[Jang Seong-hun, Director of the Global Regulatory Consulting Division at the National Clinical Trials Support Foundation] I love professional baseball. Even during the 30 years I lived in the United States, I remained an LG Twins fan and consistently followed KBO League games. When LG won the Korean Series in 2023 for the first time in 29 years, I was genuinely happy for them, even from afar.

There are many famous sayings in baseball. Perhaps the most well-known is “It’s not over until it’s over.” It’s a phrase so widely recognized that it appears not only in baseball but also in countless TV dramas and movies. There are also sayings that are familiar to baseball fans but a bit unfamiliar to the general public.

“A left-handed fireballer is worth bringing back from hell.”

This means that pitchers who throw fastballs with their left hand are that rare and valuable. While good right-handed pitchers are easier to find, left-handed pitchers who can throw fastballs exceeding 150 km/h are extremely rare. It means that if such a player exists, you must bring him in no matter where he is or what effort it takes.

We now live in a world where artificial intelligence (AI) handles countless tasks. It can retrieve vast amounts of information in an instant, analyze complex data, and even draft reports and regulatory documents. Nevertheless, I believe that when it comes to important matters, people are ultimately indispensable. Perhaps this is an old-fashioned way of thinking.

This is especially true for new drug development. Here, “new drug development” doesn’t just refer to research aimed at discovering new candidate compounds. It encompasses the entire process of designing preclinical and clinical trials to turn a discovered lead into an actual drug, determining the appropriate dosage, producing a product of consistent quality, and generating evidence that regulatory agencies can trust.

Throughout this process, problems with no clear-cut answers constantly arise. Should we proceed to the next stage based on the data we currently have? Do we need to conduct additional trials? Should we accept the U.S. Food and Drug Administration (FDA)’s requirements as is, or should we propose an alternative approach based on scientific evidence? How much risk should we take on while balancing the schedule, costs, and scientific rigor?

AI can organize the information needed for decision-making and present options. However, deciding which choice to make—and who will take responsibility for the consequences of that choice—remains a human responsibility. That is why recruiting top talent is of paramount importance for new drug development companies. This is especially true for small biotech firms that can only afford to have one expert in each specialized field.

Large pharmaceutical companies have multiple experts in each area—nonclinical, clinical pharmacology, clinical development, statistics, manufacturing and quality, and regulatory affairs. If one person is lacking, another can compensate, and important decisions undergo multiple levels of review.

The situation is different at small biotech companies. Often, there is only one Subject Matter Expert (SME) in each field. That single person must formulate the company’s strategy, review work from external vendors, and respond to inquiries from regulatory agencies. Sometimes, there isn’t even a colleague within the company who can professionally validate that person’s judgment.

In such organizations, it’s not just a matter of one person doing the work of two or three. Some individuals accomplish tasks that even a team of ten couldn’t handle. Conversely, if someone unsuited for a key position is placed there, that single person can delay decision-making and cause the entire development process to veer off course.

I experienced this difference firsthand at Elevar Therapeutics, the U.S. subsidiary of HLB INC.(028300). While searching for the nonclinical and clinical pharmacology experts the company needed, I recruited former FDA reviewers with whom I had worked or whose expertise I knew firsthand. I was even more cautious when looking for someone to lead regulatory affairs.

Someone with just experience, or someone with just energy, wasn’t enough. We needed someone who possessed both the experience to accurately understand complex issues and the drive to see things through to the end.

I was introduced to someone through a referral. From our very first few conversations, I was convinced this was exactly the person Elevar needed. His answers to my questions were brief and clear. He was honest enough to admit that he hadn’t tried things he hadn’t experienced before. Yet behind that honesty lay the confidence that he could learn and solve even unfamiliar problems. Even in his concise resume, I could sense the boldness of someone who clearly knew his strengths.

“This is the one.”

But just because I recognized a good candidate didn’t mean I could hire them right away. The candidate also had their own plans, taking into account their career, personal life, and family. I waited for nearly a year and a half, staying in touch regularly. I kept explaining why the company needed this person and what kind of work we could do together. After that long wait, I finally succeeded in recruiting them.

The results exceeded expectations. At first, there were some skeptical glances. It might have been wariness about a newcomer taking on an important role, or doubt about my judgment in strongly pushing for the hire. But it didn’t take long for those perceptions to change.

From the resubmission of the New Drug Application (NDA) for “Rivoseranib” to the submission of the NDA for “Lirapugratinib,” and through post-submission communications with the FDA leading up to final approval, this person played a crucial role. He identified the core of complex issues and prioritized the tasks at hand. He synthesized input from various departments and external experts into a unified regulatory strategy. When problems arose, rather than blaming others, he focused on finding solutions first.

It was a firsthand experience of seeing just how much a single Saramin can raise the bar for an entire organization.

Come to think of it, that Saramin is actually left-handed. I suppose it’s no coincidence that the saying, “You’d go to hell and back for a left-handed fireballer,” came to mind.

Of course, I’ve had the opposite experience as well. Driven by the urgency to fill a vacant position quickly, I once hastily hired someone only to discover—less than a month after they started—that they were completely different from how they’d appeared during the interview.

When a position remains vacant for too long, the organization becomes unstable. Other employees’ workloads increase, and schedules fall behind. It’s easy to fall into the temptation of just filling the spot with anyone, just to get someone in there. However, the cost of placing the wrong person in a key position can be far greater than the cost of leaving that position vacant for a short while.

That’s why I often use the term “recruit” rather than “hire.” While hiring is about filling a vacant position, recruiting is about finding someone the company truly needs and persuading them to join us. It’s not enough to simply wait for resumes to come in and then select one candidate from the pool. We must first define exactly who we need, then reach out to that person and explain the company’s vision and the role involved. Sometimes, this requires a long wait.

Retaining the talent you’ve worked so hard to recruit is just as important. If, after bringing in a good person, you assign responsibility without granting authority, or if job titles and office politics take precedence over professional judgment, it’s difficult to keep them with us for the long term. If you’ve recruited an expert, you must grant them the authority and trust to exercise their expertise. Their opinions may not always be correct, but at the very least, the organization must be one where their views are fully heard and discussed.

A single outstanding talent cannot solve every problem. New drug development is a team sport that cannot be accomplished by the efforts of just one person. However, just as a single good pitcher can change the course of a baseball game, a single qualified talent can transform the entire team’s way of working and the quality of its decision-making.

This is especially true for regulatory affairs. A regulatory affairs expert is not merely someone who organizes existing data and submits it to the FDA. From the early stages of development, they must anticipate what regulatory agencies will ask, prepare the necessary evidence, and be able to step in and stop the company if it is heading in the wrong direction. As a regulatory submission approaches, they must bring together the numerous scattered documents and people toward a single goal.

People capable of doing this are rare. In new drug development, the most expensive investment isn’t necessarily clinical trials or manufacturing facilities. Identifying the right person, bringing them on board, and retaining them for the long term is also an investment that determines the company’s fate.

Left-handed fireballers are rare. So if you really find one, you have to bring them in—even if you have to pull them out of hell. And you have to keep them on board for the long haul.