Cambridge Healthtech Institute’s 17th Annual
Strategic Resource Management
Enhanced R&D Productivity, Forecasting and Planning
October 16-17, 2019
Although investment in pharma R&D continues to increase, approval of new drugs remains relatively low. This productivity crisis presents new challenges to biopharma R&D in terms of resource management, forecasting, and capacity planning. To counteract
the decline in new therapeutics and high risk of product failure, biopharma must adapt with improved performance planning, intelligent outsourcing, and new big data analytics aimed at developing strategic and flexible resource management systems.
Cambridge Healthtech Institute’s and the BioPharma Strategy Series’ 17th Annual Strategic Resource Management: Enhanced R&D Productivity, Forecasting and Planning attracts over 100 senior R&D executives sharing
best practices and new ideas on how to enhance R&D productivity, forecasting and planning with important discussions on optimizing resource management, outsourcing, innovation, R&D, clinical capacity planning, forecasting and business intelligence
Wednesday, October 16
8:00 am Registration and Morning Coffee
8:50 Organizer’s Welcome
Kaitlin Searfoss Kelleher, Conference Director, Cambridge Healthtech Institute
8:55 Chairperson’s Opening Remarks
Michael Ferrante, Head, R&D Business Capabilities, R&D Strategy and Planning, Bristol-Myers Squibb
9:05 KEYNOTE PRESENTATION: Novel Resource Management via a Collaborative Drug Development Model – Master Trials
Len Rosenberg, PhD, RPh, Head, Clinical Operations, Beat AML/LLS
We are in the age of information, but we don’t necessarily use, analyze, or share data in the most effective way. What would happen if pharma routinely participated in Master Trials managed by non-profits as an alternative to traditional clinical
trials? Should it be a core element of their pipeline strategies? A centralized resource to quickly and efficiently examine drug candidates. What if our collaborative efforts would streamline decision making so that the most effective drugs could
be fast-tracked into clinical trials? Could we save time, money, and other resources if our go/no-go decisions were made in months instead of years? This presentation will describe a novel approach to genomic-based decision-making to optimize breakthrough
therapeutics. This drug development model combines scientific innovation and next-gen eclinical technologies to radically change the drug development landscape.
9:50 Forecasting Resource Requirements When There Is a New Business Strategy
Josh Kaminetz, Business Operations
Lead, Strategy Realization Office, Global Regulatory Affairs and Clinical Safety, Merck & Co., Inc.
This talk is a case study in how an evolving strategy can create unique considerations and challenges for providing accurate demand/capacity forecasts.
10:20 Scenario Modeling Analytics Using AI Machine Learning for Project, Portfolio and Resource Planning
Sam Mathew, MBA, Lean Six Sigma Black
Belt, Director, Advanced Analytics, Janssen
This talk will discuss real-world examples in scenario modeling for project and resource planning. Walk away with insights into using AI and machine learning in various project planning settings.
10:50 Coffee Break with Exhibit Viewing
11:20 Project Planning and Resource Demand Forecasting for a Global R&D Project Portfolio
Kristy McGuire, Global
Project Planner, Strategy & Business Operations, Integrated Planning, Analytics & Partnering, EMD Serono
This talk will discuss how integrated project planning and resource demand forecasting through state-of-the-art tools provide insights for executive decision making at EMD Serono Global R&D. We’ll discuss developing a standardized methodology
and establishing a single source of truth for project, portfolio, and functional reporting. An overview of the journey from implementation to application will be given.
11:50 Research Portfolio Dynamics & Management in a Fast-Changing Biotech Setting
Benoit Schmitt, PhD, PMP,
Senior Alliance & Portfolio Manager, Galapagos
The presentation will describe the process and tool we implemented to manage our resources pool. The process and tool have enabled an understanding of our research project portfolio and allowed us to build an organizational agility to manage resources.
The presentation will share a real-life example of implementation of the resource management process in a medium-sized biotech (250 FTEs pool over 25 projects).
12:20 pm NEW - Luncheon Presentation: The Capacity Quadrant – 4 Keys to Demystifying Resource Management
Manas, VP of Customer Success, PDWare
Trying to optimize limited organizational resources in a climate of rapid change and constantly shifting demand can be challenging at best. Adding to the challenge is that information on how to navigate these murky waters is all too scarce or overly complex.
Join PDWare's Jerry Manas, author of The Resource Management and Capacity Planning Handbook, as he introduces the Capacity Quadrant, a simple, tool-independent framework that allows for quickly achieving maturity in resource management and capacity
planning in four key areas: Visibility, Prioritization, Optimization, and Integration.
12:50 Session Break
1:40 Chairperson’s Remarks
Tony Dybicz, PMP, Associate Director,
Global Regulatory Affairs and Clinical Safety, Merck & Co., Inc.
1:45 Insights and Evolution of Amgen’s Process Development Resource Forecasting and Capacity Management Ecosystem
Cleat Jerden, Executive Director,
Business Performance, Business Analysis and External Process Development, Amgen
Amgen’s Process Development is a complex organization of ~1800 staff across various functions supporting both large and small molecules. This organization has been on a multi-year journey to develop the process for portfolio prioritization, combined
with improved functional resource management and governance. While this infrastructure was successfully deployed into the business, we strive for continuous process improvement and technology advancement to enable reliability, efficiency, agility,
and differentiation in management of our portfolio.
2:15 CO-PRESENTATION: Effective Implementation of a Resource Management Capability in a Clinical Development Organization
Matt Baran, Associate Director, Strategic Operations, Global Clinical Development, Celgene
Dan Portilla, Director, Strategic Operations, Global Clinical Development, Celgene
Eric Lake, Partner, Intrinsic Clinical Systems
There are many different approaches to resource management: long range workforce planning, study/program planning, and allocation of named resources. Many companies choose to do a combination of these approaches and this discussion will explore the thought
process and considerations companies should take when implementing a resource management capability.
2:45 Unified PPM Processes in Spite of Matrixed Information
Dave Penndorf, VP, Life Sciences PPM Practice, Planisware
Olivier Fleischmann, Director, Life Sciences PPM Practice, Planisware
Pharma & Biotech PPM thrives in a matrixed environment – with different data stewards, data owners and data actors. How can your PPM processes keep a handle on it all? In this session, we’ll discuss: How to drive accountability in data
stewardship; The “multi-level scheduling” paradigm; Considerations and impacts of different planning models; Incorporating external data owners (e.g., updatesfrom your CROs)
3:15 Introduction to Breakout Discussions
3:20 Refreshment Break with Exhibit Viewing
4:00 Interactive Breakout Discussions
5:00 Close of Day
Thursday, October 17
8:30 am Morning Coffee
8:55 Chairperson’s Remarks
Cleat Jerden, Executive Director, Business Performance, Business Analysis and External Process Development, Amgen
9:00 Establishing Resource Management in a Regulatory & Clinical Safety Organization – Lessons Learned from a Journey
Dybicz, PMP, Associate Director, Global Regulatory Affairs and Clinical Safety, Merck & Co., Inc.
This talk will explore the next steps in our journey of building our tools and network, with further maturation processes. These efforts are leading towards a collectively improved understanding and outputs of our resource management processes.
9:30 CO-PRESENTATION: Time Reporting: Change Management, Business Insights, and Improved Resource Forecasting
Kathy Liu, Associate Director,
Capacity Management, Janssen
Ronnie You, Senior Manager,
Capacity Management, Janssen
Time reporting data is an often ignored wealth of information for a variety of reasons. Poor reporting compliance, under-reporting of time, and attributing efforts to the wrong projects are among the top reasons many dismiss this potentially valuable
data. Two business cases will be presented that highlight one organization’s journey to improve their time reporting data quality, how this data was mined to generate some powerful insights, and explore how predictive analysis can shed
light on future performance issues.
10:00 Bringing Everybody’s Resource Management on One End-to-End Platform
Geert Vanhove, Founding Partner, Binocs
The product lifecycle in drug development requires a coordinated approach of many disciplines. From a Portfolio Management angle, PMOs want a unified and consolidated look on resource utilization.
However, functional teams such as technical R&D, labs, clinical operations, QA, and CMC operate quite differently. During the presentation, I’ll share examples of how Binocs covers different resource management flavors that all converge
to the Project Portfolio.
10:30 Coffee Break with Exhibit Viewing
11:00 Development and Implementation of a Governance Framework for a Technical Operations Organization
Zachariou, PhD, Executive Director, Technical Operations CMC Product and Portfolio Management, Technical Operations, BioMarin Pharmaceuticals
The why and how a Governance Framework was developed and implemented for a Technical Operations organization will be described, including development of metrics to measure success parameters for governance. Lessons learned from the effort will
11:30 Strategic Resource Management of CMC Commercialization
III, MBA, PMP, Senior Manager, Program & Business Excellence, Kite Pharma, a Gilead Company
In cell therapy development, the transition from clinical to commercial is very short. Utilizing an endorsed CMC Framework can be very helpful in resource modeling and forecasting in the launch of an approved therapy. This approach is useful when
launching in multiple geographies at the same time.
12:00 pm Session Break, Transition to Luncheon and Joint Keynote
12:10 Welcome from the Conference Organizer
Kaitlin Searfoss Kelleher, Conference Director, Cambridge Healthtech Institute
12:15 Luncheon Presentation: From Single Source of Truth to Single Source of Understanding
Richard Sonnenblick, PhD, CEO, Enrich
Why a single source of truth is important. Why a single source of truth is not enough for effective portfolio management. Building a case for tracking the assumptions behind the numbers. Why variance analysis is more than a ‘nice-to-have’
analysis tool. The building blocks you need for effective real-time scenario analysis
12:45 Session Break
1:25 Chairperson’s Remarks
Matthew Kokkonen, MBA, Director, Portfolio and Governance, Enterprise Excellence, CSL Behring
1:30 CO-PRESENTATION: Single Source of Truth: Using Enterprise Tools to Align Decisions
Ferrante, Head, R&D Business Capabilities, R&D Strategy & Planning, Bristol-Myers Squibb
Alexander Rucci, Senior Business Capability Analyst, R&D Strategy
& Planning, Bristol-Myers
In this presentation, we will explore how enterprise planning tools can drive better decisions. We will explore the power of multi-level planning, standard data and common definitions, and a single Book of Work can ensure alignment from the portfolio
to the project to the functional area. We will discuss the interfaces between different systems that can align a large organization effectively and nimbly.
2:00 Towards Logical and Strategic Reasoning Within Pharma Drug Development Decisions
Elayne Ko, Director, Portfolio
Decision Sciences, GSK
In Jonathan Haidt’s book, he notes “intuitions come first, strategic reasoning second” and cites neuroscientist, Antonio Damasio, who observes gut feelings and bodily reactions are necessary to think rationally. Jonathan Haidt
concludes, “the head can’t even do head stuff without the heart.” This presentation explores the implementation of the Decision Analysis process and facilitation approaches towards strategic reasoning without the cognition
and emotion dichotomy to aid pharmaceutical drug development decisions.
2:30 Analytics and Culture: Lessons Learned and Comparisons Between Pharma/Biotech, Oil & Gas, and Government
Senior Manager, Portfolio Analysis, Portfolio Management Office, BioMarin Pharmaceutical
This talk will discuss the similarities and differences in the application of decision analytics between pharma/biotech and oil and gas companies, as well as US government agencies, and how different business settings and cultures affect those
applications. What best practices can we learn from other industries and what can they learn from us?
3:00 Introduction to Breakout Discussions
3:05 Refreshment Break with Exhibit Viewing
3:35 Interactive Breakout Discussions
4:35 Networking Reception with Exhibit Viewing
5:35 Close of Strategic Resource Management