Knowledge Base - Massachusetts Biotechnology Council - Massachusetts Biotechnology Council

The Patient-Centered Medical Home: An Emerging Health Care Delivery Model November 21, 2016 in White Papers

Fundamental changes are being implemented in the healthcare industry at an accelerated rate. It is critical that life sciences companies understand the trends and undercurrents of policy and practices being employed in... Read More

WEBINAR: High-Throughput Screening: An Insider’s Guide to Outsourcing Charles River Laboratories October 28, 2016 in Presentation & Video Library

This webinar provides an overview of the screening process from assay development through to the final data package by exploring examples of successful high-throughput screening programs we have conducted in our lab. Read More

Brand & CMO Partnerships October 27, 2016 in White Papers,

Serialization ensures that drug products can move through the supply chain safely and securely by minimizing the risk of drug counterfeiting, diversion and fraud. With contract manufacturers and packagers handling large... Read More

Assessing your DSCSA Requirements, Supply Planning and Next Steps October 27, 2016 in White Papers,

FDA,
Federal Issues

When pharmaceutical companies hear the recommendation that serialization planning should start far in advance, some are skeptical. What could possibly take so long? Serialization is really just another packaging problem,... Read More

Roadmap to DSCSA Serialization for Pharmaceutical Manufacturers October 27, 2016 in Checklists,

FDA

By November 2017, all pharmaceutical products that are sold into the US must be serialized. Follow our DSCSA GPS to learn where to get started and how to chart your entire compliance journey. Read More

WEBINAR: Optimizing real-world evidence programs to generate value October 25, 2016 in Presentation & Video Library,

Value

Quintiles experts Laura Marquis, John Doyle and Dr. Aaron Mendelsohn share their thoughts on how emerging biopharma companies can leverage real-world and clinical evidence to shorten cycle times from pipeline to patient... Read More

DSCSA Serialization: Where to Begin? October 13, 2016 in Research Papers,

FDA

An Introduction to Serialization for Pharmaceutical Companies Read More

R&D Tax Credit: IRS Releases Final Regulations Related to Internal-Use Software WithumSmith+Brown October 7, 2016 in Research Papers,

On October 3, 2016, the IRS released final regulations (TD 9786) clarifying the rules regarding the treatment of research related to internal-use software (IUS) for purposes of the research credit under Section 41. The... Read More

Case study - CIC, BWH and Qlucore Qlucore October 6, 2016 in White Papers

What has been interesting since using Qlucore, says Dr. Singh, is how the software has made it possible for the biologists to visualize their research results in striking ways Read More

WEBINAR: Strategic considerations for clinical development programs in emerging biopharma companies October 6, 2016 in Presentation & Video Library

Learn from Quintiles expert Dr. Rick Sax as he discusses strategic considerations emerging biopharma companies should tackle in early phase drug development through the lens of their investors. Specific elements include... Read More