Summary
At "LETHE", we are pioneering a novel therapeutic solution
for Alzheimer's disease, unlike anything currently available in the
market. Our primary goal is to develop an innovative treatment with
minimal side effects, while ensuring it is widely accessible and
cost-effective. "LETHE" is designed for mass production,
enabling broad accessibility, particularly in regions with limited
healthcare infrastructure, such as remote areas in Greece.
The following graphics provide a clear overview of the company's
strategic direction, identifying potential opportunities and
threats while assessing market potential. These analyses support
decision-making by highlighting strengths, addressing weaknesses,
and optimizing resource allocation. Through visualizations of key
components and financial projections, we offer a comprehensive
roadmap for sustainable growth and success. Tools such as the
Business Model Canvas, SWOT, PESTEL analysis, and market
segmentation models (TAM, SAM, SOM), along with financial
projections like the cash flow statement, are essential for
building a solid foundation. Finally, our financial projections for
the first five years are summarized in the cash flow statement and
cost sheet.
This Business Plan provides a detailed explanation of the rationale
and strategic foundation of our business strategy, which was
developed in consultation with various industry experts. This
ensures that it aligns closely with real-world conditions and
addresses the needs of our start-up effectively.
How do we ensure cost-effectiveness?
Achieving cost-effectiveness in the development and delivery of our
Alzheimer's treatment is central to LETHE's mission. We
ensure broad accessibility while maintaining financial
sustainability through strategic partnerships, streamlined
production processes, and innovative distribution methods.
Our strategies for cost-effectiveness include:
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To minimize overhead costs while maximizing accessibility, our
therapeutic delivery model relies on
mobile treatment units. These vans, equipped with
refrigeration and essential medical facilities, will bring
treatment directly to patients, eliminating the need for
large, fixed infrastructure. Starting from Patras, Greece,
the location of our University where this project originated, we
will gradually expand by adding more vans instead of opening
additional physical locations. This flexible approach
significantly reduces the costs associated with setting up new
clinics, and we will also offer our treatment to clinics that can
modify their spaces accordingly.
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By purchasing essential components such as viral vectors and miRNA
materials in bulk, we can benefit from economies of scale,
reducing procurement costs. This strategy ensures that we can
produce at lower costs, making our therapy more affordable to a
larger population.
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To further enhance cost-efficiency, we will collaborate with
specialized companies to supply induced pluripotent stem cells
(iPSCs) rather than producing them in-house, particularly in the
early stages. This approach not only minimizes the risk of
mishandling due to human error but also significantly reduces
operational costs. By focusing on partnerships, we can allocate
resources to other critical areas like development and scaling.
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In addition to iPSCs, we have already, in our initial stages,
established partnerships with companies that provided us with
Exosome isolation kits (e.g., ExoPrep) for free. Adhering to
contractual agreements with these companies will allow us to keep
costs manageable by reducing expenses for essential components. We
also plan to partner with firms for plasmid production to further
drive down costs.
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Moreover, by purchasing essential components and materials in
bulk, we benefit from economies of scale, further reducing
procurement costs. This ensures that we can produce at lower costs
and make our therapy accessible to a larger population.
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As our start-up achieves greater profitability, we plan to
incorporate automated systems into our production and quality
control processes, reducing labor costs and minimizing human
error. Standardizing the manufacturing process ensures consistent
product quality while lowering overall operational costs. This
approach helps streamline production and allows for scalable
growth as demand increases.
Business Model Canvas
To structure and document our business effectively, we created the
following
Business Model Canvas, which provides a clear visualization of the key components of our
company. It highlights critical elements that define how
LETHE operates and delivers
Alzheimer's treatment to
the market.
Market Analysis
SWOT Analysis
A SWOT (Strengths, Weaknesses, Opportunities, Threats)
analysis is employed to identify and visualize our company’s
strengths, opportunities, weaknesses, and threats, with strategies
in place to mitigate weaknesses and threats.
PESTEL Analysis
PESTEL analysis is a strategic framework used to evaluate
external factors that could impact an organization's operations and
performance. It focuses on six key areas: Political, Economic,
Social, Technological, Environmental, and Legal influences. This
analysis helps businesses identify potential risks and opportunities
in their market environment to make informed decisions.
Target Market - Customers
Potential customers for our therapy include
hospitals, clinics, Geriatric Care Units, and medical
centers, while the end users will be patients diagnosed with
Alzheimer's disease. Initially, our product will be sold to clinics
and hospitals in Greece, where we have a deeper understanding of the
local market and have built strong networks with industry
stakeholders and the scientific community. After establishing a
presence in the Greek market, we plan to expand to the broader
European market, where the regulatory framework governing the
production and distribution of pharmaceutical products is similar to
that in Greece. With millions of patients worldwide and the numbers
steadily increasing, there is a vast market for effective
Alzheimer's therapies.
Defining the target market size is one of the most
important evaluation criteria for business ideas. After
extensive research and consultations with business experts, we
determined that the TAM/SAM/SOM model fits our case
appropriately.
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TAM (Total Addressable Market/Total Available Market):
Represents the total market demand for our product, or the overall
revenue opportunity available if our treatment had 100% market
share.
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SAM (Serviceable Addressable Market/Served Available
Market):
The portion of the TAM that our product could serve, based on our
business model and capabilities. Initially, "LETHE" will be sold
to the Greek population, as Greece is the base country for our
therapeutic tool.
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SOM (Serviceable Obtainable Market/Share of Market): For
our therapy, the SOM consists of
hospitals, clinics, and Geriatric Care Units located in
Patras, Greece.
Financial Analysis
Cost Sheet
Cash Flow Sheet
Prospects
We outline our company's forward-looking strategy in the Gantt Chart
below.
Business Plan
Our business plan is more than just a roadmap - it's a bold
vision for the future of healthcare. By diving into its pages,
you'll discover how we're
revolutionizing treatment accessibility and effectiveness. We
detail not only our innovative approach, but also the rigorous
research and strategic thinking behind every decision we’ve
made.
Whether you're an investor, healthcare professional, or simply
someone interested in groundbreaking solutions, our business plan
offers valuable insights into how we're positioning ourselves to
lead the market with the most cost-effective, high-impact treatments
available.
Reading our plan will give you an exclusive look at our unique
business model, our sustainable approach to minimizing costs without
sacrificing quality, and our strategic partnerships that allow us to
focus on delivering innovative, life-changing therapies.
Explore our vision, join us on our journey, and see firsthand
why our approach will shape the future of healthcare.
You can find our Business Plan by clicking
here…
References
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Alzheimer Disease—Neurologic Disorders. (n.d.). Merck Manual
Professional Edition. Retrieved 20 June 2024,
https://www.merckmanuals.com/professional/neurologic-disorders/delirium-and-dementia/alzheimer-disease
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Alzheimer's Disease Fact Sheet. (2023, April 5). National
Institute on Aging.
https://www.nia.nih.gov/health/alzheimers-and-dementia/alzheimers-disease-fact-sheet
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Dementia: Number of people affected to triple in next 30 years.
(n.d.). Retrieved 20 June 2024,
https://www.who.int/news/item/07-12-2017-dementia-number-of-people-affected-to-triple-in-next-30-years
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Global Dementia Observatory (GDO). (n.d.). Retrieved 20 June
2024,
https://www.who.int/data/gho/data/themes/global-dementia-observatory-gdo
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György, B., et al. (2014). Naturally enveloped AAV vectors for
shielding neutralizing antibodies and robust gene delivery in
vivo. Biomaterials, 35(26), 7598-7609.
https://doi.org/10.1016/j.biomaterials.2014.05.032
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NBC News, "FDA Approves Eli Lilly's Alzheimer's Drug That Slows
Memory Decline"
https://www.nbcnews.com/health/health-news/fda-approves-eli-lillys-alzheimers-drug-slows-memory-decline-rcna158794
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NPR, "FDA Greenlights New Alzheimer's Drug to Combat Memory
Loss"
https://www.npr.org/2024/07/02/g-s1-7930/fda-approves-alzheimers-drug
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JAMA Neurology, "Cost-effectiveness of Aducanumab and Donanemab
in Early Alzheimer's Disease in the U.S."
https://jamanetwork.com/journals/jamaneurology/fullarticle/2790531
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"Evaluating the Economic Value of Alzheimer’s Treatments:
Aducanumab and Donanemab"
https://pubmed.ncbi.nlm.nih.gov/38689398/
-
PubMed "Comprehensive Statistics on Alzheimer’s Disease
Prevalence and Impact"
https://www.nia.nih.gov/health/alzheimers-and-dementia/alzheimers-disease-fact-sheet#causes