|
|
|
|
|
|
|
Novel molecules require novel production processes. Read these case studies to discover how emerging technologies have been brought to market.
|
|
|
|
|
Establishing an organization that can manage a diverse development pipeline for oncology therapies requires an equally diverse wealth of expertise. The key capabilities required for research, preclinical and clinical development, commercial planning, and market access necessitate careful planning, recruitment, and strategy to get it right.
|
|
|
|
|
Ahmed Hamdy, M.D., has cofounded two major biotechs, Acerta Pharma, and now Vincerx, where they are developing a variety of hematology therapeutics. Vincerx’s teams are creating a shared vision for their therapeutics and are encouraged to take ownership of drug development, identify problems, and collaborate to design solutions.
|
|
|
|
|
Since president and CEO Nadim Ahmed arrived at Cullinan Oncology in 2021, they have rapidly expanded their clinical programs, with four clinical trials currently underway and more in the pipeline. Focusing on biologics and small molecules, Cullinan has built an intentional research model that combines outsourcing and in-house expertise.
|
|
|
|
|
At Abpro, founders and brothers Ian and Eugene Chan are designing targeted immuno-oncologic treatments that go directly to cancerous tumors. As a result, the cancer treatments in their pipeline offer patients the ability to fight cancer with their immune system rather than enduring the harmful side effects of chemotherapy.
|
|
|
|
|
Establishing a CMC strategy that proves a clinical program is tightly controlled and can address risk is critical to avoiding the pitfalls that stall many promising therapeutics. Defining the manufacturing processes and product specifications that will help ensure product safety, quality, and consistency necessitates a complex, intensive evaluation.
|
|
|
|
|
In an episode of the Business of Biotech podcast, Dr. Itri sat down to explore the promise of TRODELVY®️, a first-in-class ADC for the treatment of triple-negative breast cancer that she helped shepherd through late-stage development, and other ADCs as transformative treatments for a range of malignancies and intractable diseases.
|
|
|
