After passing a gargantuan appropriations bill that balloons the deficit by hundreds of billions and funds the government through October, the conventional wisdom in Washington is that Congress is done legislating for the rest of the year, save one major issue: addressing opioids.
After discovering that there have been up to 200 unsuccessful attempts at delivering biologic drugs orally, serial medical-device inventor and entrepreneur Mir Imran decided to tackle the problem.
A look at a unique UK-based public-private partnership (P3), called Open Targets that was created to help companies choose better drug targets and reduce attrition of candidate drugs.
CytoDyn’s expressed ambitions seem bold but reasonably free of hyperbole. It is only natural to hope for the best possible outcome here, considering the obvious need for new HIV and other immunological therapies.
The full implementation of global traceability standards is still a work in progress. Blockchain may prove to be the technology that will help save lives and secure the supply chain globally.
Can a culture with supporting systems that are simple, efficient, and effective significantly shorten drug development times? Why not?
Michael Bonney, CEO of Kaleido Biosciences, discusses some of the differences between his past and present employers.
Michael Bonney, CEO of Kaleido Biosciences, discusses some of the challenges faced — and how to overcome those — when building a diverse leadership team.
John Maraganore, CEO of Alnylam Pharmaceuticals and current chair for BIO, shares thoughts on CROs, open science, and his company’s future.
The CEO and founder of Seattle Genetics, Clay Siegall, discusses one of the company’s new technologies, sugar-engineered antibodies (SEAs).
Sitting comfortably aboard a full commercial flight, ready to depart from Boston’s busy Logan Airport, I hear the captain’s calm and assured voice issued from the cockpit.
This article presents the most recent publication of GMP drug product inspection data from the FDA's Center for Drug Evaluation and Research (CDER), which addresses drug inspections conducted in FY2017. It looks at five years of data from the FDA, examines data from 2017, and evaluates five years’ worth of trends in GMP inspection enforcement.
FDA officials and leaders in the pharma and medical device spaces agree artificial intelligence (AI) tools could enable a step change in quality management in those industries. Areas that could be impacted include supply chain management, lot release, manufacturing, compliance operations, clinical trial end points, and drug discovery, among others.
Most of us have spoken to someone and struggled to understand an accent or word choice. Even within a country like the United States, different regions can have unique language, which can be confusing to an outsider. It can be as subtle as the difference between “soda” in the East and “pop” in the Midwest. But what happens when you try to coordinate complex projects across countries and regions? How do you work successfully, accounting for the differences in culture and honoring common objectives?
Looking forward, the U.S. pharmaceutical industry needs to be aware that the despite the FDA’s year-long delay in enforcement, the Drug Supply Chain Security Act (DSCSA, with its specific compliance deadlines, is still law and that it is only draft guidance from the FDA that identifies an intent not to enforce the DSCSA for one year.
Part 2 of this two-part article reviews lessons from Spark Therapeutics’ pivotal program for Luxturna, a gene therapy approved for the treatment of patients with retinal dystrophy associated with confirmed biallelic mutation in the RPE65 gene, and summarize key considerations for the clinical development and commercialization of gene therapies.
A busy practicing physician who might be asked by a friend or a patient for a first-impression opinion of the currently pending federal Right to Try legislation will find him/herself in a position roughly analogous to the hungry child being offered candy by a stranger: viscerally tempted, but intellectually very, very wary.
How have the first few months of 2018 treated your company? Are you confident that you’ve got a good plan for the year, including internal auditing, or are you still scrambling to catch up from issues identified late last year?
