AGAH e. V.

7th AGAH Dermatological Product Development Workshop
May 11 – 12, 2017 – Bethesda, Maryland, USA

 

08:45
Welcome and introduction on behalf of the AGAH
Betsy Hughes-Formella
Workshop Chair and Regent AGAH

CANDIDATE SELECTION

Session 1

Moderator: Leandro Santos, GlaxoSmithKline

09:00
Selection of drug development candidates for dermatology
Frank Kayser, BioDuro
09:30
Immune-mediated dermatological indications: lessons from clinical transcriptomics
Deepak K. Rajpal, GlaxoSmithKline
10:00
Bioprinted three-dimensional (3D) human tissues for toxicology and disease modeling
Deborah G. Nguyen, Organovo Inc.
10:30
Break

 

Session 2

Moderator: Hans Hofland, Dermira

10:45
Topical formulation development of new chemical entities
Robert Houlden, Formulytica Pty. Ltd.
11:15
Clinical and tissue biomarkers as predictors of therapeutic response
Emma Guttman-Yassky, Icahn School of Medicine at Mount Sinai
11:45
Discussion
12:00
Break

 

 

DERMAL DOSAGE FORM DEVELOPMENT AND CHARACTERIZATION: IMPACT OF VEHICLE AND EMERGING NEW TECHNOLOGIES

Session 3

Moderator: Piyush Jain, GlaxoSmithKline

13:30
Nanotechnology in topicals: screening and identification of nanoemulsion formulations as an effective topical therapy
Susan Ciotti, NanoBio Corp
14:00
Microneedle technologies to enhance drug delivery targeted to the skin
Mark Prausnitz, Georgia Tech
14:30
Strategies for de-risking dermal formulation development
Marc Brown, MedPharm Ltd.
15:00
Break

 

Session 4

Moderator: Marc Brown, MedPharm Ltd.

15:15
Characterization of topical dosage forms: the utility of predictive data to identify potential risks during and post clinical development
Piyush Jain, GlaxoSmithKline
15:45
Impact of vehicle on performance and safety: usage of the early development data to de-risk clinical formulations
Vijendra Nalamothu, Tergus Pharma
16:15
Discussion
16:30
End of day one

 

19:00
Workshop Dinner

DERMAL PHARMACOKINETICS AND PHARMACODYNAMICS: KEY ROLE FOR EFFECTIVE DEVELOPMENT OF DERMALLY ACTING DRUGS

Session 5

Moderator: Marc Brown, MedPharm Ltd.

09:00
How dermal drug development would look like today if reliable dermal PK and PD methods could be used
Ernst Kriehuber, Novartis Institutes for BioMedical Research
09:35
Innovative dermal PK and PD: approaches using ex-vivo human skin
Jon Lenn, MedPharm Ltd.
10:10
Innovative dermal PK and PD: in vivo Proof-of-Mechanism to clinical dermal bioequivalence using Open Flow Microperfusion
Frank Sinner, Joanneum Research
10:45
Break

 

Session 6

Moderator: Frank Sinner, Joanneum Research

11:00
Cutaneous pharmacokinetics and pharmacodynamics for the 21st century
Sam Raney, FDA
11:35
Discussion
12:00
Break

 

 

STRATEGIES FOR DE-RISKING TOPICAL PRODUCT DEVELOPMENT

Session 7

Moderator: Betsy Hughes-Formella, Independent Consultant

13:30
Opinions on the current status of the field: what big pharma does best, the obstacles, how things could be improved
David Rubenstein, GlaxoSmithKline
14:00
Case studies of success from a small pharma innovator
Hans Hofland, Dermira
14:30
Case studies of success from a generics company
Shamarez Ali Mohammed, Dr. Reddy’s Laboratories
15:00
Break

 

Session 8

Moderator: Hans Hofland, Dermira

15:15
Strategic placement of clinical trials through proof-of-concept: comparison of key factors across regions
Betsy Hughes-Formella, Independent Consultant
15:45
Regulatory strategy: building the plan to include innovation
Susan J. Walker, Susan J Walker Consulting, LLC
16:15
Round table discussion
16:45
Closing remarks
16:50
End of day two
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Dates to remember
  • December 15, 2016
    Opening registration
    • March 15, 2017
  • End of early registration
      • May 11, 2017
    • End of mid registration
      •  
    • May 11–12, 2017
    • 7th AGAH e.V. Workshop Dermatological Product Development
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20249 Hamburg/DE

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