Team:TAS Taipei/HP/Gold
HP Gold - Integrated Human Practices
What we discovered through our findings in policy and practice helped shaped the trajectory of our project. We gathered data from researchers, medical doctors, veterinarians, cataract patients, and public opinions to find out the best way to develop our project so that it can benefit as many people as possible.
From surveys and a bioethics panel, we learned that the public has concerns about introducing bacteria into their bodies, as well as the invasive nature and high cost of cataract surgery. Thus, to isolate the desired proteins from bacteria, we designed our constructs with polyhistidine-tags. The public’s aversion to cataract surgery for people and pets encouraged us to design a non-invasive delivery: protein-loaded chitosan nanoparticles. Interviews with doctors and veterinarians informed us of commercial eye drops for pets, however they remain ineffective at treating cataracts since it is difficult to penetrate the cornea. This motivated us to design eye drops containing nanoparticles to increase drug delivery to the lens, which should work better than commercial eye drops. To address the public’s concern of high cost, we ensured our final product will be affordable based on a cost analysis.
Public Opinion
Bioethics Panel
We hosted a bioethics panel, where we invited teachers from various fields to engage in a conversation about bioethics and thoughts on our project in particular. The reason for including teachers from different fields is to allow our project and the topic of bioethics to be discussed from different aspects. The panelists suggested that our project could really be applicable for cataracts in dogs and cats; however, they seemed wary of the idea of possibly inserting foreign bacteria into their bodies.
Cataract Survey
During Taipei American School’s Spring Fair and our Taipei Cataract Awareness Day, we conducted a survey from which we derived a general sense of people’s understanding of cataracts, willingness to use GMO products, willingness to use our products for themselves or their pets, and opinions on cataract surgery.
From these surveys and a bioethics panel, we learned that the public has concerns about introducing bacteria into their bodies, as well as the invasive nature and high cost of cataract surgery.
First, to address the fear of inserting foreign bacteria into the bodies, we decided to include a standardized method to separate our desired proteins from bacteria: using polyhistidine-tags. This can separate proteins from bacteria, and ensure that only the extracted protein will be in our final delivery system. Next, The public’s aversion to cataract surgery for both people and pets encouraged us to opt with a non-invasive delivery mechanism. After extensive literature research, we chose to load our proteins into nanoparticles, which we plan on delivering through eye drops or contact lenses. When we offered non-surgical options, 89% of our survey participants preferred eye drops, contact lenses, or nanoparticles over surgery.
Professional Opinion
Doctors and Cataract Patients
In order to build our treatment, prevention, and prototype plans we needed to get in contact with experts in the fields of cataracts surgery and research. Our first step was to contact eye doctors to discuss specific problems and limitations associated with current cataracts treatment.
Dr. Wei-Chi Wu is a retina specialist and an associate professor at Chang Gung memorial hospital in Taiwan.
Dr. Tsu Chieh Cheng is a opthamologist at Chang Cheng eye hospital in Taiwan.
From Dr. Wei-Chi Wu, a retina specialist at Chang Gung Memorial Hospital, we learned that cataracts surgery might lead to several post operational complications such as infection, hemorrhaging, or secondary glaucoma. In regards to our project, he said one of the biggest issues we would face is non-invasive delivery. Currently, injections and incisions are the only methods for delivery because all current potential methods of noninvasive delivery either lack efficiency or induce other side effects. Furthermore, Dr. Tsu Chieh Cheng, an opthamologist at Chang Cheng Eye Hospital pointed out that we should check the effects our protein might have on other parts of the eye, and if possible, use animal models. This would further help us ensure the safety of our product.
Interviews with Cataract Patients
Apart from consulting doctors, we felt it was necessary to talk to cataract patients who have undergone surgery and take their experience into account. We interviewed two former cataract patients about their experiences with surgery. Both patients suffered from inconveniences due to the synthetic lens options, which would either make one nearsighted or farsighted. Complications due to surgery varied among individual cases; one suffered from dryness and irritation of the eye, while the other had no complications at all. Both of them stated that the surgery process was efficient and effective; however, if given the choice to apply effective eye drops instead of surgery, they’d be willing to use it rather than face surgery again. Dr. Moran’s and Mrs. Clapper’s experiences reinforce the disadvantages of surgery, and further motivated us to create a non-invasive solution.
Dr. Catriona Moranis a former patient of cataract surgery
Mrs. Sharon Clapperis a former patient of cataracts surgery
Veterinarians
As we continued to develop our project, we also hoped to treat cataracts in animals. We consulted with veterinarians at clinics around Taipei. We visited two veterinarian clinics, (Nicholas Animal Hospital and Tai Pu Veterinarian Hospital) and asked various others about the viability of our project. From these interviews we learned that there are already commercial eye drops available, which are prescribed for pets, but that these are not very effective. One of the drugs developed is called Ocluvet(R), which we purchased and used in our experiments to compare to our own treatment design.
Professional Opinion and Project Development
After consulting doctors and veterinarians, we gained a benchmark to compare our treatment proteins to: the OcluVet eye drops for pets. To determine whether our desired proteins could provide results similar (if not better) than current products, we compared the protein CH25H to the OcluVet eye drops in our cataracts model.
Our lens solutions were first incubated with H2O2, then treatments were added. As shown in the graph below, absorbance values increased when lens proteins were incubated with H2O2, suggesting protein aggregation. Adding pet eye drops did not lower the absorbance as much as treatment with 25HC, suggesting that 25HC is more effective at reducing cataracts. In addition, a higher concentration of 25HC lowered the absorbance even further (50 μM compared to 20 μM).
25HC is more effective at treating cataracts compared to pet eye drops. Increasing the concentration of 25HC increases effectiveness. Two trials were conducted and the error bars show a significant difference between untreated and 25HC-treated samples.
Researchers
We met with Dr. Eric P. Lee, Senior member of Technical Staff at Maxim Integrated, and TAS alumnus, to discuss issues we were having concerning chitosan nanoparticles. Specifically we had difficulty obtaining SEM images and with nanoparticle formation. His advice on the specific order of adding TPP to chitosan helped us make consistent nanoparticles. Additionally, he explained why we kept seeing large amorphous structures in our SEM images: a charge buildup in the nanoparticles from the electron beam. We used this information to improve our prototype and obtain quality images from both SEM and AFM.
Buisness Plan and Cost Projection
With the help of Mrs. Michelle Bruce, our business and economics teacher, we developed a comprehensive business plan for our cataract prevention and treatment products. Within this plan we performed a situational analysis based on market research, customer analysis, environmental/industrial considerations, and regulatory constraints (such as quality control and SWOT analysis). Furthermore, we statistically analyzed our products’ viability in the market by developing pricing and promotional strategies. Attached below, and in the policy and practice page, is our business plan. Taking into consideration standard pharmaceutical profit margins and a variety of factors, we have priced our product at 29.99 US Dollars for a 50 day treatment period. Compared to our product, the Ocluvet eye drops cost $80 dollars. This addresses the public’s concern about affordability, as from our surveys we found that 63% of all people were unwilling to pay for cataracts surgery for themselves, and 60% were unwilling to pay for surgery for their pets (as shown in the pie charts below).
Buisness Plan and Cost Projection
Additionally, Mr. Alexander Kaufman, a former intern at RA Capital (a biotechnology investment firm), provided constructive feedback on our business plan. He suggested that we focus on long term cost projections, for it would put us in a better position to engage with venture capitalists. He also thought that our competitor analysis and initial market sizing was impressive. Furthermore, this plan was shown to Dr. Tai-Yuan Wang and he suggested that with an FDA approval and clinical trials, he would be interested in our products. Thus,we can conclude our products have the potential to compete in market.
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