Using MBMA to run virtual “head-to-head trials” Blog Post
Osteoporosis is common in post-menopausal women. The long-term sequelae of osteoporosis include bone fractures, particularly of the hip and vertebrae. Bone mineral density (BMD) of the lumbar spine (LS) and...
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Antibody-drug Conjugates in the Clinic: Key Considerations & the Role of Modeling in Expediting Development Blog Post
Antibody-Drug Conjugates (ADCs) can be an ideal drug treatment for cancer because they deliver a cytotoxic anti-cancer drug directly to the tumor with reduced off-target damage. ADCs combine the targeting…
Using Real-World Evidence to Derive an External Control Arm for a Rare Disease Drug Trial Blog Post
Our client was developing a new anti-viral drug for a rare, life-threatening viral infection that affects Hematopoetic Stem Cell Transplantation (HSCT) patients. This rare disease had no approved therapies. Solutions...
Stepwise PIPs: A Solution for the Challenges of Pediatric Drug Development Blog Post
Early paediatric investigation plan (PIP) submissions – an unnecessarily bitter medicine? In the European Union (EU) Paediatric Regulation, the first PIP submission is requested early in the clinical development program….
Repurposing Data & Advanced Analytics to Validate Surrogate Endpoints Blog Post
Repurposed data and advanced analytics can be used to validate a surrogate endpoint. A surrogate endpoint is a substitute endpoint for a clinically meaningful endpoint in clinical trials. It is...
LABO: Data utilisation and data infrastructure in drug development: Data, Data, Data Blog Post
LABO: Über Datennutzung und Dateninfrastruktur in der Wirkstoffentwicklung - Daten, Daten, Daten Published: April 12, 2023 This is the German article written by Dr. Fabian Rauscher, Scientific Informatics Manager, Europe,...
