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


CHI-logo-color


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.

Final Agenda

Monday, October 14

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

Cohee_GregGreg Cohee, 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 KEYNOTE PRESENTATION: Thriving Beyond Cancer

Long RobertRob Long, Executive Director, Uplifting Athletes

I will talk about my journey from Division I football and Top NFL Prospect to chemo and radiation and fighting through a battle with brain cancer to be able to leverage my story to make a difference in the lives of those affected by rare diseases.

2:25 Novel Technologies in Immuno/Oncology Trials and Their Impact on Therapeutic Development

Tierno_DanDan Tierno, Associate Director, Project & Portfolio Management, Daiichi Sankyo

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

Lehr_MartinModerator: Martin Lehr, CEO, Context Therapeutics

Panelists: Charles Morris, Chief Medical Officer, Radius Health

Christina Coughlin, MD, PhD, Executive Vice President, Chief Medical Officer, Tmunity

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.

3:55 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

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

Curtis_StephenModerator: Stephen Curtis, PhD, Principal, MPM Capital


Baran_MichaelPanelists: Michael Baran, Executive Director, WRD, Principal, Pfizer Ventures


Cohen_MattMatthew 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

9:45 Herding Cats and Finding Gems: Prioritizing Investment Choices in Oncology Development

Zipp_KeelyKeely Zipp, Vice President, Marketing, Cybrexa Therapeutics

This talk will discuss how to ensure the changing external landscape is accounted for in decisions, as well as how to engage with internal teams to deliver the best thinking. We'll discuss how to preserve options when making decisions and how to balance between process and flexibility

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

LaVallee_CourtlandCourtland 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 Organizational Decision-Making: Are Your Portfolio Processes Helping or Hindering IO Assets?

Townson_DavidDavid F. Townson, PhD, Program Head Immuno-Oncology, Oncology, Bayer

Immuno-oncology programs are not only pushing the boundaries of science but also can present a major challenge to organizations whose governance models have been built on a more traditional R&D paradigm. Project and Portfolio Management functions that engage their asset teams with a strong customer mind-set may realize better outcomes and provide better service to their various stakeholders than those that try and force these innovative programs into one-size-fits-all processes

11:45 Technical Operations Initiative: Optimizing Governance for a Rapidly Growing Organization  

Moon_JaneJane Moon, MBA, PMP, Senior Manager, Program & Business Excellence, 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 escalation pathways. This presentation will present a case study of how the governance pain-points associated with going from startup to the growth and expansion phase of the company has been identified and is being addressed.

12:15 pm Enjoy Lunch on Your Own

12:45 Session Break

UTILIZING ARTIFICIAL INTELLIGENCE AND ADVANCED ANALYTICS

1:30 Chairperson’s Remarks

Matt Kiernan, Partner, Pharmica Consulting

1:35 AI Projects In An Oncology Setting

Patel_JayJay 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_RangaRangaprasad 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

Malamis_PeterPeter 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

Stein_JordanJordan 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

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


Panelists: Chris LeMasters, Executive Vice President and Chief Business Officer, Mirati Therapeutics

Shari Wahl, Executive Director, Oncology Transactions, Business Development & Licensing, Merck

Len Rosenberg, PhD, RPh, Head, Clinical Operations, Beat AML/LLS 

5:15 Close of Strategic and Operational Challenges of Oncology & Immuno-Oncology Drug Development


Register Today!

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