The Pressing Need For Needle-Free Immunization With Heather Callender-Potters

Heather Callender-Potters

Vice-Chairman, Global Business Development Officer, Co-Founder at PharmaJet, Inc.

In an effort to best serve the Blackstone Entrepreneurs Network, we are asking various members to share their stories of what they are currently working on amidst the COVID-19 pandemic. We had the opportunity to interview active BEN Member, Heather Callender-Potters, to learn more about her company, PharmaJet, and their role during this pandemic. Heather was also recently interviewed for Business Leaders Podcast, in this podcast Bob Roark and Heather discuss the pressing impetus for investing more resources into needle-free immunization. Heather is cautiously optimistic about the future.

Heather has been focused on a needle-less solution for many years. “My mother and I co-founded the business. We wanted to make a contribution to healthcare. Because of rampant needle reuse, there was a call to action by the World Health Organization for a needle-free immunization tool to be developed. We decided to rise to that occasion.” Based in Golden, Colorado, PharmaJet’s mission is worldwide acceptance of PharmaJet Needle-Free devices as a standard of care in the vaccine delivery market. 

PharmaJet has been in this space for a long time. What role do you intend to play with COVID-19?

We have 67 human clinical studies underway, with more than 50 collaboration partners. Science is a bit glacial sometimes. It takes a ton of time to prove things. What we're experiencing with the caveat of Coronavirus vaccine solutions, is that it is going to take time. We may have a solution that we think is pretty great, or even multiple solutions, but it does take time to follow the patients, understand protective immunity, and to make sure that if you need to boost your shot, that it works.

In the 15 years since the founding of PharmaJet, and the innovation you’ve been a part of, are you seeing COVID-19 accelerate or decelerate innovation on a global scale?

When we started PharmaJet, the rule-of-thumb was that it would take ~5 years to develop a medical device and take it through regulatory to launch it commercially. The objective was to prove the device was the same as, or better than, a predicate device. For drugs and vaccines to make it through clinical trials, it was expected to take about a decade. PharmaJet’s device regulatory approvals took about this amount of time, but it was about that time that FDA began to rigorously require clinical claims for all indications. This seemed to be driven by drug companies having an approved use for a drug, and without studies beginning to promote it for other uses. The FDA tightened regulations to require claims for every treatment/indication, and this flowed through to medical devices.

Devices approved for general use retained their approvals, but the changes made by the FDA contributed to a cascade effect in several other countries. As a result, timelines doubled for everyone, as more studies, cost, and time was required for everyone before they could market their products. While this was certainly a very difficult and expensive roadblock to navigate, due to lack of funding or expectation of reasonable return on the investment, PharmaJet was successful in completing clinical studies which have approval from various agencies across a number of countries and geographies (FDA, WHO, and others).

Taking a retrospective look, clinical claims have provided a distinct competitive advantage for those companies which conduct them. But, in some cases, they are unaffordable and therefore there is a massive opportunity cost as a result of the regulatory burdens, ultimately preventing certain medical innovations to be available in the US. It has caused some companies to use OUS regulatory paths for use abroad. This would be true for both large and small companies. Small and undercapitalized companies have suffered the most. One could also argue that the cost of drugs and other innovations are much more expensive to create, thus driving up the cost of healthcare.

During this unprecedented pandemic, regulators throughout the world are moving at an amazingly rapid pace and easing many restrictions for many non-invasive technologies (e.g. COVID testing) in an effort to create multiple solutions as quickly as possible.

It demonstrates that regulators can be flexible and process information more rapidly than the status quo of the past decade. My hope is that it will create lasting positive change for the world, to facilitate a least burdensome/most cost-effective approach to finding med-tech solutions to pressing problems. No doubt it will do that for vaccine developments, often considered to be less profitable (and therefore less attractive to investors) than drugs. But, because there are so many pressing disease risks for which vaccines can be created, and new vaccine platforms which can be more rapidly developed (e.g. mRNA, DNA) to address a need, I think the new fast track standards will have some positive and lasting effects on regulators globally. Given that PharmaJet is focused on immunization, it obviously is an important time for us. Through our relationships with eighteen COVID-19 candidates being developed in multiple countries, PharmaJet may have the ability to positively impact several aspects of bringing a solution to commercial state, based on our historical data and experience (60+ collaborations across 100+ injectable vaccine and therapeutic candidates).

• Being an alternative to needle-based delivery is helpful in inspiring compliance. In some cases, we have observed up to 18% more participation in mass immunization events.

• Eliminating hazardous needle risks and costs (sharps, disposal, re-use) is obviously helpful.

• But, more importantly, and based on a significant number of clinical trials completed to date, PharmaJet could help stretch the dose, or perhaps make certain vaccines more efficacious than needle-based delivery.

What type of support are you getting? What do you need that might be getting in the way of getting towards your goals?

Funding is super important in the medical technology world and the life science world, traditionally you’d find that companies are not profitable for a number of years because they’re still adding layers of development that require funding and time. We’re oriented to be a sustainable and profitable business eventually. There will be more groups multilaterally coming in to fill some of those funding gaps because it’s enormously important to support the health systems and make sure that the infrastructure doesn’t fall apart because of a lack of investments.

We need our healthcare workers. We need venues. I’m confident that innovation, not just PharmaJet, in this scenario will continue to be funded.

Ms. Callender-Potters has a Bachelor of Arts degree in International Management from Claremont McKenna College and an MBA from the Wharton School of the University of Pennsylvania. One of the co-founders of PharmaJet, Heather has over 25 years of active investment experience including Private Equity fund management and international investment (BCEE; Enterprise Investors) across multiple jurisdictions and has managed individual investments and financial investor consortiums, ranging from $1 million to an excess of $100 million. She has also held board positions with several companies across a variety of industries ranging from auto-parts to systems integration, publishing, and light-manufacturing.