In an incredible show of profligacy, Republicans forsook any notion of fiscal conservatism by substantially increasing discretionary spending by over $2 trillion over the next decade, less than two months after cutting taxes by $1.5 trillion over that same time period.
2018 will be a good year for IPOs and for financing. Rounds are larger and non-traditional investors are turning to life sciences.
According to Noubar Afeyan, founder and CEO of Flagship Pioneering, his company shouldn’t be pigeonholed as a VC firm. ““From day one, our intent was to innovate and create new companies.”
Former Pfizer exec and current partner at VC firm Polaris Partners Amy Schulman talks about what it takes to lead a pharma startup.
“A partnering deal with a bigger pharma company would certainly help us through [the Phase 3] process,” explains Jeff Davidson, CEO of Keystone Nano, a company that develops nanoparticles that target solid tumors by going after cancer cells and leaving the normal cells intact.
Clay Siegall, the founder of Seattle Genetics, explains how his company became an unintentional-startup incubator for Alder BioPharmaceuticals.
The CEO of Seattle Genetics discusses the past, present, and future of some of his company’s partnerships.
The CEO of Seattle Genetics reveals what surprised him about founding a biopharmaceutical company.
Three top biopharmaceutical executives share their ideas on what bio clusters biopharmaceutical executives should be paying attention to for 2018. In addition, insights are provided on other future potential bio hot spots.
Despite progress, the current patient response rates and side effects associated with immunotherapies have created a sense of urgency to more accurately identify which patients would most benefit from a particular treatment option.
Many sponsors and CROs conduct mock inspections to determine organizational inspection and audit readiness. Investing in a regulatory mock inspection demonstrates a serious commitment to patient safety, data integrity, and regulatory compliance. It is also a proactive strategy to safeguard financial health, particularly for startups and companies with sparse pipelines.
Since my first Amazon article, readers contacted me about Amazon-like transformations in clinical research. I never expected clinical research trends to emulate Amazon’s playbook.
A group of academics who work at the intersection of drug development and medical ethics are jumping into the kerfuffle over proposed Right To Try (RTT) legislation, noting they are deeply concerned about the ramifications of a federal RTT law for patients and families. In a letter to the leadership of the House of Representatives’ Energy and Commerce Committee health subcommittee, the group notes it has “strong opposition’ to the pending legislation.
The transition from research to product development is a bit more involved than simply adding “&D” to “R.” Involving regulatory affairs early in the development process facilitates definition and execution of the development pathway while considering both regulatory requirements and the company’s business needs.
In recent years, the growth in U.S. drug spending has become a hot-button issue. Data released in 2017 by the pharmacy benefit manager (PBM) Express Scripts illustrates which drugs account for the increased spending. In 2016, spend on so-called specialty drugs, a class that contains many biologics, grew by over 13 percent, while spend on traditional drugs actually declined by 1 percent. Five of the top 10 earning drug therapies in the U.S. in 2016 were biologics.
#MeToo and Time’s Up are spotlighting illegal, unethical, improper, and undesirable behaviors and showing that well-established people and businesses can be toppled by their actions. Illegal, unethical, improper, and undesirable behavior exists in the GMP world, too, and we’ve been warned as well.
Today’s healthcare leaders must carefully decide how to spend their time — and be clear about what will come off their plate. Unfortunately, even the best leaders may inadvertently take the wrong things off the priorities list.