Winning Regulatory Trust: Six Smart Strategies for Emerging Biotechs

Effective communication with regulatory authorities is critical for emerging biotechs. Here are six of the most valuable aspects of regulatory communication and relationship building.

Effective communication with regulatory authorities is critical for small biotech companies, as it is often the key to success in clinical trials. When small and emerging companies are able to build strong, trust-based relationships with regulators, they often see benefits like reduced development risk and accelerated timelines. However, to achieve these benefits, sponsors must have experience in and knowledge of the regulatory landscape. This can be a challenge for biotech companies that are new to the regulatory process or exploring new regions for approval.

This blog reviews six of the most valuable aspects of regulatory communication and relationship building that, when executed properly, are often able to enhance a therapy’s chance of getting to market. When a company applies these approaches, even small or novice drug developers will see increased efficiency.

1. Start early and be proactive

Early engagement is a powerful way to bolster a sponsor’s ability to adequately plan around regulatory agency expectations. Being proactive allows teams to identify potential risks and make better decisions. When teams are well prepared ahead of time, it builds credibility with regulators, and credibility is a valuable currency in the regulatory approval process. When proactive communication is prioritized, it allows for:

• Alignment of development strategies
• Full clarity on regulatory expectations
• More thorough preparation for major milestones
• Shorter and more predictable timelines

2. Prepare thoughtfully for each interaction

Early preparation will only be helpful if it is also thorough and thoughtful. Meetings with the regulatory body, both virtually and in person, are key opportunities for alignment, strategy development, understanding expectations and risk reduction. Before these meetings, it is important to do the necessary research on the agency involved and what information they will want. This enables drug developers to define their objectives clearly for every meeting and curate and structure briefing materials with precision. Prepare questions that are aligned with existing guidance documents, regulations and agency precedents — to demonstrate an understanding of the applicable framework and scientific rigor. Keep transparency and respectful communication at the forefront throughout preparations. Regulators want to understand a company’s product, mission and strategy, and the more sponsors are able to foster that understanding, the more trust and credibility are built.

3. Leverage regulatory programs

A crucial part of understanding the regulatory landscape is awareness of the expedited pathways and enhanced engagement programs that regulatory agencies offer. These programs can drastically expedite timelines and provide further support to teams that qualify. A few examples of these programs include:

• Fast Track, Breakthrough Therapy, Accelerated Approval, Priority Review and Orphan Drug Designation in the U.S.
• PRIME or Accelerate Assessment in the EU

These programs may also increase the frequency and depth of engagement with regulators. Sponsors’ planning should include research into what programs they may qualify for and what is required to participate.

4. Choose the right team for regulatory meetings

The right team is often foundational in navigating the regulatory pathway toward success. It is important to include subject matter experts who are well-versed in the topics that will be discussed, in addition to institutional knowledge of regulatory processes and expectations. To ensure optimal preparation, teams should:

• Have mock meetings and rehearsals
• Be adept in both the technical and interpersonal aspects of regulatory engagement
• Be practical, collaborative and problem-solving, and have extensive regulatory experience

Rather than thinking of regulatory engagements as a series of transactions, sponsors should see them as a long-term relationship. Taking the time and effort to build a strong team — one that shares this mindset and is experienced in navigating regulatory relationships — is essential to achieve success in the drug development landscape.

5. Understand the regulatory perspective

Many successful sponsors achieve their goals by understanding the regulatory process from the regulator’s perspective. Regulatory agencies operate based on scientific rationale and public health imperatives. Therefore, keeping patient centricity at the core of the drug development process is crucial for understanding how these agencies approach the regulatory pathway. Regulators might also have specific perspectives on product types or disease areas. Teams can gain insights into a regulator’s point of view by researching public talks or articles from reviewers or division heads.

Sponsors should also focus on building a relationship with regulators that demonstrates commitment while adapting to the systems these agencies have in place. When sponsors and regulatory agencies are able to balance transactional and collaborative interactions, this sets the scene for streamlined timelines and mutual respect. This requires recognizing the unique nature of each agency and regulator. Some regulatory representatives adhere to rigid processes, while others are more flexible. And many regulators have incredibly limited time and resources, so respecting these limitations is paramount.

6. Remember that details matter

The smallest interactions and details can signal a team’s dedication and attitude to regulatory agencies. This is one of the biggest reasons that logistical preparation is essential, even down to the smallest elements of the meetings. These details may include:

• Arriving early for meetings
• Allotting enough time to navigate parking and security at the location
• Communicating clearly and concisely
• Having well-organized materials
• Being prompt in communication responses
• Taking regulatory feedback in stride without responding defensively
• Having focused and detailed supporting data that shows preparation and scientific rigor, while not being too dense to follow

Some of these considerations may seem small, but they can easily add up to create a bad impression of the team if not executed well. Paying attention to the details signals professionalism to the regulators and helps build the trust that is so valuable in a regulator and drug developer relationship.

Partner with an experienced provider of CRO services

Collaborating with a contract research organization (CRO) partner that understands both the technical and cultural dimensions of regulatory engagement is a powerful way to fill the gaps in knowledge and resources that a biotech company may have. This is particularly important for small teams that are new to the process. An experienced CRO partner has the ability to educate internal teams and improve regulatory interactions, while translating their extensive experience into strategies that work for early-stage biotech companies to build solutions that are fit-for-purpose. Partnering with the right CRO services provider enables sponsors to have access to knowledge gained over years of experience. Combining this with a network of global resources streamlines processes, avoids cost overruns and increases the chance of regulatory success.

We know how to communicate the biotech mindset to regulators

Implementing all of these elements when approaching a regulatory agency, especially when a team is new to the process, can be overwhelming. The right CRO partner is often the key to approaching these strategies with the care and expertise they require. The PPD™ clinical research business of Thermo Fisher Scientific is well-practiced at navigating complex regulatory relationships and has the global resources needed to achieve success, even across borders.

Where a biotech company may falter in experience and resources, PPD Biotech solutions provide the resources needed to fill these gaps and streamline the path to regulatory approval. Our teams are built to reflect the entrepreneurial mindset of the biotechnology industry, and we tailor our regulatory strategies to each sponsor’s specific goals and challenges. We also have the breadth and depth of experience needed to understand the regulatory perspective and navigate these relationships with global regulatory authorities, building a foundation for regulatory success for even the smallest or most inexperienced biotech companies.