
6th AGAH Dermatology Product Development Workshop
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 |
Sponsors
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 |
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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
Registration
CSi Hamburg GmbH
Jungfrauenthal 22 · 20149 Hamburg, Germany
Tel.: +49 40 30770 300 Fax: +49 40 30770 301
E-Mail: agah-veranstaltungen ( a t ) csihamburg.de
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
Organization
- 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.
Speakers
- 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
London
Großbritannien (Vereinigtes Königreich)