In this episode of Life Science Success, my guest is Mara Holinger. Mara is the SVP and co-founder of Quantum Regulatory Solutions. She has extensive experience in assisting pharmaceutical and biotech firms with preparing their regulatory pathway, providing regulatory input for clinical trial designs and clinical development plans, performing gap analyses for preclinical testing and writing regulatory applications.
Key points covered in this interview:
Background and Expertise: Mara Holinger has a strong background in Regulatory Affairs, with a Ph.D. in a related field. She also highlighted her co-founders’ scientific expertise, making their team unique in the regulatory consulting field.
Client Base: Quantum Regulatory Solutions primarily serves small to midsize pharmaceutical companies, offering a range of services beyond just regulatory strategy, including pre-meeting support and long-term pathway planning.
Team Collaboration: Mara emphasized the importance of collaboration within her team, combining their diverse skill sets to provide comprehensive solutions to clients. This collaborative approach sets them apart from others in the field.
Leadership and Empowerment: She mentioned the value of strong leadership and role models who encouraged her to speak up and not apologize for her opinions. This empowerment has been crucial in her career.
Passion for Problem-Solving: What excites Mara is the opportunity to solve complex puzzles in the regulatory space, working closely with various stakeholders to ensure that innovative therapies can navigate the regulatory process successfully.