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                                                                           full access to the conference for just €549!
                      Presents the 2nd Annual                                                                         *Terms Apply


                                                                                                 Overall very valuable. Topics
                                                                                               interesting with valuable new
                                                                                         information that is appropriate &
                                                                                           relevant to what I am doing now.
                                                                                                           Apo Pharma Inc.


                                                                                         Location:
                                                                                         THE WESTIn GRAnD, MUnICH
                                                                                         two Day conference:
                                                                                         17TH – 18TH MAy 2011
                                                                                         Pre-conference workshoP Day:
                                                                                         16TH MAy 2011



Driving Clinical Development and Speeding Time to Market through Effective Relationship
Management, Establishing CRO Accountability and Running Trials in BRIC Regions

  Come away with fresh ideas on how to:                                             Get exclusive insight from leading
                                                                                    industry experts including:
           Develop your outsourcing strategy by exploring the various               Dr Larry Blankstein, Senior Director of
           Sponsor-CRO business models. Access over 5 case studies and              Clinical Research, Genzyme
           discussion focused sessions with pioneers from across the                Dr Silvio Klimovsky, Head of Clinical
           industry including Larry Blankstein, Genzyme                             Research Argentina and Uruguay, Pfizer
                                                                                    Uwe Schneider, Head of Global Sourcing
           Establish CRO accountability and ensure your expectations                Management & GCD Business Support,
           are met by developing a clear RFP/RFI from the outset.                   Grünenthal
           Hear first hand from Annika Ekelow, Outsourcing Manager,                 Corinne Pala, Vendor Relationship
           Clinical Operations, Swedish Orphan Biovitrium                           Manager, Grünenthal
           Hone your negotiation skills and understand the                          Pia Sauer Larsen, Outsourcing
                                                                                    Manager, LEO Pharma
           importance of a thoroughly drafted contract in our series of
           exclusive masterclasses. Discuss directly with Deirdre Hall,             Hellen Boering, Director Clinical Research
                                                                                    Resources Management, Genzyme
           Pfizer, Maria Agcaoili, Ascent Pharma Solutions and
           Roger Joby, 1to1to1                                                      Stig Moller Christensen, International
                                                                                    Planning & CRO Manager, ALK Abello
           Explore the opportunities and complexities of running                    Christian Hucke, Head of Clincal
           clinical trials in BRIC and emerging regions with expert insight         Operations, Affimed Therapeutics
           from Argentina, the Philippines and the wider Asia-Pacific Region        Roger Joby, Managing Director, 1to1to1
           Maximise the efficiency and quality of your clinical                     Yariv Hefez, Director Global Business
           development programmes through good relationship                         Development and Alliance Management,
                                                                                    Merck Serono
           management and trial oversight with expert case studies from
           Larry Blankstein, Genzyme and Corinne Pala, Grünenthal                   Annika Ekelow, Outsourcing Manager,
                                                                                    Clinical Operations, Swedish Orphan
           Devise risk sharing partnerships and evaluate the change                 Biovitrium
           management implications. Get first hand insight from                     Mubera Krijezi, Senior Project Manager
           Yariv Hefez, Director Global Business Development and                    Phase I Group, Actelion
           Alliance Management, Merck Serono                                        Mayur Trivedi, Senior Clinical QA
                                                                                    Auditor, Antisoma
                                                                                    Maria Acagoili, CEO and Founder Ascent
 Pre-conference Workshop Day:                                                       Pharma Solutions (Formerly Director
                                                                                    Contracts and Outsourcing, Pfizer)
 This is a unique opportunity to get in depth insight into the critical
 factors for successful outsourcing and drug development. Take the                  Richard Pompe, Group R&D Purchasing
 time to discuss and share ideas with leading experts in the field of clinical      Director, Mylan
 outsourcing, working in emerging markets and adopting the                          Deirdre Hall, Director, Global Team Lead
 right relationship strategy for your organisation.                                 Business Operations, Contracts
    Workshop A:                                                                     & Outsourcing, Pfizer
    Optimising Clinical Development Emerging and Take Off Markets                   Anne Maria Ylisaari, Head of In and
    Dr Silvio Klimovsky, Head of Clinical Research Argentina                        Outsourcing, Orion Pharma
    and Uruguay, Pfizer
                                                                                    Dr Ashish Gawde, Head of Monitoring
    Negotiation Masterclass                                                         & Site Management, India, Taiwan,
    Roger Joby, Managing Director, 1to1to1                                          Indonesia and the Philippines, Bayer


W W W.G L O B A L C L I n I C A L O U T S O U R C I n G .C O M
                           MeDia
sPonsor:                   Partners:




     +44 (0)20 7368 9300               +44 (0)20 7368 9301        www.globalclinicaloutsourcing.com          enquire@iqpc.co.uk
PREconfEREncE	WoRkshoP	DAy                                                                      Monday 16th May 2011

optimising your clinical Development and Patient recruitment through effective
negotiation, relationship Management and running trials in emerging Markets


workshoP a – 10.30 – 13.30




                                                                                                                              cAsE	sTUDy
optimising clinical Development emerging and take off Markets
This hands-on workshop will enable participants to explore and understand the challenges and opportunities
associated with outsourcing clinical trials in Latin America.
There will be an interactive case study and hypothetical scenario session where participants will be able to work
together and share ideas before feeding back to the group.
You will walk away from this workshop with new ideas on:
•	 Regulatory	and	quality	assessment	in	Latin	America
•	 Evaluating	potential	hurdles	and	taking	a	preventative	approach	to	avoid	delays
•	 Developing	a	long	term	strategy	in	Latin	America
Dr Silvio Klimovsky, Head of Clinical Research Argentina and Uruguay, Pfizer


negotiation Masterclass – 14.30 – 17.30
This masterclass will provide a practical approach to contract development and negotiation to ensure that
you get the best start to your working relationship. You will get first hand insight from the full spectrum of
participants from big pharma, small to medium sized biotech and the CRO perspective.
Roger Joby, Managing Director, 1to1to1

               about your workshop Leader
               Roger is a chartered scientist and a member of the Association for Project Management (APM) and has been
               involved in the pharmaceutical industry for over 30 years. He has experience in Clinical Operations, Project
               Management, Proposal Generation and third party contracts at all levels.
               He has worked as an employee and more recently as a consultant for several Pharmaceutical Companies and
               Clinical Research Organisations (CROs)
               Roger also takes an active part in project management research and has published several papers on the role
               of Earned Value Analysis in clinical research with a colleague Dr. David Bryde (Liverpool JM University).
               In addition to Earned Value, Roger is also interested in Risk Analysis, Project Pricing, Forecasting and
               Stakeholder analysis.




  Why Attend?
  Explore	the	latest	strategies	and	approaches	for	                      Informative, examples from daily practice.
  efficient outsourcing and clinical development.                                                  Medigene AG
  Hear from a mix of pharma organisations of all
  shapes and sizes and share strategies and
  relationship management approaches.



                                                                                                      I learned a lot at
     A good mix of functional areas. For training                                                  this conference-the
             purposes it has been enlightening.                                                topics were interesting.
                      ONO Pharmaceutical UK                                                                    Janssen




W W W.G L O B A L C L I n I C A L O U T S O U R C I n G .C O M
    +44 (0)20 7368 9300                                +44 (0)20 7368 9301                                 enquire@iqpc.co.uk
confEREncE	DAy	onE                                                                                                                Tuesday 17th May 2011

08.15          registration and coffee                                                                Panellists:
09.00          Pharma iQ’s welcome and opening remarks from chairperson                               Dr silvio klimovsky, Head of Clinical Research
               Uwe schneider, Head of Global Sourcing Management                                      Argentina and Uruguay, Pfizer
               & GCD Business Support, Grünenthal                                                     Maria agcaoili, CEO, Founder, ascent Pharma solutions
                                                                                                      (Formerly Director, Contracts & Outsourcing, Pfizer)
               Uncovering the opportunities and accessing new Populations                             Dr ashish Gawde, Head of Monitoring & Site Management
               by running trials in emerging and take off Markets                                     India, Taiwan, Indonesia and the Philippines, Bayer
09.10          keynote Presentation: evaluating the future trends in clinical        10.40            networking refreshment Break
               Development in ‘Pharmerging’ and Latin american regions
                                                                                     11.10            sponsor spotlight session
cAsE	sTUDy




               •	 An	overview	of	those	regions	experiencing	a	“take
                  off” path in the market growth/life cycle curve                                     This session will be dedicated to a leading service provider
	              •	 Predicting	and	investigating	the	new	challenges	posed              	                within	the	clinical	field,	offering	you	the	opportunity	to	hear
	              •	 Tapping	into	local	resources	and	populations                       	                first	hand	how	the	latest	innovations	can	help	you	reach	your
	              •	 Real	life	examples	of	trials	run	in	Korea	and	Latin	America                         drug development goals.
               Dr silvio klimovsky, Head of Clinical Research,                                        Developing optimal strategies for niche studies
               Argentina and Uruguay, Pfizer                                                          and ensuring cost-efficiency
09.40          running clinical trials conducted in the asia-Pacific region          11.40            Understanding when and how to implement
               •	 Key	challenges	and	opportunities	for	running	trials	in                              insourcing solutions
                  emerging markets                                                                    •	 In-sourcing	vs.	outsourcing	-	getting	the	right	balance




                                                                                     cAsE	sTUDy
	              •	 An	overview	of	patient	recruitment	strategies	                     	                •	 Saving	time	and	money	through	recruiting	external
                  and opportunities                                                                      CRAs for multiple, smaller studies
	              •	 Enhancing	trial	efficiency	through	complete	understanding          	                •	 Developing	recruitment	strategies	and	accessing
                  of regulations and legislation                                                         local talent
	              •	 The	impact	of	cultural	awareness                                                    hellen Boering, Director Clinical Research Resources
               Dr ashish Gawde, Head of Monitoring & Site Management                                  Management, Genzyme
               India, Taiwan, Indonesia and the Philippines, Bayer                   12.10            speed networking – ‘young Guns and old hats‘
10.10          PaneL: successfully outsourcing to emerging Markets                                    An opportunity to exchange ideas with other participants at
               and take off regions                                                                   different levels of experience to you. This session will be
               As clinical development and outsourcing become truly                  	                divided	based	upon	your	experience	in	the	outsourcing	field
               global, how are you maximising the opportunities of                                    and will allow you to forge new contacts and get
               emerging markets and developing relationships with                                     a fresh perspective.
               partners in these regions? you can put these questions and            12.40            networking Lunch
               more to the panel in this interactive discussion about the
               future of clinical outsourcing.

stream a:                                                                                         stream B:
addressing the needs of small and Medium sized organisations                                      addressing the needs of Big Pharma and risk sharing Partnership
CHAIR: Uwe schneider, Head of Global Sourcing Management                                          Development
& GCD Business Support, Grünenthal                                                                CHAIR: yariv hefez, Director Global Business Development and
                                                                                                  Alliance Management, Merck serono
14.10          establishing optimum selection criteria to enhance the                             open Discussion session - a risky Business
               cro selection Process                                                              Many big players in the pharma industry are consolidating down
               •	Matching	the	right	CRO	to	your	company	and	individual	trial	needs                to one or two clinical research partners in order to drive cost
cAsE	sTUDy




	              •	Assessing	the	track	record	and	capabilities	of	CROs                              containment and achieve economies of scale.
	              •	Can	we	really	maximise	clinical	development	by	working	                          This session will allow you to discuss openly with peers as to
                 with a large CRO?                                                                the risks and opportunities and how to develop an outsourcing
	              •	Setting	realistic	KPIs	from	the	outset	and	ensuring	these	are	met                strategy to meet your company’s need and pipeline.
	              •	Implementing	pilot	studies	to	directly	assess	several	partners                   yariv hefez, Director Global Business Development and Alliance
                 simultaneously and taking a comparative approach                                 Management, Merck serono
	              •	Ensuring	access	to	high	quality	CRAs
               christian hucke, Head of Clinical Operations, affimed therapeutics
14.40          successful relationship Management strategies and                                  successful relationship Management strategies and
               Gauging efficiency                                                                 Gauging efficiency
               •	Driving	efficiency	and	trial	success	through	close	communication                 •	 Facilitating	relationship	management	and	communication
                 and relationship management with your trial manager                                 through a reduced number of partners
	              •	Setting	realistic	KPIs	and	ensuring	your	project	team	is	on	track                •	 Setting	realistic	KPIs	and	ensuring	your	project	team	is	on	track
	              •	Getting	your	voice	heard	throughout	the	partnership                              •	 Achieving	cost	savings	from	reduced	sponsor	oversight	requirements
               corinne Pala, Vendor Relationship Manager, Grünenthal                              Dr Larry Blankstein, Senior Director of Clinical Research, Genzyme
15.10          successful strategies for full outsourcing and establishing                        establishing an innovative operational risk sharing Partnership
               cro accountability                                                                 •	 Understanding	the	key	drivers	for	the	change	to	a	new	
               •	An	overview	of	full	vs.	functional	outsourcing	                                     innovative business model
cAsE	sTUDy




                                                                                     cAsE	sTUDy




	              •	The	role	of	RFP	and	contract	negotiation	in	ensuring                             •	 An	overview	of	the	partnering	process	
                 expectations are met                                                             •	 The	key	changes	needed	in	order	to	implement	the	new	model	
	              •	Taking	a	collaborative	approach	to	clinical	development                          •	 Successfully	implementing	the	change	management	plan	
	              •	Transferring	accountability	to	your	CRO	for	patient                              yariv hefez, Director Global Business Development and Alliance
                 recruitment, site selection etc.                                                 Management, Merck serono
               annika ekelow, Outsourcing Manager, Clinical Operations,
               swedish orphan Biovitrium

15.40                                                                networking refreshment Break
16.10                 PaneL: assessing the Varying strategies of Different organisations according to size - what can we Learn from each other?
                This	session	brings	together	the	findings	from	the	afternoon	streams	to	compare	and	contrast	the	different	approaches	of	big	and	small
	              pharma.	A	perfect	opportunity	to	share	best	practices	and	find	out	what	your	peers	are	doing	to	drive	clinical	development.	
                                                                              facilitators:
                                       Uwe schneider, Head of Global Sourcing Management & GCD Business Support, Grünenthal
                                                         corrine Pala, Vendor Relationship Manager, Grünenthal
                                                          Pia sauer Larsen, Outsourcing Manager, Leo Pharma
                                                   christian hucke, Head of Clincal Operations, affimed therapeutics
                                  yariv hefez, Director Global Business Development and Alliance Management, Merck serono
17.00                                                    closing remarks from chairperson and end of Day one
17.10                                                                 networking Drinks reception


             +44 (0)20 7368 9300                                          +44 (0)20 7368 9301                                                  enquire@iqpc.co.uk
confEREncE	DAy	TWo                                                                                              Wednesday 18th May 2011

08.15           registration and coffee                                           14.20     PaneL: how we created the Perfect Partnership
                                                                                            This interactive session brings you a real life, working
09.00           Pharma iQ’s welcome and opening remarks                                     example of how a sponsor and CRO established the perfect
                from chairperson                                                            deal and partnership from scratch. Engage directly with
                                                                                            those who have overcome the challenges and are on their way
                ensuring appropriate Quality standards and GcP                              to successful drug development.
                for clinical trials worldwide                                               Pia sauer Larsen, Outsourcing Manager, Leo Pharma
                                                                                            yariv hefez, Director Global Business Development and
09.10           Maintaining Quality and GcP standards through
                                                                                            Alliance Management, Merck serono
                effective trial oversight
                                                                                            richard Pompe, Group R&D Purchasing Director, Mylan
cAsE	sTUDy




                •	 The	importance	of	trial	oversight	to	ensure	compliance
	               •	 Understanding	GCP	levels	in	emerging	markets	and               14.50     Breakout roundtable Discussions
                   strategies to ensure high standards                                      Participants will be able to choose one of the roundtables
	               •	 Our	approach:	how	we	monitor	trials	in	various	regions	                  outlined below and spend 1hour discussing the points.
                Mayur trivedi, Senior Clinical QA Auditor, antisoma
                                                                                            a) functional vs. full outsourcing - evaluating the
                Perfecting contract Development and negotiation                             Best approach for your company
                strategies in a competitive environment                                     Explore alternative approaches to outsourcing and the pros
                                                                                            and cons of functional and full outsourcing strategies. This is
09.40           interactiVe workshoP session
                                                                                            a perfect opportunity to share, benchmark and discuss the
                the contract’s role in an outsourcing relationship
                                                                                            challenges and solutions with your peers.
                This session aims to provide better understanding of the
                                                                                            Pia sauer Larsen, Outsourcing Manager, Leo Pharma
	               importance	of	a	well-drafted	contract	to	a	successful
                outsourcing relationship. The speakers will impart                          B) ensuring optimum Patient recruitment through
                approaches and techniques during contract development                       effective contract negotiation and setting Milestones
                that will assist in managing the outsourcing engagement                     This session will address the challenges of patient
                throughout the project and there will be an open discussion                 recruitment and retention and strategies to overcome this in
	               session	for	a	full	20	minutes	following	the	presentation	-	find             a bid to speed trials and time to market. There will be an
                out all you need to know from the experts!                        	         emphasis	on	setting	milestones	and	KPIs	during	
                LearninG oBJectiVes:                                                        contract development.
	               •	 Identify	the	value	of	a	well-written	contract	to	an                      stig Moller christensen, International Planning
                   outsourcing relationship.                                                & CRO Manager, aLk abello
	               •	 Develop	familiarity	with	approaches	and	techniques	in
                   developing an outsourcing contract.                                      c) effective approaches to Measuring Performance
	               •	 Develop	skills	to	utilise	the	contract	in	managing	                      Management
                   an outsourcing relationship.                                             Keeping	on	track	with	performance	and	measuring
                co-facilitators:                                                            milestones will be addressed in this session, where you can
                Maria agcaoili, CEO, Founder, ascent Pharma solutions                       explore the necessary steps to achieve a successful study
                (Formerly Director, Contracts & Outsourcing, Pfizer)                        that gets results on time. you can get expert insight into
                Deirdre hall, Director, Global Team Lead Business                 	         setting	KPIs	and	how	to	minimise	the	impact	of	problems	by
                Operations, Contracts & Outsourcing, Pfizer                                 spotting them early on.
                                                                                            christian hucke, Head of Clinical Operations,
11.00           networking refreshment Break                                                affimed therapeutics
                Guaranteeing success and cost effective clinical                  15.50     avoiding Mistakes in cro selection
                Development through effective relationship Management                       •	 Understanding	the	fundamentals	of	building	and
                                                                                               maintaining successful partnerships
11.30           relationship Management strategies
                                                                                  	         •	 Predicting	and	resolving	common	sources	of	conflict
                •	 Assessing	the	effectiveness	of	micromanagement	over	a
                                                                                  	         •	 Evaluating	strategies	to	overcome	these	issues
                   less formal approach
                                                                                            anne Maria ylisaari, Head of In and Outsourcing,
	               •	 Improving	productivity	and	avoiding	delays	through	
                                                                                            orion Pharma
                   good communication
	               •	 Maintaining	quality	and	ensuring	GCP	through                   16.20     closing remarks from chairperson and end of Day two
                   comprehensive trial oversight
                Mubera krijezi, Senior Project Manager Phase I Group,
                actelion
                                                                                      Who will attend?
12.00           old hats, young Guns - Part two
                The follow up to yesterday’s introduction, a chance to discuss        Directors, senior managers and managers within pharmaceuti-
                what you’ve gained from the experience and how you can                cal manufacturers, biotech, CROs and academic institutes with
                apply that to what’s going on in your organisation                    responsibility for:
                                                                                      •	 Outsourcing
12.30           sPonsor sPotLiGht session                                             •	 Clinical	Development
                This session will be dedicated to a leading service provider          •	 Clinical	Operations
	               within	the	clinical	field,	offering	you	the	opportunity	to	hear       •	 Vendor	Relationship	Management
	               first	hand	how	the	latest	innovations	can	help	you	reach	your         •	 Contract	Management
                drug development goals.                                               •	 Alliance	Management
13.00           networking Lunch




                                 Overall very valuable. Topics interesting with valuable new information
                                         that is appropriate & relevant to what I am doing now.
                                                             Apo Pharma Inc.




W W W.G L O B A L C L I n I C A L O U T S O U R C I n G .C O M
             +44 (0)20 7368 9300                                        +44 (0)20 7368 9301                                        enquire@iqpc.co.uk
sPonsoRs	AnD	ExhibiToRs

MAxiMisE	yoUR	invoLvEMEnT:	
sPonsoRshiP	AnD	ExhibiTion	
oPPoRTUniTiEs
Pharma IQ’s Global Clinical Outsourcing Forum is the only event
                                                                         Web:	www.pharma-iq.com	
that provides dedicated streams to separately address the different      Become a member of Pharma IQ and receive complimentary access
needs and strategies of big pharma and of small to mid sized pharma/     to resources that will keep you at the forefront of industry change.
biotech companies. However, as budgets tighten across the globe,         You will receive access to our growing library of multi-media
the industry is looking for the best approach to speed up clinical       presentations from industry leaders, an email newsletter updating
development, get first time approval and ensure their drug reaches       you on new content that has been added, free aggregated news feed
the market first.                                                        from over 1000 global news sources tracking your industry and special
                                                                         member only discounts on events.
The conference is attended by senior officials and decision-makers
from the outsourcing, clinical and contract management fields,
bringing together buyers and suppliers together in one place.
Focused and high-level, the event will be an excellent platform
                                                                         Media Partners
to	initiate	new	business	relationships.	With	tailored	networking,	                         The International Chamber of Commerce’s Business action to stop
                                                                                           counterfeiting and Piracy (BascaP) initiative unites the global business
sponsors can achieve the face-to-face contact that overcrowded                             community	to	more	efficiently	identify	and	address	intellectual	property	
                                                                                           right (IPR) issues and petition for greater commitment by local, national
trade shows cannot deliver.                                                                and	international	officials	in	the	enforcement	and	protection	of	
                                                                                           intellectual property. By delivering compelling messages from corporate
Exhibiting	and	sponsorship	options	are	extensive	and	packages	                             executives across industries, BASCAP underscores the severity of the
                                                                                           problem and compels governments and media to take action.
can be tailor-made to suit your company’s needs. Packages include                          to learn more visit www.iccwbo.org/bascap
complimentary entry passes, targeted marketing to industry officials                       Medical news Today is the largest independent medical and health news
and executives, and bespoke networking opportunities.                                      site	on	the	web	-	with	over	2,500,000	unique	monthly	users	it	is	ranked	
                                                                                           number one for medical news on Google and yahoo! Medical news Today
                                                                                           is	used	by	Blue	Chip	pharmaceutical	and	health	organizations,	advertising	
Other features of sponsorship include:                                                     agencies, PR companies and vertical ad networks to deliver targeted
                                                                                           disease/condition and general health campaigns.
•	Prominent	exhibition	space	in	the	main	conference	                                       for more information contact peter@medicalnewstoday.com or visit
  networking area                                                                          www.medicalnewstoday.com.
•	Participation	in	comprehensive	pre-event	marketing	campaigns                             Adis	journals	not	only	offer	independent,	high-quality	content	with	
•	Tailored	marketing	strategies	to	suit	your	organisation’s	size,                          enviable impact factors; they also provide an unparalleled evaluation
                                                                                           of the available evidence on new and established pharmacological
  capabilities and individual requirements                                                 interventions. Covering all aspects of the drug development continuum
                                                                                           from	bench-to-bedside,	Adis	journals	are	a	unique	must-have	resource	
                                                                                           for researchers, clinicians, clinical pharmacists and pharmacologists,
For more information and to discuss the right                                              teachers, students, and anyone with an interest in independent reviews
opportunity, contact Michael Adeniya on                                                    and original research needed to support better therapeutic decisions.
                                                                                           Adis	journals	offer	the	most	comprehensive	and	objective,	evidence-based	
+44 (0)207 368 9300 or enquire@iqpc.co.uk                                                  information	on:	•	Clinical	pharmacology	•	Health	economics	and	outcomes	
                                                                                           •	Pharmacovigilance		•		Biotechnology	and	personalized	medicine	–	
                                                                                           adisonline.com

                                                                                           International	Pharmaceutical	Industry	(IPI)	IPI	was	established	to	fill	in	the	
                                                                                           void for effective marketing and communication between all stakeholders
Featured Exhibitor                                                                         in the life sciences sector globally. Clients use us due to the extensive
                                                                                           knowledge and reach we have built up over the years with our Editor,
                                                                                           Editorial Advisory board and market research. We give you links into all
                                                                                           areas of Biopharm, Medical, Pharmaceutical and Healthcare. In addition
                                                                                           to our extensive reach in the Americas & Europe, we have established a
                                                                                           strong presence in the Middle East, Latin America, Eastern Europe, Asia
                                                                                           and Africa which are becoming increasingly important to the way the
                                                                                           industry is moving forwards in areas of Research and Development, Trials,
                                                                                           manufacturing and Technology Transfer. www.ipimedia.com

                                                                                           Journal	for	Clinical	Studies	–	Published	bi-monthly,	JCS	is	a	unique	
                                                                                           journal, dedicated to providing information to the global pharmaceutical,
The Leading Life Science Logistics Specialists.                                            biotechnology, medical devices and CROs, practical and theoretical
                                                                                           operational procedures, challenges, validatory and regulatory guidelines
Founded in 1980, Marken is focused on supporting the premium                               when conducting trials on a multisite basis and particularly within the
logistics of pharmaceutical, biotechnology and clinical service                            emerging markets, naïve patient population, and remote access areas.
                                                                                           We give you country by country objectives on all disease study areas, but
companies.	Through	our	strategically	placed	offices	we	manage	                             uniquely bring you experiences in developing country diseases such as
                                                                                           Liver diseases, kidney diseases, insect borne diseases, malnutrition and
the collection, transport of specimens and distribution of                                 under nutrition. Led by a strong editorial advisory board sourced out for
temperature sensitive clinical trial supplies. Additionally through                        their experiences, you will get the most practical insight for your global
                                                                                           studies. So join us, write for us, feature your experiences with us, advertise
our depot network we support the storage and distribution of                               your capabilities with us, and ask our advisory board for suggestions and
life science assets. Our team members and network of facilities                            guidelines. Let us make health care available to all. www.jforcs.com
bridge the distance between patients and the essential resources                           Swiss Biotech Association (SBA) was founded in March 1998. Today over
of life science companies.                                                                 200 companies represent this growing association. SBA is the industry
                                                                                           association	of	small-	and	medium-sized	enterprises	active	in	all	areas	
Marken understands the specialised and dynamic needs of our                                of biotechnology as well as a very good networking platform for the
                                                                                           multinational companies active in the sector. The membership is open to
industry; we retain our global agility by continuously investing                           companies	of	various	size	concerned	with	different	aspects	of	modern	
in our people, technologies and global installations to better                             biotechnology	such	as	R&D,	production,	marketing	and	sales,	finance,	
                                                                                           services and consulting. Activities of member companies span different
support our clients.                                                                       sectors	of	biotechnology	including	(bio-)pharmaceuticals,	diagnostics,	
                                                                                           agriculture, food, environmental biotechnology, nanotech, nutrition,
People                                                                                     marine-oriented	research	and	specialty	chemicals.www.swissbiotech.org
With	over	400	people	in	25	offices	spanning	the	world,	                                    Pharmatching.com	is	an	efficient,	targeted	and	easy-to-use-“Web2.0”-tool	
Marken has the expertise to ship globally and deliver locally to                           for	finding	the	right	partners	in	the	pharmaceutical	industry	worldwide.	
                                                                                           It saves time and costs in all (out)sourcing and business development
investigator sites or directly to patients.                                                processes, as it facilitates and accelerates the searching process for
                                                                                           appropriate	business	partners	significantly.	
Technologies                                                                               Pharmatching.com is particularly advantageous for projects where a
Our state of the art management, tracking and information                                  special service is (immediately) required or to offer capacities which are
                                                                                           currently available. It is useful for services in all categories and stages of
systems are second to none offering our clients real time                                  drug development including contract manufacturing, contract research,
visibility to the last mile. From hand to hand our chain of custody                        laboratory	investigations,	contractual	testing,	non-clinical	and	clinical	
                                                                                           research, active pharmaceutical ingredients, consulting, marketing,
reflects	our	dedication	to	supporting	and	exceeding	our	client's	                          registration,	in-	and	outlicensing	etc.
expectations.                                                                              BioM Biotech Cluster Development GmbH serves as the coordinating
                                                                                           agency of the Munich Biotech Cluster, and is the top address for all
The combination of expertise, agility, and resources are                                   biotechnology	companies	and	start-ups	in	the	region.	The	MunichBiotech	
complemented by our dedication to supporting our clients, their                            Cluster is a constantly growing hotbed of innovation. The Greater Munich
                                                                                           Area counts over 20,000 persons employed by more than 350 companies
patients and the many lives that depend on our services.                                   in the life science sector (Biotech, Pharma, CRO, Suppliers) – plus more
                                                                                           than	10,000	scientist	in	world	renowned	institutions	like	Max-Planck,	the	
www.marken.com                                                                             universitie	LMU	and	TUM	-	making	Munich	one	of	the	top	regions	in	Europe.
                                                                                           Munich has won a governmental grant in combination with substantial
                                                                                           commitment	from	industry	running	now	a	€100	Mio-program	in	
                                                                                           “personalized	medicine”:	www.bio-m.org/en




W W W.G L O B A L C L I n I C A L O U T S O U R C I n G .C O M
     +44 (0)20 7368 9300                                         +44 (0)20 7368 9301                                                  enquire@iqpc.co.uk
5 Ways to Register
                                                                                                                                                                                       Freephone:          0800 652 2363 or
                                                                                                                              Location:                                                                    +44 (0)20 7368 9300
                                                                                                                              THE WESTIn GRAnD, MUnICH
                                                                                                                              two Day conference:
                                                                                                                              17TH – 18TH MAy 2011
                                                                                                                              Pre-conference workshoP Day:                             Fax:                +44 (0)20 7368 9301
                                                                                                                              16TH MAy 2011

                                                                                                                                                                                       post:               your booking form to
                                                                                                                                                                                                           IQPC
                            To speed registration, please provide the priority code located on the mailing label or in the box below.
                                                                                                                                                                                                           Customer Services
                            My registration code            PDFW                                                                                                                                           129 Wilton Road
                                                                                                                                                                                                           Victoria, London
                            Please contact our database manager on +44(0) 207 368 9300 or database@iqpc.co.uk quoting the                                                                                  SW1 V1JZ
                            registration code above to inform us of any changes or to remove your details.

                                                                                                                                                                                                           enquire@iqpc.co.uk
                                                            Register now for as little as €549!                                                                                        email:


                              stanDarD sUPPLier rates                                                                                                                                  www.globalclinicaloutsourcing.com
                              Packages                                       register and pay           register and pay         register and pay        standard
                                                                              by 25th feb*               by 25th Mar*             by 29th april*           Price
                                                                                                                                                                        team Discounts*
                              conference + 2 workshops + full                     saVe €500                 saVe €450                  saVe €350         €3747 + VAT
                              access to conference recordings                     €3247 + VAT               €3297 + VAT                €3397 + VAT                      Teams of 3 receive 10% off, Teams of 5 receive 15% off, Teams of 7 receive 20%
                              conference + 1 workshop + full                      saVe €400                 saVe €350                  saVe €250                        off Team discounts are only available on standard pricing packages and there is only
                                                                                                                                                         €3098 + VAT
                              access to conference recordings**                   €2698 + VAT               €2748 + VAT                €2848 + VAT                      one discount available per person booking at the same time from the same company
                                                                                  saVe €200                 saVe €150
                              conference only                                                                                          €1899 + VAT       €1899 + VAT

                              audio recordings
                                                                                  €1699 + VAT               €1749 + VAT

                                                                                                                          €550 + VAT
                                                                                                                                                                        Venue & accommoDation
                                                                                                                                                                        Venue: The Westin Grand, Munich, Arabellastrasse 6, 81925 München,
                              PharMa anD Biotech ManUfactUrer rates                                                                                                     Germany, Tel: +49 89 9264 0, Fax: +49 89 9264 8699
                                                                                                                                                                        Accommodation: Travel and accommodation are not included in the
                              Packages                                       register and pay           register and pay         register and pay        standard       registration fee, however a number of discounted bedrooms have been
                                                                              by 25th feb*               by 25th Mar*             by 29th april*           Price
                                                                                                                                                                        reserved at the Westin Grand Hotel. Please call the hotel directly on
                              conference + 2 workshops + full                     saVe €1898                saVe €1898                 saVe €1698                       Tel: + 49 89 92640 and quote booking reference IQPC to receive your
                                                                                                                                                         €3747 + VAT
                              access to conference recordings                     €1849 + VAT               €1849 + VAT                €2049 + VAT                      discounted rate, prices start from €159 excluding taxes and breakfast. There
                              conference + 1 workshop + full                      saVe €1649                saVe €1649                 saVe €1449                       is limited availability so we do encourage attendees to book early to avoid
                                                                                                                                                         €3098 + VAT
                              access to conference recordings**                   €1449 + VAT               €1449 + VAT                €1649 + VAT                      disappointment. For a further selection of discounted hotels please visit:
                              conference + full access                            saVe €1600                saVe €1600                 saVe €1500                       www.4cityhotels.com/munich.html
                              to conference recordings                            €849 + VAT                €849 + VAT                 €949 + VAT        €2449 + VAT


                              conference only
                                                                                  saVe €1350
                                                                                  €549 + VAT
                                                                                                            saVe €1350
                                                                                                            €549 + VAT
                                                                                                                                       saVe €1250
                                                                                                                                       €649 + VAT        €1899 + VAT    Free online resources
                            * To qualify for discounts, payments must be received by the early bird registration deadline.                                              To claim a variety of articles, podcasts and other free resources please visit
                            Early booking discounts are not valid in conjunction with any other offer.
                            ** Please select your choice of Workshop: A or the Masterclass                                                                               www.globalclinicaloutsourcing.com
                            ***Tick this box to remove conference recordings and reduce the price by 300 euros
                            German VAT charged at 19%. VAT Registration # DE 261 1019 14
                                                                                                                                                                        Digital conFerence on cD-rom
                             Delegate Details                                                                                                                           A digital version of the conference proceedings, including all presentations,
                            Please photocopy for each additional delegate                                                                                               is available to buy.
                            6 Mr 6 Mrs 6 Miss 6 Ms 6 Dr 6 Other                                                                                                         6 I cannot attend the event, please send me the CD Rom priced at £599 plus VAT
                                                                                                                                                                        Recent digital conferences available - £599 plus VAT each
                            First Name                                               Family Name
                                                                                                                                                                        6 Innovation in Phase I Clinical Trials
                            Job Title                                                                                                                                   6 Clinical Data Standardisation and Management
                            Tel No.                                                                                                                                     6 Innovation in Clinical Design, Analysis and Reporting
                            Email                                                                                                                                       6 Optimising Clinical Development in Oncology
                            6 Yes I would like to receive information about products and services via email                                                             6 Optimising Clinical Development for CNS
                            Organisation                                                                                                                                6 Clinically Relevant Drug Transporters
                            Nature of business                                                                                                                          6 Please send me conference materials indicated above
                            Address                                                                                                                                     6 I have filled out credit card details opposite
                            Postcode Country                                                                                                                            For further information Please call: 0207 368 9300 or email: knowledgebank@iqpc.co.uk
                            Telephone                                                               Fax                                                                 To search IQPC’s archived conference documentation visit: www.iqpcknowledgebank.com
                            Approving Manager
                            Name of person completing form if different from delegate:                                                                                  terms anD conDitions
                                                                                                                                                                        Please read the information listed below as each booking is subject to IQPC Ltd standard
                            Signature                                                                                                                                   terms and conditions. Payment Terms: Upon completion and return of the registration
                                                                                                                                                                        form, full payment is required no later than 5 business days from the date of invoice.
                            I agree to IQPC’s cancellation, substitution and payment terms.                                                                             Payment of invoices by means other than by credit card or purchase order (UK Plc and
                                                                                                                                                                        UK government bodies only) will be subject to a €69 (plus VAT) per delegate processing
                            Special dietary requirements: 6 Vegetarian 6 Non-dairy 6 Other (please specify)                                                             fee. Payment must be received prior to the conference date. We reserve the right to refuse
                            Please indicate if you have already registered by Phone 6 Fax 6 Email 6 Web 6                                                               admission to the conference if payment has not been received. IQPC Cancellation,
                                                                                                                                                                        Postponement and Substitution Policy: You may substitute delegates at any time by
                            Please note: if you have not received an acknowledgement before the conference, please call us to confirm your booking.                     providing reasonable advance notice to IQPC. For any cancellations received in writing not
                                                                                                                                                                        less than eight (8) days prior to the conference, you will receive a 90% credit to be used
                                                                                                                                                                        at another IQPC conference which must occur within one year from the date of issuance of
                             payment methoD                                                                                                                             such credit. An administration fee of 10% of the contract fee will be retained by IQPC for all
                                                                                                                                                                        permitted cancellations. No credit will be issued for any cancellations occurring within seven
                            Total price for your Organisation: (Add total of all individuals attending):                                                                (7) days (inclusive) of the conference. In the event that IQPC cancels an event for any reason,
conFerence coDe 18514.002




                                                                                                                                                                        you will receive a credit for 100% of the contract fee paid. You may use this credit for another
                                                                                                                                                                        IQPC event to be mutually agreed with IQPC, which must occur within one year from the date
                            Card Number: VISA 6 M/C 6 AMEX 6                                                                                                            of cancellation. In the event that IQPC postpones an event for any reason and the delegate
                            6666666666666666                                                                                                                            is unable or unwilling to attend in on the rescheduled date, you will receive a credit for
                                                                                                                                                                        100% of the contract fee paid. You may use this credit for another IQPC event to be mutually
                                                                                                                                                                        agreed with IQPC, which must occur within one year from the date of postponement. Except
                            Exp. Date: 6 6 6 6 Sec: 6 6 6 6                                                                                                             as specified above, no credits will be issued for cancellations. There are no refunds given
                                                                                                                                                                        under any circumstances. IQPC is not responsible for any loss or damage as a result of a
                                                                                                                                                                        substitution, alteration or cancellation/postponement of an event. IQPC shall assume no
                            Name On Card:                                                                  Signature:                                                   liability whatsoever in the event this conference is cancelled, rescheduled or postponed
                                                                                                                                                                        due to a fortuitous event, Act of God, unforeseen occurrence or any other event that renders
                            Billing Address (if different from below):                                                                                                  performance of this conference impracticable, illegal or impossible. For purposes of this
                                                                                                                                                                        clause, a fortuitous event shall include, but not be limited to: war, fire, labour strike, extreme
                                                                                                                                                                        weather or other emergency. Please note that while speakers and topics were confirmed at
                            City/County/Postcode                                           Cheque enclosed for: €                         (Made payable to IQPC Ltd.)   the time of publishing, circumstances beyond the control of the organizers may necessitate
                                                                                                                                                                        substitutions, alterations or cancellations of the speakers and/or topics. As such, IQPC
                                                                                                                                                                        reserves the right to alter or modify the advertised speakers and/or topics if necessary
                            (Please quote 18514.002 with remittance advice)                                                                                             without any liability to you whatsoever. Any substitutions or alterations will be updated on our
                                                                                                                                                                        web page as soon as possible. Discounts: All ‘Early Bird’ Discounts require payment at time
                            IQPC Bank details: HSBC Bank Plc, 67 George Street, Richmond, Surrey, TW9 1HG, United Kingdom                                               of registration and before the cut-off date in order to receive any discount.
                                                                                                                                                                        Any discounts offered by IQPC (including Team Discounts) require payment at the time of
                            Sort Code: 40 05 15 Account No: 59090618 IBAN Code: GB98 MIDL 4005 1559 0906 18                                                             registration. Discount offers cannot be combined with any other offer.
                            Swift Code: MIDLGB22 Account name: International Quality & Productivity Centre Ltd

                            payment must Be receiVeD prior to the conFerence

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  • 1. Register and pay before 25th February 2011 to get full access to the conference for just €549! Presents the 2nd Annual *Terms Apply Overall very valuable. Topics interesting with valuable new information that is appropriate & relevant to what I am doing now. Apo Pharma Inc. Location: THE WESTIn GRAnD, MUnICH two Day conference: 17TH – 18TH MAy 2011 Pre-conference workshoP Day: 16TH MAy 2011 Driving Clinical Development and Speeding Time to Market through Effective Relationship Management, Establishing CRO Accountability and Running Trials in BRIC Regions Come away with fresh ideas on how to: Get exclusive insight from leading industry experts including: Develop your outsourcing strategy by exploring the various Dr Larry Blankstein, Senior Director of Sponsor-CRO business models. Access over 5 case studies and Clinical Research, Genzyme discussion focused sessions with pioneers from across the Dr Silvio Klimovsky, Head of Clinical industry including Larry Blankstein, Genzyme Research Argentina and Uruguay, Pfizer Uwe Schneider, Head of Global Sourcing Establish CRO accountability and ensure your expectations Management & GCD Business Support, are met by developing a clear RFP/RFI from the outset. Grünenthal Hear first hand from Annika Ekelow, Outsourcing Manager, Corinne Pala, Vendor Relationship Clinical Operations, Swedish Orphan Biovitrium Manager, Grünenthal Hone your negotiation skills and understand the Pia Sauer Larsen, Outsourcing Manager, LEO Pharma importance of a thoroughly drafted contract in our series of exclusive masterclasses. Discuss directly with Deirdre Hall, Hellen Boering, Director Clinical Research Resources Management, Genzyme Pfizer, Maria Agcaoili, Ascent Pharma Solutions and Roger Joby, 1to1to1 Stig Moller Christensen, International Planning & CRO Manager, ALK Abello Explore the opportunities and complexities of running Christian Hucke, Head of Clincal clinical trials in BRIC and emerging regions with expert insight Operations, Affimed Therapeutics from Argentina, the Philippines and the wider Asia-Pacific Region Roger Joby, Managing Director, 1to1to1 Maximise the efficiency and quality of your clinical Yariv Hefez, Director Global Business development programmes through good relationship Development and Alliance Management, Merck Serono management and trial oversight with expert case studies from Larry Blankstein, Genzyme and Corinne Pala, Grünenthal Annika Ekelow, Outsourcing Manager, Clinical Operations, Swedish Orphan Devise risk sharing partnerships and evaluate the change Biovitrium management implications. Get first hand insight from Mubera Krijezi, Senior Project Manager Yariv Hefez, Director Global Business Development and Phase I Group, Actelion Alliance Management, Merck Serono Mayur Trivedi, Senior Clinical QA Auditor, Antisoma Maria Acagoili, CEO and Founder Ascent Pre-conference Workshop Day: Pharma Solutions (Formerly Director Contracts and Outsourcing, Pfizer) This is a unique opportunity to get in depth insight into the critical factors for successful outsourcing and drug development. Take the Richard Pompe, Group R&D Purchasing time to discuss and share ideas with leading experts in the field of clinical Director, Mylan outsourcing, working in emerging markets and adopting the Deirdre Hall, Director, Global Team Lead right relationship strategy for your organisation. Business Operations, Contracts Workshop A: & Outsourcing, Pfizer Optimising Clinical Development Emerging and Take Off Markets Anne Maria Ylisaari, Head of In and Dr Silvio Klimovsky, Head of Clinical Research Argentina Outsourcing, Orion Pharma and Uruguay, Pfizer Dr Ashish Gawde, Head of Monitoring Negotiation Masterclass & Site Management, India, Taiwan, Roger Joby, Managing Director, 1to1to1 Indonesia and the Philippines, Bayer W W W.G L O B A L C L I n I C A L O U T S O U R C I n G .C O M MeDia sPonsor: Partners: +44 (0)20 7368 9300 +44 (0)20 7368 9301 www.globalclinicaloutsourcing.com enquire@iqpc.co.uk
  • 2. PREconfEREncE WoRkshoP DAy Monday 16th May 2011 optimising your clinical Development and Patient recruitment through effective negotiation, relationship Management and running trials in emerging Markets workshoP a – 10.30 – 13.30 cAsE sTUDy optimising clinical Development emerging and take off Markets This hands-on workshop will enable participants to explore and understand the challenges and opportunities associated with outsourcing clinical trials in Latin America. There will be an interactive case study and hypothetical scenario session where participants will be able to work together and share ideas before feeding back to the group. You will walk away from this workshop with new ideas on: • Regulatory and quality assessment in Latin America • Evaluating potential hurdles and taking a preventative approach to avoid delays • Developing a long term strategy in Latin America Dr Silvio Klimovsky, Head of Clinical Research Argentina and Uruguay, Pfizer negotiation Masterclass – 14.30 – 17.30 This masterclass will provide a practical approach to contract development and negotiation to ensure that you get the best start to your working relationship. You will get first hand insight from the full spectrum of participants from big pharma, small to medium sized biotech and the CRO perspective. Roger Joby, Managing Director, 1to1to1 about your workshop Leader Roger is a chartered scientist and a member of the Association for Project Management (APM) and has been involved in the pharmaceutical industry for over 30 years. He has experience in Clinical Operations, Project Management, Proposal Generation and third party contracts at all levels. He has worked as an employee and more recently as a consultant for several Pharmaceutical Companies and Clinical Research Organisations (CROs) Roger also takes an active part in project management research and has published several papers on the role of Earned Value Analysis in clinical research with a colleague Dr. David Bryde (Liverpool JM University). In addition to Earned Value, Roger is also interested in Risk Analysis, Project Pricing, Forecasting and Stakeholder analysis. Why Attend? Explore the latest strategies and approaches for Informative, examples from daily practice. efficient outsourcing and clinical development. Medigene AG Hear from a mix of pharma organisations of all shapes and sizes and share strategies and relationship management approaches. I learned a lot at A good mix of functional areas. For training this conference-the purposes it has been enlightening. topics were interesting. ONO Pharmaceutical UK Janssen W W W.G L O B A L C L I n I C A L O U T S O U R C I n G .C O M +44 (0)20 7368 9300 +44 (0)20 7368 9301 enquire@iqpc.co.uk
  • 3. confEREncE DAy onE Tuesday 17th May 2011 08.15 registration and coffee Panellists: 09.00 Pharma iQ’s welcome and opening remarks from chairperson Dr silvio klimovsky, Head of Clinical Research Uwe schneider, Head of Global Sourcing Management Argentina and Uruguay, Pfizer & GCD Business Support, Grünenthal Maria agcaoili, CEO, Founder, ascent Pharma solutions (Formerly Director, Contracts & Outsourcing, Pfizer) Uncovering the opportunities and accessing new Populations Dr ashish Gawde, Head of Monitoring & Site Management by running trials in emerging and take off Markets India, Taiwan, Indonesia and the Philippines, Bayer 09.10 keynote Presentation: evaluating the future trends in clinical 10.40 networking refreshment Break Development in ‘Pharmerging’ and Latin american regions 11.10 sponsor spotlight session cAsE sTUDy • An overview of those regions experiencing a “take off” path in the market growth/life cycle curve This session will be dedicated to a leading service provider • Predicting and investigating the new challenges posed within the clinical field, offering you the opportunity to hear • Tapping into local resources and populations first hand how the latest innovations can help you reach your • Real life examples of trials run in Korea and Latin America drug development goals. Dr silvio klimovsky, Head of Clinical Research, Developing optimal strategies for niche studies Argentina and Uruguay, Pfizer and ensuring cost-efficiency 09.40 running clinical trials conducted in the asia-Pacific region 11.40 Understanding when and how to implement • Key challenges and opportunities for running trials in insourcing solutions emerging markets • In-sourcing vs. outsourcing - getting the right balance cAsE sTUDy • An overview of patient recruitment strategies • Saving time and money through recruiting external and opportunities CRAs for multiple, smaller studies • Enhancing trial efficiency through complete understanding • Developing recruitment strategies and accessing of regulations and legislation local talent • The impact of cultural awareness hellen Boering, Director Clinical Research Resources Dr ashish Gawde, Head of Monitoring & Site Management Management, Genzyme India, Taiwan, Indonesia and the Philippines, Bayer 12.10 speed networking – ‘young Guns and old hats‘ 10.10 PaneL: successfully outsourcing to emerging Markets An opportunity to exchange ideas with other participants at and take off regions different levels of experience to you. This session will be As clinical development and outsourcing become truly divided based upon your experience in the outsourcing field global, how are you maximising the opportunities of and will allow you to forge new contacts and get emerging markets and developing relationships with a fresh perspective. partners in these regions? you can put these questions and 12.40 networking Lunch more to the panel in this interactive discussion about the future of clinical outsourcing. stream a: stream B: addressing the needs of small and Medium sized organisations addressing the needs of Big Pharma and risk sharing Partnership CHAIR: Uwe schneider, Head of Global Sourcing Management Development & GCD Business Support, Grünenthal CHAIR: yariv hefez, Director Global Business Development and Alliance Management, Merck serono 14.10 establishing optimum selection criteria to enhance the open Discussion session - a risky Business cro selection Process Many big players in the pharma industry are consolidating down • Matching the right CRO to your company and individual trial needs to one or two clinical research partners in order to drive cost cAsE sTUDy • Assessing the track record and capabilities of CROs containment and achieve economies of scale. • Can we really maximise clinical development by working This session will allow you to discuss openly with peers as to with a large CRO? the risks and opportunities and how to develop an outsourcing • Setting realistic KPIs from the outset and ensuring these are met strategy to meet your company’s need and pipeline. • Implementing pilot studies to directly assess several partners yariv hefez, Director Global Business Development and Alliance simultaneously and taking a comparative approach Management, Merck serono • Ensuring access to high quality CRAs christian hucke, Head of Clinical Operations, affimed therapeutics 14.40 successful relationship Management strategies and successful relationship Management strategies and Gauging efficiency Gauging efficiency • Driving efficiency and trial success through close communication • Facilitating relationship management and communication and relationship management with your trial manager through a reduced number of partners • Setting realistic KPIs and ensuring your project team is on track • Setting realistic KPIs and ensuring your project team is on track • Getting your voice heard throughout the partnership • Achieving cost savings from reduced sponsor oversight requirements corinne Pala, Vendor Relationship Manager, Grünenthal Dr Larry Blankstein, Senior Director of Clinical Research, Genzyme 15.10 successful strategies for full outsourcing and establishing establishing an innovative operational risk sharing Partnership cro accountability • Understanding the key drivers for the change to a new • An overview of full vs. functional outsourcing innovative business model cAsE sTUDy cAsE sTUDy • The role of RFP and contract negotiation in ensuring • An overview of the partnering process expectations are met • The key changes needed in order to implement the new model • Taking a collaborative approach to clinical development • Successfully implementing the change management plan • Transferring accountability to your CRO for patient yariv hefez, Director Global Business Development and Alliance recruitment, site selection etc. Management, Merck serono annika ekelow, Outsourcing Manager, Clinical Operations, swedish orphan Biovitrium 15.40 networking refreshment Break 16.10 PaneL: assessing the Varying strategies of Different organisations according to size - what can we Learn from each other? This session brings together the findings from the afternoon streams to compare and contrast the different approaches of big and small pharma. A perfect opportunity to share best practices and find out what your peers are doing to drive clinical development. facilitators: Uwe schneider, Head of Global Sourcing Management & GCD Business Support, Grünenthal corrine Pala, Vendor Relationship Manager, Grünenthal Pia sauer Larsen, Outsourcing Manager, Leo Pharma christian hucke, Head of Clincal Operations, affimed therapeutics yariv hefez, Director Global Business Development and Alliance Management, Merck serono 17.00 closing remarks from chairperson and end of Day one 17.10 networking Drinks reception +44 (0)20 7368 9300 +44 (0)20 7368 9301 enquire@iqpc.co.uk
  • 4. confEREncE DAy TWo Wednesday 18th May 2011 08.15 registration and coffee 14.20 PaneL: how we created the Perfect Partnership This interactive session brings you a real life, working 09.00 Pharma iQ’s welcome and opening remarks example of how a sponsor and CRO established the perfect from chairperson deal and partnership from scratch. Engage directly with those who have overcome the challenges and are on their way ensuring appropriate Quality standards and GcP to successful drug development. for clinical trials worldwide Pia sauer Larsen, Outsourcing Manager, Leo Pharma yariv hefez, Director Global Business Development and 09.10 Maintaining Quality and GcP standards through Alliance Management, Merck serono effective trial oversight richard Pompe, Group R&D Purchasing Director, Mylan cAsE sTUDy • The importance of trial oversight to ensure compliance • Understanding GCP levels in emerging markets and 14.50 Breakout roundtable Discussions strategies to ensure high standards Participants will be able to choose one of the roundtables • Our approach: how we monitor trials in various regions outlined below and spend 1hour discussing the points. Mayur trivedi, Senior Clinical QA Auditor, antisoma a) functional vs. full outsourcing - evaluating the Perfecting contract Development and negotiation Best approach for your company strategies in a competitive environment Explore alternative approaches to outsourcing and the pros and cons of functional and full outsourcing strategies. This is 09.40 interactiVe workshoP session a perfect opportunity to share, benchmark and discuss the the contract’s role in an outsourcing relationship challenges and solutions with your peers. This session aims to provide better understanding of the Pia sauer Larsen, Outsourcing Manager, Leo Pharma importance of a well-drafted contract to a successful outsourcing relationship. The speakers will impart B) ensuring optimum Patient recruitment through approaches and techniques during contract development effective contract negotiation and setting Milestones that will assist in managing the outsourcing engagement This session will address the challenges of patient throughout the project and there will be an open discussion recruitment and retention and strategies to overcome this in session for a full 20 minutes following the presentation - find a bid to speed trials and time to market. There will be an out all you need to know from the experts! emphasis on setting milestones and KPIs during LearninG oBJectiVes: contract development. • Identify the value of a well-written contract to an stig Moller christensen, International Planning outsourcing relationship. & CRO Manager, aLk abello • Develop familiarity with approaches and techniques in developing an outsourcing contract. c) effective approaches to Measuring Performance • Develop skills to utilise the contract in managing Management an outsourcing relationship. Keeping on track with performance and measuring co-facilitators: milestones will be addressed in this session, where you can Maria agcaoili, CEO, Founder, ascent Pharma solutions explore the necessary steps to achieve a successful study (Formerly Director, Contracts & Outsourcing, Pfizer) that gets results on time. you can get expert insight into Deirdre hall, Director, Global Team Lead Business setting KPIs and how to minimise the impact of problems by Operations, Contracts & Outsourcing, Pfizer spotting them early on. christian hucke, Head of Clinical Operations, 11.00 networking refreshment Break affimed therapeutics Guaranteeing success and cost effective clinical 15.50 avoiding Mistakes in cro selection Development through effective relationship Management • Understanding the fundamentals of building and maintaining successful partnerships 11.30 relationship Management strategies • Predicting and resolving common sources of conflict • Assessing the effectiveness of micromanagement over a • Evaluating strategies to overcome these issues less formal approach anne Maria ylisaari, Head of In and Outsourcing, • Improving productivity and avoiding delays through orion Pharma good communication • Maintaining quality and ensuring GCP through 16.20 closing remarks from chairperson and end of Day two comprehensive trial oversight Mubera krijezi, Senior Project Manager Phase I Group, actelion Who will attend? 12.00 old hats, young Guns - Part two The follow up to yesterday’s introduction, a chance to discuss Directors, senior managers and managers within pharmaceuti- what you’ve gained from the experience and how you can cal manufacturers, biotech, CROs and academic institutes with apply that to what’s going on in your organisation responsibility for: • Outsourcing 12.30 sPonsor sPotLiGht session • Clinical Development This session will be dedicated to a leading service provider • Clinical Operations within the clinical field, offering you the opportunity to hear • Vendor Relationship Management first hand how the latest innovations can help you reach your • Contract Management drug development goals. • Alliance Management 13.00 networking Lunch Overall very valuable. Topics interesting with valuable new information that is appropriate & relevant to what I am doing now. Apo Pharma Inc. W W W.G L O B A L C L I n I C A L O U T S O U R C I n G .C O M +44 (0)20 7368 9300 +44 (0)20 7368 9301 enquire@iqpc.co.uk
  • 5. sPonsoRs AnD ExhibiToRs MAxiMisE yoUR invoLvEMEnT: sPonsoRshiP AnD ExhibiTion oPPoRTUniTiEs Pharma IQ’s Global Clinical Outsourcing Forum is the only event Web: www.pharma-iq.com that provides dedicated streams to separately address the different Become a member of Pharma IQ and receive complimentary access needs and strategies of big pharma and of small to mid sized pharma/ to resources that will keep you at the forefront of industry change. biotech companies. However, as budgets tighten across the globe, You will receive access to our growing library of multi-media the industry is looking for the best approach to speed up clinical presentations from industry leaders, an email newsletter updating development, get first time approval and ensure their drug reaches you on new content that has been added, free aggregated news feed the market first. from over 1000 global news sources tracking your industry and special member only discounts on events. The conference is attended by senior officials and decision-makers from the outsourcing, clinical and contract management fields, bringing together buyers and suppliers together in one place. Focused and high-level, the event will be an excellent platform Media Partners to initiate new business relationships. With tailored networking, The International Chamber of Commerce’s Business action to stop counterfeiting and Piracy (BascaP) initiative unites the global business sponsors can achieve the face-to-face contact that overcrowded community to more efficiently identify and address intellectual property right (IPR) issues and petition for greater commitment by local, national trade shows cannot deliver. and international officials in the enforcement and protection of intellectual property. By delivering compelling messages from corporate Exhibiting and sponsorship options are extensive and packages executives across industries, BASCAP underscores the severity of the problem and compels governments and media to take action. can be tailor-made to suit your company’s needs. Packages include to learn more visit www.iccwbo.org/bascap complimentary entry passes, targeted marketing to industry officials Medical news Today is the largest independent medical and health news and executives, and bespoke networking opportunities. site on the web - with over 2,500,000 unique monthly users it is ranked number one for medical news on Google and yahoo! Medical news Today is used by Blue Chip pharmaceutical and health organizations, advertising Other features of sponsorship include: agencies, PR companies and vertical ad networks to deliver targeted disease/condition and general health campaigns. • Prominent exhibition space in the main conference for more information contact peter@medicalnewstoday.com or visit networking area www.medicalnewstoday.com. • Participation in comprehensive pre-event marketing campaigns Adis journals not only offer independent, high-quality content with • Tailored marketing strategies to suit your organisation’s size, enviable impact factors; they also provide an unparalleled evaluation of the available evidence on new and established pharmacological capabilities and individual requirements interventions. Covering all aspects of the drug development continuum from bench-to-bedside, Adis journals are a unique must-have resource for researchers, clinicians, clinical pharmacists and pharmacologists, For more information and to discuss the right teachers, students, and anyone with an interest in independent reviews opportunity, contact Michael Adeniya on and original research needed to support better therapeutic decisions. Adis journals offer the most comprehensive and objective, evidence-based +44 (0)207 368 9300 or enquire@iqpc.co.uk information on: • Clinical pharmacology • Health economics and outcomes • Pharmacovigilance • Biotechnology and personalized medicine – adisonline.com International Pharmaceutical Industry (IPI) IPI was established to fill in the void for effective marketing and communication between all stakeholders Featured Exhibitor in the life sciences sector globally. Clients use us due to the extensive knowledge and reach we have built up over the years with our Editor, Editorial Advisory board and market research. We give you links into all areas of Biopharm, Medical, Pharmaceutical and Healthcare. In addition to our extensive reach in the Americas & Europe, we have established a strong presence in the Middle East, Latin America, Eastern Europe, Asia and Africa which are becoming increasingly important to the way the industry is moving forwards in areas of Research and Development, Trials, manufacturing and Technology Transfer. www.ipimedia.com Journal for Clinical Studies – Published bi-monthly, JCS is a unique journal, dedicated to providing information to the global pharmaceutical, The Leading Life Science Logistics Specialists. biotechnology, medical devices and CROs, practical and theoretical operational procedures, challenges, validatory and regulatory guidelines Founded in 1980, Marken is focused on supporting the premium when conducting trials on a multisite basis and particularly within the logistics of pharmaceutical, biotechnology and clinical service emerging markets, naïve patient population, and remote access areas. We give you country by country objectives on all disease study areas, but companies. Through our strategically placed offices we manage uniquely bring you experiences in developing country diseases such as Liver diseases, kidney diseases, insect borne diseases, malnutrition and the collection, transport of specimens and distribution of under nutrition. Led by a strong editorial advisory board sourced out for temperature sensitive clinical trial supplies. Additionally through their experiences, you will get the most practical insight for your global studies. So join us, write for us, feature your experiences with us, advertise our depot network we support the storage and distribution of your capabilities with us, and ask our advisory board for suggestions and life science assets. Our team members and network of facilities guidelines. Let us make health care available to all. www.jforcs.com bridge the distance between patients and the essential resources Swiss Biotech Association (SBA) was founded in March 1998. Today over of life science companies. 200 companies represent this growing association. SBA is the industry association of small- and medium-sized enterprises active in all areas Marken understands the specialised and dynamic needs of our of biotechnology as well as a very good networking platform for the multinational companies active in the sector. The membership is open to industry; we retain our global agility by continuously investing companies of various size concerned with different aspects of modern in our people, technologies and global installations to better biotechnology such as R&D, production, marketing and sales, finance, services and consulting. Activities of member companies span different support our clients. sectors of biotechnology including (bio-)pharmaceuticals, diagnostics, agriculture, food, environmental biotechnology, nanotech, nutrition, People marine-oriented research and specialty chemicals.www.swissbiotech.org With over 400 people in 25 offices spanning the world, Pharmatching.com is an efficient, targeted and easy-to-use-“Web2.0”-tool Marken has the expertise to ship globally and deliver locally to for finding the right partners in the pharmaceutical industry worldwide. It saves time and costs in all (out)sourcing and business development investigator sites or directly to patients. processes, as it facilitates and accelerates the searching process for appropriate business partners significantly. Technologies Pharmatching.com is particularly advantageous for projects where a Our state of the art management, tracking and information special service is (immediately) required or to offer capacities which are currently available. It is useful for services in all categories and stages of systems are second to none offering our clients real time drug development including contract manufacturing, contract research, visibility to the last mile. From hand to hand our chain of custody laboratory investigations, contractual testing, non-clinical and clinical research, active pharmaceutical ingredients, consulting, marketing, reflects our dedication to supporting and exceeding our client's registration, in- and outlicensing etc. expectations. BioM Biotech Cluster Development GmbH serves as the coordinating agency of the Munich Biotech Cluster, and is the top address for all The combination of expertise, agility, and resources are biotechnology companies and start-ups in the region. The MunichBiotech complemented by our dedication to supporting our clients, their Cluster is a constantly growing hotbed of innovation. The Greater Munich Area counts over 20,000 persons employed by more than 350 companies patients and the many lives that depend on our services. in the life science sector (Biotech, Pharma, CRO, Suppliers) – plus more than 10,000 scientist in world renowned institutions like Max-Planck, the www.marken.com universitie LMU and TUM - making Munich one of the top regions in Europe. Munich has won a governmental grant in combination with substantial commitment from industry running now a €100 Mio-program in “personalized medicine”: www.bio-m.org/en W W W.G L O B A L C L I n I C A L O U T S O U R C I n G .C O M +44 (0)20 7368 9300 +44 (0)20 7368 9301 enquire@iqpc.co.uk
  • 6. 5 Ways to Register Freephone: 0800 652 2363 or Location: +44 (0)20 7368 9300 THE WESTIn GRAnD, MUnICH two Day conference: 17TH – 18TH MAy 2011 Pre-conference workshoP Day: Fax: +44 (0)20 7368 9301 16TH MAy 2011 post: your booking form to IQPC To speed registration, please provide the priority code located on the mailing label or in the box below. Customer Services My registration code PDFW 129 Wilton Road Victoria, London Please contact our database manager on +44(0) 207 368 9300 or database@iqpc.co.uk quoting the SW1 V1JZ registration code above to inform us of any changes or to remove your details. enquire@iqpc.co.uk Register now for as little as €549! email: stanDarD sUPPLier rates www.globalclinicaloutsourcing.com Packages register and pay register and pay register and pay standard by 25th feb* by 25th Mar* by 29th april* Price team Discounts* conference + 2 workshops + full saVe €500 saVe €450 saVe €350 €3747 + VAT access to conference recordings €3247 + VAT €3297 + VAT €3397 + VAT Teams of 3 receive 10% off, Teams of 5 receive 15% off, Teams of 7 receive 20% conference + 1 workshop + full saVe €400 saVe €350 saVe €250 off Team discounts are only available on standard pricing packages and there is only €3098 + VAT access to conference recordings** €2698 + VAT €2748 + VAT €2848 + VAT one discount available per person booking at the same time from the same company saVe €200 saVe €150 conference only €1899 + VAT €1899 + VAT audio recordings €1699 + VAT €1749 + VAT €550 + VAT Venue & accommoDation Venue: The Westin Grand, Munich, Arabellastrasse 6, 81925 München, PharMa anD Biotech ManUfactUrer rates Germany, Tel: +49 89 9264 0, Fax: +49 89 9264 8699 Accommodation: Travel and accommodation are not included in the Packages register and pay register and pay register and pay standard registration fee, however a number of discounted bedrooms have been by 25th feb* by 25th Mar* by 29th april* Price reserved at the Westin Grand Hotel. Please call the hotel directly on conference + 2 workshops + full saVe €1898 saVe €1898 saVe €1698 Tel: + 49 89 92640 and quote booking reference IQPC to receive your €3747 + VAT access to conference recordings €1849 + VAT €1849 + VAT €2049 + VAT discounted rate, prices start from €159 excluding taxes and breakfast. There conference + 1 workshop + full saVe €1649 saVe €1649 saVe €1449 is limited availability so we do encourage attendees to book early to avoid €3098 + VAT access to conference recordings** €1449 + VAT €1449 + VAT €1649 + VAT disappointment. For a further selection of discounted hotels please visit: conference + full access saVe €1600 saVe €1600 saVe €1500 www.4cityhotels.com/munich.html to conference recordings €849 + VAT €849 + VAT €949 + VAT €2449 + VAT conference only saVe €1350 €549 + VAT saVe €1350 €549 + VAT saVe €1250 €649 + VAT €1899 + VAT Free online resources * To qualify for discounts, payments must be received by the early bird registration deadline. To claim a variety of articles, podcasts and other free resources please visit Early booking discounts are not valid in conjunction with any other offer. ** Please select your choice of Workshop: A or the Masterclass www.globalclinicaloutsourcing.com ***Tick this box to remove conference recordings and reduce the price by 300 euros German VAT charged at 19%. VAT Registration # DE 261 1019 14 Digital conFerence on cD-rom Delegate Details A digital version of the conference proceedings, including all presentations, Please photocopy for each additional delegate is available to buy. 6 Mr 6 Mrs 6 Miss 6 Ms 6 Dr 6 Other 6 I cannot attend the event, please send me the CD Rom priced at £599 plus VAT Recent digital conferences available - £599 plus VAT each First Name Family Name 6 Innovation in Phase I Clinical Trials Job Title 6 Clinical Data Standardisation and Management Tel No. 6 Innovation in Clinical Design, Analysis and Reporting Email 6 Optimising Clinical Development in Oncology 6 Yes I would like to receive information about products and services via email 6 Optimising Clinical Development for CNS Organisation 6 Clinically Relevant Drug Transporters Nature of business 6 Please send me conference materials indicated above Address 6 I have filled out credit card details opposite Postcode Country For further information Please call: 0207 368 9300 or email: knowledgebank@iqpc.co.uk Telephone Fax To search IQPC’s archived conference documentation visit: www.iqpcknowledgebank.com Approving Manager Name of person completing form if different from delegate: terms anD conDitions Please read the information listed below as each booking is subject to IQPC Ltd standard Signature terms and conditions. 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For any cancellations received in writing not less than eight (8) days prior to the conference, you will receive a 90% credit to be used at another IQPC conference which must occur within one year from the date of issuance of payment methoD such credit. An administration fee of 10% of the contract fee will be retained by IQPC for all permitted cancellations. No credit will be issued for any cancellations occurring within seven Total price for your Organisation: (Add total of all individuals attending): (7) days (inclusive) of the conference. In the event that IQPC cancels an event for any reason, conFerence coDe 18514.002 you will receive a credit for 100% of the contract fee paid. You may use this credit for another IQPC event to be mutually agreed with IQPC, which must occur within one year from the date Card Number: VISA 6 M/C 6 AMEX 6 of cancellation. In the event that IQPC postpones an event for any reason and the delegate 6666666666666666 is unable or unwilling to attend in on the rescheduled date, you will receive a credit for 100% of the contract fee paid. You may use this credit for another IQPC event to be mutually agreed with IQPC, which must occur within one year from the date of postponement. Except Exp. Date: 6 6 6 6 Sec: 6 6 6 6 as specified above, no credits will be issued for cancellations. There are no refunds given under any circumstances. IQPC is not responsible for any loss or damage as a result of a substitution, alteration or cancellation/postponement of an event. IQPC shall assume no Name On Card: Signature: liability whatsoever in the event this conference is cancelled, rescheduled or postponed due to a fortuitous event, Act of God, unforeseen occurrence or any other event that renders Billing Address (if different from below): performance of this conference impracticable, illegal or impossible. For purposes of this clause, a fortuitous event shall include, but not be limited to: war, fire, labour strike, extreme weather or other emergency. Please note that while speakers and topics were confirmed at City/County/Postcode Cheque enclosed for: € (Made payable to IQPC Ltd.) the time of publishing, circumstances beyond the control of the organizers may necessitate substitutions, alterations or cancellations of the speakers and/or topics. As such, IQPC reserves the right to alter or modify the advertised speakers and/or topics if necessary (Please quote 18514.002 with remittance advice) without any liability to you whatsoever. Any substitutions or alterations will be updated on our web page as soon as possible. Discounts: All ‘Early Bird’ Discounts require payment at time IQPC Bank details: HSBC Bank Plc, 67 George Street, Richmond, Surrey, TW9 1HG, United Kingdom of registration and before the cut-off date in order to receive any discount. Any discounts offered by IQPC (including Team Discounts) require payment at the time of Sort Code: 40 05 15 Account No: 59090618 IBAN Code: GB98 MIDL 4005 1559 0906 18 registration. Discount offers cannot be combined with any other offer. Swift Code: MIDLGB22 Account name: International Quality & Productivity Centre Ltd payment must Be receiVeD prior to the conFerence