| S2. Episode 5: Will Patients’ Absorption be Impacted by PPIs and, if So, How? How Well do We Predict These Phenomena Using PBPK? |
Jennifer Dressman
Eva Gil Berglund, PhD
Domagoj Segregur, PhD
Xinning Yang, PhD
Diansong Zhou, PhD |
Physiologically Based Pharmacokinetic Modeling and Simulation (PBPK) of absorption-related issues is an area of great present and future potential. Drug interactions with modulators of gastric potential of hydrogen (pH), also called as acid-reducing agents (ARAs, such as PPIs, H2 blockers, antacids), is of concern for orally administered drugs having a pH sensitive solubility. PBPK simulations could be used to inform internal decision making on allowed comeds in clinical studies. It could also be used in regulatory applications, either alone or combined with other data/analysis in totality of evidence approaches. The recently finalized US Food & Drug Administration guidance on gastric pH change-mediated drug-drug interactions (DDI) (i.e., pH-DDI) when used with ascending reticular activating systems (ARAs) mentions PBPK as an alternative approach and encourages consultation with the agency. This podcast addresses questions which were posed during a webinar initially presented on January 29, 2024, by the PBPK Community. |
| S.2 Episode 4: Impact of Organ Impairment on Pharmacokinetics of Therapeutic Proteins |
Yow-Ming Wang, PhD, FDA
Christine Hon, PharmD, FDA
Qin Sun, PhD, FDA |
<This episode is part of a multi-episode series regarding the impact of organ impairment on pharmacokinetics of therapeutic proteins and peptides, hosted by ASCPT Biologics Community and ASCPT Regulatory Science Community. Regarding the impact of organ impairment on therapeutic proteins, the current FDA guidance has some recommendation for renal impairment, but limited information for hepatic impairment. The mechanism and the impact of organ impairment on the PK of therapeutic proteins could be very different compared to small molecules, especially for hepatic impairment which could lead to decreased exposure of therapeutic proteins compared to increased exposure of small molecules. In addition, there are lots of unique considerations for a specific type of therapeutic proteins (e.g., mAb, ADC, growth hormone). This podcast will provide expert opinions about mechanisms, examples, and scientific considerations for evaluating the impact of renal and hepatic impairment on PK of therapeutic proteins. The knowledge will help facilitate the development of therapeutic proteins and enhance rational dose recommendation in patients with renal and hepatic impairment. |
| S2. Episode 3: Impact of Organ Impairment on Pharmacokinetics of Therapeutic Peptides |
Raajan Naik, PharmD, FDA
Elimika Pfuma Fletcher, PharmD, PhD, FDA
Lin Zhou, PhD, FDA |
This episode is part of a multi-episode series regarding the impact of organ impairment on pharmacokinetics of therapeutic proteins and peptides, hosted by ASCPT Biologics Community and ASCPT Regulatory Science Community. Regarding the impact of organ impairment on therapeutic peptides, their impact has been inconsistently studied. This is likely due to an expectation of a lower likelihood of impact due to alternate pathways of metabolism compared to the small molecules and the larger size of peptides. In general, elimination pathways differ for small molecules and peptides. Peptides can exhibit adsorption, distribution, metabolism, and elimination (ADME) characteristics that are, in some cases, similar to small molecules, while in some cases to therapeutic proteins. In addition, the complexity of peptides has increased over the years with a goal of increasing stability and improving the ADME characteristics, e.g., the use of modified or synthetic AAs. Series 2 podcast will provide expert opinions about mechanisms, interesting examples, and scientific considerations for evaluating the impact of renal and hepatic impairment on PK of therapeutic peptides. The knowledge will help facilitate the development of therapeutic peptides and enhance rational dose recommendation in patients with renal and hepatic impairment. |
| S.2 Episode 2: Supporting Clinical Development from the Lens of a QSP Modeler |
Tu Mai, PhD, Genentech
Monica Susilo, PhD, Genentech |
In this podcast, Biologics Steering Committee member Tu Mai, PhD (Genentech), will be interviewing Monica Susilo, PhD (Genentech). Monica Susilo is a senior scientist at Genentech in the CP department, specialized in QSP modeling. She is supporting a variety of TDB oncology programs. On the podcast, Monica will share with us her experience in utilizing QSP models to support early clinical development. |
| S2 Episode 1: Journeys and Visions of Leaders in Clinical Pharmacology |
Neeraj Gupta, PhD, Takeda Pharmaceuticals
Hao Zhu, PhD, Division of Pharmacometrics, FDA |
The ASCPT PMK (pharmacometrics and pharmacokinetics) community will be hosting a new multipart series within the ASCPT Catalyst Podcast. In this first episode of the series Dr. Neeraj Gupta interviews Dr. Hao Zhu regarding his expertise in MIDD and his visions for the future of pharmacometrics. Join us to hear important lessons Dr. Zhu has learned in his career and his advice for early-career scientists and students. *Recorded June 2023 |
| Episode 24: A Great Story Can Make All the Difference: Why ASCPT is the Society of Choice for Top Member Advocates |
Shravani Etrouth, PharmD, Jawaharlal Nehru Technological University
Pradeep Lukka, PhD, AstraZeneca |
Join recent Top Member Advocates Shravani Etrouth, PharmD, and Pradeep Lukka, PhD, as they discuss how they learned about ASCPT and decided to join, why they choose to share their membership stories and refer colleagues, and how they leveraged ASCPT membership to their advantage to enhance their professional development. |
| Episode 23: Road to University of Cincinnati’s Online Pharmacogenomics Degree Program. |
Lisa Infelise, Senior Director, Member Services (ASCPT)
Carrie Hoefer, PhD, Director of Pharmacogenomics & Assistant Professor of Pharmaceutical Sciences (University of Cincinnati)
Alex Driscoll (University of Cincinnati) |
The University of Cincinnati’s Masters of Pharmaceutical Sciences: Pharmacogenomics and Personalized Healthcare program offers a unique opportunity for students to gain in-depth knowledge about Pharmacogenomics and understand the effects of genomics, environment, patient-specific factors on drug response, allowing for individualized therapy and optimal clinical outcomes. This episode was sponsored by University of Cincinnati. Listen to the episode. |
| Episode 22: Continuing the Conversation: Improving the Efficiency of Drug Development Through Clinical Data Leveraging |
Hazem Hassan, PhD, Regeneron Pharmaceuticals
Shamir Kalaria, PharmD, PhD, University of Maryland
Islam R. Younis, PhD, Gilead Sciences Inc. |
Join Islam Younis, PhD, and Shamir Kalaria, PharmD, PhD, as they address audience questions not able to be addressed during their recently presented webinar in June 2021, Improving the Efficiency of Drug Development Through Clinical Data Leveraging: A Clinical Pharmacology Success Story in Schizophrenia. Interviewer Hazem E. Hassan, PhD, continues the conversation with the panelists on extrapolation, the value of large databases in improving the efficiency of drug development, and how this has been applied in schizophrenia drug development. |
| Episode 21: Evolution of mechanistic model-informed drug development and consulting Part 2 with Keroles Nakhla and Karen Rowland Yeo |
Keroles Nakhla, BSc – Rutgers University
Karen Rowland Yeo, PhD – Certara |
Moderated by Student/Trainee member, Keroles Nakhla, BSc (Rutgers University), in part two of this two-part series, Karen Rowland Yeo, PhD (Certara) gives her opinion on the most challenging and rewarding aspects of consulting, takes you through the latest trends in mechanistic modeling, provides insight on what it’s like to work at a small vs. large company and details how modeling and simulation can help to combat the COVID-19 pandemic. This episode was sponsored by Certara. |
| Episode 20: Evolution of mechanistic model-informed drug development and consulting Part 2 with Keroles Nakhla and Karen Rowland Yeo. |
Keroles Nakhla, BSc – Rutgers University
Karen Rowland Yeo, PhD – Certara
|
Moderated by Student/Trainee member, Keroles Nakhla, BSc (Rutgers University), in part two of this two-part series, Karen Rowland Yeo, PhD (Certara) gives her opinion on the most challenging and rewarding aspects of consulting, takes you through the latest trends in mechanistic modeling, provides insight on what it’s like to work at a small vs. large company and details how modeling and simulation can help to combat the COVID-19 pandemic. This episode was sponsored by Certara. |
| Episode 19: ASCPT Pets with Paul Malik |
Paul Malik, PharmD, University of Waterloor |
Paul Malik, PharmD, (University of Waterloo) discusses his two cats and Lord of the Rings! Paul is a 2020 ASCPT Presidential Trainee and an ASCPT member. Check out Paul’s work at www.oovi.org or follow him on twitter @prvmalik! |
| Episode 18: ASCPT Musician Series – Adam Cohen |
Adam Cohen, MD, PhD, Director Innovation Services (InnoS), Professor emeritus of Clinical Pharmacology, Centre for Human Drug Research |
Moderated by Diana Tsuji, (ASCPT), ASCPT musician Adam Cohen, MD, PhD, (Centre for Human Drug Research) discusses string instruments and how playing can make you a better scientific presenter! Be sure to check out Adam’s recommended Spotify playlist for some Clarinet for clinical pharmacologists! |
| Episode 17: "Full House": Balancing Kids and Work During COVID-19 with Alethea Gerding and Alaina Webster |
Alethea Gerding, ASCPT Managing Editor
Alaina Webster, ASCPT Deputy Managing Editor |
Moderated by Diana Tsuji, (ASCPT), Alethea Gerding and Alaina Webster discuss balancing work, kids, school, and expectations during the COVID-19 pandemic. Alethea and Alaina are both members of the ASCPT Journals Department. |
| Episode 16: Entrepreneurship and Consulting in Clinical Pharmacology and Pharmacometrics Part 2 |
Patrick Smith, PharmD, Certara
Emily Cicali, PharmD, University of Florida |
Moderated by Early Career Community member Emily Cicali, PharmD (University of Florida), Patrick Smith, PharmD (Certara) discusses the ample opportunities for small biotech companies that has arisen from changes in regulations. This episode is a great listen for anyone interested in pursuing opportunities in consulting! |
| Episode 15: Entrepreneurship and Consulting in Clinical Pharmacology and Pharmacometrics Part 1 |
Patrick Smith, PharmD, Certara
Emily Cicali, PharmD, University of Florida |
Moderated by Early Career Community member Emily Cicali, PharmD (University of Florida), Patrick Smith, PharmD (Certara) discusses the risks and rewards with entrepreneurship in the field of clinical pharmacology and pharmacometrics. Patrick talks honestly about the mistakes made early on and the differing needs of team members who are starting a business in varying stages of life. |
| Episode 14: "Full House": Balancing Kids and Work During COVID-19 with Josh Peterson |
Josh Peterson, MD (Vanderbilt University) |
Josh Peterson, MD (Vanderbilt University Medical Center) discusses what it is like to parent older children during a pandemic with some living at home and some living on a college campus. Josh is the 2020 recipient of the Malle Jurima-Romet Mid-Career Leadership Award at ASCPT as well as a working parent to three boys. |
| Episode 13: ASCPT Musician Series - Sarah Holstein |
Sarah Holstein, MD, PhD, University of Nebraska Medical Center
Matthew Brooks, DMA, University of Nebraska Omaha
Mary Perkinson, DMA, University of Nebraska Omaha |
Moderated by Diana Tsuji, CHES, (ASCPT), ASCPT musician Sarah Holstein, MD, PhD (University of Nebraska Medical Center), Matthew Brooks, DMA, (University of Nebraska Omaha), and Mary Perkinson, DMA (University of Nebraska Omaha) talk about the inspiration behind the Nebraska Medical Orchestra, nerves when performing, and music’s connection to health and wellbeing. |
| Episode 12: "Full House": Balancing Kids and Work During COVID-19 with Antoinette Ajavon-Hartmann |
Antoinette “Toni” Ajavon-Hartmann, PhD |
Moderated by Diana Tsuji, (ASCPT), Antoinette “Toni” Ajavon-Hartmann, PhD (Bayer AG) discusses transitioning from maternity leave to full-time work in Germany during the COVID-19 pandemic. Toni is a member of the 2020-2021 ASCPT Scientific Program Committee, a Vice Chair for the Oncology Community, and mother to a 1-year old. |
| Episode 11: ASCPT Musician Sereis - Andy Stein |
Andy Stein, PhD, Novartis Pharmaceuticals |
Moderated by Diana Tsuji, (ASCPT), PKPD modeler and musician Andy Stein, PhD (Novartis Pharmaceuticals) discusses music, patterns, and the legendary Shark Banana!
Check out a preview of the episode. |
| Episode 10: ASCPT Webinar Committee |
Eric Masson, PharmD
Bianca van Groen, PharmD, PhD |
Moderated by Diana Tsuji, (ASCPT), ASCPT Webinar Committee Chair Eric Masson, PharmD (Biogen) and Webinar Committee member Bianca van Groen, PharmD, PhD (Roche) talk about best practices for submitting a webinar to ASCPT. Submit your webinar today! |
| Episode 9: Gender Gap in Publishing |
Deanna Kroetz, PhD, University of California San Francisco
Alethea Gerding, ASCPT Managing Editor |
Deanna Kroetz, PhD, (University of California San Francisco) and Alethea Gerding (ASCPT) discuss the gender gap in publishing as a result of the COVID-19 pandemic. ASCPT has gathered some anecdotal evidence that suggests men are submitting more papers for publication during the quarantine than women. In this podcast Deanna and Alethea discuss the fear that female professors will be scrutinized when reviewed for tenure in the future.
Check out a preview of the episode. |
| Episode 8: ASCPT Musician Series - Greg Kearns and Sander Vinks |
Greg Kearns, PharmD, PhD
Sander Vinks, PharmD, PhD |
Moderated by Diana Tsuji, CHES, (ASCPT), ASCPT musicians Greg Kearns, PharmD, PhD, (Texas Christian University) and Sander Vinks, PharmD, PhD, (Cincinnati Children’s Hospital) talk about the intersection between science and music, the importance of practice, what inspires them, and how to get started!
Greg plays the piano, trumpet, & mandolin. Sander plays the bassoon, guitar, & recorder.
Check out a preview of the episode. |
| Episode 7: Network and Community Volunteerism |
Ryan Funk, PharmD, PhD, University of Kansas Medical Center
Lisa Infelise, ASCPT Senior Director of Member Services |
Moderated by Diana Tsuji, CHES, (ASCPT), Quantitative Pharmacology Network Chair Ryan Funk, PharmD, PhD (University of Kansas Medical Center) and Lisa Infelise (ASCPT) talk about up-and-coming volunteer opportunities for ASCPT members.
Check out a preview of the episode. |
| Episode 6: The Complexity of Developing Therapeutics for COVID-19 Webinar Q&A |
Gauri Rao, PharmD
Prabha Fernandes, PhD |
Moderated by Dr. Gauri Rao (UNC at Chapel Hill), speaker Dr. Prabha Fernandes answers all follow-up questions from the ASCPT webinar " The Complexity of Developing Therapeutics for COVID-19 Webinar" originally aired on June 15, 2020. Dr. Fernandes has over 35 years of experience in pharmaceutical discovery, development and management and is a member of the NIH working group for the therapeutics and vaccines for COVID-19. If you would like to view the original webinar, please visit the Online Library. Members will need to be logged in to access the webinar library.
Check out a preview of the episode. |
| Episode 5: ASCPT Career Center Micro-Recruitment Session with Certara Webinar Q&A |
Lisa Infelise, ASCPT Senior Director of Member Services
Julie Bullock, Vice President, Integrated Drug Development
Emily Cox, Director, Talent Acquisition from Certara |
Moderated by Lisa Infelise, (ASCPT), speakers Julie Bullock, PharmD, (Certara) and Emily Cox, (Certara) answer follow-up questions from the ASCPT webinar "ASCPT Career Center Micro-Recruitment Session with Certara Webinar Q&A" originally aired on June 11, 2020. If you would like to view the original webinar, please visit the Online Library. Members will need to be logged in to access the webinar library. Visit the Career Center to find more opportunities! |
| Episode 4: Meet the Career Development Committee: Sonya Tang Girdwood and Jon Wagner |
Sonya Tang Girdwood, MD, PhD
Jonathan Wagner, DO |
Moderated by Diana Tsuji, CHES, (ASCPT), new Career Development Committee members Sonya Tang Girdwood, MD, PhD (Cincinnati Children’s Hospital) and Jonathan Wagner, DO (Children's Mercy Hospital) talk about Kansas City Chiefs, career development, the use of Twitter as a tool, and the joys of fishing!
Check out a preview of the episode. |
| Episode 3: Drug Development for COVID-19 - A Clinical Pharmacology Perspective Webinar Q&A |
Matthew Rizk, PhD, ASCPT Board of Directors
Su-Young Choi, PhD
Vikram Arya, PhD |
Moderated by Matthew Rizk, PhD, (Merck Pharmaceuticals), speakers Su-Young Choi, PhD, (FDA), and Vikram Arya, PhD (FDA) answer follow-up questions from the ASCPT webinar "Drug Development for COVID-19 - A Clinical Pharmacology Perspective" originally aired on May 4th, 2020. Members can access the original webinar in the Online Library.
Check out a preview of the episode. |
| Episode 2: Racial Inequality in Academic Medicine |
Tamorah Lewis, MD, Board Member |
ASCPT Board of Directors member Tamorah Lewis, MD, PhD (Children’s Mercy Hospital) advocates for black women in academic medicine through her article on racial inequality, “The Burden of Having Ears That Can Hear.” In this episode, she encourages clinical pharmacologists and translational scientists to combat racism through ongoing education, conversation, and the use of Association of American Medical Colleges’ (AAMC) Anti-racism in Medicine Collection.
Check out a preview of the episode. |
| Episode 1: Diversity at Scientific Meetings |
Kathryn Momary, PharmD, SPC Chair |
SPC Chair Kathryn Momary, PharmD (Mercer University, discusses the Society's goals for diversity in terms of speaker demographics, education strategies, and poster design. Importantly, Kathryn offers insight on how the SPC will look for sessions that will work well on a virtual platform, use of the Poster 2.0 format, and the importance of avoiding "manels."
Check out a preview of the episode. |
| Episode 0: Welcome to ASCPT Catalyst |
Susan Abdel-Rahman, PharmD, ASCPT President
Sharon Swan, FASAE, CAE, ASCPT CEO |
Sue Rahman, PharmD (Children's Mercy Hospital) and Sharon Swan FASAE, CAE (ASCPT) launch ASCPT's new podcast: ASCPT Catalyst!
Check out a preview of the episode. |