Being in the early stages of starting our business, there’s nothing more exciting than just the idea of merely getting a meeting with someone who has even the vaguest interest in financially backing our project.

On the 16 of August we've met and presented our project to Mr. Yigal Vidal, head of the North Maccabi Healthcare. Maccabi Healthcare is the second largest health maintenance organization in Israel. Maccabi Healthcare is about to open a big research center and an incubator for medical startups.

Maccabi operates 150 medical clinics throughout the country, as well as 20 medical diagnostic and therapeutic centers, 43 pharmacies and two hospitals - Assuta Medical Center and Ramat Marpeh.

In the meeting we discussed how we came up with the idea for our project, our potential product pipeline, and our team.

The questions we were asked: "how much are you looking to raise, and how long will that last you?", “What are the key differentiated features of your product or service?”, “What is the cost of a customer acquisition?”, “What legal risks do you have?”, and more.

We did a good preparation, but still for some of the questions we didn’t have a definitive answer. It was a great experience, and we were told to continue with the research and keep them updated, as we proceed to have more scientific evidence and progress.

The meeting encouraged us to write tips for the future iGEM teams that will meet angel, VC or other type of investor.

Here are some Do’s and Don’t’s, and a great list of websites that helped us to prepare for the meeting.

Do: Research. Do the VCs you meet invest in your market and in companies of your size/stage, and are they active? Have they been making investments recently? Prepare pitch that will include the following slides: Current status: funds raised to-date, monthly budget, revenue, team size, team expertise, customers, metrics • Problem you’re solving • Market size & potential • Solution • Competition • Go to market strategy • Unfair advantage • $$$ (how much you want to raise and why) Be specific about your existing and target customers. Demonstrate that you understand their purchasing decisions, based on real knowledge and interactions with them. Be prepared to provide references -- the stronger your customer buy-in, the better.  Make sure you can answer each one of the following questions.

Don't Don't be late nor outstay your welcome (typically one hour, but check in advance and keep to it). Don’t overpromise. Potential investors are going to ask a lot of questions. The key here is to be honest with them, foregoing any bluster or pretending. As a young company, there will be many things to figure out. Don’t cover up your uncertainty by lying to or overpromising an investor. Don't dress unappropriately- Let your appearance reflect your business and the customer you serve so potential investors can get a true sense of who you are going after for your target market.

References and must read articles:

How to prepare for your business presentation with investors
How to nail your meeting with a VC investor
4 Things You Need To Know Before Your First VC Meeting
The First VC Meeting
8 Questions on How to Prepare for VC Meetings

BUSINESS PLAN DRAFT

Prepared by:_Igem entrepreneurship team BGU_ISRAEL

Contents

1. Executive Summary
2. Company Description
        Advisors
        Milestones
        SWOT Analysis
        Timeline
3. Market Analysis
        Target Market
        Total Market Valuation
        Market Trends
        Profile of Competitors
4. Marketing/Sales Strategy
        Pricing
5. Staffing and Operations
        The Management and Organization Structure
6. Financial Projections

1. Executive Summary

Engineering a Novel Synthetic System for Cancer Therapy & Diagnostics

The rapidly evolving field of synthetic biology holds tremendous therapeutic potential. Synthetic biology aims to design and construct facilities or biological systems with useful purposes, by using tools from biology, biotechnology, biochemistry and engineering. We are developing applications for the diagnosis and treatment of cancer. Despite the huge investment in research and the development of a variety of treatment methods, cancer is still a major cause of death in the world. Today, both surgical and pharmacological treatments against most types of cancer are not accurate enough to identify and treat the disease on a cellular level. On the other hand, novel biological treatments being developed were only found effective for a relatively small number of patients.

In cancer, many cellular and molecular processes take place, enabling the tumor to develop and spread in the body. We believe that it is possible to take advantage of the many typical biological mechanisms of cancer cells, by developing a synthetic biology-based system for identifying and treating cancer on a cellular level. Together as a team, we developed a modular system which identifies numerous genetic changes in cancer cells and responds by activating a synthetic machine that executes a cell suicide program or enables color-based "tagging" of the cells for tumor detection, ensuring complete surgical removal. The novelty of the system relies on its high specificity, achieved by conditional activation based on a number of genetic changes that take place specifically in cancer cells. Because such changes vary depending on the person or type of tumors, a modular system of such will enable personalized care for each patient.

About Us
Our team includes eight students of different academic backgrounds (Biotechnology Engineering, Biology, Medicine, Neuroscience and Cognition, Economics & Political Science). The team is supervised by Prof. Smadar Cohen, Dr. Emil Ruvinov and Dr. Efrat Forti from the department of Biotechnology Engineering.

2. Company Description

        Products and services

        Boomerang is developing a novel cancer therapy based on an advanced methods is genetic engineering. Using the Crispr-Cas9 system, our drug is designed to work only under the presence of two cancer-specific signals, making it an extremely specific therapy. In addition, our treatment was designed to be personalized for each patient, based and its specific tumor signature.

        Background to its development

        Although being one of the most researched and funded fields in medicine, cancer is still one of the greatest challenges facing medicine today. We recognised three weak points in current treatments, that prevent them from eliminate cancer: Low specificity, low efficiency and low personalization. We therefore tried to develop a treatment that will be both specific, efficient and personalized in hope to revolutionize cancer management.

        Benefits and Features

        Our product's main benefit is its high specificity for cancer cells. In contrast to other treatments that recognize cancer cells based on only one cellular change that known to be unique for cancer (for example - cell division in chemotherapy, specific protein in targeted therapy), our treatment is the first to recognize and work on tumours only in the presence of two cancer-specific cellular changes, making it extremely specific and free of toxicity and adverse effects. Although cancer is not a single disease but a huge group of different diseases characterized by different genetic changes, the same exact treatments are addressed today for thousands of patients, not considering the differences between patients. Another important benefit of our treatment is the ability to design it easily and cheaply to recognise and kill every tumor type based on its unique genetic profile. The two signals that activate our drug are promoters – the 'switches' that turn on and off genes. Each cancer have its unique cocktail of promoters activity that allows it to create the proteins needed for its survival and proliferation. Analysing this hyper-activated promoters in each tumor within each patient, and inserting these promoters to our system allow our treatment to be personalized, and therefore effective and specific of every patient.

        Advantages to customers

        A drug that is specific and personalized to patient has a great advantage for both patients and healthcare providers. Patients, of course, are interested in a treatment that is the most effective against their disease and with minimum side effects. Even though such treatment is expected be more expansive than other drugs, governments and healtcare providers also have an interest in such a treatment. An effective and specific cancer treatment will reduce the huge expanses of hospitalization days, palliative treatments, lost of productivity and death.

        Disadvantages or weak points

        In order to work effectively, our drug requires a systemic delivery into the patient’s cells. Our drug is composed of three DNA plasmids that are packed in a viral vector for transfection and delivery. The biggest challenge in gene therapy today is a good delivery system with a high transfection rates. Our treatment's dependency on the effectiveness of external components, is a major weak point.

        Long Term Aim of the Business

        Our aim is to revolutionize cancer treatment with a highly specific, effective and personalized therapy.

        Advisors

        Prof. Rechavi Gideon, M.D. Ph.D. Head, Sheba Cancer Research Center

        Prof. Samuel Ariad, M.D. director of oncology, Soroka Medical Center

        Dr. Ahmi Ben-Yehudah, ‏Director of Medical Research Administration

        Dr. Omri Amirav-Drory, Founder and CEO at Genome Compiler

        Mr. Erez Livneh, Founder and CEO at Vecoy Nanomedicines

        Mr. Yossi Shavit, Project Manager at the Bengis Center for Entrepreneurship and Hi-Tech Management

        Milestones

        I) Designing and validating final product containing variable targets for different cancer types.

       II) Improving the output application of our product, including combination of non- fluorescent colors for diagnosis and search after methods applicable in science today to destroy tumors, whether through immunological tool or other.

       III) Export our vectors to other cancer research labs throughout the world, in order to test our vector in other conditions and other cancer cells and to improve our product.

        IV) Testing the vector in animal experiments to test possible toxicity and dose regimens

        V) Testing the vector in animal experiments to test the efficiency in vivo.

      V) After achieving positive proof-of-concept results in animal experiments, our strategy will require intensive R&D program toward clinical testing in patients.

        SWOT Analysis

Weaknesses Delivery- our system is relying on other delivery systems which will be effective enough in vivo. The features of each target are still not clear, and there we will need to build a "biological bank" to gather this information.

Strengths Specific tool which can easily diagnose and treat cancer, using the biological characteristics of the tumor cells. In comparison to other methods in the market today, our system offers the most accurate way to diagnose and treat cancer cells. The treatment is unique for the specific features of every tumor. Our product has modular design, and can be modified according to specific needs (e.g., personalized for each patient tumor profile).

Threats Our system relies on intensive research that need to be done on DNA vectors and delivery systems. Competitors.

Opportunities Our system is modular, so we can match the system to many other methods which are in use today. Collaborations between different aspects of science can occur with our system, uniting synthetic biology with other fields of medicine.

        Timeline

3. Market Analysis

        Target Market

Global spending on oncology reached $100 billion in 2014 as new treatments and increased demand drive steady growth.

-Global spending on oncology medicines – including therapeutic treatments and supportive care, and measured at ex-manufacturer prices not reflecting off-invoice discounts, rebates and patient access schemes – increased 10.3% in 2014 and reached $100 billion, up from $75 billion five years earlier.

-Targeted therapies now account for almost 50% of total spending and have been rising at a compound average growth rate of 14.6% over the past five years.

-In the major developed markets, a sharp increase in the volume of protected brands since 2011 and significant new product launches have been the primary drivers of spending growth, while the impact of patent expiries has moderated over the past few years.

-On a per capita basis, spending on therapeutic oncology medicines in the U.S. reached $99 in 2014,up from $71 in 2010, with similar levels of percentage increase occurring in other major markets with the exception of Spain where per capita spend has been flat.

-Oncology drug spending has risen slightly as a percentage of total drug spending over the past five years in all regions, most notably in the EU5 countries where oncology now represents 14.7% of total drug spending, up from 13.3% in 2010, while the U.S. has seen oncology increase more modestly from10.7% to 11.3% of total drug spending over the same period.

-Future spending on oncology medicines through 2018 is expected to be in the 6-8% range, compared to 6.5% over the past five years as growing demand and new therapy options are offset to some extent by new competition from biosimilars and small molecule generics following patent expiries.

        Total Market Valuation

Spending on targeted therapies continues to grow rapidly in all regions Targeted Therapies Growth 2010-14

Chart notes:
Oncology includes therapeutic treatments as well as supportive care, radiotherapy and immunotherapies
For the 5 year period 2010-2014 targeted therapies have grown by 14.6 % globally while cytotoxic, hormonal and supportive therapies have remained at about $52 Bn in annual sales.

        Market Trends

The global pharmaceutical market is expected to grow to nearly $1.3 trillion by 2018

Chart notes:
Spending in US$ with variable exchange rates. Charted growth from 2008-13 and 2014-18 include impacts of exchange rate variability. In 2008-13, exchange rates contributed approximately -$25Bn to growth. In 2014-18, they are expected to contribute approximately -$18Bn.

Spending on medicines globally is expected to reach nearly $1.3Tn by 2018.
Using actual and forecast exchange rates, the absolute global spend for pharmaceuticals will change by $290-320Bn, compared to $194Bn in the past five years; using constant exchange rates, absolute growth is expected to be $305-335Bn, compared to $219Bn in the prior five years.
Global economic recovery continued in 2013 and is expected to strengthen during the first half of the forecast period.
Significant downside risks remain however, due to uneven economic recovery in Europe, political tension in Russia and recent events in Africa and the Middle East.
The global population aged 65 and over will grow faster than any other age segment, and will account for almost 30% of overall population growth in the next five years
Demographic trends will act as a significant driver of global demand for pharmaceuticals during the next five years: increase in diagnosis and treatment of chronic conditions and an aging population will drive developed markets, while population growth coupled with improved access to healthcare will drive emerging market growth.
Most countries will experience an increase in pharmaceutical spending per capita by 2018.

Chart notes:
Spending used to calculate spend per capita in US$ at actual and forecasted variable exchange rates. Growth in the U.S. market will remain strong, disproportionate to its population growth; this is driven by fewer patent expiries than in previous years, innovative product launches and rising prices. Despite high growth in pharmerging countries, there remains a large difference in pharmaceutical spending per capita versus developed markets Only France and Spain will see a contraction of pharmaceutical spend per capita in 2018, due to policies intended to control spending growth. Highest growth is anticipated in China, where per capita spending is anticipated to grow by over 70% in the next five years. As the second largest market in the world, China’s spend is expected to be just 9% per capita of that in the U.S.

        Profile of Competitors

Drug	Brand name	Company	Indications	Cost
Trastuzumab	Herceptin	Roche	Adenocarcinoma of the stomach or gastroesophageal junction	$70,000 for a full course of treatment
			Breast cancer
Bevacizumab	Avastin	Roche	colorectal cancer	$100,000 a year
			glioblastoma
Cetuximab	Erbitux	Bristol-Myers Squibb	colorectal cancer	$30,000 for eight weeks of treatment per patient
			squamous cell carcinoma of the head and neck
Rituximab	Rituxan	Biogen	Lymphoma

Although specific, these treatments are indicated only for a very specific group of patients that carry the protein or the mutation that these drugs target. Boomerang, on the contrary, can be designed to work for every kind of tumor and patient best on the analysis of the promoter activity of the tumor, that responsible to activate our drug.

In addition, since these drugs work on a single pathway in the cancer cells, many tumors develop a resistance to the treatment. Our system is based on DNA strands rather than on proteins and therefore, our therapy act as a micro drug factory that is able to synthesize inside the cell a few killing proteins that intervene with multiple pathways, increasing our efficiency in eliminating cancer cells.

4. Marketing/Sales Strategy

Patient access to oncology medicines varies widely by country and closer scrutiny is being placed on value by payers and patients who may face a growing share of treatment costs.
• The availability of new medicines varies widely across the major developed countries with patients in Japan, Spain and South Korea having access in 2014 to less than half of the new cancer drugs launched globally in the prior five years.
• In pharmerging markets, availability of newer targeted therapies remains low though increasing.
• Even when available, lack of reimbursement for drugs, particularly in countries employing formal cost effectiveness methodologies based upon cost per quality life year gained, constrains access for patients.
• Assessment of value for oncology products is becoming more complex as fewer new drugs have single indications and by 2020 it is expected most will have three or more indications.
• Divergence in clinical value by indication complicates assessments of appropriate pricing by payers since in many cases the majority of a drug’s clinical value may be in areas with small patient populations while most of its use is for indications with relatively less value.
• Overall therapy treatment costs per month have increased 39% over the past ten years in inflation- adjusted terms, similar to the 42% increase in overall response rates and 45% increase in months that patients are on therapy, which also contribute to higher overall spending levels associated with improved survival rates.
• In the U.S., patient out of pocket costs associated with IV cancer drugs have risen steeply as consolidation of smaller group practices into larger hospital systems has triggered higher outpatient facility costs shared with patients.
• Patient concerns about the financial burden of living with cancer is a frequent topic of discussion on social media sites which are increasingly used as a source of information and for sharing experiences.
• Pricing a new cancer drug involves trading off a complex set of variables. The potential for multiple uses, with differing clinical value and numbers of patients, further complicates the process.
• Pricing based upon favorable clinical data in a small population may produce a price that is higher than optimal for one or more uses, and may lead to restricted access.
• Pricing based upon a weighted average of clinical values and expected patient volumes appears to offer a solution; however, this approach can threaten a product’s commercial viability where a low weighted average price is negotiated, but access then is restricted to small patient groups.
• Alternative pricing strategies that allow separate and distinct prices to be paid for individual patient groups, based upon the clinical value demonstrated by real world evidence, may be preferred by payers and manufacturers

        Pricing

Our product pricing is complicated due to the following reasons:
There is no similar product available on the market
Potentially similar products are in use only in clinical trials
Our product depends on development of other technologies which are not on the market yet (gene delivery vectors etc.).

5. Staffing and Operations

        The Management and Organization Structure

6. Financial Projections Draft

Estimates of the financial plan for one year of activity. The data gathered from previous iGEM business plans and lab workers.

References:

Developments in Cancer Treatments, Market Dynamics, Patient Access and Value
Global oncology spend has grown to $100 billion in 2014
Global Outlook for Medicines Through 2018
Aalto-Helsinki Business Plan