COG West Coast: Harnessing Patient Populations in Developing Countries, Eric Humphriss

In early November the Pharmaceutical Business Conference Group hosted the inaugural COG West Coast meeting in Burlingame, California. Eric Humphriss, VP, Global Program Team Leader at Annexon Biosciences, presented on his experiences when conducting studies in developing countries.

Annexon Biosciences, a clinical-stage biopharmaceutical company, is conducting multiple clinical trials in Bangladesh for their drug ANX005 to treat Guillain-Barré Syndrome (GBS). GBS is an autoimmune disease that affects peripheral nerves and nerve roots, often leading to rapid neuromuscular paralysis.

Conducting trials in Bangladesh offers clear advantages, as the country has one of the highest GBS diagnosis rates globally. Annexon has partnered with a highly experienced site management organization in the country to oversee trial execution and regulatory submissions. Additionally, they have established partnerships with principal investigators renowned locally for their expertise in diagnosing and managing GBS.

To enable the trials, Annexon has funded the construction of dedicated clinical trial units within hospitals that are fully equipped and staffed to run all elements of the study protocols. Extensive training and workshops have been conducted to ensure research staff understand the protocols and can uphold high standards for ethical clinical research. Multiple audits by competent authorities provide oversight on standards and quality.

While operational cost savings and access to an appropriate patient population were key benefits to locating trials in Bangladesh, challenges existed around infrastructure reliability, regulatory nuances, and potential standard of care differences. Annexon has worked diligently to mitigate these risks through community engagement, patient protections, and by building local capabilities in clinical research.

Overall, Annexon's collaborative approach, with a focus on training, transparency and patient centered values, demonstrates that trials conducted responsibly in developing nations can yield productive outcomes for certain clinical development programs. The infrastructure and capabilities being built will also serve the region in future trials across disease areas.