This meeting covers the whole area of regenerative medicine from ethics of best practice for human embryonic stem cell derivation, through to stem cell commercial translation and regulation. This meeting is our final meeting of the 2006-2007 session of network events and will appropriately finish with a Keynote from the ‘Godfather’ of regenerative medicine, Dr. Paul Kemp with his predictions for the future. Since this meeting also coincides with the 2nd Birthday of the LRMN, there will be a sparkling wine buffet afterwards!

SPEAKERS

KEYNOTE – DR. PAUL KEMP

Dr. Paul Kemp is the founder and Chief Scientific Officer of Intercytex plc, a recognised global leader in regenerative medicine. Paul has been heavily involved in commercial regenerative medicine for the last 20 years both in the USA and the UK. After post- doctoral research on the biochemistry of collagen cross-links at Manchester University, he joined Organogenesis (MA, USA) in late 1986 where he was instrumental in the commercial development of Apligraf ‘tissue-engineered skin’ which was to become the FDA’s first approved manufactured human organ and has currently been used in the USA on over 150,000 patients suffering with chronic leg ulcers.

Paul left Organogenesis in 1997 to return to the UK and founded Intercytex in 1999. This company is devoted to the cellular induction of human tissues and organs and has four products in hair and skin regeneration that are all undergoing clinical studies in the UK, USA and Canada. Paul is international recognised as a leading authority in the field having given numerous presentations at major events and published both papers and patents all whilst building a stock market listed company with over 75 employees based in Cambridge, Manchester and Boston (USA).

http://www.intercytex.com

In this Keynote presentation, Paul will discuss the various scientific and commercial areas that make up regenerative medicine and give his own personal views of where the commercial sector is going to go over the next few years as more and more patient treatments become available. DEFINITELY NOT TO BE MISSED!!!

PROF. SARAH FRANKLIN

Sarah Franklin is Professor of Social Studies of Biomedicine and Acting Director of the BIOS Centre for the Study of Biomedicine, Bioscience and Society at the London School of Economics. Sarah has written and edited more than a dozen books on the social aspects of IVF, cloning, embryo research, and stem cells. Her most recent book, published in May 2007, is titled ‘Dolly Mixtures: The remaking of genealogy’ which uses Dolly the sheep as an opportunity to begin developing a critical language to identify and evaluate the reproductive possibilities post-Dolly. Sarah works closely with clinicians and scientists in an attempt to widen sociological engagement with emerging issues in bioscience and biomedicine by developing collaborative partnerships with the professionals and communities, policy makers, and patient groups most closely involved in areas such as assisted conception, embryology, human embryonic stem cell derivation, and cloning.

http://www.lse.ac.uk/collections/sociology/whoswho/franklin.htm

Sarah’s presentation will focus on the UK Human Embryonic Stem Cell Coordinators network (hESCCO), which she leads together with Prof.
Peter Braude (King’s College London). hESCCO was set up in response to the public sensitivity and logistical complexity of embryo donation to stem cell research. The aim of hESCCO is to contribute to the formation and implementation of national standards for hES cell derivation and banking, in particular the ethical protocols for patient information and informed consent. A publicly-funded initiative launched by the MRC in 2003, the hESCCO project is an innovative practical intervention within the broader attempt to establish greater transparency, consistency, efficiency and standardisation of hES derivation in the UK. The lessons learned in this context may be relevant to other practitioners and regulators as a model of best practice in hES cell derivation.

DR. ROD WESTROP

Dr Rod Westrop is the Chief Operational Officer of Axordia Ltd, one of the UK’s leading human embryonic stem cell companies. Rod has over twenty years experience in the biotechnology sector with a number of major life science companies such as Bio-Rad Laboratories and Pharmacia Biotech. He has a wide range of commercial and operational experience related to development and launch of new products for use in both bioprocessing and life science research. Before joining Axordia, Rod set up Lark Technologies in Europe and established the business as a Good Laboratory Practice (GLP) accredited company with numerous contracts for clinical trial work with top ten pharmaceutical companies. He has an extensive experience of regulatory issues through his work in bioprocessing where he was responsible for setting up biotechnology production units across northern Europe and a background in managing, sales, marketing and business development functions with global responsibility in the life science market.

http://www.axordia.com

There has been huge media interest in the ethical use of human embryonic stem cell lines and in the cures that they purport to bring about. Commercial companies have found that in order to bring such treatments into the clinic there are a number of significant hurdles to overcome. The regulatory environment is only just becoming clear but there are still areas of uncertainty, there is no set of rules that companies can follow to ensure product registration. Using Axordia as an example, Rod’s presentation will elucidate what is required from companies by the regulators both in the UK and USA.

This meeting is free of charge to everyone through the generous financial support of PEPROTECH EC LTD. The LRMN also continues to enjoy financial underpinning from both GlaxoSmithKline and the Guy’s, King’s & St Thomas’ Annual Fund, plus invaluable support from the Advanced Centre for Biochemical Engineering, UCL and the Wolfson Centre for Age-Related Diseases, KCL.

AGENDA:

18.00 – Registration + networking over tea and coffee

18.30 – Introduction – Chris Mason (UCL) – Co-organiser – LRMN

18.35 – ‘Best practice in human embryonic stem cell derivation – Forming and implementing ethical protocols’ – Prof. Sarah Franklin, London School of Economics

19.00 – Q+A Session

19.05 – ‘Developing regenerative therapeutics in an emerging regulatory environment’ – Dr. Rod Westrop – Axordia Ltd.

19.30 – Q+A Session

19.35 – KEYNOTE – ‘The development of regenerative medicine as a future medicine’ – Dr. Paul Kemp – Intercytex plc.

20.10 – Q+A Session

20.20 – Closing remarks – Chris Mason (UCL) – Co-organiser – LRMN

20.25 – 22.00 – Networking reception – SECOND BIRTHDAY CELEBRATIONS – enjoy a glass of bubbly or two in the Wolfson Centre for Age-Related Diseases, KCL