Biopharma FAQs

Foundation Medicine is your partner to help accelerate biomarker-driven drug development - from target discovery to commercial launch, we can assist biopharma partners with the following offerings: 

Research 

Our partners can leverage our genomic knowledgebase in their clinical scientific investigations or use our assays to perform biomarker discovery in prospective and retrospective clinical specimens. 

Development 

We facilitate molecularly-guided clinical trial design by connecting patients with trials, targeting their unique genomic profiles. We utilize our comprehensive genomic profiling platform as a Clinical Trial Assay (CTA) for prospective patient selection. 

Commercialization 

We offer comprehensive Companion Diagnostic development, full regulatory support services (including submissions), as well as integrated post-approval services. 

FoundationCore^® is a molecular information knowledgebase that contains genomic information from more than 500,000 patients whose tumors have been profiled by Foundation Medicine. Our partners can access and query this knowledgebase through our de-identified web-based platform, FoundationInsights^®, or can collaborate directly with our Cancer Genomics Research scientists in bespoke projects. This dataset is notably enriched for rare cancers relative to population prevalence, making it an invaluable source for genomic targeting of populations with high unmet medical need. 

Foundation Medicine offers both liquid and tissue next-generation sequencing (NGS) comprehensive genomic profiling (CGP) cancer assays to enable a synergistic approach to support drug development.

Enrollment and Regulatory Strategy

• Leveraging both platforms can support accelerating enrollment by providing more access to subjects who may not have the ability to provide a tissue biopsy

• Having a synergistic tissue approach enables reflex to tissue if the liquid biopsy has insufficient ctDNA, as well as a regulatory strategy leveraging both tissue and liquid to broaden access to subjects once the therapy is on market

Liquid biopsy can also accelerate learnings to inform drug development pipelines by

• Translational learning through ctDNA resistance analysis¹

• Monitoring ctDNA dynamics for early insights into treatment effect²

• Early information from ctDNA, through treatment response monitoring, could inform approaches to treatment by helping stratify subjects with a high risk of resistance who might be candidates for escalation, versus those with a low risk of recurrence who might benefit from de-escalation to reduce risk of toxicities³

• Detectable ctDNA following surgery or neoadjuvant treatment for early-stage cancers, known as molecular residual disease, is associated with a high risk of recurrence and could provide valuable risk stratification information for making adjuvant treatment decisions⁴

References:

¹ Awad MM, et al. Acquired resistance to KRAS G12C Inhibition in Cancer. N Engl J Med. 2021;384(25):2382-2393.

² Cheng ML, Lau CJ, Milan MS, Supplee JG, Riess JW, Bradbury PA, Jänne PA, Oxnard GR, Paweletz CP. Plasma ctDNA Response Is an Early Marker of Treatment Effect in Advanced NSCLC. JCO Precision Oncology. 2021 Feb;5:393-402.

³ Dasari A, Morris VK, Allegra CJ, et al. ctDNA applications and integration in colorectal cancer: an NCI Colon and Rectal-Anal Task Forces whitepaper. Nat Rev Clin Oncol. 2020;17(12):757-770. doi:10.1038/s41571-020-0392-0

⁴ Tie J et al. Circulating Tumor DNA Analyses as Markers of Recurrence Risk and Benefit of Adjuvant Therapy for Stage III Colon Cancer [published correction appears in JAMA Oncol. 2019 Dec 1;5(12):1811]. JAMA Oncol. 2019;5(12):1710-1717. doi:10.1001/jamaoncol.2019.3616

Foundation Medicine sits at the nexus of medicine and pharmaceutical research, combining our multi-faceted expertise with more than 500,000 sequenced patient samples and over 65 pharmaceutical partners. We help our partners optimize their clinical trials in a number of ways: 

Trial Design 

Utilize more than 500,000 profiles in the FoundationCore knowledgebase to define biomarker criteria, map geographic ordering patterns, and select sites with the highest testing volumes. 

Trial Screening for Enrollment 

Find and enroll patients efficiently from real-world testing, including those with rare genomic findings. We profile thousands of new patients per week. 

Trial Access 

Access a just-in-time network of more than 300 sites to enroll matched patients in remote geographies. 

Learn more about our clinical trial offerings

FoundationInsights^TM is a secure web application, which pulls data from our FoundationCore® knowledgebase of more than 500,000 de-identified patient genomic profiles, spanning more than 150 cancer subtypes.

Learn more about our database insights. 

To contact our Biopharma Solutions team please email bmailbox@foundationmedicine.com.