Hit-to-Lead & Lead Optimization of Small Molecules and Natural Products

Hit-to-Lead & Lead Optimization of Small Molecules and Natural Products

Das Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) bietet einen Workshop im digitalen Format an fünf Mittwochen im November/Dezember von 15:00-17:00 Uhr an.

Der Workshop richtet sich an Wissenschaftler(innen) (vornehmlich Post-Docs und Doktoranden) von DZIF-Projekten in der frühen Produktentwicklungsphase. Die Vorträge werden von Experten aus der Akademie, der Industrie und den regulatorischen Behörden gehalten.

Ihre Anmeldungen richten Sie bitte unter Angabe Ihrer DZIF-Projektnummer bis zum 30.09.2020 an:

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Programm

04.11.2020

Lead Structure & Lead Optimization

Martin Empting (HIPS, Saarbrücken)
Fundamental criteria for LO – drug activity, cytotoxicity and solubility:
• Target Product Profile (TPP)
• Example and case studies how to make analogous more effective and safer
• Discussion and Questions

Success Story

Holger Zimmermann,Tamara Pfaff (AiCuris, Wuppertal)
From hit to market authorization: AIC246 – Letermovir (with focus on early pre-clinical development)

11.11.2020

In vivo PK/PD

Pia Empting (Goethe-University Frankfurt)
Veterinary medicine/ laboratory animal science:
• Animal models/ animal testing
• Microbiological/ histological sample evaluation
• Ethics

Katharina Rox (HZI, Braunschweig)
In vivo efficacy & in vitro safety – single and repeat dose to confirm in vivo pharmacologic effects:
• PK/PD Unit at the HZI
• in vitro safety
• Metabolite ID
• in vivo genotoxicity

18.11.2020

Biological Assays, in vitro ADME

Jennifer Herrmann (HIPS, Saarbrücken)
Basics in vitro Biology – microbiological potency of drug:
• Structure Activity Relationship (SAR)
• Target Identification
• Activity testing (in vitro MICs)
• Resistance development/ frequency of resistance
• Mechanism of resistance
• Examples and case study

Ken Page (Cyprotex, UK)
In vitro ADME – suitable availability of drug:
• Basics & Terminology
• Interpretation of data

25.11.2020

Entrepreneurs in AMR

Marc Creus (University Basel; Juvabis AG)
Current needs and prospects for antibiotics R&D

Technology Transfer

Kordula Kruber (Provendis, Mülheim)
From research to marketable products:
• Invention or discovery?
• Patents & other IP
• Options/chances for commercialisation
• Timelines & pitfalls
• Licensing & cooperations

02.12.2020

Regulatory guidance during LO and preclinical stage

BfArM (Bonn)
Excursion through relevant guidelines:
• What information/data are necessary in the different development stages