Ron Squarer believes for a company to be successful, especially in a capital-intensive area such as biotechnology, it has to know what it is good at and target those skills. Squarer is the CEO of Array BioPharma, a company focused on the discovery, development, and commercialization of targeted, small-molecule drugs to treat patients with cancer.
“Researching and developing new, life-changing medicines is best when done collaboratively. Today’s announcement from the NIHR [National Institute for Health Research] sets out clear standards for how the pharmaceutical industry should work with patients to develop better vaccines and medicines.”
The Deloitte Center for Health Solutions recently interviewed 43 biopharmaceutical industry stakeholders to explore where the industry sees value and opportunities for using digital technologies in the clinical development process; understand reasons behind the relatively slow pace of digital adoption; and uncover strategies to overcome barriers and accelerate the use of digital in clinical trials. This is the first of two articles that shares interview findings and insights published in the new Deloitte Center for Health Solutions report Digital R&D: Transforming the future of clinical development.
The key law that governs the pharmaceutical industry in India is the Drugs and Cosmetics (D&C) Act, 1940 and Rules, 1945. Over time, several amendments have been made to the D&C Act and rules. Schedule Y and Part XA (which covers rules 122A, 122B, 122D, 122DA, 122DAB, 122DAC, 122DB, 122DC, 122DD, and 122E) describe the various procedures for importing or manufacturing new drugs for sale or undertaking clinical trials (CTs) in the country. The Central Drugs Standard Control Organization (CDSCO), the national regulatory agency (also known as the Central Licensing Authority), regulates CTs in India.
How and why leading institutions have made the decision to switch from reliance on just one external IRB to partnering with multiple independent IRBs.
How to ensure participant materials are the most effective, useful, and compliant they can be.
Navigate the process of EDC vendor selection and make a better-informed purchase decision on this key technology for clinical research.
Applying lessons learned to the future of Immuno-oncology.
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Understand the expanding influence of HTA in China and how awareness about HTA is spreading to health policy makers and health-related workers worldwide.
What is the government doing to improve the affordability, accessibility, and appropriate use of prescription drugs.
Life science industry peers can share knowledge and strategies as they make adjustments and strive to establish new best practices and navigate necessary system changes.
Avoid additional work and expense by mastering dual IRB and IBC review.
CROs & Sponsors: Have we overcome the limitations of early site payment solutions? Learn how a Site Payment Advisory Group helped improve site payment technology for all stakeholders.
