Cambridge Healthtech Institute’s Second Annual
Strategic and Operational Challenges of Oncology & Immuno-Oncology Drug Development
Responding to the New Reality and Pace of Immuno-Oncology and Immunotherapy Projects and Trials
October 14-15, 2019
In partnership with Pharmica Consulting, we invite you to attend CHI’s and the BioPharma Strategy Series’ 2nd Annual Strategic and Operational Challenges of Oncology and Immuno-Oncology Drug Development conference
being held October 14-15, 2019 at The Bellevue Hotel in Philadelphia, PA.
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 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 to learn about the latest drug development and project management challenges across the oncology, immuno-oncology and immunotherapy combinations value chain and how
to navigate what has become the most research-intensive therapeutic area in drug development. Hear from others on what being successful in this challenging arena requires.
Day 1 | Day 2 | Download Brochure
Monday, October 14
12:45 pm Registration
1:35 Organizer’s Welcome
Kaitlin Searfoss Kelleher, Conference Director, Cambridge Healthtech Institute
1:40 Chairperson’s Remarks: The State of Oncology and Immuno-Oncology: An Overview
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
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
Tuesday, October 15
Day 1 | Day 2 | Download Brochure
8:15 am Morning Coffee
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
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
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
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
1:30 Chairperson’s Remarks
Greg Cohee, Partner, Pharmica Consulting
1:35 AI Projects In An Oncology Setting
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
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,
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
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
Day 1 | Day 2 | Download Brochure