Pharma Executive Program (PharmaExec)

This course has been carefully designed to encourage and facilitate optimal interaction between attendees. With participation restricted to senior executives (director level or higher) from the pharmaceutical and biotech industries, speakers and attendees bring considerable knowledge to the timely topics that will be covered. Some of the strategic and operational questions that will be addressed include:

As an attendee, you can expect to gain insight and actionable advice on these and other more specific issues. You will be asked to complete an optional survey prior to the conference, indicating both topics of particular interest to you, as well as your areas of expertise. Responses will allow us to provide you with names of other attendees you will find particularly beneficial to seek out for conversations.

Case studies, workshops, panels and ample time for networking will ensure the opportunity for you to share your own experiences and to learn from your peers. To further encourage discussion and interaction, the course will be closed to vendors and the media (except for sponsors), and all discussions will be confidential. In order to maintain a non-commercial atmosphere at the meeting there will be no exhibits permitted.

ATTENDANCE IS BY INVITATION OR QUALIFICATION ONLY

Attendance at this forum is by invitation or qualification only to ensure that the audience consists of senior level executives (director level or above) from pharmaceutical and biotechnology firms. This restricted access approach guarantees that the level of experience represented in the audience will be extremely valuable for networking and discussion purposes. To increase these opportunities, delegates and speakers will be asked to complete a pre-conference survey indicating areas of expertise and interest in strategic issues, so that people sharing similar experience can be matched prior to the event.

Session One: R&D Productivity

The efficiency of the drug development process has come under fire, with calls for significant reductions in the length of time required and high cost. At the same time, the industry faces the prospect of trying to address many new targets about which little may be known, integrate powerful new technologies, and overcome resistance to change. Improved R&D productivity will clearly be a major factor in distinguishing industry leaders from those that lag.

Opening Remarks
R&D Productivity Trends, Issues, and Prospects
Pharmaceutical R&D has been fully transformed during the past few decades. In the late 1970s and throughout the 1980s, companies centered around reengineering, chemistry, and genetics work. Later, in the 1990s, applying technology became the focal point, with companies developing discovery simulations and virtual R&D. Now, we face perhaps the most complex and least quantifiable challenge for R&D: managing human dynamics. Companies must coordinate teams, manage workflow, integrate groups, and discover ways to work more effectively and efficiently on an increasingly global scale. This talk will present the varied history of the R&D function and discuss what we can expect for the future based on experiences of the past and present. I will address which factors driving our work today will set the stage for companies' performance down the road and how they can create a path for performance improvement in R&D in an ever-changing and increasingly competitive market.

Metrics for Determining Productivity Gains from Genomic Information
Genomic and proteomic data represent both an opportunity and a challenge for the drug discovery and development process. More detailed information at the molecular level, as well as detailed pathway information, can result in better validated targets, more of a basis for structure-based design, and cleaner drugs through examination of potential cross-reactivity. But those expecting to measure the benefits of this information being available strictly in terms of reduced development time may be disappointed. Metrics that take into account target novelty, target quality, drug efficacy, and competitive positioning, as well as time and investment cost, must be balanced to arrive at a truer picture of the impact of genomics on drug development productivity.

Productivity Benchmarking within R&D
Productivity benchmarking involves a comparison of strategies and specific steps employed within a company to examples of best practices that can be identified elsewhere within the industry. Such comparisons can bring to light certain changes that can be relatively easy to implement, particularly when improved communication results from making people aware of the right questions. Several specific examples will be reviewed, along with the practical and strategic impact of changes brought about by the benchmarking process.

Case Study of R&D Productivity Analysis
As the race to capitalize on human genetic information enters a new phase, it is important to understand and address the bottlenecks in the target identification and validation pathway. The advent of automation to molecular and cell biology has created the opportunity for higher throughput and higher content phenotypic analysis. One accelerator in the field has been the parallel synthesis of adenoviral gene expression vectors to enable phenotype analysis of expression of a library of genes. The process is not without caveats, and other high throughput tools are required to complete the arsenal. A specific case study will be presented and discussed.

SESSION TWO: CONCURRENT ORGANIZATIONAL BEHAVIOR WORKSHOPS

Drug development is increasingly dependent upon the quality and skill of the people employed. Getting the most out of these people, retaining the best, and having them work effectively together doesn't just happen. These four workshops, each dealing with specific organizational challenges, will be offered twice, enabling attendance at two out of the four. A summary of lessons emerging from the workshops will then be provided by workshop leaders as a roundup to the session.

A. Unleashing Team Competencies to Achieve Business and Performance Goals
If your organization is thinking about jumping on the "team bandwagon," this is a must-see session. Teams are not the panacea for all corporate challenges, although they can be extremely beneficial if you're trying to tackle complex or transformational issues. EquiPro International and Pfizer, Inc. have worked together over the past six years to orchestrate and launch many teams throughout the world. During this session you will learn from the experiences of Pfizer and other companies how to:

B. Scaling HR Training and Retention Programs to Meet Skill and Talent Needs for Growth: Shared Perspectives and Incorporating New Technology Tools
As the war for talent wages and the pressures to increase quality and quantity of New Molecular Entities (NMEs) entering the consumer market become greater, all at lower cost, companies are faced with how to balance the apparent diametrically opposed priorities and still do good science. Certainly key to the hope of achieving this duality in priorities is getting the right talent with the requisite skills when you need them and then keeping them. This workshop/break-out session will explore a staffing agency's perspective, discuss some relevant case studies on successful application, engage the participants in what they've used and have seen work, and then wrap up with a synthesis of the ideas presented in the hourlong session.

C. Mentoring Programs: Recent Developments, Future Strategies
Mentoring is still the most time-proven way to develop people. By working with a wide variety of Fortune 500 companies, Corporate Mentoring Solutions has experienced first hand the sweeping revolution taking place in mentoring. This session will benefit you if can answer yes to one or more of the following.

The mentoring session will enable you to determine what the implications of five recent, major developments in corporate mentoring triggered by demographic and technical changes, legal issues, and globalization are for your company.
The session will cover five forward-looking strategies and their implications for your organization. These include three types of alignment, multilevel leadership, and new mentoring options. During both sessions, participants will have the opportunity to sample an Online Mentoring Solutions System-a new electronic tool for mentoring programs.

D. Encouraging Entrepreneurial Thinking in a Conservative Environment
Are managers developing the entrepreneurial skills needed for organizational effectiveness in the knowledge economy? Understanding the role of entrepreneurial thinking as a discipline is becoming essential for management performance, especially in a knowledge-based organization. In this session you will capture the nucleus of entrepreneurship, creativity, and innovation as managerial practices based on the fundamental principles for managing knowledge as capital. During this session you will:

Identification of Health Genes Based on Studies of Centenarians
There is a substantial distinction to be made between the genetics of aging and the genetics of exceptional longevity. Twin studies suggest that the average set of genetic variations facilitate the average human's ability to live well into his/her octogenarian years, spending the majority of those years in good health. However, many people counteract such genetic endowment with poor health habits resulting in a substantially lower average life expectancy and relatively more time spent in poor health. To live beyond the octogenarian years, life span experiments in lower organisms and mammals and population and molecular genetic studies of centenarian sibships indicate that genetic factors play an increasingly important role as the limit of life span is approached. These factors are likely to influence basic mechanisms of aging, which in turn broadly influence susceptibility to age-related illnesses. Lacking genetic variations that predispose to disease and having variations that confer disease resistance (longevity enabling genes) are probably both important to such a remarkable survival advantage. Recent studies indicate the likelihood that such factors will be elucidated in the near future.

SESSION THREE: INFORMATICS AND POST-GENOMIC DRUG DEVELOPMENT
High-throughput methods are resulting in a huge increase in the volume and type of genomic and proteomic data available to researchers. Increasingly comprehensive data at the molecular level, however, do not immediately translate into knowledge without sophisticated informatics for interpretation and data mining. To what extent will the paradigm of hypothesis-driven empirical research be replaced by observation-driven and computational approaches? What are the implications and challenges of these shifts?

From Genomics to Discovery
The completion of the human genome provides the foundation for developing new understanding of biology and, ultimately, new diagnostic and therapeutic products. Celera's strategy has been to employ high-throughput techniques for acquiring complementary biological information including sequence, SNP, and proteomic information and to apply highly sophisticated bioinformatics for interpretation and analysis of these data. Perspectives on how these capabilities will be integrated to discover new targets and markers and ultimately new therapeutic and diagnostic products will be presented.

Productively Utilizing the Flood of Genomic Data for Impact across the Drug Development Pipeline

Multiple novel technologies have recently been developed to improve the analysis of genetic sequences, to rapidly assess RNA or protein levels in relevant tissues, and to validate the function of potential new drug targets. The challenge facing pharmaceutical research is one of effective integration of these new technologies in ways that can maximally affect the discovery and development pipeline. Database mining and transcriptional profiling have clearly increased the number of putative new drug targets; hence much of the current focus is toward assigning function to new gene targets using a variety of high-throughput functional genomic and target validation technologies. To enable this we need to incorporate parallel processes into our traditionally linear progression from gene identification, functional elucidation, target validation, screen development, and beyond. In this presentation several examples will be given that illustrate how Bristol-Myers Squibb is tackling these issues.

Implications and Challenges of Bioinformatics under Post-genomic Conditions
The rapid increase in the volume and diversity of genetic, genomic, and proteomic data has placed enormous challenges on the field of bioinformatics to manage these data and to play a pivotal role in the translation of these data into information and into knowledge. One significant challenge is making sure that these data, information, and knowledge are available to the right people at the right time in the right format to facilitate better decisions. Finding effective ways to integrate diverse types of data across different databases represents both a major challenge and a huge opportunity for mining to find novel relationships and interactions. As more and better information becomes widely available, the expertise with which it is managed and analyzed will increasingly become the basis of competitive advantage for the creation of new medicines.

Impact of Pharmacogenomics on Pharmaceutical Strategies
Few developments have as much potential to impact the shape of the competitive pharmaceutical landscape as pharmacogenomics. Whereas the traditional strategy has been to identify opportunities for blockbuster drugs and markets, pharmacogenomics seems to run counter to this by slicing up patient populations into smaller segments. Much of the pharmaceutical aversion to pharmacogenomics may be the result of applying it to drugs that have been developed, as they enter the clinical evaluation stage, rather than using it as early as target selection. Pharmacogenomics may also have significant impact on pricing and marketing messages, once higher rates of efficacy can be demonstrated for more selective populations. Panelists will share opinions and perspectives on the strategic implications of pharmacogenomics, as they see the developments taking place.

Prospects, Potential, and Hurdles for in Silico Research
The proliferation of potential drug targets has made it even more clear how important it has become to be able to employ simulation approaches for evaluating our understanding of biology and potential targets. As the cost of doing empirical wet lab studies continues to increase relative to computational efforts, economics alone dictates increased use of these tools. How accurate do models need to be in order to provide useful insights or substantial competitive advantages? Executives from two of the leading developers of in silico models, based on quite different approaches, provide an assessment of how the field has progressed, what challenges still need to be met, and the prospects for more widespread application of the technology in the future. Perspectives of end-users of the technology may also be provided.

Session Four: Knowledge Management

With more information becoming available about biology and target structures, chemical compounds, diseases, and clinical populations, drug development is very much an information science. Effective knowledge management involves learning as an organization, sharing information and transforming information into value. The nature of the tasks required in this area are shifting, but clearly those organizations that do the best job of managing information will have a competitive advantage.

Support Your Knowledge Management Initiative with Innovative Technology
In today's fast-moving, increasingly complex environment where intellectual capital drives the pharmaceutical industry, companies that can leverage their internal knowledge and expertise will increase their competitive position. The main challenges to implement a Knowledge Management Initiative relate to three main categories: business/strategy direction, human/collaboration environment, and the role of information technology. In this session, we will focus on the third aspect-the role of information technology. Challenges and methodologies to be addressed prior to bringing a technology based solution will be presented.

Competitive Intelligence: Knowledge of a Different Kind
In most biotech and pharmaceutical companies the intelligence functions have not yet moved out of first "gear." Skills and systems necessary to get to the targets are largely underdeveloped. Information is used by many managers more as a means of exercising influence rather than gaining new insights on opportunities, crises, or radical changes. However, what counts today more than ever before is efficiency and speed by which companies build and utilize this knowledge. Precondition for long-term survival and success is knowledge about competitors' pipelines and their strategies. The presentation focuses on ways that companies can use competitive intelligence to achieve their goals and get market superiority for their products.

Brilliant Opportunities and Sophisticated Burdens in Assessing, Protecting, and Exploiting Intellectual Property
There are recent changes in U.S. patent laws that have a stunning impact on the strength of a company's patents in the marketplace, as well as on the ability of a biotech company to obtain patent protection at all. What should a biotech company know about the new patent laws and policies to protect itself effectively? What strategies should the company now employ to create and enforce its patents? Competitor patents may now be much weaker in strength and scope; how can these patents be assessed and exploited? What new approaches should a company take to avoid a competitor's patent? This presentation addresses the brilliant opportunities and sophisticated burdens that the patent laws now afford.

Maximizing Knowledge Flow into and within R&D: The People Aspect
The people aspect of knowledge management initiatives in pharmaceutical R&D is often underestimated or overlooked entirely as most of the effort goes into implementing information technology tools. As a result, a significant portion of the expected benefit from these initiatives is never realized. This presentation outlines how the flow of knowledge into and within R&D can be maximized by tackling the people aspect proactively. We will show how to map and analyze scientific communication networks using innovative ideas derived from "small world theory" in order to increase the leverage from both internal and external experts. And we will discuss how to remove the cultural and organizational barriers that often impede the flow of knowledge.

SESSION FIVE: INTEGRATION

There are numerous specific pieces that contribute to the success of a company, but often the real value of management is seen in the way in which these pieces are brought together. Companies that previously worked as autonomous departments and insulated organizations have given way to greater collaboration. The lines between departments, discovery, and development, within the company and outside, as well as across national boundaries, have been blurred. Managing the challenges presented by this integration requires being prepared for new approaches, creative thinking, and adaptation, but the difference in results can be enormous.

Financial Implications of Impression of Pharmaceutical Integration Strategies
In the short run, the value of pharmaceutical companies is largely based on earnings generated by marketed drugs. In the longer run, however, confidence in how well the company is integrating responses to changes in the competitive market affects perceptions of how well the company will be able to develop new therapies over time. This confidence, or lack of it, will ultimately drive stock valuations. What strategies are companies employing that increase investor confidence that they will be productive enough to compete more effectively in the future? Are there specific approaches or signs that suggest that a company is relying on outdated thinking and that they will increasingly fall behind industry standards?

Integration across Multiple Locations and Cultures
In the era of very large Drug Discovery organizations with multi-site, multi-national and multi-partner activities it is difficult to understand what the organization is presently doing and has already done. This presentation will aim to address some of the issues with globalization vs local autonomy. This will look at the presentation from three aspects, picking drug targets, data integration, and global technical/technology groups.

Integration of Technology and Business to achieve Productivity and Revenue
For large pharmaceutical companies, technology is the key to increased productivity and the efficient prosecution of therapeutic pipelines to meet critical growth targets whereas for many biotechnology companies, technology is a launching point from which to enter into the discovery and development of therapeutic products. Despite large expenditures on technology components, productivity enhancements within big pharma have been elusive. Critical to achieving hoped for productivity is the integration of disparate technologies, restructuring processes to utilize new capabilities, and organizational change management to take advantage of scales inherent in systems biology approaches. Platform companies leveraging technologies to enter into therapeutic development face the challenge of integrating their technology through partnerships and alliances to achieve revenue while developing early pipelines. Successful execution of these strategies requires functional coordination of science, technology, and business. How, When, Where, Examples.