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9th Biosimilars
          Implementing clinical, legal, regulatory and developmental strategies for
                              biosimilar safety and acceptance


       5th - 7th October 2011, Thistle City Barbican, London, UK                                                                            BOOK NOW!

  Key Speakers
  Dr. Ulrike Jägle, Senior Manager R&D Policy, Global Public Affairs, Novartis
  Dr Ian Hudson, Director of Licensing, MHRA
  Dr Angela Thomas, Chair of Biologicals and Vaccines Expert Advisory Group-Comission on Human Medicines, MHRA
  Dr Meenu Wadhwa, Leader Cytokine & Growth Factors Section, National Institute for Biological
  Standards and Control
  Fredrik Sundberg, Global Director, Strategic Market Development, GE Healthcare
  Dr Sandy Eisen, Chief Medical Officer, Frontline Pharma Consulting
  Annie Hubert, Director European Government and Public Affairs, Amgen
  Dr Frank Moffart, Business Developments Emerging Markets, Solvias
  Dr Steinar Madsen, Medical Director, Department of Drug Information, Norweigan Medicines Agency
  Dr Anita O’Connor, Senior Director Biopharmaceuticals, Celerion
  Dr Lincoln Tsang, Partner, FDA & healthcare-Arnold & Porter LLP
  Sebastian Moore, Partner, IP-Herbert Smith LLP
  Dr Carsten Brockmeyer, Biosimilars Expert & Managing Director, Brockmeyer Biopharma
  Kristie Khul, Senior VP, Health, Markovsky + Company
  Dr Jean-Yves le Cotonnec, CEO, Triskel Integrated Services
  Anna Valeri, Non-Clinical Assessor, MHRA
  Geoff Hale, Chief Sciene Officer, Merck Millipore

                                               Pre-conference Workshop, Wednesday 5th October, 2011
               Assessing regulatory challenges: US and Europe Perspectives and Update on current regulation situation
           Led by: Dr. Angela Thomas, Chair of Biologicals and Vaccines Expert Advisory Group-Comission on Human Medicines, MHRA &
                                      Dr Anita O’Connor, Managing Partner, Anita O’Connor Consulting



Gold Sponsor                            Silver Sponsor                                            Associate Sponsor

                                                                                                                                                  Organised By
                                          Driving the Industry Forward | www.futurepharmaus.com
                                                                                                                        BioPharm
Media Partners                                                                                                          Insight
                                                                                                                An Infinata BioPharm Solution




       To Book Call: +44 (0) 20 7336 6100 | www.visiongain.com/biosimilars
Conference Introduction
                                                                                                                      9th Biosimilars
                                                                                                 5th - 7th October 2011, London, UK

Dear Colleague,                                                                                    Gold Sponsor:
	 	 iopharmaceuticals	are	an	essential	therapeutic	option	accounting	for	a	substantial	
  B                                                                                                                   Merck	Millipore	is	the	Life	Science	division	of	Merck	KGaA	of	Germany	and	offers	a	
                                                                                                                      broad	range	of	innovative,	performance	products,	services	and	business	relationships	
  part	of	the	global	therapeutic	market.	With	the	patents	of	many	blockbuster	drugs	                                  that	enable	our	customers’	success	in	research,	development	and	production	of	
  coming	to	an	end,	an	opportunity	has	arisen	for	the	manufacture	and	approval	of	                                    biotech	and	pharmaceutical	drug	therapies.	Through	dedicated	collaboration	on	
  biosimilars.                                                                                                        new	scientific	and	engineering	insights,	and	as	one	of	the	top	three	R&D	investors	
                                                                                                                      in	the	Life	Science	Tools	industry,	Merck	Millipore	serves	as	a	strategic	partner	to	
	 	n	a	climate	where	the	ever-increasing	healthcare	costs	are	a	concern,	biosimilars	
  I                                                                                                                   customers	and	helps	advance	the	promise	of	life	science.	Headquartered	in	Billerica,	
  are	 promising	 to	 increase	 access	 to	 essential	 drugs,	 lower	 treatment	 costs	 and	       Massachusetts,	the	division	has	around	10,000	employees,	operations	in	64	countries	and	pro	forma	
  provide	savings	to	the	healthcare	systems.	                                                      2009	revenues	of	$2.9	billion.	Merck	Millipore	operates	as	EMD	Millipore	in	the	U.S.	and	Canada.
	 	 isiongain’s	 9th	 Biosimilars	 Conference	 will	 look	 at	 the	 multiple	 facets	 of	
  V                                                                                                For further information please visit: www.merckmillipore.com
  biosimilars,	 ranging	 from	 the	 evolving	 regulatory	 landscape	 and	 challenges	              Silver Sponsor:
  in	 clinical	 development,	 to	 the	 legal	 and	 economic	 aspects.	 By	 attending	 this	                                  At	Pfizer,	we	apply	science	and	our	global	resources	to	improve	health	and	
  conference	you	will	gain	a	comprehensive	outlook	on	the	key	issues	surrounding	                                            well-being	at	every	stage	of	life.	We	strive	to	set	the	standard	for	quality,	safety	
  biosimilars.	Do	not	miss	this	opportunity	to	further	your	knowledge	in	an	interactive	                                     and	value	in	the	discovery,	development	and	manufacturing	of	medicines	for	
                                                                                                                             people	and	animals.	Our	diversified	global	health	care	portfolio	includes	human	
  learning	environment	and	network	with	diverse	leaders	in	the	industry!                                                     and	animal	biologic	and	small	molecule	medicines	and	vaccines,	as	well	as	
                                                                                                   nutritional	products	and	many	of	the	world’s	best-known	consumer	products.	Every	day,	Pfizer	colleagues	
Reasons to register today:                                                                         work	across	developed	and	emerging	markets	to	advance	wellness,	prevention,	treatments	and	cures	that	
                                                                                                   challenge	the	most	feared	diseases	of	our	time.	Consistent	with	our	responsibility	as	the	world’s	leading	
	    •		 valuate	the	emerging	markets:	focus	on	far	east	
        E                                                                                          biopharmaceutical	company,	we	also	collaborate	with	health	care	providers,	governments	and	local	
	    •		 xamine	economic	and	commercial	prospects	
        E                                                                                          communities	to	support	and	expand	access	to	reliable,	affordable	health	care	around	the	world.	For	more	
                                                                                                   than	150	years,	Pfizer	has	worked	to	make	a	difference	for	all	who	rely	on	us.	
	    •		 xplore	the	changing	regulatory	landscape	of	biosimilars	
        E                                                                                          For further information please visit: www.pfizer.com
	    •		 nalyse	comparability	studies:	designing	the	manufacturing	process	and		
        A                                                                                          Assocaite Sponsor:
        preclinical	testing	                                                                                               ORION	Clinical	Services	is	a	European-based	CRO	with	offices	in	UK,	
	    •		 ssess	challenges	in	the	clinical	development	of	biosimilars:	demonstrating		
        A                                                                                                                  Germany,	France,	Australia,	US,	Russia	and	Italy.	We	offer	a	full	range	of	
        efficacy	and	overcoming	immunogenecity	                                                                            services	in	support	of	the	clinical	development	process	including	Strategic	
                                                                                                                           and	operational	regulatory	support;	Monitoring;	Project	Management;	
	    •		 eview	key	issues	such	as	naming,	labelling	and	substitution:	steps	to	ensure		
        R                                                                                                                  Medical	Writing;	Quality	Assurance;	Data	Management	and	Statistics	and	
        patient	safety	in	clinical	practice	                                                       Pharmacovigilance	–	for	both	pre	and	post	authorisation.We	conduct	clinical	research	across	Western,	
                                                                                                   Central	and	Eastern	Europe;	Scandinavia,	USA/Canada,	Australia	and	parts	of	the	Pacific	Rim.	
	    •		dentify	steps	for	securing	acceptance	of	biosimilars	on	to	the	market	
        I                                                                                          For further information please visit: www.orioncro.com
	    •		 ain	insight	in	to	the	clinician’s	perspective:	utilising	biosimilars	and	challenges		
        G
        for	acceptance	(focus	on	monoclonal	antibodies)	                                           Media Partners:
                                                                                                                               PharmiWeb.com	is	the	leading	industry-sponsored	portal	for	the	
	    •		 evelop	post	marketing	surveillance	strategies	
        D
                                                                                                                               pharmaceutical	sector.	Supported	by	most	of	the	leading	pharmaceutical	
	    •		nvestigate	legal	aspects	surrounding	biosimilars:	intellectual	property,	innovation	
        I                                                                                          corporations,	PharmiWeb.com	provides	dynamic	real-time	news,	features,	events	listings	and	
        and	marketing	approval	issues	                                                             international	jobs	to	industry	professionals	across	Europe	and	the	US.	
	    •		 tilise	networking	opportunities	with	diverse	leaders	
        U                                                                                          For further information please email: corporate@pharmiweb.com
	    I	look	forward	to	meeting	you	at	the	conference	                                                                            BIOTECHNOLOGY	EUROPE	is	owned	by	BIOTECHNOLOGY	WORLD.	It	is	
	    Best	regards	                                                                                                               based	and	located	in	Warsaw,	Poland.	Biotechnology	World	was	founded	in	
                                                                                                   2007	to	provide	the	world’s	biotech	and	pharma	information	and	market	to	make	it	universally	accessible	
                                                                                                   and	useful	for	scientific	and	business	processes.	Its	first	step	to	fulfilling	that	mission	was	building	the	
                                                                                                   BIOTECHNOLOGY	EUROPE	platform	that	will	allow	a	quick	spread	of	information	in	different	channels.	
                                                                                                   BIOTECHNOLOGY	EUROPE	offers	companies	completed	internet	public	relations,	publication	and	
                                                                                                   marketing	solutions.	One	of	the	mains	goals	of	BIOTECHNOLOGY	EUROPE	is	to	integrate	the	Biotech	and	
	 Carrie Lancaster                                                                                 Pharma	Sector	in	Europe	to	global	biotechnology,	pharmaceutical	and	life	science	activities.	
     Conference Producer                                                                           For further information please visit: www.biotechnology-europe.com
                                                                                                               Driving the Industry Forward | www.futurepharmaus.com




                                                                                                                              Future	Pharmaceuticals	has	forged	powerful	relationships	with	key	
                                                                                                                              industry	leaders	to	provide	a	platform	for	successful	brand	recognition,	
                                                                                                   and	for	senior	decision-makers	to	have	the	means	to	procure	and	plan	implementation	strategies	
                                                                                                   based	on	the	topics	covered.	Positioned	to	be	an	authoritative	resource	within	top	pharma	
    Who should attend?                                                                             companies	as	well	as	small,	specialty,	and	biotech,	Future	Pharmaceuticals	magazine	is	geared	
                                                                                                   to	create	a	deep	penetration	into	a	highly	targeted	and	responsive	audience,	bridging	the	gap	
    Presidents, Vice Presidents, CEOs, Directors, Heads, Team Leaders, CSOs, Senior
                                                                                                   between	the	industries’	top	issues	and	the	solutions	top-tier	vendors	can	provide.	
    Managers, Senior Business Developers, Researchers, Parteners & Consultants
    involved in:                                                                                   For further information please visit: www.futurepharmaus.com
    Biosimilars/Follow-on Biologics/Follow-on Proteins                                                                                                                 InPharm	is	the	online	platform	for	exclusive	pharmaceutical	news,	
    Biologics/Biopharmaceuticals/Biogenerics/Biotechnology                                                                                                             comment,	contracts,	services,	jobs	and	events	and	is	home	to	
    Clinical Immunology                                                                                                                                                InPharmjobs.com,	Pharmafile	and	Pharmafocus.	
    Drug Safety                                                                                    For further information please visit: www.inpharm.com
    Patient Safety                                                                                             BioPharm     The	leading	provider	of	intelligence	to	the	biopharma	industry.	Detailed	
    Regulatory Affairs                                                                                         Insight      company	profiles;	investigational	&	approved	drugs;	contact	info;	product	
                                                                                                       An Infinata BioPharm Solution
    Quality Assurance/Quality Control                                                                                       forecasts;	and	exclusive	editorial	intelligence.	Our	proprietary	journalists	cover	
    Scientific Affairs                                                                             the	most	important	situations	taking	place	in	the	life	sciences	industry,	providing	forward	looking	insight	
    Pharmacovigilance                                                                              into	drug	pipelines,	upcoming	litigation,	drug	licensing	deals,	and	mergers	&	acquisitions.	
    Research and Development                                                                       For further information please visit: www.biopharminsight.com
    Process Science & Manufacturing
    Analytical Characterization
    Business Development
    New Product Development
    Commercial Affairs                                                                             Sponsorship and exhibition opportunities
    Legal Affairs                                                                                  This	event	offers	a	unique	opportunity	to	meet	and	do	business	with	some	of	the	key	players	in	
                                                                                                   the	pharmaceutical	and	biotech	industries.	If	you	have	a	service	or	product	to	promote,	you	can	
    Intellectual Property                                                                          do	so	at	this	event	by:	
    Patent Law                                                                                     •	Hosting	a	networking	drinks	reception		
    Regulatory Compliance                                                                          •	Taking	an	exhibition	space	at	the	conference		
    Health Economics                                                                               •	Advertising	in	the	delegate	documentation	pack		
    Pricing and Reimbursement                                                                      •	Providing	branded	bags,	pens,	gifts,	etc.
    Marketing and Sales                                                                            If	you	would	like	more	information	on	the	range	of	sponsorship	or	exhibition	possibilities	for	
                                                                                                   visiongain's	9th	Biosimilars	Conference,	please	contact	us:
    Branded and Generic Pharmaceutical Companies, Contract Research
    Organisations/ Contract Manufacturing Organisations, Drug Regulators,                          Damian Gorman, +44 (0)20 7549 9934
    Academics & Government                                                                         damian.gorman@visiongainglobal.com
Pre-Conference Interactive Workshop
                                                                                                             9th Biosimilars
                                                                                                Wednesday 5th October 2011


    Assessing regulatory challenges: US and Europe Perspectives and
                 Update on current regulation situation

Led by:           Dr. Angela Thomas                               Dr Anita O’Connor                    Timings:		 	 9:30	-	10:00	 Coffee	&	Registration	
                                                                                                                  0
                  Chair	of	Biologicals	and	Vaccines	Expert	       Managing	Partner	                               10:00	- 	17:00	 Workshop
                  Advisory	Group-Comission	on	Human	              Anita O’Connor Consulting            	             T
                                                                                                                     	 iming	includes	lunch	and	refreshment	breaks
                  Medicines	
                  MHRA




About the workshop:                                                                    About your workshop leaders:
The purpose of the workshop is to allow you to engage in                               Dr Angela Thomas MB BS PhD FRCPE FRCPath FRCPCH
knowledge sharing with your peers in a smaller, less formal                            Dr Angela Thomas MB BS PhD FRCPE FRCPath FRCPCH, is Consultant
environment than the main conference. As such, the audience                            Paediatric Haematologist at the Royal Hospital for Sick Children in Edinburgh.
size will typically be no more than 20 participants in order to
enable maximum interaction between the workshop leaders                                After qualifying in Medicine from the University of London in 1980, Angela
and the delegates. The format is also more interactive, with                           trained in general medicine and then adult haematology, subsequently
less emphasis on ‘lecture-style’ presentations and more                                developing a special interest in paediatrics. She was a fellow in molecular
emphasis on group discussions, exercises and Q&A sessions.                             biology at University College London and was awarded a PhD on Genetic
                                                                                       Variation of the Fibrinogen Gene.
Agenda:                                                                                Angela was appointed in 1992 as a consultant paediatric haematologist
                                                                                       at the Royal Hospital for Sick Children in Edinburgh and is co-director of
The EU
                                                                                       the Haemophilia Centre at the Edinburgh Royal Infirmary with specific
• The introduction of biosimilars                                                      responsibility for paediatrics. She cares for children with a wide range of
• Lessons learned                                                                      haematological disorders, including those with leukaemia, immune deficiency,
• The changing Paradigm                                                                haemolytic anaemias and bleeding disorders. She has a special interest in
                                                                                       the education of paediatricians in the varied presentation of haematological
• New developments on the Horizon
                                                                                       disease, particularly bleeding disorders presenting as possible non-accidental
The US                                                                                 injury.
• The recent introduction of biosimilar legislation in the US                          In addition to her clinical post, Angela is a member of the Commission for
• The basics of the US legislation                                                     Human Medicines (CHM) and chairs its Biologicals and Vaccines Expert
                                                                                       Advisory Group. The CHM advises on the quality, safety and efficacy of human
• New developments since the law was passed
                                                                                       medicinal products and advises the Licensing Authority on the granting
• Challenges to expect in the future

The regulatory challenges for Biosimilar Medicines in the UK
                                                                                       Anita O’Connor
• European guidance
                                                                                       Anita O’Connor, PhD, is the Senior Director for Biopharmaceuticals at Celerion.
• How similar does similar have to be                                                  Anita is responsible for the leadership of biopharmaceutical and biosimilar
• Experience to date                                                                   drug development projects and programs for Celerion. She advises clients on
                                                                                       the pivotal elements and regulatory strategy needed for approval of biosimilar
                                                                                       and innovator biopharmaceuticals for the EU and US markets.
                                                                                       Prior to joining Celerion in 2008 Anita founded ANITA OCONNOR
                                                                                       CONSULTING, LLC, where she advised clients from the pharmaceutical and
About visiongain:                                                                      financial industry on small and large molecule development. From 1989
Visiongain is a specialist business information company focused on providing cutting   to 2005, Anita worked for the US FDA in the Center for Biologics (CBER),
edge products and services across the Pharmaceutical/Biotech, Telecommunications,      the Center for Drugs (CDER), the Center for Veterinary Medicine (CVM),
Defence and Finance sectors, which include reports, conferences, online daily
news and offline news analysis and bespoke consultancy. With a commitment
                                                                                       the Center for Food Safety (CFSAN) and the Office of the Commissioner
to innovation and excellence, visiongain offers flexible solutions to meet our         (OC). As an FDA pharmacologist she worked on the submissions of several
clients’ business intelligence needs, providing the right information at the right     blockbuster biopharmaceuticals to include Orencia®, Avastin®, Kepivance®,
time to facilitate the commercial decision-making process. Our pharmaceutical          Remicade®, Remaira®, and Rituxan®. She also reviewed vaccine and
products include Pharma Business Daily, the leading daily email newsletter for the     blood product INDs and BLAs. Other FDA experience extends to food safety,
pharmaceutical, biotech and healthcare industries, and a range of independent,         animal drugs, women’s health, medical devices, and regulatory science policy.
high-quality, in-depth reports covering focused and topical areas of concern.          During her tenure at FDA, Dr. O’Connor was detailed to the US House of
Our pharmaceutical conferences address the hottest commercial, regulatory              Representatives to work on food safety and biotechnology issues for House
and technical topics and provide an ideal forum for debate and networking for
                                                                                       Agriculture committee. In 2008, she wrote a chapter for a reference book on
pharmaceutical professionals from around the world.
                                                                                       the preclinical development of biopharmaceuticals. She speaks and writes
For further information, please visit: www.visiongain.com                              frequently on biopharmaceuticals and biosimilars.
Day 1
                                                                                                                                                    9th Biosimilars
                                                                                                                                        Thursday 6th October 2011

	
    09:00              Registration and refreshments                                                              12:40         Networking lunch


    09:30              Opening address from the chair                                                             13:40         Overview of legal issues
                                                                                                                  	             •	Overview	of	the	European	regulatory	pathway

                                                                                                                  	             •	The	legislative	and	policy	developments	for	biosimilars
    09:40              Biosimilars: challenges and choices in developing
                       a biosimilars business                                                                     	             •	Standards	for	approval
    	                •	Rewards	&	Risks                                                                          	            •	Protection	for	the	innovators	rights
    	                •	The	story	so	far	–	what	is	known?                                                                             Dr Lincoln Tsang
    	                 •	Definitions                                                                                                   Partner	
          CASE STUDY




    	                 •	Impact	of	globalization                                                                                       Arnold & Porter LLP

    	                •	Major	stake-holders
    	                •	Barriers	and	potential	pitfalls
                                                                                                                  14:20         Biosimilar IP issues in Europe
    	                •	Regulatory	issues	in	comparability
                                                                                                                  	            •		 reedom	to	operate	issues	and	confronting	patents	with	broad	
                                                                                                                                  F
    	                •	Case	studies	highlighting	analytical	CMC	challenges
                                                                                                                                  protection-pitfalls	and	tips
                             Dr Frank Moffatt
                                                                                                                  	             •	Supplementary	Protection	Certificates	and	biosimilars	–	unresolved	issues
                             Product	Manager,	Biopharmaceutical	Analysis	
                             Solvias                                                                                                   Sebastian Moore
                                                                                                                                       Partner,	IP	Group	
                                                                                                                                       Herbert Smith LLP

    10:20              New European legislations and their implications for
                       biologicals including biosimilars                                                          15:00         Afternoon refreshments
    	                  •		 re	there	specific	issues	for	use	of	biologicals,	including	biosimilars	in	
                         A
                         clinical	practice?
    	                 •	INN	prescription	and	applicability	for	biologicals                                       15:20         Biosimilars - a balanced view based on experience
    	                  •		 equirement	of	the	new	pharmacovigilance	directive:	identification		
                         R                                                                                                      from both sides
                         and	traceability
                                                                                                                  	             •		ncreased	patient	access,	supporting	sustainable	healthcare	systems,	
                                                                                                                                  I
    	                  •	Naming	in	the	cross-border	healthcare	directive                                                          commercially	viable	
    	                 •	R&D	based	industry	position	on	biosimilars	healthcare	policies
                                                                                                                  	             •		 roadening	group	of	companies	interested	in	originator	and		
                                                                                                                                  B
                             Annie Hubert                                                                                         biosmilar	biologics	
                             Director,	European	Government	and	Public	Affairs	
                             Amgen                                                                                	             •		 cience-based	and	fair	biosimilar	pathways	
                                                                                                                                  S
                                                                                                                                       Dr. Ulrike Jägle
                                                                                                                                       Senior	Manager	R&D	Policy,	Global	Public	Affairs	
    11:00              Morning refreshments                                                                                            Novartis


    11:20              The changing regulatory landscape of biosimilars: a
                       non-clinical assessor’s perspective                                                        16:00         Presentation to be announced
    	                  •		 hanges	in	the	EU	regulatory	framework
                         C                                                                                                             Dr Jean-Yves le Cotonnec
                                                                                                                                       CEO	
    	                  •		 uality	matters
                         Q
                                                                                                                                       Triskel Integrated Services
    	                  •		 reclinical	issues
                         P
    	                  •		mmunogenicity
                         I
    	                  •		 hoice	of	biomarkers
                         C                                                                                        16:40         Closing remarks from the chair
                             Anna Valeri
                             Non-Clinical	Assessor	
                             MHRA

                                                                                                                  16:50         Networking drinks
    12:00              Presentation to be announced
                                                                                                                                Take your discussions further and build new
                             Geoff Hale                                                                                         relationships in a relaxed and informal setting
                             Chief	Sciene	Officer,	
                             Merck Millipore


                                Due to unforeseen circumstances the programme may change and visiongain reserves the right to alter the venue and/or speakers c Copyright visiongain Ltd, 2011
Day 2
                                                                                                                       9th Biosimilars
                                                                                                             Friday 7th October 2011


09:00             Registration and refreshments                                       12:40   Networking lunch


09:30             Opening address from the chair                                      13:40   Uptake of biosimilars in clinical practice
                                                                                      	       •	What	do	doctors	know	about	biosimilars?
09:40             Insights into biosimilar licensing
                                                                                      	       •	What	are	the	obstacles	to	increased	use?
	                •		 verview	of	current	licensing	process
                    O
                                                                                      	       •	What	do	we	know	about	prices	on	biosimilars?
	                •		 onsidering	the	challenges
                    C
                                                                                      	       •	Who	shall	decide	which	drug	to	use?
	                •		 evelopment	of	licensing	strategies
                    D
                                                                                                    Dr Steinar Madsen
                        Dr Ian Hudson                                                               Medical	director,	Department	of	Drug	Information	
                        Director	of	Licensing	                                                      Norwegian Medicines Agency
                        MHRA

                                                                                      14:20   Safety issues with biosimilars

10:20             Manufacturing issues and comparability                              	       •		 verview	of	safety	issues
                                                                                                O

	                 •	The	technical	aspects                                             	       •		mmunogenicity
                                                                                                I

	                 •	The	business	aspects                                              	       •		 ost	marketing	surveillance
                                                                                                P
     CASE STUDY




	                •		 ase	study:	innovative	approach	for	comparability	testing	of		
                    C                                                                 	       •		 uture	innovation
                                                                                                F
                    biological	products                                                             Dr Sandy Eisen
                        Fredrik Sundberg                                                            Chief	Medical	Officer	
                        Global	Director,	Strategic	Market	Development	                              Frontline Pharma Consulting
                        GE Healthcare

                                                                                      15:00   Afternoon refreshments

11:00             Morning refreshments
                                                                                      15:20   Sponsor Spotlight Session
                                                                                      	       T
                                                                                              	 ake	this	unique	opportunity	to	be	a	part	of	the	conference	theme,		
11:20             Immunogenicity issues with biosimilars
                                                                                              network,	share	ideas	and	provide	an	overview	of	your	product/services		
	                 •	The	importance	of	immunogenicity	issues                                   to	the	audience.	For	more	information	please	contact		
                                                                                              damian.gorman@visiongainglobal.com
	                 •	Strategies	and	methods	for	detection	of	immunogenicity

	                 •	Update
                        Dr Meenu Wadhwa                                               16:00   The development of biosimilar monoclonal
                        Leader,	cytokine	&	Growth	Factors	Section	                            antibodies and other complex molecules
                        National Institute for Biological Standards                   	       •		 onoclonal	antibodies:	context	of	market
                                                                                                M
                        and Control
                                                                                      	       •		 anufacturing	process
                                                                                                M

                                                                                      	       •		 roduct	heterogeneity
                                                                                                P
12:00             Biosimilar market uptake – taking the question
                  out of acceptance                                                   	       •		 tandard	product	characterisation
                                                                                                S

	                •		 xamining	the	business	risks	and	marketplace	opportunities
                    E                                                                 	       •		 iological	comparability
                                                                                                B

	                 •		 easuring	regulators	and	financial	analysts	mandates
                    M                                                                 	       •		 uture	opportunities
                                                                                                F

	                 •		 rojecting	data	and	clinical	confidence
                    P                                                                               Dr Carsten Brockmeyer
                                                                                                    Managing	Director	
	                 •		 racking	health	professional	and	patient		expectations
                    T                                                                               Brockmeyer Biopharma
	                 •		 uilding	an	awareness	and	third-party	advocacy	program
                    B

	                 •		 nderstanding	needed	services	and	communications
                    U                                                                 16:40   Chair’s closing remarks
	                 •		 etting	a	course	for	payers	and	patient	pull-through
                    S
                        Kristie Khul
                                                                                      16:50   End of Conference
                        Senior	VP,	Health	
                        Marlovsky + Company
Registration Form
                                                                                                                                  9th Biosimilars
                                                                                                             5th - 7th October 2011, London, UK


	               	 	 	           	              	               	          	               Conf.	code	PP

Standard Prices                                                                                                   9th Biosimilars
Conference and workshop                            Fee: £1699      VAT: £339.80      Total: £2038.80
                                                                                                                  5th - 7th October 2011
Conference only                                    Fee: £1299      VAT: £259.80      Total: £1558.80
Workshop only                                      Fee: £599       VAT: £119.80      Total: £718.80
                                                                                                                  Location:	Thistle	City	Barbican
Number of bookings:                                                  Total cost:                                  Address:		
                                                                                                                  Central	Street,	Clerkenwell
                                                                                                                  London	
                                                                                                                  EC1V	8DS
Promotional Literature Distribution                                                                               UK
Distribution of your company’s promotional literature to all conference attendees
                                                   Fee: £999       VAT: £199.80      Total: £1198.80

                                                                                                              How to book
Details
                                                                                                              Email:	Piyush.patel@visiongainglobal.com             	
Forename:	                                         Surname:                                                   Web:	http://www.visiongain.com/biosimilars	
                                                                                                              UK Office:
Job	Title:	                                        Company:                                                   Tel: 	+44 (0) 20 7549 9961
                                                                                                              Fax:	+44(0)	20	7549	9932	
Main	Switchboard	Number:                                                                                      Visiongain	Ltd
                                                                                                              230	City	Road	
                                                                                                              London
Address:                                                                                                      EC1V	2QY
                                                                                                              UK
                                                                                                              General information
                                                                                                              Venue:	Thistle	City	Barbican,	Central	Street,	Clerkenwell,	London,	EC1V	8DS,	Phone:	0871	376	9004	/	
Country:	                                          Postcode:                                                  +44	845	305	8304,	Fax:	0871	376	9104	/	+44	845	305	8343
                                                                                                              http://www.thistle.com/en/hotels/united_kingdom/london/thistle_city_barbican/index.html				
Phone:	                                            Fax:                                                       Payment terms:	Visiongain	require	the	full	amount	to	be	paid	before	the	conference.	Visiongain	
                                                                                                              Ltd	may	refuse	entry	to	delegates	who	have	not	paid	their	invoice	in	full.	A	credit	card	guarantee	may	
Email:	                                                                                                       be	requested	if	payment	has	not	been	received	in	full	before	the	event.	Visiongain	Ltd	reserves	the	
                                                                                                              right	to	charge	interest	on	unpaid	invoices.
Signature:                                                                                                    Substitutions/name changes or cancellations: There	is	a	50%	liability	on	all	bookings	once	
                                                                                                              made,	whether	by	post,	fax,	email	or	web.	There	is	a	no	refund	policy	for	cancellations	received	on	or	
I	confirm	that	I	have	read	and	agree	to	the	terms	and	conditions	of	booking                                   after	one	month	before	the	start	of	the	event.	Should	you	decide	to	cancel	after	this	date,	the	full	invoice	
                                                                                                              must	be	paid.	Conference	notes	will	then	be	sent	to	you.	Unfortunately,	we	are	unable	to	transfer	places	
                                                                                                              between	conferences.	However,	if	you	cannot	attend	the	conference,	you	may	make	a	substitution/name	
Methods of payment                                                                                            change	at	any	time,	as	long	as	we	are	informed	in	writing	by	email,	fax	or	post.	Name	changes	and	
                                                                                                              substitutions	 must	 be	 from	 the	 same	 company	 or	 organisation	 and	 are	 not	 transferable	 between	
Payment	must	be	made	in	sterling                                                                              countries.	Please	note	that	discounted	delegates	places	at	a	visiongain	event	are	non	refundable.
By Mail: Complete	and	return	your	signed	registration	form	together	with	your	cheque	payable	                 Invoice alterations:	There	will	be	an	administration	charge	of	£50	for	any	changes	to	an	invoice,	
                                                                                                              excluding	 substitutions/name	 changes,	 requested	 by	 the	 customer.	 This	 will	 be	 charged	 to	 the	
to	Visiongain	Ltd	and	send	to:	visiongain	Ltd,	BSG	House,	226-236	City	Road,	London,	EC1V	2QY,	UK             customer	by	credit	card	prior	to	the	changes	being	made.
By Fax: Complete	and	fax	your	signed	registration	form	with	your	credit	card	details		                        Indemnity:	 Visiongain	 Ltd	 reserves	 the	 right	 to	 make	 alterations	 to	 the	 conference/executive	
to	+44	(0)	20	7549	9932                                                                                       briefing	content,	timing,	speakers	or	venue	without	notice.	The	event	may	be	postponed	or	cancelled	
                                                                                                              due	to	unforeseen	events	beyond	the	control	of	visiongain	Ltd.	If	such	a	situation	arises,	we	will	try	
By Phone:	Call	us	on	+44	(0)	20	7336	6100	with	your	credit	card	details	                                      to	reschedule	the	event.	However,	visiongain	Ltd	cannot	be	held	responsible	for	any	cost,	damage	or	
                                                                                                              expenses,	which	may	be	incurred	by	the	customer	as	a	consequence	of	the	event	being	postponed	or	
By Credit Card:	Fill	in	your	card	details	below	and	fax	back	to	+44	(0)	20	7549	9932                          cancelled.	We	therefore	strongly	advise	all	our	conference	clients	to	take	out	insurance	to	cover	the	
                                                                                                              cost	of	the	registration,	travel	and	expenses.
By Bank Transfer:
                                                                                                              Data Protection:	 Visiongain	 Ltd	 gathers	 and	 manages	 data	 in	 accordance	 with	 the	 Data	
Visiongain	Ltd	                                                                       A/C:	visiongain	Ltd	    Protection	Act	1988.	Your	personal	information	contained	in	this	form	may	be	used	to	update	you	on	
                                                                                                              visiongain	Ltd	products	and	services	via	post,	telephone,	fax	or	email,	unless	you	state	otherwise.	We	
Barclays	Bank	                                                                       Sort	Code:	20-71-64	     may	also	share	your	data	with	external	companies	offering	complementary	products	or	services.	If	you	
Piccadilly	Branch	                                                                Account	No:	6038	7118	      wish	for	your	details	to	be	amended,	suppressed	or	not	passed	on	to	any	external	third	party,	please	
48	Regent	Street	                                                                 Swift	Code:	BARC	GB22	
                                                                                                       	      send	your	request	to	the	Database	Manager,	visiongain	Ltd,	BSG	House,	226-236	City	Road,	London,	
                                                                                                              EC1V	2QY.	Alternatively,	you	can	visit	our	website	at	www.visiongain.com	and	amend	your	details.	
London,	W1B	5RA	                                                   IBAN:	GB80	BARC	20716460387118             Please	allow	approximately	30	days	for	your	removal	or	update	request	to	be	applied	to	our	database.	
                                                                                                              Following	your	removal	or	update	request,	you	may	receive	additional	pieces	of	communication	from	
Please debit my credit card:                                                                                  visiongain	Ltd	during	the	transitional	period,	whilst	the	changes	are	coming	into	effect.
    	Access	     	MasterCard	       	Visa	   	American	Express                                                Fee: The	conference	fee	includes	lunch,	refreshments	and	conference	papers	provided	on	the	day.	
                                                                                                              This	 fee	 does	 not	 include	 travel,	 hotel	 accommodation,	 transfers	 or	 insurance,	 (which	 we	 strongly	
                                                                                                              recommend	you	obtain).
Card	number:                                                                                                  VAT: VAT	will	be	charged	at	the	local	rate	on	each	conference.	Delegates	may	be	able	to	recover	VAT	
                                                                                                              incurred	by	contacting	Eurocash	Corporation	plc	+44	(0)	1273	325000,	eurocash@eurocashvat.com.	
                                                                                                              Eurocash	specialise	in	recovering	cross-border	VAT.
Expiry	Date:	                                                                                                 How we will contact you: Visiongain	Ltd’s	preferred	method	of	communication	is	by	email	and	
                                                                                                              phone.	Please	ensure	that	you	complete	the	registration	form	in	full	so	that	we	can	contact	you.
Security	number	(last	3	digits	on	back	of	credit	card):                                                       Unable to attend
                                                                                                              Obviously	nothing	compares	to	being	there	but	you	need	not	miss	out.	Simply	tick	the	box	and	send	
Signature:                                                                                                    with	your	payment.	You	will	receive	speaker	talks	in	PDFs	two	weeks	after	the	event.
                                                                                                              Yes, please send me speaker talks                    Price£550       VAT:£110          Total:£660
Cardholder’s	name:
                                                                                                              Office use only
News updates
Please	tick	if	you	do	not	want	to	receive	email	news	updates	in	the	future




                                                                        www.visiongain.com/biosimilars

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  • 1. 9th Biosimilars Implementing clinical, legal, regulatory and developmental strategies for biosimilar safety and acceptance 5th - 7th October 2011, Thistle City Barbican, London, UK BOOK NOW! Key Speakers Dr. Ulrike Jägle, Senior Manager R&D Policy, Global Public Affairs, Novartis Dr Ian Hudson, Director of Licensing, MHRA Dr Angela Thomas, Chair of Biologicals and Vaccines Expert Advisory Group-Comission on Human Medicines, MHRA Dr Meenu Wadhwa, Leader Cytokine & Growth Factors Section, National Institute for Biological Standards and Control Fredrik Sundberg, Global Director, Strategic Market Development, GE Healthcare Dr Sandy Eisen, Chief Medical Officer, Frontline Pharma Consulting Annie Hubert, Director European Government and Public Affairs, Amgen Dr Frank Moffart, Business Developments Emerging Markets, Solvias Dr Steinar Madsen, Medical Director, Department of Drug Information, Norweigan Medicines Agency Dr Anita O’Connor, Senior Director Biopharmaceuticals, Celerion Dr Lincoln Tsang, Partner, FDA & healthcare-Arnold & Porter LLP Sebastian Moore, Partner, IP-Herbert Smith LLP Dr Carsten Brockmeyer, Biosimilars Expert & Managing Director, Brockmeyer Biopharma Kristie Khul, Senior VP, Health, Markovsky + Company Dr Jean-Yves le Cotonnec, CEO, Triskel Integrated Services Anna Valeri, Non-Clinical Assessor, MHRA Geoff Hale, Chief Sciene Officer, Merck Millipore Pre-conference Workshop, Wednesday 5th October, 2011 Assessing regulatory challenges: US and Europe Perspectives and Update on current regulation situation Led by: Dr. Angela Thomas, Chair of Biologicals and Vaccines Expert Advisory Group-Comission on Human Medicines, MHRA & Dr Anita O’Connor, Managing Partner, Anita O’Connor Consulting Gold Sponsor Silver Sponsor Associate Sponsor Organised By Driving the Industry Forward | www.futurepharmaus.com BioPharm Media Partners Insight An Infinata BioPharm Solution To Book Call: +44 (0) 20 7336 6100 | www.visiongain.com/biosimilars
  • 2. Conference Introduction 9th Biosimilars 5th - 7th October 2011, London, UK Dear Colleague, Gold Sponsor: iopharmaceuticals are an essential therapeutic option accounting for a substantial B Merck Millipore is the Life Science division of Merck KGaA of Germany and offers a broad range of innovative, performance products, services and business relationships part of the global therapeutic market. With the patents of many blockbuster drugs that enable our customers’ success in research, development and production of coming to an end, an opportunity has arisen for the manufacture and approval of biotech and pharmaceutical drug therapies. Through dedicated collaboration on biosimilars. new scientific and engineering insights, and as one of the top three R&D investors in the Life Science Tools industry, Merck Millipore serves as a strategic partner to n a climate where the ever-increasing healthcare costs are a concern, biosimilars I customers and helps advance the promise of life science. Headquartered in Billerica, are promising to increase access to essential drugs, lower treatment costs and Massachusetts, the division has around 10,000 employees, operations in 64 countries and pro forma provide savings to the healthcare systems. 2009 revenues of $2.9 billion. Merck Millipore operates as EMD Millipore in the U.S. and Canada. isiongain’s 9th Biosimilars Conference will look at the multiple facets of V For further information please visit: www.merckmillipore.com biosimilars, ranging from the evolving regulatory landscape and challenges Silver Sponsor: in clinical development, to the legal and economic aspects. By attending this At Pfizer, we apply science and our global resources to improve health and conference you will gain a comprehensive outlook on the key issues surrounding well-being at every stage of life. We strive to set the standard for quality, safety biosimilars. Do not miss this opportunity to further your knowledge in an interactive and value in the discovery, development and manufacturing of medicines for people and animals. Our diversified global health care portfolio includes human learning environment and network with diverse leaders in the industry! and animal biologic and small molecule medicines and vaccines, as well as nutritional products and many of the world’s best-known consumer products. Every day, Pfizer colleagues Reasons to register today: work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as the world’s leading • valuate the emerging markets: focus on far east E biopharmaceutical company, we also collaborate with health care providers, governments and local • xamine economic and commercial prospects E communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. • xplore the changing regulatory landscape of biosimilars E For further information please visit: www.pfizer.com • nalyse comparability studies: designing the manufacturing process and A Assocaite Sponsor: preclinical testing ORION Clinical Services is a European-based CRO with offices in UK, • ssess challenges in the clinical development of biosimilars: demonstrating A Germany, France, Australia, US, Russia and Italy. We offer a full range of efficacy and overcoming immunogenecity services in support of the clinical development process including Strategic and operational regulatory support; Monitoring; Project Management; • eview key issues such as naming, labelling and substitution: steps to ensure R Medical Writing; Quality Assurance; Data Management and Statistics and patient safety in clinical practice Pharmacovigilance – for both pre and post authorisation.We conduct clinical research across Western, Central and Eastern Europe; Scandinavia, USA/Canada, Australia and parts of the Pacific Rim. • dentify steps for securing acceptance of biosimilars on to the market I For further information please visit: www.orioncro.com • ain insight in to the clinician’s perspective: utilising biosimilars and challenges G for acceptance (focus on monoclonal antibodies) Media Partners: PharmiWeb.com is the leading industry-sponsored portal for the • evelop post marketing surveillance strategies D pharmaceutical sector. Supported by most of the leading pharmaceutical • nvestigate legal aspects surrounding biosimilars: intellectual property, innovation I corporations, PharmiWeb.com provides dynamic real-time news, features, events listings and and marketing approval issues international jobs to industry professionals across Europe and the US. • tilise networking opportunities with diverse leaders U For further information please email: corporate@pharmiweb.com I look forward to meeting you at the conference BIOTECHNOLOGY EUROPE is owned by BIOTECHNOLOGY WORLD. It is Best regards based and located in Warsaw, Poland. Biotechnology World was founded in 2007 to provide the world’s biotech and pharma information and market to make it universally accessible and useful for scientific and business processes. Its first step to fulfilling that mission was building the BIOTECHNOLOGY EUROPE platform that will allow a quick spread of information in different channels. BIOTECHNOLOGY EUROPE offers companies completed internet public relations, publication and marketing solutions. One of the mains goals of BIOTECHNOLOGY EUROPE is to integrate the Biotech and Carrie Lancaster Pharma Sector in Europe to global biotechnology, pharmaceutical and life science activities. Conference Producer For further information please visit: www.biotechnology-europe.com Driving the Industry Forward | www.futurepharmaus.com Future Pharmaceuticals has forged powerful relationships with key industry leaders to provide a platform for successful brand recognition, and for senior decision-makers to have the means to procure and plan implementation strategies based on the topics covered. Positioned to be an authoritative resource within top pharma Who should attend? companies as well as small, specialty, and biotech, Future Pharmaceuticals magazine is geared to create a deep penetration into a highly targeted and responsive audience, bridging the gap Presidents, Vice Presidents, CEOs, Directors, Heads, Team Leaders, CSOs, Senior between the industries’ top issues and the solutions top-tier vendors can provide. Managers, Senior Business Developers, Researchers, Parteners & Consultants involved in: For further information please visit: www.futurepharmaus.com Biosimilars/Follow-on Biologics/Follow-on Proteins InPharm is the online platform for exclusive pharmaceutical news, Biologics/Biopharmaceuticals/Biogenerics/Biotechnology comment, contracts, services, jobs and events and is home to Clinical Immunology InPharmjobs.com, Pharmafile and Pharmafocus. Drug Safety For further information please visit: www.inpharm.com Patient Safety BioPharm The leading provider of intelligence to the biopharma industry. Detailed Regulatory Affairs Insight company profiles; investigational & approved drugs; contact info; product An Infinata BioPharm Solution Quality Assurance/Quality Control forecasts; and exclusive editorial intelligence. Our proprietary journalists cover Scientific Affairs the most important situations taking place in the life sciences industry, providing forward looking insight Pharmacovigilance into drug pipelines, upcoming litigation, drug licensing deals, and mergers & acquisitions. Research and Development For further information please visit: www.biopharminsight.com Process Science & Manufacturing Analytical Characterization Business Development New Product Development Commercial Affairs Sponsorship and exhibition opportunities Legal Affairs This event offers a unique opportunity to meet and do business with some of the key players in the pharmaceutical and biotech industries. If you have a service or product to promote, you can Intellectual Property do so at this event by: Patent Law • Hosting a networking drinks reception Regulatory Compliance • Taking an exhibition space at the conference Health Economics • Advertising in the delegate documentation pack Pricing and Reimbursement • Providing branded bags, pens, gifts, etc. Marketing and Sales If you would like more information on the range of sponsorship or exhibition possibilities for visiongain's 9th Biosimilars Conference, please contact us: Branded and Generic Pharmaceutical Companies, Contract Research Organisations/ Contract Manufacturing Organisations, Drug Regulators, Damian Gorman, +44 (0)20 7549 9934 Academics & Government damian.gorman@visiongainglobal.com
  • 3. Pre-Conference Interactive Workshop 9th Biosimilars Wednesday 5th October 2011 Assessing regulatory challenges: US and Europe Perspectives and Update on current regulation situation Led by: Dr. Angela Thomas Dr Anita O’Connor Timings: 9:30 - 10:00 Coffee & Registration 0 Chair of Biologicals and Vaccines Expert Managing Partner 10:00 - 17:00 Workshop Advisory Group-Comission on Human Anita O’Connor Consulting T iming includes lunch and refreshment breaks Medicines MHRA About the workshop: About your workshop leaders: The purpose of the workshop is to allow you to engage in Dr Angela Thomas MB BS PhD FRCPE FRCPath FRCPCH knowledge sharing with your peers in a smaller, less formal Dr Angela Thomas MB BS PhD FRCPE FRCPath FRCPCH, is Consultant environment than the main conference. As such, the audience Paediatric Haematologist at the Royal Hospital for Sick Children in Edinburgh. size will typically be no more than 20 participants in order to enable maximum interaction between the workshop leaders After qualifying in Medicine from the University of London in 1980, Angela and the delegates. The format is also more interactive, with trained in general medicine and then adult haematology, subsequently less emphasis on ‘lecture-style’ presentations and more developing a special interest in paediatrics. She was a fellow in molecular emphasis on group discussions, exercises and Q&A sessions. biology at University College London and was awarded a PhD on Genetic Variation of the Fibrinogen Gene. Agenda: Angela was appointed in 1992 as a consultant paediatric haematologist at the Royal Hospital for Sick Children in Edinburgh and is co-director of The EU the Haemophilia Centre at the Edinburgh Royal Infirmary with specific • The introduction of biosimilars responsibility for paediatrics. She cares for children with a wide range of • Lessons learned haematological disorders, including those with leukaemia, immune deficiency, • The changing Paradigm haemolytic anaemias and bleeding disorders. She has a special interest in the education of paediatricians in the varied presentation of haematological • New developments on the Horizon disease, particularly bleeding disorders presenting as possible non-accidental The US injury. • The recent introduction of biosimilar legislation in the US In addition to her clinical post, Angela is a member of the Commission for • The basics of the US legislation Human Medicines (CHM) and chairs its Biologicals and Vaccines Expert Advisory Group. The CHM advises on the quality, safety and efficacy of human • New developments since the law was passed medicinal products and advises the Licensing Authority on the granting • Challenges to expect in the future The regulatory challenges for Biosimilar Medicines in the UK Anita O’Connor • European guidance Anita O’Connor, PhD, is the Senior Director for Biopharmaceuticals at Celerion. • How similar does similar have to be Anita is responsible for the leadership of biopharmaceutical and biosimilar • Experience to date drug development projects and programs for Celerion. She advises clients on the pivotal elements and regulatory strategy needed for approval of biosimilar and innovator biopharmaceuticals for the EU and US markets. Prior to joining Celerion in 2008 Anita founded ANITA OCONNOR CONSULTING, LLC, where she advised clients from the pharmaceutical and About visiongain: financial industry on small and large molecule development. From 1989 Visiongain is a specialist business information company focused on providing cutting to 2005, Anita worked for the US FDA in the Center for Biologics (CBER), edge products and services across the Pharmaceutical/Biotech, Telecommunications, the Center for Drugs (CDER), the Center for Veterinary Medicine (CVM), Defence and Finance sectors, which include reports, conferences, online daily news and offline news analysis and bespoke consultancy. With a commitment the Center for Food Safety (CFSAN) and the Office of the Commissioner to innovation and excellence, visiongain offers flexible solutions to meet our (OC). As an FDA pharmacologist she worked on the submissions of several clients’ business intelligence needs, providing the right information at the right blockbuster biopharmaceuticals to include Orencia®, Avastin®, Kepivance®, time to facilitate the commercial decision-making process. Our pharmaceutical Remicade®, Remaira®, and Rituxan®. She also reviewed vaccine and products include Pharma Business Daily, the leading daily email newsletter for the blood product INDs and BLAs. Other FDA experience extends to food safety, pharmaceutical, biotech and healthcare industries, and a range of independent, animal drugs, women’s health, medical devices, and regulatory science policy. high-quality, in-depth reports covering focused and topical areas of concern. During her tenure at FDA, Dr. O’Connor was detailed to the US House of Our pharmaceutical conferences address the hottest commercial, regulatory Representatives to work on food safety and biotechnology issues for House and technical topics and provide an ideal forum for debate and networking for Agriculture committee. In 2008, she wrote a chapter for a reference book on pharmaceutical professionals from around the world. the preclinical development of biopharmaceuticals. She speaks and writes For further information, please visit: www.visiongain.com frequently on biopharmaceuticals and biosimilars.
  • 4. Day 1 9th Biosimilars Thursday 6th October 2011 09:00 Registration and refreshments 12:40 Networking lunch 09:30 Opening address from the chair 13:40 Overview of legal issues • Overview of the European regulatory pathway • The legislative and policy developments for biosimilars 09:40 Biosimilars: challenges and choices in developing a biosimilars business • Standards for approval  • Rewards & Risks  • Protection for the innovators rights  • The story so far – what is known? Dr Lincoln Tsang  • Definitions Partner CASE STUDY  • Impact of globalization Arnold & Porter LLP  • Major stake-holders  • Barriers and potential pitfalls 14:20 Biosimilar IP issues in Europe  • Regulatory issues in comparability  • reedom to operate issues and confronting patents with broad F  • Case studies highlighting analytical CMC challenges protection-pitfalls and tips Dr Frank Moffatt • Supplementary Protection Certificates and biosimilars – unresolved issues Product Manager, Biopharmaceutical Analysis Solvias Sebastian Moore Partner, IP Group Herbert Smith LLP 10:20 New European legislations and their implications for biologicals including biosimilars 15:00 Afternoon refreshments • re there specific issues for use of biologicals, including biosimilars in A clinical practice?  • INN prescription and applicability for biologicals 15:20 Biosimilars - a balanced view based on experience • equirement of the new pharmacovigilance directive: identification R from both sides and traceability • ncreased patient access, supporting sustainable healthcare systems, I • Naming in the cross-border healthcare directive commercially viable  • R&D based industry position on biosimilars healthcare policies • roadening group of companies interested in originator and B Annie Hubert biosmilar biologics Director, European Government and Public Affairs Amgen • cience-based and fair biosimilar pathways S Dr. Ulrike Jägle Senior Manager R&D Policy, Global Public Affairs 11:00 Morning refreshments Novartis 11:20 The changing regulatory landscape of biosimilars: a non-clinical assessor’s perspective 16:00 Presentation to be announced • hanges in the EU regulatory framework C Dr Jean-Yves le Cotonnec CEO • uality matters Q Triskel Integrated Services • reclinical issues P • mmunogenicity I • hoice of biomarkers C 16:40 Closing remarks from the chair Anna Valeri Non-Clinical Assessor MHRA 16:50 Networking drinks 12:00 Presentation to be announced Take your discussions further and build new Geoff Hale relationships in a relaxed and informal setting Chief Sciene Officer, Merck Millipore Due to unforeseen circumstances the programme may change and visiongain reserves the right to alter the venue and/or speakers c Copyright visiongain Ltd, 2011
  • 5. Day 2 9th Biosimilars Friday 7th October 2011 09:00 Registration and refreshments 12:40 Networking lunch 09:30 Opening address from the chair 13:40 Uptake of biosimilars in clinical practice • What do doctors know about biosimilars? 09:40 Insights into biosimilar licensing • What are the obstacles to increased use?  • verview of current licensing process O • What do we know about prices on biosimilars?  • onsidering the challenges C • Who shall decide which drug to use?  • evelopment of licensing strategies D Dr Steinar Madsen Dr Ian Hudson Medical director, Department of Drug Information Director of Licensing Norwegian Medicines Agency MHRA 14:20 Safety issues with biosimilars 10:20 Manufacturing issues and comparability • verview of safety issues O • The technical aspects • mmunogenicity I • The business aspects • ost marketing surveillance P CASE STUDY  • ase study: innovative approach for comparability testing of C • uture innovation F biological products Dr Sandy Eisen Fredrik Sundberg Chief Medical Officer Global Director, Strategic Market Development Frontline Pharma Consulting GE Healthcare 15:00 Afternoon refreshments 11:00 Morning refreshments 15:20 Sponsor Spotlight Session T ake this unique opportunity to be a part of the conference theme, 11:20 Immunogenicity issues with biosimilars network, share ideas and provide an overview of your product/services • The importance of immunogenicity issues to the audience. For more information please contact damian.gorman@visiongainglobal.com • Strategies and methods for detection of immunogenicity • Update Dr Meenu Wadhwa 16:00 The development of biosimilar monoclonal Leader, cytokine & Growth Factors Section antibodies and other complex molecules National Institute for Biological Standards • onoclonal antibodies: context of market M and Control • anufacturing process M • roduct heterogeneity P 12:00 Biosimilar market uptake – taking the question out of acceptance • tandard product characterisation S  • xamining the business risks and marketplace opportunities E • iological comparability B • easuring regulators and financial analysts mandates M • uture opportunities F • rojecting data and clinical confidence P Dr Carsten Brockmeyer Managing Director • racking health professional and patient expectations T Brockmeyer Biopharma • uilding an awareness and third-party advocacy program B • nderstanding needed services and communications U 16:40 Chair’s closing remarks • etting a course for payers and patient pull-through S Kristie Khul 16:50 End of Conference Senior VP, Health Marlovsky + Company
  • 6. Registration Form 9th Biosimilars 5th - 7th October 2011, London, UK Conf. code PP Standard Prices 9th Biosimilars Conference and workshop Fee: £1699 VAT: £339.80 Total: £2038.80 5th - 7th October 2011 Conference only Fee: £1299 VAT: £259.80 Total: £1558.80 Workshop only Fee: £599 VAT: £119.80 Total: £718.80 Location: Thistle City Barbican Number of bookings: Total cost: Address: Central Street, Clerkenwell London EC1V 8DS Promotional Literature Distribution UK Distribution of your company’s promotional literature to all conference attendees Fee: £999 VAT: £199.80 Total: £1198.80 How to book Details Email: Piyush.patel@visiongainglobal.com Forename: Surname: Web: http://www.visiongain.com/biosimilars UK Office: Job Title: Company: Tel: +44 (0) 20 7549 9961 Fax: +44(0) 20 7549 9932 Main Switchboard Number: Visiongain Ltd 230 City Road London Address: EC1V 2QY UK General information Venue: Thistle City Barbican, Central Street, Clerkenwell, London, EC1V 8DS, Phone: 0871 376 9004 / Country: Postcode: +44 845 305 8304, Fax: 0871 376 9104 / +44 845 305 8343 http://www.thistle.com/en/hotels/united_kingdom/london/thistle_city_barbican/index.html Phone: Fax: Payment terms: Visiongain require the full amount to be paid before the conference. Visiongain Ltd may refuse entry to delegates who have not paid their invoice in full. A credit card guarantee may Email: be requested if payment has not been received in full before the event. Visiongain Ltd reserves the right to charge interest on unpaid invoices. Signature: Substitutions/name changes or cancellations: There is a 50% liability on all bookings once made, whether by post, fax, email or web. There is a no refund policy for cancellations received on or I confirm that I have read and agree to the terms and conditions of booking after one month before the start of the event. Should you decide to cancel after this date, the full invoice must be paid. Conference notes will then be sent to you. Unfortunately, we are unable to transfer places between conferences. However, if you cannot attend the conference, you may make a substitution/name Methods of payment change at any time, as long as we are informed in writing by email, fax or post. 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Yes, please send me speaker talks Price£550 VAT:£110 Total:£660 Cardholder’s name: Office use only News updates Please tick if you do not want to receive email news updates in the future www.visiongain.com/biosimilars