קטגוריה: הכשרות מקצועיות
Breakfast Seminar
Clinical Pharmacology and Pharmacometric
Ms. Catrin Ball-Rosen, גב' תחיה טואף
תאריך: 28 ינואר 2020
מיקום הקורס:  משרדי ביופורום, גולדה מאיר 3, נס ציונה. קומה 4
שפת הקורס: אנגלית
משך הפעילות: חצי יום לימודים
שעות: 9:00-11:30
התכנסות והרשמה: 8:30
עלות: 500 ₪ + מע"מ; חינם ללקוחות ביופורום
נקודות זכות: 1
מק''ט: 201037
 
http://www.pulseem.com/Pulseem/ClientImages/2700/Data/280120.jpg
When: January 28, 2019; 9:00-11:30
Where: Bioforum offices, Ness Ziona, Israel
SKU: 201037

At Bioforum, we partner with sponsors to provide the highest-quality and regulatory compliant Pharmacometric, clinical Pharmacology, biostatistics strategy and analysis consultation services. We offer the benefit of many years of experience across various therapeutic areas and product development phases.

We invite you to attend a morning session in which we will provide a brief introduction on the Clinical Pharmacology and Pharmacometric topics every sponsor conducting a clinical trial should know.

Agenda

9:00- 09:15 Gathering
9:15- 10:15

The Clinical Pharmacologist and Pharmacometrician roles in accelerating the drug development process
Dr. Itay Perlstein
Ph.D, Clinical Pharmacology and Pharmacokinetics consulting, Magic Wand Research LLC

Clinical pharmacology studies have a key role in drug development and support major decision milestones throughout the entire process -“giving the right dose, at the right time, to the right patient”. Its importance can be seen in drug labeling where some say it accounts for 50% of the label.
Clinical Pharmacology is a multidisciplinary science that requires an understanding of the drug mechanism of action, the disease pathophysiology, and the pharmacokinetics of the drug in the body (absorption, distribution, metabolism, and elimination). In order to reach informed decisions on key development questions, the Clinical pharmacologist relies on quantitative results obtained from a variety of modeling and simulation techniques (pharmacometrics) analyzed by a pharmacometrician. Together, they develop the modeling and simulation analysis plan. Depending on the questions asked by the development team, PK and PK/PD models (from simple to very complex) are developed. The analysis may be done at different stages of the study: to optimize the study design, for interim analysis, study report, designing new studies, and for registrational purposes. The clinical pharmacologist then translates the quantitative results into clear recommendations that contribute to effective decision making.
The seminar will describe the Clinical Pharmacologist and Pharmacometician roles, the type of support they can provide to the drug development team and the advantage of having such type of collaboration to accelerate the sponsor drug development process.

10:15- 10:30 Break
10:30- 11:30

Optimizing the entire drug development process using Pharmacometric tools
Prof. Serge Guzy
VP Pharmacometrics, Bioforum

Pharmacometrics is mathematical models of biology, pharmacology, disease, and physiology used to describe and quantify interactions between xenobiotics and patients. A major focus of pharmacometrics is to understand variability in drug response, optimizing efficacy and minimizing safety concerns. Pharmacodynamic endpoints are often used as surrogates for the clinical endpoints and must be linked to the exposure of the drug in patients (Pharmacokinetics). State-of-the-art Pharmacometric methods play a key role in every step of the drug development process and will be presented in this seminar. Case studies will be analyzed with a focus on the model-based assessment of Pharmacokinetic/Pharmacodynamic correlation and dosage regimen optimization.

 http://www.pulseem.com/Pulseem/ClientImages/2700/Data/Serge.jpg Serge Guzy acquired his Chemical Engineering Degree in 1982 from the University of Brussels and received his master’s degree in Chemistry and Biophysics in 1985 from the Weizmann Institute. Serge obtained his Doctorate in Biomedical Engineering in 1990 from Technion and, one year later, got his Post-doctorate Degree from UC Berkeley in Chemical Engineering. Serge held a faculty position at UCSF School of Pharmacy between 1991-1996.
Serge serves as VP of pharmacometrics in Bioforum and holds over 30 years of experience in providing pharmacometrics services to pharmaceutical and biomedical companies to optimize the entire drug development process. Serge established new methods for statistical population approaches in drug development, based on Monte Carlo simulation algorithms.
Serge serves also as Affiliate Professor at the University of Maryland, Adjunct Professor at the University of Minnesota, Courtesy Professor at the College of Pharmacy, Florida and Adjunct Professor at the University of Denver.

 http://www.pulseem.com/Pulseem/ClientImages/2700/Bioforum%202018%20Summit/Itay_Photo.jpg Dr. Itay Perlstein, PhD graduated from the Hebrew University in Pharmaceutical Sciences in 2000 (PK/PD correlation of CNS drugs) and pursued his post-doctorate fellowship at the University of Pennsylvania/The Children’s Hospital of Philadelphia (development of novel gene delivery systems). He then moved to the Pharma industry where he served in the Clinical Pharmacology and Pharmacometrics departments of GSK, Merck, and Bristol-Myers Squibb with growing responsibilities as a Sr. PK/PD Modeling Scientist, a Study Director, and a Clinical Pharmacology Lead. Itay has extensive experience in pre-clinical and all clinical phases of drug development, from first-in-human to successful global filing of blockbuster drugs. He is experienced in the development of small molecules, and biologics. Throughout the years Itay gained broad experience in interactions with the FDA, EMA, and major global Health Authorities. Dr. Perlstein published a large number of peer-reviewed articles and several book chapters. Due to his outstanding experience in generics, biosimilar, and 505(b)(2) products development, Dr. Perlstein serves as an editorial board member of the Journal of Bioequivalence & Bioavailability. Dr. Perlstein has extensive experience in new technology development, mainly in modeling & simulation software and applications for pre-clinical and clinical purposes. Since 2011 Dr. Perlstein is providing trough consulting services of PK and Clinical Pharmacology leadership for Pharma, Biotech, Medical Devices, and VC companies.



http://www.pulseem.co.il/Pulseem/ClientImages/2700/reg-noww.pngTarget Audience:
This symposium is a perfect learning session for Sponsors of phase I-III trials

Bioforum clients: First participant free of charge

General Admission: 500 NIS +VAT

Space is limited. Registration will be pre-approved by Bioforum

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