Tagged: biopharma

Reflections on James Lind’s Scurvy Trial, Pharmacoeconomics, Sovaldi and Other Hot Topics in Clinical Research

Yesterday we celebrated May 20 as International Clinical Trials Day because James Lind started his famous trial of scurvy treatments on this date in 1747. Lind’s study remains noteworthy as perhaps the first controlled study that demonstrated the efficacy of a treatment that is still known to be effective. Lind conducted the multiarm trial aboard… Read more »

Biopharma’s R&D Productivity Problem Resurfaces as We Enter 2014

While FDA approvals of truly new drugs and biologics soared to 39 in 2012, the story as we enter 2014 shows a striking reversion to lower productivity levels that have long plagued the industry. The number of FDA approvals dropped to 27 in 2013. Big Pharma can take credit for only 14 of the approved… Read more »

Looking Ahead: Reducing Risk in Biologics Trials

Despite their complexity, biologics are going mainstream. According to a report by Evaluate Pharma, biologics represent 40% of development pipelines for companies they surveyed. You might even say biologics programs involve lower risks than small-molecule programs – a higher percentage of biologics progress from preclinical to approval. But going mainstream hasn’t made biologics more predictable…. Read more »

Three Ways to Target Inefficiency in Clinical Development

Based on years of poor R&D productivity, the pharma industry is rethinking clinical development. Novartis CEO Joseph Jimenez is rethinking the traditional blockbuster.  Tomas Philipson and former FDA Commissioner Andrew von Eschenbach are rethinking  phase III trials. A third aspect of clinical development also requires rethinking but I’ll leave that for the end of this… Read more »

Surviving the Big Squeeze in Biopharma Development

The biopharma industry finds itself in a squeeze that rivals the drama of the garbage-compactor scene in Star Wars. On one side, operational inefficiency keeps closing in. Outlook 2013 from the Tufts Center for the Study of Drug Development reminds us that new business models haven’t solved the industry’s efficiency problems. Another recent Tufts CSDD… Read more »

DSMBs and Business Decisions in Clinical Research

Interim reviews in clinical trials have always been controversial in some circles because they require somebody to look at otherwise confidential data while a trial is in progress, raising the possibility of introducing bias. On the other hand, not letting anybody see interim data is a great way to have a trial with serious issues… Read more »

The Rhetoric of “Risk Sharing”

Derek Lowe’s observation about AstraZeneca’s bracing for change also applies to the pharma industry as a whole: “…things can’t go on the way that they have been.” AstraZeneca is not alone in failing to get enough new drugs approved to sustain their business model, but they’ve made themselves the poster child for that dilemma. Somehow… Read more »