PK/PD of Novel Constructs 

Scientific Advisory Board

Balaji Agoram, Ph.D., Director, Clinical Pharmacology, MedImmune

Dhavalkumar K. Shah, Ph.D., Assistant Professor, Pharmaceutical Sciences, School of Pharmacy and Pharmaceutical Sciences, SUNY Buffalo


Understanding the metabolism of novel constructs in animal models and clinical studies is critical to their success. This year’s conference will cover the role of PK in optimizing novel constructs, look at opportunities for improvement of antibody-drug conjugates, share examples of implementing mechanistic modeling to inform drug design, and review the state-of-the-art techniques for applying multi-specific medicines. Drafting successful PK/PD principles and translating candidates from preclinical development to the clinic will be developed.

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Monday, November 11

7:30 am Registration and Morning Coffee

8:30 Chairperson’s Opening Remarks

Nahor Haddish-Berhane, Ph.D., Senior Principal Scientist, Pfizer

Clinical Experience with PK/PD of Novel Constructs 


8:40 Impact of Brentuximab Vedotin in the Treatment of Lymphoma

Ranjana AdvaniRanjana Advani, M.D., Saul A. Rosenberg Professor of Lymphoma, Professor of Medicine/Oncology, Stanford Cancer Institute

The recent FDA approval of Brentuximab vedotin (ADCETRIS®) an anti CD 30 antibody drug conjugate represents a major therapeutic advance in Hodgkin Lymphoma and Anaplastic Large Cell Lymphoma therapy after almost three decades. Pivotal trials report overall response rates exceeding 70% in patients with relapsed or refractory disease. These results, have led to investigation of Brentuximab vedotin in the front line setting in combination with chemotherapy and is rapidly changing the standard of care of CD30-positive lymphoproliferative malignancies.

9:25 Trends in Novel Constructs: Quality Attributes That May Impact PK or Mechanism of Action

Marjorie A. ShapiroMarjorie A. Shapiro, Ph.D., Chief, Laboratory of Molecular and Developmental Immunology, Division of Monoclonal Antibodies, FDA/CDER

Current trends in antibody development include novel constructs, cocktails, antibody-drug conjugates and Fc engineering to enhance or reduce effector function or to enhance PK.   This presentation will highlight current trends in MAb development with a focus on analytical studies and control strategies to support the development of novel products. – Read Exclusive Interview - Getting FDA Approval for ADCs and Bispecifics 

10:05 Sponsored Presentation (Opportunity Available)

10:35 Coffee Break in the Exhibit Hall with Poster Viewing

Nonclinical PK/PD of ADCs: Where Are the Opportunities for Improvement? 

11:10 Chairperson's Remarks

Nahor Haddish-Berhane, Ph.D., Senior Principal Scientist, Pfizer

11:15 PK-PD Considerations in the Development of Antibody-Maytansinoid Conjugates

Jan PinkasJan Pinkas, Ph.D., Director, Pharmacology, ImmunoGen, Inc.




11:45 Exploiting the Properties of Fleximer™ to Improve Pharmacokinetics: Applications to Small Molecules, Biologicals, and Antibody-Drug Conjugates

Timothy B. LowingerTimothy B. Lowinger, Ph.D., CSO, Mersana Therapeutics

Fleximer is a highly biocompatible, fully biodegradable polyvalent polymer with unique properties, which include tremendous water solubility, plasma stability, and the ability to improve pharmacokinetics and biodistribution. Examples of the application of Fleximer to improve the drug-like qualities of proteins, small molecules and antibody-drug conjugates will be presented.

12:15 pm Sponsored Presentation (Opportunity Available)

12:45 Luncheon Presentations (Sponsorship Opportunities Available) or Lunch on Your Own

Use of Mechanistic PK/PD Modeling 

2:15 Chairperson’s Remarks

Nahor Haddish-Berhane, Ph.D., Senior Principal Scientist, Pfizer

2:20 Does It Take Two or Four to Tango? Modeling & Simulation of Bispecific Antibodies in Oncology

Tamara Van SteegTamara Van Steeg, Ph.D., Senior Consultant PK/PD, LAP&P Consultants BV

Modeling and simulation is a powerful tool to aid understanding in complex systems with multiple interactions. As such, M&S is especially useful in the development of bispecific antibodies by assessing the interactions of these molecules with its biological target already at an early stage. The interplay of M&S activities, experimental data and available knowledge on the system (e.g. receptor densities) will provide guidance on the strategies for further development of these drugs.

2:50 Could We Have a Ballpark Idea about Tumor Targeting Priorto the Accurate Measurement?

Guozheng LiuGuozheng Liu, Ph.D., Research Assistant Professor, Radiology, University of Massachusetts Medical Center

This talk introduces a very simple kinetic model that considers a solid tumor as a “reactor,” aiming to prepare researchers to get some information about tumor accumulation with less efforts or prior to feasible measurement. It will rationalize the authors’ observations on tumor accumulation by pretargeting, summarize them into “rules of thumb”, and provide some general insights to tumor accumulations.

3:20 Refreshment Break in the Exhibit Hall with Poster Viewing

4:00 Guiding ADC Development by Employing PK/PD Modeling and Simulation Approaches

Nahor Haddish-BerhaneNahor Haddish-Berhane, Ph.D., Senior Principal Scientist, Pfizer

The talk will highlight a diverse set of multi-scale models, including a PBPK model for ADC, which can used to support ADC programs at various development stages. Two different case studies will be presented to demonstrate the utility of PK/PD models for preclinical-to-clinical translation of ADC efficacy. Use of mathematical models to guide the discovery of ADC and precision medicine approach will be briefly discussed.

4:30 PK/PD Modeling to Determine Individual Dose Response

Rakesh SindhiRakesh Sindhi, M.D., Professor of Surgery, Co-Director, Pediatric Transplantation, Children’s Hospital of Pittsburgh

Anticipating efficacy and safety before early or late phase clinical trials can promote informed use of novel drugs and regimens. PK/PD modeling of immunosuppressant(s) using ex-vivo cell-based assays will be discussed to illustrate several uses for clinical drug development. These uses include identifying effective doses and biomarkers which can be used as companion diagnostics and surrogate endpoints.

5:00 pm Panel Discussion with Speakers

5:30 Welcome Reception in the Exhibit Hall with Poster Viewing

6:30 End of Day One of PK/PD of Novel Constructs

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Celebrating 25 years