Tumor Growth Dynamic Modeling in Oncology Drug Development and Regulatory Approval: Past, Present, and Future Opportunities

tumor growth, drug developement, drug approval, TGD, MIDD, PDUFA

Model-informed drug development (MIDD) has advanced rapidly in recent years, especially in oncology. The Prescription Drug User Fee Act (PDUFA) VI includes commitments to enhance MIDD. Tumor growth dynamic (TGD) modeling is a key MIDD approach used to accelerate drug development, support new dru…

Jun 26^th • 18 mins read

Positioning Yourself to Become an MSL in 2022

MSL role, clinical background, academic background, research background, industry, MSL Society, conference, scientific expert, therapeutic expertise, pharma companies

After attending the MSL Society’s 9th annual conference in Vegas Last week, I have taken some time to reflect on inquiries our team received about how to effectively step into the MSL role from a clinical, academic, or research background. Industry is a tough nut to crack, but it is absolutely…

Dec 21^st • 10 mins read

Leveraging existing data to contextualize phase II clinical trial findings in oncology

HER2, phase II trials, oncology, iDFS, EBC, early stage breast cancer

In the USA, over 250,000 women are diagnosed with early-stage breast cancer (EBC) yearly, with up to 30% having HER2 amplification. The standard care for HER2-positive EBC involves chemotherapy plus HER2-directed therapy for one year. The phase II Adjuvant Paclitaxel and Trastuzumab (APT) tr…

Sep 21^st • 3 mins read

Evaluating External Validity of Oncology Biosimilar Safety Studies

biologics, external validity, FDA, biosimilars, trastuzumab

Biologics are the fastest growing medication class in the US, significantly contributing to healthcare costs. The Biologics Price Competition and Innovation Act of 2009 created an abbreviated approval pathway to make biological products more accessible. A phase 3 randomized trial of SB3, a trast…

Apr 6^th • 2 mins read