1.1 Who composes Neurognos Team? +
Alejandro Bisquertt: CEO and co-founder. Biochemist and master (c) in Biotechnology Enterprise and Entrepreneurship at John Hopkins University. He has more than 8 years in R&D applied to Neuroscience and neurodegeneration with multiple peer reviews papers in neuroscience journals. (Linkedin Profile)
Manuel Donoso: CFO and co-founder. He has more than 10 years of experience in business development in multinational companies. (Linkedin Profile)
David Chamorro: Biomarker discovery scientist. Biochemist and Master in Biochemistry and Molecular Diagnostics. More than 8 years of research experience in the area of cellular and molecular biology with multiple peer reviews papers in neuroscience journals. (Linkedin Profile)
Pablo Recabal: Data Scientist. Electrical Engineer and Master of Music Technology. More than 8 years of experience in Data Analytics and Machine Learning. (Linkedin Profile)
José Miguel Vega: Operations Director. Biotechnology Engineer. (Linkedin Profile)
1.2 Who composes the advisory board of Neurognos? +
Juan Sebastian Morales: Commercial Engineer, With more than 5 years of experience managing companies in acceleration & fast growing processes. Currently is the COO of a real estate company that in less than 2 years they have captured more than 3% of the real estate market share in Chile.
Jorge Canales: Pharmacist and Master in Industrial Engineering at The Pontifical Catholic University of Chile. He has more than 11 years in Pharma and Medical Devices Manufacturing, Operations and QA/QC in a highly regulated environment with top-ranked International companies including Pfizer, Johnson & Johnson among others.
Alejandro Tocigl: Commercial Engineer. Was part of the Graduate Studies Program at NASA. Has extensive experience in technology and entrepreneurship. In 2013, he founded Miroculus, a company located in San Francisco that developed a platform for microRNAs detection. Miroculus was highlighted by Stanford, Google and Johnson & Johnson as one of the most promising companies in Silicon Valley. Alejandro was recognized as one of the winners "world's top 35 innovators under the age of 35" awarded by the MIT Technology Review.
Markus Schreyer: German executive and entrepreneur with over twenty-five years of international industry and market experience. Markus has lived and worked extensively in Europe, the USA, Brazil and Asia, and is now focused on the Chilean & Latin American market. During his 25 years long career in the Life Science Technology industry with leading manufacturers like Thermo Fisher Scientific and Fisons Instruments, Markus held various leadership positions. He gained significant experience in strategic transitions through market differentiated product innovations resulting in significant value generation, growth and market leadership. (Linkedin Profile)
2.1 What is the technology behind Neurognos first product NeuropreciseTM? +
Neurognos first product, NeuropreciseTM, is a diagnostic test for Alzheimer's Disease (AD), is based on the quantification of a set of peripheral micro RNAs (miRNA) using qPCR technology. This peripheral miRNAs are small molecules present in the blood which, in this case, are related to various brain processes that are affected in people suffering from AD. The values obtained are then interpreted by our algorithm based on machine learning, which was trained to discern between people who have AD or not, thus delivering a diagnostic tool that is easy to implement, fast and reliable.
2.2 What time of Intellectual property Neurognos have? +
Our product has a provisional patent in USPTO in place and we are working in the PCT application. This patent was developed by Foley Hoag, an international legal firm with extensive experience in life science and technology IP.
2.3 What is Machine Learning? +
Machine Learning refers to a computer system capable of making predictions or decisions based on the "interpretation" of the data. This is achieved by building an algorithm that is trained by sample data, and that manages to identify patterns and differences that traditional mathematical models are not able to interpret.
2.4 Do you have results on clinical studies already done? +
During 2017-2018, we conducted our first clinical study along with Clínica Davila, one of the best medical centers in Chile. In this study, 40 patients diagnosed with Alzheimer's disease were recruited, as well as another 47 healthy patients. With the clinical information and biological samples obtained, we were able to train and improve the performance of our test.
3. About the FDA regulatory pathway +
In order to commercialize in the North American (USA) and global market, we want our product to have a market approval from the FDA. We have just completed a regulatory assessment with NAMSA, which defines a regulatory strategy and road map to get our product to market as soon as possible. Therefore, we conclude that the best way to achieve this goal is through a De Novo classification of our product with a fast track trough Breakthrough Device Program
3.1 Who is NAMSA? +
Namsa is a medical research organization (MRO) specialized in the support of medical device development for medtech, diagnostic and regenerative medicine companies. With more than 45 years of experience in regulatory consulting, it is known as one of the best in its area worldwide.
3.2 What is a De Novo classification for Medical Devices? +
The De Novo classification is a device classification process that allows to obtain a clearance by the FDA. This process provides a pathway to classify novel medical devices for which general controls alone, or general and special controls, provide reasonable assurance of safety and effectiveness for the intended use, but for which there is no legally marketed device that has a substantial equivalence to the novel medical device.
3.3 What is a Breakthrough Device Program fast Track? +
The Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions, like Alzheimer’s Disease.
The program offers manufacturers an opportunity to interact with the FDA’s experts through several different program options to efficiently address topics as they arise during the premarket review phase, which can help manufacturers receive feedback from the FDA and identify areas of agreement in a timely way. Manufacturers can also expect prioritized review of their submission.
4.1 What is the size of the target market? +
It is estimated that in 2016, 47 million people were affected by some type of dementia, a total larger than the population of Spain, and it is believed that this number will increase to more than 131 million in the year 2050 as the population ages (World Alzheimer Report 2016). These figures are alarming taking into account that AD is the main cause of dementia representing 60-80% of these cases and its prevalence increases twice every 5 years after the age of 65 years. The above mentioned acquires special relevance if we look at the epidemiology data of the EA. In the US 75 million people are close to turning 75 years old or more and an average of 10 thousand people per day will reach the age of 65. Considering the average prevalence of AD (5-6%), it is expected that 180 thousand people a year will develop this disease only in the USA. In Chile, the number of people affected by AD is estimated at 180,000 people and it is expected that this number will increase according to the fact that our population has a growing rate of aging.
4.2 What are the potential savings for a pharmaceutical company? +
Currently, there is no drug that stops the progression of AD and the 5 drugs that have been approved by the FDA to combat this disease are only of a palliative nature. In the last 20 years, there has been no effective treatment for AD and the failure rate of clinical trials between 2002 and 2012 reached 99.6%. This figure is too high if we consider that the value of phase III clinical study is around 200 million dollars. This high percentage of failure is largely explained by the lack of an adequate diagnosis in the selection of patients participating in the studies, which has an error rate of 33%. That is 1 out of every 3 participants of clinical studies destined to find a drug to fight this disease does not have Alzheimer's. The latter takes on radical importance if we take into account that according to data from the Alzheimer Association, a safe and early diagnosis would only imply a saving of 7.9 trillion dollars in the US alone.
5.1 Regulatory Risk +
As part of an international marketing strategy, the design and methodology of each of the aspects involved in the development of our product have been structured in accordance with the required regulations, including incorporating a quality management system based on international standards. This in order to establish an internal regulatory framework according to the standards imposed by the FDA and where it is possible to record each of the steps of production, inputs, services required and skilled labor in the stages of product development.
5.2 Are there competitors with the same technological process? +
At the market level, there is currently no national or international company that has successfully developed and marketed an in vitro or molecular diagnostic test for Alzheimer's disease based on blood. Different companies such as Diamir, Avid radiopharmaceuticals and ADX neuroscience are focused on the development of products related to the diagnosis of AD. These companies based their technology on biomarkers that are present in the brain or cerebrospinal fluid, which makes theirs tests highly invasive. At the same time, this still needs to be approved by the respective regulatory and health agencies.