Access challenges to cell and gene therapy are well documented. Precision’s Christina Poschen and David Carr discuss how some innovative manufacturers are moving away from the role of being purely a researcher and manufacturer and toward involvement at the point of diagnosis through manufacturing and delivery to patient access support in order to address those challenges head on.
Circulating Tumor Cells Detected from Angiosarcoma Cancer Patients with use of ApoStream® Technology in a First-of-its-kind Study
PROMISING RESULTS DERIVED FROM THE PIVOTAL PHASE 3 TAPPAS TRIAL OF TRC105 AND VATRIENT® IN PATIENTS WITH ADVANCED ANGIOSARCOMA
HOUSTON, TX – November 14, 2018 – Precision for Medicine and TRACON Pharmaceuticals (NASDAQ:TCON) announced today the presentation of biomarker results from the TAPPAS phase 3 clinical trial that utilized ApoCell’s proprietary circulating tumor cell (CTC) enrichment system, ApoStream. The study, titled Detection of Endoglin-Expressing CTCs in Patients Enrolled in an Adaptive Enrichment Phase 3 Trial of TRC105 and Pazopanib Versus Pazopanib Alone in Patients with Advanced Angiosarcoma (TAPPAS), is the first of its kind to show the detection and capture of CTCs from angiosarcoma cancer patients. Interim study results were presented at the Connective Tissue Oncology Society (CTOS) annual meeting in Rome, Italy. (more…)
PHE in Health Affairs, Value in Health,and more…
Health Affairs Blog Article on Patient-Centered Formularies
PHE Senior Director Jason Shafrin and Director Mark Linthicum published an article on the importance of accounting for patient heterogeneity in formulary design and the potential use of tools to help payers understand and assess patient-centered value.
Health Affairs Blog Article on Components of Value Frameworks
PHE Scientific Advisor Anupam Jena, along with Lauren Neves and Randy Burkholder, published an article in the Health Affairs Blog on April 16, 2018, on the importance of capturing comprehensive components of the value of medical innovations in value frameworks.
Value in Health Study on the Impact of Improved Mobility
PHE researchers quantified the impact of improved mobility on using PHE’s proprietary microsimulation THEMIS, finding that improvements in mobility are likely to lead to significant reductions in medical expenditures and nursing home utilization and significant increases in employment.
Pharmaceutical Executive Article on the Role of Pharmaceutical Companies in Value Assessment
PHE’s Ross Maclean and Jeroen Jansen published an article in Pharmaceutical Executiveon the role of pharmaceutical companies in conducting transparent and relevant evaluations of value, advocating an open-source approach to conducting cost-effectiveness evaluations.
In part 2 of their Guest Commentary series, Precision’s Todd Edgar, Alex Grosvenor, and Kellie Rademacher highlight the takeaways of the NOR-SWITCH trial and how the EU’s view of biosimilars as therapeutic alternatives is influencing US policy. (more…)
Precision’s Ross Maclean and Jeroen Jansen encourage biopharma and medical device industries to embrace the developments around value assessment and to take a leading role in improving the transparency of cost-effectiveness evaluations. (more…)
In a feature in Pharma Live, Precision’s Jeremy Schafer and Maureen Hennessy predict that the projected growth in healthcare spend is creating an inevitable marketplace shift from volume to value. (more…)
With increased biomarker and specialty lab data being incorporated into FDA submissions, drug developers are running into challenges as they prepare data that comply with new regulatory requirements. (more…)