De-Risking the Technical Partnership

Drug development is a costly, long, and uncertain endeavor. The cost of taking a drug from preclinical research through market approval is $2.6 billion according to a recent study by the Tufts Center for the Study of Drug Development.¹ This huge cost has largely been attributed to rising clinical development costs and high failure rates of drugs tested in Phase 2 studies or later. On average, only 14% of drugs in development make it to market² and the average time to move a drug from Phase 1 to approval is about 10 years.³ In addition, failure can also happen in the drug manufacturing process or the industrialization of the drug delivery device.

At Portal, we are acutely aware of the costs, risks and uncertainty involved with drug development and delivery. We know that introducing a novel needle-free drug delivery device into the market may appear to increase the technical risks. So, we have taken deliberate steps to identify and “de-risk” the process of partnering with us.

• Custom Primary Container: No pharmaceutical executive wants to modify, let alone completely change an existing drug primary container, as the process of pre-qualifying and validating manufacturing processes can be very expensive and risky. Therefore, when we realized that we would have to design our own primary container we were careful to set certain design considerations in place to minimize risk:
• We designed our proprietary cartridge to be compatible with standard pharmaceutical fill/finish lines. It is based on the ISO 1 mL long standard to minimize any need for equipment customization.
• The entire fluid path is contained in the single-use disposable cartridge.
• We designed the cartridge to work with off the shelf components and industry-accepted materials.
• We developed both silicone and silicone-free options to cater to differing needs of pharmaceutical firms.
• We picked a manufacturing partner, Gerresheimer, with a strong quality track record and brand value recognition.

• Molecule Integrity: Portal’s needle-free delivery system can deliver a 1 ml injection in less than a third of a second compared to 10-15 seconds using an auto-injector or a needle and syringe. Naturally, the question that we get asked the most is what effect the method of delivery has on the drug molecule. To date, we have successfully demonstrated that our injection method does not impact the function or structure of 18 different molecules. We invested heavily in modeling and test set-ups and spent the time to build and qualify our novel platform. We developed and validated a porcine model in-house to characterize new drug formulations and develop device parameters for successful delivery. This provided us with the platform to rapidly test new devices, design changes, and injection profiles with target drug profiles. We also follow strict quality procedures and are ISO 13485:2016 certified.

• Scale: Another area of concern when working with a company of our size is the ability to scale up as needed. In this regard, Portal chooses supplier partners with established supply chains and proven quality systems who produce pharma-accepted products at scale for the world wide market. We strategically pick world class manufacturers and vendors to work with to explicitly leverage their existing expertise and relationships within the pharmaceutical industry. These key vendor relationships set us up early for product development success and make us an attractive partner.

The development of new drugs is inherently risky. Portal Instruments is transforming the drug delivery landscape by responding to a real patient unmet need, backed with robust science. Needle-based self-injections are a real struggle for patients at a time when they are vulnerable and affected by sometimes a life-threatening disease. We can change that and turn the self-injection challenge into an opportunity to assist patients on their road to improve their health. Portal’s vision for a needle-free world is enabled by our maniacal obsession to systematically and rigorously identify, break down, and mitigate risks. This has been the key to make our pharmaceutical partners feel confident about working with us.

1. ^{https://dukespace.lib.duke.edu/dspace/bitstream/handle/10161/12742/DiMasi-Grabowski-Hansen-RnD-JHE-2016.pdf;jsessionid=913C78F128FB36F9B4BBD2C3CA8FAA02?sequence=1}
2. ^{https://cen.acs.org/articles/96/i7/Drug-development-success-rates-higher.html}
3. ^{http://phrma-docs.phrma.org/sites/default/files/pdf/rd_brochure_022307.pdf}