Nanotechnology A different kind of licensing A

Nanotechnology – A different kind of licensing? A View from the Pharmaceutical industry Beatrice Leigh BB Consultants Ltd LES Annual Conference June 2004

A different kind of licensing? Probably not But there are things to be aware of Talk will cover: - • Big Pharma’s use of technology • Recent examples of nano licensing • New evolving technologies • Challenges for licensing • Public understanding/engagement • Look to the future

What’s the problem? Indexed R&D Expenditure/Sales/NME Output (1989=100) 300 275 R&D Expenditure 250 225 200 175 150 New Drug Output 125 100 75 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 Year CMR International based on data collected from 55 pharmaceutical companies and 13 trade associations. Data presented includes R&D expenditure and output from traditional pharmaceutical as well as the biotech industry

Capturing the potential of the human genome: industrialisation of drug discovery Huge array of molecular targets Genetics Genomics Proteomics + Vast, diverse chemical libraries Rapid identification of leads Extensive survey of biological function Highthroughput chemistry Ultra-high throughput screening Highthroughput biology Novel technologies, including through partnerships

What is changing in the industry? Current technology: Several generations of incremental ‘smaller, faster, cheaper, better’ - Improved data density, bandwidth, size, weight, strength…. . etc New areas of science and technology ‘–onics’ and ‘-omics’ and new behaviours associated with micro/nano scale Unprecedented changes - probably towards active, autonomous devices: - Detect, Synthesise, Measure, Decide - Fluidics and/or sub-Heisenberg scale non-binary, fuzzy, life-like Integration of tasks Intelligent but complex devices Simple use Destructive technologies lead to irreversible changes

Shortage of compounds ie products makes technology more important Classically Big Pharm buys or licenses technology GSK set up Technology Development to : • New Platforms • Disruptive Technologies • Gaps in technology that have high impact • Internal Venture Fund And because everything is …smaller, faster, cheaper, better… Automation and miniaturisation It’s nano or micro

Is it micro or nano and does it matter? For Example the DTI Initiative is called MNT to avoid disputes It’s about new ways of doing things Using new materials Learning from other industries Very multi-disciplinary Stretches across R&D: from Discovery Research to Pharmaceutical Technologies

Some recent Nano licensing deals • Pervasis Therapeutics. . MIT Startup $500 K Semiconductor memory cell technology -integration of biomaterials with drugs and cells Applied Technology licence with un-named Japanese display maker $500 K +2% royalties Flat panel carbon nanotube technology- brighter displays and more efficient Use in consumer markets. In healthcare? Flamel’s Medusa nanoparticles and Micropump technologies allow native proteins to be effective therapeutics. BMS entered into a licensing deal with Flamel to develop unmodified once daily human insulin and paid $25 M upfront, $145 M in Milestones and royalties in mid-teens

What are the new enabling technologies? • Fabrication facilities for new micro/nano technologies • Research into novel, non-silicon – glass, polymers, ceramics, metals etc. • Research into novel fabrication techniques • Research and development of micro fluidic devices – understanding their properties and applications • Integrated devices and mixed materials research • Sensors and actuators

Challenges for licensing nanotechnology Do you know what it is? Do you know what it is worth? $$$$$ Very hard for new Disruptive technologies which have many applications Care needed with patent drafting Nanotechnology has not developed a uniform language: Patents granted that an experienced eye would have discarded Patent infringement disputes because competitor holds similar claims but has used different language Exponential increase in nano patents filed in last 5 years Care needed with Field of use for the licence May need a bundle of patents – not all from one source

Public Engagement is the key to managing safety issues - What is the cost of not dealing with and managing the issues? GM debate largely lost in UK (along with the income!) Public (rightly) worried about small particles they cannot see. RS/RSEng – current state of knowledge - areas for development - health safety environment - regulation Research Councils – help separate the application from the technology -Gene therapy -Stem cells -Tissue engineering Effective Communication “What’s in it for me? ” What if I don’t? …. is already open Manage it!

It’s a People Game

Right kind of people Scientists and technologists Multi-disciplinary and inter-disciplinary EPSRC calls Discipline hopping Object to get a mathematician to communicate with a biologist A materials scientist with a chemist “Jack of all Trades and master of none”. . not held in high regard by the academic peer review system Patent agents and licensing people Business development/commercial people It’s a Brave New World and should not be damned by Grey Goo

Potential 2020 ‘New Worlds’: (- key enablements) Homelife: Domestic energy sources: fuel cells, hydrogen – (microfabrication, microfluidics). Intelligent/autonomous heat, light, waste, logistics – (microelectronics, photonics) Smart/adaptive fluids for health, food, cleansing – (microfluidics, nanoparticulates) Entertainment: Unprecedented opportunities from stochastic devices - fuzzy, lifelike behaviour engaging with all (rather than 2) senses - (microfluidics, microelectronics, photonics) Travel and Leisure: Identity, security, detection/elimination of infectious agents; skin protection, subdermal dosing, enhanced sports equipment - (microfabrication, microfluidics, nanoparticulates) Medicine: Surgery diagnostics, Rx medicine and consumer heath product discovery and development – from gen- to chem-omics; Active (ATP – fuelled) drug delivery, artificial organs and augmented biochemistry – (microfabrication, microfluidics, nanoparticulates)

Crime: Tracking, tracing, detection and analysis – (micro/nano fabrication, microfluidics) Industry: Self-configuring UHT property based search for Pharma, Consumer Health Care, polymers, new semiconductor materials, catalysts, photonics materials; altered energy sources (Fuel cell, hydrogen economy) - (micro/nano fabrication, microfluidics, nanostructures, nano-featured surfaces, micro/nano mechanical devices, novel material for tool fabrication and for devices) Education: Expansion of syllabus, Provision of training (- representative tools and aids) Ecology: Potential for active monitoring and recovery. Maintain, recover, reclaim. - (quantity manufacture of micro/nano devices, microfluidics, etc) Telecommunications: ‘sub-Heisenberg’ devices, wave-like rather than particulate behaviour. Extension of current scaling and properties (e. g frequency/bandwidth), new behaviours (fuzzy) - (micro/nano fabrication, novel materials)

Future licensing in Healthcare will probably be dominated by technology rather than compound/product. Valuation and Field will be critical to success. Having the right people to spot and champion the new, unexpected, often disruptive technologies is also critical.

And Finally………. . Integration of tasks Intelligent but complex devices Simple use No new technology is without risk No old technology gives much return Organised response to uninformed opinion (without fear or favour!) They can’t see the alcohol in the beer – should they ban it?