Lade Veranstaltungen

6th AGAH Dermatology Product Development Workshop

23. Juni 2015 - 24. Juni 2015
AGAH Workshop, London

The 6th AGAH Dermatological Product Development Workshop was held June 23-24, 2015, in London, UK. 71 participants from 12 countries helped make this international workshop focused on bridging strategies from early development to regulatory approval a resounding success. The workshop featured an outstanding speaker panel of experts from industry, academics and the MHRA.

Many of the current issues and challenges in the development of both innovative and generic topically applied drug products were addressed. Key approaches interlaced throughout the two-day workshop included

  • Building confidence towards selection of clinical candidates using a tool-kit approach
  • Risk mitigation strategies for major vs. minor formulation changes during development
  • Indication specific development strategies
  • Regulatory perspectives from both sides of the pond

The workshop provided a unique platform to discuss practical and regulatory aspects of dermatological development which are critical to risk mitigation and success of new products from the perspective of both big pharma and leading dermatology companies to small biotech start-ups. An engaged audience contributed to lively question and answer sessions with discussions continuing in the networking breaks.

The AGAH would like to especially thank the industry sponsors without whom this workshop would not have been possible as well as the speakers, moderators and attendees who contributed to making this workshop a huge success!


6th Dermatological Product Development Workshop

23.06.2015 – 24.06.2015 in London, UK

An International Workshop on Bridging Strategies from Early Development to Regulatory Approval

  • Building confidence towards selection of clinical candidate using tool kit approach
  • Risk mitigation strategies for major vs. minor formulation changes during development
  • Indication-specific development strategies
  • Regulatory perspectives from both sides of the pond

Day 1: 23.6.2015 Tuesday

Time Content Lecturer
08:45 Welcome and introduction on behalf of the AGAH Betsy Hughes-Formella, bioskin, Germany

Session 1

Moderator: Marc Brown
09:00 Quality by Design (QbD) approach for topical formulation development: Utilization of Critical Material Attributes (CMAs) and Critical Process Parameters (CPPs) that are linked to the Critical Quality Attributes (CQAs) in order to develop a topical product Vijendra Nalamothu, USA
09:45 Predicting, measuring and optimising drug delivery to the skin Richard Guy, UK
10:30 Break

Session 2

Moderator: Vijendra Nalamothu
11:00 A fresh look on the relationship of dermal drug delivery and physicochemical properties Leandro Santos, Stiefel, a GSK company, USA
11:30 The importance of drug disposition in the skin Hans Hofland, USA
12:00 Reducing the risk of topical formulation development: the optimal route from drug candidate selection to proof of concept studies Marc Brown, UK
12:30 Break

Session 3

Moderator: Jon Lenn
14:15 TCAT: a novel PBPK model sheds light on the role of formulation on dermal pharmacokinetics Richard Lloyd, UK
14:45 Increasing confidence in candidate selection through repurposing and in vivo screening Edward Hsia, USA
15:30 Break
16:00 Use of high resolution actigraphy and advanced signal processing to quantify nocturnal scratching events in patients with atopic dermatitis Barry T. Peterson, USA
16:30 Translational biomarkers in dermatological drug development Mads Almose Røpke, Denmark
17:00 FibroTx TAP: A novel skin-ELISA platform technology for non-invasive biomarker measurements from skin Pieter Spee, Estonia
17:30 End of day one
19:30 Dinner Meeting

Day 2: 24.6.2015 Wednesday

Session 4

Time Content Lecturer
Moderator: Betsy Hughes-Formella
08:30 Surrogate methods for bioequivalence of locally acting topical products: Optimization and IVIVC Isadore Kanfer, SA
09:00 Tissue specific PK and PD enabled by Open Flow Microperfusion (OFM): From bioequiva-lence to mechanism of drug action PoC studies Frank Sinner, Austria
09:30 Nanoscale phenotyping reveals barrier dysfunction of the skin at a subclinical level Christoph Riethmueller, Germany
10:00 Break
10:30 Applying a patient centric strategy in design of new innovative products for people with psoriasis Karsten Petersson, Denmark
11:15 Mitigation of the risks: Clinical development plan Karl R. Beutner, USA
12:00 Break

Session 5

Moderator: Melissa Green
13:30 Differences and similarities between US and EU clinical endpoint studies for generic drug approval Charles Bon, USA
14:00 Regulatory considerations of bioequivalence in generic topical formulation development: In vitro or in vivo Ian Claydon, Marc Brown, UK
14:30 Break
15:00 Regulatory experience and challenges with topical drug development Quan Yang, MHRA, UK
15:30 Building a weight of evidence to support modifications to novel topical formulations during development Melissa Green, USA

Session 6

Moderator: Melissa Green  
16:00 Strategic panel discussion

Ways to streamline topical drug development and mitigate risk throughout development

17:00 End of day two


Silver Sponsors

Bronze Sponsors

Other Sponsors

Registration Fee

Early registration until April 30, 2015

950€ Non-Members
750€ Member of the AGAH

Registration after April 30, 2015

1050€ Non-Members
850€ Member of the AGAH

The participation fee is per person. Please note: according to §4, para. 22, German Turnover-Tax Law workshop fees are exempt from VAT. Registration fees are charged and collected on behalf of AGAH e.V. (PO Box 10 14 58, 41546 Kaarst, VAT No: 122/5786/2578). All bookings are subject to change.

Workshop Venue

The Cumberland Hotel, London
Great Cumberland Place
London, W1H 7DL, United Kingdom


CSi Hamburg GmbH
Jungfrauenthal 22 · 20149 Hamburg, Germany
Tel.: +49 40 30770 300 Fax: +49 40 30770 301
E-Mail: agah-veranstaltungen ( a t )

May we please ask you to use the registration form.

Room Reservations

Room reservations are possible at conference rates and
can also be made using the online-registration.

Scientific Committee

  • Marc Brown, MedPharm
  • Melissa Green, Stiefel, a GSK company
  • Betsy Hughes-Formella, bioskin
  • Jon Lenn, Stiefel, a GSK company
  • Vijendra Nalamothu, Tergus Pharma


  • Ilka Schmeichel, bioskin
  • Andrea Schmidt, bioskin

Supporting Society

The Association for Applied Human Pharmacology (AGAH) is a scientific medical non-profit organisation with members from the field of explorative drug development and human pharmacology.


  • Karl R. Beutner, MD, PhD
    Chief Medical Officer, Rogne Bioscience Inc., USA
  • Charles Bon, MS
    President, Biostudy Solutions, LLC, NC, USA
  • Professor Marc Brown, BSc (Hons), Ph. CChem FRSC
    Chief Scientific Officer and Chief Operating Officer MedPharm, Guildford, UK
  • Ian Claydon
    Regulatory Consultant, UK
  • Melissa Green 
    Director, Global Regulatory Affairs, PSO and AD Care Area, Stiefel, a GSK company, USA
  • Professor Richard Guy
    University of Bath, Department of Pharmacy & Pharmacology, UK
  • Hans Hofland, PhD
    VP Research and Nonclinical Development Dermira, USA
  • Edward Hsia, PhD
    Director, Dermatology Research, Allergan, USA
  • Isadore Kanfer, PhD
    Chief Executive Officer, CRO Consulting, South Africa
  • Richard Lloyd
    Modeling and Transational Biology, DMPK, GlaxoSmithKline, UK
  • Vijendra Nalamothu, PhD
    Co-founder & CEO, Tergus Pharma, USA
  • Barry T. Peterson, PhD
    Sr. Manager, Clinical Affairs, Philips Healthcare, USA
  • Karsten Petersson, 
    Principal Scientist & Project Lead, PharmTech Ideation, LEO Pharma, Denmark
  • Christoph Riethmuller, PhD 
    Serendip GmbH, Center of Nanotechnology, Muenster, Germany
  • Mads Almose Røpke,
    Senior Principal Scientific Advisor, Clinical Pharmacology, LEO Pharma, Denmark
  • Leandro Santos
    Manager, Topical Drug Delivery, Stiefel, a GSK company, USA
  • Frank Sinner, PhD 
    Director Health – Institute of Biomedicine and Health Sciences, Joanneum Research, Graz, Austria
  • Pieter Spee, PhD MSc Ing
    Chief Technology Officer, FibroTx LLC, Tallinn; Estonia
  • Quan Yang, PhD, MPharm
    Pharmaceutical Assessor, Licensing Division, MHRA, UK

23. Juni 2015 - 24. Juni 2015

6th AGAH Dermatology Product Development Workshop

AGAH Workshop

Großbritannien (Vereinigtes Königreich)