FDA Approval for Kite Pharma’s Yescarta and HR’s Crystal Ball


If you’re in the life sciences, you already know the challenge -- and reward -- that leads up to FDA approval. And for anyone who’s ever experienced the ups, downs, frustrations, and ultimate relief/joy of obtaining approval, you also know that my description doesn’t cover half of it.

Achieving what Kite Pharma has -- multiple treatments approved by the FDA in oncology in just three years -- requires incredible focus and dedication from a team. While Kite was acquired by Gilead in October, its advancements were already in the works long before.

Leadership's role in FDA approval for pharma

Having the right leaders is essential to getting a treatment approved by the FDA. Beyond medical leadership, Kite would have also turned to leaders who could navigate regulations, develop essential strategic partnerships, hire the right contributors and motivate the team to keep pushing.

Here’s the problem: to get the right team in place, HR would need a crystal ball. Particularly in life sciences, it’s never as simple as just hiring someone with “experience” in the industry. Someone from big pharma, for example, may sound great on paper but may not be accustomed to wearing all the hats -- a requirement when dealing with pre-approval stage firms. A leader from a competitor may be a terrible cultural fit. In either situation, the company will have to rehire, which makes delays inevitable.

Hiring teams, including internal HR departments and outsourced retained search firms, need to know how and if a leadership candidate will succeed long before that candidate signs. Sounds impossible, right? That’s why the crystal ball or a good stand-in for it is needed.

Assessing executive candidates: can HR find the right ones for each development stage in the life sciences?

When my team does this, we use a very thorough and detailed search and assessment process which we continue to fine tune into our fourth decade. Some candidates are turned off by our thoroughness and we consider that a plus because it weeds out the candidates who won’t succeed. For everyone who makes it through, who has the skills needed for each development phase, who fits the company’s culture, and whom we’ve motivated to take a chance on a small firm hanging its hat on the approval of a single treatment, we move forward.

If you haven’t already read the article on Kite Pharma’s recently approved Yescarta, I’d suggest you do. It’s impressive, and, while use of the treatment still faces some challenges, it has the potential to make a difference in so many lives. And congratulations to Kite Pharma and its HR and hiring teams for having the vision needed to get the right leaders and contributors in place to achieve this goal.



Category: Life Sciences | News

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