Breakout Discussions

Interactive Breakout Discussion Groups

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.

STRATEGIC AND OPERATIONAL CHALLENGES OF ONCOLOGY AND IMMUNO-ONCOLOGY DRUG DEVELOPMENT

Table: Partnerships, Alliance Management, and Program Execution in Oncology and Immuno-Oncology

Moderators: Jordan Stein, RPh, MBA, PMP, Director. Project Management Lead, Innovative Medicines, Bristol-Myers Squibb

Nathan Sanburn, Senior Advisor, Global Business Development and Strategic Collaborations, Oncology Business Unit, Eli Lilly and Company

  • Approaches to partnering for success in Immuno-Oncology: Not one-size-fits-all!
  • Big and Small Companies sharing risk, doing in-/out-licensing and trying to do co-development: How to engage and partner with your Business Development and Alliance Management departments to achieve success?
  • With so many partnerships and shorter timelines, how do you ensure your Alliance Management and Program Management capabilities are up to the task?

Table: Regulatory Strategy as a Key Component of Oncology and IO Drug Development Planning

Moderators: Eric Lake, Partner, Pharmica Consulting

  • Different class labels. Navigating the BLA, MAA. What can be done with each?
  • How fast are review cycles: What is involved in Orphan drug designations, Breakthrough designations, accelerated approvals?
  • What are regulators willing to accept as novel endpoints (which gets back to feasibility); Utilizing interim end points to know if the drug is working: What are the options for this?

Table: Building a Program Management Capability for Unique Challenges and Timelines of Oncology and IO

Moderators: Matt Kiernan, Partner, Pharmica Consulting

Stephen Curtis, PhD, Principal, MPM Capital

  • Without a clear pathway for development in the current oncology, immuno-oncology, immunotherapy combinations landscape what does this mean for drug development, program planning and execution?
  • With oncology drugs being developed and approved at the fastest rate ever, how do you game plan and work in this expedited world?
  • With the surge of oncology and small combination products in the immunotherapy arena and subsequent trials jamming the pipelines, how do sponsors, CROs, suppliers and sites respond to this wave of clinical projects?

Table: Clinical Trial Design and Operations Challenges in Oncology and Immuno-Oncology

Moderators: Greg Cohee, Partner, Pharmica Consulting

Rangaprasad Sarangarajan, Chief Scientific Officer & SVP, Clinical and Translational Sciences, Research & Development, BERG LLC

Adam Kinsey, Executive Director, Clinical Sciences and Study Management – Oncology, Merck

  • How do deal with patient recruitment challenges?
  • How do you do instream data?
  • How to find qualified sites that can get started quickly, are able to conduct complex oncology studies, and who aren’t already doing competitive studies?

Strategic Resource Management

Table: Developing Models for Pipeline Flow and Resource Forecasting What-If Scenarios

Moderators: Sean Gallagher, MS, MBA, Assoc. Director of Capacity Management, Janssen R&D

Richard Bayney, PhD, President & Founder, Project & Portfolio Value Creation (PPVC)

Christine Antis, Senior Director, Portfolio Governance and Head of Portfolio Decision Sciences, Portfolio Management, GSK

  • Why is modeling the project pipeline important?
  • What questions can be answered and how can such a model be used?
  • How do you conduct these types of analyses today?
  • What inputs and tools are utilized?
  • What are the challenges in developing the model and/or getting buy-in?

Table: Resource Management Across International Borders

Moderators: Josh Kaminetz, Business Operations Lead, Strategy Realization Office, Global Regulatory Affairs and Clinical Safety, Merck

  • Centralized work versus decentralized work, which is better
  • Managing the exponential demand increase that comes with geography-specific requirements
  • Modeling the reality of international labor policies

Table: Right-Sizing Your Resource Dataset for Real-Time Capacity Planning

Moderators: Cleat Jerden, Executive Director, Business Performance, Business Analysis and External Process Development, Amgen

Samantha Fairbairn, Director, Business Performance, Business Analysis and External Process Development, Amgen

  • Is data-driven capacity planning a success story or a cautionary tale at your firm?
  • What is the right level (function, franchise, TA, whole-company) for capacity planning?
  • Is it realistic to think data is updated frequently enough to enable real-time capacity planning?

Table: Building Partnerships between Project Management, Resource Management, Functional Management, and Finance to Drive Productivity

Moderators: George Fountain III, MBA, PMP, Senior Manager, CMC Performance and Analytics, Kite Pharma, a Gilead Company

Tony Dybicz, PMP, Associate Director, Global Regulatory Affairs and Clinical Safety, Merck & Co., Inc.

  • What are the pitfalls to avoid when trying to develop partnerships internally?
  • What is an “engagement model” to use to establish trust, uncover real resource needs, and maintain a strong relationship with each department?

Table: Developing and Leveraging Integrated Analytics for R&D

Moderators: Michael Ferrante, Head, R&D Business Capabilities, R&D Strategy and Planning, Bristol-Myers Squibb

Sam Mathew, MBA, Portfolio Analytics & Capacity Management Group Leader, Janssen

  • How are companies advancing analytics to boost R&D productivity?
  • Where are the greatest opportunities inside of biopharmaceutical organizations for business operations optimization and improved decision making?
  • What are pragmatic examples of implementation of predictive and prescriptive modeling analytics for risk management, forecast error, portfolio simulation & modeling?

Table: Achieving More Effective and Real-Time Portfolio Management and Resource Allocation

Moderators: Benoit Schmitt, PhD, PMP, Senior Alliance & Portfolio Manager, Galapagos

  • What is real-time portfolio management and resource allocation?
  • Have you achieved this at your company?
  • What are some approaches you have tried?

Portfolio Management

Table: Change Management Skills for Driving Change in Portfolio Decision Making

Moderators: Crissy Tevis, Director, TOPS Portfolio Management, Technical Operations, BioMarin Pharmaceuticals

Christine Antis, Senior Director, Portfolio Governance and Head of Portfolio Decision Sciences, Portfolio Management, GSK

  • Gain support by getting to the source of the organizations pain (e.g., too many projects / not enough people)
  • How to say “no” or “not now” to all of the great ideas and proposed projects
  • Establish appropriate levels of decision-making for portfolio governance (e.g., pros / cons of centralizing all portfolio decisions under one group)

Table: Creating a Governance Body and Corporate Structure to Enable Agile Decision Making

Moderators: Matthew Kokkonen, MBA, Director, Portfolio and Governance, Enterprise Excellence, CSL Behring

Daniel Patrick, Senior Director, Global Project Management and Leadership, Daiichi Sankyo

Michael Zachariou, PhD, Executive Director, Technical Operations CMC Product and Portfolio Management, Technical Operations, BioMarin Pharmaceuticals

  • Centralized vs. Decentralized approach?
  • Level of decision granularity needed for senior leaders? (financial, scientific, operational, commercial)
  • Who needs to know? (empowering decision makers in your organization)

Table: Making Hard Decisions: Building a Portfolio That Balances Short- and Long-Term Objectives

Moderators: Ozgur Ozkan, Decision Science Director, Biometrics and Information Sciences, AstraZeneca Pharmaceuticals

Cleat Jerden, Executive Director, Business Performance, Business Analysis and External Process Development, Amgen

Samantha Fairbairn, Director, Business Performance, Business Analysis and External Process Development, Amgen

Elayne Ko, Director, Portfolio Decision Sciences, GSK

  • How can long-range planning activities work in tandem with shorter-term project-level decision-making?
  • Can you provide prospective portfolio investment suggestions for executives without threatening their desire to be in the driver’s seat?
  • Are your company strategic goals driving your project selection? Should it, and how can that change?

Table: Balancing Internal R&D Investments and Resources with External Collaborations

Moderators To Be Announced

  • What analysis do you use to evaluate investments and resource planning?
  • How do you prioritize resources when evaluating both internal and external projects against each other?

Table: How Do Companies Do Portfolio Management within TA’s and across the Pan-Company Portfolio?

Moderators: Richard Bayney, PhD, President & Founder, Project & Portfolio Value Creation (PPVC)

Timothy Nieman, Senior Manager, Portfolio Analysis, Portfolio Management Office, BioMarin Pharmaceutical

  • What is your model (central team vs. TA embedded?) How do companies do portfolio management within TA’s and across the pan-company portfolio?
  • What is your decision-making model for cross-TA portfolio optimization?
  • What systems and metrics are they using to enable the portfolio management?
  • Who has accountability for portfolio performance?


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For questions about this year's event, please contact:

Kaitlin Searfoss Kelleher
Conference Producer
Cambridge Healthtech Institute
T: (+1) 781-972-5498
E: kkelleher@healthtech.com