By Allison Proffitt
March 1, 2022 | During a plenary panel last week at the Molecular & Precision Med TRI-CON event, pharma and diagnostics company took on the challenges in developing companion diagnostics and how important these tests are to achieving our precision medicine aims.
Edward Abrahams, president of the Personalized Medicine Coalition, moderated the discussion, began by asking what pharma and diagnostic company partnerships should look like. Maria Orr, Head of Precision Medicine Biopharmaceuticals at AstraZeneca, emphasized the role of openness and transparency in healthy pharma-diagnostics partnerships. Marielena Mata, Director and Diagnostic Lead at Pfizer, placed much of that responsibility firmly on pharma’s shoulders. Pharma companies need to be more proactive about understanding what it takes to develop a diagnostic test, she said, decrying the attitude she’s noted in pharma that diagnostics companies simply exist to serve the more-valuable drug discovery group. She challenged her colleagues across pharma to learn about the business model, the risks, and the regulatory landscape diagnostic developers face.
Representing AbbVie, Christopher Conn, Director of Companion Diagnostics, said that his group is seeking true partnerships as well, ideally a pharma partner to support the diagnostic process before and after approval. For instance, he said, the diagnostic may be dependent on a biomarker that isn’t currently routinely testing in clinical practice. We want a partner to help drive awareness of the value of that biomarker, Conn said, so that not only is the rest test developed, but it is also widely adopted.
Adoption is crucial to this process, said Andrea Stevens, a director at Janssen Pharmaceuticals. I want a partner that understands not just the US landscape, but the global environment for development, regulatory approval, and use of a test, she said. She hopes for a diagnostic partner who is committed to working in innovative ways to make sure there are no barriers to testing anywhere in the world, maximizing the number of patients with access to the test and the therapy.
These types of partnerships need to start as early as possible, the panel agreed, but also acknowledged that starting line can be tricky. Jeffrey Venstrom, Chief Medical Partner, Genentech, suggested that diagnostic companies use what publicly available information they can find to reach out to therapeutic companies working in appropriate areas and ask about development plans and needs.
Orr highlighted that the optimal timing really depends on the biomarker a company is working on. She, too, tasked pharma companies with reaching out to diagnostic companies as early as possible, not overlooking the real talent that is accessible in diagnostic companies.
Stevens again emphasized the global market. Janssen, she said, isn’t limiting itself to one test or approach. Some tests or technologies may be more accessible in some geographic regions than others, she pointed out, and diagnostics companies aware of those regional markets will be well-positioned to make get tests and therapies to as many patients as possible.
Regulatory Hurdles, Real World Evidence
When the audience asked the panel to address the regulatory landscape for companion diagnostics and other tests, Mata pointed out that in the US, at least, regulatory and reimbursement paths are hugely disconnected, and the panel agreed that better overlap between the two could and should be addressed with policies. Conn again mentioned that expertise outside of the US is particularly useful as companies seek global markets.
The whole panel agreed that quality is the most important goal for all involved, but Venstrom encouraged developers to consider regulatory demands as negotiable. Push back on the number of samples or diseases to be profiled, he said. Carefully discuss what is feasible and what challenges you face meeting the validation expectations of the regulatory body. It should be, he said, a conversation.
Real world evidence, the panel agreed, is extremely useful in the diagnostics space to be sure that real world use cases are being considered. We need to think of multi-pronged approaches, Orr said, to be sure no real patients are left behind. Stevens agreed; even demonstrating the true patient population—in size, demographic, geography, etc—is extremely needed. Conn also called for real world assessments of current clinical practice: what’s the real prevalence of the biomarker in disease state and how is that marker being tested for in clinical practice?
Abrahams closed the discussion by asking the panel what they see accelerating our vision of precision medicine and what trends or hurdles are slowing our progress. Across the panel, members highlighted our people, technology, and science as key accelerators.
Venstrom returned to the first point of partnerships: more strategic master agreements between partners could be written to better use our talent, he said, making the most of both pharma and diagnostic company strengths to accelerate precision medicine.
Mata praised the technical advances of liquid biopsy, home-based testing, and next-generation sequencing while Orr highlighted the fantastic strides we’ve made in understanding the underlying biology of disease, immune response, and biomarkers. Our strengths, indeed, are many.
But access still slows our progress. Venstrom highlighted equity and lack of representation in research so that the full breadth of patients who aren’t included in our research. Real world evidence, he noted, can help with that.
Stevens and Mata both flagged issues of cost. Lack of reimbursement for next-generation sequencing is a huge problem, Stevens said, and she called for sequencing of cancer patients at the very least. But Mata pointed out that the issues of reimbursement go even deeper than just paying for a certain kind of test. We frown at the idea of spending $5,000 on a test, but we think nothing of spending hundreds of thousands of dollars on therapies, she said, quipping that—on the whole—we are penny wise and pound foolish.
Finally, Conn warned that we need to build awareness of the role and value of these types of tests outside the academic medical centers. Even in community oncology centers diagnostic tests are not being used for patients with the most well-established benefit. He hopes to increase the delivery of what precision medicine can do now, and even expand our vision of precision medicine to immunology and beyond.