2014 Archived Content

PK/PD of Multi Domain Proteins

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 Safety Stream Brochure | Download Overall Event Brochure | Speaker Bios 

Recommended Pre-Conference Short Courses* 

Translational Strategies for Development of Monoclonal Antibodies from Discovery to Clinic, Part 1: Focus on Early Discovery - View Detailed Agenda 
& Part 2: Focus on Nonclinical Development to Clinic - View Detailed Agenda 

*Separate registration required. 



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 

Peter CR Emtage, Ph.D., Vice President, Immune Mediated Therapies, 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. 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


PK/PD, ADME and Molecular Construct Design 

11:05 Chairperson's Remarks

Joe Ponte, Ph.D., Senior Scientist, Immunogen, Inc.

11:10 OPENING KEYNOTE PRESENTATION: Application of PK/PD in Modality Design

MohammadTabriziMohammad 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

AlisonBettsAlison 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 Bioanalysis of Novel Antibody Constructs Approaches and Challenges

Abberley_LeeLee Abberley, Ph.D., Section Manager, Bioanalysis, DMPK, GSK

12:40 Luncheon Presentations (Sponsorship Opportunities Available) or Lunch on Your Own

1:40 Session Break



2:00 Chairperson's Remarks

K. Dane Wittrup, Ph.D., J.R. Mares Professor, Chemical Engineering & Bioengineering, Massachusetts Institute of Technology

2:05 Limits of Tumor Targeting in Immunotherapy: Theory & Experiment

DaneWittrupK. 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

IsabelFigueroaIsabel 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

KentaHarayaKenta 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 Applying PK/PD Principles to Optimize Development of Antibody Maytansinoid Conjugates

JoePonteJoe Ponte, Ph.D., Senior Scientist, Immunogen, Inc.

This talk will address current challenges in optimizing and developing ADCs and the role PK/PD can play in addressing some of the concerns.

4:05 Refreshment Break in the Exhibit Hall with Poster Viewing

4:45 Problem Solving Breakout Discussions

TABLE: How to Employ PK/PD Principles to Validate the Target for Novel Biologics

Dhaval K. Shah, Ph.D., Assistant Professor, Pharmaceutical Sciences, School of Pharmacy and Pharmaceutical Sciences, University at Buffalo

  • Discussions on different type of biologics in development i.e. ADCs, BiTE, DART etc.
  • How the plasma and tissue PK of these biologics affects target selection
  • Systems pharmacology principles to help decide on the optimal target

TABLE: Integrating Your Biologics Safety Strategy

Moderator: Peter Lloyd, Head, PK/PD, Biologics, Novartis

  • Impact of immunogenicity on analytical formats and PK and PD assays
  • Target expression and target turnover
  • The effect of target biology on PK behavior of mAbs

Additional Breakout to be Announced

5:45 Welcome Reception in the Exhibit Hall with Poster Viewing

6:45 End of Day


Day 1 | Day 2 | Download Safety Stream Brochure | Download Overall Event Brochure | Speaker Bios 

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