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!
Informationen
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
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
