Bio Therapeutic Drugs Business Investment Opportunity in Manlius, United States

- We have five in-house scientific projects:

1) An exosome-based delivery system for the transport, delivery, and localization of therapeutic molecules within the skin tumor microenvironment to treat human skin cancer.

2) The development of a confocal virtual reality (VR) 3-dimensional (3-D) immersive system for the diagnosis and analyses of human skin cancer tumors.

3) A skin cancer patient blockchain whereby skin cancer patients can set up smart contracts & receive payment for the use of their data from drug companies, research institutes, medical device companies, etc.

4) The utilization of ML and AI to visualize and analyze the resultant data from skin cancer subjects for the benefit of skin cancer patients, their family, and their healthcare providers.

5) The development of an in vitro toxicology system that uses human umbilical cord- and placental- derived mesenchymal stem cells, and cell lineages that may be derived from these, to serve as a developmental toxicological tool to reduce the number of animals use in preclinical drug research.

- The company also works with pharmaceutical and diagnostic companies, research institutes, CROs, and CDMOs to help them develop molecular bioassays and digital pathology products, and to visualize and analyze the resultant data via AI and ML for the benefit of patients, their family, and their healthcare providers.

- Currently, we have 3 clients: Klotho Therapeutics Inc. (a biotechnology company in San Diego, CA, USA), Unger Medical PC (a hair restoration medical practice in NY, NY, USA), and Astrix Technology Group (a life sciences strategy, technology, and staffing services company based in Red Bank, NJ, USA).

• Target Market:

- The business is specialized in developing diagnostics and therapeutics for human basal cell carcinoma, squamous cell carcinoma, and melanoma. This skin cancer group comprises the most diagnosed cancers worldwide of all cancer types with over five million cases diagnosed each year.

- The skin cancer therapeutics diagnostics and therapeutics products industry worldwide were worth $8.2 billion USD in 2019 and is projected to reach $15 billion by 2027. This represents a CAGR of 7.5%.

- What share of the total skin cancer target market is realistic for us to obtain? A conservative estimate is that our company should be able to reach $150 million USD in annual revenues by the close of 2028.

• Problem or Need:

- The main project involves the development of a Skin Cancer Patient Data Blockchain.

- Currently there is a serious problem concerning how oncology patients organize and share their medical data, how companies get access to this data, and a lack of return in value to the patients for sharing their personal data. The blockchain is designed to tackle and solve these problems.

- The blockchain for skin cancer patients will be comprised of multiple decentralized nodes contributing data to a shared ledger where patients can set up smart contracts to share and control their data.

- Skin cancer patients will be able to share their data with research institutions, drug companies, diagnostic companies, contract research organizations, client trials organizers, and other stakeholders.

- Also, planning to launch a medium of exchange within the blockchain system to allow patients to be given money for participation in the sharing of their data with the mentioned company stakeholders.

- Therefore, the company stakeholders that plan to utilize the patient’s data would provide revenues and income to support the operations of the blockchain.

- For example, pharmaceutical companies would be important customers that the business would cultivate as users of the patient’s healthcare data. This is because pharma companies can use this blockchain to discover patients with the right profile for a skin cancer clinical trial, even if those patients were not actively searching to participate in a clinical trial for a product from which the pharma or diagnostics company might benefit. This should greatly streamline for the pharma company the time it takes to enroll the right patients into clinical trials and get them started.

• Solution:

- What is the core value proposition? For the company stakeholders in the skin cancer patient blockchain, the business is hoping to demonstrate that this blockchain technology will be a way to improve business outcomes through better efficiency, risk management, and security.

- For these customers, this will enable them to maintain and capture new sources of profit. At the same time, company stakeholder participation will also grow the business as the integrator and host of the blockchain and result in significant profit growth for the company.

• Team:

The team is comprised of:

- Founder, President, and CEO, a 100% full-time permanent employee has a Ph. D. in Cell and Molecular Biology from St. John’s University (New York, NY), a M. S. in Microbiology & Immunology from Long Island University, and a M. B. A. from Le Moyne College. In addition, he has 20 years of quality assurance and regulatory affairs experience at the Bristol-Myers Squibb Company, Charles Rivers Laboratories, and Vybion, Inc. This includes moving numerous human therapeutic products from R&D, through clinical trials, and into the marketplace via approval by the US FDA and worldwide regulatory bodies. In addition to the above experience, Joseph has an addition 18 year of experience in human therapeutics research and development and in the management of laboratory-based cell culture, toxicological, or bioassay projects within the biopharmaceuticals industry.

However, he is a Senior Member of the food, drugs & cosmetics section of the American Society for Quality (ASQ), and a society member of The American Association for the Advancement of Science (AAAS).

- The President of Hillberg Consulting is a part-time, non-permanent hourly contract employee of R&D department. She is an accomplished executive and board member with a reputation for delivering bottom-line profitability while building the infrastructure to support growth and success. She has served at Johnson & Johnson Ortho Clinical Diagnostics as VP of R&D, and as Chief Technology Officer at Carestream Health. Holly has a B. S. in Chemical Engineering from Michigan Technology University and a M. S. in Electrical Engineering from Rochester Institute of Technology.

- Marketing Consultant - part-time, non-permanent hourly employee. He is a professional engineer and entrepreneurial executive with a focus on emerging technology solutions applied to real world problems. He has substantial experience in team building and in developing market strategies & partnerships. This includes over two decades of technology & networks business planning, development, & implementation. He has a Masters in Entrepreneurial Studies - MIT Sloan School of Management, and M. S. & B. S. in Engineering from Syracuse U. and Utica College.

- Blockchain Development Technical Project Management Consultant - Part-time, non-permanent hourly employee that is a contractor from EffectiveSoft Corporation, San Diego, CA. She has eight years of experience as VP of Service Delivery and as the Head of Sales for enterprise level software solutions at Effective Soft Corp. She has a M. B. A. from The University of Manchester and a B. S. degree from Minsk State Linguistics U.

– Legal Counsel - Part-time, non-permanent hourly contract employee. He holds the Juris Doctor from Boston College Law School, and B. A. in Political Science from Binghamton University. He is a Partner at Newman & Lickstein, with eight years of experience in representing technology companies and investors in licensing, IP development, real estate, mergers & acquisitions, and business litigation.

- Demonstrating results to stakeholders will be the key to success. For skin cancer, there is a lot of data collected from various heterogeneous sources – pathology imaging data, genetic testing, surgery, drugs intervention, payer, and insurance information, etc.

- Some companies are using a website or app to meet the social needs of patients to discuss their concerns with other patients or a few qualified physicians. No competitor is comprehensively focusing on skin cancer data & treatment to the level that we do. Possible competitors have thus not yet integrated the patient data, shared consent, and the patient monetization blocks together into a comprehensive and workable blockchain system for skin cancer patients, or for any segment of the oncology market, for that matter.

- This team, on the other hand, has decades of experience in oncology research, the development of products and services for cancer patients, in oncology clinical biomedicine and in oncology marketing, and that makes the company well-equipped to solve the problems around skin cancer patient data acquisition, its organization, and its beneficial use for the patients and for their healthcare providers. For example, regarding the latter, the company also harnesses artificial intelligence (AI) and machine learning (ML) to extract relevant data from the patient’s database that will help healthcare providers to better understand the patient’s tumor and the tumor microenvironment (i. e. , tumor growth, cellular migration, blood supply to the tumor, subcellular trafficking, and tumor metastasis), drug efficacy (including drug penetration into the tumor, possible tumor shrinkage or tumor death, and drug toxicity, and side effects), or the immediate or long term results of surgical intervention.

- When competitors enter this specific market, the business plans to stand out by utilizing a value-based strategy that clearly displays our brand and the above competitive advantage.

• Traction:

- Currently works with pharmaceutical and diagnostic companies, research institutes, and contract research development and manufacturing companies to help them obtain and organize their molecular bioassays and pathology data. We propose to utilize this traction and intercompany personal connections to gain and grow customers that will use and pay for patient data on the blockchain.

- Also use social media & patient advocacy organization to recommend the blockchain to skin cancer patients so that we can grow the patient database.

- The company is also a member of the Hyperledger Foundation Healthcare Special Interest Group. Hyperledger, as part of the Linux Foundation, provides technology leaders with a uniquely open and collaborative international community from which to develop, validate, and field enterprise-grade blockchain technology solutions. It is the mandate of the Hyperledger Healthcare Special Interest Group (HC-SIG) to represent healthcare professionals and technologists, to globally unite these individuals, and to advance the state of the healthcare industry through the implementation of technology solutions using blockchain technologies in general, and the umbrella of Hyperledger frameworks and toolsets specifically.

• Revenue Model:

- Within the ecosystem surrounding the above patients, who would buy/lease the skin cancer blockchain services that the company wishes to market? In this blockchain system, individuals will be allowed to store and monetize their own health data including blood test results, medical history, genetic profile, skin photographs, pathology images and other sensitive information.

- In the healthcare marketplace, cancer patients would be paid in stablecoin currency to lease their individual data to companies for a certain amount of time.

- Pharmaceutical (pharma) companies would be important customers that the company would cultivate as users of the patient’s permitted healthcare data.

- Blockchain can help pharma companies discover patients with the right profile for a clinical trial, even if those patients were not actively searching to participate in a clinical trial for a product from which the pharma or diagnostics company might benefit.

- According to Milind Kamkolkar, chief data officer at Sanofi, patients could be prompted based on their data to join a clinical trial, thereby also accelerating the process and accuracy of trial recruitment. Using this blockchain if a person declines, no personal information will be shared, and the person's identity will remain private. If the person agrees, the overall process will move faster by abolishing the need for intermediaries.

- For pharma companies, better inclusion in clinical trials and better reproducibility for studies can reduce the time and money needed to develop new drugs.

- Besides pharma companies, research institutes will be willing to pay for the data from skin cancer patients, and the introduction of our blockchain-based data ecosystem may help ensure that the individuals take control over their data and companies and research institutions may acquire data more freely after the latter have obtained consent from individual patients.

- How are the products and services going to generate revenue? The most straightforward way to generate revenue is to have the blockchain client customers pay for the products and services that exceed by a large margin what it costs to develop and operate the blockchain (a cost-plus strategy).

- When competitors enter this specific market, plan to stand out by utilizing a value-based strategy that clearly displays the brand and competitive advantage.

• Market Projections:

- What share of the total skin cancer blockchain target market can we estimate is realistic for to obtain? The global skin cancer blockchain customer market size stood at USD 8.19 billion in 2019 and is projected to reach USD 14.55 billion by 2027, exhibiting a CAGR of 7.5% during the forecast period.

A conservative estimate is that the company should be able to reach $150 million in annual revenues in 4 years.

- These financial projections would be possible because of the company participating and partnering with individuals and companies within the oncology community to create superior value for the products and services.

- Over the next 4 years, the company anticipates receiving funding from investors, and revenues from pharmaceutical companies and research institute customers.

- However, expenditure are also expected to increase. Expenses incurred will be for the development of products and services, and for personnel, equipment, supplies, business development & marketing.

• Competition:

- We have identified Nebula Genomics and Longenesis as competitors. These two leading firms in artificial intelligence and blockchain technology for healthcare, are developing a platform for the storage and exchange of genomic data.

- Nebula Genomics is a San Francisco-based biotechnical company that uses blockchain to “build a marketplace” for clinical genetics data.

- Longenesis is a Hong Kong-based partnership between Insilico Medicine and the Bitfury Group, which makes blockchain platforms for the exchange of health data.

- The above companies will reportedly apply artificial intelligence and blockchain technology to develop a platform for individuals and large data providers to store, manage, exchange, and profit from genomic and other types of clinical data. To automate data acquisition, the project developed by both Nebula Genomics and Longenesis will utilize smart contracts.

- Unlike the Nebula Genomics and Longenesis blockchains, this blockchain project will be focused on oncology patients and the ecosystem around them rather than on a multitude of disease sectors.

- In addition to Nebula Genomics and Longenesis, the U. S. -based life science research marketplace, Scientist. com, has revealed the development of a pharmaceuticals blockchain platform. This latter blockchain-powered platform is reportedly designed to track and protect pharmaceutical data. Thus, the Scientist. com DataSmart TM platform enables pharmaceutical and biotech companies to demonstrate that critical supplier information and important research data has not been tampered with and remains unaltered before submission to regulators such as the FDA and the EMEA. - However, the above platforms do not adequately address the pressing concerns of cancer patients regarding the control and sharing of their personal data.

Competitive Advantage:

• Strategy.

Specifically for oncology blockchain products, the major company players that may join our blockchain to gain access to data from skin cancer patients include:

Almirall S. A.

Amgen, Inc.

Boehringer Ingelheim GmbH.

Bristol-Myers Squibb Company.

Eli Lilly and Company.

Elekta AB.

F. Hoffmann-La Roche Ltd.

GlaxoSmithKline plc.

Merck & Co. , Inc.

Mylan NV.

Novartis AG.

Pfizer.

Regeneron.

Sanofi.

Sun Pharmaceutical Industries Ltd.

Varian Medical Systems, Inc.

Sensus Healthcare.

ICAD, Inc.

Accuray, Inc.

-We have four in-house scientific projects:

1) An exosome-based delivery system for the transport, delivery, and localization of therapeutic molecules within the skin tumor microenvironment to treat human skin cancer.

2) The development of a confocal virtual reality (VR) 3-dimensional (3-D) immersive system for the diagnosis and analyses of human skin cancer tumors.

3) A skin cancer patient blockchain whereby skin cancer patients can set up smart contracts & receive payment for the use of their data from drug companies, research institutes, medical device companies, etc.

4) The utilization of ML and AI to visualize and analyze the resultant data from skin cancer subjects for the benefit of skin cancer patients, their family, and their healthcare providers.

5) The development of an in vitro toxicology system that uses human umbilical cord- and placental- derived mesenchymal stem cells, and cell lineages that may be derived from these, to serve as a developmental toxicological tool to reduce the number of animals use in preclinical drug research.

- The company also works with pharmaceutical and diagnostic companies, research institutes, CROs, and CDMOs to help them develop molecular bioassays and digital pathology products, and to visualize and analyze the resultant data via AI and ML for the benefit of patients, their family, and their healthcare providers.

Tangible assets:

Estimated to have a value of $4,000,000 USD - laboratory equipment, materials, furniture, electrical equipment etc.

The business also totally owns and operates six online website properties that describes products and services offered by the company or by those of our partners:

1) Main company website.

2) The Biotechnology Business Network - delivers breaking news and analysis about biotechnology and drug companies, the FDA, and the broader pharma industry, including manufacturing, marketing, and products and services offered by companies.

3) Website providing reviews and discussions of various categories of electronic, telecommunication, and data sharing devices and services that allow you to remain always on connect at work, at home, for your health, and at play.

4) Description of the companies, products, services, and behaviors that support healthier productive and engaged longer lives.

5) Description of our in vitro toxicology services that performs high-throughput in vitro assays using human cells in culture under conditions that closely mimic in vivo human tissue microenvironments. These cell culture toxicological assays are offered as a service-for-a-fee to companies within the pharmaceuticals, consumer goods, agricultural and cleaning products, chemicals, and medical devices industries.

6) Website for our online skin care company and skin cancer patient blockchain.

Leasing space at the Central New York Accelerator in Syracuse, NY.

A sole proprietorship business which is 100% owned by one shareholder who is also the CEO and President.

In terms of capital, the CEO and Founder has contributed $75,000 (USD, cash) in funding support for this project till date.

The U. S. Small Business Administration has also provided a loan of $9,600 2 years back to the company at an annual rate of 3.75% to be paid over 20 years.

Besides the past funding cited above, the business is currently funded by fees received from R&D, quality, and regulatory consulting from three major clients: Klotho Therapeutics Inc. (a biotechnology company in San Diego, CA, USA), Unger Medical PC (a hair restoration medical practice in NY, NY), and Astrix Technology Group (a life sciences strategy, technology, and staffing services company based in Red Bank, NJ, USA).