DIA 2016 Annual Meeting

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-615-L04-P; CME 1.25; IACET 1.25; RN 1.25

A recent French clinical trial resulted in one subject dead and five with severe health problems. The panel will examine how to best understand the risks in providing feedback to address participant safety, timelines, and costs.

Learning Objectives

Working with the sponsor, identify IP risks and best understand potential adverse events/serious adverse event (AE/SAE); Formulate a process to best address participant safety; Adapt to clinical information in addressing participant safety and timelines and cost of study.

Chair

William B Smith

Speaker

Panelist
Howard Greenberg, MD

Panelist
Thijs Van Iersel, MD

Panelist
Mary L. Westrick, PhD

Component Type: Session
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-554-L01-P; CME 1.25; IACET 1.25; RN 1.25

In this session, representatives from large pharmaceutical companies will present and discuss the science, current methodologies and achievements in their advanced clinical programs in the area of immuno-oncology. They will address what makes the difference to standard and targeted therapies, what has been learned by studying the interaction of the tumor and the immune system, and the predictors for patient response.

Part 2 is scheduled for Monday, June 27, 10:45AM-12:00PM.

Learning Objectives

Describe the most recent advances in cancer immunotherapy; Discuss the interaction of the tumor and the immune system; Identify predictors for patient response.

Chair

Holger G. Adelmann

Speaker

Overview of Immuno-Oncology
Ashok K. Gupta

Molecular Predictors of Response to Immuno-Oncology Therapeutics
Brandon Higgs, PhD

Opportunities and Challenges for the Use of Biomarkers in Anti-PD1/PD-L1 Immunotherapy
Ti Cai, PhD

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-562-L01-P; CME 1.25; IACET 1.25; RN 1.25

In this forum, the panelists will give a state-of-the-art overview of the exciting new area of cancer immunotherapies, the current learnings and methodologies, the benefits and challenges, as well as an outlook into the future.

Part 1 is scheduled for Monday, June 27, 2016, 8:30-9:45 AM.

Learning Objectives

Discuss examples of clinical implementation of biomarkers in the development of cancer immunotherapies; Describe what the future looks like for cancer immunotherapies; Explain the role of new technologies for companion diagnostics.

Chair

Holger G. Adelmann

Speaker

Panelist
Arnold B. Gelb

Panelist
Brandon Higgs, PhD

Panelist
Marc Theoret, MD

Component Type: Symposium
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-524-L05-P; CME 1.25; IACET 1.25; RN 1.25

This symposium examines the complex challenges encountered in special population study design. Appropriate management of specialty populations with comorbidities on multiple medications creates challenges in protocol design and enrollment to ensure patient safety and accurate and quality data.

Learning Objectives

Discuss strategies to adapt to industry trends and changing demands of special population studies; Identify options in protocol design and the process for screening patients with comorbidities and concomitant medications; Evaluate the impact of subject population on subject safety data and on assessment of drug safety.

Chair

William B Smith

Speaker

Special Populations in Clinical Pharmacology Studies: Evolving Challenges
William B Smith

Investigational Product and Drug-Drug Interactions in Specialty Populations with Comorbidities: Options in Addressing Safety, Data, Timelines, and Costs
Harry W Alcorn, JR, PharmD

Fast to Patient: Shifting from Healthy Volunteer to Patient Population
Richard Scheyer, MD

QTcF in Special Populations
Robert Kleiman

Component Type: Symposium
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-598-L04-P; CME 1.25; IACET 1.25; RN 1.25

Presentations will examine different but overlapping aspects of assuring safety and evaluating activity in early clinical development activities to enable rational clinical development, followed by an interactive discussion of potential future directions.

Learning Objectives

Discuss different aspects of including safety in early phase drug development processes; Identify aspects to be considered for risk assessments during a first-in-human study; Describe a dose selection process for cell and gene therapies to increase likelihood of efficacy; Explain recommended standards for operating an early phase CPU with staff training programs.

Chair

Howard Greenberg, MD

Speaker

Structured Risk Assessment and Risk Mitigation in First-in-Human Studies
Thijs Van Iersel, MD

Dose Finding for Cell and Gene Therapies: Is Safety the Main Driver?
Gopalan Narayanan, MD, FFPM, FRCP

Site Training as a Critical Key to Safety
Donna W. Dorozinsky

Component Type: Session
Level: Intermediate
CE: CME 1.00; IACET 1.00; RN 1.00

The session will address the nonclinical regulatory development of robust human tissue (HT) technologies/models, validation, applications and the possible future switch from in vivo animal models to HT technologies.

Learning Objectives

Discuss the acceptability of human tissue (HT) technologies data in support of clinical trials and MAA submissions; Identify nonclinical requirements for the use of data generated with HT technologies; Describe validation of models; Identify GLP requirements.

Chair

Michelle Cathian Beharry, MS

Speaker

Overcoming Barriers to Human Tissue Use for Safety Assessment
Anthony Holmes, PhD

The Use of Human Tissue Technologies in Support of Clinical Trials and Marketing Authorization Regulatory Submissions
Michelle Cathian Beharry, MS

Component Type: Symposium
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-525-L01-P; CME 1.25; IACET 1.25; RN 1.25

Analgesics are useful drugs but have limitations of effectiveness, safety, and tolerability in some patients. In this symposium, we will discuss why evaluating abuse deterrent opioids, drug interactions and targeting specific pain phenotypes are critical areas of analgesic research.

Learning Objectives

Discuss the benchtop/clinical evaluations required to assess abuse deterrent opioid formulations; Explain the challenges in evaluating drug-drug interactions between pain medications or withdrawal maintenance drugs and other drugs; Describe European Medicine Agency views on how particular biomarker methods can be used in the stratification of patient populations in neuropathic pain trials.

Chair

Beatrice Setnik, PhD

Speaker

Abuse Deterrent Opioids: Benchtop and Clinical Approaches to Testing Real World Drug Abuse
Beatrice Setnik, PhD

A Quantitative Approach to Understanding the Dynamic Interplay Between Pain and Concomitant Medications, and Genetics
Galina Bernstein, PhD

Proposal for the Use of Biomarker Methods to Enable Stratification of Patient Populations in Clinical Trials for Neuropathic Pain
Andrew Whiles, LLM, MBA

Component Type: Session
Level: Intermediate
CE: CME 1.00; IACET 1.00; RN 1.00

The need for biomarkers means that expertise in handling frozen samples is required. This session will present strategies and solutions to ensure both that frozen specimens are correctly collected and shipped and that they arrive in stable conditions at the lab where biomarkers can be reliably tested.

Learning Objectives

Discuss how handling of critical biological samples is essential to be able to rely on the lab results obtained after testing; Describe how to collect, handle, store and ship samples appropriately.

Chair

Hermann Schulz, DrMed

Speaker

Piecing Together a Successful Biomarker Strategy: A Catalyst for Precision Medicine
Paul Travis, MSc

Ensuring Sample Stability When Handling Biomarkers
Hermann Schulz, DrMed

Component Type: Forum
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

A moderated panel of phase 1 clinical research experts, representing sponsor, CRO and site perspectives, will identify and discuss several hot button issues that can provoke conflict between sponsors and sites or diminish conduct efficiency. Attendees will be invited to join in.

Learning Objectives

Recognize issues that can provoke sponsor/site conflict or diminish conduct efficiency when they arise in the course of preparing to conduct or conducting phase 1 studies; Discuss how to handle such issues with counterparts when they arise; Describe ways to formulate/negotiate when issues resolution.

Chair

Gary L. Steinman, MS

Speaker

Tales from the Front Lines: An Introduction
Gary L. Steinman, MS

Panelist
William B Smith

Panelist
Mary L. Westrick, PhD