{"id":92,"date":"2020-02-13T16:43:59","date_gmt":"2020-02-13T16:43:59","guid":{"rendered":"https:\/\/whcbc.org\/pulse\/2020\/02\/13\/2020-2-12-combating-ebola-a-conversation-with-anant-shah-of-merck\/"},"modified":"2020-08-20T11:22:30","modified_gmt":"2020-08-20T11:22:30","slug":"combating-ebola-a-conversation-with-anant-shah-of-merck","status":"publish","type":"post","link":"https:\/\/www.whcbc.org\/pulse\/combating-ebola-a-conversation-with-anant-shah-of-merck\/","title":{"rendered":"Combating Ebola, a conversation with Anant Shah of Merck"},"content":{"rendered":"

Over the last three months, the world has witnessed a series of historic global health milestones: regulatory agencies approved Merck & Co.\u2019s Ebola Zaire vaccine, ERVEBO\u00ae (pronounced er-vee-boh). ERVEBO is the world\u2019s first Ebola vaccine approved by the FDA and EMA, prequalified by the World Health Organization, and approved in an initial set of African countries, including the Democratic Republic of the Congo. The Pulse sat down with Anant Shah, global new product lead for Merck\u2019s Ebola vaccine, to discuss the world\u2019s effort to make this innovative vaccine.<\/em><\/p>\n

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The Pulse: How did this vaccine originate and how did Merck become involved in its development?<\/strong><\/p>\n

Anant Shah<\/strong>: In a way \u2013 through a mix of mother nature, scientific serendipity, and match-making. It was the West African Ebola outbreak in 2014-2016, the largest Ebola outbreak in history, that catalyzed the world to pursue new medical innovations against the disease with an increased sense of urgency, including, but not limited to, what is now Merck\u2019s Ebola Zaire vaccine, ERVEBO\u00ae. The world was fortunate that well before that outbreak ever happened, scientists from the Public Health Agency of Canada had already performed the early science and engineered the original vaccine construct, which was subsequently licensed to an American biotechnology company, NewLink Genetics. As the outbreak grew, Merck was approached by the FDA [U.S. Food and Drug Administration] asking us to leverage our expertise and work with partners to take forward the early science and drive a full research and development effort toward an approved vaccine. Merck acquired the rights for the vaccine from NewLink Genetics in late 2014, and thus began Merck\u2019s journey as part of what remains an unprecedented global collaboration involving so many people and organizations. Through it all, it was a shared purpose, a strong sense of urgency and unique partnership that brought the world together and helped make this vaccine a reality.<\/p>\n

The Pulse: What made Merck a particularly well-qualified company to develop ERVEBO? How does it fit in with your broader vaccine or global health strategy?<\/strong><\/p>\n

Anant Shah<\/strong>: Everyone involved in the effort brought their own, complementary expertise. Our specific role was driven by having relevant technical capabilities, combined with a longstanding culture of commitment and partnership. Technically, we could bring-to-bear commercial-scale expertise in process research, clinical development, regulatory affairs, and manufacturing, along with experience in live-virus vaccines. Our technical expertise was able to supplement the expertise of others, which together was a formidable combination. Beyond that, and perhaps more fundamental, we are a company that believes in the power of public-private partnerships and are inherently committed to tackling some of the world\u2019s most urgent health threats. It\u2019s part of our culture and is reflected in the decision by our leadership to embark on this journey along with partners. In many ways, the Ebola program speaks to the core of who we are: a purpose- and science-driven organization seeking to serve patients and help protect public health. <\/p>\n

The Pulse: You mentioned that the Ebola outbreak kicked off a large public-private partnership. Which organizations are involved in this partnership? <\/strong><\/p>\n

Anant Shah<\/strong>: So many, and too many to list here. Individuals and organizations of all shapes and sizes, from across the world and from multiple sectors came together to make this vaccine possible. Just to name a few: governments, across Africa, the United States, Canada, and Europe; the World Health Organization; companies; Gavi [the Vaccine Alliance]; M\u00e9decins Sans Fronti\u00e8res; academic institutions; research organizations; community-based organizations, including for example, Alima and the International Federation Red Cross and Red Crescent; and importantly, individual patients, volunteers, and frontline responders. The list goes on \u2013 it\u2019s truly remarkable, and a partnership that will help write a new chapter in the history of public health. It\u2019s a partnership that continues today focused on the important work ahead, following regulatory registrations. Beyond the vaccine itself, partnership was really the hero and breakthrough of the entire effort. <\/p>\n

The Pulse: How do you coordinate partnerships with so many different types of organizations around the world?<\/strong><\/p>\n

Anant Shah<\/strong>: We, Merck, are not officially coordinating any specific partnership on our own, per se. But in terms of the spirit and nature of partner coordination \u2013 it\u2019s as much art as it is science. Fundamentally, I think successful coordination and collaboration comes down to a shared mission and human relations. Other ingredients include trust, transparency, open lines of communication, determination, and in this case, a particular sense of urgency. Admittedly, these types of partnerships are not easy or inevitable. They require intentional effort and an \u201ceyes wide open\u201d approach, often times involving divergent perspectives and disagreement. In the words of our CEO: \u201cA great partnership means finding ways to work around, beyond, or beside your differences to find common ground.\u201d In the end, when you do that, together you can achieve greatness.<\/p>\n

The Pulse: How do you think the vaccine will change how we respond to future outbreaks? <\/strong><\/p>\n

Anant Shah<\/strong>: Over time, a vaccine \u2013 any vaccine \u2013 should help fundamentally change-the-game and transform the way the world can prepare for and respond to Ebola outbreaks. Certainly, a vaccine is only one component of a complex collection of solutions required. Great products require great systems to succeed. But I would argue there are few, if any, interventions as discrete, elegant and disruptive as a new vaccine. I\u2019d like to believe that a vaccine brings new hope and meaning to global public health preparedness against Ebola. In our case, a much-needed new tool in the global fight against Zaire ebolavirus.<\/p>\n

The Pulse: What major lessons have you learned?<\/strong><\/p>\n

Anant Shah<\/strong>: We\u2019ve learned so many lessons and are still learning so many lessons. We\u2019re working with partners to share those lessons to help inform other, similar endeavors being pursued by others. <\/p>\n

As mentioned earlier, one major lesson is about partnership: they are necessary and powerful but are not inevitable or easy. Another major lesson is about sustainability and a so-called business mode: how do partners make efforts like this possible in a way that is attractive and sustainable to everyone involved? How does one balance doing the right thing and ensuring equitable access while not placing disproportional burdens on any one entity? Developing and bringing-to-market a vaccine for a relatively rare, unpredictable disease with unpredictable demand is not always a naturally viable scenario. The entire global health community \u2013 across government, non-government organizations, and companies \u2013 are working to better dissect these challenges and pursue improved solutions, while recognizing there is no one-size fits-all template either. <\/p>\n

We\u2019re also learning about process efficiency: there is a fundamental tension between the need for fast and flexible epidemic preparedness and the heterogeneity of procedures to research, develop, manufacture, and make available a vaccine. For vaccines against relatively rare, outbreak-prone diseases, you don\u2019t necessarily know where, when, and in what amount you\u2019ll need the vaccine, so it\u2019s not clear where and how to register, supply, store, or ship the vaccine. Every country has different regulatory, legal, and logistical requirements. Before you know it, you\u2019re doing lots of atomized work, when instead, you need something more uniform so you can be fast, responsive, and flexible. Developing more fit-for-purpose, or so-called \u201charmonized\u201d procedures and systems is a critical area that requires more innovation. <\/p>\n

We all have to continue challenging the status-quo and pursing creative solutions that make similar, future endeavors even more successful. The Ebola vaccine experience offers incredible insights on both, successes on which to build and challenges to continue solving.<\/p>\n

The Pulse: What major themes have you taken away from being involved in this process?<\/strong><\/p>\n

Anant Shah<\/strong>: There are many inspiring themes. Believing in the \u201cart-of-the-possible\u201d stands out for me. When the world puts its mind to a problem and acts with a serious sense of urgency, imagination, compassion, and cooperation, anything is possible. Forty-plus years after the discovery of the Ebola virus and only about five years after the world united following the West African outbreak, we now have at least one vaccine. And the world is on the verge of other important interventions against this terrible disease as well. Ebola Zaire disease is now vaccine preventable, and with new medicines on the horizon, Ebola will hopefully soon be treatable too. Imagine that. Now, imagine if the world tackled other major problems with the same shared mission and relentless determination with which we are tackling Ebola. The possibilities are endless.<\/p>\n

Interviewed by Michele Dragoescu, December 2019<\/em><\/p>\n","protected":false},"excerpt":{"rendered":null,"protected":false},"author":2,"featured_media":314,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[7],"tags":[],"class_list":["post-92","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-conference-2020"],"acf":[],"jetpack_featured_media_url":"https:\/\/www.whcbc.org\/pulse\/wp-content\/uploads\/2020\/02\/anant-shah-tn.jpg","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/www.whcbc.org\/pulse\/wp-json\/wp\/v2\/posts\/92","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.whcbc.org\/pulse\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.whcbc.org\/pulse\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.whcbc.org\/pulse\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.whcbc.org\/pulse\/wp-json\/wp\/v2\/comments?post=92"}],"version-history":[{"count":0,"href":"https:\/\/www.whcbc.org\/pulse\/wp-json\/wp\/v2\/posts\/92\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.whcbc.org\/pulse\/wp-json\/wp\/v2\/media\/314"}],"wp:attachment":[{"href":"https:\/\/www.whcbc.org\/pulse\/wp-json\/wp\/v2\/media?parent=92"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.whcbc.org\/pulse\/wp-json\/wp\/v2\/categories?post=92"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.whcbc.org\/pulse\/wp-json\/wp\/v2\/tags?post=92"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}