Senior leaders from more than a dozen biopharmaceutical companies came together today with world-class academic clinicians from four leading cancer centers, representatives from oncology non-profits, the FDA, and other key stakeholder organizations to advance the most promising avenues for curing cancer: accelerating the development of investigational drug combination therapies of two or more investigational treatments which may hold great promise for cancer patients.
The endeavor, called the CoNNCT (Collaborative Novel-Novel Combination Therapies) Initiative, is the brainchild of Keith T. Flaherty, MD, Director of Developmental Therapeutics at Massachusetts General Hospital and Director of the Termeer Center for Targeted Therapies, a cutting-edge research organization with 24 disease centers, bringing together leading physicians and clinical investigators witha broad spectrum of biomedical disciplines.
Boston based Clarion Healthcare, a life sciences strategy and organizational consultancy working with life sciences industry to envision, define and realize growth opportunities, and with deep expertise in oncology, provided support to enable this event. Clarion’s purpose is to help clients transform novel science and technology into products and services that positively impact patients? live.
“It?s time to take bold action to capitalize on the remarkable opportunities offered by today?s scientific advances…”
A new approach needed
?There are tremendously exciting advances today with individual novel therapeutics,? Flaherty noted, ?but individual therapies are rarely going to cure cancer. The true promise of the science clearly lies in combinations of these novel therapies.? While combination therapies of two or more investigational treatments hold the greatest promise for patients, combining not-yet-approvednovel drugs may not be easy.
Currently there is pre-clinical evidence to support thousands of combinations among the >1000 individual agents in the oncology pipeline. Only a tiny fraction of these are likely to be explored, however, due to numerous challenges including financial constraints, limited patient populations, finite bandwidth among clinical trial experts, and the challenge of cross-company partnerships.
Novel-novel drug combinations
The new paradigm calls for collaboration across diverse stakeholder groups, with drugs, funding and expertise contributed by multiple pharmaceutical companies, and governance and execution led by a non-profit entity and academic centers
Flaherty highlighted critical innovative elements of the endeavor. ?CoNNCT is the first time a group of this kind is focusing on novel-novel drug combinations for potential treatments that have not yet been reviewed by the FDA,? he stated. ?Our goal is to work together to speed the decision-making around go/no-go decisions in oncology combination drug development using higher throughput and early signal finding.?
?Developing novel therapeutics for cancer is hard. Developing novel combination therapeutics is even harder. And developing novel combinations among multiple companies adds still another layer of complexity. But the scientific evidence and urgent medical need for a new, faster paradigm far outweighs the strategic and organizational challenges that have prevented the community from tackling this in the past,” added Dennis Chang, PhD, a Principal at Clarion.
?At Clarion our experience shows that seemingly intractable problems?when framed strategically, addressed systematically, and approached collaboratively?are in fact solvable. We?re excited to help leaders come together today to describe the vision and take early critical steps in defining a new, faster paradigm.? Chang continued.
Flaherty?s dream of collaboration to determine ways to overcome the myriad of challenges involved ininvestigate combinations not-yet-approved compounds in oncology, aims to create a paradigm change in clinical trials and may require bod action of many stakeholders.
?It?s time to take bold action to capitalize on the remarkable opportunities offered by today?s scientific advances,? Flaherty agreed, ?and the CoNNCT Workshop was an important step forward. The ?coalition of the willing? in attendance is passionately motivated as well as deeply knowledgeable. Together, we?re beginning to map a path for CoNNCT to bring combination therapies to cancer patients more quickly.?
Last editorial review: March 7,2016.
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