www.outsourcing-pharma.org

CPHI STRATEGIES IN PHARMA OUTSOURCING 2011

CPhi STRATEGIES IN PHARMA OUTSOURCING 2011

25 - 26 May 2011 The Park Inn Berlin, Alexanderplatz, Germany

Amer Alghabban, Merck Serono

Ulrich Rümenapp, Bayer Schering Pharma AG

Jim Loftus, Pfizer

Discover big and small pharma’s strategies and exclusive industry insights from:

Driving collaborations and fostering innovation to optimise the contribution of CROs and CMOs to your business

Beatrice Serckx-Poncin, UCB

Anne Maria Ylisaari, Orion Pharma

Dr. Volker Hartmann, Boehringer Ingelheim Pharma

Sponsored by: Media partners:

4TH ANNUAL PROGRAMME

Brought to you by:

&

UPDATED AGENDA

WITH NEW

PHARMA

CASE STUDIES

TRACK A TRANSFORMING CRO PARTNERSHIPS

Assessing current CRO partnership models and identifying the right model for your organisation

Examining current approaches to clinical research outsourcing and how the CRO industry is adapting to the evolving demands

Weighing up the costs and benefits of small versus large CROs

Identifying your core competencies and needs and determining which partner will ensure ongoing success through a qualitative and quantitative selection process

Developing an effective collaboration and ensuring that your partner upholds the agreement

Understanding how to effectively manage the risks associated with outsourcing clinical research

Reviewing the financial, compliance, strategic and operational risks associated with outsourcing drug discovery

Identifying the risks that are specific to LCCS CROs

Determining how to evolve from transactional and functional partnerships to strategic collaborations

Evaluating the pros and cons of short vs. long term collaborations in terms of risk mitigation

Assessing the advantages and disadvantages of different management and auditing strategies

Understanding how to develop a clear and well communicated negotiation strategy Walter Cabri, R&D Chemistry and Analytical Development Director, sigma-tau

CONFERENCE DAY ONE: 25 MAY 2011

09:00 Registration and coffee

09:20 Chairman’s opening remarks

09:30 Pharma outsourcing trends and strategies driving fundamental shifts in custom research and manufacturing

Explaining the drivers behind the use of CMOs/CROs and future market opportunities

Identifying and assessing the key global hubs for custom research and manufacturing

Investigating the key players in the CMO/CRO industry and reviewing their performance

Evaluating the key strengths and weaknesses of the leading CMOs/CROs Exploring the M&A landscape between pharmas and CMOs

Reviewing an industry case study of a landmark M&A deal

Detailing possible scenarios for the pharma outsourcing industry over the next five years: the “Big Squeeze” Andrew Badrot, Founder & CEO, CMS Pharma

10:15 Examining the evolving roles of CRAMs and what is now expected of them Understanding what pharma companies expect from their contract research and manufacturing partners - When does one partner’s role end and another’s start? Analysing global trends in the evolution of CRAMs and region specific characteristics Identifying the differing criteria that large and small pharma companies use to choose their outsourcing partners Evaluating the different types of outsourcing partnerships and their pros and cons - Functional vs. Strategic Determining how to overcome communication and cultural challenges to ensure an efficient working partnership Establishing efficient cross-supplier collaboration Gerhard Klement, Director Pharma Solutions, Piramal Healthcare

11:00 Morning refreshments

11:30 1:1 Networking Using our Meeting Manager software, benefit from a choice of four meetings with industry peers to catch up, develop new business partnerships and discuss new business opportunities.

12:45 Lunch

Only 5 weeks left to secure your place... To register: www.outsourcing-pharma.org

14:00

14:45

15:30 Afternoon refreshments

16:00 Regional focus sessions: Delegates from both Tracks A & B will be able to choose from one of the following sessions:

SESSION 1: REGIONAL ROUNDTABLES: EXAMINING INDUSTRY TRENDS IN INDIA, CHINA AND EASTERN EUROPEIn this session, expert analysts will provide critical intelligence on the characteristics and trends of CROs and CMOs in India, China and Eastern Europe.

Delegates will have the opportunity to join one of 3 roundtables and hear about the expertise and knowledge available in each region, the leading CROs and CMOs as well as the challenges that will need to be overcome to ensure successful outsourcing partnerships.Jim Zhang Ph.D., President, JZMed Inc.

SESSION 2: PANEL DISCUSSION: EVALUATING THE COSTS AND BENEFITS OF OUTSOURCING TO THE DIFFERENT REGIONS AROUND THE WORLDA panel of leading experts will discuss their experiences of working with both CROs and CMOs in different regions of the globe. They will share their lessons learnt and best practice on working with outsourcing partners in LCCS as well as developed markets.Daniel Chapple, General Manager, Life Sciences BPO, CognizantRoger Cassidy, Former Procurement Director – Outsourcing, GlaxoSmithKline

17:00 Chairman’s closing remarks

17:10 Close of day one

DRINKS RECEPTION FOLLOWED BY NETWORKING DINNERAt the end of day one, all delegates, speakers and sponsors are invited to an evening drinks reception followed by a networking dinner.

Produced by: & 25 - 26 May 2011, The Park Inn Berlin, Alexanderplatz, Germany

TRACK B TRANSFORMING CMO PARTNERSHIPS

Exploring the changing status of CMOs – what is the subsequent impact on collaborative partnerships?

Understanding the drivers behind the changing role of CMOs in a pharmaceutical supply network

Mitigating the impact by implementing internal structures to effectively manage manufacturing partners

Identifying potential challenges that may arise from the blurring of both partners roles

Assessing the roles in a collaborative network Ulrich Korneck, Managing Consultant, Camelot Management Consultants

Auditing CMOs – a win win situation

Reviewing different country regulations and their effect on quality assurance

Examining best practice examples of monitoring processes by pharma companies

Identifying possible risks and ensuring that the strategies are put in place to monitor and mitigate these

Evaluating the need for a specific internal structure to manage CMO partners and assessing the value of various auditing programmes Amer Alghabban, Director, GCP Quality Assurance Audit Management, Merck Serono

IND

UST

RY F

AC

TS A

ND

FIG

UR

ES

7 essential need to knows that you’ll take away from Strategies in Pharma Outsourcing 2011… 1. Learn about Merck Serono’s CMO auditing strategy and find out how they ensure it is a win-win situation for both parties

2. Hear about the latest industry trends in India, China and Eastern Europe from experts in the regions

3. Discover how Bayer Schering Pharma are overcoming the challenges associated with biotechnology manufacturing

4. Evaluate the different partnership options available to you with a panel of leading experts from Pfizer, UCB and Boehringer Ingelheim

5. Hear how you can guarantee IP protection when working with your overseas partners from a panel of specialists

6. Understand how a specialist pharma company like Sigma-Tau mitigate the risks associated with outsourcing their clinical research

7. See the latest facts and figures and find out about the latest industry trends with CMS Pharma

Tel: +44(0)20 7921 8039 Email: conferences@ubm.com

16:00 Chairman’s closing remarks

16:10 Close of conference

TRACK A TRANSFORMING CRO PARTNERSHIPS

Managing operational and financial risks with outsourcing partners

Understanding what Japan disaster teaches with regards to risk management

2nd site versus 2nd Source Examining country specific risks in

China and India Establishing a strategy for financial

risk management Dr. Volker Hartmann, Head of Corporate Purchasing Production Material, Boehringer Ingelheim Pharma

Exploring the new trends in technology and understanding best practices to ensuring effective data transfer

Evaluating old technology - what’s wrong with it and what is driving change?

Understanding what is meant by new technology and pinpointing where we are

Investing in new technology - what advantages does it bring for a CRO/CMO?

Supporting new technology in emerging markets

Putting together contracts and data sharing strategies Alan Harris, Partner, Alacrity Pharma Associates

TRACK B TRANSFORMING CMO PARTNERSHIPS

Comparing and contrasting the differences between large and small pharma companies manufacturing outsourcing strategies

Assessing the outsourcing needs of both large and smaller pharma companies

Evaluating the particular challenges affecting both large and small pharma outsourcing strategies

Examining the different management models for both small and larger pharmas

Understanding the different relationship management strategies

Assessing lessons learnt from both sides

Overcoming the challenges associated with outsourcing biotechnology manufacturing

Identifying and examining the process and process complexities that invoke challenges in biotechnology outsourcing

Evaluating the pros and cons of outsourcing biotechnology manufacturing rather than keeping it in-house

Assessing the regulatory environment for biotechnology outsourcing

Developing effective biotechnology outsourcing partnerships Ulrich Rümenapp, Contract Manufacturing Biotech, Head Biotech Projects, Bayer Schering Pharma AG

14:30

15:15

© UBMi BV 2011. This programme may change due to unforeseen circumstances. UBMi BV reserves the right to alter the venue and or sponsors.

CONFERENCE DAY TWO: 26 MAY 2011

Produced by: &25 - 26 May 2011, The Park Inn Berlin, Alexanderplatz, Germany

12:30 Lunch

13:30 1:1 Networking Using our Meeting Manager software, benefit from a choice of four meetings with industry peers to catch up, develop new business partnerships and discuss new business opportunities.

08:30 Registration and coffee

08:50 Chairman’s opening remarks

09:00 Managing multiple outsourcing partners to ensure compliance, efficiency and quality Reviewing a successful multiple partner management structure Determining the type of partnership you want and need to develop with each supplier Sourcing the correct geographical mix of partners and overcoming the cross-cultural differences Ensuring efficient communication and data exchange between the multiple partners Understanding how to rationalise your contractor network Anne Maria Ylisaari, Senior Manager, Global Clinical Alliances & Sourcing, Orion Pharma

09:45 Fulfilling your environmental responsibility by effectively collaborating with your CRO and CMO partners Understanding your environmental responsibilities Assessing the varying geographical regulatory and environmental legislation by region Examining the different strategies available when working with both CROs and CMOs Implementing and managing effective environmental sustainability strategies with your suppliers

10:30 Morning refreshments

11:00 Panel Discussion: Evaluating the partnership options available to you Pinpointing the different partnership options available to both large and small pharmas Identifying the key characteristics of each and the pros and cons in managing these particular partnerships Understanding how different regions require different partnerships Determining how the different partnerships will impact your internal company structure Evaluating real-life case studies and understanding the lessons learnt Beatrice Serckx-Poncin, Local Manufacturing and CMO Governance, UCB Jim Loftus, Biology Outsourcing Lead, Pfizer Dr. Volker Hartmann, Head of Corporate Purchasing Production Material, Boehringer Ingelheim Pharma

11:45 Ask the experts: Guaranteeing IP protection when working with overseas partners Discussing past cases of leaked research, data and knowledge Understanding how IP protection challenges in emerging markets differ from those in western markets Identifying the practical strategies that can be put in place to ensure IP protection in both western and emerging markets through real-life case studies Determining how to adapt your outsourcing strategies to specific regional challenges Mark D. Penner, Partner, Patent Agent, Trade-mark Agent, Fasken Martineau DuMoulin LLP Mia Qu, Intellectual Property Lawyer, Partner, King & Wood Tim Worden, Partner, Taylor Wessing Tariq Sayfoo, Paralegal, RT Coopers Solicitors

Sponsoring “Strategies in Pharma Outsourcing 2011” is an effective means of promoting your business to a highly targeted group of key decision makers with a specific interest in your products and services in an intimate, knowledge-based environment. To find out how you can take advantage of this opportunity, please contact:

Richard Fahy, Business Development ManagerTel: +44 (0)20 7955 3936Email: Richard.Fahy@ubm.com

Conference Sponsorship and Exhibition Opportunities

BIG

PH

AR

MA

INSI

GH

TSLE

GA

L FO

CU

S BIO

PH

AR

MA

SPO

TLIG

HT