Cambridge Healthtech Institute’s Second Annual
Strategic and Operational Challenges of Oncology & Immuno-Oncology Drug Development
( 在肿瘤研究以及癌症免疫疗法药物开发上，战略面及业务面所面临的课题 )
与Pharmica Consulting共同举办的以肿瘤研究及癌症免疫疗法药物开发当中，在战略上及业务面所面临问题的会议议程、将于2019年10月14日至15日、在美国宾州费城的The Bellevue Hotel举办。
Day 1 | Day 2
12:45 pm Registration
1:35 Organizer’s Welcome
Kaitlin Searfoss Kelleher, Conference Director, Cambridge Healthtech Institute
SURVIVING AND THRIVING IN ONCOLOGY AND IO
1:40 Chairperson’s Remarks: The State of Oncology and Immuno-Oncology: An Overview
Matt Kiernan, Partner, Pharmica Consulting
The pace of oncology and IO drug development is constantly accelerating. The need to be first to market and to help patients in desperate need of new therapies puts increasingly larger demands on oncology and IO team members. This presentation will explore the latest developments in oncology and IO therapies.
1:55 Addressing Operational Challenges in Oncology and IO
Kelly White, MSN, RN, Global Operations Lead, Oncology, Merck & Co., Inc.
2:25 Novel Technologies in Immuno/Oncology Trials and Their Impact on Therapeutic Development
Dan Tierno, Associate Director, Global Clinical Data Sciences and Analytics, Bayer
The bridge between novel technologies and their application in Immuno/Oncology therapeutic development is stronger than ever, with intense collaboration between regulatory authorities, academia and industry shaping the Immuno/Oncology development landscape for today and tomorrow. This presentation will focus on technologies presently in use as well as a look into what to expect from technological applications in Immuno/Oncology therapeutic development.
2:55 PANEL DISCUSSION: Competing Against Goliath – How David Runs Clinical Trials
Moderator: Martin Lehr, CEO, Context Therapeutics
Panelists To Be Announced
Oncology clinical trials are challenging – from patient enrollment, to managing complex comorbidities, to financing. This panel discussion will have you learn from the best on how to navigate the oncology space.
3:25 Sponsored Presentation (Sponsorship Opportunity Available)
3:55 Introduction to Breakout Discussions
4:00 Networking Refreshment Break
4:30 Breakout Discussions
5:30 Welcome Reception with Exhibit Viewing
6:30 Close of Day
Day 1 | Day 2
8:15 am Morning Coffee
INVESTING IN ONCOLOGY AND IO
8:40 Chairperson’s Remarks
Eric Lake, Partner, Pharmica Consulting
8:45 PANEL DISCUSSION: Investing in Oncology and IO: Perspectives from Venture Capitalists and Pharma Ventures
Moderator: Stephen Curtis, PhD, Principal, MPM Capital
Panelists: Michael Baran, Executive Director, WRD, Principal, Pfizer Ventures
Matthew Cohen, PhD, Partner, Osage University Partners
This panel will discuss key challenges in investing in oncology and IO, including:
- What VCs look for vs. what pharma looks for before investing in a company – the molecule, the stage, and the business goals
- Insights into the market – competition, cost to invest, and sharing the field with tech investors
- The role of combinations in investing vs. partnering
10:15 Coffee Break with Exhibit Viewing
OPTIMIZING ASSETS AND GOVERNANCE
10:45 The Key Components of Driving Innovation in Drug Development: Culture and Governance
Courtland R. LaVallee, Head, Immuno-oncology Program Management, Program Management, BeiGene USA
We often hear a call for, or promise of, increased R&D innovation. But what does that mean, how do we get it, and how do we know when we have it? This presentation will provide a provocative look at answering these questions, with a particular look into culture and governance, and the unique landscape of oncology and IO drug development.
11:15 Oncology Collaborations Trends
Karen LaRochelle, MBA, Chief Business Officer, PsiOxus Therapeutics
Join us for insights into oncology dealmaking, ranging from research through late-stage clinical, including a review of partnerships, M&A and clinical collaboration trends. How are the hundreds of clinical collaborations struck in past years influencing today’s landscape? How is the oncology collaboration landscape evolving? Is IO dealmaking still the shining star of a few years ago, and what does it take to succeed? How are pharma and biotech best working together to deliver on the promise of innovative pipelines for patients? What does a healthy alliance look like, and importantly, what doesn’t work?
11:45 CO-PRESENTATION: Optimizing Governance for a Growing Organization
Jane Moon, MBA, PMP, Senior Manager, CMC Performance and Analytics, Kite Pharma, a Gilead Company
Anup Patel, MPH, Senior Manager, CMC Engagement, Kite Pharma, a Gilead Company
In the fast-paced environment of cell therapy development, decisions need to be made in a robust manner, creating the need for clearly defined governances and business processes. This presentation will present a case study of how a cross-functional team was able to quickly come together and create a successful process that represents different groups across the organization in the development of a global clinical labeling business process.
12:15 pm Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own
12:45 Session Break
UTILIZING ARTIFICIAL INTELLIGENCE AND ADVANCED ANALYTICS
1:30 Chairperson’s Remarks
Greg Cohee, Partner, Pharmica Consulting
1:35 AI Projects In An Oncology Setting
Jay Patel, Director, Oncology Operations, US Oncology, Bristol-Myers Squibb
AI projects are notoriously hard to develop and execute, especially in the oncology sector. This talk will provide insights for those executives interested in integrating AI projects into their project portfolios and explore common challenges, best practices, and lessons learned.
2:05 Leveraging Data and AI Analytics with RWD-Based Support for Planning Next Steps in Clinical Development in the IO Space
Rangaprasad Sarangarajan, Chief Scientific Officer & SVP, Clinical and Translational Sciences, Research & Development, BERG LLC
This talk will outline how BERG utilizes advanced analytics to propel its products through clinical development.
2:35 Improving Clinical Trials Through Performance Analytics
Peter Malamis, CCO, ImmunoRestoration, Inc.
Clinical trials are driven by the needs and perspectives of four key stakeholders: patients, sites, sponsors, and, in many cases, CROs. This panel will explore those views and how understanding, accepting, and accommodating them is central to conducting a high-quality, efficient trial. Data from an Applied Clinical Trials comprehensive assessment of clinical trial quality will be presented publicly for the first time.
3:05 Refreshment Break with Exhibit Viewing
INNOVATION IN ONCOLOGY AND IO THROUGH ALLIANCES AND COLLABORATIONS
3:45 Academic and Pharma Networks Can Be an Incubator for Knowledge Exchange, Innovation, and Collaboration
Jordan Stein, RPh, MBA, PMP, Director. Project Management Lead, Innovative Medicines, Bristol-Myers Squibb
Oncology and immune-oncology drug development poses many scientific, technical and operational challenges. Developing external networks to engage academic institutions in order to collaborate can help forge an integrated exchange of information, and novel research will further answer key questions and advance knowledge sharing. This session will review some of the partnering strategies that Bristol-Myers Squibb has developed to help advance scientific exchange and data generation, along with other companies who have taken a similar approach.
4:15 PANEL DISCUSSION: Clinical Collaborations Between Pharma and Biotech for Combination Drugs in IO
Nathan Sanburn, Senior Advisor, Global Business Development and Strategic Collaborations, Oncology Business Unit, Eli Lilly and Company
Panelists To Be Announced
5:15 Close of Strategic and Operational Challenges of Oncology & Immuno-Oncology Drug Development