Cambridge Healthtech Institute’s Second Annual
PK/PD of Multi-Domain Proteins
Bench to Bedside Translation of Bispecifics, ADCs, and Antibody Fragments
Part of the Tenth Annual PEGS: the essential protein engineering summit
May 5-6 2014 | Seaport World Trade Center | Boston, MA
Cambridge Healthtech Institute’s Second Annual PK/PD of Multi-Domain Proteins will address how PK/PD and ADME are driving molecular construct design, modeling for multiple targets, and unique characteristics of ADCs, bispecifics, and fragments. Risk management plans will be reviewed from study design to an impact assessment plan and experts will present integrated bioanalytical strategies for attendees to take back to their labs. Optimizing PK/PD is crucial to the clinical success of novel drug candidates; this event will help to ensure attendees move forward with the best analytical strategy for bench to bedside translation.
Day 1 | Day 2 | Download Brochure
7:00 am Registration and Morning Coffee
Plenary Keynote Session
8:30 Chairperson’s Opening Plenary Remarks
Kristi Sarno, Chair, Greater Boston Chapter, Women in Bio; Director, Business Development, Pfenex, Inc.
8:40 Harnessing the Patient’s Immune System to Combat Cancer
Bahija Jallal, Ph.D., Executive Vice President, MedImmune
With recent FDA approvals, modulation of the immune system is now a clinically validated approach in the treatment of some cancers. At MedImmune, the Oncology Department is developing assets and expertise in Immune Mediated Therapy of Cancer (IMT-C). The challenges from a drug development perspective are multi-fold. The talk will focus on the relevance of preclinical models and translational science to address key issues, including dose selection and rationale combinations.
9:25 Building Regeneron’s Pipeline: From Trap Technology to the VelocImmune Platform to Veloci-Next
George D. Yancopoulos, M.D., Ph.D., President, Regeneron Laboratories; CSO, Regeneron Pharmaceuticals, Inc.
George D. Yancopoulos, M.D., Ph.D., who is the Founding Scientist, President, Research Laboratories and Chief Scientific Officer of Regeneron Pharmaceuticals, one of the world’s top biotechnology companies, will discuss how he and his colleagues exploited a commitment to science and technology to start the company, withstand years of challenges and failures, and emerge with a pipeline of promising technologies and novel/biologics that are beginning to bring hope to countless patients and their families.
10:10 Grand Opening Coffee Break in the Exhibit Hall with Poster Viewing
11:05 Chairperson's Remarks
11:10 OPENING KEYNOTE PRESENTATION:
Application of PK/PD in Modality Design
Mohammad Tabrizi, Ph.D., Head & Senior Fellow, PK/PD, Merck
With scientific advances, it is now possible to rapidly and effectively generate highly tailored and specific antibody-based therapeutics that interact with a diverse array of soluble or cell-associated target antigens. Additionally, engineering advances have made it possible to generate modalities that bind two or more unique targets within a single molecular entity or deliver potent payloads to specific targets. In this presentation, application of PK/PD for the design of novel and specific modalities will be discussed.
11:40 Which Parameters Do I Need to Optimize for Design of a Successful Antibody-Drug Conjugate: A Modeling and Simulation Approach to Understand PK and PD Drivers of ADC Disposition and Response
Alison Betts, Modeling and Simulation Leader, Associate Research Fellow, Translational Research Group, Pharmacokinetics, Dynamics & Metabolism, Pfizer Global R&D
This presentation will include a review of the processes involved in cellular and whole body disposition of ADCs, along with novel experimental approaches to measure these processes. It will also show a proposed mechanistic model for predicting tumor payload concentrations of ADCs, and linkage to tumor regression data using a pharmacodynamic model of tumor growth and cell kill.
12:10 pm Sponsored Presentation (Opportunity Available)
12:40 Luncheon Presentation I (Sponsorship Opportunity Available)
1:10 Luncheon Presentation II (Sponsorship Opportunity Available)
1:40 Session Break
2:00 Chairperson's Remarks
2:05 Limits of Tumor Targeting in Immunotherapy: Theory & Experiment
K. Dane Wittrup, Ph.D., J.R. Mares Professor, Chemical Engineering & Bioengineering, Massachusetts Institute of Technology
Targeted agents such as immunocytokines are often developed with the intention of achieving improved therapeutic index via a compartment-specific targeting moiety. Simple PK/PD theoretical analyses of intravenously administered agents suggests that strong limits exist for this approach, and we have experimentally validated key predictions of this analysis.
2:35 Considerations for Design of Bispecific Modalities
Isabel Figueroa, Associate Principal Scientist, PK/PD, Merck
Bi-specific antibodies (BsAb) are based on the concept that the blockage or neutralization of two targets will result on superior drug performance when compared to monoclonal antibody therapy. However, their observed therapeutic effect will depend on the kind and extent of pharmacological interaction between the neutralization or binding of both targets. In this talk, we discuss how the BsAb properties theoretically impact their expected therapeutic performance.
3:05 PK Optimization and Preclinical PK of Novel Bispecific Antibody against FIXa and X for the Treatment of Hemophilia A
Kenta Haraya, Researcher, Chugai Pharmaceutical Co., Ltd.
A novel bispecific antibody against FIXa and X was generated for the treatment of hemophilia A. Clinical candidate, ACE910, was generated by improving the pharmacokinetics through minimizing non-specific binding and reducing isoelectric point. Preclinical study of ACE910 demonstrated long half-life and high subcutaneous bioavailability in cynomolgus monkey. Details of the preclinical pharmacokinetic analysis of this bispecific antibody will be discussed.
3:35 PK-PD Considerations in the Development of Antibody-Maytansinoid Conjugates
Joe Ponte, Ph.D., Senior Scientist, Immunogen, Inc.
4:05 Refreshment Break in the Exhibit Hall with Poster Viewing
4:45 Problem Solving Breakout Discussions
5:45 Welcome Reception in the Exhibit Hall with Poster Viewing
6:45 End of Day
Day 1 | Day 2 | Download Brochure