American College of Clinical Pharmacology

American College of Clinical Pharmacology (ACCP) is a non-profit membership association with a 40+ year history of providing exceptional interdisciplinary,

Founded in 1969 by a group of eminent physicians, the College today consists of a full spectrum of healthcare professionals who remain dedicated to advancing clinical pharmacology with the goal of providing exceptional patient care. As an organization whose primary role is education, the College does not concentrate on any one aspect of the discipline. Rather, the College seeks to address the educational needs of its diverse membership and all healthcare professionals, covering a range of topics that span the entire area of the interaction between drugs and humans. These areas include, but are not limited to, pharmaceutical chemistry, biochemistry, drug metabolism, pharmacokinetics, pharmacodynamics, pharmacometrics, pharmacogenomics, clinical pharmacology practice in the outpatient and inpatient settings, human toxicology, drug interactions, and clinical drug trials. The diversity of the College is expressed not only in the composition of its membership, but also in its leadership. Maintaining a balance of elected Regents and Officers from all pertinent professional backgrounds ensures that the College remains attuned to the needs of all professionals engaged in the practice of or with a strong interest in clinical pharmacology, from the research laboratory (academic and industrial) to the classroom, and from the clinical trial to improved patient care.

American College of Clinical Pharmacology (ACCP) is a non-profit membership association with a 40+ year history of providing exceptional interdisciplinary, accredited Continuing Education programs, publications, networking and other career-enhancing opportunities to a wide spectrum of health care professionals using clinical pharmacology in disciplines from research to patient care.

Mission: Vision & Mission To improve health by optimizing therapeutics. Provide innovative leadership and interdisciplinary education that will enable the generation, integration and translation of scientific knowledge to optimize research, development and utilization of medication for the benefit of all.

Maximal Usage Trials for Topically Applied Active Ingredients Being

FDA Announces Availability of a Final Guidance, “Maximal Usage Trials for Topically Applied Active Ingredients Being Considered for Inclusion in an Over-the-Counter Monograph: Study Elements and Considerations”

On May 9, 2019, the U.S. Food and Drug Administration (FDA) announced the availability of a final guidance for industry entitled "Maximal Usage Trials for Topically Applied Active Ingredients Being Considered for Inclusion in an Over-the-Counter Monograph: Study Elements and Considerations."

A Maximal Usage Trial (MUsT) is a standard approach to assess the in vivo bioavailability of topical drug products intended for local therapeutic effects. Information from a MUsT can help identify the potential for systemic exposure to a topically applied active ingredient and inform an FDA determination of whether additional safety data are needed to support a finding that a topical over-the-counter (OTC) drug containing that active ingredient is generally recognized as safe and effective (GRASE) for its intended use. This guidance outlines FDA’s recommendations for designing and conducting a MUsT for this purpose, including critical study elements, data analysis, and considerations for special topic areas (e.g., pediatrics, geriatrics).

A critical safety consideration for topical drugs is whether applying the drug to the skin results in dermal penetration and systemic exposure to the active ingredient, and, if so, to what extent. This information helps identify potential safety concerns and helps determine whether an adequate safety margin exists for an active ingredient to be included in a relevant OTC monograph. To assess an active ingredient proposed for use in any topical drug product under the OTC monograph system, the underlying goal of the MUsT is to evaluate systemic exposure levels under conditions relevant to real-world use that maximize the potential for dermal absorption. Accordingly, the conduct of a MUsT should be consistent with maximal use of the product as specified by existing or anticipated labeling. An example of a MUsT was recently published in the May 6, 2019, Journal of the American Medical Association, in which Matta et al. describe the results of an exploratory MUsT evaluating the systemic absorption of sunscreen active ingredients using four commercially available sunscreen products applied under maximal use conditions.1 In this pilot study, all four active ingredients tested were absorbed from each formulation tested, demonstrating that absorption of sunscreens is not just a theoretical safety concern.

The FDA recognizes that more than one study design can provide this information and that many factors can influence the specific approach to be used. Study sponsors should seek FDA’s input on the formulations to be tested and other proposed study elements prior to conducting the MUsT.

The "Maximal Usage Trials for Topically Applied Active Ingredients Being Considered for Inclusion in an Over-the-Counter Monograph: Study Elements and Considerations" final guidance is available at http://bit.ly/2PWXnyr. Please refer to the final guidance for more details. This guidance represents the current thinking of the FDA on this topic. It does not establish any rights for any person and is not binding on FDA or the public. An alternative approach can be considered if it satisfies the requirements of the applicable statutes and regulations.

1. Matta MK, Zusterzeel R, Pilli NR, et al. Effect of sunscreen application under maximal use conditions on plasma concentration of sunscreen active ingredients: a randomized clinical trial [published May 6, 2019]. JAMA. doi:10.1001/jama.2019.5586. http://bit.ly/2Q6qmjL

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🌟 Join us for a Unique Hands-on Pre-meeting Workshop on Pharmacogenomics at the 2019 ACCP Annual Meeting (#2019ACCP)!

Interprofessional Education in Pharmacogenomics, an ACCP/AACP Jointly-sponsored Workshop
Saturday, September 14th
1:30 – 5:30 PM ET

This hands-on Workshop is sponsored by Genemarkers LLC and provides attendees with the opportunity to submit a sample to receive blinded, personal genetic testing reports included in the registration fee for the Workshop.

A panel of outstanding Faculty Speakers will share information on how to:

1. Identify resources related to healthcare provider competencies in pharmacogenomics;
2. Identify the pharmacogene(s) of interest to be evaluated for specific patient cases;
3. Interpret pharmacogene genotyping results relative to drug/drug dose selection for specific patient cases and
4. Describe a decision-making process integrating current pharmacogenomic guidelines and information.

Supply is limited - don’t miss this opportunity to submit a sample and receive blinded, personal testing reports for your use in the Workshop!

Register today! http://bit.ly/2Jnn3QT

Student, Trainee & Early-stage Professional Events | #2019ACCP

ACCP Annual Meeting STEP-specific events include a Welcome Breakfast, a Panel Discussion on Career Guidance, a Networking Reception, Podium Presentations and CV Reviews.

Be sure to check out the Symposium on Sept 15th, "Communicating Your Science: An Integrated Scientific Writing Symposium & Workshop for Early-stage Professionals & Trainees", which focuses on skills that are critical to writing excellent scientific manuscripts.

Register today to secure your spot: http://bit.ly/ACCPAM

www.accessdata.fda.gov

*FDA Approves SKYRIZI (risankizumab-rzaa) for the Treatment of Moderate-to-Severe Plaque Psoriasis in Adults who are Candidates for Systemic Therapy or Phototherapy*

On April 23, 2019, the U.S. Food and Drug Administration (FDA) approved SKYRIZI (risankizumab-rzaa) for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. The approved recommended dosage of SKYRIZI is 150 mg (two 75 mg injections) administered by subcutaneous injection at Week 0, Week 4, and every 12 weeks thereafter.

SKYRIZI may increase the risk of infections. Treatment with SKYRIZI should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated. Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with SKYRIZI. Do not administer SKYRIZI to patients with active TB. Avoid use of live vaccines in patients treated with SKYRIZI. Additional information regarding these warnings and precautions can be found in the full prescribing information linked below.

Mechanism of Action (MOA) and Pharmacokinetics (PK)

• MOA: Risankizumab-rzaa is a humanized immunoglobulin G1 (IgG1) monoclonal antibody that selectively binds to the p19 subunit of human interleukin 23 (IL-23) cytokine and inhibits its interaction with the IL-23 receptor. Risankizumab-rzaa inhibits the release of pro-inflammatory cytokines and chemokines.

• General PK: Risankizumab-rzaa plasma concentrations increased dose-proportionally from 90 to 180 mg and from 18 to 300 mg (0.06 to 1.2 and 0.12 to 2.0 times the approved recommended dosage) following subcutaneous administration in subjects with plaque psoriasis and healthy subjects, respectively. Steady-state concentrations were achieved by Week 16. At the 150 mg dose, the estimated steady-state peak concentration (Cmax) and trough concentration (Ctrough) were approximately 12 mcg/mL and 2 mcg/mL, respectively.

• Absorption: The absolute bioavailability of risankizumab-rzaa was estimated to be 89%. Cmax was reached by 3-14 days.

• Distribution: The estimated steady-state volume of distribution (inter-subject CV%) was 11.2 L (34%).

• Elimination: The estimated systemic clearance (inter-subject CV%) was 0.31 L/day (24%) and terminal elimination half-life was approximately 28 days.

• Metabolism: The metabolic pathway of risankizumab-rzaa has not been characterized. As a humanized IgG1 monoclonal antibody, risankizumab-rzaa is expected to be degraded into small peptides and amino acids via catabolic pathways in a manner similar to endogenous IgG.

• Immunogenicity: By Week 52, approximately 24% (263/1079) of subjects treated with SKYRIZI at the recommended dose developed antibodies to risankizumab-rzaa. Of the subjects who developed antibodies to risankizumab-rzaa, approximately 57% (14% of all subjects treated with SKYRIZI) had antibodies that were classified as neutralizing. Higher antibody titers in approximately 1% of subjects treated with SKYRIZI were associated with lower risankizumab-rzaa concentrations and reduced clinical response.

Use in Specific Populations

No clinically significant differences in the pharmacokinetics of risankizumab-rzaa were observed based on age (≥ 18 years). No specific studies have been conducted to determine the effect of renal or hepatic impairment on the pharmacokinetics of risankizumab-rzaa.

Risankizumab-rzaa clearance and volume of distribution increase and plasma concentrations decrease as body weight increases; however, no dose adjustment is recommended based on body weight.

Drug Interactions

Risankizumab-rzaa has no clinically significant effect on the pharmacokinetics of drugs metabolized by cytochrome P450 (CYP)1A2, CYP2C9, CYP2C19, CYP2D6, or CYP3A when used concomitantly.

Efficacy and Safety

Efficacy of SKYRIZI was demonstrated in multicenter, randomized, double-blind studies that enrolled subjects 18 years of age and older with moderate to severe plaque psoriasis. Additional information regarding efficacy trials can be found in the full prescribing information linked below.

The most common adverse reactions (≥ 1%) are upper respiratory infections, headache, fatigue, injection site reactions, and tinea infections.
________________________________________
Full prescribing information is available at http://bit.ly/2POc6vN.

accessdata.fda.gov

The Journal of Clinical Pharmacology - May 2019, Vol 59, Issue 5 is now available!

*Editor's Choice: Review*
4β‐Hydroxycholesterol as an Endogenous Biomarker for CYP3A Activity: Literature Review and Critical Evaluation
Scott R. Penzak PharmD, Carlos Rojas‐Fernandez PharmD
Pages: 611-624 | First Published: 12 February 2019

*Review*
Accelerating Drug Development in Pediatric Oncology With the Clinical Pharmacology Storehouse
Mohamad Shebley PhD, Rajeev M. Menon PhD, John P. Gibbs PhD, Nimita Dave PhD, Su Y. Kim MD, PhD, Patrick J. Marroum PhD
Pages: 625-637 | First Published: 18 December 2018

*Continuing Education: Review*
Accurate Prediction of Initial Busulfan Exposure Using a Test Dose With 2‐ and 6‐Hour Blood Sampling in Adult Patients Receiving a Twice‐Daily Intravenous Busulfan‐Based Conditioning Regimen
Jingjing Huang MS, Ziwei Li MS, Wu Liang PhD, Bing Chen PhD, Jiong Hu MD, PhD, Wanhua Yang MS
Pages: 638-645 | First Published: 04 December 2018

*Therapeutics*
Simplification of Imipenem Dosing by Removal of Weight‐Based Adjustments
Mallika Lala PhD, Michelle Brown BS, Bhavna Kantesaria MS, Brittany Walker MS, Amanda Paschke MD, MSCE, Matthew L. Rizk PhD
Pages: 646-653 | First Published: 11 December 2018

*Pediatric Pharmacology*
Pharmacokinetics, Safety, and Tolerability of Single‐Dose Intravenous Moxifloxacin in Pediatric Patients: Dose Optimization in a Phase 1 Study
Heino Stass PhD, John Lettieri PhD, Konstantina M. Vanevski MD, Stefan Willmann PhD, Laura P. James MD, Janice E. Sullivan MD, Antonio C. Arrieta MD, John S. Bradley MD
Pages: 654-667 | First Published: 25 January 2019

Population Pharmacokinetic Analysis of Decitabine in Pediatric Patients With Acute Myeloid Leukemia
Wangda Zhou PhD, Dolly A. Parasrampuria PhD, Sepideh Nemat MD, PhD, Susumu Nakahara MD, Italo Poggesi PhD, Joseph Massarella PhD, Liping Zhang PhD, Carlos Appiani MD
Pages: 668-676 | First Published: 11 December 2018

*Pharmacokinetics/Pharmacodynamics*
Safety, Tolerability, and Pharmacodynamics of Intrathecal Injection of Recombinant Human HGF (KP‐100) in Subjects With Amyotrophic Lateral Sclerosis: A Phase I Trial
Hitoshi Warita MD, PhD, Masaaki Kato MD, PhD, Ryuta Asada PhD, Atsuko Yamash*ta PhD, Daichika Hayata, Kiichi Adachi PhD, Masashi Aoki MD, PhD
Pages: 677-687 | First Published: 11 December 2018

Pharmacokinetics, Pharmacodynamics, and Safety of E6011, a Novel Humanized Antifractalkine (CX3CL1) Monoclonal Antibody: A Randomized, Double‐Blind, Placebo‐Controlled Single‐Ascending‐Dose Study
Hiroko Tabuchi MS, Toshinori Katsurabara MS, Masahiko Mori BS, Muneo Aoyama MS, Takashi Obara PhD, Nobuyuki Yasuda PhD, Tetsu Kawano MD, PhD, Toshio Imai PhD, Ichiro Ieiri PhD, Yuji Kumagai MD, PhD
Pages: 688-701 | First Published: 21 December 2018

*Pharmacokinetics*
Development of a Subcutaneous Fixed‐Dose Combination of Pertuzumab and Trastuzumab: Results From the Phase Ib Dose‐Finding Study
Whitney P. Kirschbrown PharmD, PhD, Chris Wynne MB, ChB, FRANZCR, Matts Kågedal PhD, Russ Wada PhD, Hanbin Li PhD, Bei Wang MSc, Ihsan Nijem MS, Tanja Badovinac Crnjevic MD, PhD, Helena Gasser RN, gDipPH, PgDip PhV, Sarah Heeson BSc, Jennifer Eng‐Wong MD, MPH, Amit Garg PhD, FCP
Pages: 702-716 | First Published: 19 December 2018

A Phase 1 Randomized Study of Single Intravenous Infusions of the Novel Nitroxyl Donor BMS‐986231 in Healthy Volunteers
Douglas Cowart PharmD, FABCP, RAC, Robert P. Venuti BA, Kim Lynch RN, BSN, Jeffrey T. Guptill MD, MA, MHS, Robert J. Noveck MD, PhD, FACEP, CPI, Shi Yin Foo MD, PhD, MMSc
Pages: 717-730 | First Published: 31 January 2019

*Physiologically Based Pharmacokinetic Modeling*
Physiologically Based Modeling Approach to Predict Dopamine D2 Receptor Occupancy of Antipsychotics in Brain: Translation From Rat to Human
Yin Cheong Wong PhD, Maddalena Centanni MS, Elizabeth C. M. de Lange PhD
Pages: 731-747 | First Published: 24 January 2019

*Pharmacometrics*
Population Pharmacokinetics and Exposure‐Response Analyses for CPX‐351 in Patients With Hematologic Malignancies
Qi Wang PhD, Kamalika Banerjee MS, Grygoriy Vasilinin PhD, J.F. Marier PhD, Jacqueline A. Gibbons PhD
Pages: 748-762 | First Published: 19 December 2018

Population Pharmacokinetic Analyses and Model Validation of Tolvaptan in Subjects With Autosomal Dominant Polycystic Kidney Disease
Shankar Lanke PhD, Susan E. Shoaf PhD
Pages: 763-770 | First Published: 07 January 2019

*Letter to the Editor*
Running Out of Time: Facilitating Off Label Approval in Cancer Treatment
Alberto A. Mendivil MD, Julie A. Chad RN, Bram H. Goldstein PhD
Pages: 771-772 | First Published: 07 March 2019

http://bit.ly/2tOl1Ue #ACCPJCP

ACCP is pleased to announce the 2019 ACCP Recognition Award Winners!

These distinguished individuals were selected by the ACCP Honors & Awards Committee based on outstanding contributions to the global clinical pharmacology community as noted in the criterion for each award. The awardees will be honored during the 2019 ACCP Annual Meeting, September 15th - 17th, in Chicago, IL. Congratulations to all the award winners and we look forward to recognizing you for your achievements!

*ACCP Distinguished Investigator Award*
Julie A. Johnson, PharmD – Dean & Distinguished Professor, Univ of Florida, Coll of Pharmacy

*ACCP Honorary Fellowship Award*
Amarnath Sharma, MPharm, PhD – Vice President, Global Head, Clinical Pharmacology & Pharmacometrics, Janssen R&D

*Nathaniel T. Kwit Memorial Distinguished Service Award*
Peter Wiernik, MD – President, Cancer Research Fdtn

*McKeen Cattell Memorial Award*
James Truong, PharmD – Clinical Pharmacy Coordinator of Infectious Diseases, Brooklyn Hosp Ctr

*Bristol-Myers Squibb Mentorship in Clinical Pharmacology Award*
Guenther Hochhaus, PhD – Professor, Univ of Florida Coll of Pharmacy

*Roger Jelliffe Individualized Therapy Award*
Diane R. Mould, PhD, FCP, FAAPS – President, Projections Research Inc

View award winner details here: http://bit.ly/2J6aB7o
#2019ACCP

📣 Don't Forget to Visit the Pharmacometrics Web-based Learning Resource!

The ACCP Student, Trainee & Early-stage Professional Committee and the University of Maryland School of Pharmacy Ctr for Translational Medicine worked diligently to bring us this new Pharmacometrics web-based learning resource. The content offers a beginner's guide to pharmacometric theory, modeling and application. Be sure to check it out! http://bit.ly/2P0PfQq

ACCP "Excellence in Achievement" - Eman Biltaji, RPh, MSc, PhD

ACCP is pleased to recognize Eman Biltaji, RPh, MSc, PhD, Post Doctoral Research Associate, Division of Clinical Pharmacology, Dept of Pediatrics, School of Medicine, Univ of Utah. Since joining ACCP, Eman has been heavily involved with the society. She is currently serving on the Student, Trainee & Early-stage Professional (STEP) Committee, co-managing the STEP Mentoring Program and presented a Poster at the 2017 ACCP Annual Meeting.

After obtaining an MSc in Clinical Pharmacy and BSc in Pharmacy from Jordan Univ of Science & Technology, she received a PhD in Pharmacotherapy Outcomes Research & Health Policy at the Univ of Utah. Throughout her education, Dr. Biltaji received multiple awards, certificates and scholarships. She successfully completed her fellowship in March 2019 and looks forward to pursuing her first full-time professional position.

Dr. Biltaji’s research focuses on evaluating pharmacogenetic and pharmacogenomic information and how it can be used to personalize treatment decisions. The main objective of her research is to assess various outcomes when incorporating this information into clinical practices across patient populations. She is trying to integrate her clinical knowledge with her research focus to answer clinically relevant questions. Dr. Biltaji is a burgeoning scholar whose research interests started when she was working as a clinical pharmacist, preceptor and lecturer at the Dept of Clinical Pharmacy, Jordan Univ of Science & Technology, Jordan.

Dr. Biltaji shared her thoughts on what ACCP membership means to her: “Joining ACCP shifted my professional career in the right direction on many perspectives. From a research perspective, ACCP provides an excellent platform to learn about the latest research ideas in the field, whether it is through reviewing newsletters and updates or attending educational webinars and the ACCP Annual Meetings. I had the chance to present my research project and receive valuable feedback given by leaders in the field. From a professional perspective, ACCP offers endless opportunities to advance my career through the ACCP Mentoring Program, various committee activities, postings at the ACCP Job Center or networking at the ACCP Annual Meetings. On a personal perspective, I learned a lot from my professional interactions with ACCP Members and Staff, a very supportive community which is always willing to help. I am very grateful I have been introduced to ACCP by my mentors, Dr. Catherine Sherwin and Dr. Jonathan Constance. I consider ACCP an integral part of my professional identity and would encourage other Members to become more involved with the society to get the maximal benefits from their membership.”

Congratulations, Dr. Biltaji, on being recognized for your outstanding achievements and contributions to ACCP!

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ACCP is a member-driven/member-focused organization that provides accredited continuing education to healthcare professionals. ACCP also publishes The Journal of Clinical Pharmacology and will soon publish the eJournal Clinical Pharmacology in Drug Development.
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