At IAOCR we’re always excited to speak with people that have a passion for improving approaches and standards within the clinical research industry. This month we’re delighted to share our interview with Bernie Zeiher, president, Development, at Astellas.
Thanks, Bernie, for telling us about your clinical research career, your views on the biggest challenges for our industry and your thoughts on developing new talent . . . Here is what Bernie had to say:
1. How long have you worked in the pharmaceutical industry?
I have worked in the pharmaceutical industry for the last 18 years.
2. How did you get into clinical research and what career path did you take?
I am a physician by training and background. I went to medical school at Case Western Reserve University in Cleveland, Ohio. One of the things that I realized while I was studying was how hard it is to do clinical research. With this in mind, I decided to move over into the clinical research industry to help bring forward therapies and make an impact on a large number of patients, rather than just helping individual patients. I started by working for Eli Lilly, where the research I was conducting was aligned with my medical background and training in pulmonary and critical care medicine. This is where I got hooked. I really enjoyed determining patient needs and new areas for development of novel therapies. After working at Eli Lilly, I went to work with Pfizer. In 2010, I then moved to Astellas.
3. What do you most enjoy about working at Astellas Pharma?
What first attracted me to Astellas was that they were not only focused on growing and aggressively investing in their portfolio, but also the development function included both early and late phase research. This gave me the opportunity to work with compounds throughout the drug development process. Being a mid-size company, there is also greater opportunity to make a difference with less bureaucracy.
4. What is the most challenging aspect of your role?
The most challenging aspect is keeping up with the pace of change which is even more rapid than a decade ago. As an organizational leader, it is a fine balance between needing to make changes to improve the quality or efficiency of the organization, and not making so many changes that it overwhelms teams or disrupts our clinical programs. Finding the right balance is key.
5. What is the most rewarding aspect of your role?
The most rewarding aspect of my role is delivering medicines to patients. A great example of this is the development of CRESEMBA® (isavuconazonium sulfate). CRESEMBA is a drug that has orphan status and was developed for patients who are immunocompromised and develop rare fungal infections. In particular, CRESEMBA is used to treat adults with invasive aspergillosis and invasive mucormycosis. Without treatment these infections are often fatal.
Our team overcame a number of challenges during the conduct of the clinical studies, which ultimately led to the approval of the U.S. Food and Drug Administration (FDA) in March 2015. Following the FDA approval, Astellas immediately shipped more than 70 vials of CRESEMBA to reach appropriate patients. Seeing this impact and hearing the stories of patients successfully treated with CRESEMBA has been incredibly rewarding. It reminds me why I went into this field.
6. How has the industry changed since you started your career?
There have been a number of significant changes across the industry. Some of the key ones I would highlight include:
- The regulatory requirements to demonstrate both efficacy and safety have increased not just in the United States, but also globally. Also post-approval commitments have increased significantly.
- The importance of the payer, such as national health authorities and insurers, has increased. When we are developing a novel therapy, we not only need to consider the requirements of regulators, but also collect data that will aid in performing analyses of the health economic impact of the new treatment.
- In the past, we often focused on developing blockbusters for common indications affecting large numbers of patients. Due to advances in understanding the biologic basis of disease, we are often developing targeted therapies for patients with rare diseases or subsets of patients with more common diseases. This is particularly the case in oncology where the understanding of the genetic mutations in tumors has led to more targeted and effective treatments.
7. What advice would you give to someone starting their clinical research career?
You can never go wrong if you keep the patient at the forefront of your mind. If you do that, you will make good decisions on trial designs and study conduct as well as what therapies to advance into later stages of development. The other recommendation is to immerse yourself in your projects and take advantage of opportunities which are presented to you. If you do this, you will continue to grow and be prepared for future roles.
8. Describe yourself in five words.
Calm. Collaborative. Pragmatic. Patient-focused. Results- orientated.
9. What do you think the industry should be doing to attract, train, qualify and retain new talent?
I think everything always starts with the patient. The industry needs to have a commitment to focus on addressing the unmet needs of patients. If we then bring the best science to address these unmet needs, people will be motivated to work in the industry. At the same time, you also need to allow people to have a career and grow within an organization, by providing training and development opportunities.
10.How is Astellas addressing this industry-wide issue?
Astellas is addressing this industry-wide challenge by trying to pursue the best science, with the best talent, in the best location. We really think that the best science will attract the top people as long as we also provide them with growth and development opportunities. We try to access the best science not only through our internal research, but also through collaborations with academia and the biotech industry. At our headquarters in Japan, we recruit a number of recent graduates each year. At our other offices, we recruit colleagues at various stages in their career.
11.What do you think will be the top 3 challenges for the industry in the next few years?
There are a number of challenges that the clinical research industry is experiencing at the moment, but I think the key ones are:
- Improving the speed and efficiency of bringing a medicine to market. There is a high risk of failure—nine out of 10 treatments will fail to make it to the marketplace. Increasing the success rate and speeding the development process could have a major impact on the ever increasing cost of drug development.
- Exploiting new technologies such as cell therapies, including stem cell therapy. We need to learn where these new technologies may have benefit, how to demonstrate that benefit and how we can make these therapies available to patients who need them.
- Communicating the value of medicines. We need to do a better job of communicating the value of medicines to the wider community and how medical research can help patients.
Many thanks to Bernie for taking the time out to speak with us. If you would like to know more about IAOCR accreditations and workforce quality solutions, please email us or telephone +44 1628 784906 (International) 01628 784906 (UK) +1 855 407 6679 (US Toll Free).
Please CLICK HERE to read our last months Spotlight on Leadership blog with David Friedman from the Kellogg School of Management.