Navigating the Regulatory Landscape for Healthcare Product Development: Key principles and best practices

Developing an innovative healthcare product (a drug or a biologic, or a medical device) from the proof-of-concept stage to the marketing stage is an expensive and complex process. It involves many years of research and development work.

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BiotechTuesday

BiotechTuesday is Boston's premier biotech networking group, which has been around since 2002. It currently caters to over 4,000 individuals involved with the biotech field by hosting monthly events that have an average turnout of 150-200 people. Our target audience is senior management at associated companies in the industry. Our philosophy is to offer no lectures or agenda, but instead offer a pure networking experience to all.

OTHER WHITEPAPERS
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Covid-19 Vaccine Distribution System

whitePaper | April 14, 2021

Delivering Covid-19 vaccines to 7.8 billion people is a daunting challenge that will stretch supply chains past their limits. Even if all the needed doses were ready today, vaccine manufacturers still must find solutions to deliver multiple doses of those vaccines to most people on the planet. To read more, please download this free white paper.

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Advanced Biopharmaceutical Manufacturing: An Evolution Underway

whitePaper | June 5, 2022

The past decade has seen a significant shift in the nature of the products being manufactured and sold by the innovative biopharmaceutical (biopharma) industry. The global biopharmaceutical portfolio of today reflects increased therapeutic competition, a greater prevalence of large molecule drugs, expansion in the number of personalized or targeted products, and a rise of treatments for many orphan diseases.

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BLOCKCHAIN ENABLED GENOME SECURITY FROM THE MOMENT IT IS SEQUENCED

whitePaper | June 8, 2022

Sequencing of human genomes is fast becoming an affordable technology for general consumer.

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HIGH THROUGHPUT AAV VIRAL TITERING USING NANOPLATE-BASED DIGITAL PCR

whitePaper | December 22, 2022

Determining the physical titer of viral vectors has typically been accomplished using digital droplet PCR (ddPCR). Droplet-based methods, however, are challenged by matrix effects and long analysis times (up to 7 hours).

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BIOTECHNOLOGY INNOVATION ORGANIZATION

whitePaper | January 4, 2022

The Biotechnology Innovation Organization (BIO) appreciates the opportunity to participate in the 2022 Special 301 Review: Identification of Countries under Section 182 of the Trade Act of 1974: Request for Public Comment and Announcement of Public Hearing.

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Early engagement and regulatory considerations for biotech

whitePaper | March 24, 2023

Biotechnology companies are at the epicenter of innovative drug development, with discoveries spanning from small molecules, large molecules, and biologics to genomic medicines and first-inclass immunotherapies.

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Spotlight

BiotechTuesday

BiotechTuesday is Boston's premier biotech networking group, which has been around since 2002. It currently caters to over 4,000 individuals involved with the biotech field by hosting monthly events that have an average turnout of 150-200 people. Our target audience is senior management at associated companies in the industry. Our philosophy is to offer no lectures or agenda, but instead offer a pure networking experience to all.

Events