From Clinical Trials to Market Success: 3 Approaches You Can Use Right Now for Allogeneic Therapies

Patient centricity and access highlight keys to success for new development.

Advances in cell and gene therapies, such as autologous CAR-T treatments that reprogram a patient’s own immune system to recognize and kill cancer cells, have revolutionized hematologic cancer treatment.

Recent FDA approvals of multiple CAR-T therapies have shown that many of the clinical and regulatory challenges of these autologous therapies have been addressed. However, they still face certain challenges in the marketplace, including complex manufacturing, cost-effectiveness, on-time delivery, and access issues.

To overcome the barriers around cost, production, and access that concern autologous cell therapies, multiple allogeneic therapies are being developed. Allogeneic cell therapies that use immune cells from healthy donors offer many advantages: they’re readily available, high quality, and cost-effective.

This is where readily available allogeneic therapies could be a game changer, because a single manufacturing run could produce enough for multiple patients or multiple doses for a single patient. This production scale could make the treatment more accessible and, at the least, reduce wait times.

A search of clinicaltrials.gov shows a number of studies currently registered, and many more are on the way. Allogeneic strategies being explored include T cells, virus-specific T cells, memory T cells, γδ cells, αβ T cells, invariant natural killer T cells, natural killer cells, and human stem cell–derived islet cells. Some of these allogeneic treatments may already be launch-ready 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 adopting at least 3 of these strategies from day 1.

A patient-centric approach

Patient engagement will be a key consideration to drive lasting relationships—from the first contact to enrollment, follow-up, and support. Many manufacturers don’t integrate patient programs directly into their clinical trial phase. But optimizing patient experience can remove barriers, encourage patient enrollment, and improve compliance with the trial protocol.

A patient-centric approach can guide patient education around the disease, compliance, and treatment expectation. Engaging advocacy groups and training healthcare providers early on informs and educates patients and manages their expectations. They may be overwhelmed during initial trial screening, express reservations about new gene therapy, or fear the side effects of a novel, unproven treatment.

Putting patients first will also aid in determining the long-term financial burden and clarify who will pay for the therapy.

And finally, a commonly overlooked part in many medical communications is the language. A patient-centric approach will ensure 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 it will provide them a voice for a higher quality of life before, during, and after the treatment.

Integration of information

We all understand how crucial data-driven marketing is and how it can focus and target campaigns, reduce media costs, increase revenue, and stimulate growth. That means data need to be integrated. All streams of data—from clinical trials, patient research, market intelligence, prelaunch, postlaunch, etc—have to be in one place talking to each other.

Processing, aggregating, and organizing them into an easily accessible format is the first step. Once processed, raw data can be turned into meaningful, easily digestible information presented as dashboards, data visualizations, and reports. Analyzing the data to gain insights and digital intelligence would be the next step to inform business decisions.

Another need of the hour is integrating, mining, and analyzing datafor 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 seed key opinions and thought leadership for novel immunotherapy. These data also educate and guide governments and regulatory bodies on how the novel product can be classified to inform pricing and contracting decision-making.

Postlaunch market data about a product’s safety, efficacy, or optimal use can ensure continuous frontline feedback and help the drug differentiate and outperform through adjusted messaging, tweaked patient care, and experience.

Digital data collected from apps, websites, email communication, search engine optimization, and CRM programs inform decisions and allow for timely, relevant, and personalized user experiences for patients, caregivers, and healthcare professionals.

Treatment access

Market access to novel allogeneic immunotherapy comprises just a small portion of a new drug launch. The question to ask here is: How can we make cell therapies more accessible? Thinking beyond payer access, reimbursements, and co-pays will be the key to success. Patient access, information access, infusion center access, managing adverse events, and patient and HCP education must be included in the conversation as early as possible.

Once again, all of these factors must be integrated into the early-phase clinical trial. Access needs to be designed like a patient support program right from day 1. Many clinical studies incorporate patient support at the trial level, but a complete rethink is necessary for novel immunotherapies to create a patient-centric treatment access program.

Launching a novel therapy and creating a successful brand is a monumental task by itself. It requires establishing product differentiation, superior efficacy, and readily accessible treatment. With advanced cell and gene therapies, you have to take it one step higher. You will need a patient-centric care model, well-integrated data, and readily available, in-place access. Following these guidelines will ensure your allogeneic therapy enjoys the highest chances for market success.

Dan Schroen is the head of Photo 51, a Fingerpaint company, and consultancy focused solely on advanced therapeutics, such as gene and cell therapies. He may be reached at dschroen@photo-51.com.