2015 Archived Content
November 2-3, 2015
13th Annual
Enhanced R&D Productivity, Forecasting and Planning
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Monday, November 2
8:00 am Registration and Morning Coffee
9:00 Organizer’s Welcome
Micah Lieberman, Executive Director, Conferences, BioPharmaceutical Strategy Series, Cambridge Healthtech Institute
(CHI)
9:05 Chairperson’s Opening Remarks: Remaining Productive in a Time of Scarcity
Charles Dormer, Principal, APEX STP; former Vice President, Strategy and Operations, Innovative Medicines, AstraZeneca
9:15 OPENING KEYNOTE: The Importance of Realistic Planning as a Foundational Element of an Enterprise Planning and Resource Management Framework that Informs Portfolio & Project Decisions
Jean Lee, M.D., Vice President, Portfolio Operations & Project Management, Pfizer R&D
One of the essential building blocks of any Planning and Forecasting framework is realistic planning, which needs to be trusted by stakeholders and leaders alike. With a solid foundation and associated culture of realistic planning, the portfolio
& project management ecosystem is enhanced and has provided business value to our R&D organization, by enabling integrated, informed decisions. The benefits associated with project scenario planning will be highlighted, together with the
importance of agreed business processes that apply to all projects in the system.
9:45 Delivering the Promise: Operationalizing Innovation across the Organization
Mike Hess, Vice President, Bradycardia R&D, Medtronic
The idea is the easy part. How do you set up a team for success and build a shared appreciation of the risks and potential payoffs of the project? In the tradeoff between aggressive risk-taking and schedule confidence, who wins? This presentation
will provide real-world operational examples of helping teams deliver successful projects.
10:15 Networking Coffee Break
11:00 Redesigning the R&D Budget Management Process at Bristol-Myers Squibb
Aaron Salancy, Director, Portfolio & Asset Strategy, Bristol-Myers Squibb
In 2014, BMS undertook a cross-functional effort to address inefficiencies in the existing R&D budget management process. The ensuing effort considered the generation and allocation of R&D budget targets, the assignment of budget management
decision rights, the information required to support high-quality decision-making, and the evaluation of budget management performance. The ultimate decisions on the new approach were guided by a desire to streamline processes, create transparency,
speed decisions, and ensure an integrated view of the budgetary landscape across the organization.
11:30 Transforming R&D through Innovative Resourcing Models
Angelo Filosa, Ph.D., Global Head of Scientific Services, Life Sciences Solutions, PerkinElmer
This talk will focus on strategies that increase efficiency of scientists in a lab. It will describe innovative approaches; provide a roadmap outlining the approaches and their effect on scientific productivity. The talk will expand these approaches
to explore alternative models for value creation that drive scientific and business innovation. In particular, a case study on building a public-private partnership that expands R&D capabilities through access to external global scientific
talent, assets and resources.
12:00 pm Luncheon Presentation (Sponsorship Opportunity Available, please contact Ilana Quigley +1.781.972.5457, iquigley@healthtech.com) or Lunch on Your Own
1:40 Chairperson’s Remarks
Tim LaCroix, Head, Strategic and Business Development, Strategic Development, PharPoint Research
1:45 Adaptive Outsourcing Modalities for Improved Resource Management, Development and Downstream Clin Ops
Reb Tayyabkhan, MBA, Executive Director, Head, Central Clinical Services, Bristol-Myers Squibb
Over the past 2 decades, BMS has embraced a variety of outsourcing models to execute its clinical portfolio. Through those experiences and an appreciation of a shifting and dynamic portfolio, BMS is implementing a flexible sourcing model with a structured
outsourcing framework. This presentation will provide an overview of the various sourcing modalities employed by BMS and how those decision processes align with the broader Resource and Portfolio Management activities.
2:15 Resource Management Case Study: Moving Beyond the Chaos of Spreadsheets to a Holistic Approach to Capacity Planning and Performance Tracking
Tony Dybicz, MBA, PMP, Associate Director, Business Consulting, Merck
This talk will share a 6-year journey from push to pull – from spreadsheets and chaos to a maturing EPPM in our organization. More specifically, it will focus on: 1) Our cross-product hub, the things we’ve done to enable prioritization
across multiple products and sites, and the practical limitations of resource flow; 2) Items preventing us from getting to the ideal state of EPPM, and things we’re trying to do to overcome those hurdles; and 3) Using resource data to drive
intake decisions in groups that used to try to do it all.
2:45 Portfolio Prioritization and Capacity Planning Exercise: Living in a Resource Constrained Environment
Cindy Murray, Director, R&D Strategy and Portfolio, GlaxoSmithKline
Like many other companies, the pressures on resourcing the pipeline require active portfolio prioritization and execution. Following the successful delivery of 6 NMEs launches over the last 2 years the pipeline was faced with the need for further
prioritization to bring forward the next wave of exciting assets, learning from the lessons from the previous wave. A planned effort was undertaken to shift resources towards the most promising assets and stop or drastically reduce resources on
the lower priority projects. Reported effort data has then been used to monitor the situation to enable course correction but also to highlight where within TA and cross portfolio tradeoffs are required. Forward looking resource forecasts are
also being assessed to ensure the long term impact is known. Significant progress has been made but we continue to refine the approach to ensure the larger platforms have the granularity needed to do integrated capacity planning across the enterprise.
3:15 Breakout Discussion Groups Remarks & Introduction to Tables and Moderators
Deborah Stoyko, Applications Sales Manager, Primavera Global Business Unit, Oracle
3:20 Refreshment Break with Exhibit Viewing
4:00 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. Current topics to be discussed:
TABLE 1: Realistic Planning for Drug Development Projects: The Implications to Resource Forecasting and Overall Portfolio Delivery
Moderators: Jean Lee, M.D., Vice President, Portfolio & Project Management, Portfolio Operations & Project Management, Pfizer R&D
Gary Summers,
Ph.D., President, Pipeline Physics LLC; Associate Research Professor Portland State University
- Understand and discuss how different groups manage the optimistic planning assumptions used during the early phases of drug development, which have downstream implications;
- Discuss the different tools and processes that are being used to inform realistic planning.
- How are these tools used to inform appropriate resource allocation or workforce planning?
TABLE 2: Portfolio Management Process Implementation: Success Factors
Moderator: Chami Karandana Evans, Global Strategic Portfolio Manager, Strategy, Indivior
- What are the key success factors in implementing Portfolio Management Processes and ensuring sustainability?
- Who are the key personal that contribute to the success in implementing Portfolio Management Processes and ensuring sustainability?
- How do you identify and engage stakeholders?
TABLE 3: Quantification of Uncertainty, What Can we Quantify and What Not
Moderator: 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 4: Optimizing Project Management Business Impact: Start, Stop, Continue
Moderator: Mark Lane, Ph.D., former Assistant Vice President, PMO North American Medical Affairs, Sanofi; Consultant, TayganPoint Consulting Group
- Are we relying too much on tools and processes without focusing on adding business value? What does this look like in an organization and in communication?
- How do you increase the impact project and portfolio management can have on organizations?
- What do we as project and portfolio managers need to start, stop, continue to maximize business value?
TABLE 5: Leveraging Private-Public Partnerships and Alternative Business Models to Drive Innovation in Global Health
Moderators: Alexandre Portet, MBA, Deputy Director, Strategy, Planning & Management, Global Health R&D, Bill & Melinda Gates Foundation
Chandra Ramanathan, Global Program Head, External Innovation - Life Sciences, Bayer AG
Brett Kleger, Chief Commercial Officer, DrugDev
- Are How can both the Public and the Private partners achieve a sustainable model for both parties?
- What would it take for the private sector to commit best resources and assets to global health (beyond corporate social responsibility)? What incentives need to be in place? What might be the levers to lower the cost of opportunity? Where
might the first areas of collaboration be (i.e., where should we start)?
- What have we learned from past examples on how to structure such endeavors?
TABLE 6: Strategic Resource Management Partnerships and Intelligent Outsourcing for Product Development and Clinical Operations
Moderator: Tim LaCroix, Head, Strategic and Business Development, PharPoint Research
- What service offerings are in fact best left to resource management partnerships and why? How do you ensure consistent interlocking service operations given that each program may have different partnership stakeholders (e.g., vendors,
investigative sites)?
- Can resource management that requires global, highly complicated planning be nimble? Why do some studies take 6-9 months to recruit the 1st patient? What are the latest practices improving feasibility?
- Are there lessons across growing Industries (Companion Animal R&D/Med Device/Nutraceuticals are looking much like the drug Industry)?
TABLE 7: Making Decisions in the Presence of Growing Information and Complexity
Moderator:
Gill Eapen, CEO, Decision Options, LLC
- How does “gut feel” decisions fare in the modern world, dominated by exponentially growing information?
- How could information technology and analytics help make better and faster decisions?
- How does one measure decision quality? How do decisions relate to Value and Risk?
5:00
Welcome Reception with Exhibit Viewing
6:00 Close of Day
Tuesday, November 3
8:30 am Registration
8:30 Morning Coffee
8:55 Chairperson’s Remarks
Tom Defay, Ph.D., Global Project Leader, Head of Informatics, Neuroscience iMed, AstraZeneca
9:00 CASE STUDY CO-PRESENTATION: Beyond the Data: Driving to Action
Kevin Doyle, Resource Estimation and Planning Business Partner, Decision Analytics and Resource Planning, Shire
Obtaining the data is generally not the problem. Translating that data into meaningful action is more often our challenge. Getting there quickly is the Holy Grail. This case study will illustrate how Resource Management helped ensure business
continuity during a period where the portfolio was expanding and over half of the R&D workforce was being replaced due to site closures and organizational restructuring.
9:45 Resource Management: Its Role as an Organizational Ringmaster in the Project Management Process
Simon Hornby, Director, Capacity, Planning & Analytics, Clinical Biologics, MedImmune
The development of pharmaceuticals is a complex, and dynamic, project management activity requiring information to flow between many stakeholders including the project team, supporting functions and finance. Resource Management can, and frequently
does, provide a trusted source of project information used by these stakeholders and others throughout the organization. This presentation will describe the ringmaster role Resource Management plays in the collection and coordination of
this information, and describes some of the processes used to ensure that this data is a trusted source throughout the organization.
10:15 Coffee Break with Exhibit Viewing
11:00 Governance: The Key to Efficient Resource Management and Successful GO LIVEs
Thomas Riesenberg, Associate CIO, Office of the CIO, Penn Medicine
Achieving successful, on-time, on-budget deployment of fully integrated IT solutions requires collaboration between IT, administration, operations and providers. The cost of deploying fully integrated IT solutions is very expensive. Effective
governance is “the key” to achieving expected business outcomes, improving patient and employee satisfaction, and completing initiatives on time, and on budget. Governance committees should be comprised of key stakeholder organization
senior management, result in mutually agreed to expected business outcomes, and provide a forum where project status and critical adjustments can be made.
11:30 Bridging the Gap between Portfolio Planning and Operational Execution: How a Critical Chain Operating Strategy Can Help Your Organization Reach Its Potential
Jesse Conard, Director, Project Management, Janssen R&D’s Biotechnology Center of Excellence, Janssen
Faced with constant pressure to increase efficiency, accelerate products to market, and fund the right opportunities, most organizations invest heavily in portfolio and project management systems. Unfortunately, these investments often fail
to enable the business to translate even the best-laid plans into operational success. By building the processes, tools, and culture to support a Critical Chain operating strategy, we can finally gain the clarity necessary to drive the
execution of an optimal project portfolio.
12:00 pm Session Break
12:10 pm Welcome Portfolio Management Conference Registrants & Joint Session Luncheon Announcements
Micah Lieberman, Executive Director, Conferences, BioPharmaceutical Strategy Series, Cambridge
Healthtech Institute (CHI)
12:15 LUNCHEON PRESENTATION: Lessons From the Field: Presenting Your Assets for Effective Decision Making
Richard Sonnenblick, Ph.D., CEO, Enrich Consulting
This lunch and learn presentation will focus on three key lessons: 1) Identifying the portfolio strategy when your executives haven’t; 2) Preparing an effective portfolio dossier: critical processes and methods; and 3) Ensuring
executives get what they need before, during, and after the portfolio review meeting.
1:10 Chairperson’s Opening Remarks for Shared Keynote Session
Chris Beck, MBA, Vice President, Schedule and Resource Decision Analytics, Shire
1:15 Relevancy and Integration: Two Keys to Potentiating Decision-Impacting Strategic and Operational Portfolio Management in Resistant Organizations
Peter Ray, MBA, Vice President, Strategic & Operational Portfolio Management, Bristol-Myers Squibb
The last two decades have seen dramatic improvements in tools and methodologies for both strategic and operational portfolio management, frequently discussed at conferences such as this one. In spite of these advances, most companies
seem to be struggling to fully embrace and embed these capabilities into their decision-making DNA. Our BMS experience suggests that two key success factors are relevancy and integration. Efforts across the strategic and operational
portfolio management continuum have to provide relevant, actionable insights to senior leaders, with underlying data reliability and fast response time; and to do this effectively, the overall system has to fully integrate clinical
development strategy and R&D portfolio prioritization with operations and functional resource management, with dynamic and flexible feedback loops.
1:45 From Innovation to Impact: Bringing Best-In Class Investment and Portfolio Management Practices to Global Health
Alexandre Portet, MBA, Deputy Director, Strategy, Planning & Management, Global
Health R&D, Bill & Melinda Gates Foundation
The Gates Foundation invests ~$1B every year in Global Health R&D. This is across 10+ diseases and 150+ product candidates, including vaccines, drugs, diagnostics and vector control. This presentation will focus on: 1) Moving
from emotions and beliefs to facts: How do we use data to develop strategies, prioritize portfolio of investments and evaluate specific product candidates? 2) Leveraging new partnership and business models to further our mission:
How to creatively source innovation? 3) How have we implemented public/private partnerships to bring best-in class partners and capabilities to the global health arena?
2:15 Does the Triple Constraint add Business Value, or Has Over-Reliance on Tools/Processes Lessened Impact of Project-Portfolio Management?
Mark Lane, Ph.D., former Assistant Vice President, PMO North American Medical
Affairs, Sanofi; Consultant, TayganPoint Consulting Group
As leaders, decision support experts and project managers are we relying too much on tools and processes without focusing on adding business value? Have we lost our way when it comes to being strategic in our discussions and decisions?
What does this look like in an organization and in communication? Are we “connecting the dots” between R&D, Med Affairs, and Commercial? And, how do you increase the impact project and portfolio management can
have?
2:45 Diversification Strategies in Pharmaceutical Portfolios: Hedging Downside and Upside Risk?
Jonathan Freeman, Ph.D., Senior Vice President, Global Portfolio Management, Global
Strategy & Franchises, Merck Serono
Through lifecycle management and other lower-risk diversification strategies pharmaceutical companies have become familiar if not adept at covering downside “catastrophic” risk scenarios. Although these approaches ensure
comfort in delivering market-tracking growth by definition, they cannot be expected to offer outperform potential. How can pharma ensure that it can retain upside risk in its portfolio at a price that it can afford and can
that price be reduced by turning the unilateral risk into collective uncertainty through effective risk pooling and partnering?
3:15 INTERACTIVE PANEL DISCUSSION: Translating Innovation into Customer Value: Culture, Partnerships and Pipeline Impact
There has been a lot of discussion in industry about addressing the R&D productivity crisis though alternative business models, pre-competitive collaboration, open innovation, public-private-academic partnerships, risk sharing
and other approaches. There is no question that the desire to change our thinking and to do a better job at “innovating” is valid, but what does this actually mean? What exactly can we do as strategists, R&D
leaders, investors, tech transfer and business development folks, portfolio managers and people in this room? This panel will bring together voices from pharma, academia, the investment community and attempt to address:
- Driving innovation in R&D organizations: How do you alter the DNA of a company’s culture to be more entrepreneurial?
- Evaluating all the data and internal/external opportunities to improve ROI: How do you take a systematic approach to evaluating the science and technology so you don’t get left out of the “innovation game”?
- Understanding where to find innovation opportunities both within your organization and externally: Take the low hanging fruit
- Moving beyond early stage licensing and internal process optimization to broader strategies: VC engagement, academic partnerships, risk-sharing
- Impacting the pipeline: Maximizing value through innovative partnerships and external collaboration
- Moderator: Chandra Ramanathan, Global Program Head, External Innovation
- Life Sciences, Bayer AG
- Panelists:
Issi Rozen, Senior Director, Strategic Alliances, Broad Institute
Peter Ray, MBA, Vice President, Strategic & Operational Portfolio Management, Bristol-Myers Squibb
Mark Lane, Ph.D., former Assistant Vice President, PMO North American
Medical Affairs, Sanofi;Consultant, TayganPoint Consulting Group
Jonathan Freeman, Ph.D., Senior Vice President, Global Portfolio Management,
Global Strategy & Franchises, Merck Serono
Brett Kleger, CCO, DrugDev
4:00 Breakout Discussion Groups Remarks & Introduction to Tables and Moderators
Deborah Stoyko, Applications Sales Manager, Primavera Global Business Unit, Oracle
4:05 Refreshment Break with Exhibit Viewing
4:35 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. Current topics to be discussed:
TABLE 1: Realistic Planning for Drug Development Projects: The Implications to Resource Forecasting and Overall Portfolio Delivery
Moderator: Jean Lee, M.D., Vice President, Portfolio & Project Management, Portfolio Operations & Project Management, Pfizer R&D
- Understand and discuss how different groups manage the optimistic planning assumptions used during the early phases of drug development, which have downstream implications;
- Discuss the different tools and processes that are being used to inform realistic planning.
- How are these tools used to inform appropriate resource allocation or workforce planning?
TABLE 2: Portfolio Management Process Implementation: Success Factors
Moderator: Chami Karandana Evans, Global Strategic Portfolio Manager, Strategy, Indivior
- What are the key success factors in implementing Portfolio Management Processes and ensuring sustainability?
- Who are the key personal that contribute to the success in implementing Portfolio Management Processes and ensuring sustainability?
- How do you identify and engage stakeholders?
TABLE 3: Quantification of Uncertainty, What Can we Quantify and What Not
Moderators: Daniel Zweidler, Ph.D., Senior Fellow, Mack Institute for Innovation Management, The Wharton School, UPenn; President, DZA, Inc.
Gary
Summers, Ph.D., President, Pipeline Physics LLC; Associate Research Professor Portland State University
- 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 4: Optimizing Project Management Business Impact: Start, Stop, Continue
Moderator: Mark Lane, Ph.D., former Assistant Vice President, PMO North American Medical Affairs, Sanofi; Consultant, TayganPoint Consulting Group
- Are we relying too much on tools and processes without focusing on adding business value? What does this look like in an organization and in communication?
- How do you increase the impact project and portfolio management can have on organizations?
- What do we as project and portfolio managers need to start, stop, continue to maximize business value?
TABLE 5: Leveraging Private-Public Partnerships and Alternative Business Models to Drive Innovation in Global Health
Moderators: Alexandre Portet, MBA, Deputy Director, Strategy, Planning & Management, Global Health R&D, Bill & Melinda Gates Foundation
Chandra Ramanathan, Global Program Head, External Innovation
- Life Sciences, Bayer AG
Brett Kleger, Chief Commercial Officer, DrugDev
- Are How can both the Public and the Private partners achieve a sustainable model for both parties?
- What would it take for the private sector to commit best resources and assets to global health (beyond corporate social responsibility)? What incentives need to be in place? What might be the levers to lower
the cost of opportunity? Where might the first areas of collaboration be (i.e., where should we start)?
- What have we learned from past examples on how to structure such endeavors?
TABLE 6: Strategic Resource Management Partnerships and Intelligent Outsourcing for Product Development and Clinical Operations
Moderators: Tim LaCroix, Head, Strategic and Business Development, PharPoint Research
- What service offerings are in fact best left to resource management partnerships and why? How do you ensure consistent interlocking service operations given that each program may have different partnership stakeholders
(e.g., vendors, investigative sites)?
- Can resource management that requires global, highly complicated planning be nimble? Why do some studies take 6-9 months to recruit the 1st patient? What are the latest practices improving feasibility?
- Are there lessons across growing Industries (Companion Animal R&D/Med Device/Nutraceuticals are looking much like the drug Industry)?
TABLE 7: Making Decisions in the Presence of Growing Information and Complexity
Moderator:
Gill Eapen, CEO, Decision Options, LLC
- How does “gut feel” decisions fare in the modern world, dominated by exponentially growing information?
- How could information technology and analytics help make better and faster decisions?
- How does one measure decision quality? How do decisions relate to Value and Risk?
5:30 Close of Strategic Resource Management Executive Forum (Portfolio Management continues on through Wednesday, November 4)
Again this year, we will be running the meeting back to back with the Tenth Annual meeting focused on Portfolio Management,
which takes place November 3-4, 2015, creating a three-day event (Nov. 2-4) covering the topics most important to you. There is also a Thurs-Friday Project Portfolio Management Certification Master Class this year, which gives attendees a five-day event option (see map below).