Business development and strategic planning services. for life sciences and medtech ventures

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1 Business development and strategic planning services for life sciences and medtech ventures

2 ttopstart - Business development and strategic planning services Design: Studio Edwin de Boer

3 Business development and strategic planning services for life sciences and medtech ventures

4 ttopstart - Business development and strategic planning services Business development & Strategic planning ttopstart operates at the intersection of science and business. Because life sciences and medical markets are highly challenging, it takes more than a breakthrough technology to reach the finish line. Whether it is exploring markets, strategic decision making or business development, ttopstart is your partner to take the next step. We provide concrete guidance, spur venture funding and expedite commercial success. ttopstart's vision on modern medicine Introducing innovations in the healthcare sector is particularly challenging due to the many stakeholders involved, fierce regulations, long time to market and enormous upfront investments. For this reason, the pharmaceutical, biotechnology and medical technology industry are characterised by an extremely high attrition rate. You have to implement more than a sound business strategy to succeed. Our vision is that in all phases of business development, it is crucial to gain detailed insight into market opportunities, competition, the regulatory environment and stakeholder interests. This allows the creation of tailored commercialisation strategies that leverage the value of your developments and straighten the route to market. Second, we believe it is vital to effectively balance dilutive and non-dilutive funding and make use of only those resources that enforce your business. Finally, efforts should be targeted at deal making. The ultimate goal of ttopstart is to enable a business to reach its full economic, scientific and societal potential - supporting the market introduction of breakthrough medical products. Leadership in science and business consulting ttopstart is a European science and business consulting company that supports innovative companies and research organisations with the commercialisation of breakthrough innovations. The ttopstart team collaborates with more than 150 academic and corporate clients across Europe in the fields of life sciences, health and medical technology. We add value to the development of innovative products such as blood-based biomarker diagnostics, targeted immunotherapies and medical devices. We do this through the design of tailored business models, funding plans and commercialisation strategies - all based on the latest scientific and sector information. 4

5 "The funding and business development expertise of ttopstart has played a major role in the rapid development of our therapeutic cancer vaccine" Prof. Ada Kruisbeek, DC Prime Our services are always tailored to your specific needs and venture maturity, and include the following activities: 1. Market research providing strategic market insights and intelligence; The first step is to oversee your options, enabling informed decision making Strategic planning of the optimal route-to-market; Based on the latest insights in science and business, you carefully plan your next move In-house support; Finally you prepare and complete actions to achieve your business mission Financing consultancy providing access to dilutive and non-dilutive funding. and attract the capital to finance all operations. Market research Strategic planning In-house support Strategic martket insights Business plan Business 5

6 What are critical unmet medical needs that can be addressed by my technology? (value proposition) What are the trends and characteristics of relevant market segments? What products / applications / indications / markets should I prioritise? Who are my competitors and market comparables? What is their strategy? What is the best strategy to capture my primary and secondary markets? (business models) Who could be strategic partners and how should our deal be structured? How should I negotiate a licensing deal with my university? How can I capture the value of my venture through an exit? How can I reduce risks and investment needs while maximising the value of my technology? What is the optimal funding mix to address my capital needs? 6

7 Why ttopstart? ttopstart integrates extensive knowledge of the healthcare, biotech and medtech industries with advanced market research and business skills to accelerate the growth of your venture and expedite the profitability of your products ttopstart is a frontrunner in the design of effective business models and commercialisation strategies "Strategy is about making choices, tradeoffs; it's about deliberately choosing to be different." - Michael Porter. ttopstart has created a unique method to rapidly map your window of business opportunities. This enables setting the right goals - and moreover - to collaboratively design a business model and strategy that fully matches your product and your market. ttopstart builds upon a strong network Based on hundreds of projects in many different fields, ttopstart has established a global network of key opinion leaders, end-users, financers, reimbursement agencies, regulatory bodies and other stakeholders. This ensures access to the latest developments in the field and the rapid validation of value propositions and business strategies. opportunities specific for the life sciences, biotechnology and medical device industries. As such, we are excellently positioned to provide key insights for strategic planning of integrative preclinical and clinical product development, marketing, intellectual property and regulatory strategies. Synergy with other ttopstart services: corporate and academic funding ttopstart also employs its science and business consulting expertise to acquire dilutive and non-dilutive funding. This includes national and international subsidy applications (e.g. Horizon 2020), venture capital and loans (e.g. innovation credits). Over the past 3 years, more than 70% of our proposals were granted with multiple #1 rankings in competitive European programs. The synergy is evident: our funding experience ensures a business plan with clear funding milestones, while we can swiftly capitalise on available funding sources. ttopstart provides an encompassing view ttopstart oversees the needs and trends in healthcare and related industries, as well as the entire route to market of healthcare innovations, including the hurdles and More information on our funding services can be found on our website: 7

8 ttopstart - Business development and strategic planning services Key achievements Our services have successfully supported the start and growth of over 50 highly innovative companies throughout Europe. Below you can find a couple of examples. DCPrimeDC Prime is a clinical-stage biotech company that develops highly innovative vaccines for the treatment of cancer. The lead product is a dendritic cell vaccine for the treatment of leukemia. ttopstart has supported DCPrime with: Setting up a persuasive business plan that was used to raise non-dilutive capital Raising several Dutch and European subsidies to finance preclinical and clinical operations A market landscape study to identify key business threats and opportunities ACS Biomarker BV ACS Biomarker BV is a Dutch biotechnology company dedicated to the discovery, validation and commercialisation of novel biomarkers that improve prognosis and management of cardiac disease. ttopstart has supported ACS Biomarker BV with: Developing a business strategy in the highly competitive cardiac biomarker market 8

9 Lavoisier Lavoisier is a rapidly growing group of high-tech medical ventures that is dedicated to the translation of emerging technologies into meaningful medical products. Products include: a biomarker platform, a pathogen detection platform and a breath analysis platform. ttopstart has supported Lavoisier with: The identification of possible medical applications of a novel sensing platform as well as their strategic prioritisation. Design of a route-to-market strategy for a medical device for orthopedic surgery. Multiple national and international subsidy applications A selection of other key corporate clients 9

10 ttopstart - Business development and strategic planning services Methodology ttopstart employs a unique market research approach in combination with powerful methods for developing targeted business strategies. These proven methods have been specifically tailored by ttopstart for the challenges faced by life sciences entrepreneurs. 360 degree stakeholder and landscape analysis ttopstart specialises in 360 degree stakeholder and landscape analyses - targeted at early identification of key opportunities and critical marketing success factors. We picture your company amidst all stakeholders in your specific field or niche and the broader market - e.g. patients, physicians, industry, regulators, investors, insurers, competitors, clients etc - and zoom in on each of them to get a good feeling for decisive stakeholders positions, interests and needs. We do this through activation of our strong stakeholder network and semi-structured interviews. The result is a clear and detailed overview of the external environment that is decisive for the success of your product. Moreover, you will know what opportunities to target and which challenges you face - whether it is about product development, reimbursement, regulatory or commercial aspects. Specific market research methodologies we would like to highlight: top-down market analysis: quick overview of market quantifiers; bottom-up customer analysis: interviewing potential customers; IP landscaping: identifying competition and potential partners; competition war room: one-day session to outsmart the competition; interviews with key opinion leaders and end-users; evaluation of applicable policies; determining price elasticity. Strategic planning To develop lean and mean business models, ttopstart regularly uses the Business Model Canvas (Osterwalder et al., 2009). This is a strategic business development template that integrates partners, activities, resources, customer relationships, customer segments, infrastructure, value proposition, cost structure and revenue streams. Additionally, we have extensive hands-on experience with the business models commonly applied in your industry, including for the commercialisation of biomarkers, drug delivery systems, diagnostic devices and therapeutic compounds. 10

11 When will physicians recommend our product? How can we engage in co-development deals? What are the unmet needs of patients? What is the strategy and position of competitors? Which evidence is needed for the market approval? What is industry searching for? What are the requirements to get our product reimbursed? When will hospitals buy our products? When developing your business, we will implement the 'Lean Start-up methodology'. This is a methodology proposed by Eric Ries in 2011 that is based on the famous 'lean manufacturing' principles established by Toyota. Lean Start-up provides a framework for driving a start-up (how to steer, when to turn, and when to persevere) and growing a business with maximum acceleration. It entails short iterations cycle and innovation accounting which together minimises resources wasted on the development of unneeded innovation. In-house support Your company may wish to expand the capacity to implement our recommendations. ttopstart therefore offers experienced business developers to be posted temporarily at your company. They can establish and manage important partnerships, contracts, corporate communication and R&D. But more importantly they will ensure that our recommendations will contribute to successful commercialisation of your technology. 11

12 ttopstart - Business development and strategic planning services Ideas Learn Build Data Product Measure Design for reimbursement ttopstart has developed and implemented a novel paradigm for the development of winning commercialisation strategies for medical devices: 'Design for reimbursement'. This paradigm is based on the following two insights:(1) reimbursement is crucial for the success of a medical device and (2) reimbursement agencies require the highest level of clinical evidence of all stakeholders (long-term cost-effectiveness studies). Despite its eminent impact on development costs and time, the reimbursement process is often underestimated and/or ignored. Design for reimbursement ensures that when making crucial strategic and product design decisions, the impact on the clinical evidence that is needed for the reimbursement process is well recognised. Balancing dilutive and non-dilutive funding ttopstart has over the past four years raised over 170 million of financial funds for public and private R&D projects. Companies can make effective use of funding from venture capital, venture philanthropy, (government) loans, national and international subsidies, disease foundations etc. But how can you strategically combine various funding sources? How does this match your business model? ttopstart can advise how to optimally mix dilutive and nondilutive funding. 12

13 Contact us Jochem Bossenbroek MSc. - partner jochem@ttopstart.com Patrick de Boer MSc. - partner patrick@ttopstart.com Marije aan den Toorn, PhD - consultant marije@ttopstart.com ir Jasper Levink - partner jasper@ttopstart.com For more information please contact one of our consultants or visit our website at 13

14 ttopstart - Business development and strategic planning services About ttopstart ttopstart is a science and business consulting company that serves leading researchers and innovative companies in the fields of life sciences and medical technology. We acquire funding for cutting-edge research and development, co-create corporate strategies and conduct detailed market assessments. Our driver is the contribution to development of innovations that can strongly advance healthcare, such as diagnostics and treatments for a wide range of diseases with unmet medical needs. 14

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