Speed to Study
Accelerate your drug to proof of concept with PCI’s new Speed to StudyTM services.
Pharmaceutical companies need to streamline early phase development to establish proof of concept, efficacy, and stability of their drug candidates quickly and efficiently. PCI’s Speed to Study services are designed to help companies manoeuvre complex trial designs with maximized flexibility and speed.
We have invested in global teams, sites, and resources to provide you with time-tested phase-specific processes, operations, and the experts you need to get your early phase studies off to a running start.
- How can Speed to StudyTM accelerate my drug to proof of concept?
- Just-in-Time Manufacturing for Early Phase Studies
- Just-in-Time Aseptic Processing for Early Phase Studies
- Powder in Capsule (PIC) & Powder in Bottle (PIB) Services
- Import/Export & Permitting of Drug Products
- Custom Kit Design Services
- Why Australia?
Speed to StudyTM services are designed to initiate Phase I trials quickly so you can get the necessary safety data to move into phase II, gather efficacy data, and get your proof of concept. It accelerates drug development timelines, and moves your drug candidates forward using a mix of our team’s expertise and our time-tested processes such as Just-in-Time (JIT) manufacturing, PIC/PIB services, import/export & permitting of drug products, and custom kit design.
When you have limited dose strength data or limited API for your clinical trial, consider using Just-in-Time (JIT) manufacturing services to collect safety and pharmacokinetics data without sacrificing quality. It maximizes your dosing flexibility by not committing your drug supply to a few finite dosing options.
PCI’s JIT manufacturing services support early phase adaptive clinical study designs by reducing drug wastage down to only 5-10% drug overage, compared to 50-100% drug overage using traditional manufacturing programs. JIT manufacturing is an effective method to handle clinical supplies that have minimal CMC data, as it allows you to take advantage of your drug product’s limited shelf-life stability.
“Our decision to execute early phase trials in Australia has significantly accelerated our timelines. The combination of Australia’s favorable regulatory environmental and PCI Melbourne’s JIT services has contributed to this time savings.”
-Eric J. Daniels, MD, MBA Co-Founder &COO, Okogen
PCI’s licensed, GMP facilities in Melbourne, Australia house our JIT manufacturing services. Our primary focus during manufacture is API conservation and environmental control, and our team verifies that the qualification of our GMP processes meets microbiological requirements to ensure safety for clinical use.
We utilize single-use disposable technology for our aseptic processes, which reduces the risks of cross contamination and enhances sterility assurance. Our Speed to StudyTM JIT aseptic processing systems are designed to optimize your dosing flexibility for your drug, even if you may have only limited stability data.
PCI has built a global network that allows us to prepare your desired dosage using JIT techniques, and get it to the clinic in time for you to take advantage of your drug’s short expiry period (24-72 hours).
Key aspects of our JIT Phase I Aseptic Processing include:
- Single-use aseptic processing for Phase I
- Bulk formulation manufacture
- Double filtration to ensure sterility
- Short product expiry (24-72 hours)
- Sterility and endotoxin testing
- Small batch aseptic vial and syringe filling
- Per cohort IV infusion bags
- Media fills and process verification
- Grade B filling suite with Grade A laminar flow
- HEPA filtered pass throughs.
There are a number of phase-appropriate CMC strategies that keep costs down while building asset value. At the beginning of the drug development pathway, a focus on intellectual property, safety and efficacy are the key drivers to building proof of concept. At this point, having an in-depth look at the CMC profile of small molecules does not add value.
PCI’s PIC/PIB services provide an effective way to quickly manufacture your drug at the desired dosage so you can get it into the clinic quickly. This approach allows you to delay costly formulation activities such as excipient compatibility until you have data to support it.
The import/export and permitting of drug products is often left to the last minute, which can result in unfortunate delays to drug supply chains. PCI has over 50 years of experience walking our clients through the processes and required documents for the import/export and permitting of drug products.
Different countries have different requirements. In some countries, once an order is raised, documents need to be prepared and submitted to the Importer of Record. Sponsor companies can plan on a 7-10 business day delivery timeline, from order generation.
In other countries, once an order is raised, documents are submitted to the Importer of Record. An import permit must be obtained and typically takes more than two weeks to acquire. Additionally, there are multiple steps in the customs clearance. Time from order generation to delivery is, on average, 20-25 business days or possibly longer.
If speed is of the essence, then country selection for your early phase trials is critical. For more information on which countries have favorable drug import/export and permitting timelines and regulations, feel free to contact our team.
Each country requires different documents and taxes related to import, export and permitting (Table 1), which should factor into a sponsor company’s country selection decision.
In-house custom kit design and manufacturing services can eliminate up to three weeks of lead time, allowing you to bring your first patient-in deadline forward. Our three dimensional modeling and in-house prototyping capabilities facilitate rapid prototype design and development. This allows for expedited response and efficient concept generation to enable Speed to StudyTM for clinical products.
PCI Melbourne has the early phase specific expertise, processes and operations needed, such as JIT manufacturing, to maximize the dosing flexibility needed to secure solid stability and efficacy data.
On top of this, Australia has become a top destination for Phase I trials due to:
- R&D Tax Incentive – 43.5% rebate for eligible companies.
- Overseas clients with less than $20 million AUD aggregate T/O set up subsidiaries to claim rebate
- Short Clinical Trial Notification (CTN) scheme – approval as little as 1 week following Human Research Ethics Committee (HREC) review
- Patients can be dosed 6-8 weeks from submission of IRB to HREC
- Access to trials in the absence of a CMC package
- Data procured in Australia can be used for Phase II IND applications
- Phase I exempt from regulatory inspection (PCI’s facilities are TGA-licensed GMP facilities)
- Multiple Phase I units in Australia are co-located in Tertiary teaching hospitals
- Access to world class educational institutions which promote collaborative research.