PBSS Workshop Clinical Pharmacology & Modeling Strategies for your Drug Development -2017-12-11

Event Information
Event Name: 
PBSS Workshop Clinical Pharmacology & Modeling Strategies for your Drug Development
Event Date: 
12/11/2017 - 8:30am
Event Location: 
SF Bay Area: Foster City Crowne Plaza
Event Details
Event Type: 
Panel Discussions
Event Details: 

PBSS Workshop, Monday, Dec. 11, 2017

Event Name: Clinical Pharmacology & Modeling Strategies for your Drug Development Program: Fundamentals, Best Practices and Real World Applications
Speakers: David Lau (Foresee Pharmaceuticals), Geoff Banks (Nuventra), Mark Sale (Nuventra), Lauren Lohmer (Nuventra)
Date and Time: Monday, Dec. 11, 2017, 8:45-17:00
Preliminary Agenda
8:45 – 9:00 Welcome and Intro
9:00 – 10:30 – David Lau (Senior Vice President, NCE Preclinical and Clinical Development, Foresee Pharmaceuticals)
Purpose of Clin Pharm Studies in Drug Development
Type of Clin Pharm studies (SAD, MAD, BA/BE, DDI, Disease population, QT, etc)
• What are these studies
• When to do the studies
• Typical study design
• Examples
10:30 – 11:00 – Break and Vendor Presentation
11:00 – 12:30 – Geoff Banks (CEO, Nuventra)
How to Form a Clin Pharm Strategy for your NDA / BLA
• What studies you do & don’t need
• “Gap analysis” in your program
• Real world examples
12:30 – 1:30 – Lunch
1:30 – 3:00 – Mark Sale (Senior Vice President, Pharmacometrics, Nuventra)
Modeling & Simulation / Population PK Fundamentals
• What is it?
• How do you do it?
• Allometric scaling
• How do you use it for safety and efficacy?
3:00 – 3:30 Break and vendor presentation
3:30 – 5:00 – Mark Sale and Lauren Lohmer (Manager, Clinical Pharmacology, Nuventra)
Using Modeling & Simulation to Avoid Clinical Trials
• Overview and case studies:
o CQT
o Exposure response
o Additional DDI studies
o Special population studies
o Renal impairment

Location: SF Bay Area: Foster City Crowne Plaza
Registration fee (US$): Academic: $125; Regular: $195; For unemployed or students: $30; For major-sponsor rep (incl lunch): $0; For vendor-show rep: $35;
Details and registration at http://www.pbss.org/aspx/eventInfo.aspx?eID=557
Registration deadline:12/8/2017 (it will close sooner if the seating cap is reached)
This is a friendly reminder that you have not registered for the following Workshop . If you plan to attend, please register at www.pbss.org before it is closed (it may close BEFORE the deadline if the seating capacity is reached early).

Payment Dec 12th Evening Event - $20 to TheGeneral Public

Attention B2DG members: You must login to your account first to see the members' early-bird admission rate.
If you are not a B2DG member or if you had missed the early-bird deadline, the registration fee is $20. Please follow these instructions to register.

We use PAYPAL to process your online payment. Print and bring a copy of your online receipt with you. If space permits, walk-ins are welcomed; please be prepared to pay $25 at the door (cash or check). There is no refund, exchange, or transfer. Thank you for your cooperation.
To register now, please select your meal preference from the pull-down menu below and enter the attendee's information. Then click on the "Pay Now" button to reach the PayPal payment page. Each attendee must be registered separately.
Make sure you enter the attendee's meal choice, name, and email address.


Meal Choice
Name of Attendee
Email Address