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Upcoming Developments in Precision Medicine

precision-medicine-biomarkers
Future of immunotherapies

Immunotherapies are on the fast growth trajectory which will be moderated based on responder groups, toxicity and efficacy results and high costs and increasingly used in combination therapies. The overall immune oncology checkpoint inhibitor market was over $2.0 billion and is set to grow to $14 billion by 2018.

Approximately 245 companies globally are developing therapies in the checkpoint inhibitor area, with over 80% in the United States. Significant opportunity awaits medium to small sized companies with innovative immuno-oncology products in development to receive substantial investment income through collaborations via large pharma company partnerships and alliances.

Precision medicine outside oncology

Undoubtedly, oncology continues to dominate the precision medicine and companion biomarker research space for targeted therapeutics. However, recently, we can see a few examples (both pharma and Dx) that are trying to shift their targeted therapeutics focus beyond the crowded oncology therapies, and spreading more toward non-oncology therapeutic opportunities such as Diabetes, Inflammatory diseases, Neurosciences, and infectious diseases (HIV, hepatitis).

For example, a recent analysis by Diaceutics Group suggests that 93% of the current phase 3 pipelines are diagnostic dependent (i.e. targeted therapeutics) and, interestingly about two-thirds are focused on non-oncology areas. Also, a quick analysis on the FDA’s pharmacogenomics (PGx) therapy list indicates a slow yet gradual decreasing share of oncology therapies every year. This creates a strong impetus for scaling the existing CDx platforms, technologies and tests to find precision medicine value beyond oncology.

It is also important to understand the feasibility for companion biomarker research (omics), and possible non-omics biomarkers strategies for developing targeted therapeutics across different therapeutic areas. For example: take the CNS therapeutic area where current focus of CDx developed for targeted therapeutics are primarily inclined towards diseases that have strong genetic correlation and successful biomarkers identification such as Schizophrenia, Parkinson and Alzheimer’s disease.

Similarly, for cardiovascular diseases CDx, tests aim to determine sensitivity to the current drugs and treatments that have a narrow therapeutic index. For example, Celera (acquired by Quest Diagnostic) has developed diagnostic markers for the diagnosis and prediction of therapeutic responses in cardiovascular disease. Roche is also developing CDx tests for Acute Coronary Syndrome.

Additionally, lifestyle-driven chronic health conditions such as Diabetes, CVD and depression (CNS) provide a fertile ground for non-omics/non-Dx biomarker strategies. Patient stratification being a central concept to precision medicine practice, today pharma companies are leveraging the evolving ecosystem of remote patient monitoring technologies to look beyond intrinsic omics factors and incorporating exogenous end-points (capturing critical data such as family history, food habits, alcohol, smoking, weight, salt intake, activity, etc.) to eventually facilitate stratified medicine practice for lifestyle driven chronic health conditions.

The change in the R&D model

Precision medicine is a new model of medicine with new disease taxonomy – it aims to integrate personalized health data collected over time both from direct and indirect sources, probing the deepest mysteries affecting individual health and well-being. This demands a new paradigm shift from traditional intuition-based trial-and-error pharma R&D model towards CDx biomarker and algorithm-based R&D models for targeted therapeutics.

As the drug development industry transitions from blockbuster (one-size-fits-all) approach to stratified medicines, it becomes critical to integrate the biomarker strategies into R&D model aiming to refine drug targets and segment patient populations. Co-development and commercializing drug and diagnostic (CDx) has become one of the best practice as they require considerable investment depending on the test positioning and novelty for developing targeted or precision medicines.

Considering the core competencies for majority of pharma companies (which is often not developing CDx), collaboration with external CDx provides will be key ingredients for the future success. By employing a companion diagnostic organization (CDO) or choosing a CDO for outsourcing partner can enable a better time management in terms of co-development timelines. A CDO also has advantages of integrating the abilities of a CRO, clinical diagnostic lab, and diagnostic manufacturer capabilities and in some cases, serves as a regulatory consultant as well.

Today, most global pharmaceutical companies developing targeted therapies are cognizant about these synergies and prefer an external CDx partner to access technology and in vitro diagnostic expertise. Further, from a clinical trial design prospective, we also see emerging Patient-centric models that aim to utilize molecular profiling (target mutation profiles) and exogenous factors (non-omics biomarkers) to optimize these time and capital intensive R&D activates.

Having said that, considering the nascence of the precision medicine concept, complexities around the Rx/CDx will continue to loom, depending on several fluctuating factors such as regulation governing CDx and LDTs, different entry points for co-developed products and individually developed CDx, etc. As multiple stakeholders are involved in the co-development of drug and diagnostic, it is critical to involve and engage patients, physicians, payers and testing laboratories at early stages to enable an acceptance and adoption.

Precision Medicine

 

Dorman Followwill is a Partner at Frost & Sullivan. He has played a leading role in some of the largest consulting engagements in the history of the firm, including work with Bayer Biologicals and Philips.

 

View the agenda for the 4th Global Precision Medicine & Biomarkers Leaders Summit

Precision Medicine & Biomarkers Leaders Summit Munich

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