Earlier this year we proudly hosted an in-depth webinar for professionals in the healthcare and life sciences sector. The aim? Giving startup founders in the industry an insight into the latest goings-on within the FDA.

The event sought to provide an update on the activities of the regulator, what growing firms need to bear in mind in their interactions with the agency and how new policies may impact the investment landscape in the sector.

The panel assembled to discuss these issues included experts with many years of legal, regulatory and industry experience working within and alongside the FDA. They were:

• Deb Autor (Moderator), former FDA Deputy Commissioner for Global Operations and Advisor, Healthcare Innovation Catalysts
• Daniel Orr, Senior Counsel, Wilson Sonsini
• Adam George, President and Founder of ANG Regulatory Consulting
• Ben Eloff, Vice President, Healthcare Innovation Catalysts

Here are some of the key moments and insights from the webinar.

Our participants all agreed that the last 12 months have been a turbulent time - both for the agency itself, and healthcare and life sciences companies looking to engage with the regulator. However, despite the upheaval, the panellists emphasised that there remain opportunities for investors in the sector.

Moderator Deb Autor summed up the situation by noting that while much has changed within the FDA over the past year, "the sky has not fallen." She added that the essential day-to-day work of the regulator continues, with reviews moving forward as anticipated. This should provide reassurance for investors in the sector, with pathways to approval still the same as they have ever been.

"The funding environment sees that," Ms Autor said. "Product development should continue and perhaps there are opportunities to do things more quickly, or more flexibly than have been the way ... in the past."

One challenge that all healthcare firms seeking regulatory approval are likely to have to deal with is the amount of turnover within the FDA. The senior leadership team at the agency has been almost completely overhauled over the past 12 months, while on a wider level, around 20% of staff have left through a combination of early retirement, involuntary redundancies and other streamlining of the agency's headcount.

What this means for companies is a loss of institutional knowledge within the regulator, which the panel recognised may be of concern to investors and startups. Panelists noted that it will be important for firms to engage closely with the regulator using FDA programmes and have all relevant information to hand to cope with these changes.

Keeping thorough records will be essential in the event of further personnel changes or policy shifts. It will also be crucial for companies to make sure they have sufficient capital to cope with any potential delays that may arise as a result of the turnover.

"The reality on the ground is not as bad as people think," Ms Autor observed.

Our panel also talked about the importance of keeping up with shifts in FDA policy - and noted that under its current leadership, this will require a change in mindset and focus from organisations within the sector. The experts explained how changes are now often communicated via the media, through press releases, interviews and podcasts, rather than formal guidance - a trend described as 'podium policies'.

This potentially means more uncertainty for businesses and investors, as while many of these announcements may make headlines, they do not have the force of law. This could leave such policies open to challenges.

Dan Orr stated that while firms must pay close attention to these announcements and policy shifts, they must also show caution. He suggested that while there could be opportunities for firms that qualify for more assistance or fast-tracked approval under such policies, they should be viewed as "limited-time offers."

"Don't build a business around them," he warned. Instead, he advised businesses to stay focused on long-term codified law that is clearly set out in the Code of Federal Regulations.

The panel was keen to stress that, despite the regulatory uncertainty in the sector, biotech investment remains strong. In fact, forward-looking organisations may be able to take advantage of policies that seek to promote US investment.

Ms Autor described the environment as "alive and well," noting how there are positive signs that FDA approval pathway changes are influencing biotech funding decisions and early-stage company strategy.

This could prove a strong incentive for investors. Ms Autor noted: "It informs your interactions with the agency to know that one of their priorities is bringing product development back to the US, bringing production back to the US. And I think that's a useful lever for people to be aware of."

Worries about uncertainty are widespread in the healthcare and life sciences sector at the moment, especially when it comes to the pace of regulatory approvals and other potential hurdles that could delay new product development. As a result, it will be important for businesses to plan carefully and make sure they have the capital in place to meet any unforeseen challenges.

For instance, the panel observed that there may be less guidance available to businesses. Ben Eloff observed that In the last 12 months, there were 87 issuances published by the regulator, compared with 189 for the previous year, which could mean less clarity during the approvals process.

As well as ensuring finances are in place, developing close relations with the FDA will be essential in navigating this environment. Ben Eloff noted that staff at the regulator are facing large volumes of work, so anything companies can do to make their lives easier will be greatly appreciated.

"People at the agency are working very hard," he explained. "What we should all be doing in our interactions with them is being patient, being clear in our communication ... Be a good collaborator with the agency and that will turn around and make your process much more smooth."

A final point of discussion in the webinar was the value of being adaptable and having multiple options, should interactions with the FDA not go as planned. This flexibility is something that investors into startups in the sector will be particularly focused on in the coming years.

Mr Orr added firms should consider multinational development programmes, with product development based on International Council for Harmonization standards.

This can ensure firms have opportunities to pivot if there are signs that FDA approval may not work out. "You have a lot of potential pathways and a lot of potential options available to you, than if you just were focused on obtaining approval from one agency," he said.

"A lot of VCs value a plan B," he continued. "Maybe it's an animal indication out of the same molecule, maybe it's an alternative regulatory pathway pursuing approval in Europe or somewhere else. Maybe it's a second product. But they value having a belt and suspenders approach."