To Our Readers

Global Norming

hanks to the emission (and transmission) of knowledge, disagreements are melting and the levels of convergence are rising steadily on the shores of the world.

We are living in an age of remarkable alignment of viewpoints and initiatives in the healthcare product development ecosystem, though much work remains to be done to ensure affordable patient access to medicines (see my June column). The major issues are the same, the conversations are similar, the goals are shared, the approaches differ but are inspired by comparable overarching concerns.

We see evidence of this in the July issue of Global Forum.

The 10^th DIA China Annual Meeting in May brought together more than 3,000 participants (a historic high) around familiar themes – regulatory reform, innovation, clinical development efficiency, big data, pharmacovigilance, patient engagement, and artificial intelligence. We are grateful to the many authors who submitted summaries of important sessions for publication here. The rapid progress of China (a member of ICH only since 2017, but a fast-moving one) is both visible and consequential. It is also aligned with progress in other parts of the world.

We are likely to see the birth of the African Medicines Agency within a year or less. The regulatory environment in the Middle East is poised for further evolution and strengthening. Patient centricity is making strides in Japan. Canada is grappling with a new universal healthcare scheme. ASEAN is pursuing regional regulatory excellence through education and training.

All of this is occurring because the needs of patients are urgent but also because communication is so much easier today and stakeholders (industry, regulators, payers, physicians, patients, academics) can “compare notes” across continents, collaborate easily, dialogue more readily and comfortably, learn from each other and find mutual alignment. There is greater transparency than ever before, and more of it will come.

One can think of the healthcare product development enterprise as a kind of “global team” that comprises all stakeholders regardless of geography. This team has a mission. In 1965, Bruce Tuckman posited that teams go through four successive phases of activity: forming, storming, norming, and performing. Our virtual global team has gradually formed over decades by leveraging improved telecommunications and the novel idea of harmonization; it has brainstormed thousands of ideas; it is now considering and adopting norms of behavior that are intriguingly similar across geographies; and it is on the verge of performing the task that the world expects of it: better healthcare for all. We are not there yet, but we will deliver by working together as a team.

As you read this issue, you may reflect on how far we have come in the last four decades. The DIA 2018 Global Annual Meeting has just concluded in Boston. We will bring you the highlights in the August issue for your Southern hemisphere winter and Northern hemisphere summer reading pleasure.

Alberto Grignolo, PhD
Editor
Global Forum

Fellow of DIA