Patient Focused Drug Development
Food and Drug Administration’s (FDA) Patient-Focused Drug Development Initiative (PFDDI) is a new program established by the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA). The PFDDI is a series of 20 disease-specific public meetings designed to gather patient perspectives on conditions with serious unmet medical need.
Patient-Contributed Tumor Genetics Data: A Pathway to Better Drug Development
As genetic testing and study become increasingly important to our understanding of cancer, researchers will need to develop scalable approaches to obtaining genetic information from patient tumors to accelerate and improve drug development. -
Sharing Clinical Data: A Paradigm Change
Pharmaceutical companies are now seeing the benefits of sharing clinical trial or patient data to create a pool of data-allowing for the emergence of patterns which might assist further studies.
Infographic: Is Scientific Collaboration Broken?
The people at Science Exchange surveyed over 1,500 scientists about their collaborations. This infographic summarizes the enlightening data they garnered.
Pooling Resources, Targeted Clinical Trials
The public and private sectors are increasingly pooling resources. For example, under the Accelerating Medicines Partnership, the NIH and ten biopharmaceutical companies will fund a five-year effort to validate promising targets in three disease areas. In cancer research the goal is to test multiple therapies in a single trial and identify the most responsive patients.
AstraZeneca turns to Open Innovation
Astra has developed partnerships with health charities, academic researchers and even its competitors. The collaborations include the sharing of early-stage research with mutual knowledge usage rights.
The Successes and Challengs of Open Source Biopharmaceutical Innovation
Increasingly, open-source–based alliances seek to provide broad access to data, research-based tools, preclinical samples and downstream compounds. The challenge is how to create value from open-source biopharmaceutical innovation. This value creation may occur via transparency and usage of data across the biopharmaceutical value chain as stakeholders move dynamically between open source and open innovation.
It is the author’s opinion that the assessment of when and how value creation will occur, through open-source biopharmaceutical innovation, is paramount. The key is to determine the metrics of value creation and the necessary technological, educational and legal frameworks to support the downstream outcomes of now big data-based open-source initiatives. The continued focus on the early-stage value creation is not advisable. Instead, it would be more advisable to adopt an approach where stakeholders transform open-source initiatives into open-source discovery, crowdsourcing and open product development partnerships on the same platform.
Read More: http://informahealthcare.com/doi/abs/10.1517/17460441.2014.905539?af=R
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