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2014 Archived Content

Interactive Breakout Discussions

Concurrent breakout discussion groups are interactive, guided discussions hosted by a facilitator or set of co-facilitators to discuss some of the key issues presented earlier in the day's sessions. Delegates will join a table of interest and become an active part of the discussion at hand. To get the most out of this interactive session and format please come prepared to share examples from your work, vet some ideas with your peers, be a part of group interrogation and problem solving, and, most importantly, participate in active idea sharing. Continental breakfast will be served.

Thursday, May 22 | 7:30 – 8:30am


Table: HTS Approaches for Early Cardiac Liability Evaluation

Moderator: Heribert Bohlen, M.D., CEO, Axiogenesis AG

  • HTS of Calcium transients for early toxicity screens
  • Functional cardiac liability: Comparison of iPSC derived cardiomyocytes vs. cell lines
  • Functional and structural cardiotoxicity using label free analysis

Table: Preclinical Testing of Combination Therapy

Moderator: Alex Cao, Ph.D., Director, Oncology Translational Pharmacology, OTM, Novartis Oncology

• Combination therapies targeting dominant driver axis, and/or feedback pathway(s)
• Key technologies and approaches
• Case studies

Table: The Co-Clinical Trial Paradigm

Moderator: Andrew L. Kung, M.D., Ph.D., Director, Pediatric Hematology, Oncology and Stem Cell Transplantation, New York-Presbyterian Morgan Stanley Children’s Hospital, Columbia University Medical Center

  • Key Technologies and Approaches
  • Case Studies

Table: PDX: Patient Derived Xenografts; Promises and Challenges

Moderator: Emily Hickey, Corporate Vice President, in Vivo Discovery, Charles River  

  • Annotation and characterization
  • Predictive Value: More translational than standard cell-line xenografts
  • Advantages & challenges to apply PDX models in preclinical trials

Table: Theranostic Imaging

Moderator: Thomas Reiner, Ph.D., Assistant Member, Memorial Sloan-Kettering Cancer Center; Assistant Attending Chemist, Radiochemistry & Imaging Sciences Service; Assistant Professor, Weill Cornell Medical College

  • "Theranostic Imaging" - a novel way to treat and diagnose patients?
  • What are theranostic imaging agents?
  • What might be the clinical impact of theranostic imaging agents be?

Table: Effective Utilization of Predictive In Vitro Models for Safety

Moderators: Bernard Fermini, Ph.D., Associate Research Fellow, Global Safety Pharmacology, Pfizer Global Research & Development Yvonne Will, Ph.D., Associate Research Fellow, Compound Safety Prediction, Pfizer Global Research & Development

  • In vitro models for Cardiac Safety Testing
  • New models for predicting hepatotoxicity
  • Assays for assessing mitochondrial toxicity

Table: Safety Concerns Around Biologics Drug Development

Moderators:Joerg Bluemel, Ph.D., Director, Toxicology, Biologics Safety Assessment/Translational Sciences, MedImmune LLC Lawrence J. Thomas, Ph.D., DABT, ATS, Senior Director, Preclinical Research and Development, Celldex Therapeutics Inc.

  • Differences in safety testing between small molecules and biologics
  • Criteria for dose and species selection
  • Regulatory guidelines and recommendations

Table: Tackling Translational Challenges in Drug Safety Testing

Moderator: Siddhartha Bhatt, Ph.D., Senior Scientist, Global Safety Pharmacology, Drug Safety Research and Development, Pfizer Inc.

Table: Why Can’t We Bring More Solid Dispersions to Market?

Moderator: Robert A. Bellantone, Ph.D., Associate Professor, Division of Pharmaceutical Sciences, Arnold & Marie Schwartz College of Pharmacy and Health Sciences, Long Island University; President, Physical Pharmaceutical LLC

  • We have been studying solid dispersions for approximately five decades, why do we still not know how to control them?
  • What do we need to learn before we can make these systems work for more drugs?
  • Is there a knowledge gap between the solid state stability and dissolution performance?

Table: Selecting the Right Excipients and Understanding Their Impact on Oral Drug Bioavailability

Moderator: Ajit S. Narang, Ph.D., Senior Research Investigator, Drug Product Science & Technology, Bristol-Myers Squibb Co.

  • How does drug self-association/micellization impact oral drug absorption and its modeling?
  • When does drug excipient binding impact oral drug absorption? How can these be assessed experimentally?
  • What could be the mechanistic reasons for variability in oral drug absorption, and how could these be investigated experimentally? What value do these studies add to the drug development process and decisions?

Table: The Utility of Preclinical Animal Models in Predicting Human Absorption

Moderator: Ayman El-Kattan, Ph.D., Associate Research Fellow, Pharmacokinetic Dynamics & Metabolism, Pfizer, Inc.

  • Overview of species differences in physiological/anatomical impact on oral absorption/first pass
  • Assessment of the species differences in transporters/metabolizing enzymes impact on oral absorption
  • Recommendation on approach to project human absorption

Table: Microfluidics as Emerging Technology in Development of Poorly Soluble Drugs

Moderator: Sabiruddin Mirza, Ph.D., Sr. Research Associate, School of Engineering & Applied Science, Harvard University

  • What are the advantages of microfluidics based technologies over the more traditional ones?
  • Application and advantages of microfluidics in early stage development
  • Where is this field progressing and what are the other examples of application of microfluidics technologies in drug delivery?

Table: Evaluating and Validating Animal Models of Pain

Moderators: Edward Bilsky, Ph.D., Professor of Pharmacology and Vice President for Research and Scholarship, University of New England Kathleen Sluka, Ph.D., Professor, Department of Physical Therapy and Rehabilitation Science, University of Iowa

  • Are we making progress on the animal models?
  • Are the fundamental ways of measuring pain relief improving?
  • What are the benchmarks for assessing progress in preclinical development?

Table: Use of Imaging for Developing Pain Therapeutics

Moderators: Craig Ferris, Ph.D., Professor, Department of Psychology and Pharmaceutical Sciences, Director, Center for Translational NeuroImaging, Northeastern University David A. Seminowicz, Ph.D., Assistant Professor, Department of Neural and Pain Sciences, University of Maryland School of Dentistry

  • Extrapolation from rodent to human brain circuits
  • Imaging spontaneous versus evoked pain
  • Imaging anesthetized versus awake animals
  • Pain biomarkers
  • Stress and pain

Friday, May 23 | 7:30 – 8:30am

Topic: Syngeneic Models and Their Applications

Moderator: Michelle Morrow, Ph.D., Research Scientist II, Medimmune

  • Validation of murine syngeneic tumor models
  • Genetic and cellular characterization of syngeneic models
  • Major applications (tumor types and therapy types)

Topic: Cancer Vaccines

Moderator: Vincent K. Tuohy, Ph.D., Mort and Iris November Distinguished Chair in Innovative Breast Cancer Research, Staff, Department of Immunology, Cleveland Clinic

  • How early can we apply immune control of adult onset cancers?
  • What synergies can optimize control of adult onset cancers?
  • Should vaccines be customized and targeted to specific tumor subtypes?

Topic: Autochthonous Tumor ModelsProf. Benoît Van den Eynde, M.D, Ph.D., Branch Director, Ludwig Institute for Cancer Research, Université Catholique de Louvain, Brussels, Belgium 

Topic: Organ’s on Chip

Moderator: Dongeun (Dan) Huh, Ph.D., Wilf Family Term Assistant Professor, Bioengineering, UPENN

Design principles for the development of organs-on-chips
Current state-of-the-art of organs-on-chips
Potential of organs-on-chips for cancer research

Topic: Microfluidic 3D Cell Culture and Its Applications

Moderator: Amir R. Aref, Ph.D., Department of Cancer Biology & Medical Oncology, Dana-Farber Cancer Institute
3D Models for drug Screening
High-Content Analysis of 3D Models
Functional Analysis and Target/ Validation With 3D Models
Complex Models of tumor Microenvironment

Topic: Safety Screens for Epigenetic Drugs

Moderators: Jatinder Singh, Ph.D., Principal Scientist, Drug Safety and Metabolism, AstraZeneca Pharmaceuticals Paul Vancutsem, D.V.M., Ph.D., Senior Director, Toxicology and DMPK, Constellation Pharmaceuticals

  • Epigenetics and genetic toxicology
  • Epigenetics and reproductive toxicity
  • Epigenetics and carcinogenicity
  • Risk/benefit for epigenetic drugs: developmental and regulatory considerations for oncology v/s non-oncology

Topic: Opportunities of High-Content Analysis (HCA) for Epigenetic Screening

Moderators: Brian Reid, Ph.D., Director, High-Throughput and High-Content Screening Core Facility, University of Colorado Denver Jian Tajbakhsh, Ph.D., Program Leader, Translational Cytomics, Head, Chromatin Biology Laboratory, Cedars-Sinai Medical Center

  • Advantages of HCA in comparison to molecular screening approaches
  • Cost benefits of HCA for high-throughput screening
  • Necessary improvements needed in HCA to make it more competitive

Topic: On the Road from Lab to Filing

Moderator: Matthew M. Ravn, Ph.D., Senior Scientist III, Process R&D, GPRD Development Sciences, Abbvie

Approaches to the design and justification of the regulatory control strategy vary significantly at different companies. This roundtable will be an open forum for discussing approaches to the design, and successes and failures in presentation to regulatory bodies, of elements that define the drug substance manufacturing process and associated control strategy. Please be prepared, as able, to share your approaches and experiences in moving processes from development to filing.

  • Mechanisms (risk assessments / criticality assessments) to defining the control strategy: How are critical parameters, in-process controls, material attributes, implicit design elements selected?
  • Specification or not: Successes / failures in presentation of drug substance critical quality attributes (CQAs) which are ensured by upstream controls.
  • Approaches to defining CQAs: Successes / failures in excluding a drug substance characteristic from the CQAs.

Topic: Incorporating Flow Chemistry into Process R&D

Moderators: Bryan Li, Ph.D., Associate Research Fellow, Chemical R&D, Pfizer Pharmaceutical Science Timothy Braden, Process Chemistry Group, Chemical Product R&D, Eli Lilly and Company

  • What is the appropriate level of Process Analytical Technology that must/should be in place for a continuous process during development? During production?
  • Which is a better value proposition: designing flow chemistry into processes early, or going after post approval changes to exisiting commercial processes?
  • What types of continuous reactions or work-ups are the most difficult to scale?
  • What is a suitable technical package when taking a flow process to a vendor?
  • What are the process safety testing requirements for a flow process? What are the current practices in different companies?

Topic: Process Control Justifications

Moderator: Joerg Deerberg, Ph.D., Senior Research Investigator, Chemical Development, Bristol-Myers Squibb Co

  • Success or failures in experimental models – pathway to file and do they provide regulatory flexibility?
  • How does interpretation of QbD impact execution of Process Control Justficiations (PCJ)?
  • PCJ experimental approaches - forward (process), backward (risk assessment) or somewhere in between?
  • Success or failures on incorporation of PAT into PCJ and process validation.



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