First, we are born. Life around us seems quirky and to
explore it, we are tought how to walk. From the moment we take
the first step, we constantly think about the next, how to move forward.
Each new step brings the urge to make another one, and another one and so we all
remain in move. We hope to walk endlessly on this world, however some obstacles we
encounter, stop our dreams from being fulfilled. Pain is usually one of them.
Osteoarthritis is a chronic, debilitating disease that affects over 7% of the population worldwide.
To provide for One Less Painful Step, we first had interacted with these patients. The needs, thoughts, and troubles of those who suffer were the driver and the means for a human-centered design.In subsequent stages, the crucial dilemmas were resolved via targeted interviews with experts. Throughout the project we sought communication with the market, potential investors and policy makers to ensure a solid business plan towards a marketable product.
Interactive science communication events held during the project created numerous opportunities to open dialogue with the society, help us shape a socially acceptable solution and prepare the public to include synthetic biology into everyday life.
It was a unanimous decision amongst all team members to engage in educational activities throughout the project and create opportunities for audiences in all learning levels: from kindergarten to higher education and lifelong learning. Communicating science was fulfilling; discussing and debating synthetic biology was exhilarating! Reflecting upon this experience we now realize that each person has a different perspective, but science can be our common denominator
For better science and better society, none should be left out. Among those with less than equal representation in sciences, we identified three main groups to engage: refugees, women, and artists.
The love of science and the desire for
impact brought us together in the NOUS team. One simple goal: to
create new science and solve a real-world problem.
However, our first real problem was …to find a problem to solve. After many brainstorming sessions and thanks to the intervention of our mentors, we set up the following strategy.
Each team member formulated a real-world problem them thought to be important and interesting. All problems were to be briefly analyzed and presented along three aspects: the impact to society, the potential to engage synthetic biology for the solution, and the opportunities to reach the market.
A first deliberation on more than 10 problems-to-be-solved led us to retain 3 finalists. The team split in 3, each group undertaking to further research and develop the idea and sketch a propose solution. After a long and painful debate, we got our winner: find a cure for osteoarthritis!
This first internal brainstorming also produced the realization that our team’s collective expertise is not enough to guarantee success. One cannot solve a real-world problem without engaging and interacting with the problem and the world!
Hence, during our journey we reached out to patients, experts, professionals and entrepreneurs placing our questions and digesting input to
• to formulate the idea from the patient’s perspective
• to refine the design and the experimental procedure with the help of experts
• to prepare for real-world implementation considering options for translation from the lab to the patient
• to plan for a product that will hit the market
Here is how we integrated the patients, the experts, the professional and the entrepreneurs throughout our project:
Contact with the Hellenic League Against Rheumatism (EL.AN. A.).
Date: April 03, 2021
Major Issue: Identify important patient requirements for an osteoarthritis treatment.
Resolution: Strive for a solution that will be cheap and will require minimum visits to the doctor.
During our communication with the society, we had the opportunity to get in touch with patients and get a first realistic picture of their lifestyle. In addition, through the discussion with patient representatives we were exposed to the psychological, social and economic impact of the disease on the life of the patient.
All of this prompted us to review the implementation as we understood more clearly what the financial incentives would be for a new treatment.
We also took into account in our project design the need of several patients to limit their visits to their treating physician as it was a process with a special psychological burden for them.
Logo of organization EL.AN.A
Contact with the Skeletal Health Association “Butterfly”
Date: April 06, 2021
Major Issue: Identify important patient requirements for an osteoarthritis treatment.
Resolution: Strive for a solution to halt disease progress before the end stage of paralysis.
We were given the opportunity to attend a webinar organized by the Association on the subject of osteoarthritis. There, we met the scientific leaders of the association and held an interview with Ms. Tatiana Drakopoulou, Communications Manager of the Skeletal Health Association "Butterfly".
During the online communication, we were given the opportunity to present our idea to an audience suffering from musculoskeletal disorders including people with osteoarthritis. Patients shared with us their concerns, especially about whether the possibility of complete paralysis could be reduced or eliminated with our proposed treatment.
Finally, the club published about us on its website and on social media and so we were able to gradually get in touch with a growing audience of osteoarthritis patients.
Logo of Skeletal Health Association “Butterfly”
Link of the article (Greek) in Osteocare Website.
Call with Prof. George Skretas
Date: May 11, 2021
Major Issue: What is the best way to produce exosomes carrying a certain type of miRNA.
Resolution: Genetically modify a certain cell so that the cell itself produces the exosomes with the miRNAs of interest inside them!
George Skretas is a Research Associate Professor and head of the Laboratory of Enzyme & Synthetic Biotechnology at the Institute of Chemical Biology of National Hellenic Research Foundation.
During an online meeting we discussed exosome production. Some excerpts from the interview: “What do you think is the right way to produce exosomes, with certain type of miRNA inside them?”
“There are two ways that you can use exosomes in order to administer side specifically certain miRNAs. One way is to genetically modify the certain cell – type so that the cell itself produce the exosomes with the miRNAs of interest inside them. The other way is to produce artificial exosomes, insert the certain molecules of interest inside them and administer them again side specifically.”
He also told us that we can try to run our project with the second way, because it’s more simple and less complicated.
“However, in this alternative there is the downside that ingenuity and synthetic biology component are reduced and maybe it is something that will affect you, given the competitiveness of the therapies.”
Based on this discussion, we ruled out the possibility of producing artificial exosomes, and so the idea of using the guiding tag to produce biogenic exosomes was now the one that prevailed. Of course, in the next step we had to learn more about the management of EVs (extracellular vesicles) by experts and experienced in the field.
Screenshot of our meeting with G. Skretas
Theme: Call with George Niotis
Date: Friday, May 21, 2021
Major Issue: Working with exosomes.
Resolution: Try to avoid exosomes carrying DNA. Although difficult to insert a genetic circuit, mesenchymal stem cells might do the trick!
George Niotis is PhD student at George Garinis’ lab at Foundation for Research and Technology, Heraklion, Greece. His scientific interests are mainly focused on exosome research.
Firstly, we discussed on the use of extracellular mesenchymal stem cells to transfer the circuit to the joint cells versus the use of whole mesenchymal stem cells. We wanted to clarify if it is appropriate to use exosomes to transport DNA molecules, which we want to have satisfactory expression rates in the cells where they will end up.
He informed us that an exosome with DNA inside is more difficult to achieve expression rates in the target cell. So, this method was excluded.
We also understood that exosomes are produced at specific rates depending on the cell type. The presence of a protein in the membrane or inside the exosome depends mainly on its concentration within the cell.
The part that concerned us the most was the laboratory isolation of the EVs. Exosomes are isolated mainly with the ultracentrifuge but there is another method with magnetic beads. However, after the discussion and the services available in our own laboratory, we decided to use a different protocol with the use of a suitable kit.
Finally, he gave us an indication that it is difficult to put the whole genetic circuit into mesenchymal stem cells, but with this approach he was optimistic that you can isolate exosomes with the guiding tag and miRNA.
Screenshot from our meeting with G. Niotis
Contact with a Greek MP
Date: July 17, 2021
Major Issue: How can a new treatment be supported by public insurance?
Resolution: The chances are greater with an effective and cheaper solution.
Christos A. Dermentzopoulos is a Lawyer and Member of the Hellenic Parliament.
The primary reason for our communication with a representative of the Greek Parliament was to try to understand whether a proposed treatment could be supported by the state. In addition, we wanted to know if the state could set up structures so that people with osteoarthritis could receive our proposed treatment more directly.
He informed us that state records report that about 1 to 1.5 million people suffer from the disease in Greece. After EOF (the FDA Greek equivalent) clearance, an effective treatment would be quickly considered for inclusion in the public insurance reimbursement scheme, especially if it is affordable.
Photo from our meeting with C. A. Dermentzopoulos
Discussion with a biotech company on alternative technologies for tissue engineering
Date: September 03, 2021
Major Issue: Using a gel to hold and deliver mesenchymal stem cells via injection.
Resolution: A gel CAN be used to hold and deliver the proposed therapy. This opens the opportunity for an injectable delivery rather than surgical placement.
“ClexBio” is a biotech company that is looking for solutions for tissue engineering and single – cell techniques. “ClexBio” focuses mainly on microfluidics and hydrogel technologies. In our contact with the company, we had the opportunity to talk with Tia Tidwell who is a Lead Scientist at Translational Research sector of the company.
Tia Tidwell: Lead Scientist - Translational Research
The company is currently considering approaches that include spheroids and microbeads.
After presenting our approach to Ms. Tidwell, we were given the opportunity to solve some
questions regarding the implementation of the proposed therapeutic approach. Our concerns
on the company’s technology and the way that we could use it were the following:
• Can mammalian cells and mesenchymal stem cells in particular fit and survive inside the microbeads of a gel?
• Could this technology evolve in injectable form?
• To what extent do cells communicate with the environment? Are they metabolically active?
• What is the degree of toxicity caused by currently available gels in neighboring cells?
In the discussion that followed, we realized that the size of the alginate microbeads is ideal so that the cells that we are using can be administered via this gel. In fact, this technology already has the potential to evolve into something injectable.
Also, it was confirmed that the cells inside this bio-gel maintain an adequate viability and communication with the neighboring cells, making it ideal for our idea. There is no concern regarding the toxicity of this gel for the human body as it is specifically designed with biomaterials for this purpose. The well-tolerated environment of the gel and the very good communication of the cells around and through it allow its use.
The only remaining concern is that although an adequate viability of the cells is maintained, the cells seem to go through a quiescent phase. However, this is something that, according to Ms. Tidwell, is still under research, with very promising progress being achieved. Even though this bio-gel has not been clinically approved yet, it is a very good prospect to combine with our proposed treatment method as it is expected to be approved soon.
In this way, our idea began to take on a new trajectory, regarding the means of administration. Our approach so far included the surgery of the patient. However, the potential of this technology combined with our project, makes it more painless and less time consuming to rehabilitate the patient making an injectable form possible.
Screenshot from our meeting with T. Tidwell
Discussion with a microbiologist
Date: September 23, 2021
Major Issue: How and where to place the final envisaged product?
Resolution: Preferably a minimally invasive kit for outpatient use. Preferably separate diagnostic and therapeutic kit, so as to diversify marketing.
The envisaged final product of the proposed method is a medical kit with all the biological parts required for the delivery of the solution to the osteoarthritic joint (either transdermally or via injection).
Therefore, we visited a practicing microbiologist Dr. Fotini Sopasi to better understand the management of diagnostic and therapeutic kits and their positioning in the market.
Could such a kit be picked up from your own clinic and later proceed with a patient's treatment protocol?
“Well, the legislation in Greece requires doctors of the respective specialty to manage the diagnosis or treatment of a specific disease. The final envisaged kit of the treatment you are investigating would be prescribed and handled in cooperation with a specialist orthopedist.
For a diagnostic or therapeutic kit to hit the market for use directly by the patient means that the kit is easy to use and is as non-invasive as possible.
In a diagnostic laboratory like this one, we could certainly undertake the diagnosis part of your proposed solution.”
Question: “How feasible would it be for diagnostic laboratories like yours to work with orthopedic experts for the early diagnosis of osteoarthritis by recognizing certain exosomes that are considered to be biomarkers?”
“Well, the idea of biomarkers is inevitably something that would give impetus to the early diagnosis of osteoarthritis. However, to be honest, my own laboratory at the moment does not have the necessary equipment for the characterization of exosomes, but it is something that I am sure that other colleagues would agree to invest in and promote in their daily practice, if these biomarkers are promising”.
Photo from our visit to the laboratory of Ms. Sopasi - Romanidou
Discussion with Alexios Kontis
Date: May 2, 2021
Major Issue: How to raise funds? What is a business plan?
Resolution: A draft layout of the contents of a business plan and what each section means.
Alexios Kontis is an experienced strategy and operations consultant with more than 25 years of work in the field. We h3ld various meetings concerning the entrepreneurial aspect of our project seeking guidance and advice.
At the beginning, Mr. Kontis helped us to build a solid fundraising plan in order to cover all of our financial needs. His help consisted on advices and feedback on:
i) our business proposal.
ii) our pitching presentation.
iii) organizing the structure of our fundraising plan.
Later on, Mr. Kontis gave us foundational advices concerning our business plan and idea. More specifically, he helped us:
i) organize the structure of our business plan (sections, content etc.).
ii) reviewed and gave valuable feedback on the final drafts of our business plan.
To sum up, Mr. Kontis contributed to making us better understand the entrepreneurial world, to help us strategically organize the abovementioned sector and how to detect and take up valuable opportunities in order to implement our business idea.
Screenshot from our meeting with Mr. Kontis.
Discussion with DELOITTE
Date: September 13, 2021
Major Issue: Impress one of our biggest sponsors with our progress. Get feedback on methodology of developing a business plan.
Resolution: Comments on how to finalize our business plan.
With 45 years of presence in the Greek market, Deloitte Greece provides consulting, financial advisory, risk advisory, tax & legal, audit & assurance services. Deloitte is one of our big sponsors and we had the opportunity to visit their offices in Thessaloniki, and thus better understand how such a renowned company works.
At the same time, we met a team consisting of business strategists, market analysts and marketeers and we had the pleasure to conversate with them about the implementation of our therapy. Finally, we met and presented our work to Mr. Kafatos, who is Deloitte Greece Clients & Industries Leader, Head of Strategy Practice and in charge of the Deloitte Alexander Competence Center.
During the discussion, we talked about the best practices on developing a business plan.
Photo from our visit at Deloitte's premisses in Thessaloniki.
Discussion with DEMIUM
Date: October 14, 2021
Major Issue: Looking ahead… Key success predictors while designing a start-up.
Resolution: Pay special attention to the people, i.e. the team. Shape your idea and develop a good business plan.
Demium is an international talent investor company, operating with strong presence in 5 European countries and managing 8 business incubator programs. We had the pleasure to hold two meetings with Mr. George Platanas, Head of the incubation program in Greece.
During our meetings we pitched our project with the purpose of receiving feedback concerning:
i) our business idea and team.
ii) the implementation and action plan we have designed.
It was very important for us to receive feedback from a company that has great expertise in the field of start-ups. Mr. Platanas helped us understand the importance of a great team, the number of persons that usually make the team so as to work efficiently and the process required to implement our business idea
Last but not least, Mr. Platanas impressed by our work, saw a promising future for our business idea and thus insists that after the iGEM competition we must enroll in Demium incubation program with the potential of getting pre-seeded and receive a financial support.
Discussion with ELPEN
Date: October 16, 2021
Major Issue: Looking ahead… How to design a promising implementation approach
Resolution: Should normally get the therapy successfully through clinical trial phase I and II, before looking out for an investment from big pharma.
ELPEN is a prestigious Greek pharmaceutical company, consisting of more than 600 employers, with strong presence in the Greek and European market and has the largest educational center for translational research in the Balkans. We had the pleasure to communicate with Mr. Verivakis Georgios, Commercial Director of the company.
We communicated with him in order to have an inside view of how pharmaceutical companies work and how that affects our proposed implementation. After presenting our work and discussing many topics, we understood that for a pharmaceutical company to invest in a therapy, first promising results must be shown and it is common also (as a prerequisite) that the therapy should have passed successfully clinical trials of phase I and II, for the investment to be granted.
This information changed our thoughts, because our strategic planning consisted of an investment of a pharmaceutical company at the stage of clinical phase I. Although, this made us consider other options for funding during the early stages.
Participation in ARCHIMEDES Business Accelerator
Date: March to June, 2021
Major Issue: How to start a start-up?
Resolution: A toolbox of best practices, hands-on experience and support on how to start a business around our idea.
ARCHIMEDES is the acceleration center of National and Kapodistrian University of Athens. Its purpose is to promote entrepreneurship within the University’s community, as well as to support researchers and potential entrepreneurs to develop their ideas and bring them to the market.
We are glad to have been given the opportunity to participate in the 3rd cycle of ARCHIMEDES acceleration program and have been 1 of the 15 selected teams to enroll. This journey begun in March 19 of 2021 and is still ongoing as the program ends in February 2022.
We have actively participated in all the workshops organized, which really helped us solidify our entrepreneurial idea, learning from experienced businessmen, such as Mr. Siemos Vasilis and Dr. Livieratos Antonis, but also through a process of trial and error. The workshops analyzed and helps us understand crucial entrepreneurial terms (such as the SWOT analysis, the Business model canvas etc.).
The 1st part of the 3rd cycle of ARCHIMEDES acceleration program concluded in 19th of July giving us the opportunity to pitch our idea to many representatives of “landmark” companies in the Greek market (such as Vodafone Greece) and many investors.
Today, we are still participating in the 2nd part of the 3rd cycle of ARCHIMEDES acceleration program, which mainly consists of helping the teams build a solid business plan based on their business idea.
Dr. Dimitrakopoulos Yiannis holds the positions of Adjunct Lecturer at Athens University of Economics and Business and Technology Transfer Office Manager at ARCHIMEDES, acceleration center of National and Kapodistrian University of Athens.
Because of his field of expertise, we contacted Dr. Dimitrakopoulos in order to get informed about patent regulations and the procedures required. He gave us an insight about how patent agencies and regulations work in Greece and Europe. He also gave us valuable feedback after our project pitching, about:
i) how to apply for a patent.
ii) which are the most important sections of our project that we should consider patenting.
iii) how we should work with confidentiality, in order to be eligible to apply for a patent.
All in all, Dr. Dimitrakopoulos has been of great help and importance on developing our business plan and idea.