Let’s face it: Imagining the means of humanity’s ultimate destruction makes for great entertainment. There are no shortages of novels, movies and television shows featuring threats of global annihilation – zombie viruses, meteors hurtling through space, nuclear warfare – or opening up post-apocalyptic landscapes laid waste following a collision of unchecked scientific and technologic advances with the those worst of human traits – greed, irresponsibility, megalomania. And as an unabashedly enthusiastic science fiction fan, I love that stuff. So, naturally, when anyone starts talking game-changing technologies such as DNA cloning or CRISPR, my brain almost immediately goes rifling through its...

Summer is not officially here, according to the calendar, but the first long weekend of the season brings thoughts of beaches, mountains, travel, relaxation, lazy days and active ones. No matter what floats your boat over summer vacation, a good book should never be far away. With that in mind, assembled once again for your reading pleasure is BioWorld’s Summer Reading List – our 9th annual edition. Be forewarned: Our respondents dug deep this year, tackling a variety of thoughtful and complex issues. You won’t find any fluff on these pages, but you’ll certainly find opportunities to be dazzled and...

Patients have come a long way to get a say in the drug development and approval process. But there’s still some ground to cover if they’re going to move from the passive subject role to a 50-50 partnership that reminds researchers, drugmakers and regulators that, “Hey, this is all about us!” While major drugmakers have been hiring senior-level staff to connect and interact with patients and to incorporate the patient perspective into their R&D for a while now, the regulatory field is making slim – albeit positive – advances in that direction. In the past, patients often testified during the...

Covering the American Academy of Neurology's (AAN) 67th annual meeting in Washington – a gathering of nearly 13,000 clinicians, researchers, students, industry reps and even a few patients – was an exercise in exhaustion and a labor of love. I have a vested interest in this space, having lost my mother to glioblastoma before I reached my teens and my mother-in-law, just months ago, to Alzheimer’s disease. An even more compelling interest is the well-being of my husband, who was diagnosed with epilepsy at age 15, a year after a head injury during a soccer game. At age 40, he...

A few years ago I went to the nearby immediate care with a minor but irritating cough that wouldn’t go away. Three visits later – after two utterly ineffectual rounds of antibiotics and a prescription for a cough medicine that didn’t alleviate my cough though it helpfully revealed that I should never take codeine – I finally started digging around online. My search led me to a condition that explained my cough as well as a couple of other minor symptoms I hadn’t even thought to mention during my earlier visits because they didn’t seem related. I returned to the...

In the capital of digital sharing and over-sharing, Silicon Valley, contributing one’s whole genome to science in the name of fun and self-knowledge has never felt that controversial. Engineers share software code liberally every day on sites like GitHub and Bitbucket. Plenty of those same coders and their investors gleefully joined 23andMe spit parties back in the heady days before the Federal Trade Commission jumped in with a call to sanity. Silicon Valley is still over-sharing. Someone is literally live-streaming their walk from a train station to a bar on Twitter’s new Periscope app as I write. Superficially, it seems...

The thought of having unfettered access to all the medical and genomic data of a million Americans had researchers gathered at the National Institutes of Health’s first workshop on precision medicine licking their lips. Almost giddy with excitement, they contemplated the endless opportunities for “really big audacious research” that could lead to a man-on-the moon moment in unlocking the mysteries of life and disease. As a patient recently diagnosed with two forms of cancer – a type of breast cancer known only for what it isn’t and an indolent lymphoma for which there is no cure – I shared their...

Since being diagnosed with cancer a few months ago, I have been in an unwanted crash course on the patient perspective of everything I’ve been writing about biopharma for the past several years. It’s an eye-opener. Genetic testing, lack of research, unmet medical need, off-label use, drug shortages, adverse events, informed consent, clinical trial data that don’t represent real-world practice, drug-drug interactions, co-morbidities, labeling precautions, reimbursement, data-sharing vs. privacy issues. ... Up until now, these were all topics I wrote about or discussed with my colleagues during our news meetings. Now, they’re personal. They impact my daily life and could...

With a new year, old impatience is growing among small companies and investors eager to see the potential of federally sanctioned crowdfunding take off. In January, biotech hotbed Massachusetts, as well as Oregon and Maine, joined a growing list of states taking matters into their own hands. Irritated by the SEC's sauntering approach to finalizing proposed rules it drafted to implement crowdfunding provisions in the 2012 Jumpstart Our Business Startups (JOBS) Act, they joined a growing roster of states that have adopted their own rules for governing the offerings. (See BioWorld Insight, Aug. 11, 2014.) Massachusetts' new rules, like all...

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