A round-up of notable events and conferences for CAPKR members in spring 2024.

OGD/OCP

Amin’s visit to OGD/OCP on 8th March 2024 to give an update to FDA colleagues on several ongoing projects (mainly sponsored by FDA) and have Q&A session related to general aspects of PBPK modelling in regulatory submissions. One of the subject for discussion is related to the differences between the EMA and FDA.

ISSX Workshop

The 2nd ISSX Workshop, “Quantitative LC-MS/MS Proteomics: Methodology and Applications in Translational DMPK/PD and Precision Medicine,” was held in person on June 27-28, 2024, at the Certara Offices in Sheffield, UK. The session chaired by Prof. Amin Rostami and delivered by several CAPKR members and alumni including Dr. Jill Barber, Dr. Zubida Al Majdoub, Dr. Matthew Harwood, Dr Brahim Achour. It comprises sessions on 1) Practical Guide to Setting Up an LC-MS Lab for Quantitative Proteomics, 2) Being Mindful About Sample Preparation: Why and How? 3) Data Analysis Methodologies and Software: Labelled vs Label-Free 4) Interpretation and Application of LC-MS Proteomics Output.

Basic Pharmacokinetics workshop

One-week workshop on Basic Pharmacokinetics led by Prof. Leon Aarons held in Arosa, Switzerland from July 7-12, 2024. The workshop covers the basic concepts and applications of pharmacokinetics in the pharmaceutical, clinical, and veterinary sciences and is designed for pharmaceutical scientists, pharmacologists and other scientists, pharmacists, and physicians wishing to use pharmacokinetics in drug selection and development, drug protocol design, drug evaluation, drug registration and in the establishment of dosage regimens. For further details please visit: www.pkworkshops.com

FDA‐CRCG Workshop

Amin attended the FDA‐CRCG Workshop from May 2‐3, 2024 on ‘Considerations and Potential Regulatory Applications for Model Master File (MMF)’, where he presented and chaired discussions on maximizing the benefit from implementing the MMF framework, including 1) the type of products or therapeutics areas that may benefit the most from MMF applications, 2) useful MMF types and 3) MMF to enhance regulatory approval for product portfolios supported by M&S approaches 4) role of an MMF within a regulatory submission, 5) streamlining a regulatory submission and 6) how to support its regulatory acceptability, with a focus on the industrial models that support MMF.

On the Verge of Impossibility seminar

Amin attended an international seminar on the 23 April 2024 hosted by the Department of Pharmacy Practice, Bahauddin Zakariya University, Multan, and presented ‘On the Verge of Impossibility, Caring for All Permutations of Patient Comorbidities Affecting the Fate of Drugs,’. The event comprised of three distinct sessions, each followed by engaging Q&A sessions, followed by discussions on Physiologically-based pharmacokinetics (PBPK) and Quantitative Systems Pharmacology (QSP), inspiring a huge audience of over 1000 attendees.

EDAN (European Drug Absorption Network) meeting

Amin contributed to EDAN (European Drug Absorption Network) meeting in Leuven by presenting on Sex-Dependent outcome of bioequivalence studies. Amin was a keynote speaker alongside former commissioner of FDA, Sciott Gotlib, during the Certainty event in Philadelphia, sharing his experience of 25 years of technology transfer from academia to practical use in industry.

Meet the Experts (MEEX) – Transporters & ADME conference

Alex attended the Meet the Experts (MEEX) – Transporters & ADME conference in Budapest from May 8-10, 2024, where she delivered a keynote presentation on “Membrane Transporters in Drug Development and as Determinants of Precision Medicine: An ITC Update” highlighting key messages from the recent ITC white paper, with a particular focus on endogenous biomarkers, regulatory considerations, and future directions.

Online seminar in Oman

Dan was invited to present at an online seminar to College of Applied Sciences and Pharmacy, University of Technology and Applied Sciences, Muscat, Oman on the 21st of May 2024 speaking on “In silico simulations for translational pharmacology: Physiologically-based pharmacokinetic models”.

Basic Pharmacokinetics workshop in Cape Town

Kayode and Leon ran a one-week workshop in Basic Pharmacokinetics in Cape Town, South Africa from 26 February to 1 March 2024. The workshop was organised by Pharmacometrics Africa NPC, South Africa (an NGO) in collaboration with Stellenbosch University. It was sponsored by the University of Manchester and International Science Partnerships Fund. The workshop was attended by 53 participants, that included scientists, clinicians, pharmacists, data analysts, biostatisticians, clinical trialists, clinical pharmacology registrars, PhD students and members of the South African drug regulatory agency, SAHPRA.

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