TERMIS-EU Pre-Accelerator Programme (PAP)

Our first session will provide an introduction and overview to the current state of the TERM industry. Innovation is rapidly driving industry progression, and despite some promising clinical data coming through the industry faces complex issues in reimbursement and financing, manufacturing, regulation, and more. As an industry we are still to realise the great promise of TERM approaches, and here we look at past and present experiences to discuss how we might realise future commercial success.

– The ‘hype cycle’ and identifying major trends in the TERM industry
– Who are the major players and how is this changing?
– The role of scientific and economic innovation in building a new industry
– The importance of partnering and building alliances for future success

Generating a substantial and high-quality body of early-stage data is crucial to attracting equity investment and developing your business. Understand the needs of this dataset can be complex and nuanced, especially when investors may not have technical knowledge. Here we discuss strategies for generating such data, the importance of collaborations, and how the value of this data is best leveraged.

– What evidence does an investor expect in an early stage TERM product?
– How to build evidence? Collaborative project management.
– Is it essential to have clinical evidence before seeking investment, and to what level?
– How pre-clinical studies are best managed

TERM products face a raft of regulatory hurdles that must be successfully navigated if products are to not only reach the market, but remain on the market while achieving commercial success. The exact regulatory route-to-market depends on the nature of the product, while the innovative nature of many advanced therapies frequently complicates adherence to existing frameworks. In this seminar we aim to cover:

– Overview of the regulatory pathways available for ATMPs and other TERM products, including medical device classifications
– Key regulatory requirements for developing ATMPs in the EU
– Necessary ancillary activities for regulatory approvals
– Commercial case study

Protecting a technology in the TERM arena requires devoting considerable attention to your IP strategy. IP presence is almost always a prerequisite for equity investment, and often, companies further develop a strong patent portfolio to subjugate competitive risk. Other forms of product protection such as trade secrets and exclusive know-how offer alternative protection strategies, often preferred where direct IP filing may not be possible.

– What is IP and why does my start-up need it?
– Different patent types and alternative product protection strategies
– Current patent landscape in TERM
– Licensing and deals
– Landmark cases

Developing a financial plan for your start-up can be a daunting task, especially for founders with a scientific or technical background. Forecasting your costs as accurately as possible, realistically valuing your product within the context of its market potential, and identifying your manufacturing cost-of-goods, are crucial prerequisites to securing an appropriate level of investment. Actually securing investment a whole new ball game- pitching to investors is a real art and often requires massive time commitments from company founders.

– Financial modelling and how to forecast your costs
– Realistically valuing your company and your product
– Finding appropriate funding sources: Dilutive and non-dilutive investment
– Exit strategies- will you go all the way to the market, or aim to be acquired? Who might buy your company?
– How is your product going to be reimbursed? Who will pay for it?

Building a cohesive business plan is something many technically-trained entrepreneurs struggle with, and understandably so. Piecing together everything you need in a way that is not only attractive for investment but will facilitate long-term commercial success, is a substantial task. As well as making some fundamental decisions about your business model, a multitude of details require ironing out, while identifying weaknesses and risks in your plan will help build its quality.

– How to write a business plan: what is it, and what does it needs to include?
– When is it appropriate to seek investment, and how should this best be done?
– How will you engage with the necessary stakeholders to manage all the risks throughout your business plan?
– Who can you partner with to accelerate your development plan?

Proof-of-concept stage technologies often face significant challenges in scaling up or out to meet market-scale demand. Manufacturing presents a frequently overlooked element of risk and your long-term supply chain must be considered from the outset. Different TERM products hold different levels of risk in this regard; while medical devices may be simple enough to manufacture on a large scale, autologous cell-based therapies often face significantly greater manufacturing challenges. Further, ensuring your product can easily integrate into common clinical practice and is attractive for clinicians or other end-users to adopt is paramount to a product’s success.

– Scaling up and/or scaling out: how will you manufacture your product at scale?
– How will you store and distribute your product in a way that protects its quality? What are the regulatory requirements around this?
– How will you ensure your product is attractive for the end user?
– What recall protocols will you have in place?
– Case studies (e.g. Dendreon)