Recent FDA approvals of several CAR-T therapies have shown that many of the clinical and regulatory challenges of these autologous therapies have been resolved. However, they still face certain challenges in the market, including issues of complex manufacturing, cost efficiency, on-time delivery and access.
To overcome the cost, production and access barriers that affect autologous cell therapies, multiple allogeneic therapies are being developed. Allogeneic cell therapies that use immune cells from healthy donors offer many advantages: they are readily available, of high quality, and cost effective.
This is where readily available allogeneic therapies could be a game-changer, as a single manufacturing run could produce enough for multiple patients or multiple doses for a single patient. This scale of production could make processing more accessible and, at the very least, reduce wait times.
A search of clinicaltrials.gov shows a number of studies that are currently registered, and many more are underway. Allogeneic strategies explored include T cells, virus-specific T cells, memory T cells, γδ cells, T cells, invariant natural killer T cells, natural killer cells, and islet cells derived from cells. human strains. Some of these allogeneic treatments may already be ready for launch or in various stages of approval.
While the development of readily available allogeneic immunotherapy will be an exciting new development for those diagnosed with a variety of diseases, including cancer and type 1 diabetes, its commercial success will depend on the adoption of at least 3 of these strategies from day one.
A patient-centered approach
Patient engagement will be a key factor in building lasting relationships, from initial contact to registration, follow-up and support. Many manufacturers do not integrate patient programs directly into their clinical trial phase. But optimizing the patient experience can remove barriers, encourage patient recruitment, and improve trial protocol compliance.
A patient-centered approach can guide patient education about disease, adherence, and treatment expectations. Engaging advocacy groups and training health care providers early on informs and educates patients and manages their expectations. They may be overwhelmed during the initial trial selection, express reservations about a new gene therapy, or fear the side effects of a new, unproven treatment.
Prioritizing patients will also help determine the long-term financial burden and clarify who will pay for the therapy.
And finally, an often overlooked part in many medical communications is language. A patient-centered approach will ensure that the trial protocol and trial results are presented in a meaningful and understandable format. This attention to detail will support how patients learn, engage and communicate, and provide them with a voice for a better quality of life before, during and after treatment.
Integration of information
We all understand how crucial data-driven marketing is and how it can target and target campaigns, lower media costs, increase revenue, and drive growth. This means that the data must be integrated. All data feeds (clinical trials, patient research, market information, pre-launch, post-launch, etc.) must be in one place and communicate with each other.
Processing, aggregating and organizing them in an easily accessible format is the first step. Once processed, the raw data can be transformed into meaningful and easily digestible information presented in the form of dashboards, data visualizations and reports. Analyzing data for insight and digital intelligence would be the next step to inform business decisions.
Another current need is data integration, mining, and analytics for digital intelligence, regulatory considerations, and omnichannel marketing, including segmentation, retargeting, and real-time messaging.
Analysts can turn data collected from research, development and preclinical experience into marketing tools. These assets are the source of key opinions and thought leadership for a new immunotherapy. This data also informs and guides governments and regulators on how the new product can be classified to inform pricing and contracting decision making.
Post-launch market data on a product’s safety, efficacy or optimal use can ensure continuous return to the frontline and help the drug differentiate and outperform through tailored messaging, care to patients and adjusted experience.
Digital data collected from apps, websites, email communications, search engine optimization, and CRM programs inform decisions and enable timely, relevant and personalized user experiences for patients, patients, and patients. caregivers and health professionals.
Access to treatment
Access to the market for new allogeneic immunotherapy includes only a small part of the launch of a new drug. The question to ask here is: How can cell therapy be made more accessible? Thinking beyond the access of payers, reimbursements and co-payments will be the key to success. Patient access, access to information, access to the infusion center, management of adverse events, and patient and healthcare professional education should be included in the conversation as early as possible.
Again, all of these factors need to be incorporated into the early phase clinical trial. Access should be designed as a patient support program from day one. Many clinical studies incorporate patient support at the trial level, but a complete overhaul is needed for new immunotherapies to create a patient-centered treatment access agenda.
Launching a new therapy and building a successful brand is a monumental task in itself. This requires establishing product differentiation, superior efficacy, and easily accessible treatment. With advanced cell and gene therapies, you need to go one step further. You will need a patient-centered model of care, well-integrated data, and readily available on-site access. By following these guidelines, your allogeneic therapy will have the best chance of success in the market.
Dan Schroen is the head of Photo 51, a Fingerpaint company, and a consulting firm focused solely on advanced therapies, such as gene and cell therapies. He can be reached at email@example.com.