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
Tanja Obradovic
Tanja Obradovic's experience includes 20+ years in clinical research as well as medical strategy leadership of oncology immunotherapy drug treatment value and reimbursement policy including packages for major private and public insurers and regulatory bodies such as CMS and NICE.
Mark McCoy
Mark McCoy has over 25 years of experience in US and global pharmaceutical marketing and specializes in market access communications. His extensive experience includes developing and communicating powerful value propositions for prelaunch and launch brands in a broad range of therapeutic categories.
Wendy DeSpain
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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