• 3 Good Reasons To Never Fall In Love With A Molecule

    In my 2016 book about drug development, Nesiritide,1 I used the admonishment, “Never fall in love with a molecule,” as a chapter heading. A few weeks ago, the editors of Clinical Leader asked me to expand a bit on that aphorism. That explains why I’m sitting at my desk channeling my inner Ann Landers and writing an advice column for the pharmaceutical industry. To be entirely fair, the phrase is not originally from me. In 2005, I heard it from Randall Kaye, M.D., my first boss in the industry. But it made a real impact.

  • Don’t Take Candy From Strangers: 3 Warnings About Right To Try

    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.

  • What’s Behind The Gender And Ethnicity Imbalance In Clinical Trials?

    Boston Scientific deserves recognition for sponsoring the post-marketing PLATINUM Diversity study, a multicenter, open-label, single-arm, post-approval observational study focused on understudied populations: women, African-Americans, Latinos/Hispanics, American Indians, and Alaska Natives. PLATINUM Diversity enrolled 1,501 patients at 52 sites in the U.S.

  • CRS Lawsuit: Does FDA Guidance Require More Clarity?

    The recent announcement that the watchdog group Center for Responsible Science (CRS) has filed a lawsuit against the FDA has raised some concerns in the clinical research community. The lawsuit is regarding the denial of the group’s citizen petition, which was originally submitted in June 2014.

  • Plan Ahead To Mitigate Post-Study Conflicts

    Recently, a pharmaceutical executive raised an interesting question in the media. To paraphrase, he asked, “What should a corporate entity do when it has new information that is material to its financial situation and that new information is ‘under embargo’ until it is either published in a journal or presented at a scientific meeting?”


Roger Mills

Roger Mills, M.D., is an academic cardiologist who recently retired from Janssen Research & Development, LLC. He has worked as a site investigator or study-responsible physician in all phases of clinical research from first-in-human trials to post-approval registries. He is now retired but remains active as a peer reviewer, consultant, and writer. His book Nesiritide: The Rise and Fall of Scios won the Foreword INDIES 2016 Bronze Winner for science. Watch for his new book, 240 Beats per Minute: Life with an Unruly Heart co-authored with Bernard Witholt, early this summer.