Aspargo Labs Strengthens Leadership Team with Appointment of Former Amgen Regulatory Expert as CRO
Key Insights
Aspargo Labs (search) has appointed Dr. Mario Guralnik, former Amgen regulatory expert and founder of Synergy Research, as Chief Regulatory Officer to advance its oral suspension technology platform.
Dr. Guralnik brings significant expertise from his successful leadership of Amgen's Erythropoietin program, which led to the development of marketed products EPOGEN® and Aranesp®.
The appointment aims to accelerate Aspargo's regulatory strategy for its innovative liquid oral suspension delivery system and connected device technology across global markets.
Aspargo Labs (search), Inc., a specialty pharmaceutical and MedTech company, has appointed Mario Guralnik, Ph.D. as Chief Regulatory Officer to spearhead its regulatory strategy and expand its innovative oral suspension portfolio. The appointment marks a significant step in the company's mission to revolutionize medication delivery through liquid formulations and digitally connected devices.
Dr. Guralnik joins Aspargo Labs (search) with an impressive track record in regulatory affairs, most notably his leadership of Amgen's Erythropoietin program, which resulted in the successful development and commercialization of EPOGEN® and Aranesp®. His expertise will be crucial in navigating expedited approval pathways, including the 505(b)(2) route, for Aspargo's novel drug delivery technologies.
Strategic Vision for Regulatory Excellence
Michael Demurjian, Chief Executive Officer & Chairman of Aspargo Labs (search), emphasized the strategic importance of the appointment: "Mario's deep understanding of technical requirements for regulatory approval of new and improved drug products, combined with his entrepreneurial spirit, aligns perfectly with our mission to accelerate oral suspension technologies through expedited approval pathways."
Dr. Guralnik expressed enthusiasm about joining Aspargo Labs (search), highlighting the company's innovative approach to addressing critical medical needs: "The industry has stagnated regarding developing new ways to deliver and monitor medications, which is where Aspargo Labs will be disruptive. I look forward to leveraging my experience to enable Aspargo to achieve its goals of introducing therapeutic products to market quickly and efficiently."
Innovative Technology Platform
Aspargo Labs (search)' technology platform focuses on converting established medications into liquid oral suspensions, delivered through proprietary digitally connected devices. This approach offers several advantages:
- Improved drug absorption
- Enhanced ease of administration
- Flexible dosing capabilities
- Better patient adherence monitoring
The company's initial commercial focus includes a liquid oral suspension formulation of sildenafil for erectile dysfunction (search) treatment, currently marketed in Europe and the United Kingdom.
Distinguished Scientific Background
Dr. Guralnik brings extensive academic credentials to his new role, including:
- Ph.D. in Cellular Biophysics from UCLA
- Master's degrees in Molecular Biology and Computer Science
- Bachelor of Science in Biochemistry
His involvement with FDA advisory boards and industry committees has established him as a thought leader in regulatory affairs. He maintains active engagement in the field through lectures at the Drug Information Association and Regulatory Affairs Professionals Society, and serves on the Professional Society for Health Economics and Outcomes Research subcommittee.