Spruce Biosciences Strengthens Executive Leadership with Appointment of Rare Disease Expert as Chief Medical Officer
Spruce Biosciences, Inc., a late-stage biopharmaceutical company dedicated to developing innovative therapies for neurological disorders with significant unmet medical need, has announced the appointment of Adrian Quartel, M.D., FFPM, as its new Chief Medical Officer (CMO). Effective immediately, Dr. Quartel joins the company with more than 25 years of global pharmaceutical experience spanning clinical development, regulatory strategy, medical affairs, pharmacovigilance, and the successful commercialization of therapies for rare diseases.
The appointment comes at a critical stage in Spruce Biosciences’ growth strategy as the company advances tralesinidase alfa enzyme replacement therapy (TA-ERT) toward a planned Biologics License Application (BLA) submission to the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2026. The investigational therapy is being developed for Sanfilippo Syndrome Type B (MPS IIIB), a devastating pediatric neurodegenerative disorder that currently has no FDA-approved disease-modifying treatment.
Leadership Expansion Supports Key Regulatory Milestones
Spruce Biosciences believes that strengthening its executive leadership team is essential as it transitions from late-stage clinical development toward potential commercialization. The addition of Dr. Quartel reflects the company’s commitment to bringing experienced pharmaceutical leadership into the organization during this pivotal period.
Throughout his career, Dr. Quartel has played instrumental roles in advancing therapies from early development through regulatory approval and commercial launch. His expertise spans rare genetic diseases, pediatric disorders, enzyme replacement therapies, and neurological conditions—areas that closely align with Spruce’s development priorities.
According to company leadership, his extensive background will help guide regulatory interactions, clinical strategy, medical affairs, and commercialization planning as TA-ERT approaches potential regulatory review.
CEO Highlights Experience in Rare Disease Drug Development
Dr. Javier Szwarcberg, Chief Executive Officer of Spruce Biosciences, emphasized that Dr. Quartel’s experience will be invaluable as the company prepares for its next major milestones.
He noted that the upcoming BLA submission represents one of the most important events in the company’s history and requires leadership with deep expertise in rare disease development and regulatory strategy.
The CEO highlighted that Dr. Quartel has previously helped bring several enzyme replacement therapies to market, giving him firsthand knowledge of the scientific, clinical, and regulatory complexities involved in developing treatments for pediatric genetic disorders.
His experience navigating global regulatory agencies, managing multidisciplinary development programs, and supporting commercial launches is expected to strengthen Spruce’s efforts to deliver a potential new treatment option for families affected by MPS IIIB.
Extensive Industry Experience Across Multiple Biotechnology Companies
Before joining Spruce Biosciences, Dr. Quartel served as Chief Medical Officer at Zevra Therapeutics, where he led clinical development, medical affairs, and regulatory strategy for the company’s portfolio of rare disease therapies.
During his tenure, he helped oversee programs designed to address significant unmet medical needs while supporting regulatory interactions and clinical execution across multiple development stages.
Prior to Zevra Therapeutics, he held the role of Chief Medical Officer at Acer Therapeutics, where he directed medical strategy for rare disease programs and contributed to the advancement of therapies targeting inherited metabolic disorders.
Earlier in his career, Dr. Quartel also served as Chief Medical Officer at Adamas Pharmaceuticals, where he supported neurological disease programs and helped oversee clinical development initiatives.
These executive leadership positions have provided him with extensive experience in:
- Clinical development strategy
- Global regulatory planning
- Medical affairs leadership
- Pharmacovigilance
- Safety monitoring
- Product commercialization
- Cross-functional program management
His broad expertise is expected to benefit Spruce as the company prepares for both regulatory review and potential commercial readiness.
Significant Contributions at BioMarin Pharmaceutical
Among Dr. Quartel’s most notable achievements was his leadership role at BioMarin Pharmaceutical, where he served as Group Vice President of Global Medical Affairs.
During his time at BioMarin, he helped support the successful launch of six therapies for rare diseases and inherited genetic disorders.
These included several landmark enzyme replacement therapies, such as:
- NAGLAZYME®
- VIMIZIM®
- Brineura®
Brineura, in particular, represented a significant advancement for children suffering from a rare pediatric neurodegenerative disease, making Dr. Quartel especially familiar with the challenges associated with developing therapies for disorders affecting the central nervous system.
His experience supporting these launches provided valuable insight into physician education, regulatory engagement, patient advocacy, reimbursement strategy, and post-approval medical support.
Earlier Career Focused on Clinical Development
Before joining BioMarin, Dr. Quartel held senior leadership roles across several international pharmaceutical organizations.
His previous experience includes positions at:
- Astellas
- Chiltern
- ICON Clinical Research
Across these organizations, he directed numerous international clinical programs while overseeing medical governance, trial execution, regulatory compliance, and patient safety.
His work has involved collaboration with investigators, regulatory authorities, healthcare professionals, and patient advocacy organizations across multiple therapeutic areas.
Strong Academic and Professional Credentials
Dr. Quartel earned his medical degree from Erasmus University Medical School in Rotterdam, one of Europe’s leading medical institutions.
He later completed postgraduate specialization in pharmaceutical medicine through the Faculty of Pharmaceutical Medicine, further strengthening his expertise in drug development and regulatory science.
Additionally, he is board-certified in pharmaceutical medicine by the General Medical Council (GMC) in the United Kingdom.
These qualifications complement decades of practical industry experience spanning clinical research, regulatory affairs, safety oversight, and executive leadership.
Focus on Advancing TA-ERT
One of Dr. Quartel’s primary responsibilities at Spruce Biosciences will be overseeing the continued development of tralesinidase alfa enzyme replacement therapy (TA-ERT).
The investigational therapy is designed to treat Sanfilippo Syndrome Type B, also known as Mucopolysaccharidosis Type IIIB (MPS IIIB).
MPS IIIB is a rare inherited lysosomal storage disorder caused by deficiency of the enzyme alpha-N-acetylglucosaminidase. The disease leads to progressive accumulation of cellular waste products, causing severe neurological deterioration.
Children affected by MPS IIIB experience worsening cognitive decline, behavioral abnormalities, developmental regression, and shortened life expectancy.
Currently, there are no FDA-approved disease-modifying therapies available for the condition.
Spruce believes TA-ERT has the potential to become the first approved treatment designed to modify the underlying disease process rather than simply managing symptoms.
Preparing for Regulatory Submission
The company remains on track to submit a Biologics License Application during the fourth quarter of 2026.
Preparation for a BLA requires extensive coordination across clinical development, manufacturing, regulatory affairs, quality systems, pharmacovigilance, and medical affairs.
As Chief Medical Officer, Dr. Quartel will play a central role in integrating these functions while supporting ongoing discussions with regulatory authorities.
His experience leading successful regulatory submissions is expected to strengthen Spruce’s ability to navigate the review process efficiently.
Commitment to the MPS IIIB Community
Commenting on his appointment, Dr. Quartel expressed enthusiasm about joining Spruce during an important period in the company’s evolution.
He described the opportunity to work on TA-ERT as particularly meaningful because children living with MPS IIIB currently have extremely limited treatment options.
He emphasized that the investigational therapy has the potential to become the first disease-modifying treatment for this devastating neurodegenerative condition and stated that he looks forward to working with Spruce’s scientific, clinical, and regulatory teams to bring the therapy closer to patients and families.
He also acknowledged the dedication of patient advocacy groups, caregivers, clinicians, and researchers who have worked for years to advance therapeutic options for Sanfilippo syndrome.
Building for Long-Term Growth
The appointment of Dr. Quartel reflects Spruce Biosciences’ broader strategy of strengthening its organizational capabilities as it moves toward becoming a commercial-stage biotechnology company.
Beyond advancing TA-ERT, the company continues investing in operational infrastructure, regulatory readiness, clinical development expertise, and medical affairs capabilities needed to support future growth.
By assembling an experienced executive leadership team with proven success in rare disease development, Spruce aims to position itself for long-term success while maintaining its focus on delivering innovative therapies for patients with severe neurological disorders.
Inducement Equity Award
In connection with Dr. Quartel’s appointment, Spruce Biosciences granted him 13,000 restricted stock units (RSUs) as an employment inducement award.
The grant was approved by the Compensation Committee of the company’s Board of Directors in accordance with Nasdaq Listing Rule 5635(c)(4), which permits equity awards as an inducement for new employees joining publicly traded companies.
The RSUs will vest over a four-year period, with 25% of the shares vesting annually, subject to Dr. Quartel’s continued employment with the company. The award will be governed by the terms of Spruce Biosciences’ 2026 Inducement Plan and the applicable equity award agreement.
With regulatory preparations accelerating and a potential BLA submission targeted for late 2026, Spruce Biosciences is entering one of the most important periods in its history. The addition of Adrian Quartel as Chief Medical Officer provides the company with seasoned leadership in rare disease drug development, regulatory strategy, and commercialization planning. As TA-ERT advances toward potential approval, Spruce aims to leverage Dr. Quartel’s decades of experience to help bring what could become the first disease-modifying therapy for Sanfilippo Syndrome Type B to patients who currently have no approved treatment options.
About Spruce Biosciences
Spruce Biosciences is a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for neurological disorders with significant unmet medical need. Spruce’s lead product candidate, tralesinidase alfa enzyme replacement therapy (TA-ERT), is in late-stage development for the treatment of mucopolysaccharidoses type IIIB (MPS IIIB), or Sanfilippo Syndrome Type B, a devastating pediatric neurodegenerative disorder for which there are no FDA-approved therapies. TA-ERT has received Breakthrough Therapy Designation, Rare Pediatric Disease Designation, Fast Track Designation and Orphan Drug Designation from the FDA, as well as Orphan Drug Designation in the European Union.