09:00 - 17:30 EST | 6.00 - 14.30 PST

* Please note that the following agenda timings are Eastern Standard Time.  

For Pacific Standard Times, please download the full event guide here

8:30 am Join Our Morning Coffee Chatroom to Get Started!

8:45 am Chair’s Opening Remarks

  • Ganesh Mugundu Head of Cell Therapy Clinical Pharmacology & Modelling, Takeda

Model Innovation for Cell Therapies

9:00 am Use of Humanized Mouse Models for Better Translation in Immunotherapy

  • Mari Kuraguchi Director, in vivo Pharmacology, Principal Scientist, Biocytogen

Synopsis

• The success of immunotherapy using immune checkpoint inhibitors has changed the practice of cancer treatment tremendously. However, there are still many translational challenges, and the development of humanized preclinical mouse models that faithfully recapitulate human conditions are critical to overcome these challenges
• Various kinds of immunologically humanized mouse models that have been developed, both humanized immune-checkpoint receptor mice and human immune system reconstitution models, and their applications will be discussed

9:30 am Blending Tumor Models and Engineering to Accelerate Natural Killer Cell Therapies in Glioblastoma Multiformel

  • Aaron Goldman Director, Drug Resistance Group, Harvard Medical School

Synopsis

• Engineering a therapeutic approach to boost NK cell ligands on tumor cells
• Using a physiologically relevant 3-D blood brain barrier in-vitro model to screen optimal drug delivery mechanisms
• Human and mouse ex-vivo tumor models confirm a therapeutic dosing strategy
• Boosting NK cell ligands to improve efficacy of NKG2Ddriven cell therapies in GBM tumor models

9:50 am Orthotopic PDX Models Provide Relevant Tumor Microenvironments For Evaluating Cellular Therapies

Synopsis

• The site of tumor implantation can affect tumor growth, vascularization, and sensitivity to anti-tumor treatments
• Orthotopic implantation of tumors provides a different microenvironment than subcutaneous implantation

10:30 am Speed Networking

Synopsis

A chance for those coffee table conversations. Randomized 1-2-1 meetings with your peers to grow your network.

10:50 am Morning Networking Break & 1-2-1 Meetings

Synopsis

Take this opportunity to meet with our expert partners for 1-2-1 meetings to find out about their latest innovations.

11:00 am Conditionally Active COBRA T Cell Engagers Regress stablished Solid Tumors in Mice

  • Chad May Senior Vice President, Research & Development, Maverick Therapeutics

Synopsis

• Solid tumor directed T-cell engagers are limited by target expression on healthy tissues
• COBRA platform is engineered to restrict T-cell engagement to within the tumor microenvironment
• The COBRA T cell engager design allows for the pursuit of more broadly expressed and validated targets

11:20 am Understanding the Mechanistic Actions & Development of IL-15Rβγ Agonist

Synopsis

• Address the challenges in preclinical testing of molecules activating immune system
• Limitations of models and how to define the right strategy and assumptions in preclinical studies
• Lessons learned and future testing approaches

11:40 am Novel Preclinical Models for Investigation of Immune Oncology Therapeutics

Synopsis

• Advancements in modelling tumor regression
• New models for looking at tumor metastasis
• Insights gained from preclinical metastasis studies

Assessing Tumor Regression, Metastasis & Mechanisms

12:00 pm Live Q&A – Ask Our Speakers Your Burning Questions

12:20 pm Scientific Poster Session & Lunch Break

Synopsis

Connect with your peers and head to our poster competition to share your latest and greatest cell therapy research!

1:20 pm Panel: Diversity & Inclusion in Preclinical & Translational Studies

Synopsis

This panel presents an opportunity for the preclinical and translational communities to discuss diversity and inclusion initiatives. The industry needs to strive for better. The panel will be a platform for discussion and will allow the full potential of teams to be reached.

Guiding Clinical Design

2:00 pm Bench to Bedside Translation of Chimeric Antigen Receptor (CAR) T Cells Using a Multiscale Systems PKPD Model

  • Aman Singh Associate Director, Clinical Pharmacology M&S, Takeda

Synopsis

• Discuss multiscale mechanistic PKPD modelling framework for anti-BCMA
• (bb2121) CAR-T cell therapy to characterize:
• In vitro target cell killing in multiple BCMA expressing tumor cell lines at varying E:T ratios
• Preclinical in vivo tumor growth inhibition (TGI) and blood CAR-T cell expansion in xenograft mice
• Clinical PK and PD biomarkers in multiple myeloma (MM) patients

2:20 pm Translating Pre-Clinical Data into Innovative Clinical Trial Designs in Cell Therapies

  • Markus Vallaster Senior Medical Director, Cell Therapies & Immuno-Oncology, AstraZeneca

Synopsis

• Inform your preclinical decisions with clinical trial in mind
• Extrapolate the best data to guide clinical design
• Guide innovation and further candidate progression

2:40 pm Clinical Pharmacology of Tisagenlecleucel in Adult Relapsed/ Refractory DLBCL Patients

  • Rakesh Awasthi Clinical Pharmacology, Pharmacokinetic Oncology Sciences & Investigator, Novartis

Synopsis

• Characterization of in vivo cellular kinetics of tisagenlecleucel
• Investigate the correlation of cellular kinetics with clinical and safety endpoints
• Indication-specific differences in expansion of CAR T cells

3:00 pm Clinical Dosing – Clinical Pharmacology & Modelling of Cell Therapies

  • Ganesh Mugundu Head of Cell Therapy Clinical Pharmacology & Modelling, Takeda

Synopsis

• Review current practices in starting dose, dose escalation and RP2D Decision
• Exposure (cellular kinetics) and response safety, efficacy and biomarkers) relationships and various patient/product factors
• How to use model informed drug development approaches to enhance clinical dose decisions

3:20 pm Live Q&A – Ask Our Speakers Your Burning Questions

  • Ganesh Mugundu Head of Cell Therapy Clinical Pharmacology & Modelling, Takeda
  • Markus Vallaster Senior Medical Director, Cell Therapies & Immuno-Oncology, AstraZeneca
  • Aman Singh Associate Director, Clinical Pharmacology M&S, Takeda
  • Rakesh Awasthi Clinical Pharmacology, Pharmacokinetic Oncology Sciences & Investigator, Novartis

3:40 pm Chair’s Closing Remarks & End of Summit

  • Ganesh Mugundu Head of Cell Therapy Clinical Pharmacology & Modelling, Takeda