Certified Gene Therapy Pharmacist (CGTP)

CGTP (GNT-001) Exam Objectives

This exam certifies that the candidate possesses the specialized, high-level knowledge required to establish, manage, and lead the provision of gene therapy services within a complex healthcare environment.

Domain 1: Operational and Logistical Management (40%)

• Institutional Readiness: Develop a checklist of operational steps required before the first patient can be treated (e.g., P&T review, SOP development, staff training, site certification).
• Procurement and Handling: Describe the unique ordering, receiving, and inventory management processes for gene therapies, including ultra-cold chain requirements and chain-of-custody documentation.
• "Vein-to-Vein" Coordination: Outline the critical logistical steps required for autologous therapies, from patient cell collection (apheresis) to manufacturing and re-infusion.
• Financial and Reimbursement Navigation: Identify the challenges of billing for high-cost gene therapies and describe strategies for securing reimbursement.

Domain 2: Clinical Management and Patient Care (35%)

• Pre-Treatment Evaluation: Identify necessary pre-treatment screening and laboratory work for specific gene therapies, such as screening for pre-existing anti-AAV antibodies.
• Preparation and Administration: Describe proper thawing, preparation, and administration procedures, including any required pre-medications to mitigate infusion reactions.
• Toxicity Monitoring and Management: Recognize the signs and symptoms of common and severe toxicities (e.g., cytokine release syndrome, neurotoxicity) and outline management strategies.
• Patient Education and Long-Term Follow-up: Counsel patients on the treatment process, potential risks, and the necessity of long-term follow-up through patient registries.

Domain 3: Fundamentals of Gene Therapy (20%)

• Mechanisms of Action: Differentiate between major gene therapy strategies, including gene replacement, gene addition, and gene editing.
• Vector Science: Compare and contrast the characteristics of common viral vectors (e.g., AAV, lentivirus) and non-viral delivery systems.

Domain 4: Regulatory and Ethical Landscape (5%)

• FDA Oversight: Describe the role of Biologics License Applications (BLAs) and Risk Evaluation and Mitigation Strategies (REMS) in the regulation of gene therapies.
• Ethical Considerations: Discuss the ethical challenges unique to gene therapy, including patient selection, cost, and access.

Eligibility Requirements

To be eligible to sit for a CPS certification exam, candidates must meet the criteria outlined in one of the two pathways below.

Pathway 1: For U.S. Licensed Pharmacists

This pathway is for pharmacists licensed to practice within the United States, regardless of country of graduation.

• Hold an active and unrestricted pharmacist license in any state or territory of the United States.
• Meet educational requirements by being a graduate of an ACPE-accredited school of pharmacy or holding a Foreign Pharmacy Graduate Examination Committee® (FPGEC) Certificate.
• Fulfill the specialty experience requirement as outlined below.

Pathway 2: For International Pharmacists (Non-U.S. Licensed)

This pathway is for pharmacists who practice outside of the United States.

• Hold an active and unrestricted license to practice pharmacy in their country of practice. A certified English translation of the license must be provided if the original is not in English.
• Hold a professional degree in pharmacy equivalent to a U.S. pharmacy degree, such as a Bachelor’s degree (BPharm), Master’s degree in Pharmacy Practice (MPharm), or Doctor of Pharmacy degree (PharmD).
• Fulfill the specialty experience requirement as outlined below.

Specialty Experience Requirement (for all pathways)

To ensure candidates have foundational knowledge in the specialty, one of the following criteria must be met:

• Standard Pathway:
  Completion of at least one year of professional experience in a practice setting directly related to the certification area.
• Certificate Pathway:
  The one-year specialty experience requirement is waived for candidates who hold an active certificate of completion from a nationally recognized provider in a related subject matter. This includes, but is not limited to, the completion of a relevant PGY residency, fellowship, certificate/training program, or a relevant graduate degree (e.g., a Master's degree in the specialty field). Recognized providers of certificate programs include, but are not limited to:
  • American Society of Health-System Pharmacists (ASHP)
  • American Pharmacists Association (APhA)
  • American College of Clinical Pharmacy (ACCP)
  • American Society of Consultant Pharmacists (ASCP)

Career Path for CGTP Professionals

The CGTP certification is for pharmacists working at the cutting edge of medicine, typically in academic medical centers, specialized cancer centers, or the biopharmaceutical industry. This is a high-specialization credential that signifies leadership in an emergent and transformative area of healthcare.

Target Candidates

• Oncology pharmacists with experience in cellular therapy (e.g., CAR-T).
• Investigational drug service (IDS) pharmacists who manage gene therapy trials.
• Specialty pharmacists at academic medical centers.
• Pharmacists with fellowship training in oncology or precision medicine.

Primary Job Roles:

• Gene Therapy Program Pharmacist
• Cellular Therapy Clinical Specialist
• Oncology Clinical Pharmacist (with cellular therapy focus)
• Investigational Drug Service Pharmacist
• Medical Science Liaison (Gene/Cell Therapy)

Career Advancement:

A CGTP is uniquely positioned for senior and strategic roles. They can advance to become the Manager or Director of a Cellular Therapy Pharmacy Program, lead clinical development in the biopharmaceutical industry, or serve as a key opinion leader shaping institutional and national policies for these advanced therapies.

Study Resources

Prepare for your CGTP exam with resources designed for this complex and rapidly advancing field.