Day One

29 February 2012

8.00 Registration, Coffee & Networking

8.50 Chair’s Opening Remarks

Alain Beck, Director, Physico-Chemistry Department, Centre d’Immunologie Pierre Fabre

9.00 Antibody Drug Conjugates: Past, Present and Future

• Charting the evolution of ADCs and of the market landscape
• A guide to the leading companies, target antigens and payloads
• Gaining insight into most relevant features from ADC failures

Alain Beck, Director, Physico-Chemistry Department, Centre d’Immunologie Pierre Fabre

9.30 Antibody-Maytansinoid Conjugates (AMCs): Lessons Learned from Clinical Evaluations Over the Past Decade

• Introduction to the clinical development of AMCs, using T-DM1 and SAR3419 as examples
• Assessing AMCs potential for clinically significant myelosupression at MTD
• What factors could potentially predict clinically active compounds?

John Lambert, EVP & CSO, ImmunoGen

10.00 Adcetris (brentuximab vedotin) Success Story: From the Bench to Approval

• Lessons learned from the US regulatory process for Adcetris
• What market potential do ADCs hold in Europe?
• Achieving a successful commercialisation strategy?

Antonio Gualberto, Group Head, Clinical Research, Millennium

10.30 Morning Refreshments & Speed Networking 

Advances In Conjugation Techniques

11.45 Site Selective Conjugation and its Application to Generating Well Defined ADC Molecules

• Description of a new site selective bioconjugation protocol
• Analytical characterisation of ADC conjugates
• In vitro and in vivo profiling of ADC conjugates and comparison with current industry benchmarks

Abhijit Bhat, Head of Research in Oncology, CovX Research (Pfizer)

12.15 Novel Site-Specific Antibody Drug Conjugates Based on EuCode Technology: A Novel Amino Acid Incorporation Technology in Mammalian Cells

• Site-specific conjugation of payloads to achieve homogenous ADCs with novel amino acids
• Do NDCs have improved pharmaceutical properties over conventional antibody drug conjugates?

Feng Tian, Associate Director, Ambrx

12.45 Lunch

13.45 Preclinical Development Progress of ADCs Based on Novel Potent Payload Linker-Drug Technology

• Optimising unique linker chemistry
• ADC & payload stabilities in plasma, cleavage kinetics and in vivo therapeutic window aspects for ADCs
• Latest results of preclinical developments, efficacy & safety

Vincent de Groot, Vice President, Synthon

Optimising The Pharmacokinetics And in vivo Behaviour Of ADCs

14.15 Clinical Pharmacology and Pharmacometric Considerations in the Development of ADCs

• Impact of linker, cytotoxic drug, and mAb on safety and PK
• Preclinical and clinical pharmacokinetics to determine drug-drug interaction, QT, organ impairment and comparability

Manish Gupta, Associate Director, Clinical Pharmacology & Pharmacometrics, Bristol-Myers Squibb

14.45 Stability of Thioether-Linked ADC: Mechanistic Investigation of ex vivo Cleavage of Thioether Linkages

• Identification of a novel pathway for ex vivo maytansinoid release from thioether linked AMCs
• Oxidised thioether-linked AMCs exhibit high, targetspecific cytotoxicity toward cancer cells

Rajeeva Singh, Director, ImmunoGen

15.15 Afternoon Refreshments

15.45 Optimising Design and Translational Strategy of ADCs through Fit for Purpose Modeling and Simulation

• Mechanistic PK/PD model to predict intracellular tumour payload concentration and relate to tumour regression
• Prediction of clinically efficacious concentrations of ADCs and therapeutic window

Alison Betts, Senior Principal Scientist, Pfizer

Considerations For Effective Process Development Of ADCs

16.15 Next Generation ADCs: CMC Challenges and Strategies

• Optimising ADC drug like properties
• Reducing ADC heterogeneity and batch consistency

Alain Beck, Director, Physico-Chemistry Department, Centre d’Immunologie Pierre Fabre

16.45 Considerations in the Development of Antibody-Drug Conjugate Processes

• Considerations for the ADC process development strategy
• Case study: Overcoming the challenges in the development of ADC processes

Mike Sun, Associate Director, Seattle Genetics

17.15 Chairman’s Closing Remarks

19.00 Networking Dinner

Share discussions with your peers and enjoy a relaxing and informal dinner in comfortable surroundings.