Watch this webinar on addressing early onset cancer through strategic trial design, targeted launch indications, and increased trial access to speed up the delivery of impactful treatments.

Early onset cancer has risen dramatically, with more than a 79% increase from 1990-2019 totaling more than 3.26 million diagnoses for individuals aged 14-49 in 20191. Cancer in young adults is different and there is significant unmet medical need in this area as an emerging – and alarming – public health concern. How should drug developers respond to this disturbing trend?

The patient pathway, treatment experience and disease impact differ for young adults compared to older patients. Drug developers have an opportunity to take a more strategic approach to trial design, target launch indications, and trial access points tailored to younger and more diverse patient populations, including historically underrepresented groups.

There is a strong need for improved outcomes such as overall survival and progression free survival. An optimized regulatory and commercial strategy could bring new, meaningful products to market faster to reach patients in the most need.

1Zhao J, Xu L, Sun J, et al. Global trends in incidence, death, burden and risk factors of early-onset cancer from 1990 to 2019. BMJ Oncology 2023;2:e000049. doi: 10.1136/bmjonc-2023-000049

Key Topics Include:

  • Trends in cancer incidence, mortality, and impact of disease in young adults including those in historically underserved populations
  • Factors that increase the risk of early onset cancers and how early onset cancer differs from cancers that occur later in life
  • Unmet need in early onset cancer
  • Strategic & operational considerations to enable development success to meet the need in early onset cancer
  • Difference between fast track, accelerated approval and priority review
  • Value proposition considerations for treatments for cancer in young adults
  • Drivers of CMS Fair Market Price for a new treatment for early onset cancer

Presenters

Mark McCoy, ;RPh, MBA

Mark McCoy, RPh, MBA

Director, Client Engagement
Global Market Access
ICON

Mark McCoy has over 25 years of experience in oncology, new product development, and product launches. He has developed market access and reimbursement strategies for oncology drugs in hematology, solid tumor, and rare cancers.
Tanja Obradovic, ;PhD

Tanja Obradovic, PhD

VP, Scientific Affairs
Oncology Medical Strategy
ICON

Dr. Tanja Obradovic brings more than 25 years of experience in pharmaceutical development in oncology. As strategy lead, she led immunotherapy development and life cycle management across tumor types, including melanoma, lung, women’s cancers, and other indications.
Wendy DeSpain, ;MBA

Wendy DeSpain, MBA

Global Head
Regulatory Strategy
ICON

With more than 29 years in pharmaceuticals and 23 years focused on regulatory affairs, Wendy DeSpain offers deep experience in a variety of subject matter. Her responsibilities have included project management on regulatory-related activity and preparation of required submissions, including IND, NDA and BLA. She oversees ICON’s worldwide regulatory strategy efforts.
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