& Focus Hypothesis Reality Oncologists and patients make the treatment decision Surgeons make the treatment decision Physician follow Standard of Care set by ASCO and NCCN Only 10% of patients are treated with chemotherapy before surgery All initial value propositions are equally important (saving money, reducing toxic exposure, improving reputation) Minimizing unnecessary toxicity and saving lives through improving utilization of standard of care are most important FDA approval is important for physician adoption No, but may still be important for reimbursement
Model to visualize the improvement
of live expectancy with our test 100% Chemo responders 90% 80% % Survival 70% 60% Overall survival 50% (responders/non-responders) 40% No chemo 30% Current practice 10% patients with Chemo 20% 60 months median survival extension 10% 0% 0 12 24 36 48 60 72 84 96 108 120 132 144 156 168 Months after Randomization
Next Steps Tool provides
a dynamic display of changing diagnostic assay parameters on survival curves Use the model to obtain desired performance parameters from physicians for their adoption of PlatinDx Creating a pharmacoeconomic model of the effect of PlatinDx usage to validate value added pricing
Investment Readiness Level Level Dx
7- 8 Reimbursement and IP strategies understood but not fully implemented Left side of canvas hypotheses tested with some interviews Revenue model validated Market size validated Right side of the canvas completed and validated Fund raising and clinical trials in progress LLP focused us on bladder cancer MVP as initial product
Out of the Building Learning
& Focus Surgeons decide how patients are treated Bladder cancer is under treated with chemotherapy because of low response rates (40%) A 50-60% response rate is sufficient to change surgeon adherence to SOC Surgeons and oncologists rely more on peer reviewed clinical studies compared to FDA approval for adoption of new procedures
PlatinDx how it works Microdose
of [14C]chemo drug( ) Blood Test or Tumor Test * * ** ** * Blood/ Tumor Samples Treatment decision DNA * Accelerator Mass Spectrometry (AMS) Results ** or * * * * ** Resistant Sensitive
Customer relationship “get, keep, grow”
PlatinDx price structure What is your customer lifetime value? • Urologist: $200,000 (US) • 8000 specialists in the US • 72,500 new bladder cancer cases per year • assumed 5 year product lifetime Customer Acquisition Cost $12,500 • Marketing and Sales budget / Customer Segment Physician