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 )

癌症免疫疗法的开发专案及临床试验之新现实以及速度上的应对

2019年10月14-15日


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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。

 

癌症的最新诊断法,必须要让患者再度意识到提供最新疗法的重要性。在生物医药品业界当中,虽然已经将资源投注在新疗法的开发,但一旦开发期拉长,费用也随之高涨。开发的目标也尚未明确,到获得新药许可上市为止的时间风险会对正在进行的专案带来极大影响,评价的基准也不断地在变化。为了要优化肿瘤研究及癌症免疫疗法药物开发,在减少整体费用及减少失败专案的同时,也必须要缩短开发期,肿瘤研究的方法必须要更有效率、更创新。让负责人能够迅速下决策的有效方法尚未出现,也尚未找到开发的明确路径,在这个状况当中,制药公司的项目经理、专案经理、临床试验的负责人,都必须透过研究开发的所有阶段(到上市为止是较理想的)参与复杂的项目,在研究、事业、业务相关的部分,有其重责大任。此会议当中可以学到肿瘤研究、癌症免疫疗法、并用免疫疗法价值链当中的医药品开发、专案管理的新课题、学习如何找出医药品开发,此外还能聆听在这个拥有许多问题的领域中成功所需要的条件。

Final Agenda

10月14日(一)

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

Kiernan_MattMatt 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

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


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

Tierno_DanDan 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

Lehr_MartinModerator: 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

10月15日(二)

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

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 Oncology Collaborations Trends

LaRochelle_KarenKaren 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

Patel_AnupAnup 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

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

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

* 活动内容有可能不事先告知作更动及调整。

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