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4th Annual
  Pharmaceutical PLM
 Maximising return on investment through product life cycle management

      3rd - 4th March 2010, BSG Conference Centre, London, UK                              BOOK NOW!

  Key Speakers
  Jonathan Deutsch, Director Pharma Development Safety, Licensing and Early Development, Hoffmann-La Roche

  Maciej Gil, Medical & Regulatory Director & CIS, Eli Lilly Russia

  Mario Maio, Head of Formulation & Process Development , Merck Serono

  James Down, Vice President, Product Lifecycle Management, Beckton Dickinson

  Ralph C. Schimmer, Global Head Drug Safety Sciences - Metabolism and Cardiovascular, Hoffmann-La Roche

  Vishal K. Gupta, Director Pharmaceutical R&D, Covidien

  Alok Aggarwal, Co-Founder and Chairman, Evalueserve

  Alexandra C. Gruber, Director Business Development & Marketing, BIOCRATES Life Sciences

   Mike Rea, Chief Executive Officer, IdeaPharma

  Peter G Nielsen, Executive Vice President of Pharmaceutical Development and Chemistry Manufacturing &
  Control, Lifecycle Pharma

  Nigel Stoate, Partner, Taylor Wessing

  Paul FitzGerald, Owner, Syntropy Medica


                                                                                                          Organised By
                                   Driving the Industry Forward | www.futurepharmaus.com




Media Partners



        To Book Call: +44 (0) 20 7336 6100 | www.visiongain.com/plm2010
Conference Introduction
                                                                                     4th Annual Pharmaceutical PLM
                                                                                   3rd - 4th March 2010, London, UK

                                                                                    Media Partners:
Dear Colleague,                                                                                            PharmiWeb.com	is	the	leading	industry-sponsored	portal	for	
                                                                                                           the	pharmaceutical	sector.	Supported	by	most	of	the	leading	
	 Pharmaceutical	and	biopharmaceutical	companies	are	under	severe	
  	
                                                                                    pharmaceutical	corporations,	PharmiWeb.com	provides	dynamic	real-time	news,	features,	
     pressure	 to	 improve	 product	 pipelines,	 accelerate	 time	 to	 market,	     events	listings	and	international	jobs	to	industry	professionals	across	Europe	and	the	US.
     and	improve	margins	on	existing	products,	while	maintaining	strict	            For further information please email: corporate@pharmiweb.com
     adherence	 to	 quality	 principles	 and	 regulatory	 requirements.	 It	 is	                             BIOTECHNOLOGY	EUROPE	is	owned	by	BIOTECHNOLOGY	WORLD.	
     imperative	 that	 pharmaceutical	 and	 biotech	 companies	 address	                                     It	is	based	and	located	in	Warsaw,	Poland.	Biotechnology	World	was	
     these	 business	 challenges	 to	 stay	 competitive,	 increase	 revenue,	       founded	in	2007	to	provide	the	world’s	biotech	and	pharma	information	and	market	to	
     enhance	profit,	and	reduce	the	risk	of	noncompliance.                          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	
	 	 isiongain	4th	Annual	Pharmaceutical	PLM	Conference	will	feature	
  V                                                                                 allow	a	quick	spread	of	information	in	different	channels.		BIOTECHNOLOGY	EUROPE	offers	
                                                                                    companies	completed	internet	public	relations,	publication	and	marketing	solutions.		One	of	
  keynote	 addresses,	 presentations,	 case	 studies	 and	 interactive	             the	mains	goals	of	BIOTECHNOLOGY	EUROPE	is	to	integrate	the	Biotech	and	Pharma	Sector	
  discussions	from	development	to	commercialisation,	quality	control,	              in	Europe	to	global	biotechnology,	pharmaceutical	and	life	science	activities.
  supplier	issues,	regulation	and	inspection.	Please	be	sure	to	register	           For further information please visit www.biotechnology-europe.com
  your	participation	amongst	the	industry’s	elite	for	this	intensive	two-                                 Future	Pharmaceuticals	has	forged	powerful	relationships	with	
                                                                                          Driving the Industry Forward | www.futurepharmaus.com




  day	of	learning,	networking	and	exploiting	business	opportunities.                                      key	industry	leaders	to	provide	a	platform	for	successful	brand	
                                                                                    recognition,	and	for	senior	decision-makers	to	have	the	means	to	procure	and	plan	
	 I	look	forward	to	seeing	you	all	in	London.                                       implementation	strategies	based	on	the	topics	covered.	Positioned	to	be	an	authoritative	
                                                                                    resource	within	top	pharma	companies	as	well	as	small,	specialty,	and	biotech,	Future	
	 Best	regards	                                                                     Pharmaceuticals	magazine	is	geared	to	create	a	deep	penetration	into	a	highly	targeted	
                                                                                    and	responsive	audience,	bridging	the	gap	between	the	industries’	top	issues	and	the	
                                                                                    solutions	top-tier	vendors	can	provide.
	                                                                                   For further information please visit: www.futurepharmaus.com
                                                                                                        InPharm	is	the	online	platform	for	exclusive	pharmaceutical	news,	
                                                                                                        comment,	contracts,	services,	jobs	and	events	and	is	home	to	
     Logadassen Curoopen                                                            InPharmjobs.com,	Pharmafile	and	Pharmafocus.
     Conference Producer                                                            For further information please visit: www.In-Pharm.com
                                                                                                          ‘Pharma	Connections	Worldwide®	is	the	leading	professional	
                                                                                                          business	networking	website	focused	in	the	Pharmaceutical,	
                                                                                    Biotechnology	and	Life	Sciences	research	industry.	Our	goal	is	to	provide	a	conduit	for	
                                                                                    delivery	of	premiere	content	coupled	with	the	right	clientele	in	order	to	facilitate	business	
                                                                                    development	opportunities	among	industry	professionals	responsible	for	making	key	
                                                                                    decisions	in	a	global	marketplace.	‘
                                                                                    For further information please visit: www.pharmaconnections.com
    Who should attend?

    Vice/Presidents, Directors, Heads of:-
                                                                                   About visiongain:
                                                                                   Visiongain is a specialist business information company focused on providing cutting
    • Lifecycle Management                                                         edge products and services across the Pharmaceutical/Biotech, Telecommunications,
                                                                                   Defence and Finance sectors, which include reports, conferences, online daily news and
    • Portfolio Management Research & Development                                  offline news analysis and bespoke consultancy. With a commitment to innovation and
                                                                                   excellence, visiongain offers flexible solutions to meet our clients’ business intelligence
                                                                                   needs, providing the right information at the right time to facilitate the commercial
    • Strategic Planning Partnering                                                decision-making process. Our pharmaceutical products include Pharma Business Daily,
                                                                                   the leading daily email newsletter for the pharmaceutical, biotech and healthcare
                                                                                   industries, and a range of independent, high-quality, in-depth reports covering focused
    • Licensing & Alliance                                                         and topical areas of concern. Our pharmaceutical conferences address the hottest
                                                                                   commercial, regulatory and technical topics and provide an ideal forum for debate and
                                                                                   networking for pharmaceutical professionals from around the world.
    • Process Chemists, Pre-Formulation
                                                                                   For further information, please visit: www.visiongain.com
    • Formulation Clinical Scientists

    • Clinical Investigators
                                                                                    Sponsorship and exhibition opportunities:
    • Brand Management                                                              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	
    • Patent                                                                        service	or	product	to	promote,	you	can	do	so	at	this	event	by:	
                                                                                    •	Hosting	a	networking	drinks	reception	
    • Regulatory Affairs
                                                                                    •	Taking	an	exhibition	space	at	the	conference	
    Target audience - industry                                                      •	Advertising	in	the	delegate	documentation	pack	
                                                                                    •	Providing	branded	bags,	pens,	gifts,	etc.
    Pharmaceutical companies, biopharmaceutical                                     If	you	would	like	more	information	on	the	range	of	sponsorship	or	exhibition	
                                                                                    possibilities	for	visiongain's	4th	Annual	Pharmaceutical	PLM	Conference	2010,	
    companies, software vendors, PLM vendors, Analysts,                             please	contact	us:

    Consultants                                                                     Christopher Clegg, +44 (0)20 7549 9943
                                                                                    christopher.clegg@visiongainglobal.com
Day 1
                                                                                                           4th Annual Pharmaceutical PLM
                                                                                                               Wednesday 3rd March 2010


09:00   Registration and refreshments                                                              13:40         Enhancing life cycle management through effective
                                                                                                                 pharmaceutical licensing strategies
09:30   Chair’s opening remarks                                                                    	             •		 xamining	the	licensing	process	in	pharmaceutical	industry
                                                                                                                   E

09:40   Evaluating the potential benefit of PLM in drug                                            	             •		 eveloping	effective	strategies	while	managing	costs	effectively
                                                                                                                   D
        development process                                                                                             Jonathan Deutsch
                                                                                                                        Director	Pharma	Development	Safety,	Licensing		
	       •		 ccelerating	new	drug	development,	introduction,	and	commercialisation
          A
                                                                                                                        and	Early	Development	
	       •		 rioritising	new	product	development	and	introduction
          P                                                                                                             Hoffmann-La Roche

	       •		 anaging	collaboration	with	external	supply	and	service	networks
          M
                                                                                                   14:20         Effective brand optimisation
              Mario Maio
              Head	of	Formulation	&	Process	Development		                                          	             •	Development	of	intangible	value	
              Merck Serono                                                                         	             •	Planning	for	PLM	-	when	is	early?	And	when	is	too	late?	

                                                                                                   	             •	Best	practice	methodologies	
10:20   Lifecycle management begins at phase II
                                                                                                   	             •	Yo-yo	marketing	–	the	customer	IS	king	
	       •		 valuating	commercial	probability	of	success	in	early-stage	portfolios
          E
                                                                                                   	             •	Putting	the	‘life’	in	lifecycle
	       •		 valuating	strategic	options	in	phase	II
          E
                                                                                                                        Paul FitzGerald
	       •		 oadmapping	product	launch	options
          R
                                                                                                                        Owner	
	       •		 hat	‘great’	looks	like:	case	studies	of	brands	that	managed	early
          W                                                                                                             Syntropy Medica

              Mike Rea
              Chief	Executive	Officer	                                                             15:00         Afternoon refreshments & networking session
              IdeaPharma


11:00   Morning refreshment & networking session                                                   15:20         Panel discussion: Why new developments are
                                                                                                                 important in injectable delivery today?
11:20   Developing differentiation, innovation, and long-                                              	         P
                                                                                                                 	 anelists	will	identify	and	understand	the	growing	importance	of	injectable	
        term growth strategies with lifecycle technologies                                                       drug	delivery	on	self-administration,	drug	formulations,	drug-device	
                                                                                                                 development,	and	therapeutic	treatment	protocols.	If	you	want	to	submit	a	
	       •	Brief	introduction	on	fundamentals	of	oral	controlled	release                                          question,	please	email	it	to	logadassen.curoopen@visiongain.com
	       •	Product	innovation	through	mechanistic	changes	in	product	design

	       •	Examining	drug	delivery	technologies	as	growth	driver
                                                                                                   16:00         Reformulation using new technologies as a strategy
	       •	Big	pharma	and	generic	company	perspective                                                             to lifecycle management
	       •	Looming	patent	losses	for	big	pharma                                                     	             •		 xamples	on	how	new	technology	and	patent	protection	can	maximise	
                                                                                                                   E
                                                                                                                   the	value	of	a	product.
	       •	Examining	how	emerging	markets	drive	growth
                                                                                                   	             •		 ow	the	clinical	benefit	needs	to	be	balanced	to	the	clinical	and	
                                                                                                                   H
              Vishal K. Gupta
                                                                                                                   regulatory	requirements.
              Director,	Pharmaceutical	R&D		
              Covidien                                                                             	             •		 he	importance	of	a	timely	lifecycle	management	strategy	
                                                                                                                   T

                                                                                                                        Peter G Nielsen
12:00   Maximising ROI through patent protection strategies                                                             Executive	Vice	President	of	Pharmaceutical	Development	and	
	       •		 nderstanding	how	to	effectively	reassess,	develop	and	exploit	patent	
          U                                                                                                             Chemistry	Manufacturing	&	Control	
          protection	strategies                                                                                         Lifecycle Pharma

	       •		 nhancing	market	exclusivity	and	revenue	returns	over	the	lifecycles	of	
          E
          new	drugs
                                                                                                   16:40         Chair’s closing remarks

	       •	Successful	case	scenarios	on	strategy	application	

              Nigel Stoate
              Partner	                                                                             16:50         Networking drinks
              Taylor Wessing                                                                                     Take your discussions further and build new
                                                                                                                 relationships in a relaxed and informal setting
12:40   Lunch




                 Due to unforeseen circumstances the programme may change and visiongain reserves the right to alter the venue and/or speakers c Copyright visiongain Ltd, 2009
Day 2
                                                                                            4th Annual Pharmaceutical PLM
                                                                                                  Thursday 4th March 2010


    09:00   Registration and refreshments                                               13:40   Evaluating technical and integration issues in PLM
                                                                                        	       •		 nderstanding	the	implementation	process	of	PLM	solutions
                                                                                                  U

    09:30   Chair’s opening remarks                                                     	       •		 ustomisation	and	configuration	issues	within	the	pharmaceutical	environment
                                                                                                  C

                                                                                        	       •		 onfigurable	packages	versus	customised	PLM	projects
                                                                                                  C

                                                                                        	       •		 iscuss	successful	PLM	strategies
                                                                                                  D
    09:40   Mergers and acquisitions: The need for PLM tools
                                                                                                      James Down
    	       •		 ow	does	it	affect	the	longer	term	delivery	by	the	vendors	to		
              H
                                                                                                      Vice	President,	Product	Lifecycle	Management	
              the	customers?
                                                                                                      Beckton Dickinson
    	       •		 armonising	the	product	portfolio	and	enhancing	visibility	across		
              H
              the	value	chain                                                           14:20   Presentation to be announced
    	       •		 anaging	portfolio	of	drug	candidates	–	from	research	to		
              M                                                                                     Lorna Brazell
              development	and	beyond                                                                Partner		
                  Alok Aggarwal                                                         	       	 	 Bird & Bird
                  Co-Founder	and	Chairman	
                  Evalueserve                                                           15:00   Afternoon refreshments & networking session



    10:20   Optimising life cycle management through                                    15:20   Case study - How the integration of Product
            efficiency measurements                                                             Life-cycle Management and manufacturing
                                                                                                execution systems (MES) closes the loop between
    	       •		 xplaining	why	is	there	a	need	to	measure
              E
                                                                                                manufacturing and design, enabling rapid
    	       •		dentifying	appropriate	efficiency	measurement	tools
              I                                                                                 innovation cycles while at the same time managing
    	       •		 efining	the	challenges	
              D
                                                                                                the risk, increasing product quality, maximising
                                                                                                production yields and decreasing costs.
    	       •		 xploring	some	best	practice	examples
              E

                  Alexandra C. Gruber
                  Director	Business	Development	&	Marketing	                            16:00   Managing drug safety throughout product lifecycle
                  BIOCRATES Life Sciences                                                       management
                                                                                        	       •		 nderstanding	the	benefit-risk	decision	making	by	prescribers	and	patients	
                                                                                                  U

    11:00   Morning refreshment & networking session                                    	       •		 daptative	design	for	RMP/REMS	based	on	their	outcome	
                                                                                                  A

                                                                                        	       •		 est	practices	for	developing	transparency	with	safety	governance	committees	
                                                                                                  B

                                                                                                      Ralph C. Schimmer
                                                                                                      Global	Head	Drug	Safety	Sciences	-	Metabolism	and	Cardiovascular	
    11:20   Panel Discussion: - The role of partnership in                                            F.Hoffmann-La Roche
            implementing PLM software
    	       P
            	 anelists	will	identify	and	understand	how	partnerships	with	technology	   16:40   Complying with regulatory requirements in
            vendors	can	maximise	value	through	an	efficient	PLM	implementation.		               Pharmaceutical life cycle management
            If	you	want	to	submit	a	question,	please	email	it	to		                      	       •		 nalysing	the	increasing	pressure	by	regulatory	bodies	to	ensure	drug	safety
                                                                                                  A
            logadassen.curoopen@visiongain.com
                                                                                        	       •		 ow	FDA	requirements	and	EMEA	requirements	differ?
                                                                                                  H

                                                                                        	       •		dentifying	and	reducing	risks	of	non-compliance	through	PLM
                                                                                                  I

                                                                                                      Maciej Gil
    12:00   Managing brands across the four phases of                                                 Medical	&	Regulatory	Director		&	CIS		
            product lifecycle                                                                         Eli Lilly Russia


                                                                                        16:50   Chair’s closing remarks
    12:40   Lunch
                                                                                        17:00   End of conference




*	Invited
Registration Form
                                                                                                                4th Annual Pharmaceutical PLM
                                                                                                              3rd - 4th March 2010, London, UK


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4th Annual Pharmaceutical Plm (2010) Ta

  • 1. 4th Annual Pharmaceutical PLM Maximising return on investment through product life cycle management 3rd - 4th March 2010, BSG Conference Centre, London, UK BOOK NOW! Key Speakers Jonathan Deutsch, Director Pharma Development Safety, Licensing and Early Development, Hoffmann-La Roche Maciej Gil, Medical & Regulatory Director & CIS, Eli Lilly Russia Mario Maio, Head of Formulation & Process Development , Merck Serono James Down, Vice President, Product Lifecycle Management, Beckton Dickinson Ralph C. Schimmer, Global Head Drug Safety Sciences - Metabolism and Cardiovascular, Hoffmann-La Roche Vishal K. Gupta, Director Pharmaceutical R&D, Covidien Alok Aggarwal, Co-Founder and Chairman, Evalueserve Alexandra C. Gruber, Director Business Development & Marketing, BIOCRATES Life Sciences Mike Rea, Chief Executive Officer, IdeaPharma Peter G Nielsen, Executive Vice President of Pharmaceutical Development and Chemistry Manufacturing & Control, Lifecycle Pharma Nigel Stoate, Partner, Taylor Wessing Paul FitzGerald, Owner, Syntropy Medica Organised By Driving the Industry Forward | www.futurepharmaus.com Media Partners To Book Call: +44 (0) 20 7336 6100 | www.visiongain.com/plm2010
  • 2. Conference Introduction 4th Annual Pharmaceutical PLM 3rd - 4th March 2010, London, UK Media Partners: Dear Colleague, PharmiWeb.com is the leading industry-sponsored portal for the pharmaceutical sector. Supported by most of the leading Pharmaceutical and biopharmaceutical companies are under severe pharmaceutical corporations, PharmiWeb.com provides dynamic real-time news, features, pressure to improve product pipelines, accelerate time to market, events listings and international jobs to industry professionals across Europe and the US. and improve margins on existing products, while maintaining strict For further information please email: corporate@pharmiweb.com adherence to quality principles and regulatory requirements. It is BIOTECHNOLOGY EUROPE is owned by BIOTECHNOLOGY WORLD. imperative that pharmaceutical and biotech companies address It is based and located in Warsaw, Poland. Biotechnology World was these business challenges to stay competitive, increase revenue, founded in 2007 to provide the world’s biotech and pharma information and market to enhance profit, and reduce the risk of noncompliance. 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 isiongain 4th Annual Pharmaceutical PLM Conference will feature V allow a quick spread of information in different channels. BIOTECHNOLOGY EUROPE offers companies completed internet public relations, publication and marketing solutions. One of keynote addresses, presentations, case studies and interactive the mains goals of BIOTECHNOLOGY EUROPE is to integrate the Biotech and Pharma Sector discussions from development to commercialisation, quality control, in Europe to global biotechnology, pharmaceutical and life science activities. supplier issues, regulation and inspection. Please be sure to register For further information please visit www.biotechnology-europe.com your participation amongst the industry’s elite for this intensive two- Future Pharmaceuticals has forged powerful relationships with Driving the Industry Forward | www.futurepharmaus.com day of learning, networking and exploiting business opportunities. key industry leaders to provide a platform for successful brand recognition, and for senior decision-makers to have the means to procure and plan I look forward to seeing you all in London. implementation strategies based on the topics covered. Positioned to be an authoritative resource within top pharma companies as well as small, specialty, and biotech, Future Best regards Pharmaceuticals magazine is geared to create a deep penetration into a highly targeted and responsive audience, bridging the gap between the industries’ top issues and the solutions top-tier vendors can provide. For further information please visit: www.futurepharmaus.com InPharm is the online platform for exclusive pharmaceutical news, comment, contracts, services, jobs and events and is home to Logadassen Curoopen InPharmjobs.com, Pharmafile and Pharmafocus. Conference Producer For further information please visit: www.In-Pharm.com ‘Pharma Connections Worldwide® is the leading professional business networking website focused in the Pharmaceutical, Biotechnology and Life Sciences research industry. Our goal is to provide a conduit for delivery of premiere content coupled with the right clientele in order to facilitate business development opportunities among industry professionals responsible for making key decisions in a global marketplace. ‘ For further information please visit: www.pharmaconnections.com Who should attend? Vice/Presidents, Directors, Heads of:- About visiongain: Visiongain is a specialist business information company focused on providing cutting • Lifecycle Management edge products and services across the Pharmaceutical/Biotech, Telecommunications, Defence and Finance sectors, which include reports, conferences, online daily news and • Portfolio Management Research & Development offline news analysis and bespoke consultancy. With a commitment to innovation and excellence, visiongain offers flexible solutions to meet our clients’ business intelligence needs, providing the right information at the right time to facilitate the commercial • Strategic Planning Partnering decision-making process. Our pharmaceutical products include Pharma Business Daily, the leading daily email newsletter for the pharmaceutical, biotech and healthcare industries, and a range of independent, high-quality, in-depth reports covering focused • Licensing & Alliance and topical areas of concern. Our pharmaceutical conferences address the hottest commercial, regulatory and technical topics and provide an ideal forum for debate and networking for pharmaceutical professionals from around the world. • Process Chemists, Pre-Formulation For further information, please visit: www.visiongain.com • Formulation Clinical Scientists • Clinical Investigators Sponsorship and exhibition opportunities: • Brand Management 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 • Patent service or product to promote, you can do so at this event by: • Hosting a networking drinks reception • Regulatory Affairs • Taking an exhibition space at the conference Target audience - industry • Advertising in the delegate documentation pack • Providing branded bags, pens, gifts, etc. Pharmaceutical companies, biopharmaceutical If you would like more information on the range of sponsorship or exhibition possibilities for visiongain's 4th Annual Pharmaceutical PLM Conference 2010, companies, software vendors, PLM vendors, Analysts, please contact us: Consultants Christopher Clegg, +44 (0)20 7549 9943 christopher.clegg@visiongainglobal.com
  • 3. Day 1 4th Annual Pharmaceutical PLM Wednesday 3rd March 2010 09:00 Registration and refreshments 13:40 Enhancing life cycle management through effective pharmaceutical licensing strategies 09:30 Chair’s opening remarks • xamining the licensing process in pharmaceutical industry E 09:40 Evaluating the potential benefit of PLM in drug • eveloping effective strategies while managing costs effectively D development process Jonathan Deutsch Director Pharma Development Safety, Licensing • ccelerating new drug development, introduction, and commercialisation A and Early Development • rioritising new product development and introduction P Hoffmann-La Roche • anaging collaboration with external supply and service networks M 14:20 Effective brand optimisation Mario Maio Head of Formulation & Process Development • Development of intangible value Merck Serono • Planning for PLM - when is early? And when is too late? • Best practice methodologies 10:20 Lifecycle management begins at phase II • Yo-yo marketing – the customer IS king • valuating commercial probability of success in early-stage portfolios E • Putting the ‘life’ in lifecycle • valuating strategic options in phase II E Paul FitzGerald • oadmapping product launch options R Owner • hat ‘great’ looks like: case studies of brands that managed early W Syntropy Medica Mike Rea Chief Executive Officer 15:00 Afternoon refreshments & networking session IdeaPharma 11:00 Morning refreshment & networking session 15:20 Panel discussion: Why new developments are important in injectable delivery today? 11:20 Developing differentiation, innovation, and long- P anelists will identify and understand the growing importance of injectable term growth strategies with lifecycle technologies drug delivery on self-administration, drug formulations, drug-device development, and therapeutic treatment protocols. If you want to submit a • Brief introduction on fundamentals of oral controlled release question, please email it to logadassen.curoopen@visiongain.com • Product innovation through mechanistic changes in product design • Examining drug delivery technologies as growth driver 16:00 Reformulation using new technologies as a strategy • Big pharma and generic company perspective to lifecycle management • Looming patent losses for big pharma • xamples on how new technology and patent protection can maximise E the value of a product. • Examining how emerging markets drive growth • ow the clinical benefit needs to be balanced to the clinical and H Vishal K. Gupta regulatory requirements. Director, Pharmaceutical R&D Covidien • he importance of a timely lifecycle management strategy T Peter G Nielsen 12:00 Maximising ROI through patent protection strategies Executive Vice President of Pharmaceutical Development and • nderstanding how to effectively reassess, develop and exploit patent U Chemistry Manufacturing & Control protection strategies Lifecycle Pharma • nhancing market exclusivity and revenue returns over the lifecycles of E new drugs 16:40 Chair’s closing remarks • Successful case scenarios on strategy application Nigel Stoate Partner 16:50 Networking drinks Taylor Wessing Take your discussions further and build new relationships in a relaxed and informal setting 12:40 Lunch Due to unforeseen circumstances the programme may change and visiongain reserves the right to alter the venue and/or speakers c Copyright visiongain Ltd, 2009
  • 4. Day 2 4th Annual Pharmaceutical PLM Thursday 4th March 2010 09:00 Registration and refreshments 13:40 Evaluating technical and integration issues in PLM • nderstanding the implementation process of PLM solutions U 09:30 Chair’s opening remarks • ustomisation and configuration issues within the pharmaceutical environment C • onfigurable packages versus customised PLM projects C • iscuss successful PLM strategies D 09:40 Mergers and acquisitions: The need for PLM tools James Down • ow does it affect the longer term delivery by the vendors to H Vice President, Product Lifecycle Management the customers? Beckton Dickinson • armonising the product portfolio and enhancing visibility across H the value chain 14:20 Presentation to be announced • anaging portfolio of drug candidates – from research to M Lorna Brazell development and beyond Partner Alok Aggarwal Bird & Bird Co-Founder and Chairman Evalueserve 15:00 Afternoon refreshments & networking session 10:20 Optimising life cycle management through 15:20 Case study - How the integration of Product efficiency measurements Life-cycle Management and manufacturing execution systems (MES) closes the loop between • xplaining why is there a need to measure E manufacturing and design, enabling rapid • dentifying appropriate efficiency measurement tools I innovation cycles while at the same time managing • efining the challenges D the risk, increasing product quality, maximising production yields and decreasing costs. • xploring some best practice examples E Alexandra C. Gruber Director Business Development & Marketing 16:00 Managing drug safety throughout product lifecycle BIOCRATES Life Sciences management • nderstanding the benefit-risk decision making by prescribers and patients U 11:00 Morning refreshment & networking session • daptative design for RMP/REMS based on their outcome A • est practices for developing transparency with safety governance committees B Ralph C. Schimmer Global Head Drug Safety Sciences - Metabolism and Cardiovascular 11:20 Panel Discussion: - The role of partnership in F.Hoffmann-La Roche implementing PLM software P anelists will identify and understand how partnerships with technology 16:40 Complying with regulatory requirements in vendors can maximise value through an efficient PLM implementation. Pharmaceutical life cycle management If you want to submit a question, please email it to • nalysing the increasing pressure by regulatory bodies to ensure drug safety A logadassen.curoopen@visiongain.com • ow FDA requirements and EMEA requirements differ? H • dentifying and reducing risks of non-compliance through PLM I Maciej Gil 12:00 Managing brands across the four phases of Medical & Regulatory Director & CIS product lifecycle Eli Lilly Russia 16:50 Chair’s closing remarks 12:40 Lunch 17:00 End of conference * Invited
  • 5. Registration Form 4th Annual Pharmaceutical PLM 3rd - 4th March 2010, London, UK Angel For multiple bookings Pentonville Road Photocopy this form Conf. code TA 4th Annual Ci ty Pharmaceutical PLM Ro ad Standard Prices 3rd - 4th March 2010 Old Street Conference only Fee: £1299 VAT: £194.85 Total: £1493.85 Location: SG Conference Centre B Old Street Address: 226-236 City Road City Road Promotional Literature Distribution London EC1V 2TT Distribution of your company’s promotional literature to all conference attendees UK Fee: £999 VAT: £149.85 Total: £1148.85 Details How to book Forename: Surname: Email: conferences@visiongainglobal.com Web: http://www.visiongain.com/plm2010 Job Title: Company: UK Office: Tel: +44(0) 20 7336 6100 Main Switchboard Number: Fax: +44(0) 20 7549 9932 Visiongain Ltd Address: BSG House 226-236 City Road London EC1V 2QY UK Country: Postcode: General information Venue: Directions: BSG Conference Centre 226 – 236 City Road, London, EC1V 2TT. United Phone: Fax: Kingdom. Closest tube station is Old Street (Northern Line). Accommodation: Travelodge London City Road Hotel, 7-12 City Road, London, EC1Y 1AE, Tel: 0871 984 6333, Fax: 0207 628 2503, Email: http://www.travelodge.co.uk/search_and_book/hotel_overview.php?hotel_id=340 Payment terms: Visiongain require the full amount to be paid before the conference. Visiongain Signature: Ltd may refuse entry to delegates who have not paid their invoice in full. A credit card guarantee may be requested if payment has not been received in full before the event. Visiongain Ltd reserves the I confirm that I have read and agree to the terms and conditions of booking right to charge interest on unpaid invoices. 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 Methods of payment or 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 Payment must be made in sterling to transfer places between conferences and executive briefings. However, if you cannot attend the By Mail: Complete and return your signed registration form together with your cheque payable conference, you may make a substitution/name 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 to Visiongain Ltd and send to: visiongain Ltd, BSG House, 226-236 City Road, London, EC1V 2QY, UK organisation and are not transferable between countries. By Fax: Complete and fax your signed registration form with your credit card details 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 +44 (0) 20 7549 9932 customer by credit card prior to the changes being made. By Phone: Call us on +44 (0) 20 7336 6100 with your credit card details Indemnity: Visiongain Ltd reserves the right to make alterations to the conference/executive briefing content, timing, speakers or venue without notice. The event may be postponed or cancelled By Credit Card: Fill in your card details below and fax back to +44 (0) 20 7549 9932 due to unforeseen events beyond the control of visiongain Ltd. If such a situation arises, we will try to reschedule the event. However, visiongain Ltd cannot be held responsible for any cost, damage or By Bank Transfer: expenses, which may be incurred by the customer as a consequence of the event being postponed or Visiongain Ltd A/C: visiongain Ltd cancelled. We therefore strongly advise all our conference clients to take out insurance to cover the cost of the registration, travel and expenses. Barclays Bank Sort Code: 20-71-64 Data Protection: Visiongain Ltd gathers and manages data in accordance with the Data Piccadilly Branch Account No: 6038 7118 Protection Act 1988. Your personal information contained in this form may be used to update you on 48 Regent Street Swift Code: BARC GB22 visiongain Ltd products and services via post, telephone, fax or email, unless you state otherwise. We may also share your data with external companies offering complementary products or services. If you London, W1B 5RA IBAN: GB80 BARC 20716460387118 wish for your details to be amended, suppressed or not passed on to any external third party, please send your request to the Database Manager, visiongain Ltd, BSG House, 226-236 City Road, London, Please debit my credit card: EC1V 2QY. Alternatively, you can visit our website at www.visiongain.com and amend your details. Access MasterCard Visa American Express 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 visiongain Ltd during the transitional period, whilst the changes are coming into effect. Fee: The conference fee includes lunch, refreshments and conference papers provided on the day. Card number: This fee does not include travel, hotel accommodation, transfers or insurance, (which we strongly recommend you obtain). VAT: VAT will be charged at the local rate on each conference. Delegates may be able to recover VAT Expiry Date: incurred by contacting Eurocash Corporation plc +44 (0) 1273 325000, eurocash@eurocashvat.com. Eurocash specialise in recovering cross-border VAT. Security number (last 3 digits on back of credit card): 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. Signature: Unable to attend Cardholder’s name: Obviously nothing compares to being there but you need not miss out. Simply tick the box and send with your payment. You will receive your copy of the event CD Rom two weeks after the event. Yes, please send me a copy of the CD for Price£550 VAT:£82.50 Total:£632.50 News updates Office use only Please tick if you do not want to receive email news updates in the future www.visiongain.com/plm2010