Date Time 11:00 - 12:00
Location Webinar Timezone America/New York
Early onset cancer has risen dramatically, with more than a 79% increase from 1990-2019 totalling more than 3.26 million diagnoses for individuals aged 14-49 in 2019i. 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 optimised regulatory and commercial strategy could bring new, meaningful products to market faster to reach patients in the most need.
Join the webinar to learn more about:
- 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
- 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
Mark McCoy RPH, MBA
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 haematology, solid tumour and rare cancers.
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 tumour types, including melanoma, lung, women’s cancers and other indications.
With more than 29 years in pharmaceuticals and 23 years focused on regulatory affairs, Wendy 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.
- Clinical Directors
- Regulatory Affairs
- Regulatory Strategy
- Strategic Product Development
- Market Access
- Managed Markets
iZhao 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