Cambridge Healthtech Institute’s and Pharmica Consulting’s

Strategic and Operational Challenges of Oncology and Immuno-Oncology Drug Development

Responding to the New Reality and Pace of Immuno-Oncology and Immunotherapy Projects and Trials

October 25-26, 2018


CHI-logo-color&     Pharmica-Logo


In partnership with Pharmica Consulting, we invite you to attend CHI’s and the BioPharma Strategy Series’ Strategic and Operational Challenges of Oncology and Immuno-Oncology Drug Development conference being held October 25-26, 2018 at The Bellevue Hotel in Philadelphia, PA. The conference is a biopharma event run by and attended by experts in the field. It is designed to be highly interactive with keynote presentations, industry panels, roundtable discussions, and networking. All discussions will feature your peers who are dealing with strategic and operational challenges of oncology and immuno-oncology drug development at the intersection of science, business and operations. Each new cancer diagnosis underscores the importance of delivering new therapies to patients. The biopharmaceutical industry is investing resources in developing new treatments, but the timelines are long and the costs are very high. In addition, the pathway for development is unclear and the rapidity of new approvals is highly impactful to programs in process…and benchmarks are constantly changing! To optimize development of new oncology and immuno-oncology treatments for cancer, we must shorten the time of development, while reducing the overall costs and the number of failed attempts. We need to be smarter and more innovative about how we execute oncology studies. For program managers and TA heads, is there an efficient way to get to decisions faster? With no clear pathway for development, the program managers, project managers and clinical trial leaders in the biopharma industry who must ferry these long, complicated programs through all phases and, ideally, to market, play a critical role at the intersection of science, business and operations. Join your colleagues at Cambridge Healthtech Institute’s and the BioPharma Strategy Series’ Strategic and Operational Challenges of Oncology and Immuno-Oncology Drug Development conference being held October 25-26, 2018 at The Bellevue Hotel in Philadelphia, PA.

Final Agenda

Thursday, October 25

7:30 am Registration and Morning Coffee

Understanding Strategic and Operational Challenges of Oncology and Immuno-Oncology Drug Development

8:10 Organizer’s Welcome

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

8:15 Chairperson’s Opening Remarks

Matt Kiernan, Partner, Intrinsic Clinical Systems

8:20 Strategic Challenges of Oncology Drug Development in a Highly Complex and Rapidly Transforming Landscape

Rijhwani_SushilSushil Rijhwani, PhD, MBA, PMP, Vice President, Project Planning & Management, Taiho Oncology, Inc.

The complexity of treatments in oncology is growing exponentially with accelerating innovation enabling unprecedented development of oncology drugs. These advances bring with them the challenge of value optimization for pharma and biotech companies to make investment decisions earlier in development with higher degrees of uncertainty, smaller target patient populations & unprecedented level of competition leading to diminishing financial returns. Accelerated options for clinical development are emerging but the opportunity costs in other areas of development are tremendous requiring companies to pay extra emphasis on strategic choices and other factors related to compound development. This presentation will outline a critical need for companies to establish robust development strategies and to evaluate and adjust those dynamically to deliver clinically relevant outcomes to maintain a sustainable business model.

8:50 How to Keep Up with the Operational Challenges of Oncology Drug Development

Mulheron_JanetJanet Mulheron, Vice President, Head, Integrated Oncology Strategy & Operations, Bristol-Myers Squibb

There is no doubt that the pace of oncology drug development creates many operational challenges. The need for speed will not change. To keep up with the pace requires a team centric approach that is highly collaborative to handle the constant challenges. This presentation will discuss how to best deal with oncology portfolio management and oncology operations.

9:20 Operational Challenges and Advances in an Academic Translational and Clinical Research Program

Hammill_DanaDana Hammill, MS, MBA, Director, Business Development and Alliances, Center for Cellular Immunotherapies, University of Pennsylvania

Academic medical centers excel at being nimble and translating novel therapies from bench to bedside. However, amid immunotherapeutic product rise in both research and market, and with the increase in academic-pharma partnerships, navigating collaborative clinical research between two cultures with different institutional standards can be challenging. This talk explores the strategy and development of an academic center to respond to a pharma alliance to bring the first cellular immunotherapy product to market in the US to conquer cancer.

9:50 INTERACTIVE PANEL: The Future of Oncology and What It Means for Drug Development

Moderator: Matt Kiernan, Partner, Intrinsic Clinical Systems

Janet Mulheron, Vice President, Head, Integrated Oncology Strategy & Operations, Bristol-Myers Squibb

Sushil Rijhwani, PhD, MBA, PMP, Vice President, Project Planning & Management, Taiho Oncology, Inc.

Randall White, PhD, Senior Director, Global Project Management Oncology, Daiichi Sankyo, Inc.

Lena Frank, Executive Director, Program & Alliance Management, Oncology Business Group, Eisai, Inc.

Kelly White, MSN, RN, Global Operations Lead, Oncology, Merck & Co., Inc.

Oncology is changing how we do drug development. For biotechs, the rush to market could lead to critical mistakes that lead to bad results on your lead program. For large companies, oncology means multiple indications in parallel with a hundred million dollars at risk. Even with all the progress we have made in oncology, we need to find better therapies for treating patients and improving the patient experience. With this in mind, what will oncology products and drug development look like to meet the future needs of oncology patients?

  • Discuss current state of oncology drug development
  • Where is oncology headed with regards to how we treat patients?
  • How will oncology drug development continue to change to meet the needs of the future patient?

10:20 Networking Coffee Break

Partnering and Alliance Management

10:55 Chairperson’s Remarks

11:00 Lessons Learned for Effective Partnering

LaVallee_CourtlandCourtland LaVallee, MBA, Head, Project Management, BeiGene

We are in the thick of a collaboration on IO, and I’ve been the acting Alliance Manager from the start, so I have some opinions and experience with establishing and maintaining that partnership that may prove useful for other companies, especially small companies partnering with larger ones. Partnerships can be great or horrible; I think I have useful tips on how to make yours the former, not the latter. If this is your company’s first partnership, this may help make it work better.

11:30 Oncology Combination Therapies: A New Paradigm in Alliance Management

Frank_Lena-v2Lena Frank, Executive Director, Program & Alliance Management, Oncology Business Group, Eisai, Inc.

With the huge number of oncology combination studies currently ongoing, many companies are still in the process of figuring out the alliance best practices for these combination studies. The management for a combination alliance may require different thinking, especially in the areas of study conduct, regulatory interactions and submissions, and commercialization. This presentation will cover the following areas: 1) How do combination collaborations require different thinking from a relationship that involves a single compound, 2) What potential strategies should be reviewed prior to entering into a combination collaboration, 3) What specific areas will potentially need new alliance best practices as compared to monotherapy collaborations?

12:00 pmApproaches to Partnering for Success in Oncology Immuno-Oncology: Big and Small Companies Sharing Risk

Ganguli_AnjaliAnjali Ganguli, PhD, Executive Director, Corporate Development, Syndax Pharmaceuticals, Inc.

Multi-stakeholder partnerships in research, development and commercialization are a key driver of success in the biopharma industry, but that doesn’t make them easy. Syndax, a Boston-based biotech, is currently focused on developing an innovative pipeline of combination therapies in multiple cancer indications and is at the center of multiple partnering relationships with research institutions, independent researchers and with the key global biopharmaceutical companies in immuno-oncology, Merck & Co. (for non-small cell lung cancer, colorectal cancer and melanoma), with Genentech, Inc. (for TNBC) with AstraZeneca (for solid tumors) and with Pfizer, Inc. and Merck KGaA (for ovarian cancer).

12:30 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

Program Management and Execution in Oncology and Immuno-Oncology

1:55 Chairperson’s Remarks

Eric Lake, Partner, Pharmica Consulting

2:00 Managing Immuno-Oncology Drug Development Programs through Shifting Strategic & Operational Narratives

Patny_AkshayAkshay Patny, PhD, Director, Global Project Management, EMD Serono, Inc.

The presentation will discuss navigating complexities of managing a highly competitive, complex, international, and alliance-driven program/project-based on the real-world experience. In an era where the paradigm of immuno-oncology drug development, regulatory landscape, market access, and commercialization is evolving in a hyper competitive I-O marketplace, the presentation will focus on how to adapt the strategic priorities and operational tactics to adapt for success. Aspects of working in an entrenched alliance setting and its influence and challenges within I-O drug development framework will also be deliberated.

2:30 Enriching the Arsenal of Cancer Therapies: Development of ADC Targeted Agents in a Transformational Japanese Pharma Company

White_RandyRandall White, PhD, Senior Director, Global Project Management Oncology, Daiichi Sankyo, Inc.

Daichii Sankyo’s leading ADC cancer therapy has been granted BTD by the FDA for HER2-positive metastatic breast cancer as well as SAKIGAKI designation for gastric cancer from Japan MHLW. This represents a very exciting and challenging opportunity for a traditional non-oncology Japanese pharma company and the respective project teams responsible for development. This presentation will discuss the unique operational and management aspects of this organization and the behavioral and leadership skills necessary for successful program execution.

3:00 Sponsored Presentation (Opportunity Available)

3:15 QbD for New Drug Clinical Development in Oncology and I-O: Optimizing Integrations in a Dynamic Environment

Gabrielli_SamSam Gabrielli, Associate Director, Portfolio & Project Management, Gilead Sciences

Co-Presenter to be Announced

Quality by Design in BioPharma has been focused primarily on designing validated production processes that are transferable across a manufacturing network with minimal requirements for site specific process engineering. Likewise, Gilead is using these principles to redesign our clinical development processes to enable new technologies, acquisitions and collaborations with minimal requirements to develop new processes. In the dynamic TA of oncology and immuno-oncology drug development timelines have changed. We have also made some key acquisitions in this space. So, it’s vital that we increase our agility, speed of development and integration foresight.

3:45 Breakout Discussion Groups Remarks & Introduction to Tables and Moderators

3:50 Networking Refreshment Break

INTERACTIVE BREAKOUT DISCUSSIONS

4:20 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. >> SEE DETAILS

  • TABLE 1: Partnerships, Alliance Management and Program Execution in Oncology and Immuno-Oncology
  • TABLE 2: Regulatory Strategy as a Key Component of Oncology and I-O Drug Development Planning
  • TABLE 3: Building a Program Management Capability for Unique Challenges and Timelines of Onco/I-O
  • TABLE 4: Clinical Trial Design and Operations Challenges in Oncology and Immuno-Oncology

4:55 Breakout Discussions Summary Report Outs

At the end of the interactive breakout discussions, a representative from each table will offer a summary report out.

5:10 Close of Day

Friday, October 26

Regulatory Strategy as a Key Component of Oncology Drug Development Planning

8:15 am Morning Coffee

8:40 Chairperson’s Remarks

Greg Cohee, Partner, Pharmica Consulting

8:45 Surfing Waves of Complexity: Regulatory Considerations for the Go-Grow Immuno-Oncology Era

Brown_MattMatthew Brown, PhD, Vice President (retired), Enterprise Governance Management, Bristol-Myers Squibb

This early stage of game-changing IO therapeutics has stimulated hyperactivity in drug development, registration, and access activities. Successfully navigating that complexity includes satisfying regulatory processes that are evolving (at mixed rates) with the intent to prudently enable IO innovations. In addition to procedural differences, geographic variation in standards of care, suitable endpoints, diagnostic availability, and pricing implications raise strategic and resource challenges. Careful consideration of differing regulatory trends, procedural variations, and tactical approaches provide higher likelihood of productive outcomes.

Translating Assets from Preclinical to Clinical Development

9:15 Early Clinical Portfolio Strategy for Balancing I-O and Non-I-O Approaches

Roberts_JohnJohn Roberts, MBA, Director, Strategic Portfolio Management, Worldwide R&D, Pfizer

Discuss and understand the challenges for optimizing an I-O portfolio strategy across the many potential oncology approaches, in a rapidly changing landscape. What considerations might determine how heavily and early to invest? What could determine the balance between being focused vs. broad in targeting new scientific approaches, and how much to leverage external expertise vs. building internal capabilities?

9:45 Strategic and Operational Considerations for the Development of Immuno-Oncology Assets: Planning for Success

Stewart_ChadChad Stewart, MBA, PMP, Senior Director, Program and Alliance Management, Immatics, US

Attendees will gain critical insights into the challenges and opportunities of translating assets from preclinical development into early phases of clinical development. Key learnings will include effective planning, resourcing, and leveraging of partnerships. Included in the discussion will be an assessment of some of the risk and challenges to effective management of the drug development programs in this highly competitive space.

10:15 Sponsored Presentation (Opportunity Available)

10:45 Networking Coffee Break

Oncology and I-O Clinical Trial Planning and Operations

11:15 One Compound/Many Oncology Indications: Connecting the Right Patients to the Right Trials across Your Portfolio

White_KellyKelly White, MSN, RN, Global Operations Lead, Oncology, Merck & Co., Inc.

There is no category expanding more rapidly than immuno-oncology. Companies like Merck are actively recruiting many trials for a single compound, and over 700 open trials through academic and industry partnerships. This session will present a case study for Merck’s Keynote Clinical Trial program. To support this massive clinical program, both the sponsor and recruitment provider developed a programmatic experience on a scale that has never been attempted for a single compound, supporting over 30 indications and has expanded to include strategic partnerships offering combination therapies.

11:45 Trial and Error: Learnings from Immuno-Oncology Trials to Help Design Future Safety and Efficacy Trials

Tierno_DanDan Tierno, MBA, Strategic Implementation, Global Data Sciences and Analytics, Bayer U.S. LLC

Planning and executing clinical trials in immune-oncology presents unique challenges. Many disease states that are targeted by immuno-oncology therapeutics have fragmented prevalence, and companies pursing therapeutics can often be competing for the same patients. Further, this presentation will detail mitigations of those challenges, provide real world examples of success as well as describe novel ways that the industry can move forward.

12:15 pm INTERACTIVE PANEL: Clinical Trial Design and Operations: What Are the Key Challenges When Planning and Executing Clinical Trials in this Unique Therapeutic Area?

Kelly White, MSN, RN, Director, Global Operations Oncology, Global Trial Optimization, Merck

Dan Tierno, MBA, Strategic Implementation, Global Data Sciences and Analytics, Bayer U.S. LLC

Eric Lake, Partner, Pharmica Consulting

Courtland LaVallee, MBA, Head, Project Management, BeiGene

To optimize development of new oncology and immuno-oncology treatments for cancer, we must shorten the time of development, while reducing the overall costs and the number of failed attempts. We need to be smarter and more innovative about how we execute oncology studies.

  • Endpoints and novel clinical trial design in oncology and immuno-oncology: Lessons learned from those involved in projects now
  • How to deal with patient recruitment challenges
  • How do you do instream data? Are there examples where reduced data collection and/or source verification has been effectively implemented in immuno-oncology studies?
  • Program management, project management and study start-up: How to speed enrollment, pros/cons of including Europe, Japan and China; Cost-effective technological solutions to operational issues
  • Site Selection: Finding qualified sites that can get started quickly, are able to conduct complex oncology studies, and who aren’t already doing competitive studies

12:45 Closing Remarks

12:50 Close of Conference


* The program is subject to change without notice, due to unforeseen reason.

Choose your language
Japanese
Traditional Chinese
Simplified Chinese
Korean