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Contains 4 Component(s), Includes Credits Includes a Live Web Event on 05/29/2025 at 12:00 PM (EDT)ACCP Clinical Practice Webinars | Cytokine Release Syndrome: Implications in Drug Development - Live
Cytokine release syndrome (CRS) is a life-threatening systemic inflammatory syndrome involving elevated levels of circulating cytokines and immune cell hyperactivation that can be triggered by various therapies, pathogens, cancers, autoimmune conditions and monogenic disorders. Many therapeutics such as cancer immunotherapy (CAR-T, CD3 bispecifics, etc.) can lead to CRS. To mitigate the CRS risk, various approaches were investigated in clinical trials, including priming dosing (step-up dosing, split dosing, dose fractionation, etc.) and premedications. Translational modeling approaches such as mechanistic quantitative systems pharmacology models were also developed to optimize the dose in the clinic to minimize the CRS. In addition, CRS could also result in drug-drug interaction (DDI) risks due to the suppression of CYP enzymes and transporters by the proinflammatory cytokines. Physiologically-based pharmacokinetic approaches have been utilized to assess CRS mediated DDI risks. This activity will focus on the current scientific aspects for CRS and its implications in drug development as well as future perspectives. Learners who complete this activity will have enhanced knowledge utilizing case examples and discussions.
ACCP Clinical Practice Webinars: Cytokine Release Syndrome: Implications in Drug Development - LIVE
Live Session: Thursday, May 29th, 2025, from 12:00 to 1:00 PM ET
On Demand: May 29th, 2025 to May 29th, 2025
Why is this webinar important to your practice?
Cytokine release syndrome (CRS) is a life-threatening systemic inflammatory syndrome involving elevated levels of circulating cytokines and immune cell hyperactivation that can be triggered by various therapies, pathogens, cancers, autoimmune conditions and monogenic disorders. Many therapeutics such as cancer immunotherapy (CAR-T, CD3 bispecifics, etc.) can lead to CRS. To mitigate the CRS risk, various approaches were investigated in clinical trials, including priming dosing (step-up dosing, split dosing, dose fractionation, etc.) and premedications. Translational modeling approaches such as mechanistic quantitative systems pharmacology models were also developed to optimize the dose in the clinic to minimize the CRS. In addition, CRS could also result in drug-drug interaction (DDI) risks due to the suppression of CYP enzymes and transporters by the proinflammatory cytokines. Physiologically-based pharmacokinetic approaches have been utilized to assess CRS mediated DDI risks. This activity will focus on the current scientific aspects for CRS and its implications in drug development as well as future perspectives. Learners who complete this activity will have enhanced knowledge utilizing case examples and discussions.
Target Audience:
Interprofessional team of graduate students, postdoctoral fellows/trainees and professionals in the field of pharmacy, pharmacometrics, clinical pharmacology and clinical pharmacy practice. This activity is applicable to participants across academia, pharmaceutical industry and regulatory agencies interested in expanding their knowledge in cytokine release syndrome.
Learning Objectives
After completing this activity, the learner will be able to:
- Describe the cytokine release syndrome (CRS);
- Discuss the implication of CRS in drug development;
- Explain the utility of modeling approaches for prediction of CRS;
- Describe the utility of modeling approaches for estimating CRS mediated DDI.
Yanke Yu
Distinguished Scientist
Genentech Inc/Roche
Dr. Yanke Yu, is a distinguished scientist of clinical pharmacology in Genentech Inc. Prior to Genentech, Dr. Yu held positions in Pfizer Inc. and Eisai Inc. Dr. Yu has a wealth of experience in clinical pharmacology, and modeling and simulation. Following a 13+ year industry career, Dr. Yu contributed to multiple products regulatory approvals in both oncology and immunology. Prior to his industry career, Dr. Yu completed his Ph.D. in Pharmaceutical Sciences at the University of Michigan. Dr. Yu is a prolific publisher, with 39 peer-reviewed articles and 50+ abstracts/posters/oral presentations.
Benjamin Colton (Moderator)
Section Chief, Clinical Pharmacy Specialists
National Institutes of Health
Dr. Colton received his Doctor of Pharmacy from Drake University before completing a postdoctoral fellowship in Infectious Diseases Pharmacotherapy at the University of Illinois at Chicago. In 2015, Dr. Colton joined the NIH Clinical Center's Pharmacy Department. As the Infectious Diseases and Immunology Clinical Pharmacy Specialist, Dr. Colton collaborates with NIAID Intramural Research Program Clinical Investigators on the design, implementation, conduct, and interpretation of early phase clinical trials. His contributions to this translational research include proctocol study design, dose selection, dose modification, risk management strategies, and pharmacometric approaches and analysis. Current collaborations include research evaluating immunomodulating therapies for patients with primary immunodeficiencies and autoinflammatory disorders and optimizing antimicrobial therapy for fungal and mycobacterial disease. Further, Dr. Colton maintains a clinical practice at the NIH Clinical Center, leveraging his expertise to support the pharmacotherapy needs of these unique patient populations. Collectively, these collaborations and patient care advance the knowledge and understanding of the complexity of the immune system, the interface between host immunity and pathogen, and pioneering interventions to modulate these complex interactions to improve the health of patients with primary immunodeficiencies, autoinflammatory conditions, disseminated fungal and mycobacterial infections, and their accompanying complications.
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Contains 20 Component(s), Includes Credits
The American College of Clinical Pharmacology® monthly journal article continuing education offerings from The Journal of Clinical Pharmacology.
Registration and Pricing
The American College of Clinical Pharmacology® (ACCP) offers a monthly article from the The Journal of Clinical Pharmacology (JCP) for continuing education credit. See the CE Info tab for more information on credits. The ACCP JCP Journal CE articles are priced and packaged for January through December of the same calendar year. Packages are available at no cost to ACCP Members and $75/calendar year to Non-members. Once registered, learners have access to all of the Journal CE articles for the calendar year as the articles are released.
To register, log into your ACCP online profile and then register by clicking the green Register button at the top right. Follow the online prompts to complete the registration process and to receive your registration confirmation. If you do not have an ACCP profile, one must be created before you can register for the Journal CE articles. If you do not know if you have a profile, please contact INFO@ACCP1.org for further information to avoid creating duplicate profiles. Please address all other questions to CE@ACCP1.org.
Requirements for Credits
All requirements for claiming CE credits are listed in the CE Info (Handout) tab. Continuing education credits and certificates must be claimed within 30-days of completing the monthly article offering. Continuing Pharmacy Education (CPE) data is uploaded into the CPE Monitor at the end of each month. The pharmacist's NABP# and MMDD of birth must be updated in their ACCP Profile or emailed to CE@ACCP1.org in order to have CPE credits uploaded to the CPE Monitor.
CE Expiration 12/31/2028
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Contains 5 Component(s), Includes Credits
Learners that complete this webinar will gain knowledge about a First-in-Class drug with a novel mechanism of action. SP-624 (generic name forvisirvat) is a small molecule activator of the sirtuin (SIRT) 6 enzyme. SIRT6 is a NAD+ dependent histone deacetylase and is believed to be the first activator of the enzyme tested in human clinical trials. It is currently being assessed in a Phase 2b/3 study for the treatment of major depressive disorder. The webinar presents data from single ascending dose and multiple ascending dose studies conducted in healthy male and female subjects. The safety, tolerability and pharmacokinetics after single multiple doses of forvisirvat will be reviewed.
2025 ACCP Virtual Journal Club Webinar: Safety, Tolerability & Pharmacokinetics of Oral Doses of the Sirtuin 6 Activator SP-624 - ON DEMAND
Live Session: Tuesday, March 18th, 2025, from 12:00 to 1:00 PM ET
On Demand: March 18th, 2025 to March 18th, 2028
Why is this webinar important to your practice?
Learners that complete this webinar will gain knowledge about a First-in-Class drug with a novel mechanism of action. SP-624 (generic name forvisirvat) is a small molecule activator of the sirtuin (SIRT) 6 enzyme. SIRT6 is a NAD+ dependent histone deacetylase and is believed to be the first activator of the enzyme tested in human clinical trials. It is currently being assessed in a Phase 2b/3 study for the treatment of major depressive disorder. The webinar presents data from single ascending dose and multiple ascending dose studies conducted in healthy male and female subjects. The safety, tolerability and pharmacokinetics after single multiple doses of forvisirvat will be reviewed.
Target Audience:
Interprofessional team of Physicians, Pharmacists, PhDs and other health care professionals, including Clinical Pharmacologists and Allied Health Services, who are involved or interested in the dosing of Sirtuin 6 Activator SP-624.
Learning Objectives
After completing this activity, the learner will be able to:
- Describe the pharmacokinetics of SP-62;
- Identify key characteristics of dose estimation via ascending dose response of Sirtuin 6 Activator;
- Describe the safety assessments based on the adverse events, serious adverse events and treatment emergent adverse events (TEAEs) of Sirtuin 6 Activator;
- Discuss the use of pharmacokinetics in early drug development.
Vatsalya Vatsalya (Moderator)
Assistant Professor of Medicine
Univ of Louisville
Dr. Vatsalya is an Assistant Professor of Medicine in the Department of Medicine at the University of Louisville in the Division of Gastroenterology, Hepatology and Nutrition. He is also affiliated with the VA Robley Rex Medical Ctr as a clinical scientist. Dr. Vatsalya is trained as a physician, but his primary role is research and support for patients with their mental health conditions. He is an addiction specialist, licensed in addiction and mental health in Kentucky. He is a PI on medication trials on AUD, funded both institutionally and federally, including the National Inst of Health. During his fellowship, he developed and validated the food-alcohol task, which is used widely in human neural-mechanistic-treatment studies (disease, and non-treatment-seeking cohorts). He has developed novel clinical paradigms to study treatment efficacy in various patient populations. Dr. Vatsalya has a novel drug registered with the US Patent and Trademark Office for the treatment of AUD-ALD as a dual-target therapy, licensing efforts and phase I preparation have been initiated. Notably, he was also in a group of addiction investigators that developed the WHO's ICD 11 code for alcohol hangover conditions. He has an independent clinical research lab and has several clinical publications in high-impact, prestigious-ranking national and international journals. He mentors several clinical trainees and clinical and non-clinical students.
Greg Rigdon
Senior Vice President, Scientific Affairs
Arrivo Bioventures LLC
Dr. Greg Rigdon is Senior Vice President of Scientific Affairs at Arrivo Bioventures LLC. Dr. Rigdon’s drug development experience includes discovery through Phase 4 clinical trials and his regulatory experience includes IND and NDA filings. He has over 30 years experience in the industry from running a neuropharmacology laboratory at Burroughs Wellcome to managing clinical development teams at Glaxo Wellcome and Icagen to serving as a clinical pharmacology consultant. He has experience in multiple therapeutic areas: psychiatry, neurology, sickle cell disease, preeclampsia and multiple GI indications. In his current role he manages the nonclinical aspects of drug development, interacts with regulatory authorities and designs clinical trials.
Dr. Rigdon has authored/co-authored over 30 journal articles in pharmacology, neuroscience and clinical research. He is also an inventor with multiple patents and has guest lectured at the University of North Carolina at Chapel Hill, North Carolina State University and Campbell University. Greg earned his PhD in Pharmacology from Texas Tech University Health Sciences Center in 1985.
William Wargin
Pharmacokineticist
Sirtsei Pharmaceuticals Inc
Dr. Wargin has over 20 years of experience as a pharmacokineticist, having worked with 60+ small and large pharmaceutical companies developing drugs in several therapeutic areas including CNS, oncology, anti-viral, cardiovascular and metabolic disease. In this context, he has worked in nonclinical drug development including in vitro and in vivo metabolism and pharmacokinetics. During Phase 1 development, he participated in design and implementation of clinical pharmacology studies from First-in-Human to bioequivalence studies for new formulations post-approval, partnered with CROs for protocol development, review and study conduct, and provided pharmacokinetic and PK/PD data analysis of data and report writing. Dr. Wargin has written several nonclinical ADME/PK sections of IND submissions and clinical pharmacology sections of NDAs in CTD format and has participated in 10+ pre-IND meetings in various therapeutic areas.
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Contains 1 Component(s)
Position Yourself for Success by Perfecting Your Clinical Pharmacology Skillset - ON DEMAND WEBINAR
2025 ACCP STEP & ESP Webinar: Position Yourself for Success by Perfecting Your Clinical Pharmacology Skillset
Live webinar: February 26, 2025 from 1:00 - 2:30 PM ET
On-demand webinar recording: February 26, 2025 to February 26, 2028
Target audience:
Student, Trainee & Early-stage Professional colleagues defining their career paths or considering a change in careers that may require an assessment of their skillset.
Objectives
After completing this activity, the learner will be able to:
1. Identify specific skill sets essential to your career path;
2. Navigate resources to supplement current experiences;
3. Strategize on building a professional and mentoring network;
4. Adopt a lifelong learning mindset to stay current in the field.
Description:
Student, Trainee & Early-stage Professional colleagues defining their career paths or considering a change in careers will benefit from this webinar that elucidates the skills required across the spectrum of academic, industry, clinical, regulatory or consulting careers. Hear from established experts in the field as they share their experiences and knowledge as leaders in the field and hiring managers about what skills are desirable to achieve not only your next position but long-term success. Panel discussions will be followed by a Question & Answer period.
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Contains 48 Component(s), Includes Credits
The American College of Clinical Pharmacology® monthly journal article continuing education offerings from The Journal of Clinical Pharmacology.
Registration and Pricing
The American College of Clinical Pharmacology® (ACCP) offers a monthly article from the The Journal of Clinical Pharmacology (JCP) for continuing education credit. See the CE Info tab for more information on credits. The ACCP JCP Journal CE articles are priced and packaged for January through December of the same calendar year. Packages are available at no cost to ACCP Members and $75/calendar year to Non-members. Once registered, learners have access to all of the Journal CE articles for the calendar year as the articles are released.
To register, log into your ACCP online profile and then register by clicking the green Register button at the top right. Follow the online prompts to complete the registration process and to receive your registration confirmation. If you do not have an ACCP profile, one must be created before you can register for the Journal CE articles. If you do not know if you have a profile, please contact INFO@ACCP1.org for further information to avoid creating duplicate profiles. Please address all other questions to CE@ACCP1.org.
Requirements for Credits
All requirements for claiming CE credits are listed in the CE Info (Handout) tab. Continuing education credits and certificates must be claimed within 30-days of completing the monthly article offering. Continuing Pharmacy Education (CPE) data is uploaded into the CPE Monitor at the end of each month. The pharmacist's NABP# and MMDD of birth must be updated in their ACCP Profile or emailed to CE@ACCP1.org in order to have CPE credits uploaded to the CPE Monitor.
CE Expiration 12/31/2027
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Contains 5 Component(s), Includes Credits
This presentation incorporates the use of Model-Informed Drug Development (MIDD) approaches to address the unique challenges in drug development and regulatory decision-making for patients with obesity. Given the high prevalence of obesity in the general population, it is essential to identify appropriate drug development strategies with optimal dosing for this patient group. However, the unique physiological and pathological characteristics of the obese population may present hurdles in clinical development programs. This presentation will provide an overview of the impact of obesity on pharmacokinetics, pharmacodynamics and the efficacy of drugs and, more importantly, demonstrate how MIDD approaches are applied at various stages of drug development and regulatory review for patients with obesity, with a focus on dosing regimen optimization, through case studies from recent submissions.
2024 ACCP Virtual Journal Club Webinar: Model-Informed Approaches to Support Drug Development for Patients With Obesity: A Regulatory Perspective - On Demand
Live Session: Wednesday, October 30th, 2024, from 1:00 to 2:00 PM ET
On Demand: October 30th, 2024 to October 30th, 2027
Why is this webinar important to your practice?
This presentation incorporates the use of Model-Informed Drug Development (MIDD) approaches to address the unique challenges in drug development and regulatory decision-making for patients with obesity. Given the high prevalence of obesity in the general population, it is essential to identify appropriate drug development strategies with optimal dosing for this patient group. However, the unique physiological and pathological characteristics of the obese population may present hurdles in clinical development programs. This presentation will provide an overview of the impact of obesity on pharmacokinetics, pharmacodynamics and the efficacy of drugs and, more importantly, demonstrate how MIDD approaches are applied at various stages of drug development and regulatory review for patients with obesity, with a focus on dosing regimen optimization, through case studies from recent submissions.
Target Audience:
Interprofessional team of MDs, PhDs, PharmDs and other health care professionals, including students, trainees and professionals at all levels, who are involved or interested in drug development for patients with obesity.
Learning Objectives
After completing this activity, the learner will be able to:
- Describe the impact of obesity on drug pharmacokinetics, pharmacodynamics and efficacy;
- Identify the unique challenges and opportunities in drug development for patients with obesity;
- Recognize the utility of model-informed drug development in facilitating clinical trial design and regulatory decision-making in patients with obesity.
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Contains 2 Component(s)
Clinical Pharmacology Considerations for ADCs & Bispecific Antibodies - ON DEMAND
2024 ACCP STEP & ESP Webinar: Clinical Pharmacology Considerations for ADCs & Bispecific Antibodies
Live webinar: October 2, 2024 from 12:00 - 1:00 PM ET
On-demand webinar recording: October 2, 2024 to October 2, 2027
Target audience:
Interprofessional team of MDs, PhDs, PharmDs including Students, Trainees and all levels of professionals seeking an introduction the biological principles and clinical pharmacology considerations for antibody-drug conjugates and bispecific antibodies.
Learning Objectives
After completing this activity, the learner will be able to:
1. Understand the mechanism of actions of ADCs and bispecific antibodies;
2. Apply clinical pharmacology principles in different stages of the development of novel therapeutics;
3. Leverage model-informed drug development approaches in the dose optimization of novel therapeutics;
4. Identify the opportunities and challenges for dose optimization trials.Description:
Attendees of all experience levels will receive a practical introduction to the exciting modalities of antibody-drug conjugates (ADCs) and bispecific antibodies. ADCs and bispecifics represent new frontiers in immunotherapy and are generating massive interest from prescribers and pharmaceutical companies alike. This webinar, presented by two experts in the spaces of ADCs and bispecifics, will provide a conceptual foundation of the two modalities and how they differ from traditional antibody therapeutics. In the meantime, ADCs and bispecifics also bring novel challenges in drug development. The clinical pharmacology considerations for evaluating the two modalities, including model-informed approaches and dose optimization, will be discussed and illustrated with case studies.
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Contains 5 Component(s), Includes Credits
This study explores innovative methods to predict body fat content using easily measurable anthropometric variables like age, height, weight and waist circumference instead of relying on the expensive and less accessible dual-energy x-ray absorptiometry (DXA) scanning. This research is crucial as it provides an improved and validated algorithm for predicting absolute body fat, which can enhance clinical practices related to obesity management. Understanding these new predictive methods can directly impact practice, especially considering the critical role that body composition plays in pharmacokinetics and pharmacodynamics. Efficient and accurate body fat estimation methods are essential for optimizing drug dosing and therapeutic strategies in obese patients, thereby improving treatment outcomes and patient care. Learners that complete this activity will be provided an evidence-based, validated and predictive algorithm as an alternative to DXA scanning to accurately estimate absolute body fat.
2024 ACCP Virtual Journal Club Webinar: Estimation of Absolute and Relative Body Fat Content Using Noninvasive Surrogates: Can DXA Be Bypassed?
Live Session: Wednesday, June 26th, 2024, from 12:00 to 1:00 PM ET
On Demand: June 26th, 2024 to June 26th, 2027
Why is this article important to your practice?
This study explores innovative methods to predict body fat content using easily measurable anthropometric variables like age, height, weight and waist circumference instead of relying on the expensive and less accessible dual-energy x-ray absorptiometry (DXA) scanning. This research is crucial as it provides an improved and validated algorithm for predicting absolute body fat, which can enhance clinical practices related to obesity management. Understanding these new predictive methods can directly impact practice, especially considering the critical role that body composition plays in pharmacokinetics and pharmacodynamics. Efficient and accurate body fat estimation methods are essential for optimizing drug dosing and therapeutic strategies in obese patients, thereby improving treatment outcomes and patient care. Learners that complete this activity will be provided an evidence-based, validated and predictive algorithm as an alternative to DXA scanning to accurately estimate absolute body fat.
Target Audience:
Interprofessional team of Physicians, Pharmacists, PhDs, Nurse Practitioners and other health care professionals who use the assessment of body fat content in clinical trials and clinical practice.
Learning Objectives
After completing this activity, the learner will be able to:
- Describe at least one limitation to the use of DXA scanning for obesity clinical trials and/or drug development;
- Identify at least one DXA-determined measurement that was selected as a dependent (outcome) variable in this study;
- List at least one surrogate variable that was predictive of DXA-determined absolute body fat;
- Identify which surrogate variable had the greatest impact (i.e., magnitude of change) on DXA-determined total body fat in men and women utilizing standardized regression coefficient data.
David J. Greenblatt, MD
Professor
Tufts Univ School of Medicine
David J. Greenblatt, M.D.
Louis Lasagna Endowed Professor, Tufts University School of Medicine.
A native of Newton, Massachusetts, Dr. Greenblatt is a Magna Cum Laude graduate of Amherst College (1966). He graduated from Harvard Medical School in 1970, then trained in internal medicine at the Montefiore Hospital, New York City (1970-1971), and on the Harvard Medical Service at Boston City Hospital (1971-1972). Following a Fellowship in Clinical Pharmacology at Massachusetts General Hospital, under the mentorship of Dr. Jan Koch-Weser (1972-1974), he stayed on to head their Clinical Pharmacology Unit (1975-1979).
Dr. Greenblatt has been on the Faculty of Tufts University School of Medicine (TUSM) and the Staff of Tufts Medical Center (TMC) since 1979. He is a senior faculty member in the Graduate Program in Pharmacology & Drug Development, and has previously served as Chair of the Department of Pharmacology and Experimental Therapeutics at TUSM, Program Director and Associate Program Director of the institution’s Clinical/Translational Research Center, and Chair of the Institutional Review Board. He has received many awards and honors over his career, including the Distinguished Investigator Award from the American College of Clinical Pharmacology, and the Oscar B. Hunter Career Achievement Award from the American Society for Clinical Pharmacology and Therapeutics
There are no relevant financial relationships to disclose.
Joseph Ma, PharmD
Professor, Clinical Pharmacy
Univ of California San Diego, Skaggs School of Pharmacy & Pharmaceutical Sciences
Joseph D. Ma, PharmD, FCP is Professor in the Division of Clinical Pharmacy at the Skaggs School of Pharmacy and Pharmaceutical Sciences, Univ of California San Diego. He is also the faculty director of the Drug Development and Product Management Master’s Program at UC San Diego. He received his pharmacy degree from Univ of California San Francisco and completed a clinical pharmacology fellowship at Bassett Healthcare, Cooperstown, NY. His research interests are evaluating in vivo drug metabolizing enzyme activity in the context of drug-drug interactions and opioid pharmacokinetic variability. His current clinical practice is the Doris A. Howell Pain and Palliative Care Service at the Univ of California San Diego Moores Cancer Center. Under a collaborative practice agreement he is able to initiate, stop, and/or adjust therapy for the management of pain and other physical symptoms associated with cancer and/or chemotherapy.
There are no relevant financial relationships to disclose.
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Contains 2 Component(s)
Defining Your Journey: The Path to Professional Growth & Leadership-LIVE WEBINAR
2024 ACCP STEP & ESP Webinar: Defining Your Journey: The Path to Professional Growth & Leadership
Live webinar: June 13, 2024 from 1:00 - 2:30 PM ET
On-demand webinar recording: June 13, 2024 to June 13, 2027
Target Audience:
Student, Trainees & Early-stage Professionals interested in developing their leadership and professional growth as they transition into full-time careers.
Learning Objectives
After completing this activity, the learner will be able to:
1. Identify key elements of effective leadership styles;
2. Practice interpersonal skills to achieve effective communication;
3. Demonstrate how to inspire others to action to achieve common objectives;
4. Employ resources and prioritize time to achieve milestones toward the stated objectives.
Kacey Anderson
Director, Clinical Pharmacology
Terns Pharmaceuticals Inc
Kacey Anderson, PhD, is Director of Clinical Pharmacology at Terns Pharmaceuticals. Prior to Terns, Dr. Anderson was a Director of Clinical Pharmacology at EQRx International and prior to that she was at Gilead Sciences in clinical pharmacology. Dr. Anderson has worked on programs from early stage (IND filing and development plan) through approval, including being primary author on multiple m2.7.2’s in both US and ex-US submissions in inflammation and oncology disease areas. She has more than eight years of industry experience which includes designing and leading a variety of Phase 1 studies as well as supporting Phase 2 and Phase 3 studies. Dr. Anderson earned her PhD in Pharmaceutical Sciences from the University of Pittsburgh and holds a Bachelor of Science in Chemistry from St. Lawrence University. She is a Fellow of the American College of Clinical Pharmacology (ACCP) and has served on numerous committees and initiatives within ACCP.
Navin Goyal
Senior Director and Group Lead
Janssen Research & Development, LLC
Navin Goyal is a Senior Director and Therapy Area Lead in the Clinical Pharmacology and Pharmacometrics (CPP) Group at Janssen Pharmaceuticals, New Jersey. Dr. Goyal joined ACCP as a student in 2007, has been a Fellow since 2016, currently serves on the Board of Regents and is Treasurer for ACCP. He was the 2021 ACCP Annual Meeting Co-Chair. He has also chaired scientific symposia and presented at previous Annual Meetings.
Dr. Goyal graduated from the Department of Pharmaceutics in College of Pharmacy at University of Florida, Gainesville. After graduation, he worked in the Clinical Pharmacology, Modeling and Simulation group at GSK. At Janssen, Dr. Goyal is the CPP head of cardiovascular, metabolism, retinal, pulmonary hypertension and neuroscience therapy areas. In this role, he is responsible for applying quantitative clinical pharmacology principles and approaches across all phases of drug development spanning from early clinical studies through registration. He has published his research in clinical pharmacology and pharmacometrics across multiple therapy areas including respiratory, CNS, cardiovascular and infectious diseases. Apart from his day job, Dr. Goyal continues to mentor student interns, post-doctoral fellows and scientists within his group at Janssen and through external collaborations.
Zaid Temrikar
Clinical Pharmacologist
Gilead Sciences
Zaid Temrikar works as a clinical pharmacologist at Gilead Sciences supporting early and late stage assets within Immunology and Oncology portfolio in Foster City, CA. He completed his PhD from UTHSC in Memphis TN working on PK/PD of anti-infectives. He has held many leadership positions such as part of inaugural ACCP leadership cohort, student president of ISoP and president of AAPS student chapter. He has also been a part of ACCP STEP and ACCP Annual Meeting Program Committee.
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Contains 2 Component(s)
Defining Your Journey: The Path to Professional Growth & Leadership-LIVE WEBINAR
2024 ACCP STEP & ESP Webinar: Defining Your Journey: The Path to Professional Growth & Leadership
Live webinar: June 13, 2024 from 1:00 - 2:30 PM ET
On-demand webinar recording: June 13, 2024 to June 13, 2027
Target Audience:
Student, Trainees & Early-stage Professionals interested in developing their leadership and professional growth as they transition into full-time careers.
Learning Objectives
After completing this activity, the learner will be able to:
1. Identify key elements of effective leadership styles;
2. Practice interpersonal skills to achieve effective communication;
3. Demonstrate how to inspire others to action to achieve common objectives;
4. Employ resources and prioritize time to achieve milestones toward the stated objectives.
Kacey Anderson
Director, Clinical Pharmacology
Terns Pharmaceuticals Inc
Kacey Anderson, PhD, is Director of Clinical Pharmacology at Terns Pharmaceuticals. Prior to Terns, Dr. Anderson was a Director of Clinical Pharmacology at EQRx International and prior to that she was at Gilead Sciences in clinical pharmacology. Dr. Anderson has worked on programs from early stage (IND filing and development plan) through approval, including being primary author on multiple m2.7.2’s in both US and ex-US submissions in inflammation and oncology disease areas. She has more than eight years of industry experience which includes designing and leading a variety of Phase 1 studies as well as supporting Phase 2 and Phase 3 studies. Dr. Anderson earned her PhD in Pharmaceutical Sciences from the University of Pittsburgh and holds a Bachelor of Science in Chemistry from St. Lawrence University. She is a Fellow of the American College of Clinical Pharmacology (ACCP) and has served on numerous committees and initiatives within ACCP.
Navin Goyal
Senior Director and Group Lead
Janssen Research & Development, LLC
Navin Goyal is a Senior Director and Therapy Area Lead in the Clinical Pharmacology and Pharmacometrics (CPP) Group at Janssen Pharmaceuticals, New Jersey. Dr. Goyal joined ACCP as a student in 2007, has been a Fellow since 2016, currently serves on the Board of Regents and is Treasurer for ACCP. He was the 2021 ACCP Annual Meeting Co-Chair. He has also chaired scientific symposia and presented at previous Annual Meetings.
Dr. Goyal graduated from the Department of Pharmaceutics in College of Pharmacy at University of Florida, Gainesville. After graduation, he worked in the Clinical Pharmacology, Modeling and Simulation group at GSK. At Janssen, Dr. Goyal is the CPP head of cardiovascular, metabolism, retinal, pulmonary hypertension and neuroscience therapy areas. In this role, he is responsible for applying quantitative clinical pharmacology principles and approaches across all phases of drug development spanning from early clinical studies through registration. He has published his research in clinical pharmacology and pharmacometrics across multiple therapy areas including respiratory, CNS, cardiovascular and infectious diseases. Apart from his day job, Dr. Goyal continues to mentor student interns, post-doctoral fellows and scientists within his group at Janssen and through external collaborations.Zaid Temrikar
Clinical Pharmacologist
Gilead Sciences
Zaid Temrikar works as a clinical pharmacologist at Gilead Sciences supporting early and late stage assets within Immunology and Oncology portfolio in Foster City, CA. He completed his PhD from UTHSC in Memphis TN working on PK/PD of anti-infectives. He has held many leadership positions such as part of inaugural ACCP leadership cohort, student president of ISoP and president of AAPS student chapter. He has also been a part of ACCP STEP and ACCP Annual Meeting Program Committee.
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