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    A passion for bringing new biotherapeutics to patients

Biomanufacturing facilities at Mayo

A yearning to heal patients and excitement for the new and growing field of biotherapeutics are what attracted Wen Lu, M.D., to her new role as medical director of Mayo Clinic's Center for Regenerative Biotherapeutics in Rochester.

Dr. Lu will provide clinical input on which biotherapeutics hold the most promise and should advance to early phase clinical trials at Mayo Clinic in Rochester. In addition, she will provide clinical guidance during these early phase trials. Biotherapeutics are medicines made from biologic sources such as cells, cellular components and genes that have shown potential for targeted healing.

She points to chimeric antigen receptor-T cell therapy (CAR-T cell therapy) as an example of a biotherapeutic that has revolutionized the treatment of blood cancers. Using the immune system to fight disease, CAR-T cell therapy sends genetically modified T cells through the body with instructions to recognize and kill cancer cells.

Wen Lu, M.D.

"For patients with lymphoma, leukemia, and myeloma who previously did not respond to conventional chemotherapy, we have seen an astonishing change, with many patients achieving remission after receiving CAR-T cell therapy. There is potential to make great strides in using biotherapeutics to treat other conditions that have not had optimal results with standard pharmaceuticals," says Dr. Lu.

Regenerative biotherapeutics is an emerging field that is developing tissues, cells, and gene therapies to provide new cures. The Center for Regenerative Biotherapeutics is leading Mayo Clinic's effort to accelerate biotherapeutics from discovery to early stage clinical trials. From there, Mayo hopes to collaborate with industry to take new biotherapeutics to market so that they are available for patients around the world who have had few or no treatment options.

Opportunities in biomanufacturing

Despite recent advances, cell and gene therapies are so new that there is very limited access outside of clinical trials. Dr. Lu sees this an opportunity for Mayo Clinic to be a leader in developing new therapeutics that will one day become broadly available.

Mayo Clinic is expanding its biomanufacturing facilities across the enterprise so biologic discoveries can quickly advance from the lab bench to patient bedside. Mayo's unique four-pillar structure coordinates process development, biomanufacturing, quality control and quality assurance to ensure new biotherapeutics are safe when they are introduced to patients.

"The goal is to align our biomanufacturing with industry standards so our technologies can be easily adopted by other institutions and companies," says Dr. Lu. "I am really excited about the potential of Mayo Clinic helping to not only develop novel biotherapeutics for new indications, but also improve the accessibility of biotherapeutics globally."

A passion for healing patients

Dr. Lu's father was a pediatrician who inspired her passion at a young age to learn about science and help people.

"Hearing tidbits about his work was always fascinating. He explained science and medicine to me and how the human body works," says Dr. Lu. "It was so intriguing. I don't think I ever considered anything else but a career in medicine."

Her journey to Mayo Clinic began with a Bachelor of Science degree in biochemistry from the University of Washington and a Doctor of Medicine degree from New York Medical College. She then completed a clinical pathology residency and blood banking/transfusion medicine fellowships in the Department of Pathology and Laboratory Medicine at the University of Pennsylvania, one of the pioneers of CAR-T cell therapy. In medical director roles at other institutions, she assisted with making the first CAR-T cell therapies available to patients and collected cells for commercially available CAR-T cell therapies in support of approximately 40 investigational studies.

Dr Lu's role at Mayo Clinic will be focused on biotherapeutics in Rochester. She looks forward to working with physicians, researchers and Center for Regenerative Biotherapeutics' biomanufacturing team on technologies that are in various stages of clinical development.

"This is an amazing opportunity to learn and grow with an incredible team of clinicians, scientists and experts to advance the field. I would love nothing more than to be able to help patients who have, unfortunately, failed conventional therapies find new options that will improve their health and quality of life," says Dr. Lu. "This commitment to patients is what drew me to Mayo Clinic."