A Q&A With Bernie Zeiher Of Astellas
By Dan Schell, Chief Editor, Clinical Leader
As CMO, I started reporting directly to the CEO and my team tripled in size from around 800 to 2,400. In addition to leading critically important therapeutic candidates from Phase 1 through to registration as president of development, I now had the responsibility for functions such as Pharmacovigilance, Regulatory Affairs, Clinical and Research Quality Assurance and Medical Affairs, which I’d been less exposed to before the transition.
From a management perspective, this broadening of my remit as CMO required the biggest shift in thinking. As a member of the Astellas executive committee, I needed to think and contribute more to enterprise-level decisions at the same time as I was learning about a sizeable portion of my own organization. I had a detailed understanding of the development projects, organization, and talent but needed to learn about each of the other groups. A key focus for me was not only to understand these other organizations, but also to facilitate the interdisciplinary collaboration that is so critical to success in this industry—but not always the easiest thing to master.
2. IN ANY OF YOUR PREVIOUS POSITIONS, DID YOU HAVE THIS LEVEL OF OVERSIGHT? HOW HAVE YOU ADAPTED TO KEEPING TABS ON ALL THE KEY ISSUES OF EACH FUNCTIONAL AREA?
My current role is, by far, my largest organizational responsibility to date in terms of the breadth of functions and organization size. I read your previous piece on the role of the biotech CMO (“Are You Ready For The Chief Medical Officer Role At A Biotech?” Feb 2021) with interest and must admit I’m no stranger to feeling that I’m balancing many plates, but none of them are spinning! To adapt to the complexity that cross-functional working can bring, I’ve found it helpful to focus explicitly on two things — learning and leadership.
I spent a great deal of time learning about the divisions outside Development where I had less familiarity. I don’t see it as essential to be an expert in any of these areas, but I need a level of understanding of the work done by each division. It was an immersive process that took time. I asked myself some critical questions: How is each function organized and structured? Who are the people and what is their expertise? How do they operate cross-functionally with other teams and what are the pain points associated with these interactions? How do they add value?
Secondly, you need to ensure you have the right leaders overseeing the different functions. Particularly in a role such as CMO, you need functional leaders who you trust and respect. As with many things, it comes down to people. You need to build a relationship with those functional heads where they not only support you as the CMO but know that they have your support and respect. It often takes some time, but the goal is to build that trust and commitment not only between the CMO and each of the functional heads, but also among the functional heads themselves. If you get that sort of commitment by leaders to the success of each other, cross-functional collaboration improves, and the organization can operate even more efficiently.
My advice to managing what can sometimes feel like organized chaos is pretty simple: Take the time to learn, read, ask questions, and follow up to build the foundation of knowledge you need to succeed. And pick leaders who you trust and who are committed to not only the success of their own group, but also to the success of the broader organization. There are no shortcuts here — you have to do your own homework, in your own time.
3. IN YOUR OPINION, WHAT ASPECT OF THE CMO JOB WERE YOU LEAST PREPARED FOR WHEN YOU FIRST ACCEPTED THE POSITION? HOW HAVE YOU OVERCOME THAT?
When I came to the role, I had an in-depth knowledge of Development, but knew the least about Pharmacovigilance and Quality Assurance (QA). I needed to fully understand their operations fairly quickly.
One of my most significant learning experiences came when our head of both Regulatory and Clinical and Research Quality Assurance (CRQA) retired, and I decided to appoint a new head of Regulatory Affairs and split out the CRQA group from under this head. At the start of this year, I was again in a dual role as both CMO and interim head of CRQA while conducting an external search. I knew there were issues in the CRQA department but did not think I could wait for a new head to make some changes.
The organization seemed to measure its value based on the number of audits completed, rather than the value delivered. In my mind, it seemed to incentivize activity completion rather than value added, and it sometimes created tensions with other parts of my organization when there were differences of opinion on audit findings. I relied upon some CRQA content experts to support me in this interim role and focused on working on some of the cultural changes that were required.
I learned a lot about QA in my short stint as interim head of the CRQA organization, and it helped me identify the right new leader who brought not only content expertise, but also a passion for QA and a partnership mindset. He has significantly shifted the mindset from one of audits being a key measure of value to one where CRQA looks to partner with other organizations to build quality into the design of our programs and prevent issues. Measuring how well you prevent issues is not as easy as counting how many audits were done, but it is so much better to proactively manage quality than need to address problems after an inspection or audit.
4. WHAT ELEMENT OF THE CMO POSITION MOST SURPRISED YOU ONCE YOU GOT SETTLED IN AFTER A FEW MONTHS?
I thought my dream job was head of Development. I really enjoy the discipline of drug development and liked the fact that, as Astellas head of Development, I led the entire portfolio — all therapeutic areas and Phase 1 through 3, plus post-approval commitments. The CMO role really stretched me more than I expected. As I mentioned, the global organization tripled in size and I gained a new appreciation for the various other disciplines where I had much less familiarity. As a result, I learned a great deal and gained so much respect for these critically important functions.
I knew I was going to need to learn about these functions in this new role, but I was surprised about how much I also needed to learn about the broader enterprise and business side of our company. As the only physician on our executive committee, it’s given me the grounding and commitment to be the voice of the patient and reflect their needs in every decision we make, balancing the appropriate benefit with the risk profile for each product. In many ways, there are distinct parallels to the CMO role and that of a practicing physician. Though I’m no longer in the clinic, I’m now able to affect change for patients on a much bigger scale.
Day to day, this means always ensuring thorough assessments from a patient perspective, focusing on the development candidates that have the highest value potential for patients in our portfolio, and expanding our interests into devices that address significant unmet patient needs. As CMO, I also feel an obligation to ensure access to our medicines and devices by not only generating data to support access decisions by health authorities, but also by establishing expanded access programs.
5. CAN YOU GIVE SOME EXAMPLES OF SITUATIONS IN WHICH YOU HAVE CHALLENGED LEADERS REGARDING THE BREADTH OF THEIR TEAMS? WHAT WERE THE OUTCOMES?
In an organization such as Astellas, you have a limited number of what can be considered high-priority development-stage projects and products on the market. So, my specific challenge to my leaders has been: Do you have the best people on these projects and products? If they don’t have the right people, then they need to consider making a change. These decisions are never easy, but leaders need to make an honest appraisal and ensure that we put our best talent on our most important programs.
As an organization, we also need to keep pace with the rapid innovation across the pharmaceutical industry. We’re seeing some significant advances in the therapeutic approaches and digital technology. We are rapidly advancing cell and gene therapies, and digital technologies are changing how we do our work, such as with machine learning and robotic process automation. So, another challenge I’ve posed to our leaders is: How are we going to accelerate these new gene or cell therapies? Do we build the expertise internally or do we need to hire externally? It’s the same with new digital capabilities. You have to continue to build new capabilities either internally or through external hiring if you have any hope of keeping pace with the innovation across our industry.
6. AS CMO, WITH SO MANY DEPARTMENTS REPORTING TO YOU, IS BUILDING BENCH STRENGTH WITHIN THE AREAS YOU OVERSEE A REGULAR PART OF YOUR JOB? IS IT SOMETHING YOU’RE EVALUATING WITH YOUR DEPARTMENT HEADS ON SOME REGULAR INTERVAL?
Keeping track of talent and growing and nurturing future leaders are absolutely critical to the CMO role. It’s incredibly competitive out there, and that’s only going to increase with more investment in the industry.
For me, succession planning includes the CMO role, direct reports, the next level below, and some other key roles within the organization. I review succession plans with my leaders at least on an annual basis. As I review these, I look at where we have depth and where we may be lacking in “ready now” successors. This can help to set some of our priorities in terms of developing potential successors but also raises considerations about potential movement of talent across the organization. For groups that lack successors, we may need to consider whether to accelerate development of an internal candidate already in the functional group, move someone from another group, or recognize that an external hire would be necessary if the position opens.
In addition to succession plans, we do a review of our top talent annually to ensure there is some awareness of these individuals at the leadership team level. These are the people we want to consider for the next priority project or initiative. This will help them grow but also give us an opportunity to see how they perform with greater responsibility.
A lot of work goes into this, but it is key to having a strong and sustainable organization. When I joined Astellas a little over 10 years ago, we seemed to rely on some of the same people on every priority project or initiative. In a situation like this, one or two people leaving can create a crisis. Because these critical individuals are on every important project, they also can tend to burn out. Plus, their peers may resent that they get all of the spotlight. More importantly, you don’t build any bench strength and organizational resilience.
7. ARE YOU THE ONE PICKING CHANGE INITIATIVES AND PROCESS IMPROVEMENTS? ARE YOU THE FINAL WORD WHEN IT COMES TO CHOOSING THESE?
In general, most projects are initiated at a divisional level, for example Development, Medical Affairs, and Pharmacovigilance. At my level, I have the opportunity to review these along with my entire leadership team. We review them at the leadership team level because there may be overlap or a need for cross-functional involvement in these initiatives. This approach has helped to prioritize initiatives most likely to have an impact and avoid duplicating efforts. For example, if we consider robotic process automation, we prioritized projects in Pharmacovigilance where it could have an immediate impact and give us an opportunity to gain experience that could be applied to other projects in the future.
I generally allow my leaders to identify initiatives they will sponsor, and I get more involved in the decision-making if there is a need to prioritize or if we want to conduct an initiative that is sponsored by me or the entire leadership team rather than just one of the divisions. For example, I decided to sponsor a cross-divisional project where we looked at how to upgrade our capabilities in China. This needed to be addressed by all our divisions, and so I sponsored this initiative.