When a drug discovery company makes the move from animal research into testing on humans, there will be challenges to overcome. Understanding those challenges and being prepared to overcome them is never an easy endeavor.
Despite the fact that she came from a Big Biotech/Pharma background, making the transition still presented difficulties for Leslie Chong, CEO of Imugene Limited, a biopharma company focused on immuno-oncology. “Transitioning from a large biotech/pharma company to a small biotech company in discovery and early research and development resulted in a number of sleepless nights,” says Chong. “It involves rethinking your entire strategy on how to thoughtfully grow your business and resources. When determining the resources your small company requires, you will sometimes have to ask new hires to perform different roles they may not necessarily be prepared for. I have found there is a lot of trial-and-error and tribulations involved when making that transition, or when you experience the accelerated growth that can occur in small biotech companies.”
Compared to Big Pharma, smaller companies have far fewer resources. Figuring out what additional resources you will need is a challenge in and of itself. Will you need people to manage the study? Will you need people on the ground to manage the sites? What type of people should you consider hiring? Should you hire a CRO as an extension of your firm? Will you need to bring in regulatory expertise? Do you need to have a medical person, statistician, or clinical scientist to interpret the data as it comes in? Would you be better off working with a consultant? All of these questions need to be answered fairly quickly.
“All of these decisions are critical and will substantially impact the success of your clinical program and your business,” states Chong. “Making the transition from discovery to clinical is really where the rubber meets the road. This is where all your endless hours of planning pay off and where you will be challenged to put your risk and mitigation plans to the test. During this time of exhilaration and turmoil, no position will be more important than your director of clinical development.”
The Need For A Good Clinical Manager
Chong believes the biotech industry has seen significant change in recent years. There is currently a heavy focus on immuno-oncology trials, which is placing pressure to speed up the discovery process. Whereas many treatments can take 10 to 15 years to get from development to regulatory approval, she notes we are now seeing immuno-oncology therapies approved within 5 years.
The industry has not reduced the number of patients needed for the studies, and sponsors still need to gather the same amount of safety and efficacy data. That means the pressure to accelerate clinical timelines is putting a squeeze on companies, especially when it comes to needed resources.
“Something that used to take 15-years-worth of resources now has to be done in 5 years,” states Chong. “The contract models only work if there are sufficient pools of talent to draw from. Even then, some of the expertise needed to make key decisions must reside in house. ”
For example, every trial requires a protocol with inclusion/exclusion criteria. Although a CMO or CSO would author the document, Chong thinks it’s fine to outsource the preliminary protocol writing to a consultant with the required therapeutic expertise. Still, she thinks it’s a good idea to have qualified internal personnel to perform the final medical and science review and sign off. Then your operational and development group (or person) should determine how to execute the protocol. This is important, as someone external to the firm may not fully understand the operational needs, capabilities and strategic goals of the company.
That internal person should, of course, be the director or VP of clinical operations. “I recommend someone that can function across multi-disciplines within the company,” says Chong. “They should be expected to oversee the statisticians, data management, and anyone involved with the execution of the protocol. That person is always pivotal to the success of your trial, but even more so in a small-company setting.”
Identify The Right Candidate
If the clinical manager can determine the success or failure of your clinical trials, how do you find the individual who will be the best fit for your company? Do you hire someone with Big Pharma experience or go with someone who has served in a small- to mid-sized company?
“I think that's a great question,” says Chong. “Most of the folks I have worked with in this industry are knowledgeable and flexible. I feel anyone with clinical oversight experience could step in and successfully manage your trial. But personally, if I am leading a small biotech, I prefer someone with experience running trials for a small company. I think it is far more difficult to hire someone with clinical experience from Big Pharma companies into a small biotech company as it’s likely that person was focused on one specific area, such as operations, recruitment, budgets, or managing partners. They may not have experience overseeing an entire trial and performing a myriad of functions.”
With a small company, Chong notes you will need that one person to be “everything to everybody.” They need to be able to manage everything right down to the smallest administrative details of a clinical operation. At the same time, they need to be able to see the big picture, and think strategically about how to use the data to improve protocols or develop new ones for trials in other therapeutic areas.
Chong also prefers someone who has been in a clinical operations role for at least five years. She notes it takes time to develop the skills to perform all of the required tasks, and it is rare that she sees someone come out of Big Pharma with less than five years of experience who is adequately equipped to take on the many demands of a small biotech company. “The expectation for someone serving as the head of clinical operations at a small biotech is to be mature enough to deal with the board of directors, manage the CRO for the entire program, and strategically drive clinical goals for the company,” says Chong.
Personality Is Key
Let’s say you need to hire a clinical operations manager. You have your decision narrowed down to four candidates, and all have small-pharma experience and the skills you desire. Are there certain personality traits you should consider when making your decision?
When looking for talent at any level of her company, Chong likes to focus on what she calls the two A’s: Aptitude and attitude. Aptitude includes clinical experience and skill sets, something she says you can manage and develop. Attitude comes from an individual’s personality and work ethic, which is something that is much harder to develop.
There are certain personality types that Chong tries to avoid, including individuals who do not want to learn, who are not curious, and who are not flexible. Moving a product through development requires patience, a willingness to work in a team environment, and a belief that goes beyond just doing your job. The traits she looks for are inspiration and an ability to manage stress, balance multiple responsibilities, and solve problems. Unfortunately, these traits are not always easy to discern in an interview.
“In the clinical operations role you need flexible problem solvers,” she adds. “I will look for someone who is amenable but also a driver and who can believe in magic. That person you hire is not just providing a skill set; they will have to work closely with their colleagues, medical world leaders, sometimes the executive team or company directors, and be that transformative and inspirational leader. If the person sitting across from you during the interview does not inspire you, then they might not be the best person to lead your trials or your operational program. We are developing something that may be ultimately bigger than ourselves, life.