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November 3 - 4, 2014

Red Chess Large12th Annual

Enhanced R&D Productivity, Forecasting and Planning 



Monday, November 3

8:00 am Registration and Morning Coffee


IDENTIFIYING THE KEY CHALLENGES FOR BIOPHARMA R&D TODAY

9:00 Organizer’s Welcome

Micah LiebermanMicah Lieberman, Executive Director, Conferences, BioPharmaceutical Strategy Series, Cambridge Healthtech Institute (CHI)


Jonathan Freeman9:05 Chairperson’s Opening Remarks

Jonathan Freeman, Ph.D., Senior Vice President, Head of Portfolio Management, Merck Serono



9:15 KEYNOTE PRESENTATION: Challenges Facing the Biopharmaceutical Industry

John LaMattinaJohn LaMattina, Senior Partner, PureTech Ventures; former President of R&D, Pfizer

Ironically, despite the tremendous opportunities that now exist in biopharmaceutical R&D, the industry is facing the most challenging time in its history. There are two different aspects to these challenges. The first involves higher hurdles to R&D success due to the need to prove to the FDA and payers the value of new medicines. The second is the industry’s poor reputation. Both of these issues will be addressed.


10:00 Practical Resource Management Lessons Learned, Baxter’s Story

Michael ShiresMichael Shires, Vice President, Program and Portfolio Management, Baxter Healthcare

This presentation will share how we: determined the optimal strategy, timing and techniques for portfolio, project and resource management at Baxter; documented those lessons learned to prevent future challenges and continue successful outcomes; integrated project and portfolio management capabilities to effectively build for the future; and developed benchmarking methods to adapt to shifts in the pharmaceutical industry.

10:30 Coffee Break


CAPACITY PLANNING AND PERFORMANCE TRACKING

11:00 Leveraging Resource Planning and Pipeline Operations to Deliver on Strategic R&D Goals

Greg BayerGreg Bayer, Group Director, R&D Scheduling & Resource Management, Bristol-Myers Squibb

Ensuring successful delivery of our pipeline is key to enabling our BioPharma enterprise and our evolving strategy. Strong delivery first relies on planning effectively to “right-size” the portfolio given fixed budget and resources to ensure delivery of our pipeline within budget, but also not leaving budget or resources underutilized. It also requires managing changes as they occur across our 60+ compounds, particularly where we have strategic imperatives. This presentation will provide insight into our operational capabilities that enable our strategy, with examples of how we re-establish our portfolio budget annually, how we recently established a resource plan for a high priority program, evaluated and resolved resource gaps across our regulatory submissions, operationally plan for a globally distributed clinical trial portfolio, and track and improve the on-time performance of our clinical trials.  

11:30 Leveraging Resource Management to Drive Your Operating Plan 

Phil WolfPhil Wolf, Senior Vice President, Enterprise and On Demand Products, PDWare


11:45 pm Sponsored Presentation (Opportunity Available)

12:00 Co-Presentation: Integration of Kanban and Finance in Development of IT Solutions at Siemens Health Services

Bennet ValletBennet Vallet, Director, Product Development, Siemens


Tom StoneTom Stone, Lecturer in Business, Penn State University, Abington College

Siemens Health Services is one of the first large-scale R&D organizations to utilize the Agile development process along with the Kanban method for improving the “flow” of the development process. We are now able to measure the cost of inputs and the cost and volume of outputs and identify the work-in-process costs associated with bottlenecks in the R&D process. While our initial implementation looked strictly at the development process, we are now launching a project to apply the Kanban method across our whole value stream. The audience will learn that by understanding flow—and more importantly the metrics of flow—they would be able to take specific actions to improve overall predictability and process performance. The reason these flow metrics are preferable to traditional agile metrics is because they are much more actionable and transparent.

12:30 Luncheon Presentation: Increasing the Value of Your R&D Portfolio with Planisware Analytics

Dave PenndorfDave Penndorf, Executive Consultant, Planisware USA

Your organization has been diligently scheduling projects, forecasting resources, estimating expenses, and tracking progress and risks. How can you inspect this body of information to transform data into decisions? In this presentation, Dave Penndorf will review a selection of simulation, modeling, and optimization techniques in Planisware that provide insight for R&D organizations to make better informed, data-driven project and portfolio level decisions, to ultimately increase the value of your portfolio.


INTELLIGENT OUTSOURCING FOR IMPROVED RESOURCE MANAGEMENT

1:40 Chairperson’s Remarks

Babler_ScottScott Babler, Strategic Realization Manager, Integrated Project Management Company, Inc.





1:45 Project and Portfolio Management for Clinical Outsourcing

Arkady GusevArkady Gusev, Ph.D., US Operations Head, Biomarker Development (BMD), Translational Medicine, Novartis Institutes for BioMedical Research, Inc.

This presentation will share an approach for project-portfolio management of clinical assays and biomarkers outsourcing. The presentation will address our strategy, the value proposition, details of the project, management of assays carried out by external service providers, integration with the clinical portfolio, and differentiation between in-house and outsourced portfolio management. Other critical elements including quality and regulatory compliances and their integration into the project-portfolio management will be presented.

2:15 CRO-Pharma Co-Presentation: Intelligent Outsourcing for Improved Resource Management

Part 1: Unleashing Partners & Networks: Intelligent Outsourcing for Improved Resource Management – A CRO Perspective

Rafiq IslamRafiq Islam, Senior Director, Bioanalytical Services, Celerion

There is an accelerating trend in the biopharmaceutical industry of R&D outsourcing to CROs and other service providers. The number of suppliers (i.e. CROs and service providers) and type of offerings has also increased significantly. This growing number of supply alternatives means a wider range of the quality and cost of service. Designing the right global portfolio of R&D partners and service providers has become increasingly complex and inefficient. As a result the strategic, operational and financial benefits of R&D outsourcing often remain untapped. This presentation will provide a CRO prospective on how to set up and effectively utilize a network of partner service providers to dramatically improve R&D performance.

Part 2: Intelligent Outsourcing that Enables Right Decision at Right Time with Reasonable Cost

Ling HeLing He, Director, Clinical Bioanalysis, Daiichi Sankyo Pharma Development

The pharmaceutical R&D organizations have been increasingly challenged to “do more with less.” As a mid-size pharmaceutical company, effective outsourcing is an essential part of Daiichi Sankyo’s clinical development strategy. The author will share insights and perspectives, including value considerations, regulatory framework, and quality attributes regarding outsourcing of specialty lab work (such as clinical bioanalysis and biomarkers), and discuss the guiding principle of “right decision at right time with a reasonable cost.”

3:15 Sponsored Presentations (Opportunities Available)

3:45 Refreshment Break in the Exhibit Hall


4:30 Interactive Breakout Discussions

Concurrent breakout discussion groups are interactive, guided discussions hosted by a facilitator or set of co-facilitators to discuss some of the key issues presented earlier in the day’s sessions. Delegates will join a table of interest and become an active part of the discussion at hand. To get the most out of this interactive session and format please come prepared to share examples from your work, vet some ideas with your peers, be a part of group interrogation and problem solving, and, most importantly, participate in active idea sharing.

Monday Afternoon, November 3 & Tuesday Afternoon, November 4 

TABLE: The Use of Open Innovation in a Research and Development OrganizationModerator: Jeffrey Davis, M.D., Director, Human Health and Performance (HH&P), CMO, NASA Johnson Space Center &
Elizabeth Richard, Senior Strategist, Wyle Science, Technology and Integration
• Identifying appropriate challenges to conduct open innovation competitions
• Addressing cultural barriers to acceptance
• Strategies for co-development (virtual centers) – the NASA Human Health and Performance Center (NHHPc)
• Organizational strategies for success
 

TABLE: Drug Discovery and The Unknown UnknownsModerator: Daniel Zweidler, Ph.D., Senior Fellow, Mack Institute for Innovation Management, The Wharton School, UPenn; President, DZA, Inc.• Implication for portfolio management … what is a “portfolio” to start with?
• Implications for decision making and funding levels required for "success"
• What are the critical success factors for a thriving business environment?

TABLE: Decision Quality: Initial Investment Approval Vs. The Reality of ExecutionModerators: Elayne Ko, Director, Portfolio and Decision Analysis, Pfizer &
Tom Stone, Lecturer in Business, Penn State University, Abington College
• What importance do organizations place in the investment decisions vs. subsequent project-related decisions?
• Is decision quality valued through all stages of the project; if not, then does inconsistency create downstream issues in the future?
• How does management track the progress of the investment decisions? 

TABLE: Strategic Resource Management in the New Era of Rising New Product ProductivityModerator: John Ansell, Senior Partner, TranScrip Partners• How might we re-think deployment of resources internally in light of the rising numbers of projects across the industry at every development phase ?
• How should this affect activities externally ?
• Changing mindsets after decades of downturn.

TABLE: A Closer Look at Big Data and Analytics: Where are the opportunities vs the hype?Moderator: Krish Ghosh, Ph.D., MBA, Vice President, Informatics, Covance• Define the breadth and depth (along with the characteristics and elements) of Big Data from the Healthcare sector that directly applies across the entire Pharmaceutical R&D continuum.
• Can Big Data analytics enable faster and superior decision making in R&D from new insights, leading to improved R&D productivity? Where are the opportunities and where is the hype?
• What should be the role of the Pharmaceutical R&D Leaders in making Big Data Analytics a reality, and helping towards development of faster, cheaper and high quality drugs?

If you have a Breakout Discussion topic suggestion, please submit your idea using the online form: http://www.executivedecisionmaking.com/sra-pfo_content.aspx?ekfrm=135879&libID=135828 


5:30 Welcome Reception in the Exhibit Hall

6:30 Close of Day


Tuesday, November 4

7:30 am Registration


BIG DATA TO IMPROVE DECISION MAKING AND FORECASTING

7:45 Breakfast Presentation (Sponsorship Opportunity Available)
or Morning Coffee

8:25 Chairperson’s Remarks

Charles AlsdorfCharles Alsdorf, Director, Capital Efficiency Services, Deloitte


8:30 Big Data and Analytics for Pharma: Enabling Improved Forecasting and Decision Making

Sam MathewSam Mathew, MBA, Portfolio Capacity Management Leader, Finance/PMO, Janssen Pharmaceuticals


9:00 A Closer Look at Big Data and Analytics to Improve Drug Development Performance

Krish GhoshKrish Ghosh, Ph.D., MBA, Vice President, Informatics, Covance

Big Data is one of the hottest buzz phrases among pharmaceutical executives today. They recognize that the implications of utilizing big data in a way that will benefit the business cannot be ignored, specifically in the areas of portfolio/resource management and forecasting. Exploring the use of big data through utilization of such capabilities as data analytics and data mining, gives companies the opportunity to discover new insights among existing information that can enable improved forecasting and portfolio decision making, in ways that may have been unattainable until now.

9:30 Sponsored Presentations (Opportunities Available)

10:00 Coffee Break in the Exhibit Hall


ADDRESSING R&D CRISIS WITH OPTIMAL PROJECT PORTFOLIO MANAGEMENT

10:30 Co-Presentation Case Study: Standardizing the Resource Forecasting Algorithm into a Development Process

KraemerSimoneSimone Kraemer, Ph.D., Associate Director, Reporting Capabilities, Bristol-Myers Squibb





Jennifer DaubenspeckJennifer Daubenspeck, Ph.D., Manager, Reporting and Capabilities, Bristol-Myers Squibb


It took over 9 months to develop and deploy a resource forecasting algorithm at BMS. This protracted process was hindering the adoption and expansion of the project and resource management processes and tool. BMS standardized the process and the supporting tool equation to shorten the development and deployment process to 3 months or less.

11:00 Talk Title to be Announced

Maureen McNamaraMaureen McNamara, Executive Director, Global Project Management, Merck Research Laboratories



11:30 PANEL: Addressing R&D Productivity Crisis Leveraging Portfolio Management and the Partnership between R&D and Commercial

R&D productivity crisis needs to be addressed in terms of both its efficiency and its effectiveness; optimal Project Portfolio Management can help significantly in this endeavor. In addition, the early establishment of a partnership between R&D and Commercial is critically important; in fact already in the preclinical phase, the commercial perspective (especially in terms of market access) can be instrumental in guiding important decisions. Key discussion points include:

  • Is the FIPCo (Fully Integrated Pharmaceutical Company) model still viable in the drug industry?
  • How best define the value of a new drug years before its launch?
  • How can drug companies launch globally new products and satisfy payors with different standards of care and different needs?
  • How can shared goals be created between R&D and Commercial to ensure that R&D ‘pushes’ what Commercial ‘pulls’?
  • An alternative business model to the R&D productivity crisis - Disease Management

Pasquale CeteraModerator: Pasquale Cetera, Consultant, MKTG Pharmaceuticals; former Vice President, Portfolio Management and Strategy, Merck


Richard BayneyRichard Bayney, Ph.D., President & Founder, Project & Portfolio Value Creation; former Vice President, Portfolio Management & Decision Analysis, Johnson & Johnson


Maureen McNamaraMaureen McNamara, Executive Director, Global Project Management, Merck Research Laboratories


David ParkerDavid Parker, Ph.D., Vice President, Market Access Strategy, Precision for Medicine
 

 

BUSINESS AND OPERATIONAL MODELS

Shared Session between Strategic Resource Management & Portfolio Management 

12:15 pm Welcome Portfolio Management Conference Registrants & Joint Session Luncheon Announcements

Micah Lieberman

Micah Lieberman, Executive Director, Conferences, BioPharmaceutical Strategy Series, Cambridge Healthtech Institute (CHI)


12:30 Luncheon Presentation: Discover the Strategy Hidden in Your Portfolio and Decide if It Is the Strategy You Want

Richard SonnenblickRichard Sonnenblick, Ph.D., CEO, Enrich Consulting

This presentation will focus on three key points: How to identify the strategic dimensions of your portfolio; How to assess depth and strength in each strategic dimension; and How to build a portfolio assessment the entire company will believe, support, and act upon.


1:25 Chairperson’s Opening Remarks for Shared Keynote Session

Sultan AzizSultan Aziz, Senior Director, Capacity Management, Janssen Pharmaceuticals


1:30 Going Big! Establishing End-to-End Integrated Project & Resource Planning across Pfizer

Joseph BillittiJoseph Billitti, Ph.D., MBA, Executive Director, Strategy and Operations, Global Research & Development, Pfizer

In 2011, Pfizer committed to transforming its R&D engine and to a multi-year effort that would modernize and integrate our R&D project planning and resource management capabilities across the enterprise. In its third year, the program has now established foundational and industry leading capabilities across the entirety of R&D, including integrated end-to-end planning, resource forecasting and tracking, and holistic portfolio reporting. This session will discuss Pfizer’s implementation approach across many large and diverse functions, including the approaches to our discovery and generics portfolios. Examples will be covered of how the capabilities are being utilized across the business, and highlight the overall benefits being realized from having an integrated platform.

2:00 Implementation of R&D Operations within Merck Serono

Hartmut HeinHartmut Hein, Ph.D., Director, Global Planning Office, Merck KGaA

How to best align the book of work which needs to be delivered considering the constraints of internal resources and overall R&D budget is still a key topic within Pharma R&D. At EMD Serono we are currently running a change project to establish an integrated R&D operations environment to align project, resource, finance and portfolio management. First delivery will be achieved by end of August. Experience with first achievements and challenges focusing on resource demand to deliver the book of work will be presented.

2:30 NASA’s Human Health and Performance Business Model to Accelerate Innovation

Jeffrey DavisJeffrey Davis, M.D., Director, Human Health and Performance (HH&P), CMO, NASA Johnson Space Center

Dr. Davis will describe the new business model for the NASA Human Health and Performance (HH&P) Directorate. The 2007 and 2012 strategic plan charted a course accelerating innovation through strategic partnerships and the NASA Human Health and Performance Center (NHHPC) was established in 2010 (now with 6 active projects and over 140 members). NASA’s HH&P ran pilot programs in open innovation in 2009-2012 with outstanding results and now conducts prizes for NASA and other federal agencies through the Center of Excellence for Collaborative Innovation (CoECI). Through a rigorous risk management process, the HH&P research and development portfolio is completely expressed through deliverables – partnerships and open innovation tools are deployed where inadequate knowledge, technology or resources may be hindering progress in risk mitigation.

3:00 PANEL: Driving Innovation in R&D Organizations

Daniel ZweidlerModerator: Daniel Zweidler, Ph.D., Senior Fellow, Mack Institute for Innovation Management, The Wharton School, UPenn; President, DZA, Inc.


Joseph BillittiPanelists: Joseph Billitti, Ph.D., MBA, Executive Director, Strategy and Operations, Global Research & Development, Pfizer


John LaMattinaJohn LaMattina, Senior Partner, PureTech Ventures; former President of R&D, Pfizer


Jeffrey DavisJeffrey Davis, M.D., Director, Human Health and Performance (HH&P), CMO, NASA Johnson Space Center


Carmel EganCarmel Egan, Ph.D., Vice President, Project Management, Eli Lilly & Co.


Jonathan FreemanJonathan Freeman, Ph.D., Senior Vice President, Head of Portfolio Management, Merck Serono


Over the last decade we have witnessed an exponential increase in marginal costs of innovation in the biopharma sector, as well as a foreseen paradigm shift from blockbusters to precision medicine. These two powerful forces call for a new sustainable business model for the healthcare ecosystem in general and R&D in particular

  • What is the role of collaborative innovation in today’s R&D environment?
  • When is it the right time to invest in a disruptive technology and how?
  • How do payers (private or public) influence R&D choices?
  • What will today’s “Big Pharma” look like in 20 years?
 

3:45 Refreshment Break in the Exhibit Hall


4:15 Interactive Breakout Discussions

Concurrent breakout discussion groups are interactive, guided discussions hosted by a facilitator or set of co-facilitators to discuss some of the key issues presented earlier in the day’s sessions. Delegates will join a table of interest and become an active part of the discussion at hand. To get the most out of this interactive session and format please come prepared to share examples from your work, vet some ideas with your peers, be a part of group interrogation and problem solving, and, most importantly, participate in active idea sharing.

Monday Afternoon, November 3 & Tuesday Afternoon, November 4 

TABLE: The Use of Open Innovation in a Research and Development OrganizationModerators: Jeffrey Davis, M.D., Director, Human Health and Performance (HH&P), CMO, NASA Johnson Space Center &
Elizabeth Richard, Senior Strategist, Wyle Science, Technology and Integration
• Identifying appropriate challenges to run competitions
• Addressing cultural barriers to acceptance
• Organizational strategies for success

TABLE: Drug Discovery and The Unknown UnknownsModerator: Daniel Zweidler, Ph.D., Senior Fellow, Mack Institute for Innovation Management, The Wharton School, UPenn; President, DZA, Inc.• Implication for portfolio management … what is a “portfolio” to start with?
• Implications for decision making and funding levels required for "success"
• What are the critical success factors for a thriving business environment?

TABLE: Decision Quality: Initial Investment Approval Vs. The Reality of ExecutionModerators: Elayne Ko, Director, Portfolio and Decision Analysis, Pfizer &
Tom Stone, Lecturer in Business, Penn State University, Abington College
• What importance do organizations place in the investment decisions vs. subsequent project-related decisions?
• Is decision quality valued through all stages of the project; if not, then does inconsistency create downstream issues in the future?
• How does management track the progress of the investment decisions? 

TABLE: Strategic Resource Management in the New Era of Rising New Product ProductivityModerator: John Ansell, Senior Partner, TranScrip Partners• How might we re-think deployment of resources internally in light of the rising numbers of projects across the industry at every development phase ?
• How should this affect activities externally ?
• Changing mindsets after decades of downturn.

TABLE: A Closer Look at Big Data and Analytics: Where are the opportunities vs the hype?Moderator: Krish Ghosh, Ph.D., MBA, Vice President, Informatics, Covance• Define the breadth and depth (along with the characteristics and elements) of Big Data from the Healthcare sector that directly applies across the entire Pharmaceutical R&D continuum.
• Can Big Data analytics enable faster and superior decision making in R&D from new insights, leading to improved R&D productivity? Where are the opportunities and where is the hype?
• What should be the role of the Pharmaceutical R&D Leaders in making Big Data Analytics a reality, and helping towards development of faster, cheaper and high quality drugs?

If you have a Breakout Discussion topic suggestion, please submit your idea using the online form: http://www.executivedecisionmaking.com/sra-pfo_content.aspx?ekfrm=135879&libID=135828 


5:15 Close of Strategic Resource Management Executive Forum (Portfolio Management continues on through Wednesday, November 5)