Workshop Outline: I. Assess the Role of CMOs in the Manufacturing Strategy of Companies Commercializing Oncology Therapi
Workshop A Commercial Manufacturing Strategy Development — Defining Commercial Scale Models Early in Clinical Development Manufacturing patient-specific therapies entails several unique complexities. Yet, current manufacturing models alone cannot address these complexities such as production, balancing of costs and planning. Pharmaceutical and biotech companies must identify and develop new, distinctive models based on the type of oncology therapies being commercialized. Key Questions to Be Addressed: • How are CMOs involved in the commercialization strategy? • What other manufacturing models are available? • How do you best plan your commercialization strategy to maximize product update? Workshop Outline: I. Assess the Role of CMOs in the Manufacturing Strategy of Companies Commercializing Oncology Therapies II. Understand the Roles and Responsibilities of CMOs within Biotech Companies Before and After the Transfer of Technology and Integration into Clinical Trials III. Identify Factors to Consider when Building Manufacturing Processes to Decide Whether to Utilize a Third-Party Service Provider or Build an In-house Manufacturing Center
Workshop B The Future of Oncology Development — Rationale Approaches to Combination Therapy Novel, targeted immunotherapies possess unique attributes and toxicity profiles. They arise as single agent therapies, however, recent studies have shown great promise when used in combination. Successful combination therapies are based on complimentary mechanisms of action and how new checkpoint inhibitor targets under investigation could potentially provide new options for backbone therapies. This workshop deep-dives into the challenges of combination therapy and offers insight into critical industry movement. Key Questions to Be Addressed: • What are industry movements towards breakthrough status of combination products? • How can you better understand the science behind combination therapies? • What are the best approaches for commercializing combination products? Workshop Outline: I. Understand the Mechanism of Generating an Anti-cancer Immune Response as a Foundation for an Approach to Commercialization of Combination Therapies II. Discuss what Checkpoint Inhibitor Targets Are Under Investigation and Explore Likelihood of Serving as a New Backbone Therapy in Combination with Other Therapies III. Utilize Mechanism-based Action to Determine Criteria for Combination Therapy and Understand Usage with Both Immunotherapies and Chemotherapy to Improve Patient Care IV. Explore How Therapeutic Selection becomes More Refined through Future Research and Development Michael K. Wong, M.D., Ph.D., FRCPC, Professor of Medicine, Keck School of Medicine, USC, Berle and Lucy Adams Chair in Cancer Research; Head, Solid Tumors Section,
Skin Cancer and Melanoma Clinics
Workshop C
Reorient Your Organization Towards a More Commercial Mindset — Strategies for Building a Commercial Structure As more and more companies want to evolve from a R&D company to a fully integrated commercial organization, it is critical to begin building robust and organizationally sound commercialization strategies that will support product launch success. In this deep-dive workshop, hear key insights and lessons learned into the challenges of building a commercial infrastructure and developing specific strategies that fit your situation as an emerging company. Key Questions to Be Addressed: • Is my organization committed to independently commercializing a drug? • How do I appropriately plan and build for launch when there is still so much uncertainty in clinical development and approval? • What are some of the common pitfalls to successfully commercializing a company’s first drug and how to I avoid them? Workshop Outline: I. Hear of the Successes and Lessons Learned for Product Launch of InterMune’s Esbriet IPF Therapy II. Examine how to Reorient Your R&D Organization Towards a More Commercial Mindset III. Learn the Balance of De-Risking Regulatory Milestones and Molecules IV. Discover Strategies for Organizational Scale-Up V. Gain Best Practices for Successfully Launching Your First Product David McNinch, Former Senior Vice President, Commercial Operations,
InterMune
Workshop D Oncology Pricing and Reimbursement Strategy Development for Drugs Entering the Market With the price of oncology drugs taking up roughly 11% of all industry medical costs, and ever-increasing scrutiny on oncology drug pricing from payers and cost effectiveness watchdog organizations, it is essential for organizations to begin building a pricing and market access model based in a solid foundation of clinical data that is conducive to optimal reimbursement and patient access. In this workshop, hear vital insights into the challenges of building pricing and reimbursement strategies that will resonate with payers, patients, and oncologists, and understand actionable tactics that will increase the likelihood of successful reimbursement and product uptake. Key Questions to Be Addressed: • What influence will the current political climate have on the future of oncology drug pricing? • What roles will government agencies, professional societies, and US health technology assessment organizations play in the coming oncology reimbursement landscape? • What will a successful oncology pricing and reimbursement model look like in five years? Workshop Outline: I. Understand Key Players Changing the Oncology Reimbursement Landscape II. Learn of Market Drivers Currently Impacting Changes in Oncology Pricing III. Gain Critical Insight into Payer and Oncologist’s Attitudes Towards Upward Pricing Shifts IV. Evaluate Case Studies of Successful and Unsuccessful Oncology Market Access Launches V. Learn How to Develop and Communicate an Effective and Convincing Value Story to Stakeholders Based on Solid Clinical Data Nathan White, C.P.C., Managing Director and Head, Market Access,
eMAX Health
