The recent announcement of two vertical mergers — the $52 billion acquisition of Express Scripts, the largest pharmacy benefit manager (PBM) in the country, by Cigna, and the $69 billion purchase of Aetna by CVS Health — raise significant antitrust concerns over how these megacompanies will impact patient access and pharmaceutical pricing.
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 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).
The founder and CEO of Seattle Genetics discusses a number of interesting topics, including how he was able to get the founders of Microsoft as early investors in his company.
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?
Ever participated on one of those benchmarking exercises? You know what I mean: a (usually) fresh-faced consultant asks lots of questions and fills in a spreadsheet comparing what you do with your competitors. Well, beware.
Dr. Liz shares great advice on how leaders can be more visible within their organizations. Visibility allows for a more cohesive and productive organization.
With several first-in-class gene therapies now approved, distinct new challenges are now coming into focus. This article provides a high-level overview of the gene therapy pipeline for non-oncology rare diseases and discuss key issues impacting clinical development.
