[NMusers] Free workshop at FDA

From: Wang, Yaning <Yaning.Wang_at_fda.hhs.gov>
Date: Wed, 8 May 2019 21:49:37 +0000

Dear all:
The workshop is scheduled on August 12, 2019. The official announcement can=
 be found at https://www.fda.gov/drugs/precision-dosing-defining-need-and-a=
pproaches-deliver-individualized-drug-dosing-real-world-setting

Co-Chairs:

Food and Drug Administration
 Office of Clinical Pharmacology, Office of Translational Sciences
 Yaning Wang, PhD
 Raj Madabushi, PhD

University of North Carolina
 Bob Powell, PharmD

The Food and Drug Administration in collaboration with the University of No=
rth Carolina will host a 1-day public workshop, "Precision Dosing: Defining=
 the Need and Approaches to Deliver Individualized Drug Dosing in the Real-=
World Setting."

Date: August 12, 2019
Time: 8:00am to 5:00pm
Location: Food and Drug Administration White Oak Campus
 Great Room, Building 31, Room 1503 (B and C)
 10903 New Hampshire Avenue
 Silver Spring, MD 20993

FDA Campus Information, (e.g., local airports, directions, and local hotels=
)

Registration: TBA

Background:
 Some clinical trials in drug development are conducted to optimize the dos=
ing regimen of a new drug for the target patient population. Clinical pharm=
acology trials serve as the major source of evidence for dose individualiza=
tion (precision dosing) taking into account patient factors that can modify=
 drug response. Despite these efforts prior to a drug's approval, further d=
ose optimization may be required after drug approval (e.g., accounting for =
extremes of age, body habitus, organ function and complex multiple characte=
ristics including genotype, drug interactions, and co-morbidities). The opp=
ortunities and challenges for further dose optimization/individualization w=
ill be discussed from multiple perspectives including drug developers, regu=
lators, physicians, pharmacists and patients. These relevant groups will a=
lso discuss in what contexts precision dosing may be needed, and the challe=
nges of generating evidence to support precision dosing and applying indivi=
dualized dosing regimen in clinical practice. In addition to evidence creat=
ed during the new drug development process, real-world data/evidence will b=
e discussed to address some challenges that cannot be addressed by pre- and=
 post-approval clinical trials. The process of translating the knowledge to=
 tools that can be utilized by the medical community for patient care will =
also be discussed.

Workshop Objectives:
1.To explore the need for more precise dosing.
2.To investigate opportunities in the drug development and real-world setti=
ngs to generate the information needed to support precision drug dosing.
3.To discuss the translation of the dosing information to electronic drug d=
osing delivery tools to enable precision dosing in clinical practice.

Webcast Information:

The FDA will provide a free-of-charge, live webcast of this workshop. Reco=
rdings of the webcast can be found at the following links:

Agenda: TBA

Who should attend:

This workshop will be open to the public. This workshop is intended for div=
erse groups from academia, industry, regulatory agencies, patient advocacy =
organizations, real-world data companies and other individuals who have an =
interest in approaches to precision dosing and its impact in drug developme=
nt and patient care.

Contact:

Bernadette Johnson-Williams, MEd
 Senior Regulatory Project Manager
 Office of Clinical Pharmacology
 Office of Translational Sciences
 Center for Drug Evaluation and Research
 Food and Drug Administration
 Email: OCPWorkshops_at_fda.hhs.gov


-----Original Message-----
From: Wang, Yaning
Sent: Wednesday, January 16, 2019 4:48 PM
To: nmusers_at_globomaxnm.com; PHARMPK_at_LISTS.UCDENVER.EDU
Subject: RE: [NMusers] Free workshop at FDA

Dear Colleagues:

Due to the government shutdown, the workshop will be postponed. Detailed in=
formation will be available later.


Yaning Wang, Ph.D.
Director
Division of Pharmacometrics
Office of Clinical Pharmacology
Office of Translational Sciences
Center for Drug Evaluation and Research
Food and Drug Administration
Phone: 301-796-1624
Email: yaning.wang_at_fda.hhs.gov
Disclaimer: The contents of this message are mine personally and do not nec=
essarily reflect any position of the Government or the Food and Drug Admini=
stration.



> On Dec 6, 2018, at 12:20 PM, Wang, Yaning <Yaning.Wang_at_fda.hhs.gov> wrote=
:
>
> Dear Colleagues:
> On Feb 22, 2019, a free workshop will be held at the FDA headquarter (Sil=
ver Spring, Maryland). Experts from industry, academia, hospitals, patient =
advocacy organizations, and FDA will discuss individualized dosing from all=
 aspects. Detailed agenda will be published soon.
>
> Title: Precision Dosing: Defining the Need and Approaches to Deliver
> Individualized Drug Dosing in the Real-World Setting
> Time: February 22, 2019
> Location: FDA White Oak Great Room
>
> Thanks
>
> Yaning Wang, Ph.D.
> Director
> Division of Pharmacometrics
> Office of Clinical Pharmacology
> Office of Translational Sciences
> Center for Drug Evaluation and Research Food and Drug Administration
> Phone: 301-796-1624
> Email: yaning.wang_at_fda.hhs.gov
> Disclaimer: The contents of this message are mine personally and do not n=
ecessarily reflect any position of the Government or the Food and Drug Admi=
nistration.
>
>
>

Received on Wed May 08 2019 - 17:49:37 EDT

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