r in g d r stem cells - reed smith · 2017-04-03 · dr paul gerskowitch ceo,axordia 13.0 cpd •...

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Dr Paul Gerskowitch CEO, Axordia C PD 13.0 The latest developments in the science of stem cell technology. The regulation of stem cells in the U.K. U.S., Europe and China. How to effectively secure a licence from the Human Fertilisation and Embryology Authority for stem cell research. How to secure funding for stem cell research. Patenting of stem cells: Insights in to the U.K. Patent Office, USPTO and the EPO. Investing in stem cells. How best to set up a stem cell enterprise. Lessons learnt from the Korean controversy. Hear From The Experts Human Fertilisation & Embryology Authority UK Stem Cell Foundation Biotechnology and Biological Sciences Research Council The Royal Society Genetics Policy Institute International Federation for Cell Biology Wellcome Trust Cancer Research BioMedES Hinxton Group Merlin Biosciences Ltd Axordia ReNeuron Cardio3 Plasticell London Regenerative Medicine Network European Commission U.K. Patent Office European Patent Office University of Cambridge Oxford University Kings College London Bird & Bird Ulys Lehman,Lee & Xu Sterne,Kessler,Goldstein & Fox LLC Marks & Clerk Kilburn & Strode Taylor Wessing Bristows Reed Smith Stem Cells The First Ever Comprehensive and International Expert Guide to the Regulation and Commercialisation of Stem Cell Technology C5 has brought together expert authorities from the international stem cell industry to impart to you key knowledge on: CONFERENCE CO-CHAIRED BY: Sir Richard Gardner Professor, Oxford University Chair of the Royal Society Working Group on Stem Cell Research and Cloning, The Royal Society Media Partners: 27th & 28th November 2006 Harrington Hall, Kensington, London Key insights from the Human Fertilisation & Embryology Authority, U.K. Patent Office, European Commission and the EPO Europe’s Premier IP Conference Organiser To register call +44 20 7878 6888...or fax +44 20 7878 6885... or visit our website at www.C5-Online.com/stemcells Law Society C5’s International Symposium on Patenting, Regulating and Commercialising International Rountable Discussion on Global Regulation Endorsed By:

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Page 1: R In G D R Stem Cells - Reed Smith · 2017-04-03 · Dr Paul Gerskowitch CEO,Axordia 13.0 CPD • The latest developments in the science of stem cell technology. • The regulation

Dr Paul GerskowitchCEO,Axordia

CPD13.0

• The latest developments in the science of stem cell technology.

• The regulation of stem cells in the U.K. U.S.,Europe and China.

• How to effectively secure a licence from the Human Fertilisation and EmbryologyAuthority for stem cell research.

• How to secure funding for stem cell research.

• Patenting of stem cells: Insights in to the U.K.Patent Office, USPTO and the EPO.

• Investing in stem cells.

• How best to set up a stem cell enterprise.

• Lessons learnt from the Korean controversy.

Hear From TheExperts

Human Fertilisation &Embryology Author ity

UK Stem Cell Foundation

Biotechnology andBiological Sciences

Research Council

The Royal Society

Genetics Policy Institute

International Federationfor Cell Biology

Wellcome Trust

Cancer Research

BioMedES

Hinxton Group

Merlin Biosciences Ltd

Axordia

ReNeuron

Cardio3

Plasticell

London RegenerativeMedicine Network

European Commission

U.K. Patent Office

European Patent Office

University of Cambr idge

Oxford University

Kings College London

Bird & Bird

Ulys

Lehman,Lee & Xu

Sterne,Kessler,Goldstein& Fox LLC

Marks & Clerk

Kilburn & Strode

Taylor Wessing

Br istows

Reed Smith

Stem CellsThe First Ever Comprehensive and International Expert Guide to the Regulation and Commercialisationof Stem Cell Technology

CC55 hhaass bbrroouugghhtt ttooggeetthheerr eexxppeerrtt aauutthhoorriittiieess ffrroomm tthhee iinntteerrnnaattiioonnaall sstteemm cceelllliinndduussttrryy ttoo iimmppaarrtt ttoo yyoouu kkeeyy kknnoowwlleeddggee oonn::

CONFERENCE CO-CHAIRED BY:

Sir Richard GardnerProfessor,Oxford UniversityChair of the Royal Society Working Group on Stem CellResearch and Cloning,The Royal Society

Media Partners:

27th & 28th November 2006 • Harrington Hall, Kensington, London

KKeeyy iinnssiigghhttss ffrroomm tthhee HHuummaann FFeerrttiilliissaattiioonn && EEmmbbrryyoollooggyy AAuutthhoorriittyy,,UU..KK.. PPaatteenntt OOffffiiccee,, EEuurrooppeeaann CCoommmmiissssiioonn aanndd tthhee EEPPOO

Europe’s Premier IPConference Organiser

To register call +44 20 7878 6888...or fax +44 20 7878 6885... or visit our website at www.C5-Online.com/stemcells

Law Society

C5’s International Symposium on Patenting,Regulating and Commercialising

International

Rountable Discussion

on Global Regulation

Endorsed By:

Page 2: R In G D R Stem Cells - Reed Smith · 2017-04-03 · Dr Paul Gerskowitch CEO,Axordia 13.0 CPD • The latest developments in the science of stem cell technology. • The regulation

To register call +44 20 7878 6888...or fax +44 20 7878 6885...or visit our website at www.C5-Online.com/stemcells

Stem cells are headline news, from the Korean scandalinvolving Dr Hwang and Presidents Bush’s veto of U.S. federalfunding for embryonic stem cell research to the recent BrusselsAgreement which provides for stem cell funding from the E.U.Seven Research Programme. It is evident that the internationalcommunity is fragmented in its approach to stem cells as thereis much controversy surrounding their source and use. Yetprivate investment is on the increase and stem cell technologyis evolving. As a consequence of the different positions beingtaken by different states we find ourselves within a complexpredicament where the stem cell industry is having to developinside a global patchwork of politics, regulation and funding.

CC55’’ss IInntteerrnnaattiioonnaall SSyymmppoossiiuumm oonn PPaatteennttiinngg,, RReegguullaattiinngg aannddCCoommmmeerrcciiaalliissiinngg SStteemm CCeellllss has been developed and designedffoorr tthhoossee iinnvvoollvveedd iinn oorr,, tthhoossee tthhiinnkkiinngg ooff ggeettttiinngg iinnvvoollvveedd iinntthhee sstteemm cceellll iinndduussttrryy aanndd tthheeiirr aaddvviissoorrss. It will guide youthrough the complexities of stem cell regulation, patentabilityand commercialisation. You will be provided with a step bystep exploration of the different regulatory environmentsacross the globe and its implications for the stem cell industry.You will be advised on the commercialisation process fromhow to obtain a license and funding to carry out stem cellresearch through to ultimate commercialisation.

We have brought together an outstanding panel of speakersfrom different stem cell backgrounds including RReegguullaattoorrss,,IInndduussttrriiaalliissttss,, LLaawwyyeerrss,, SScciieennttiissttss,, AAccaaddeemmiiccss aanndd IInnssttiittuuttiioonnaallRReepprreesseennttaattiivveess to ensure that you are able to gain from theleading experts in the U.K, U.S., Europe and the Far East firsthand knowledge about the law and business of stem cells. At this conference you will have experts impart to you theirunderstandings and insights in to:

• New business models that can be used to develop stem cell commerce

• What difficulties are facing those trying to start up a stemcell venture and how to overcome them

• The real risks of investing in stem cells and how to minimise them

• The Intellectual property implications when you depositstem cell lines with the Stem Cell Bank

• To what extent are stem cells patentable in the U.S. U.K.and in Europe

• The regulation of stem cells in Spain, France, Germany and China

CC55''ss International Symposium on Patenting, Regulating andCommercialising Stem Cells is fully dedicated to supplying youwith the indispensable knowledge that will better prepare youfor this new industry, highlighting the obstacles and providingyou with solutions.

Don’t miss this opportunity to learn from the experts andnetwork with key stem cell professionals and institutions.

TThhee ccoonnffeerreennccee iiss bbeeiinngg ccoo--cchhaaiirreedd bbyy SSiirr RRiicchhaarrdd GGaarrddnneerr((OOxxffoorrdd UUnniivveerrssiittyy // TThhee RRooyyaall SSoocciieettyy)) aanndd DDrr PPaauullGGeerrsskkoowwiittcchh ((AAxxoorrddiiaa)).

NNoottaabbllee ssppeeaakkeerrss iinncclluuddee:: PPrrooffeessssoorr SSiirr CChhrriissttoopphheerr EEvveennssOOBBEE ((MMeerrlliinn BBiioosscciieenncceess LLttdd//UU..KK.. SStteemm CCeellll FFoouunnddaattiioonn)),,BBeerrnnaarrdd SSiieeggeell ((GGeenneettiiccss PPoolliiccyy IInnssttiittuuttee UU..SS..)),, DDrr SStteepphheennMMiinnggeerr (( KKiinnggss CCoolllleeggee LLoonnddoonn// LLoonnddoonn RReeggeenneerraattiivveeMMeeddiicciinnee NNeettwwoorrkk)),, EEvvee HHaarroolldd (( AAuutthhoorr ooff ‘‘TThhee SStteemm CCeellllWWaarrss’’)),, AAnnggeellaa MMccNNaabb (( HHuummaann FFeerrttiilliissaattiioonn aanndd EEmmbbrryyoollooggyyAAuutthhoorriittyy)),, MMiicchhaaeell HHuunntt ((RReeNNeeuurroonn))..

Special features of the symposium include:

A) ‘‘IInntteerrnnaattiioonnaall RRoouunndd TTaabbllee DDiissccuussssiioonn’’ in which Lawyers,Scientists and Regulators discuss differences in ethics and values with regards to stem cells, culminating in a examination of the lack of and the need for ainternational consensus.

(B) ‘‘PPaanneell DDiissccuussssiioonn wwiitthh EExxppeerrtt PPaatteenntt AAttttoorrnneeyyss who willreview and recommend international patenting strategiesfor the patenting of stem cells.

(C) ‘‘AAddvviissoorryy CCoommmmiitttteeee ffoorr tthhee IInntteelllliiggeenntt CCoommmmeerrcciiaalliissaattiioonnooff SStteemm CCeellll IInnnnoovvaattiioonnss’’ who will advise on what legal,financial and geographical aspects you need to take intoaccount for a successful stem cell venture.

Take this opportunity to hear from and network with industryleaders, top experts and colleagues. Be at this groundbreaking event on 27th and 28th November. Register now tosecure your place at this event by calling ++ 4444 2200 77887788 66888888or on line at wwwwww..cc55--oonnlliinnee..ccoomm//sstteemmcceellllss

Patenting, Regulating and Commercialising Stem Cells

SSPPOONNSSOORRSSHHIIPP AANNDD EEXXHHIIBBIITTIIOONN OOPPPPOORRTTUUNNIITTIIEESS AATT TTHHIISS EEVVEENNTTCC55 is a name synonymous with the Parma and Biotech Industries. Our intimate and authoritative knowledge of the market enables

CC55 to offer tailored marketing packages to meet your business objectives. Whether you want to influence prospective clients, projectyour brand profile or cement existing relationships, CC55 offers unrivalled access to the decision makers that really matter to you.

For a professional appraisal of the packages that best suit your firms objectives including networking and pre-arranges face-to-face meeting opportunities, branding and sponsorship, please contact

MMeellaanniiee PPuuttzzkkii on ++4444 ((00)) 2200 77887788 66887700 or email mm..ppuuttzzkkii@@CC55--OOnnlliinnee..ccoomm

Page 3: R In G D R Stem Cells - Reed Smith · 2017-04-03 · Dr Paul Gerskowitch CEO,Axordia 13.0 CPD • The latest developments in the science of stem cell technology. • The regulation

- increasing knowledge in what areas ?- developing what new techniques ?

• What are the responsibilities and powers of :- the Human Fertilisation and Embryology Authority- the UK Stem Cell Bank- the Human Tissue Authority

• Where are there ambiguities or uncertainties? - is basic cellular research permitted using embryos

and stem cells • What regulatory changes are in the pipeline?

- implementation of the Human Tissue Act 2004 - EU Tissue Directive 2004/23/EC and

subsequent Directives• Is international harmonisation possible?

1111..4455 HHooww ttoo UUssee FFeeddeerraall RReegguullaattiioonn ttoo YYoouurr AAddvvaannttaaggee

BBeerrnnaarrdd SSiieeggeellLawyer and Founder, GGeenneettiiccss PPoolliiccyy IInnssttiittuuttee ((UU..SS..))• Stem cell policy and politics in the USA. • Federal regulation and funding of stem cell research• Cloning and the FDA• Legislative bans and regulation • Michigan, Louisiana, Indiana, California, Illinois,

Florida, Texas• What is the impact upon investors and researchers

as a result of the fragmented regulation of stem cellresearch in the 50 states?

1122..1155 TThhee EEuurrooppeeaann LLeeggaall FFrraammeewwoorrkk ffoorrPPaatteennttaabbiilliittyy aanndd RReegguullaattiioonn ooff SStteemm CCeellllss::FFooccuuss oonn GGeerrmmaannyy,, SSppaaiinn aanndd FFrraannccee

MMrr.. PPaauull VVaann ddeenn BBuullcckkPartner, UUllyyss ((BBeellggiiuumm))• Which kind of stem cells may raise problem in Europe

and why? • What is the European legal framework? • What are the national continental legal frameworks?

- Germany- Spain - France

• What are the principles concerning the patentability in Europe? - The position of the Commission? - The position of the European Patent Office? - What is the position of the national continental states,

Germany, Spain and France

1122..4455 DDooiinngg SStteemm CCeellll RReesseeaarrcchh aanndd BBuussiinneessss iinn CChhiinnaa.. TThhee CCuurrrreenntt LLeeggaall FFrraammeewwoorrkk

EEddwwaarrdd LLeehhmmaannPartner, LLeehhmmaann,, LLeeee && XXuu.. ((CChhiinnaa))• Regulation of adult and embryonic stem cells

- the laws specifically created to govern stem cell research- other laws that are directly relevant and impact

on stem cell research • Enforcement

- who is enforcing the law- how is it being enforced- its effectiveness.

• How to effectively obtain patents for stem cells in China. • Protection of IP in china and its implications for stem

cell technology• Reforms

11..1155 IInnssiiddee tthhee KKoorreeaann CClloonniinngg SSccaannddaall.. LLeessssoonnss ffoorr SScciieennttiiffiicc IInntteeggrriittyy iinn aa GGlloobbaallRReesseeaarrcchh EEnnvviirroonnmmeenntt

To register call +44 20 7878 6888... or fax +44 20 7878 6885... or visit our website at www.C5-Online.com/stemcells

2277 NNoovveemmbbeerr 22000066

88::3300 RReeggiissttrraattiioonn aanndd CCooffffeeee Q99::0000 CChhaaiirr’’ss OOppeenniinngg RReemmaarrkkss

SSiirr RRiicchhaarrdd GGaarrddnneerrProfessorOOxxffoorrdd UUnniivveerrssiittyy//TThhee RRooyyaall SSoocciieettyy

99..1155 KKeeyynnoottee SSppeeeecchh TThhee LLaaww aanndd EEccoonnoommiiccss ooff SStteemm CCeellllss

SSiirr RRiicchhaarrdd GGaarrddnneerrProfessorOOxxffoorrdd UUnniivveerrssiittyy//TThhee RRooyyaall SSoocciieettyy

99..4455 HHaarrmmoonniissaattiioonn:: IIss TThheeiirr AAnnyy OOtthheerr OOppttiioonn??

In this international roundtable discussion lawyers, regulatorsand scientists will address the most pressing issues arisingfrom the lack of uniformity in the regulation of stem cells.

PPaanneell MMooddeerraattoorr::PPrrooff DDeennyyss WWhheeaattllyy Secretary General, IInntteerrnnaattiioonnaall FFeeddeerraattiioonn ffoorr CCeellll BBiioollooggyyDirector, BBiiooMMeeddEESSPPrrooffeessssoorr AAnnnnee MMccLLaarreennDevelopmental Biologist, MMeemmbbeerr ooff tthhee HHiinnxxttoonn GGrroouupp..,,WWeellllccoommee TTrruusstt,, CCaanncceerr RReesseeaarrcchh UUKK,, GGuurrddoonn IInnssttiittuuttee,,UUnniivveerrssiittyy ooff CCaammbbrriiddggeeBBeerrnnaarrdd SSiieeggeellLawyer and Founder, GGeenneettiiccss PPoolliiccyy IInnssttiittuuttee ((UU..SS..))MMaauurriizziioo SSaallvvii,, PPhhDD,, Policy Advisor to the President, Head of the EGE Secretariat,EEuurrooppeeaann BBuurreeaauu ooff PPoolliiccyy AAddvviissoorrss.. ((BBEEPPAA)),, EEuurrooppeeaann CCoommmmiissssiioonnDDrr.. SStteepphheenn MMiinnggeerrSenior Lecturer, KKiinnggss CCoolllleeggee LLoonnddoonnDirector, KKiinnggss SStteemm CCeellll BBiioollooggyy LLaabboorraattoorryyFounder, LLoonnddoonn RReeggeenneerraattiivvee MMeeddiicciinnee NNeettwwoorrkk.. ((UU..KK))• The reasons and consequences of fragmentation

of stem cell regulation• Can an effective and efficient stem cell market merely

exist on a national or regional level?• Is a global stem cell industry a reality or a mere

aspiration for the future? • Can a union be achieved?

- how?- will this union merely pay lip-service to the illusion

of unity?- who would enforce such a union?

• The Hinxton Guidelines.- the objectives of the guidelines- are they of any real use?

• What is the E.U.’s position?• Where does the U.N. stand on the issue of harmonisation?• Where do we go from here?

1111..0000 MMoorrnniinngg RReeffrreesshhmmeennttss

1111..1155 TThhee UU..KK..:: AA FFrreeee ZZoonnee ffoorr SStteemm CCeellll VVeennttuurreess??

DDrr.. GGeerrrryy KKaammssttrraaPartner, Joint Head Of International Life Sciences Group,BBiirrdd && BBiirrdd • What is the history behind the current regulatory

framework in the UK?• For what purposes may activities with human stem cells

be currently carried out?

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Page 4: R In G D R Stem Cells - Reed Smith · 2017-04-03 · Dr Paul Gerskowitch CEO,Axordia 13.0 CPD • The latest developments in the science of stem cell technology. • The regulation

EEvvee HHeerroollddDirector of Public Policy, Research & EducationGGeenneettiiccss PPoolliiccyy IInnssttiittuuttee,, aannddAAuutthhoorr,, SStteemm CCeellll WWaarrss:: IInnssiiddee SSttoorriieess ffrroomm tthhee FFrroonnttlliinneess• How common is scientific fraud?

- famous cases of fraud (the Piltdown Man, cold fusion, etc.)- the impact of fraud on their fields of endeavour

• “Could fraud happen at my institution?” • The Korean case• How the cloning fraud was “outed” by Korean

researchers and the Korean media• What evidence put an end to the fraud?

- how the internet was key• What factors made such a huge fraud possible? • How can such fraud be prevented?

11..4455 NNeettwwoorrkkiinngg LLuunncchh

22..4455 GGeettttiinngg tthhee GGrreeeenn LLiigghhtt:: LLiicceennssiinnggAApppplliiccaattiioonnss ffoorr SStteemm CCeellll RReesseeaarrcchh

AAnnggeellaa MMccNNaabbChief Executive, HHuummaann FFeerrttiilliissaattiioonn && EEmmbbrryyoollooggyy AAuutthhoorriittyy• What is the role of the HFEA?

What is the legal framework for licensing embryoresearch in the UK?

• What are the benefits of licensing embryo research?• How does the overall process work?• What is the role of local ethics committees in the

licensing process?• How do peer review and inspections contribute to licensing?• What information is given to the public about research

licence application and progress?• What are the future plans for regulating research?

33..3300 AAfftteerrnnoooonn RReeffrreesshhmmeennttss33..4455 SScciieennccee UUppddaattee

DDrr.. SStteepphheenn MMiinnggeerrSenior Lecturer, KKiinnggss CCoolllleeggee LLoonnddoonnDirector, KKiinnggss SStteemm CCeellll BBiioollooggyy LLaabboorraattoorryyFounder, LLoonnddoonn RReeggeenneerraattiivvee MMeeddiicciinnee NNeettwwoorrkk.. ((UU..KK))..• Stem Cells

- established and new sources- the types of stem cells that exists new and old.

• Therapeutic potential of - "adult" stem cells- embryonic stem cells

• Hurdles to clinical translation- technical,- logistical - regulatory

• Biopolitics of stem cell research – - why the UK is world leader

44..4455 PPrriivvaattee IInnvveessttmmeenntt IInn SStteemm CCeellllss

PPrrooffeessssoorr SSiirr CChhrriissttoopphheerr EEvveennss OOBBEEChairman, MMeerrlliinn BBiioosscciieenncceess LLttddMember of the Board of Trustees, UUKK SStteemm CCeellll FFoouunnddaattiioonn • Analysis of investing in stem cells enterprises

- the pros and cons of investment - the real potential

• Biotech Companies concerns about investing in stem cells• Current and future patterns in private investment• How can investment be increased?

- What governments must do- What scientists must do

55..3300 CChhaaiirrmmaann’’ss CClloossiinngg RReemmaarrkkss && CCoonnffeerreennccee AAddjjoouurrnnss

6888... or fax +44 20 7878 6885... or visit our website at www.C5-Online.com/stemcells

2288 NNoovveemmbbeerr 22000066

99..0000 CChhaaiirrmmaann’’ss OOppeenniinngg RReemmaarrkkss

DDrr.. GGeerrsskkoowwiittcchh CEO, AAxxoorrddiiaa

99..1155 SSuucccceessssffuullllyy PPaatteennttiinngg SStteemm CCeellllss:: KKeeyyIInnssiigghhttss iinn ttoo HHooww ttoo OObbttaaiinn PPaatteennttss ffrroomm tthheeUU..KK.. PPaatteenntt OOffffiiccee,, EEPPOO aanndd tthhee UUSSPPTTOO

CCaarrooll DDaavviieessDeputy Director (Biotechnology and Pharmaceuticals, UU..KK.. PPaatteenntt OOffffiiccee • General patentability requirements for patent protection

in the UKPO • Inventions excluded under the 1977 Patents Act• Implementation of the Biotechnology Directive• Interpretation of the Biotechnology Directive• Patentability of stem cells• Supporting innovation and public morality – the

balancing actDDrr PPiieerrrree TTrreeiicchheell Director of Patent Law, EEuurrooppeeaann PPaatteenntt OOffffiiccee• Current EPO practice as to the patenting of inventions

involving human embryos and human embryonic stem cells• Analysis of concrete examination cases

- Edinburgh- WARF- CIT - Decision T 1374/04 – Referral to the Enlarged Board

of Appeal • The questions pending before the Enlarged Board of Appeal• Consequences for pending applications

- stay of proceedings? - applicability of Rule 23d(c) EPC to pending

applications and to granted patents (opposition)? • Case law of the European Court of Justice • Case law of the European Court of Human Rights • National legislation on research pertaining to human

embryos/hESC • EU-stem cell funding – does this play a role? • Decisions of national patent Offices regarding the "uses of

human embryos for industrial or commercial purposes"• Possible outcome of the EBA proceedings and implicationsMMrr.. RRoobbeerrtt WW.. EEssmmoonnddPartner, SStteerrnnee,, KKeesssslleerr,, GGoollddsstteeiinn && FFooxx PP..LL..LL..CC• Are stem cells and methods using stem cells patentable

in the United States?• What are the particular requirements under U.S. law?• What is the extent of existing stem cell patenting in the U.S.?• Will existing stem cell patents block the development

of stem cell therapies in the United States? • Assuming licenses are available, how many will be required?• Does U.S. law exempt from infringement clinical trials

with stem cells?• Is establishment of a patent pool for stem cells the answer?

1100..4455 EEffffeeccttiivvee IInntteerrnnaattiioonnaall PPaatteennttiinngg SSttrraatteeggiieess ffoorrPPaatteennttiinngg SStteemm CCeellllss:: AA CCoommppaarraattiivvee AApppprrooaacchh

PPaanneell MMooddeerraattoorr::GGaarreetthh WWiilllliiaammssPartner, MMaarrkkss && CClleerrkkPPaauull CChhaappmmaannPartner, KKiillbbuurrnn && SSttrrooddeeMMrr.. RRoobbeerrtt WW.. EEssmmoonnddPartner, SStteerrnnee,, KKeesssslleerr,, GGoollddsstteeiinn && FFooxx PP..LL..LL..CC• Key points regarding patentability of stem cell-related

inventions in US / EPO / UKPane

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Page 5: R In G D R Stem Cells - Reed Smith · 2017-04-03 · Dr Paul Gerskowitch CEO,Axordia 13.0 CPD • The latest developments in the science of stem cell technology. • The regulation

• What is the extent of existing stem cell patenting in the three jurisdictions?

• Will clinical trials infringe patent rights in the US / EU / UK?• Will third party rights block the development of

stem cell therapies?• If so, are the main patents vulnerable to attack?

Would patent pooling be the answer?• What patenting strategies should be used to ensure

the broadest coverage?

1111..1155 MMoorrnniinngg RReeffrreesshhmmeennttss

1111..3300 DDeeppoossiittiinngg CCeellllss WWiitthh tthhee SStteemm CCeellll BBaannkk::TThhee MMaaiinn IImmpplliiccaattiioonnss ffoorr IIPPRR HHoollddeerrss

GGaarreetthh MMoorrggaannSenior Associate, TTaayylloorr WWeessssiinngg• What IPR exist in the cell line • What is the UK Stem Cell Bank • Who runs it and who uses it • What are the advantages and disadvantages of deposit • How is the ownership of IPR managed by the UK Stem

Cell Bank • What options do potential donors have • What is the scope of the licence given to users • Opportunities for further licensing, i.e. what other rights

could a donor hold back

1122..1155 RReegguullaattoorryy IInntteerraaccttiioonnss;; AAnn OOvveerrvviieeww ooff PPhhaarrmmaa aanndd BBiiootteecchh LLaaww aanndd WWhheerree SStteemm CCeellll RReegguullaattiioonn FFiittss

PPeennnnyy GGiillbbeerrtt Partner, BBrriissttoowwss ((UU..KK..))GGeeoorrggee PPiicckkeerriinnggSenior Associate, RReeeedd SSmmiitthh ((UU..KK..))• The ‘Community Code on Medicinal Products for

Human Use’ explained• Proposed Regulation on Advanced Therapy

Medicinal Products • Scope of the new regime and product classification issues • Impact of the proposed regime on development

of stem cell therapies• Human Tissue Act 2004• EU Directives on Human Tissues, Cells and Blood Products• EU Directive on in vitro diagnostic and medical devices

as it applies to stem cells

11..0000 NNeettwwoorrkkiinngg LLuunncchh

22..0000 WWhheerree aanndd HHooww ttoo GGeett YYoouurr HHaannddss oonn FFuunnddiinngg

BBiiootteecchhnnoollooggyy && BBiioollooggiiccaall SScciieenncceess RReesseeaarrcchh CCoouunncciill,,Speaker TBC • Where to look for stem cell research funding

- who is currently providing funding?- what purposes is the funding being made available for?- who can apply for the funding?

• Making successful funding applications • After the research, securing funding for a start up

22..4455 AAddvviissoorryy CCoommmmiitttteeee:: IInntteelllliiggeennttCCoommmmeerrcciiaalliissaattiioonn ooff SStteemm CCeellll IInnnnoovvaattiioonnss

This advisory committee will impart expert advice on how to best go about setting up a sustainable stem cell venture. It will advise on the legal and commercial considerationsthat need to be taken into account. Experienced stem cellindustrialists will impart to you their experiences, thedifficulties that they have encountered and how best toovercome them.

t www.C5-Online.com/stemcells ©C5, 2006

PPaanneell MMooddeerraattoorr::JJoohhnn WWiillkkiinnssoonnPartner, RReeeedd SSmmiitthh ((UU..KK..))MMiicchhaaeell HHuunnttCEO, RReeNNeeuurroonn ((UU..KK..))IIkkee LLeeeeDirector, CCaarrddiioo33 ((BBeellggiiuumm))DDrr.. RRaapphhaaeell GGoorrooddeettsskkyy,, PPhhDD,,Chief Scientist, HHaappttoo BBiiootteecchh LLttdd ((IIssrraaeell))Head of Biotechnology and Radiobiology Labs,SShhaarreetttt IInnssttiittuuttee ooff OOnnccoollooggyy ((IIssrraaeell))Hadassah, HHeebbrreeww UUnniivveerrssiittyy MMeeddiiccaall CCeennttrree,, ((IIssrraaeell))• Choosing the Business Model

- understanding the potential of the opportunity- understanding the range of rights that protect the

innovation- issues raised by autologous vs allogeneic tissue- understanding the advantages and disadvantages

of certain jurisdictions• Practicality of Commercialisation

- problems encountered by members of the industry- possible restrictions on scope of use- control of materials transferred- issues raised by a treatment requiring processing- quality issues in respect of processing- regulatory issues

• Policing Rights

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various stem cell technology platforms? • What are the business models which are being pursued

by various players in the field? • What are the risks inherent in these business models? • What will be the upside if these models prove successful? • Is there a business model that offers investors minimal

risk and maximum upside?

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Page 6: R In G D R Stem Cells - Reed Smith · 2017-04-03 · Dr Paul Gerskowitch CEO,Axordia 13.0 CPD • The latest developments in the science of stem cell technology. • The regulation

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