Launch of a novel cancer treatment
"For our work together on this product, Mary provided clear strategic legal thinking throughout the process to navigate the many issues that arose as a result of dealing with a complex radiopharmaceutical. She approached each and every issue with a very collaborative, solution oriented mindset. I have no doubt that without Mary’s support on this project we would not have come up with such a clear roadmap for our customers to deal with the ordering, delivery and administration of such a complex therapy."
Nadim Ahmed, CEO, Cullinan Oncology
Challenge
In 1999, a company entered a collaboration to jointly develop and commercialize a ground-breaking mAb-radiation conjugate. The startup had figured out how to deliver targeted radiation directly to cancer cells with a radio-labeled isotope attached to a monoclonal antibody.
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The orphan-designated product was innovative. And the patients who needed it were gravely ill. But with complex supply requirements and an uncharted reimbursement path, getting it to market would be difficult. Regulators didn’t know what to do with it. I worked on the due diligence and was the product’s attorney through late-stage development and launch.
Solutions
The brand team and I began by solving issues associated with handling radioactive substances. The product had to be transported in special containers known as “lead pigs” and required qualified distribution partners.
Next, we attacked care coordination, exploring ways the team could encourage collaboration among the many disciplines that needed to be involved in administration. Recognizing the limitations of existing reimbursement methodologies could impede economic viability and hinder uptake, we engaged experts to carve out a workable path.
And because each patient received an individually calculated “dosimetric dose” of radiation, we built a coordinated production and delivery system involving several participants, including sales support, trade, manufacturing, and external parties. We developed a one-stop product support service to manage orders and other customer issues.
Separately, our clinical team worked with the small biotech to address data gaps. I advised on clinical trial issues, including the creation of an expanded access trial to address unmet patient need.
Following a BLA that met with FDA resistance, including a Complete Response Letter (CRL), we helped the startup redeploy the sales staff it had hired in anticipation of receiving an approval. After the CRL was successfully appealed, and the product was finally headed to FDA’s Oncologic Drug Advisory Committee, we prepared experts to advocate on the product’s behalf.
Results
Through the grit and collaboration of countless people across two organizations, the product was finally approved. Unfortunately, the economic realities of inadequate payment prevented uptake of this revolutionary product and its entire class.
Corporate accolades seldom follow a launch with disappointing sales. But the win was pulling it off. This product was ahead of its time and our team’s work was groundbreaking. In many ways, the product was a forerunner of today’s more complex delivery systems, where sophisticated patient hubs and access limitations can be the norm. And when I see the intricacy of delivering cutting-edge cell therapies – one patient at a time – I can’t help but think about lead pigs, dosimetric doses and the team that made it happen.