The Killer Question(s) and Associated Experiment(s)
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This presentation aims to show how to eliminate risk and prove your innovation will improve upon the current situation.
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The Killer Question(s) and Associated Experiment(s)
- 1. CRAASH Presentation Template The Killer Question(s) and associated Experiment(s) Wolfgang Krull CIMIT Accelerator Executive http://cimit.org 1
- 2. CRAASH Presentation Template Some common terms: Strategy: How to grow and protect the business to make it a sustainable success Business Model: A set of hypotheses about how an organization creates, delivers, and captures value from the activities of making and selling something MVP: Minimum Viable Product Pitch: Convince funders to support the opportunity Killer Question & Experiment: Address the hardest question today’s funders can ask
- 3. CRAASH Presentation Template Goals/Objectives • Objective: o Describe how to ‘Kill’ your program before you spend too much of your own or someone else’s money o Describe a technique that will substantially remove risk and leave no doubt that the product will be an improvement over the status quo. • Agenda o Learn what IS and IS NOT a Killer Question and associated experiments o Selection of controls o Case study examples o Design your Killer Question and Experiment (next week’s homework ) 3
- 4. CRAASH Presentation Template What is a Killer Question • A “question” meant to “kill” a project before significant resources are put into developing and perfecting the technology • It’s really ‘Serial’ Killer Questions: There are more than one Killer Questions and associated experiments throughout a project/program • An experiment or set of experiments intentionally aimed at pressure testing critical features/attributes/requirements of your envisioned product in as little time and as few resources as possible o Could be in‐vitro, in‐vivo, or even human, depending on the level of evidence required o Can be an economic or process oriented o Control group in killer experiment is critical; sometimes it should be a negative control, other times it should be the current gold standard, sometimes both o Tests the claims of superiority over current methods o Can be pre-clinical or clinical study • Depending on the stage of your technology, it is the burden of proof required to demonstrate feasibility, regulatory strategy, etc. 4 ‘KILL’ (test) early, test inexpensively
- 5. CRAASH Presentation Template What is NOT a Killer Question • Exploratory in nature • Establishment of mechanism of action • Basic science • An experiment that leaves one wondering where the effect came from • For the most part, it is NOT the definitive clinical study 5
- 6. CRAASH Presentation Template Selection of groups and controls • Experimental groups: If a technology is composed of multiple components, experiments must be designed such that it is demonstrated that all of the components are necessary. For example, if one invents an engineered material combined with a growth factor, the killer experiment would include 4 groups: 1) the material alone; 2) the growth factor alone; 3) the material with the growth factor; and 4) an appropriate control • Controls: Controls should be very carefully selected. In killer experiments, controls should be selected as to remove all doubt that the newly invented technology, economics, or processes will be ‘superior’ to existing technologies or standard of care. Read the literature to see what others are using as a comparator and speak to clinicians. Standard positive and negative controls may not suffice. 6
- 7. CRAASH Presentation Template Case Study Examples • Case I: What was Netflix Killer Question? • Case II & III: O-arm: Intraoperative, mobile, 2-D (fluoroscopic) and 3-D (‘Cat Scan’) Imaging system focused on Orthopedics and Spine procedures. o What is the killer experiment, and what are the questions that must be answered by the killer experiment? • Case III: The #1 Program o How to test demand and acquisition cost? • Case III: LumeRx o What considerations are important in the Killer Questions(s)? 7
- 8. CRAASH Presentation Template Example: O-arm Killer Questions BI Original Concept (2003) Today 1) O-arm won’t fit/move in OR 2) O-arm won’t take 3D images Intraoperative, mobile, 2-D (fluoroscopic) and 3-D (‘Cat Scan’) Imaging system focused on Orthopedics and Spine procedures.
- 9. CRAASH Presentation Template Case 1 Killer Question: O-arm won’t fit in OR environment or around table 9 Wooden Model: <$1K Wooden Model at Syracuse University Hospital. Compared to existing C-arm (not shown) Result: 1. O-arm does fit and can be maneuvered similar to C-arm 2. Everyone hates the ‘drawbridge’ door Team received $500K investment Experiment:
- 10. CRAASH Presentation Template Case 2 Killer Question Example : O- arm cannot do a 3-D reconstruction 10 Set up: Flat Panel, Use turn-table for rotating object; Simple electronics/mechanics First CT Reconstruction: Frozen Duck! Spine vertebral column ???? Experiment:
- 11. CRAASH Presentation Template Case 3 Killer Question-#1 Problem- Urinary incontinence affects 25 Million American adults Pelvic floor muscle training (PFMT) through biofeedback is considered the best method Biofeedback training is currently only available in hospital and medical clinics Social Barriers: stigma associated with condition, existing devices available only for women #1 Solution- Mobile App and PFMT trainer via pad and EMG Comfortable, available to both men and women Page 11
- 12. CRAASH Presentation Template The Kill Experiment Online sales, customer acquisition Google AdWords campaign ($1,750) Website creation- sales page, SEO, overall traffic Page 12 Results: • 3 week bolus of activity- 2,995 total clicks • Average ad position- 2.1 • 34 Committed Customers • Customer acquisition cost: $25
- 13. CRAASH Presentation Template Case 4 Killer Question: LumeRx Photo Therapy example Problem H. pylori causes gastrointestinal ulcers. Antibiotic overuse leads to resistant bacterial strains. Significant antibiotic side-effects/compliance problems. 500,000 new, 4 Million recurrent ulcer cases/year (US). H. pylori causes stomach cancer. A CDC Class I Carcinogen. LumeRx Solution H. pylori bacteria accumulate porphyrins. Specific wavelengths of visible light excite porphyrins and kill H. pylori BUT: Bacteria live in glands/crypts in stomach wall. Blue/Violet light doesn’t penetrate mucosa Will it work in human stomachs???
- 14. CRAASH Presentation Template The Kill Question: In vivo Human Tests In vivo studies Initial pilot studies done. Demonstrate sufficient kill. Human stomach. H. pylori surface. During standard endoscopic biopsy. Spot laser light. Non-significant risk test- IRB
- 15. CRAASH Presentation Template In vivo Human Tests 105 106 107 108 109 Patient 1 Patient 2 Patient 3 Patient 4 Patient 5 Patient 6 Patient 8 Patient 9 Patient 10 mean CFU from biopsies from clinical trial control treated CFU/g tissue
- 16. CRAASH Presentation Template Key Points • A successful Killer Question and Experiment will substantially remove risk, and leave no doubt that the product will be an improvement over the status quo; this requires very careful design and controls • The model used for the Killer Question must be meaningful to people who work in the area, or the experiment will be non‐convincing; • do lots of benchmarking with MD’s, industry, and investors • A Killer Question that results in a definitive “kill it” decision is a success! • Serial Killer Questions 16
- 17. CRAASH Presentation Template Killer Question Homework (next week) • Describe the objectives, rationale, and plan for your Killer Question. • Describe the specific activities you will need to perform in order to execute your Killer Question. • Describe the specific measures and quantitative targets you will be using to evaluate performance, progress, and ultimate success. • Describe limitations of any models, tools, or methodologies you will use and offer a rationale for their use. • Document the contact information of any business advisors and/or potential commercial partners who helped you define the Killer Question (This is strongly encouraged). Team # | Company Name
- 18. CRAASH Presentation Template References • https://hbr.org/2010/05/beating-the-odds-when-you- launch-a-new-venture • http://sloanreview.mit.edu/article/disciplined- entrepreneurship/ • http://insight.kellogg.northwestern.edu/article/what-does- not-kill-your-business-makes-it-stronger 18
- 19. CRAASH Presentation Template Thank you http://cimit.org 19
Editor's Notes
- The concept of Killer question is a key part of a new technology or business proposition.
- This is the CRAASH pyramid that was presented last week with the overall goal of how to grow and protect your business Last week we described the business model (business canvas) and beginning market segmentation Today we will talk about what critical questions funders can ask Question: Any idea of why we call the Killer question “Killer”? : Not just ‘kill’ the risk. It actually Kills your idea or ‘proves’ that a major indication works. In the future we will work with you on your pitches and minimal viable product
- Throughout this presentation, I want you to imagine that you are preparing to put $250K personal $’s into your program (not just your sweat equity). What DEFINATIVE testing/proof will make you invest and continue on your project? Objective: Describe the questions that will KILL your program before you and your investors invest too much time, money, and resources Describe a technique to substantially remove risk and leave no doubt your product will be improvement over the status quo.
- In science/academics: most investigators will take an incremental, perhaps multi-year, approach to ‘research’ an idea or hypothesis and iterate… In a Killer Question and resulting Experiment: I want to ‘destroy’ what I have been working on. Find a key indication/premise and prove it does not work! If you fail – you have actually shown it does work, if you succeed – you have, hopefully, saved lots of time, $’s. resources Question: Who will be the audience for the killer question results and data?: Answer: Investors, SBIR, customers, … Investors are key as they provide next $’s. You should note that in the life of a program – there will be multiple Killer Questions – in other words you are really a Serial Killer In general, many experiments will eventually be in-vivo , in large animals/humans, or economic/process. Key is how to design experiments to test early and minimize costs. Investors use this after initial seed round. They may hire outside firms to assess data. Reduce risk before significant resources spent: $, Time, People Killer experiments don’t have to be technical (although, many times are).
- It is not a ‘fishing’ expedition Need controls and design of experiment Mechanism of Action: Specific biochemical interaction through which a drug substance produces Pharma effects REMEMBER: It is supposed to be fast, inexpensive, and definative!
- Design of experiments is very important: If technology has multiple components – then design experiment to demonstrate all necessary combinations. Controls must me carefully selected. Minimize the effects of variable by ideally having only 1 independent variable. Select controls so that they help remove all doubt that new technology, economics, or processes will be superior to existing!
- Targeted Experiments These are designed to pinpoint a deal-killer or path-dependent risk. Examples might include running tests on battery life before launching a new portable device, checking for toxicity in a drug before running full-scale efficacy tests, and testing bandwidth and connectivity concerns before launching an online learning program at various locations across the country. Integrated Experiments These are designed to test how various elements—the actual business model and operations—work together. In essence, they involve launching the business, or some part of it, in miniature. Although pilot programs are nothing new, our experience suggests that entrepreneurs rarely give them sufficient time to play out.
- Control’s: 1) Full Scale Model 2) OR 3) Competitive, working product: C-arm
- Controls: Prototype System, Object to image
- Describe problem and system. Solution is Pelvic Floor Muscle training (Kegle?) Initial target market: Women and post childbirth women Work determined large underserved market for men
- Question: Would people (Men) find or buy this product w/o references What is customer acquisition cost; how much ‘real’ demand is there? SEO – Search Engine optimization: Tag words 0.75M ‘Impressions’ (seeing ad) 3000 clicks on Ad – reached 2nd highest ad position Kill: <25 clicks/day – it was 250 Cost: >$75-100: it was $25 They are using data in presentations/competitions
- LumeRx Photo Dynamic Therapy The H. Pylori bacteria causes gastrointestinal ulcers and, if not treated, can cause stomach cancer. The standard treatment is antibiotics H. Pylori bacteria accumulate porphyrins – which is a ring of photosensitive pigmented They question was will LumeRx’s photo dynamic therapy wavelenghts of light penetrate glands/crypts in stomach wall where bacteria live in humans? SO HOW CAN THIS TEST BE ‘EASILY’ DONE w/o huge regulartory hurdles for human testing?
- SOLUTION: Set up a trial in a human stomach at same time as a standard endoscopic biopsy to test for H. pylori. This was a non-significant risk test IRB! Basically – set up a spot laser light to irradiate sections of the stomach and take biopsy samples at from those sections as well as non-irradiated sections.
- The results were significant! Unfortunately, the company failed because clinicians believed antibiotics were effective 95% of time. The company recognized this and where going after people who failed treatment or became bacteria resistant Unfortunately, people who finished treatment did not come back to gastro enterologist and used primary care and/or treated themselves At that time, this prevented raising more $’s