PPD’s Early Development Services Can Help Expedite the Clinical Process
In response to the global pandemic, clinical research units (CRUs) at PPD have changed their approach to protocols and procedures to manage prevalent health concerns. During these unprecedented times, our CRUs have developed a comprehensive operational plan to ensure the safety of our employees and volunteers, while adhering to strict guidelines. In this blog post, Nick Scott (VP Early Development) and Fiona Markwood (VP Early Development) explain why you should consider PPD’s Early Development Services for your early development needs.
During the drug development process, companies have a choice of different approaches based on their development plan requirements. Some, in order to access patients as early as possible, integrate a drug to drug interaction (DDI), food effect or patient arm with a single ascending dose/multiple ascending dose (SAD/MAD) study, potentially providing early signals of efficacy in the patient population. Others conduct multiple, simpler studies, sometimes in parallel, sometimes staggered, often reflecting the level of risk and complexity the sponsor is willing to incorporate into their drug program. Whichever route a company takes, deliberate decision making around the nature and timing of early phase studies is important to manage risks in the clinical development process.
Early Development services are crucial to this and to determine the impact of a drug in humans, safety and potential signals of efficacy. With over 30 years of experience in Phase I and Phase Ib trials, PPD’s Early Development teams work with you to identify potential pitfalls and set your molecule up for success in later-phase programs through accelerating development timelines and containing costs.
PPD has three CRUs, located in Austin, Texas; Orlando, Florida; and Las Vegas, Nevada. We also have a network of 12 U.S. and 17 global Phase I research sites, allowing wide access to healthy patients, volunteers and specialty populations.
What are the benefits to using an early development service?
There are several elements of early development studies that set them apart from those in later development, including but not limited to: subject/patient population, rapid turnaround from study startup to top line results or clinical study report; volume of Phase I studies expected compared to later phase; and common assessments/methodologies across multiple study types.
PPD’s Early Development organization brings colleagues and teams that are:
- Experts in clinical program and trial design, and able to recommend options for clinical development planning scenarios to meet multiple risk scenarios
- Comfortable with the rapid throughput and high volume of studies
- Accustomed to progression from startup to closeout in a period that can be as quick as just a few weeks
- Specialized in working hand-in-glove with PPD owned clinics to manage the specific challenges associated with early phase (criticality of assessment timing, blood draws, data for dose escalation meetings, etc.)
- Day-in, day-out dealing with the technical aspects of pharmacokinetic (PK) and pharmacodynamic (PD) data, medical aspects of safety data and for whom identifying and resolving potential issues in these specialist areas is second nature
Additionally, an organization dedicated to early phase does not have to manage the conflict of prioritizing resources between large, higher dollar value later phase studies, and the small, critical path studies often run by a fit-for-purpose organization whose existence relies on their high quality, efficient delivery for decision making purposes.
What differentiates PPD’s Early Development Services from others in this space?
PPD continues to invest in the expansion of an early development group and in new CRUs by adding new sites and new patient capabilities (e.g. PPD acquired, in 2019, an Orlando unit with decades of CNS patient focus). With a focus on continuous improvement, PPD is also investing in technologies that not only drive greater quality at these units, but also enable a more seamless and more efficient end-to-end journey for our sponsors’ clinical trial data.
While PPD’s 700+ strong early development organization is dedicated to Phase I and Phase Ib clinical trials, the group has access to approximately 25,000 other PPD staff who can bring a broad range of expertise across numerous therapeutic and function areas.
How can using PPD’s Early Development Services detect potential dangers/challenges in a drug’s development?
PPD’s Early Development organization has been enhancing its offering in the execution of Phase Ib patient trials, often in the context of combined/hybrid SAD/MAD studies to really characterize the PK/PD in patients and assess safety and early efficacy signals. Our Safety Committee reviews every protocol that we prepare to execute in the CRUs to ensure that the safety profile and procedures are aligned with the team’s safety risk tolerance profile. Working alongside our pharmacovigilance medical monitors and the therapeutically aligned physicians in our medical organizations enables us to ensure the right level of focus on patient safety throughout the design and execution of the trial.