Learn how life science startups achieve FDA and EMA regulatory approval on their first try. Discover strategies and insights from successful companies in the biotech space.
Fun fact: Only 15% of life science startups gain regulatory approval on their first try. Learn from the experiences of this top group.
Introduction
Regulatory approval for startups in this space is like climbing a mountain. You first have to pass through the maze of complicated and often ever-changing rules just to get near the summit. Staggeringly, a mere 15% of these early-stage businesses succeed at the top on their first try. So, what do these chosen few have in common? What do they do that unlocks the door for regulatory approval while others fail to even enter? Step into the lives of this elite 15% and discover what you can learn from them.
Regulatory Roadblock: The Sad Truth
Now, before we explore how the top 15% do it differently let me also share with you a sobering fact – the sad truth is that when compared to regulatory approvals, Life science startups are worse. Getting a new drug, medical device or therapeutic through safety and efficacy assessment by regulatory agencies is a long process filled with obstacles:
Heavy regulations:
Regulatory authorities such as the FDA and EMA impose rigorous guidelines to guarantee safety for patients as well as efficacy of products. For many resource-strapped startups, just meeting these standards can be a challenging exercise.
Challenging Application Process:
The preparation and submission of a regulatory application is laborious and lengthy. This requires thorough data, deep tests, and extensive knowledge of regulatory guidance.
Failure Risk:
Regulatory approval is never a certainty and the repercussions from a rejection can be devastating. Failed attempts waste resources and prolong time-to-market, which can hinder patients from accessing potentially life-saving treatments.
With all these hurdles to overcome, it is no surprise that a very small percentage of startups survive the regulatory gauntlet. However, amongst that 15% is where the lessons are.
Involvement with Regulatory Experts at an Early Stage
For the top 15%, a key differentiator was early involvement with regulatory experts. These professionals, typically from quality and regulatory consulting firms, provide invaluable insights and experience.
The startups that ask for guide from regulators at the outset have a leg up. They can:
Manage Complicated Regulations:
Regulatory specialists guide startups through the complicated, regulatory web for their specific product and market.
Strategic Planning:
Consultants help build a regulatory strategy based around the specific characteristics of the product, minimizing costly mistakes.
Save time and capital:
Startups save their time and capital by refraining from duplicate efforts.
Mitigate Risks:
Experienced consultants can help to identify potential regulatory hurdles early in the process, giving startups time to address any issues before they become a problem.
Forward thinking startups can identify that when it comes time to get into the approval pipeline, regulatory experts are not merely hired guns but rather every bit as important partners on the journey.
Collecting Strong Data and Evidence
The data and evidence of product safety and efficacy are the foundations for regulatory approval. Some startups (the remaining 15%) realize that launching a successful business begins with gathering sound, well-documented data.
Here is how they do it:
Do Research: Great startups spend as much time as it takes with preclinical and clinical research to generate good data. It always entails partnering with top research centers and experts.
Quality systems work lined up in every walk of product development. This guarantees that the data remains uncorrupted and is in accordance with regulatory standards.
Pragmatic expectations: These are not aspirational startups — they understand the amount and type of evidence necessary to achieve approval, and they plan studies to gain support without making unrealistic claims that could backfire.
Comprehensive Documentation: Records of every step in research and development are documented, allowing at a minimum transparency and auditability.
With extensive data collection and record-keeping, these startups are making a strong argument for the safety and effectiveness of their product greatly improving the likelihood of winning over regulators.
Adaptability and Agility in Action
The regulatory landscape is always changing. The approval process can surprise us when regulations change. The top 15% of startups are flexible and responsive when navigating change.
They possess the following characteristics:
Regulatory Intelligence: Tracking and monitoring the regulatory changes and trends prepares them for being obliged.
Adaptive Clinical Trials: Allows for the flexibility to adapt clinical trial designs and endpoints based on data trends or regulatory guidance emerging during a study.
Transparent Communication: They are proactively communicating with regulators and embracing feedback early in the process.
Preparation for Hard Shoots: Contingency plans are derived from and prepared for any eventualities or untimely regulatory difficulties.
Adaptability is a currency that can help convert missteps into resilient strides forward in an ever-evolving regulatory landscape.
Skilled Regulatory Teams
There is a regulatory team behind every successful startup. These teams consist of specialists who are well versed in regulatory affairs, compliance, and submission processes.
Elements Of a Strong Regulatory Team:
These are Role of Regulatory Strategists: Responsible for high-level regulatory strategy development and ensuring business goals are in alignment.
QA Leads: People who take care of ensuring product quality and compliance with regulations
Clinical and Scientific Advisors: Experts to advise on research, clinical trials, and product development.
Submission Specialists: Experts who prepares and compiles your regulatory applications accurately and in complete form.
Project Managers: These are the ones who handle the full regulatory process, ensuring timelines are fulfilled and resources are applied where necessary.
They are simply smart — The best startups understand that the regulatory environment is complicated and they need a diverse and strong regulatory team responsible for getting through hurdles.
Putting Patients First: A Moral Imperative
Though the end goal of receiving regulatory approval is centered around product safety and efficacy, 15% startups practice a patient-centric approach. They put the people who will use their products first and ethical considerations second.
Simply put, this patient-centric approach includes:
Involving Patient Advocacy Groups: By engaging patient advocacy groups earlier on in the development process, these startups are receiving insights and feedback at the front end, rather than waiting until a product launch to better understand what patients want or need.
Transparency and Informed Consent: They maintain the highest ethical standards, ensuring that patients are fully informed about the risks and benefits of participating in clinical trials.
Post-Market Commitments:
These are assurances of ongoing long-term monitoring and follow-up for safety, proving that agencies prioritize patient safety well after the approval process.
To innovate and get ahead, focusing on the patient, creating an ethical framework, and working around that will not only lead these startups down a rightful path in bringing their products to life while getting necessary press attention or gaining regulatory approval but also help them achieve something much more fundamental trust among patients and physicians.
Never-ending improvement and learning
Finally, the 15% of startups know that the path to regulatory approval is not a fatally important event. They embrace a culture of continuous quality improvement (CQI) and iterate on their processes to increase the likelihood of success.
There are several key components in their approach to CQI:
Post-Market Surveillance: Ongoing observation of product efficacy and safety after approval to recognize and resolve any arising concerns.
Audit and Feedback: Periodic internal audits and external assessments to detect opportunities for improvement.
Utilization of modern technologies: Newer methods to be incorporated in trade facilitation process aiding data collection and creating platform for analysis.
Training & Skill development: Investing in continued training and skill development of their regulatory and quality teams.
Conclusion
By embracing the mindset of constant evolution, these startups not only gain access to regulatory approvals but also ensure their long-term prospects as leaders in life sciences
Reach out to BioBoston Consulting today or head over to our website for more details on how we can help your organization!
