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View Track: Outsourcing
Outsourcing
Wednesday, March 26, 2008
O-1: State of the Pharmaceutical Outsourcing Industry 2008 9:00AM - 10:00AM (Wednesday, March 26, 2008)
General:
2007 was another resounding year contract services providers. The drug development pipeline continued to expand, especially for early development candidates (Phase I and II), creating strong demand for clinical research and clinical supplies manufacturing and packaging. Major pharmaceutical companies accelerated their restructuring efforts, closing more facilities and confirming plans to outsource more of their development and manufacturing needs. Contract manufacturing and research organizations (CROs and CMOs) received record numbers of RFPs.
Along with the positive environment some significant risks remain, however. High profile drug candidates continue to struggle in late phase trials, and CMOs report that cancellations and delays are making it increasingly difficult to forecast revenues and utilization. Pharmaceutical companies and venture capital investors are paying higher valuations for evermore risky candidates and technologies, a trend that could ultimately threaten the flow of capital into the early stage pipeline as the implications of the bad deals are felt. European CMOs and CROs struggle in the face of the US dollar’s devaluation, tightening regulations, and imports from Asia. The penetration of low-cost Asian suppliers continues into all segments of the pharmaceutical services industry.
This session looks at the state of the industry and the opportunities and challenges facing CROs and CMOs and the sponsors that use their services. We will analyze the trends and discuss the implications for the CMO and CRO business models. OPEN TO ALL BADGEHOLDERS
O-2: Best Practices for Outsourcing in the Life Sciences - An Advanced Session on the Essential Considerations to Make the Outsourcing Relationship Work 10:15AM - 11:15AM (Wednesday, March 26, 2008)
This session provides an advanced discussion of key considerations and best practices for those involved in strategic relationships or considering implementing outsourcing programs in the life sciences industry. With nearly two decades of outsourcing experience, Michael Pillion of Morgan Lewis' highly-regarded outsourcing team and a client will provide a variety of legal and business of insights to include: the structuring of services relationships (including the key components of the outsourcing agreement and their interrelationships); the structured processes that help ensure a favorable negotiation outcomes; suitable exit strategies, and those unique considerations of ooutsourcing in a regulated environment. The audience will be able to leave more prepared to successfully understand the negotiation, documentation, selection, and execution/governance of a successful outsourcing relationship.
O-3: Optimizing R&D Outsourcing Business Model: From Preclinical to Development - A Case Study. 2:00PM - 3:00PM (Wednesday, March 26, 2008)
Numerous pharmaceuticals and biotechnology companies are outsourcing pharmaceutical chemistry to CROs world wide to evade rising R&D cost pressures, regulatory challenges and shorter product life cycles. DOV Pharmaceutical Inc. is a biopharmaceutical company focused on the discovery, in-licensing, development and commercialization of novel drug candidates for central nervous system (CNS). We are one of the pioneers in the arena of drug discovery and development outsourcing. We collaborate with CROs and CMOs around the world for projects from early stage drug discovery, process development, custom manufacturing to clinical trials. In this case study, I will report on my personal experience in utilizing external technological expertise, evaluating and making technological decisions and forging strategic alignments with collaborators.
Zhengming Chen, PhD - Senior Director of Chemistry & CMC, DOV Pharmaceutical, Inc.
O-4: Innovation in Sourcing - Optimizing Your Outsourcing Strategy and Enabling a High Performance Governance Organization 3:15PM - 4:15PM (Wednesday, March 26, 2008)
Pharmaceutical and biotech organizations continue to face extreme revenue pressures as a result of shrinking “blockbuster” pipelines, near-term patent expirations, increased generic competition and a trend towards personalized medicine. Cost pressures also remain intense with customers, shareholders and regulators requiring increased customer service and compliance and reduced operational costs. Outsourcing (including offshoring) has become an established approach for many large and small organizations to assist in driving profitable growth from a manufacturing perspective and is starting to become more widely adopted for services as well. Yet, many firms have been disappointed by the results of outsourcing. Typically, outsourcing strategy and deals are poorly designed and/or executed and the governance organizations put in place to manage the outsourced functions or processes, after the deals are signed, are ill-equipped and/or lacking the key competencies needed to drive significant value creation from outsourcing. Also, many firms implement one-off deals, often in disparate areas of the business, without considering the impact on value creation (or destruction) at an enterprise level. The net business outcome is that there is often significant ‘value leakage' and unfulfilled expectations from outsourcing. So, how can organizations gain maximum benefit from outsourcing and deliver high performance, with valuable outcomes for both the buyers and providers of outsourced services, while mitigating the risks of value leakage? In this session, Chris Nuttall will describe best practice and innovations in how pharmaceutical and biotech organizations can optimize the outsourcing strategy at both an enterprise-wide level and a deal level and make that strategy sustainable by enabling a high performance governance organization. Drawing on more than thirteen years' of client experiences across both BPO and ITO, Chris will cover: • The typical challenges faced in optimizing the outsourcing strategy and enabling a high performance governance organization • Typical symptoms of under-performance and value-leakage and the underlying root causes • How to take a portfolio wide approach and formulate/implement an effective enterprise-wide outsourcing strategy, including aligning this across the organization from both ‘top down' and ‘bottom up' perspectives • How to create a balanced enterprise portfolio using a combination of outsourcing, in-house and captive delivery, alliances and shared services • How to recognize and meet the interests of all key stakeholders, including customers, employees, regulators and business partners • Typical business performance metrics that allow performance to be managed effectively • How to ensure that value creation can be sustained over time • Key lessons learned / takeaways for organizations that are both buyers and providers of outsourced services. The session will primarily take the perspective of buy-side organizations (i.e organizations that buy outsourced services) – this will allow both buyers and providers of outsourced services to establish an understanding of best practice and translate the findings into actions for their own organizations. The session will be illustrated throughout by case studies and real life examples.
O-5: Outsourcing Utilities to Focus on Core Business 9:00AM - 10:00AM (Thursday, March 27, 2008)
Outsourcing utilities to focus on core business» Manufacturing drugs is a long and a complex process which involves many skills. Nowadays, a drug manufacturing site needs numerous utilities in order to produce pills, tablets, capsules, vaccines etc. For example: a site will need potable water for lavatories, electricity for running the machines, compressed air for component activation, clean steam for process sanitisation, industrial steam for heating buildings/processes, chilled water for cooling tanks, vacuum for packaging lines, water for injection for making parenteral products. All this utilities are part of a drug manufacturing facility but are not the core business of the pharmaceutical company. This course will examine existing possibilities in outsourcing for a pharmaceutical industrial site, outline goals and objectives of both parties and the service provider's guarantees needed in order to be compliant with regulatory issues. - What kind of utilities can be found in a typical pharma plant? - Why is it important to focus on core business? - What does ‘outsourcing utilities' mean? - What are the solutions for the industrial site (O&M, BOT, ROT, AOT, BOOT,…)? - Key decision factors for choosing outsourcing - How to implement outsourcing without disrupting the plant operation? - How to consider assets, staff, quality and cost control? - How can outsourcing help a site to grow? - Does regulatory compliance match with contract guarantees & performance? - Industry feed back experiences
Johann Bonnet - Market Manager, Veolia Water Solutions & Technologies
O-6: Performance Measurement Techniques for Outsource/Contract Manufacturing 10:15AM - 11:15AM (Thursday, March 27, 2008)
Measuring the performance of your contract manufacturer is difficult task, especially as you have little control over the contract organization. As well, as a contract manufacturer your ability to differentiate against your competition is also a difficult task as the last differentiator you want to use is price. Our presentation will discuss the real world techniques used to collect/present data in format to allow the outsourcing company to retrieve near real time supply chain data as well as present key performance indicators (KPIs) and dash boards for each contract manufacturer. For the contract manufacturer our presentation will provide a view into how you can proactively present data to your customers that provide visibility and these KPIs to provide greater value as a business partner and position yourself against the competition.
John Postle - Vice President - Life Sciences, Court Square Group
O-7: Finding and Delivering Value Through Collaboration: Recent Research, Case Studies, and Practical Advice on How to Increase Value from Key Supplier Relationships 2:00PM - 3:00PM (Thursday, March 27, 2008)
On the Boeing 777, the specification control document for suppliers to build the electrical distribution system was 2500 pages. The equivalent documentation for the 787 Dreamliner was 25 pages. Drawing on recent Vantage Partners research from both buy-side and sell-side executives and relationship managers at hundreds of companies, this presentation will provide important insights on barriers to collaboration, and how to enable breakthrough partnerships with CROs, external manufacturers, and other supply chain partners. Learn how to companies inside and outside the pharmaceutical industry have tapped into the power of partnering with key suppliers, and how your organization can take collaboration to the next level.
O-8: Operational CMO Strategies for Competitive Advantage 3:15PM - 4:15PM (Thursday, March 27, 2008)
The presentation would contain two main themes including operational excellence and network optimization as well as competitive advantage strategies. The content would be present in general terms along with examples of how Patheon has been implementing these concepts in our operations as a dedicated CMO.
Speaker:
Steve Liberty - Senior VP of Operations, Canada, Patheon, Inc.
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