Viprax Pharmaceuticals

Anthony P Mack

Anthony Mack is a driving force behind the success and triumphs at Virpax Pharmaceuticals, skillfully engaging in diverse activities that significantly contribute to the company's achievements. Leading regulatory meetings, he navigates intricate product development processes, involving formulation and preclinical research. His strategic prowess shines in securing non-dilutive funding. Collaborating with grant writers, Mack ensures precise grant submissions to esteemed institutions like the NIH and the DoD, while maintaining impeccable compliance standards. His influence extends to liaising with investment banks, vital for licensing assets globally. Partnerships in Europe and China secure upfront fees, milestones, and royalties, aligning with the company's US market focus. Mack's journey spans roles from sales to co[1]founding ProSolus, culminating in a successful acquisition. His weekly agenda encompasses dynamic regulatory negotiations, grant strategies, investment collaborations, and a focused US market approach, epitomizing his background and aspirations in driving Virpax's continued success.

In an interview with Pharma Tech Outlook magazine, Mack shares his insights on the challenges and emerging trends in the pharma consulting industry and the experience he has gathered in the domain.

What, are some of the major priorities, and hurdles, that you are currently managing in this role?

As a development stage company, we have a lot on our plate. We are currently focused on securing assets through licensing agreements, specifically at the preclinical stage. Our top priority is to refine the formulation to meet our optimal standards. We are unwavering in our commitment to achieving a robust formulation before advancing to the clinical phase. This strategic approach is non-negotiable for every asset we bring on board.

Once we attain this critical formulation milestone, our immediate objective shifts to our current phase of progress. This entails navigating through the preclinical stage with utmost diligence.

We focus on conducting thorough animal studies, strategically aligning with regulatory requirements, and engaging proficient Contract Research Organizations (CROs). We are determined to comprehensively fulfill all FDA prerequisites, propelling us toward the subsequent phase. Our projected timeline is clear-cut: We are gearing up for human trials, an endeavor we anticipate initiating in 2024.

As the Chairman and CEO, how do you effectively implement a range of strategies in the multidisciplinary field of pain management and ensure that these strategies are closely aligned with your organization's objectives?

Our company is dedicated to mitigating development risks wherever possible. We differentiate ourselves by not working with new molecules but enhancing existing ones like bupivacaine. This is achieved through liposomal encapsulation, extending its effectiveness significantly. Our twin objectives are clear: establishing cost efficiency that can compete across various markets—branded or generic—and setting ourselves apart distinctly. 

For instance, consider our Probudor™ asset. Before acquisition, rigorous preclinical research was essential to prove its markedly superior and more durable effects compared to existing options in the market. This meticulous approach isn't limited to one asset— it's consistently applied to our entire portfolio. Every purchase we consider must showcase a strong potential for surpassing existing alternatives or offering remarkable differentiation. This comprehensive strategy guarantees that our portfolio matches our mission and delivers substantial value.

How does your company's approach differ from the traditional methods in the marketplace today?

While we might not be drastically different from other micro-companies or startups in the preclinical stage, there's a key factor that sets us apart. It's our remarkable ability to evaluate assets thanks to our exceptional team.

Our team's diversity speaks volumes about our distinctiveness. We don't just assess products based on their novelty; we bring in medical experts to weigh in. With physicians on board, including directors specializing in anesthesia, pain management, and regulatory affairs, our evaluation goes beyond medical potential. We also delve into regulatory feasibility—can these products navigate the intricate FDA process?

Consider Dr. Eric Floyd, who boasts an impressive track record of getting 30 to 40 products approved within the regulatory realm. Coupled with my experience and Gerald Bruce's insights, we focus on another crucial aspect: market access. Will insurance companies cover these products? In essence, our approach covers all bases.

In this complex landscape, overlooking any dimension could prove detrimental. You might breeze through the approval process but stumble on reimbursement, or you might possess a groundbreaking molecule with an exceptional delivery mechanism yet face challenges with FDA approval. While success isn't guaranteed, our goal is to minimize risks. That's why every product we license undergoes a thorough assessment—considering clinical, regulatory, and market access facets.

Could you offer insights into any ongoing projects you're currently engaged in? Specifically, what processes and technologies have you employed to ensure their success?

 A particularly intriguing focus has been our Molecular Envelope Technology (MET). While our liposomal technology is impressive, MET takes it even further. Leveraging intranasal delivery, we're revolutionizing the administration of orally taken products, channeling them directly to the brain—their intended destination. This bypasses the liver and the gastrointestinal route entirely. With no plasma involvement, everything now reaches the brain, highlighting substantial potential.

MET enables us to transport molecules to the brain that wouldn't typically breach the blood-brain barrier on their own—such as our enkephalin asset. We are elevating the bioavailability of select products. For instance, consider our cannabidiol application. Our technology achieves equivalent brain delivery using only around one-third of the dosage required for an oral form. This approach effectively addresses issues associated with liver interactions, gastrointestinal disruptions, and plasma degradation.

Our current focus revolves around these groundbreaking advancements. The significance of these products is emphasized by the backing of the National Institutes of Health (NIH). We've secured tangible grant opportunities and in-kind grants from the NIH, substantially propelling the early-stage progress of both our Molecular Envelope Technology and liposomal delivery platforms. The excitement isn't confined to our team—it's a clear testament to the monumental potential these innovations harbor.

What advice would you like to give your colleagues and peers in the industry?

When evaluating assets, maintaining authenticity is paramount for our company. We are resolute about bringing to market only what we genuinely believe in. Equally important is the composition of our team. We ensure that those surrounding us possess the necessary experience and expertise in the given area. If such individuals are lacking, we proactively seek them out. This step is not just important; it's critical.

Our board of directors is a testament to this approach. It's a dynamic blend of expertise spanning finance, commercialization, medical, regulatory affairs, and academia, forming a comprehensive team. The emphasis on encompassing diverse knowledge and skills is pivotal. By creating this collaboration, authenticity naturally shines through, especially when we choose which molecules to pursue.