The challenges of drug development are vast and demanding. Keeping up with scientific advances, the competition, clinical trial roller coasters, global regulatory hurdles, financing innovation, pricing … the list is endless. But have the myriad responsibilities distracted us from the assumed main reason for developing new medicines? Is improving the human condition in a way that prioritizes the largest problems first too lofty a goal? What risks should sick patients take in the name of science and who is protecting the vulnerable? Who decides what’s right and safe in tinkering with our genetic makeup?

Though watchdogs aplenty monitor various parts of the process from discovery through commercialization – investors, IP attorneys and regulatory agencies – few are focused on ethics.

Who is asking the big questions? How many company C suite executives are involved in those discussions? What about the patients and everyone else in the orbit circling the industry?

For 25 years BioWorld has objectively reported on and analyzed the incremental developments of therapies with a focus on the most innovative. Now we’re introducing Ethically Speaking, a new column exploring the intersection of patients' needs with advances in medicine. Who better to raise the thorny questions than the same outfit – BioWorld ‑ which brings you actionable intelligence on the most innovative drug development news that drives the business, which funds the means to heal disease.

Ethically Speaking is written by Charles Craig, who has earned the right to explore intensely complex ethical questions – he took the long road to this new column.

Craig, who has a master of arts in bioethics, is a writer, editor and lecturer on bioethics and biotech issues. Craig has been deeply immersed in the biopharma industry for more than 20 years, starting with BioWorld as a writer and editor in the early 90s and then moving on to become the director of publications with the Biotechnology Innovation Organization. After that, he was author and editor of Ernst & Young's annual Global Biotechnology Report. More recently he served as president of Georgia Bio, the trade organization representing Georgia’s life sciences organizations, and currently serves as a member of the Emory University Institutional Review Board.

In his introductory columns, Craig already red-flagged the first-in-human cancer trial of CRISPR gene editing technology. (Tinkering with genetics.)

Are we ready for Sean Parker’s CRISPR trials?

He has declared that a human right to scientific progress should not take a back seat to private sector profit margins in setting health priorities and saving lives. (Is that fathomable?)

Governments should lead, not follow on prioritizing drug development

Most recently, Craig challenged the ethical justifications for randomized clinical trials (RCT) involving those wildly popular targeted cancer drugs, calling RCTs “outdated” because they overlook the most significant players in the high-stakes experiments: patients. (Imagine that.)

Patients deserve a stronger voice in clinical trial design

Take a reality check break from your busy day and read for yourself. We welcome your comments and topic suggestions. Send them to lynn.yoffee@thomsonreuters.com.