Sunday, August 16, 2009
Short Course #1:
Vaccine Business Opportunities: Collaborations, Mergers and AcquisitionsSuccessful Strategies for your Product and Technology
Today’s vaccine industry is responding to unmet medical needs and opportunities with exciting innovations such as new antigens, new adjuvants, new vectors and new administration as well as with new approaches such as therapeutic vaccines. The Big 5 that currently dominates over 80% of the global vaccine market as well as other vaccine producers are responding with an increasing level of interaction with the smaller players. Academia, governmental departments and increasingly NGOs also play a major role in collaboration. An understanding of the pipeline building strategies of the major players and of public sector goals as well as a knowledge of the requirements for effective cooperation are essential for success in today’s vaccine market.2:00 Chairperson’s Opening RemarksJim Self, Executive Director, Business Development, Merck Vaccines and Infectious Diseases
2:05 Adventures in Collaboration when the US Government is the CustomerRobert V. House, M.S.P.H., Ph.D., President, DynPort Vaccine Company LLC
For vaccines against certain high-hazard agents, the U.S. Government is presently the primary, if not the only, customer. Contracting requirements for government-sponsored work are often unattractive for large, vertically-integrated companies. Thus, many such products must be developed by collaborative arrangements between small-to-mid sized biotechnology or pharmaceutical companies combining resources to achieve the critical mass necessary for product development. Sometimes these collaborations involve divergent cultures, and often they involve divergent expectations. This is compounded by the expectations of the customer, often not explicitly defined. Given the extended lifecycle of vaccine development, the potential for serious conflict must be anticipated and systems put in place to avoid such conflict if all parties are to succeed. This presentation will detail case histories of such collaborative efforts, showing what went well, what went south, and how a learning culture is absolutely essential to make such arrangements work.
2:35 Experiences and Lessons Learnt from Collaborations from the Perspective of a Leading playerJim Self, Executive Director, Business Development, Merck Vaccines and Infectious DiseasesRecent examples of collaborations between Merck and other players will be examined in terms of Merck’s pipeline building strategy and features that make outside players, both biotech and public sector, attractive. It will reflect on the initial approach between the partners, due diligence experiences, assessment of risk, and experiences with handling IP, royalties and terms. The challenges encountered and lessons learnt will be described including the experiences of integrating a new technology into an existing platform. The benefits to both parties will be assessed in terms of cost reductions, speed to market, efficacy of the product and other factors.
3:05 Building and Leveraging Relationships with the Public SectorJacob Licht, Director, Corporate Development, Emergent BiosolutionsThis talk will describe our experiences with navigating the complexities of working with government entities, how listening to the public sector and delivering effective solutions builds a strong relationship, and how developing a product franchise can cater to public need.
3:35 Refreshment Break
4:05 Experiences of a Recent Collaboration Between Private and Public SectorsBernd Eisele, M.D., Chief Scientific Officer, Vaccine Project Management GmbHThe talk will report on how we have developed products in a fast and cost-efficient way together with a consortium of well-experienced partners that belong both to academia and the private sector. It will examine the steps followed for a successful collaboration and present a case study on such a successful collaboration. The benefits to both parties will be assessed and information on handling IP, royalties and terms will be given.
4:35 Collaboration Experiences from the Perspective of a Small PlayerMelissa Malhame, M.B.A., Senior Director, Marketing & Product Management, Dynavax Technologies Corp.Expectations, perspectives and reality all play roles in the negotiation and implementation of highly interactive and dependent collaborations between small and large vaccine companies. Lessons learned from the inside of a two recent and very different collaborations will be described and discussed.
Positioning your Product and Company to take Advantage of Opportunities in the Vaccine Industry
Discussion Leader:Jim Self, Executive Director, Business Development, Merck Vaccines and Infectious Diseases
Delegates will be encouraged to submit topics for discussion during the seminar. Discussion to include
1) New opportunities for technologies and target diseases
2) Current focus of the major players
3) Opportunities for collaborations/mergers between small/mid-size vaccine companies
4) Preplanning required to make a successful collaboration/partnership
5:30 End of Short Course Short Course #2:
Managing Process Change in Vaccine Manufacturing Successful regulatory submissions throughout the product life-cycle
The process defines the product, yet how is the industry to accommodate this definition with the numerous and inevitable process changes that occur in development from bench to clinic and beyond to the marketed product? Apart from the inevitable scale up during development, there can be site changes and changes of cell lines and manufacturing ingredients as more economical methods of large scale manufacturing are sought. The industry needs to be fully aware of the impact the change has on the product and be able to characterize the product sufficiently to convince the regulatory authorities that product quality has been maintained and to thereby avoid costly bridging studies.
2:00 Chairperson’s Opening RemarksKimber L. Poffenberger, Ph.D., Vice President, Head, Regulatory Affairs, Intercell USA, Inc.
2:05 Developing and Implementing Internal Strategy to Prioritize and Manage Proposed Changes to VaccinesKimber L. Poffenberger, Ph.D., Vice President, Head, Regulatory Affairs, Intercell USA, Inc.When balancing needs and nice-to-haves against regulatory reality, timing (and data) is everything. The stage of development, the process and product type, and the scope of the change dictate the approach to building the data package to show that quality does not change. The stage of development and the competent authority involved are key to the regulatory strategy; the business needs impact the timeline. These factors and how they are prioritized will be discussed briefly, with examples of typical changes made to vaccines at different stages. A more in-depth case study for an early stage change will be presented covering the nature of the change, how the process defined the approach to comparability, technology applied for characterization, and the nature of the bridging study.
2:35 Analytical Technologies for the Well Characterized Recombinant Vaccine, Gardasil: From Bench to Commercial ManufactureRobert D. Sitrin Ph.D., Executive Director, GVTE-Bioanalytics, Merck Manufacturing DivisionThe inevitable manufacturing changes in the development of a commercially successful vaccine will be discussed together with technologies for fully characterizing the product. Merck’s experiences with setting up a panel of characterization tests together with validation and interpretation of results will be presented. The inevitable manufacturing changes in the development of a commercially successful vaccine will be discussed together with technologies for fully characterizing the product. Merck’s experiences with setting up a panel of characterization tests together with validation and interpretation of results will be presented. The discussion will also describe how the in vitro potency assay was validated against in vivo and human clinical data.
3:05 Rapid Production of Vaccine against New Annual Strains of Influenza VirusValerie Mermall, Ph.D., Director, Quality Assurance, Protein Sciences CorporationVaccination is the most effective method for preventing influenza (flu), the highly contagious, acute viral respiratory disease caused by influenza viruses. The flu strains in circulation and vaccine composition can vary annually. The composition of three strains is determined in February/March and patients are vaccinated in the fall. Insect cell production technology offers a method for the rapid production of vaccine in this challenging field. Annual strain change requires cloning, process development, process transfer to production and verification at scale for up to three new strains per year. Our systems for annual strain change and experiences at scale will be discussed.
3:50 Regulatory Considerations for Change Management throughout the Vaccine Development LifecycleNancy Kavanaugh, Ph.D., Senior Director, Regulatory Affairs-Vaccines, MedImmune Inc.Throughout the vaccine development and commercialization lifecycle, it is imperative that an appropriate level of change management be applied for process changes and improvements. For vaccines and other biological products, significant changes, such as the introduction of a new cell line or a formulation change, can be particularly difficult to assess and characterize. Consideration must be given to analytical comparability, toxicological effects, adventitious agent and other safety risks and the introduction of impurities which may be difficult to assess. The goal of this presentation is to provide a strategy for the maintenance of a comprehensive history of process changes, commensurate with the stage of product development, that meet both US and EU quality and regulatory standards and that will lead to successful regulatory submissions throughout the vaccine development lifecycle.
4:20 Negotiating the Regulatory Minefield of Process Change Control Sheila M. Magil, Consultant, BioProcess Technology Consultants, Inc.This paper aims to provide the key to successful change control. We will discuss the design of comparability studies and their application to change control, in the context of the national and international regulations. We will examine how to determine the relationship between the magnitude of the change and the required scope of the comparability studies and the way in which the change is to be reported and approved by the regulatory agencies. Actual case histories will be used to illustrate these topics.
4:50 Discussion: Risk Assessment and Optimal Protocol for Process Change
To be led by:Kimber L. Poffenberger, Ph.D., Vice President, Head, Regulatory Affairs, Intercell USA, Inc.Delegates will be encouraged to submit topics for discussion during the seminar. Discussion to include:
1) Requirements for a comprehensive risk assessment and product impact assessment before undertaking a process change
2) The optimum timing for a process change
3) The amount of comparability that has to be done for specific changes
4) Differences experienced in FDA vs EMEA approaches to process change control
5:20 End of Seminar
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