| Day One, Module One | OUTSOURCING PARTNERSHIP TRENDS AND STRATEGIES | | 9:00 | Session 1: Establishing the domestic and global outsourcing landscape – will outsourcing continue to be a long-term strategy for the pharma industry?
- Determining whether the trend of outsourcing at almost every stage of the value chain is an inevitable and long-term strategy
- Examining the implications of this increasing incidence of outsourcing for the core competencies of pharma companies
- Assessing the impact of the global recession on the outsourcing sector – when, what and where to outsource?
- Leveraging global outsourcing as a tool to gain entry into emerging markets and capitalize on their potential to be the next buyers in the future global pharma market
Jan Paul Zonnenberg, Partner, Healthcare Practice, PricewaterhouseCoopers | | 9:30 | Session 2: Overcoming the different challenges encountered by small and large pharma companies when outsourcing to drive innovation and reduce costs
- Overcoming the different challenges encountered by small and large pharma companies when outsourcing to drive innovation and reduce costs
- Examining the different outsourcing partner management models available to determine which is the most appropriate for large or small pharma companies
- Identifying the specific criteria that large and small pharma companies use when selecting their outsourcing partners
- Outlining strategies and techniques to effectively manage operational units of different sizes and outsourcing partners, and ensure quality throughout
-Managing the impact of outsourcing on internal departments within a company from a quality, cost and technical perspective
- Implementing an efficient organizational structure and appropriate procurement/sourcing team to ensure robust communication, timelines and contracts, and good relationships with the right service providers
Philip Pratten, VP Business Development, Alkermes Contract Pharma Services | | 10:00 | Session 3: Panel Discussion
Pharma-Service Provider Relationship: Building stronger partnerships and ensuring transparency in outsourcing and operations
- Examining current approaches, new trends and latest strategies for pharma/biotech and service providers working together to form strong partnerships for long term success
- Openly communicating the capabilities of each partner and building the right team at the start of the project
- How to keep the relationship healthy – enabling honesty, trust, flexibility and open lines of communication, and understanding the changing needs of the client
- Ensuring transparency by implementing a winning plan to manage change of scope, construction of partner agreement and statement of work
- Assessing the benefits of pharma companies building strategic alliances and partnerships with outsourcing partners to add value, reduce costs, and increase innovation
- Sharing lessons learned, pitfalls to avoid and successful examples of how to structure pharma-service provider partnerships
Richard Busby, Director, Client Services, Novella Clinical Resourcing
Christina S. DiArcangelo, Chief Executive Officer and Founder, Armonia Clinical Research, LLC
Krystyna Kowalczyk, Executive VP, Clinical Operations, Novella Clinical Resourcing
| | 10:30 | Ask the Experts: Q&A strategic panel session | | Day One, Module Two | PARTNER SELECTION, CONTRACTING AND RELATIONSHIP MANAGEMENT
| | 11:15 | Session 1: Effective strategies for selecting the most appropriate outsourcing partners to deliver on your business goals
- Assessing business needs to establish partner requirements and identifying where to find potential partners appropriate for meeting these needs
- Determining the assessment criteria and metrics to measure potential partners against during the selection process
- Overcoming the ongoing challenge of finding partners who are qualified and comply with regulations
- Understanding what type of vetting procedures to put in place and performing the necessary background checks and due diligence when selecting domestic and global partners in an effort to mitigate risk
- Examining the importance in investing time upfront in the transfer of methods and technology from one partner to another
Bernie Huyghe, Senior Director, Biotherapeutics & Vaccine Outsourcing, Pfizer, Inc. | | 11:45 | Session 2: Practical strategies for structuring supplier service agreements to ensure maximum return and the protection of quality standards
- Developing clear vendor contracts that are easily understood by all parties, support collaboration and explicitly outline all requirements, including expected levels of performance and quality
- Assessing the legal issues involved in developing domestic and global partner agreements to ensure protection of all parties' interests
- Creating a robust contract with outsourcing partners to ensure regulatory compliance, IP protection and the delivery of quality
- Devising global agreements which clearly specify ownership and responsibility and address problem resolution
- Building terms into contractual arrangements that allow the client access to critical data, documentation and IP
Speaker TBA
| | 12:15 | Session 3: Best practice supplier relationship management – Managing and monitoring partners to realize the full potential of outsourcing and achieve long-term business goals
- Understanding why good relationship management is critical to a successful partnership and identifying the key elements to achieving this
- Developing effective monitoring processes to ensure ongoing partner evaluation and the delivery of quality
- Formulating strategies to ensure partners adhere to timelines and are conscientious with documentation
- Clearly defining roles and responsibilities and building trust and good communication between partners to achieve success
- Exploring how to ensure a smooth interface between client/outsource partner and craft the day-to-day management of the relationship
- Determining how to manage multiple outsourcing partners effectively to ensure compliance, efficiency and quality
Stefan Proniuk, PhD, Vice President Product Development, Arno Therapeutics | | 12:45 | Ask the Experts: Q&A strategic panel session | | Day One, Module Three | WORKING WITH LCC OUTSOURCING PARTNERS | | 2:15 | Session 1: Assessing the latest trends around working with low cost countries (LCCs) as outsourcing partners
- Identifying and capitalizing on the benefits international partners can provide and overcoming financial, compliance and operational risks
- Determining the most appropriate activities to be outsourced internationally
- Establishing to what extent it is better to manufacture in LCCs or closer to home where there is a higher degree of control, more knowledge and a better cultural fit
- Assessing the varying geographical regulatory and environmental legislation in key target regions and how this landscape is evolving to identify how multinational companies can benefit
- Implementing and managing effective environmental sustainability strategies with your partners
- Examining the impact of the domestic economic downturn and the economic growth in emerging markets on outsourcing
Victoria Phelan, Director – Pharmaceutical and Life Sciences – KPMG’s Shared Services and Outsourcing Advisory (SSOA), KPMG
Marc Stark, Director, Shared Services and Outsourcing Advisory, KPMG | | 2:45 | Session 2: Identifying and overcoming the specific challenges encountered when working in India, China and Eastern Europe
- Outlining the key customs, work ethic and etiquette pertinent when doing business in China, India and Eastern Europe
- Establishing the criteria and parameters for identifying a reliable partner who will consistently deliver quality
- Detailing accountability and quality – strategies to ensure open communication around issues and problems in manufacturing and to avoid the cutting of corners to meet deadlines
- Determining how to overcome communication, language, geographical and cultural differences to ensure an efficient working relationship and protect timelines and quality
- Assessing FDA and international regulatory expectations when working with LCCs to ensure compliance
- Identifying the typical vulnerabilities which exist in the US pharma-LCC outsourcing partner relationship to minimize their negative impact
Parminder Sidhu, Associate Director, Drug Product Science and Technology, Bristol-Myers Squibb
| | 3:15 | Session 3: Best practice example of an effective partnership with an LCC
- Examining how to build a robust partnership and strategically collaborate to ensure a win-win scenario for all stakeholders
- Identifying the issues, pitfalls and headaches when working with LCCs and how to get the job done despite these challenges
- Applying past learnings to help US pharma companies build trust and achieve stronger working relationships with partners
- Building flexibility into your supply chain to allow adequate time for approvals given regulatory pressures and the increasing number of audits
- Prioritizing open communication and adapting organizational structure and processes to enable this
- Real world recommendations on meeting regulatory requirements and responding to correspondence from regulatory agencies
Bing Yu, PhD, General Manager, GLSyntech, LLC
| | 3:45 | Ask the Experts: Q&A strategic panel session | | |
