Integrated team harmonizing between Science and Business

Thinking of new targets of drug development for the future, I have tried to review two innovational medical technologies at the R&D stages. One of them is the imaging technology of a non-invasive approach. For instance, there is an interesting research project known as "brain map project" that is mapping brain function using the result of imaging medical devices ( 3-1 ). Because Brain imaging techniques are providing different views of brain structure and function, these techniques enable high-quality visualization of brain activity or the location of atrophies, and facilitate the study of disease mechanisms in the healthy brain ( 3-2 ). Imaging techniques have also been used for effectively studying the brain in several fields, they could lead to the development of effective therapies or drugs against diseases. Surprisingly, I read recently the article about "No More Woof" with great interest because the innovational technology will appear in unexpected fields of a plaything ( 3-3 ). From my opinion, "No More Woof" is an indication for an innovative tool on the outskirts of the medical field because it testified that we could predict vital phenomena from vital signs such as brain waves. The key point of my opinion is to play an important part to convert vital signs into digital signals to investigate the human physical conditions. The key point makes it possible to research human bodies and diseases using many informational technologies based on the biological digital networks (3-4). I come to the conviction that the digital bio-networks system, that is meaning "open source virtualization" at the same time, will contribute to medical diagnoses, treatments, and the proof of medications. In other words, if we could reveal the brain map for the future, we could get probability information of human's physical conditions, minds and emotions. It is noteworthy that digital bio-networks could predict vital phenomena with the new probability methods such as "Bayesian network theory" and "Hidden Markov model". The probability functions lead to medical innovation, and have be applied in the pharmacotherapy ( 3-5 ). Using these methods, we can correct information as a prediction both sides of a causal relationship. The theories will especially be useful for diagnoses and treatment in the medical fields, that digital bio-networks could make it possible to treatment of drugs with precision in human body by supporting with non-invasive approach using medical devices such as small sensors for the future.

Second innovational example is that the giant step was recently announced that scientists created first living organism containing artificial DNA ( 3-6 ). That will open the door to a future in the new field of the medical industry because the breakthrough will bring us a giant step closer to being able to synthesize new bio-materials such as artificial protein products. In other words, the challenge to discover the artificial protein products will be a very promising research because we can not get any method to produce the artificial protein yet. Although the technology of artificial DNA is in start up stage, I am convinced that the approach of artificial DNA will be useful because the development of the artificial DNA will provide useful approach to lead the artificial protein products for the future.

As mentioned above, the development of treatment with new drugs will provide us a lot of benefits. However, there would be a lot of mysterious problems in especially innovational drugs, such as the artificial proteins. One of the example is that the difficulty of the solution is the unsolved actions coursed by drugs in human body. The non-invasive approach with wearable medical devices is useful for developing new drugs because I think that digital bio-networks systems could make it possible to predict the drug's action in human body with precision. In other words, it could provide us more drug's information based on the vital-digital signals that are bring from the non-invasive and environmental approach using medical devices. Using the digital bio-networks systems, we could control the drugs to act on pharmacotherapy with precision. Under the circumstances, I am imagining the new medical innovational technology that compounds such as drugs and candidates of the drug will act on the human body with precision by supporting with non-invasive approach using medical devices.

Now, I am convinced in the new complicated medical markets that the key point for the developing new products is a mix of diverse professionals such as doctors, biologist, chemist, soft ware & hardware engineers, marketing and sales. In addition, the keystone in this process may be the person who can integrate the knowledge between science and business in the point of finical aspects of open-innovational issues. I will consider the concept of integrated team because the idea is very attractive for the commercialization process of New Drugs ( 3-7 ). Fundamentally, PQS(Pharmaceutical Quality System, ICH Q10) goals for commercialization is very important for a pharmaceutical development, technology transfer, commercial management, product discontinuation. I take notice about the recent USA's policy and the FDA's plan for commercialization ( 3-8 ). Thus, Obama's strategy for American Innovation is that technology transfer plays an important role to advance economic growth and job opportunities. In addition, the FDA think that accelerating technology transfer and commercialization will support high growth business to increase the number of technology transfer partnership activities, to improve their technology transfer business processes, to expand technology transfer knowledge. The FDA intends to increase its focus on technology marketing toward commercialization partnerships. Accelerating technology transfer and commercialization will create new business opportunities. Under the new cooperative trend of drug market, project management will embrace the opportunities to make a success and accelerate the speed of developments for the commercialization process of new drugs (3-9). According to the McKinsey's repots ( 3-7 ), the integrated project team started working together planning for PoC in Ph2 to fix the gap that was searched for and was design by the team. The critical point of integrated project team is that the team need a mix of scientific and business skill and learn by experience. Consequently, the teams make a relationship between patient, competitors and stakeholders to be able to react to changing circumstances.

Reference

3-1) Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Working Group (september 16, 2013)., The Brain Activity Project and the Challenge of Functional Connectomics. (Neuron., 2012, 74, p970)

3-2) A WEARABLE DEVICE FOR REALTIME ASSESSMENT OF VIGILANCE. (Biomed Tech., 2013, 58.), Multi-voxel pattern analysis in human hippocampal subfields. (Frontiers in Human Neuroscience., 2012, 6, 1)., Healthcare: Into the cortex. (FINANCIAL TIMES)., Electric Field Encephalography as a Tool for Functional Brain Research: A Modeling Study. (journal.pone.0067692)., Charged by GSK investment, battery of electroceuticals advance. (Nature., 2013., 19, 654).

3-3) No More Woof by The Nordic Society for Invention and Discovery (http://www.youtube.com/watch?v=CweAeshjObA)., Reactivity of DOg's Brain Oscillations to Visual Stimuli Measured with Non-Invasive Electroencephalography. (journal.pone.0061818).

3-4) Once more, with feeling. (Nature., 2013, 497, 176.)., Association between Physical Activity Levels and Physiological Factors Underlying Mobility (pone.0074227)., Design of a Wearable Sensing System for Human Motion Monitoring in Physical Rehabilitation. (sensors., 2013, 13, 7735)., Bodily maps of emotions. (PNAS-2014-646-51)., Wireless Contact-Lens Tear Glucose Monitoring. (IEEE Journal of Solid-state circuits., 2012, 47, 335).

3-5) Monitoring motor capacity changes of children during rehabilitation using body-worn sensors. (Journal of NeuroEngineering and Rehabilitation., 2013, 10, 83)., Three Dimensional Gait Analysis Using Wearable Acceleration and Gyro Sensor s Based on Quaternion Calculations (Sensors., 2013, 13, 9321-9343)., 脳 MRI データの統計解析 (計量生物学. 2012, Vol. 33, No. 2, 145–174., The Mathematician versus the Malignancy., (Nature Medicine., 20, 460-463, 2014)., Mathematical Modeling of PDGE-Driven Glioblastoma Reveals Optimized Radiation Dosing Schedules., (Cell., 2014, 156, 603-616)., Adaptive Therapy., (Cancer Res., 2009, 69, 4894-4903).

3-6) A semi-synthetic organism with an expanded genetic alphabet. (Nature., 2014, May 7. doi: 10.1038/nature13314)., Three Dimensional Gait Analysis Using Wearable Acceleration and Gyro Sensors Based on Quaternion Calculations. (Sensors., 2013, 13, 9321-9343; doi:10.3390/s130709321)

3-7) Value-driven drug development—unlocking the value of your pipeline. (McKinsey & Company.)., Pharma 2020: Virtual R&D: Which path will you take? (PriceWaterHouseCoopers)., Pharma 2020: Challenging business models. Which path will you take? (PriceWaterHouseCoopers).

3-8) Accelerating Technology Transfer and Commercialization of Federal Research in Support of High-Growth Businesses. (U.S. Department of Commerce., October 28, 2011)., Accelerating Technology Transfer and Commercialization of Federal Research in Support of High-Growth Businesses. (FDA., April 2012)., Federal Laboratory Technology Transfer., (Fiscal Year 2010).

3-9) STIMULATING SMALL BUSINESS GROWTH., (Progress Report on the Goldman Sachs

10,000 Small Businesses UK Programme., April 2013).