Caring Cross’ Boro Dropulić Shares His Vision for Affordable Cell and Gene Therapies
By Alex Keown
May 2, 2023
Boro Dropulić, cofounder and executive director of Caring Cross shared his vision of affordable cell and gene therapies with an international audience at the inaugural Cell and Gene Therapy Summit in Belgium.
The summit brings together thought leaders in the cell and gene therapy space from around the world to discuss challenges faced by drugmakers in bringing these cutting-edge therapeutic modalities to market. Summit participants will discuss methods to reduce costs related to development and manufacturing, as well as market access and reimbursement; regulatory pathways and ultimately, delivery to patients.
An outspoken advocate for affordable cell therapies, Dropulić, who will be the keynote speaker at the third-annual BioBuzz Awards on May 18, has urged for alternative solutions that will lead to equitable access to cost-effective cell and gene therapies. He said key players in the cell and gene therapy space should strive to lower the cost of goods for the production of advanced therapy medicinal products (ATMPs) during clinical development and following approval. He said this begins with the vector, which is the single largest cost for manufacturing ATMPs.
“We need to improve the way the products are manufactured and distributed. For autologous products, a better model is distributive or point-of-care manufacturing of the patient-specific cells which can decrease the cost 10-fold,” Dropulić told BioBuzz.
Additionally, he pointed to other products in development such as allogenic and direct vector gene delivery. Although these products “to date have not proven as effective as autologous products,” Dropulić said a two-pronged approach to decrease costs and improve delivery of autologous products, while developing new technologies could further decrease cost and improve distribution in the future.
With a whole-hearted belief in leaving no patient behind, the non-profit Caring Cross was established to develop cell therapy treatments for HIV and other diseases, including various oncology indications and the blood disorders sickle cell disease and beta-thalassemia. In 2022, Caring Cross dosed the first patient in a Phase I/IIa trial evaluating the organization’s Anti-HIV DuoCAR-T cell therapy for HIV. The therapy has been designed to eliminate HIV-infected cells and generate long-term suppression following a single infusion. Preclinical data showed potent suppression and elimination of HIV in animal models.
Hear more insights from Dr. Dropulić at the 3rd Annual BioBuzz Awards on May 18. Register Today!
Dropulić maintains treatments such as the Anti-HIV DuoCAR-T cell therapy and other similar approaches should not cost $500,000 or more, like many such therapies do. For example, Zolgensma, a gene therapy for spinal muscular atrophy has a price tag of $2.1 million.
“The current centralized model for manufacturing and distribution of autologous cell and gene therapies is expensive and leads to very high costs, limiting their access to underserved populations, including those in low- and middle-income countries,” Dropulić said. “We need alternative solutions to improve affordability and access.”
He added that organizations agreeing to cap the prices of an approved cell or gene therapy to levels that are affordable to global health systems should be rewarded with assistance during clinical development. As an example, Dropulić suggested one type of assistance a company could receive is cost recovery of clinical trial costs during development and for regulatory approval.
To counter current pricing models, Caring Cross maintains a decentralized approach to manufacturing that could potentially include a network of partnerships between industry players that will create a manufacturing ecosystem for cell and gene therapies. The shared responsibilities could lower costs and allow for increased access to these therapies, he said.
Additionally, Dropulić said it’s important for the industry to rethink the development and reimbursement model for cell and gene therapies. He noted those approaches can provide long-term and even curative results to patients but are more expensive to develop and manufacture. Dropulić suggested a way to reduce the costs of manufacturing and development is through the support of organizations that are willing to cap their price of a product to levels “that are affordable and sustainable for private and national health systems.” These organizations that are willing to cap their prices could be supported through such things as cost recovery during clinical development.
Dropulić has an extensive background in the development of gene therapies. Before Caring Cross, he was the founder of Lentigen, which developed the lentiviral vector used to produce Novartis’ CAR-T cell therapy, Kymriah, the first such therapy approved by the FDA. He currently serves as chief executive officer of Vector BioMed, a B Corp spinout of Caring Cross, a non-profit organization dedicated to accelerating the development of advanced medicines and enabling access to cures for all patients.
“One important goal is to decrease the cost of manufacturing CGT (cell and gene therapy) products. This includes the cost of vectors used to genetically modify the cells that target the disease. Another is how these products are distributed,” Rimas Orentas, Co-founder and Scientific Director of Caring Cross said in a statement. “ For autologous CGTs, a point-of-care distributive model has several advantages over centralized manufacturing including lower cost of goods due to the lack of long-distance shipping and storage of cells, reduced infrastructure costs, shorter fresh-in fresh-out cell manufacturing processes, and decreased vein-to-vein times, which are critical for patients with advanced disease.”
The Cell and Gene Therapy Summit is sponsored by Economist Impact, part of The Economist Group.
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Alex Keown is a freelance journalist who writes about a variety of subjects including the pharma, biotech, and life science industries. Prior to freelancing, Alex has served as a staff writer and editor for several publications.
