Margaret Jenkins, Principal and FounderIt has been a pivotal force for over two decades, guiding groundbreaking medical breakthroughs from conceptualization to regulatory approval.
The cornerstone of its remarkable track record is a team of seasoned professionals, each with an impressive three decades of expertise in drug development and regulatory affairs. This deep well of knowledge, paired with a profound empathy for the scientific quest, allows GPS to stand out as a partner deeply invested in supporting biotech companies by paving the way so their products can save and improve lives.
When faced with the inevitable challenges of product and clinical development, GPS doesn’t see it as a dead end but a pivot to a new opportunity. It’s not uncommon for clients with pre-designed trials to encounter difficulties in achieving the desired outcomes, highlighting the need for recalibration and strategic reassessment. GPS delves into the data, extracts the critical lessons and de-risks the development program by supporting firms in consulting with FDA early in the program, to gain a clear pathway forward to approval.
One of the focus areas for GPS is ensuring development of and compliance with potency assays for biologics, where compliance with FDA guidance and advice is critical. These assays are pivotal, verifying each product batch delivers consistent clinical effects for patient safety and product efficacy. GPS’s vigilant approach in this area ensures clients establish robust potency assurance strategies before progressing to advanced clinical phases of development.
“Our nuanced, problem-solving mindset is our differentiator,” succinctly puts Margaret Jenkins, principal and founder of GPS. “For us, it’s not just about overcoming hurdles; it’s about transforming challenges into a strategic advantage and guiding our clients every step of the way.”
A notable instance highlighting GPS’s proactive approach involved detecting a formulation issue during a clinical trial that threatened the study’s integrity. By quickly communicating this issue to the client and pausing the trial, GPS not only prevented a potential failure but saved significant time and resources. The decisive move also exemplifies GPS’s commitment to prioritizing the project’s long-term success over immediate progress.
The secret behind GPS’s capability to delve into the intricacies and anticipate challenges lies in its rigorous methodology. This framework, based on decades of experience, streamlines the development and regulatory journey and expedites project timelines, ensuring clients move through regulatory hurdles with unparalleled efficiency.
Here’s how GPS transforms the development process into an efficient model.
The journey begins with an exhaustive analysis of the proposed program, pinpointing any issues or gaps in the available data, including CMC, nonclinical and clinical data that would need to be addressed to achieve final regulatory approval.
For us, it’s not just about overcoming hurdles; it’s about transforming challenges into a strategic advantage and guiding our clients every step of the way
Next, GPS embarks on a diagnostic evaluation, crafting bespoke strategies that may involve expedited pathways such as accelerated approval and/or designations such as Breakthrough or Regenerative Medicine Advanced Therapy (RMAT). Each strategy is laid out step by step and consultation with FDA is sought where appropriate.
Finally, GPS and the client collaboratively implement these recommendations, resulting in an efficient de-risked pathway to approval.
The influence of this approach extends worldwide, with GPS’s dedicated team spread across the U.S., Australia and partners across the Asia Pacific region. Their understanding of global and local regulatory nuances and proactive engagement ensures every potential interpretation or challenge is addressed thoughtfully, with insight based on decades of hands-on experience and always in consultation with clients. This fosters a culture of informed decision-making, guaranteeing clients are fully versed in regulatory expectations throughout the product development journey.
Undoubtedly, GPS is a guiding light in pharmaceutical development, establishing a paradigm of collaboration, strategic foresight and regulatory acumen. Directing the industry toward innovative solutions that positively impact patient lives, GPS proves that with the right guidance, navigating the regulatory landscape can be a seamless journey of discovery and achievement.
