Clinical Pharmacology Strategies in Drug Development
You are welcome to attend this one day seminar/workshop to get an understanding of the clinical pharmacology trials that are required and might be needed in order to obtain the intended label claim, linked to your target product profile.
Program
- Registration and welcome coffee
- Morning session
- Clinical Pharmacology Strategy from TPP to SmPC: Framing the Small Molecule and monoclonal antibody (mAb) Tracks
- Angelica Quartino (AstraZeneca)
- Designing Early Phase Studies for Small Molecules
- Mia Lundblad (NovoNordisk)
- ADME Foundations and Special Populations for Small Molecules
- Anna Nordmark (Nordmark Clin Pharm Consulting)
- Clinical Pharmacology Strategy from TPP to SmPC: Framing the Small Molecule and monoclonal antibody (mAb) Tracks
- Lunch
- Midday session
- Small Molecule Drug–drug interactions Strategy: From In Vitro Risk Assessment to Clinical Studies and Labeling
- Eva Berglund (Certara)
- Managing Formulation Changes for small molecules and design of relative bioavailability/bioequivalence studies
- Susanne Prothon (AstraZeneca)
- Designing Early Phase Studies for mAbs
- René Bouw
- Small Molecule Drug–drug interactions Strategy: From In Vitro Risk Assessment to Clinical Studies and Labeling
- Coffee
- Afternoon session
- Drug–drug interactions Strategy for mAbs
- Carolina Säll (NovoNordisk)
- Immunogenicity risk assessment and evaluation of clinical consequence of ADA
- Cecilia Arfvidsson (AstraZeneca)
- Managing formulation and device changes for mAbs and consideration for BA/BE studies
- Scott Roberts (NovoNordisk)
- Translating clinical pharmacology data into the SmPC: Posology, Interactions, Clinical Pharmacology, and Special Populations
- TBC
- Drug–drug interactions Strategy for mAbs
- Wrap up and key takeaways
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- Angelica Quartino (AstraZeneca)
- Mia Lundblad (NovoNordisk)
- Anna Nordmark (Nordmark Clin Pharm Consulting)
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Target audience
Target groups are those working in industry, academia, CRO or healthcare and aims to provide a basic understanding of the requirements and planning of clinical pharmacology trials and how these could influence the SmPC/label text.
Focus will be both on small molecules and larger ones such as monoclonal antibodies.
Time & Place
The 17th of March
At 9:30-17:30
Online or at Wallingatan 26A, Stockholm
Free for members
As a member, you can join this event at no cost. Guests pay a fee of 500 SEK – the same as a one-year membership! Not a member yet? Sign up today and the event is included. You’ll also get free access to upcoming Apotekarsocieteten events arranged by our local branches and sections during the membership period*.
*Excluding larger conferences administered through Läkemedelsakademin.