To Our Readers

Stepping Up The Pace of Change

r. Paul Janssen, founder and leading light of Janssen Pharmaceuticals until he passed away in 2003, often said, “There is so much more to be done; the patients are waiting.”

This was true then and it holds true now – except that more is being done faster, and some of it is happening in unexpected places.

As we show in this issue of Global Forum, platform trials and enrichment trials are pointing the way to faster drug development and the delivery of the right drug to the right patients. China is working to reduce the “drug lag” and to implement Health Technology Assessment (HTA) to pave a rational way to medicines pricing and reimbursement. Harmonization initiatives are underway in Africa. Pharmacovigilance is leveraging new technology tools and machine learning to improve patient safety reporting. Sri Lanka (a non-small country of 22 million people) is setting up a drug regulatory framework to serve its patients better, in alignment with global standards.

With surprising speed and convergence, regulators all around the globe are rolling out expedited regulatory pathways for drug review and approval – often conditional approval. The decade-old pioneering efforts of the U.S. FDA, the EMA, and MHLW/PMDA in this respect are now being matched by China, South Korea, and Taiwan (as was illustrated in vivid detail at the 12th DIA Asia New Drug Conference, in Tokyo, in late March). Others may follow, sooner or later. Inter-Agency collaborations on drug application reviews are also occurring in Africa, ASEAN and the Consortium (Australia, Canada, Singapore and Switzerland). The acceleration is palpable, momentum has increased, whether driven by a renewed sense of humanitarian mission, the social cost of disease, a better understanding of drug development, three decades of regulatory harmonization, or all of the above.

Not all patients are content to wait. Patient advocacy and activism are on the rise, along with a growing sense that engaging the doctor in serious conversations about one’s own disease management and cure is increasingly the right thing to do and, if that fails, one must relentlessly find and pursue other doctors. At the recent Fortune Brainstorm Health Conference in California, survivors and patient champions Anne Romney and Kathy Giusti emphasized that patients must own their situation and be part of the solution, rather than passively accept their “fate”.

There is a new sense of urgency these days. There is reason to be hopeful, and certainly every reason to be forceful on one’s own behalf. Because more changes are on the way in science, drug development, regulatory efficiency, HTA, and market access.

Can’t wait.

Alberto Grignolo, PhD
Editor
Global Forum

Fellow of DIA