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A Call to the Forefront: Seeking SMEs in Advanced Clinical Practice & Investigational Drug Services
Charting the Leading Edge of Pharmacy Practice
The practice of pharmacy is in a perpetual state of forward motion, constantly pushing into new and complex territories. Today, the leading edge of this evolution is found at the intersection of clinical care, pioneering research, and novel therapeutics. This is the world of specialty pharmaceuticals, biologics, gene therapies, and the rigorous clinical trials that bring these innovations to patients. Pharmacists are not just participants in this new frontier; they are essential navigators, ensuring the safe, effective, and ethical use of the most advanced treatments in modern medicine.
As pharmacy practice continues to expand into these highly specialized and high-stakes domains, the standards that define professional excellence must evolve in lockstep. The Council on Pharmacy Standards (CPS) is committed to ensuring that our certification programs always reflect the most current and advanced roles within the profession.
To that end, we are officially embarking on the development of our next generation of specialty certifications. To build these new programs with the unimpeachable authority and real-world relevance they require, we must collaborate with the trailblazers and foremost experts in these fields. Today, we are launching a special, targeted Call for Subject Matter Experts (SMEs) to help us define the future of Advanced Clinical Practice and Investigational Drug Services.
Why Now? The Mandate to Standardize New Frontiers
This new development initiative is a direct and proactive response to the most powerful trends shaping modern healthcare. The era of the blockbuster small-molecule drug is giving way to a new age of highly targeted, complex, and often costly therapies. This shift presents a host of new challenges and demands a new level of expertise from the pharmacists who manage them.
Our research and environmental scanning have identified three critical areas where the need for a national, evidence-based standard of competence has become undeniable:
The Explosion of Specialty Pharmaceuticals: The pipeline of specialty drugs for rare and complex diseases continues to expand, requiring pharmacists to have deep knowledge of unique administration, monitoring, and reimbursement pathways.
The Growing Complexity of Clinical Trials: As more novel agents move through the development pipeline, academic medical centers and other research institutions are conducting a greater number of complex clinical trials, demanding specialized skills from Investigational Drug Service (IDS) pharmacists.
The Expanding Role of Pharmacists in Industry: The pharmaceutical and biotech industries are increasingly relying on the clinical and scientific expertise of pharmacists in key roles such as Medical Science Liaisons (MSLs) and regulatory affairs specialists.
This Call for SMEs is our first and most important step in building the rigorous, credible certification programs that will serve these advanced and expanding areas of practice.
We Are Seeking Your Expertise in Three Critical Domains
We are recruiting a select, national panel of experts with deep, hands-on experience in the following highly specialized domains. If your career is defined by the challenges and responsibilities described below, we invite you to lend your expertise.
Domain 1: Advanced Specialty Pharmacy Practice
This domain focuses on the comprehensive management of high-cost, high-touch medications for patients with complex, rare, or chronic conditions. We are seeking experts from fields such as solid organ transplant, oncology, rheumatology, multiple sclerosis, and rare diseases. Your expertise should include navigating complex prior authorization and reimbursement landscapes for specialty drugs, managing patient support and assistance programs, and providing advanced clinical monitoring and counseling for patients on novel therapeutics, including biologics and gene therapies. This work will directly inform the development of our upcoming Certified Advanced Specialty Pharmacist (CASP) credential.
Domain 2: Clinical Trials and Investigational Drug Services (IDS)
This domain is dedicated to the unique operational and clinical challenges of managing investigational drugs within a research setting. We are seeking leaders from established Investigational Drug Services who possess a deep, working knowledge of Good Clinical Practice (GCP) and FDA regulations governing clinical trials (21 CFR Part 312). Your expertise should cover the entire lifecycle of an investigational product within an institution, including study protocol review and feasibility assessment, managing complex randomization and blinding procedures, meticulous inventory control and accountability, and the specialized compounding and preparation of study drugs. This panel will be instrumental in building the new Certified Clinical Trials Pharmacist (CCTP) and Certified Investigational Drug Services Pharmacist (CIDSP) programs.
Domain 3: Medical and Regulatory Affairs in the Pharmaceutical Industry
This domain addresses the unique roles pharmacists play within the pharmaceutical, biotech, and medical device industries. We are seeking experienced professionals who can provide insight into the competencies required for success in these roles. We are looking for experts in Medical Affairs, including Medical Science Liaisons (MSLs) and medical information specialists, who are skilled in communicating complex scientific data to healthcare providers. We are also seeking experts in Regulatory Affairs, who understand the drug approval process, FDA regulations on drug promotion and labeling, and the management of post-marketing surveillance and REMS programs. Your contributions will be foundational to the new Certified Medical Affairs Pharmacist (CMAP) and Certified Regulatory Affairs Specialist (CRAS) certifications.
The Role of a High-Level SME: Defining the Gold Standard
Serving as a CPS SME for these advanced programs is a high-impact professional service. You will not just be writing questions; you will be a founding architect of the national standard in your highly specialized field. Working alongside our staff psychometricians, you will:
Participate in a formal Job Task Analysis to define the scope of practice.
Help construct the examination blueprints that will guide the content of the new certifications.
Write, review, and validate complex, case-based examination questions that test the advanced clinical judgment and decision-making skills required for expert-level practice.
For the Nation’s Leading Experts: Why Volunteer?
We recognize that your time is exceptionally valuable. We believe that contributing to this process offers a unique and compelling value proposition for a national leader in your field. This is your opportunity to:
Shape Your Niche: Be a part of the definitive group that codifies the body of knowledge for your specialty on a national scale.
Collaborate with Your True Peers: Join a select, national panel of the foremost experts in your specific domain, creating an unparalleled opportunity for high-level networking and collaboration.
Cement Your Legacy: This is a chance to make a lasting contribution that will elevate your specialty and influence the profession for years to come.
Eligibility and Application Process
Due to the advanced and specialized nature of these forthcoming certifications, the eligibility criteria for this SME call are stringent.
Experience: We are seeking nationally recognized experts with a minimum of seven (7) to ten (10) years of focused experience in one of the specific domains listed above.
Advanced Training/Recognition: Completion of a relevant PGY2 residency or fellowship, a significant record of publications, and a history of presenting at national conferences are highly desirable.
If you meet these qualifications and are passionate about defining the future of your specialty, we invite you to apply. Please visit our volunteer portal to submit your detailed Curriculum Vitae (CV) and a Letter of Interest outlining your specific expertise. The deadline for applications is December 1, 2023.
If you are practicing at the leading edge of the pharmacy profession, we invite you to help us define it. Lend your expertise and build the future standard of advanced practice.
The Department of Volunteer Engagement, Council on Pharmacy Standards (CPS)
