FOSTERING HEALTHY COMMUNITIES HEALTHCARE INFRASTRUCTURES BIOPARKS Optimising Healthy

FOSTERING HEALTHY COMMUNITIES: HEALTHCARE INFRASTRUCTURES BIOPARKS: Optimising Healthy Living Solutions for Europe’s Ageing Populations Lisette Mermod-Cox CEO, BDKT Lifescience Facilities 0

HOW INDUSTRY SEES OPPORTUNITIES The Union's ageing population and declining labour force present a challenge to the competitiveness of European regions and cities. As part of the response to ageing It is essential to take steps to increase the number of healthy life years for its population through measures to prevent health risks, fill gaps in health infrastructure and promote e-health systems. 1

HEALTHCARE INDUSTRY DRIVERS FOR BIOPARKS Bioparks are an innovative solution to the problems of healthcare R&D, IT and therapeutic treatment in Europe and elsewhere. National, regional and local capital budgets for healthcare projects are under pressure to increase, without being able to project a proportionate increase in revenue. This affords the opportunity for commercial opportunties for new biomedical and biotechnology businesses sited at and around bioparks. 2 l Clinical research and trials facilities l Diagnostic, screening, testing & analystical laboratories l Data & Biologicals Storage & logistics facilities and businesses l Health sciences public education, training & entertainment businesses

What is the role of a biopark? The IASP currently does not have a precise definition for a biotechnology park. A science and technology park is an organisation which provides services and facilities to companies l Geographical focus l Linked to research institute, university or teaching hospital l Driven by inward investment and economic development l May be for-profit, most often not-for-profit l Tenancy on park site the norm but not always a requirement The biopark is emerging as part of a global bioscience supply chain spanning from R&D to healthcare delivery 3

Definitions IASP Definition: A science park is an organisation intended to enable, facilitate and often create new or enhance the growth of existing business entities Typically it’s goals include l Inward investment l Enterprise creation l Job & wealth creation To date the science park and incubator programmes have been topdown ‘inputs’ driven, with few measurable ‘throughputs’ or ‘outputs’ 4

Definitions BDKT definition: A biopark is an organisation designed to attract, grow and sustain people and businesses within a biomedical-techno-scientific community by means of enabling and facilitating commercial relationships among the community. Typically it’s goals include l Innovative convergence model for industry, government and research to produce innovation and inventions l Promotion of the biopark community as a preferred partner or destination for wider community based upon existing expertise l Redirect, increase or create new commercial activity among members of the community with global connectivity l Serve as an engine/source of innovation and invention l Integration of science, healthcare and technology into the social community (science-to-society) 5

Critical Success Factors for Bioparks (1) To enable, facilitate and create new or enhance the growth of existing business entities a successful biopark organisation must promote and maintain a high quality business environment l l l l 6 Attractive & Positive International Business culture Respect for Intellectual Property Rights Protection High Quality Professional Expert Advisors (Legal, Patents, Regulatory) Client Focused, Service Culture Inclusive Behaviour & Management Style Ability to promote/host/sponsor Collaboration & Co-opition Market Aware & Responsive Easy Access to Organisation and Community Clear & Effective Communications Professional & Flexible Management Approach Agile Problem Solving Attitudes Lean Organisational & Operational Structure Competitive Pricing Structure

Critical Success Factors for Bioparks (2) Ensuring Competitiveness in a Global Market The global healthcare system, pharmaceutical companies, their suppliers, information technology and the medical device industry are all clients and partners to the biotechnology sector. In order to meet the requirements of these highly regulated sectors a biopark organisation must be able to demonstrate excellence for enabling and supporting the competitiveness of the community 7 l Regulatory Affairs & FDA/EMEA compliance l GLP, GCP & ICH Guidelines l GMP, c. GMP l International commercial best practise l Healthcare Accreditation (UK, USA) and Quality schemes (labs) l Continuous Professional Training (CPDs)

Critical Success Factors for Bioparks (3) Offering services, access to technology, equipment and patients, and specialist facilities at reduced risk and reduced costs to early and growing companies Shared technologies suites l MASS/NMR l Small & larger scale animal models for pre-clinical ADME/toxicological testing Pilot Plant for the production of biological materials for clinical trials l Ability to produce small doses in a variety of dosing forms for clinical studies Clinical Research facilities for Phase I studies l 12 -36 bed wards for healthy male volunteers Larger teaching hospital for Phase II, III & IV studies of acute and critically ill patients l 8 Specialist dedicated clinical research units within chronic and acute wards

Critical Success Factors for Bioparks (4) Global connectivity, networking & sharing information = competitiveness How well people communicate ideas and information informs the ability of the success of the biopark organisation. Investment into appropriate IT is critical to the competitiveness of its community and companies. Information technology is changing the opportunities for business. Time & financial resources need not be duplicated on projects or ideas being developed by others in different markets. Open-resource competitions and co-opition are changing business relationships l l l 9 l Networked Industry for Innovation Interdisciplinary Collaborations Teamwork Conferences, Workshops, Seminars Partnering Strategic Alliances Transnational reciprocal agreement facilities

Critical Success Factors for Bioparks (5) Targeting Successful Biopark Clients & Community Universities and hospitals have received the bulk of public sector investment (EU and national budgets) for creating new science parks. These traditionally organised institutions are thought by government to be the main sources for biomedical and biotechnology R&D, innovation and inventions. The pharmaceutical industry has made good use of universities and their hospitals for contract research in the past 20 years in the UK/Europe on an ad hoc basis, often arranged by and contracted to individuals within large institutions. Most innovation bioscience companies have emerged from mature middle managers exiting established scientific and medical companies taking with them expertise and experience in industry. The latter are the most successful companies within science parks environments to date. 10

Challenges for Bioparks Science parks are about business, not science. Not all scientific or biomedical ideas are suitable as businesses. Financing opportunities for start-up and grow on biotechnology and medical device companies in the UK and Europe are seriously undervalued and first round investment is extremely limited. Many science park managers emerged from government civil service, university or hospital administration with little or no business experience or expertise. Many European universities and hospitals are still inexperienced with industry’s intellectual property rights protection concerns. Many existing science parks have been pushed to spin-out new companies too early, which have been left underinvested and ultimately undervalued by industry. Global shifts in economic trends have resulted in emerging competition from India, China and Brasil for innovative science park models. 11

Thank you for your attention Lisette Mermod-Cox BDKT Lifescience Facilities London, UK Mobile: +44 7968 970 942 Office: +44 20 7638 5559 Email: LMC@bdkt. com Web: www. bdkt. com 12