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Team:UIUC Illinois/business-plan
From 2012e.igem.org
Illinois Synth was formed directly as a result of the collaboration of members from the 2012 University of Illinois iGEM Team. The company corporate headquarters and principal product development facility will be located at the University of Illinois Urbana-Champaign’s Institute for Genomic Biology. Upon expansion and generation of a consistent revenue stream, Illinois Synth will look to occupy the Enterprise Works Tech Incubator located at 60 Hazelwood Drive, Champaign IL.
Illinois Synth’s manufacturing and laboratory facilities and equipment are all serviced regularly to maintain the highest performance standards consistent with aseptic technique. Additional capital equipment is projected subsequent to product release to utilize capacity and meet sales demand.
The company will be incorporated as a C-Corporation in the state of Delaware.
The management team of six executives will look to conduct research and development independent of other employees for the first three quarters of company growth. Future expansion in the fourth quarter and beyond will require several production and sales personnel.
The global synthetic biology market is estimated to grow to $4.5 billion over the next three years. This is due to major developments in biomedicine, pharmaceutical drug synthesis, energy and environmental research, biomaterials, nanotechnology, and biosecurity. There have been significant investments in the industry by companies such as Amyris Inc, GeneScript, Bayer, and Blue Heron Biotechnologies. Additionally, developments in DNA synthesis and sequencing technologies and bioinformatics have catalyzed the progress of synthetic biology ever since the creation of the first synthetic cell in 2010. Synthetic biology is being recognized around the world as an emerging technology that has the potential to provide solutions to energy and food shortage, pollution, infectious diseases, and even climate change. The diagram on the left depicts the distribution of the global synthetic biology market share, as of 2011.
Competition for the GEM Toolkit product development line primarily takes the form of other types of RNA binding proteins shown below:
Competitors to IOPiC include alternative ways to produce piceatannol, which currently only take the form of chemical synthesis by companies such as Sigma-Aldrich, Santa Cruz Biotech, and Tocris Bioscience. A price comparison of the three companies is shown below:
Indirect competition to the field of synthetic biology as a whole is high, given other technologies that have been around for decades. In the specific niche market within which Illinois Synth is positioned, however, such competition is negligible, because of the inability of non-biological tools to regulate micro-scale biological processes such as gene expression.
Future competition will likely come in the form of new technologies and findings. Proteins with higher binding specificities with a great degree of customizability would render our GEM Toolkit obsolete. Additionally, chemical processes that produce piceatannol with a high efficiency at a low cost would cause a great reduction in the utility of IOPiC. Other compounds, if found to greatly inhibit adipogenesis, could also make a piceatannol-production system unnecessary. Based on current research results, Illinois Synth does not expect such developments to arise in the next decade, will continue to monitor all relevant research, and expects to exit the market prior to major technology advances.
Illinois Synth expects that its products, particularly IOPiC, its piceatannol-production cascade will require a substantial amount of developmental effort. Government approval will likely be required to market any product that involves the use of bacterial cell culture to produce a compound that would be tested with human adipocytes. The company will take the necessary steps to patent and license its products in the United States, as well as negotiate with pharmaceutical companies abroad to obtain marketing approval in a particular country. The target market for Illinois Synth’s products, therefore, will take several forms, including:
Our marketing team will make contact with academic universities institutions that are involved in Synthetic Biology research. This will likely be done by leveraging connections to members and advisors of iGEM teams at some of these academic institutions. We will provide our GEM Toolkit at no cost to these institutions, and will look instead to establish a reputation for the product. Upon receiving feedback about the GEM Toolkit, we will look to make any necessary changes or improvements before commercializing it.
Next, the company will look to enter into distribution agreements for the registration and sales of its products in the United States, and eventually foreign countries. These distribution agreements will take the form of contracts with research labs at biotechnology firms, as well as certified manufacturers of chemical compounds such as Sigma-Aldrich.
Illinois Synth will also actively pursue online advertising, advertise our products at biotechnology oriented trade shows, and release a monthly newsletter to keep potential and current customers updated about product developments.
The GEM toolkit will be developed around the features of the Pumilio and FBF homology (otherwise known as PUF) protein domain of the human PUM1 gene. PUF proteins are found in most eukaryotes, and have the unique ability to be programmed to recognize any 8 nucleotide ssRNA sequence. Illinois Synth has successfully demonstrated that this PUF domain can be tethered to other functional domains, such as an endonuclease for the purpose of silencing gene expression through site specific mRNA cleavage. Our findings came in the form of biobricks that have a wide range of possible functions including gene expression modulation and the scaffolding of metabolic pathways.
IOPiC is in essence an enzymatic conveyer belt, combining the functionality of the programmable PUF protein with a designer RNA scaffold, to achieve the low cost, and efficient production of the compound piceatannol, a compound that inhibits the process of adipogenesis, or fat-cell formation. The reason piceatannol was chosen as the compound of interest was due to a study conducted at the Kee-Hong Kim lab at Purdue University. The study demonstrated how piceatannol binds to the insulin receptors found on preadiopocytes, impairing the cells ability to control cell cycles and successfully develop into adipocytes. The following video provides an overview of the findings of the Kim laboratory, and the potential impact piceatannol may have in controlling obesity, one of the most of most widespread diseases of the 21st century.
RNA has characteristics that are important in human gene expression (i.e. alternative splicing of mRNA, noncoding RNA). Therefore, a modular RNA binding protein is an invaluable tool for gene regulation. The PUF domain of human PUM1 gene contains eight tandem repeats, each recognizing one of the four nucleotide bases. In theory, a PUF protein can be programmed to recognize any 8-nt ssRNA sequence. Illinois Synth has demonstrated that PUF can be tethered with other functional domains for applications in E. Coli. Specifically, we have shown that a PUF/endonuclease fusion protein acts as RNA scissors, silencing gene expression through site specific mRNA cleavage. The GEM Toolkit of PUF biobricks will offer an extension of the abilities of PUF to regulate and control gene expression. A schematic of some of these functions is shown in Figure 1.
Obesity is today one of the leading preventable causes of death worldwide, and given the recent discovery of piceatannol’s anti fat cell properties, we foresee demand for efficient, low cost, piceatannol production by research labs, and eventually pharmaceutical companies to increase dramatically over the next decade. Illinois Synth has also tethered the PUF protein domain to split GFP to test its ability to co-localize proteins using a RNA scaffold. This proof of concept will be the basis for IOPiC, which will also take the form of an RNA Scaffold, and will catalyze the production of piceatannol from L-tyrosine along the pathway depicted in Figure 2.
The GEM toolkit will be used to tether PUF domains on the RNA scaffold to the TAL, 4CL-STS, and BM3 enzymes as shown in Figure 3.
Tests conducted by our team of engineers have proven the ability of PUF to tether to an endonuclease functional domain to facilitate gene silencing. Additionally, studies by the Pamela Silver group at Harvard University have successfully demonstrated the utility of an RNA scaffold to catalyze H+ production. The programmable ability of PUF to target a specific 8-nt sequence is documented in a variety of literature studies, referenced under Attributions.
Illinois Synth is currently in its early developmental stage of product development. While the proof of concepts for our products has been established, additional research is required to produce functioning prototypes of the GEM Toolkit and IOPiC. Once complete, we expect both products to follow the following life cycle:
Illinois Synth will have the policy of using patents, trademarks, and trade secrets to protect the results of its research and development activities and, to the extent it may be necessary or advisable, to exclude others from appropriating its proprietary technology. That being said, the company's policy is to advance the progressive of synthetic biology by making its products available at competitive prices, collaborating with universities and academic institutions to further research and development, and providing discounts and sponsorships to research groups that may benefit from our technologies.
Illinois Synth has stringent policies and procedures for ensuring that all intellectual property is protected prior to any public disclosure of new products or technologies.
Governmental trials or marketing of Illinois Synth’s biological-microorganism-based products may expose the company to liability claims from the use of the products. Illinois Synth will therefore carry liability insurance for that purpose. Due to the maintenance of hazardous materials at its lab facilities, it is subject to federal, state, and local laws and regulations governing the use, manufacture, storage, handling, and disposal of hazardous materials and waste products. In the event of an accident, the company could be held liable for resulting damages. The company will therefore maintain a database of technical product related inquiries from all users of our product, academic and industrial. Illinois Synth will also maintain a record of all complaints or reports of an actual or potential failure of any product to meet the specifications set forth in regulatory filings.
Product information materials will be put in place explaining proper use and efficacy of direct sale merchandise. This will take the form of lab protocols, safety instructions, brochures, and contact information for any problems and complaints.
Illinois Synth will look to establish a reputation within the Synthetic Biology industry as a company with the highest quality products, based on research backed by demonstrable results.
Illinois Synth will issue a full refund for products that do not perform as per their specifications, when returned with a written description of the customer concern. The company will provide a toll-free number for both technical information and customer service assistance. Illinois Synth’s management team believes strongly in the notion that retaining a customer who has had a product problem costs less than developing a new customer.
The use of outside sales representatives has not been contemplated at this time. The company’s management board currently fulfills this role.
Illinois Synth’s research findings will be published in scientific and trade journals as IP protection is put in place on new technologies and developments.
During research and development, all product offerings will be hosted here. Following commercialization, a company website will be set up for ease of consumer access.
In order to maintain the highest profitability, the following pricing strategy shown in Figure 1 will be used to stay consistent with the life cycles of each product. The unit maximization phase, immediately following commercialization, will provide products to consumers at a low rate, to maximize the availability of Illinois Synth’s technologies within the synthetic biology and pharmaceutical industries. Following unit maximization, the prices of our products will be elevated to maximize revenue. This stage of the pricing strategy will be closely monitored, to ensure that the increase in price does not lead to a significant decrease in customers. Next, during the maturity phase of each product, at maximum unit availability in the market, the price will be lowered to account for new technologies (developed both within and outside of Illinois Synth) in the marketplace that may offer competition. The decline phase of the product, if reached, will be characterized by a similar profit maximization strategy as the maturity phase.
Illinois Synth will offer discounts to academic and research institutions in order to receive feedback on existing products, and make necessary improvements before sale to industrial manufacturers. Introductory offers will be available at lower costs during the first year that product lines are marketed.
Illinois Synth’s management board is made up of executives from a variety of scientific, engineering, and business backgrounds. The individual members have worked together on the 2012 University of Illinois collegiate iGEM team.
Adi is a third year undergraduate junior in Bioengineering at the University of Illinois, and was the 2012 UIUC iGEM team’s corporate director. As corporate director, he was in charge of making and maintaining relationships with biotechnology companies and academic departments at the University. As CEO of Illinois Synth, he will coordinate the research focus and direction of the company and its employees. As a consultant with Illinois Business Consulting, he has had experience providing business development and strategic solutions for multinational companies such as John Deere, as well as startup companies that will operate on a similar scale as Illinois Synth.
Uros is a fourth year student in Molecular & Cell biology at the University of Illinois. He has worked extensively with molecular biology, as a researcher at the UIUC Hergenrother Laboratory and the University of Belgrade Medical School. His work has included proving through fluorescent labeling and electrophoretic mobility shift assays that complexation of the disease specific RNA and MBNL protein can be inhibited. As COO, he is in charge of overseeing the smooth management and communication between Illinois Synth’s internal departments and laboratory. He is also the principal product manager for IOPiC.
Anthony is a fourth year student in Biochemistry at the University of Illinois. As treasurer of the 2012 UIUC iGEM team, he was responsible for managing all funds for lab procedures, travel, and construct synthesis. He is also proficient in advanced molecular biology techniques such as kinetic enzyme assays, molecular docking, molecular dynamics simulations, genome neighborhood analysis, cloning, tagless protein purification, high throughput screening, various spectrophotometric assays to probe for substrates, and bioinformatics utilizing Cytoscape. As VP Finance, he will be in charge of managing all finances, and creating quarterly financial reports for Illinois Synth.
Isiah is a second year student in Agricultural and Biological Engineering at the University of Illinois. As lab manager of the 2012 UIUC iGEM team, he maintained the laboratory and took inventory every two weeks to make sure all sure all supplies were sufficiently stocked. As VP Lab Management for Illinois Synth, he will extend this role to include the oversight of all lab procedures and protocols, ensuring the highest safety and aseptic technique standards.
Bob is a second year student in Molecular and Cell Biology at the University of Illinois. As webmaster of the 2012 UIUC iGEM, he was in charge of uploading all data and results online, as well as other components of the iGEM project. As VP Technology, he will be in charge of maintaining the Illinois Synth website, including all relevant product and research developments.
Angela is a junior year in chemical engineering at the University of Illinois. With two years of synthetic biology experience under her belt as a member of the UIUC iGEM team, she is a valuable asset to the product development wing of Illinois Synth. As VP Product development, she will be in charge of drafting research proposal timelines for the GEM Toolkit and IOPiC. She is also the principal product development manager for the GEM Toolkit.
Illinois Synth’s Advisory Board of Directors includes:
Dr. Kaustubh Bhalerao, Department of Agricultural & Biological Engineering. Research Interests:
Dr. Christopher Rao, Department of Chemical & Biomolecular engineering. Research Interests:
Dr Yong-Su Jin, Department of Food Science and Human Nutrition. Research Interests:
Dr. Bradley Evans, Institute for Genomic Biology
Dr. Joe Bradley, College of Business. Research Areas:
Dr. Zefang Wang, Department of Pharmacology, UNC. Research Areas:
Courtney Fuentes Evans, Institute for Genomic Biology. Lab Manager
Alex Stomp, Web Developer, Chicago IL
Todd Freestone, B.S Brigham Young University
Cara Schornak, B.S Molecular & Cell Biology
Divya Tankasala, B.S Bioengineering
Asha Kirchoff, B.S Bioengineering
William Jones, B.S Biochemistry
Kori Dunn, B.S Chemical Engineering, Cornell
Ahmet Badur, B.S Chemical Engineering, University of Wisconsin
80 percent of the equity of Illinois Synth is distributed equally among the members of the management board, as seen in Figure 1. The remaining 20 percent is reserved for issuance to employees and directors. Under this plan, eligible directors will receive all or a portion of their quarterly retainer fees in shares of the common stock of the company. The number of shares each eligible director receives is based on the average fair market value of the common stock for the last 20 business days of the fiscal quarter. Illinois Synth stock option plans for directors, officers, employees, and consultants that provide for grants of nonqualified and incentive stock options. Options generally are granted at fair market value, expire between five and 10 years from grant date and vest ratably over three to five years.
The president will meet as needed with vice presidents at least every two weeks. Weekly staff meetings are held by the vice president of each section of the company, such as finance, product development and lab management. These meetings are used to inform personnel of changing company policies, ask personnel for input to develop company strategy, and create awareness of the activities of the various departments within the company. Employees are to report all incidents of concern to their respective vice president. It is then the responsibility of that vice president to inform the president to determine if any action is to be taken.
Illinois Synth startup costs will include costs for the following lab procedures:
The estimated annual cost for the lab procedures listed above is $20,000. Due to an arrangement with the Institute of Genomic Biology, lab space is provided free of cost during the Illinois Synth’s research and product development phase.
Given the worldwide demand for gene expression regulators, and the forecasted demand for piceatannol as a research tool to address obesity as a global disease, Illinois Synth is projecting increasing profitability from 2015 on. One the necessary equipment is in place, expense ratios will decline dramatically each year due to capacity and efficiency maximization.
Private investment dollars are being sought. One round in 2012-2013 will facilitate growth plans for the next five years. A 15 percent interest in the company is being offered with payout at exit in 8-10 years.
As with any synthetic biology enterprise, there are numerous risks associated with generating profitable sales for Illinois Synth. Some of these risks are summarized below:
