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
& 
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
8:10 am Registration and Morning Coffee
8:40 Organizer’s Welcome
Micah Lieberman, Executive Director, Conferences, BioPharmaceutical Strategy Series, Cambridge Healthtech Institute (CHI)
8:45 Chairperson’s Opening Remarks: How Oncology has Ended the Blockbuster Era
Matt Kiernan, Partner, Intrinsic Clinical Systems
Oncology has changed the way we do drug development. Development programs are different. Clinical trials are designed differently. FDA has created new programs just for oncology. The new products are far superior to traditional chemotherapy agents so
the price is much higher. Is this sustainable and has oncology truly changed drug development for all therapeutic areas forever? This presentation will explore these topics.
9:05 Strategic Challenges of Oncology Drug Development in a Highly Complex and Rapidly Transforming Landscape
Sushil 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.
9:35 How to Keep Up with the Operational Challenges of Oncology Drug Development
Janet 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.
10:05 Operational Challenges and Advances in an Academic Translational and Clinical Research Program
Dana 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.
10:35 Networking Coffee Break
11:05 Chairperson’s Remarks
11:10 Lessons Learned for Effective Partnering
Courtland 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.
11:40 Oncology Combination Therapies: A New Paradigm in Alliance Management
Lena 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?
12:10 pmApproaches to Partnering for Success in Oncology Immuno-Oncology: Big and Small Companies Sharing Risk
Anjali 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).
12:40 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own
(Please contact Katelin Fitzgerald +1.781.972.5458, kfitzgerald@healthtech.com)
2:10 Chairperson’s Remarks
Eric Lake, Partner, Pharmica Consulting
2:15 Managing Immuno-Oncology Drug Development Programs through Shifting Strategic & Operational Narratives
Akshay 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.
2:45 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.
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?
3:15 Breakout Discussion Groups Remarks & Introduction to Tables and Moderators
3:20 Networking Refreshment Break
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. >> SEE DETAILS
- TABLE: Partnerships, Alliance Management and Program Execution in Oncology and Immuno-Oncology
- TABLE: Regulatory Strategy as a Key Component of Oncology and I-O Drug Development Planning
- TABLE: Building a Program Management Capability for Unique Challenges and Timelines of Onco/I-O
- TABLE: Clinical Trial Design and Operations Challenges in Oncology and Immuno-Oncology
4:35 Breakout Discussions Summary Report Outs
At the end of the interactive breakout discussions, a representative from each table will offer a summary report out.
5:00 Close of Day
Friday, October 26
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
Matthew 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.
9:15 Early Clinical Portfolio Strategy for Balancing I-O and Non-I-O Approaches
John Roberts, MBA, Senior 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
Chad 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 Networking Coffee Break
10:45 Oncology Combination Therapy: Exploring the Synergy Between Loco-Regional Therapies and Immuno-Oncology Drugs
Grant Morgan PhD, PMP, SVP & Head Portfolio Planning, Systems
& Analytics, BTG PLC
Some tumor types don’t respond to the current marketed Immuno-Oncology drugs and for others, response rates are low, particularly in large solid tumors. The oncology community is therefore actively seeking additional therapies to combine
with these drugs to increase the number of cancer patients who benefit. Loco-regional therapy (LRT) refers to various minimally invasive therapeutic procedures, where a device, drug, or chemical is introduced directly to the tumor, causing
tumor death with minimal impact on healthy tissue. Necrotic cell death caused by such ablative and transarterial LRT also releases tumor-specific antigens, which then provoke immune responses such as proliferation of tumor-specific T cells.
We describe the building preclinical and clinical research to indicate the potential for LRT in combination with Immuno-Oncology drugs and the challenges faced in bringing such combination therapies to the market. .
11:15 One Compound/Many Oncology Indications: Connecting the Right Patients to the Right Trials across Your Portfolio
Kelly 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 Case Study: Immuno-oncology Tech Transfer in a Start-Up Environment – Nothing But a Party
Peter Malamis, COO, ImmunoRestoration
There’s amazing clinical research being done in academic medical centers all over the country. Ironically, commercializing that work sometimes feels more like art than science. This presentation reviews the challenges, opportunities,
and the pitfalls of that process from the perspective an organization founded to bring a potentially groundbreaking immunotherapeutic vaccine to market.
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
Peter Malamis, COO, ImmunoRestoration
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