Development of Medicines for Pediatric and Rare Diseases
the chair
We would like to draw your attention to the 3rd conference ”Development of Medicines for Pediatric and Rare Diseases - Annual Event for Interdisciplinary Challenges” in Basel, Switzerland, February 2-3, 2017, preceded by a master class on commercial drug development in the morning of February 1, and a master class on Pediatric Drug development in the afternoon of February 1.
The first two conferences in 2015 & 2016 attracted more participants than we had hoped for. We are confident that even more attendees will participate in 2017. We would highly appreciate your participation and would kindly ask you to block the date in your agenda. Registration is possible from now on. A first draft agenda and further updates will be sent out in the next weeks and months.
For organisational questions please direct your questions to nadine.schrutt@ukbb.ch; for content question to Prof. Johannes van den Anker, Johannes.vandenAnker@ukbb.ch and Dr. Klaus Rose, klaus.rose@klausrose.net; for sponsoring suggestions to Martin Austin, mcaustin@transformrx.com.
Looking forward to see you in Basel, Switzerland, in February 2017
Best regards
Klaus Rose and John van den Anker
in name of the organization committee
Conference Chair
Prof. Dr. med. Johannes N. van den Anker
Chair, Department of Pediatric Pharmacology, Eckenstein-Geigy Professor of Pediatric Pharmacology, University Children’s Hospital Basel
Dr. med. Klaus Rose
Pediatric Drug Development & More, Aeussere Baselstrasse 308, 4125 Riehen, Switzerland
Programme Committee
Phil Walson, USA & Germany
Klaus Rose, Switzerland
Martin Austin, Switzerland
John van den Anker, Switzerland & USA
Marc Pfister, Switzerland
Urs Frey, Switzerland
Solange Rohou, France
Further Faculty
Phil Walson, USA & Germany
Koenraad Norga, Belgium & London
Hulya Oezsahin, SwissMedic, Switzerland
Trish Smith, Aerogen, Ireland & USA
Hubert Caron, Roche, Switzerland & USA
Adina Tokoian, Shire, Switzerland
Karin Jorga, Switzerland
Jean-Marc Nuoffer, Switzerland
Norbert Poellinger, Glatt, Germany
Martin Graham, USA
Michael Katz, USA
Conference Secretariat
Dr. Leoni Barrios
Matthias Burkhalter
Email : dmprd2017@mdpi.com
Tel. +41 61 683 77 35
Sponsoring Opportunities
For information regarding sponsoring opportunities, please contact Martin Austin.
Email : mcaustin@transformrx.com
Commercial Drug Development MasterClass
Wednesday, 1st February 2017, Basel, UKBB
Trainer: Martin Austin, Basel, Switzerland
| 8:30h | Registration & Coffee |
| 9:00h | Welcome |
| 9:10h | "Over the Rainbow" - Making medicines from ideas |
| 9:50h | Steps to successful commercialization: An Overview |
| 10:30h | Morning coffee |
| 11:00h |
Step 1: know yourself! Could you pull it through? |
| 11:30h | Step 2: Environment, Market & Competition |
| 12:00h | Step 3: Creating a Plan : The threshold criteria. |
| 12:30h | Wrap-Up |
| 13:00h | End of Masterclass |
Pediatric Drug Development MasterClass
Wednesday, 1st February 2017, Basel, UKBB
Trainer: Klaus Rose, klausrose Consulting, Basel, Switzerland
| 13.30h | Registration & Coffee |
| 14:00h | Welcome |
| 14:10h | EU & US Pediatric pharmaceutical legislation |
| 14:40h | The EU Pediatric Investigation Plan (PIP) |
| 15:30h | Childrens’ special needs in pharmaceutical treatment: developmental physiology, pediatric formulations, pediatric clinical pharmacology |
| 16:00h |
Operational challenges of pediatric clinical trials:
|
| 16:30h | Break |
| 17:00h | Impact of US & EU pediatric legislation on drug development |
| 17:30h | Interactive training : EMA pediatric website |
| 18:00h | Wrap-Up & End of Masterclass |
Email : mcaustin@transformrx.com
Main Conference incl. Pre-Conference Workshops 1* & 2**
Registration Fee in CHF
Industry
By 28 October 2016 - CHF 2000
29 Oct – 4 Dec 2016 - CHF 2200
From 5 Dec 2016 - CHF 2400
Academia
Regulatory Authorities
Patient Organisation
By 28 October 2016 - CHF 1000
29 Oct – 4 Dec 2016 - CHF 1100
From 5 Dec 2016 - CHF 1200
Main Conference incl. Pre-Conference Workshop 1*
Registration Fee in CHF
Industry
By 28 October 2016 - CHF 1500
29 Oct – 4 Dec 2016 - CHF 1650
From 5 Dec 2016 - CHF 1800
Academia
Regulatory Authorities
Patient Organisation
By 28 October 2016 - CHF 750
29 Oct – 4 Dec 2016 - CHF 825
From 5 Dec 2016 - CHF 900
Main Conference incl. Pre-Conference Workshop 2**
Registration Fee in CHF
Industry
By 28 October 2016 - CHF 1500
29 Oct – 4 Dec 2016 - CHF 1650
From 5 Dec 2016 - CHF 1800
Academia
Regulatory Authorities
Patient Organisation
By 28 October 2016 - CHF 750
29 Oct – 4 Dec 2016 - CHF 825
From 5 Dec 2016 - CHF 900
Conference Only
Registration Fee in CHF
Industry
By 28 October 2016 - CHF 1000
29 Oct – 4 Dec 2016 - CHF 1100
From 5 Dec 2016 - CHF 1200
Academia
Regulatory Authorities
Patient Organisation
By 28 October 2016 - CHF 500
29 Oct – 4 Dec 2016 - CHF 550
From 5 Dec 2016 - CHF 600
Workshops 1* & 2**
Registration Fee in CHF
Industry
By 28 October 2016 - CHF 1000
29 Oct – 4 Dec 2016 - CHF 1100
From 5 Dec 2016 - CHF 1200
Academia
Regulatory Authorities
Patient Organisation
By 28 October 2016 - CHF 500
29 Oct – 4 Dec 2016 - CHF 550
From 5 Dec 2016 - CHF 600
Workshop 1*
Registration Fee in CHF
Industry
By 28 October 2016 - CHF 500
29 Oct – 4 Dec 2016 - CHF 550
From 5 Dec 2016 - CHF 600
Academia
Regulatory Authorities
Patient Organisation
By 28 October 2016 - CHF 250
29 Oct – 4 Dec 2016 - CHF 275
From 5 Dec 2016 - CHF 300
Workshop 2**
Registration Fee in CHF
Industry
By 28 October 2016 - CHF 500
29 Oct – 4 Dec 2016 - CHF 550
From 5 Dec 2016 - CHF 600
Academia
Regulatory Authorities
Patient Organisation
By 28 October 2016 - CHF 250
29 Oct – 4 Dec 2016 - CHF 275
From 5 Dec 2016 - CHF 300
Networking Event Evening of February 2: Complimentary
* Pre-Conference Workshop Commercial Drug Development MasterClass (Morning of 1 February 2016)
** Pre-Conference Workshop Paediatric Drug Development MasterClass (Afternoon of 1 February 2016)Registration fees include
• Attendance to all sessions
• Conference Documents
• Lunch
• Coffee breaks
• Networking Event
Confirmation
Upon receipt of the correct registration fee, each participant will receive a confirmation of registration. Please bring this confirmation to the registration desk at the conference venue as proof of your registration.
Cancellation/Name change
Refund of fees, less 25% administrative charges, can be applied for in writing until 18 December 2016 to the Administrative Secretariat. After this date no refund will be possible. Substitutions of attendees can be made at any time. For any change of names, a fee of CHF 30 will be charged.
Students
Students have the possibility to apply for a special discount. Please send your application together with a copy of a valid student card. The rate for students is CHF 120.
Responsibility
The participant acknowledges that he/she has no right to lodge damage claims against the organizers should the holding of the congress be hindered or prevented by unexpected political or economic events or generally by force majeure, or should the non-appearance of speakers or other reasons necessitate programme changes. With registration, the participant accepts this proviso.
By finishing the application, the participant declares that he/she agrees to its personal and company data being processed by MDPI and that this data may be used for information purposes on congresses and events in related fields organized by MDPI. In the opposing case, the participant should notify MDPI at the time of returning the signed application.
For inquiries, please contact Conference Secretariat.
Third Annual Conference on Drug Development in Pediatric and Rare Diseases: Successes & Opportunities - 2/3rd February 2017 Basel, Switzerland.
Day 1 |
| Time | Activity | Speaker |
| 8:00 | Breakfast and Registration | |
| 8:45 | Welcome | Klaus Rose & John van den Anker |
| Session 1: Success Stories 1 - Pediatric Drug Development. Moderation: Swissmedic & Koenrad Norga | ||
| 9:00 | Pediatric Drug Development | Adina Tokojan |
| 9:30 | Update on the March of Dimes | Michael Katz |
| 10:00 | ||
| 10:30 | Coffee Break | |
| 11:00 | Pediatric Drug Development | Hubert Caron |
| 11:30 | Neonatal Pulmonary Drug Delivery Devices | Trish Smith |
| 12:00 | Hands-on diagnosis & treatment of rare diseases | Jean-Marc Nuoffer |
| 12:30 | Lunch Break & Exhibitors Hall Visit | |
| Session 2: Regulatory Challenges. Moderation: Phil Walson & Michael Katz | ||
| 13:30 | EMA/PDCO perspective | Koenraad Norga |
| 14:00 | Pediatric perspectives in drug development: Switzerland | Hulya Oezsahin |
| 14:30 | Industry Perspective | Solange Rohou |
| 15:00 | Adopting the last therapeutic orphans: an update on the latest developments | John van den Anker |
| 15:30 | Discussion | |
| 16:30 | Refreshments for die-hards and networking | |
| 18:00 | Come Together | |
Day 2
|
| Time | Activity | Speaker |
| 8:45 | Welcome | Klaus Rose & John van den Anker |
| Session 3: Regulatory and scientific challenges - Strategic Thoughts. Moderation: Martin Austin | ||
| 9:00 | From research to bedside: academic drug development- reality, promise, successes | Phil Walson |
| 9:30 | What regulatory authorities do in pediatric drug development – and what they should do | Klaus Rose |
| 10:00 | Coffee Break | |
| 10:30 | Demonisation of commercial drug development: why more entrepreneurs are needed and how to do it | Martin Austin |
| 11:00 | Round Table Discussion | |
| 12:30 | Lunch Break & Exhibitors Hall Visit | |
| Session 4: Technical Advances & Challenges. Moderation: Marc Pfister | ||
| 13:30 | Pediatric Formulations | Norbert Poellinger |
| 14:00 | Scaling Models in pediatric PK/PD | Martin Graham |
| 14:30 | Bottom-up meets top-down: Complementary PBPK and PopPK modeling for regulatory approval of a dosing algorithm of valganciclovir in very young children. | Karin Jorga |
| 15:00 | Wrap-up | |
| 16:30 | End of day 2 | |
The conference will be preceded by a half day Masterclass on Commercial Drug Development by Martin Austin (morning of February 1) and by a Masterclass on Pediatric Drug Development by Klaus Rose (afternoon of February 1).