RareMoon's Clinical Operations Consultant Offers Her Insights.
What are the most effective ways to liaise between regulatory teams and clinical/CRO teams?
One of the most frequent challenges I've encountered is the existence of multiple, conflicting timelines and plans across different functional groups and CRO partners. Establishing a Single Source of Truth (SSOT) for the entire program ensures alignment among all stakeholders. Maintaining a unified program timeline ensures every stakeholder, from the CRO monitor to the Regulatory strategist, is operating from an accurate and consistent understanding of the program's status.
Synergy across Regulatory and Clinical teams, and CRO Partners is fundamental to executing a successful trial, and core to that synergy is a unified strategy, clear governance, and transparent communication.
Implementing consistent cross-functional Project Team meetings establishes stakeholders' presence and accountability, and cultivates a partnership culture, which in turn creates accountability and drives the mission.
What recommendations you give to biotech companies as they approach IND?
Navigating the Pre-IND and IND stages is the most critical inflection point for start-up, virtual, and small biotech companies. Dedicate the time to write a high-quality documents including an Investigator's Brochure (IB). Drafting the IB early enables the team to synthesize all the data and identify gaps before assembling the full Pre-IND or IND application. And, I would also suggest including a preliminary Target Product Profile (TPP) in your briefing document. This demonstrates you have a vision for the final approved product, allowing the Agency to provide feedback that supports your long-term goals, not just your Phase I protocol.
What is the biggest challenge that start-ups face when initiating clinical trials?
Start-ups often transition overnight from a preclinical organization to a clinical-stage company. Unlike large pharmaceutical companies, they lack institutional experience and established processes, which leads to critical bottlenecks.
The biggest challenge start-ups face when initiating clinical trials is recognizing and managing the operational complexity to conduct a clinical trial. This is felt most strongly during study start-up; the time between filing the IND and enrolling the first patient. These companies may have teams with strong scientific backgrounds but lack dedicated, experienced leaders in Regulatory, Clinical Operations, and Quality Assurance. Recognizing the needed experience early on reduces challenges during trial initiation. For example, the most significant resource challenge I've observed is the absence of a clinical supply chain strategy and dedicated resource.
How do you see your clinical operations expertise supporting RareMoon's clients?
I have been fortunate to have had a diverse career, gaining experience at large pharmaceutical companies, fast-paced biotech firms, and lean start-up environments. This combined background has allowed me to create a specific, high-impact skill: expertly moving a start-up from an approved IND into the clinic within one year.
My track record includes successful launches at three different start-up companies, most notably leading the clinical activities for one company to secure approval for a treatment targeting a rare type of leukemia.
My core vision is to bring this experience, specifically, my ability to establish a quality and compliant operational foundation, to RareMoon clients, guiding them seamlessly from the IND stage through critical corporate milestones and toward pivotal studies.