Model Answers R&D Pty Ltd, in collaboration with the School of Pharmacy at the Chinese University of Hong Kong, will be hosting a 2-day beginner’s workshop in Hong Kong from December 6-7th, 2019.

Population modelling of drugs, or pharmacometrics, has been increasingly recognized as an important component in drug development to support evidence of effectiveness, predicting clinical outcomes, informing clinical trial designs, and predicting product safety [FDA.  How Simulation Can Transform Regulatory Pathways].

This 2-day course is a condensed introduction to population modelling, and the course material are specifically designed to target those that wish to gain a fast-track understanding of the fundamental concepts in pharmacometrics.  The course will consist of a series of lectures and hands-on exercises using NONMEM®, the industry-standard software used in performing population model analysis.

The workshop will be taught by Model Answers, the leading CRO offering pharmacometric consulting services within the Asia-Pacific region.

Topics Covered

This course is designed for participants with a range of diverse backgrounds, and prior knowledge in population modelling is not required.  Throughout the course, participants will gain an understanding of the general concepts of population modelling through a combination of lectures and hands-on exercises, which are expected to cover the following topics:

  • Raw data review
  • Introduction to NONMEM®
  • Components of a population model
  • Between subject variability and residual error models
  • Covariate model building
  • Model evaluation techniques

Register your interest, using the Workshop Registration Form, and we will contact you soon to arrange for your payment to confirm your participation in the Workshop.

Model Answers Instructors: Bruce Green, Steve Choy and Winn Ungphakorn

Bruce is the Founder of Model Answers and remains passionate about delivering the highest quality pharmacometric tools to the drug industry in an efficient and practical manner.  He has developed numerous pharmacometric models and delivered many reports to regulatory authorities around the globe to assist drug approvals across many continents. He has first-hand experience of the FDA, having worked as a ‘Guest Reviewer’ in the Office of Clinical Pharmacology and Biopharmaceutics during sabbatical in 2005. He leads a team of highly talented individuals who are innovative, excel across multiple disciplines in this complex field, and enjoy sharing their knowledge with others.    Bruce’s publications

Steve is a Senior Pharmacometrician at Model Answers.  During his time in Model Answers, Steve has supported multiple NDA/BLA applications to the FDA in various disease areas including oncology, infectious diseases and rare diseases.  Prior to joining Model Answers, Steve was a postdoctoral fellow in the Division of Pharmacometrics in the FDA.  Steve has developed numerous pharmacokinetic/pharmacodynamic models with a specific focus on disease progression of type 2 diabetes.  He received his Ph.D. in pharmacometrics at Uppsala University under the supervision of professor Mats Karlsson and associate professor Maria Kjellson.  Steve’s publications

Winn is a Pharmacometrician at Model Answers, and has a background in clinical pharmacy.  Prior to joining Model Answers, Winn was a postdoctoral fellowship in the Pharmacometrics group, and was a researcher at the Department of Medical Sciences, both in Uppsala University.  Winn’s research interests include pharmacokinetic/pharmacodynamic modelling of antibacterial drugs and in vitro studies for antibiotics.  He received his Ph.D. at the University of Strathclyde in Glasgow under supervision of Dr Alison Thomson.  Winn’s publications

Guest Speaker: Xiaoyu Yan

Xiaoyu Yan is an Assistant Professor at the School of Pharmacy, the Chinese University of Hong Kong (CUHK).  Before joining the CUHK, he worked as a clinical pharmacometrician/pharmacologist at Janssen Research & Development (Johnson & Johnson) and Regeneron Pharmaceuticals, USA.  He contributed to the global approval of multiple products in various disease areas, such as oncology, immunology, cardiovascular, and neuroscience.  He received his Ph.D. from the Department of Pharmaceutical Sciences, University at Buffalo (SUNY). 

Register your interest, using the Workshop Registration Form, and we will contact you soon to arrange for your payment to confirm your participation in the Workshop.

Workshop Schedule

Day 1: Friday 6th December

Time

Session Topic

9:00 – 9:15

Opening Address

9:15 – 10:30

Session 1: Overview / Introduction

10:30 – 11:00

Coffee Break

11:00 – 1:00

Session 2: Raw Data Review & Regression

1:00 – 2:00

Lunch

2:00 – 3:15

Session 3: Welcome to NONMEM

3:15 – 3:45

Coffee Break

3:45 – 5:00

Session 4: Structural Model & Diagnostics

5:00 – 5:30

Special Topic: To be given by Xiaoyu Yan

6:30

Social Dinner (Optional)

Day 2: Saturday 7th December

Time

Session Topic

8:30 – 9:00

Arrive / Coffee

9:00 – 10:30

Session 5: Between Subject Variability & Diagnostics

10:30 – 11:00

Coffee Break

11:00 – 12:30

Session 6: Residual Unexplained Variability & Diagnostics

12:30 – 1:30

Lunch

1:30 – 3:00

Session 7: Covariates

3:00 – 3:30

Coffee Break

3:30 – 5:00

Session 8: Building a Model & Evaluation

5:00

Close Workshop

 

Registration Fee

The registration fee includes all workshop materials, printed course lectures, and a USB drive containing NONMEM® for the hands-on exercises during the workshop only.  Refreshments and lunch on both days are also included, with participants expected to bring their own laptop for use during the hands-on portion of the workshop.  Registrations close November 15th, 2019.

Early bird rate (20% discount before September 30th 2019):

Non-Student: $1,400 AUD per person

Student: $460 AUD per person (limited availability)

Regular rate (on or after October 1st 2019):

Non-Student: $1,740 AUD per person

Student: $580 AUD per person (limited availability)

Special registration for students from developing countries:

Student: $0 AUD per person* (limited to 2 participants)

* Model Answers recognises the need to foster growth for students coming from disadvantaged backgrounds, and a sponsorship programme is available to support the traveling costs (return airfare) of up to 2 Ph.D. students from developing countries.  Interested applicants for the special registration are encouraged to submit an application to training@model-a.com.au with the subject title “Workshop Special Registration” with the following information before September 30th 2019:

  1. Cover letter stating motivation to attend the workshop.
  2. Reference letter from current academic supervisor.
  3. CV.

All applicants applying through the special registration pathway will be assessed based on the information provided above and will be contacted individually by Model Answers within 2 weeks after the submission date of September 30th 2019.

Social Dinner (Optional):

$145 AUD per person

An optional social dinner is available on the night of Friday, December 6th and will be held at a separate location (TBA) from the workshop venue.

Cancellation Policy

Cancellations made prior to September 30th, 2019 will be eligible for a 75% refund.

Cancellations made on or after September 30th, 2019 and before October 31st2019 will be eligible for a 50% refund.

Cancellations made on October 31st, 2019 and before November 15th, 2019 will be eligible for a 25% refund.

Cancellations made on or after November 15th, 2019 will not be eligible for any refund.

Model Answers is aware of the current political situation in Hong Kong.  As planning for the workshop has been underway for sometime, we decided to proceed and will continue to consider the potential impacts on the workshop participants and instructors.  We will delay sending invoices to all registered participants at this time. If the situation changes, such that it is deemed unsafe to host the workshop in December, the workshop will be rescheduled to a later date, and all registration payments made will be reimbursed.

Terms and Conditions

Payment must be made within 30 days from the date of the invoice.  Invoices issued for registrations made after November 6th, 2019 require payment within 7 days.  Invoices will be issued once your registration has been received.

If for any reason the course cannot be held due to unforeseen circumstances, Model Answers will notify all registered participants as soon as possible and all workshop registration fees will be returned fully.

Contact Us

All enquiries regarding the workshop can be made to training@model-a.com.au