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Trk 04: Preclin Transl-Early Clin Dev [clear filter]
Monday, June 27
 

8:30am

#107: Fatal Drug Trials in Phase 1: Understanding Risk, Subject Safety, Timelines, and Cost
Limited Capacity seats available

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



Chair
avatar for William Smith

William Smith

CEO, Alliance for Multispecialty Research/NOCCR
William B. Smith, MD, FACC, is a Professor of Medicine at the University of Tennessee Medical Center in Knoxville, Tennessee. Dr. Smith is board certified in Nephrology, Internal Medicine, Cardiology and Critical Care. Dr. Smith is the President of New Orleans Center for Clinical... Read More →

Speakers
avatar for Howard Greenberg

Howard Greenberg

Medical Safety Officer, Janssen Research and Development, LLC
Dr. Greenberg is a Medical Safety Officer for Janssen Pharmaceuticals R&D, and Adjunct Associate Professor in the Department of Pharmacology & Experimental Therapeutics of Thomas Jefferson University. He is a Clinical Pharmacologist with education and experience in chemical engineering... Read More →
avatar for Mattheus Van Iersel

Mattheus Van Iersel

Senior Director, Scientific Affairs - Clinical Pharmacology, PRA Health Sciences
Dr van Iersel is an MD with 25 years of experience in clinical development. He is trained in Clinical Pharmacology in the UK and the Netherlands. Currently he is a Senior Director of Science at PRA. Previously he worked as Researcher at Urology and as Principal Investigator, Medical... Read More →
avatar for Mary Westrick

Mary Westrick

Adjunct Professor, University of Wisconsin
Dr. Mary Westrick holds a BS in Chem, and MS & PhD degrees in pharmacology from Purdue University. She has held leadership positions in Global Clinical Pharmacology at Covance, Astellas and Quintiles and currently teaches Project Management and Leadership in the MS Program in Biotechnology... Read More →


Monday June 27, 2016 8:30am - 9:45am
202AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

8:30am

#113: Clinical Developments in Immuno-Oncology, Part 1 of 2: Science, Current Methodologies, and Achievements
Limited Capacity seats available

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



Chair
avatar for Holger Adelmann

Holger Adelmann

Senior Vice President and Managing Director, DIA EMEA
Dr. Holger G. Adelmann, MD PhD. Board certified Clinical Pharmacologist. Clinical training in internal medicine. Several leading positions in pharma since 1989 with Bayer & Tropon (Germany), AstraZeneca (UK and Sweden), and Merck Serono (Germany). He is member of the American Association... Read More →

Speakers
TC

Ti Cai

Director, Global Clinical Biomarkers and Companion Diagnostics, EMD Serono
Ti Cai joined EMD Serono in March 2015 as Director, Clinical Biomarkers and Companion Diagnostics. He is currently leading clinical biomarker development for avelumab (anti-PD-L1 antibody) program. Prior to EMD Serno, Ti worked at Celgene, Sanofi and Amgen where he led biomarker research... Read More →
AG

Ashok Gupta

Vice President, Head of Clinical Immuno-Oncology, Medimmune
avatar for Brandon Higgs

Brandon Higgs

Director, MedImmune
Dr. Higgs leads the Bioinformatics function within Translational Medicine at MedImmune. He has 15+ years of industry experience in biomarker development within indications of oncology, autoimmunity, inflammation, CNS, and transplantation. He has a PhD in Computational Biology and... Read More →


Monday June 27, 2016 8:30am - 9:45am
108B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

10:45am

#135: Clinical Developments in Immuno-Oncology, Part 2 of 2: Clinical Implementation of Biomarkers
Limited Capacity seats available

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



Chair
avatar for Holger Adelmann

Holger Adelmann

Senior Vice President and Managing Director, DIA EMEA
Dr. Holger G. Adelmann, MD PhD. Board certified Clinical Pharmacologist. Clinical training in internal medicine. Several leading positions in pharma since 1989 with Bayer & Tropon (Germany), AstraZeneca (UK and Sweden), and Merck Serono (Germany). He is member of the American Association... Read More →

Speakers
avatar for Arnold Gelb

Arnold Gelb

Senior Director, Clinical Biomarkers and Companion Diagnostics, EMD Serono Research & Development Institute, Inc.
avatar for Brandon Higgs

Brandon Higgs

Director, MedImmune
Dr. Higgs leads the Bioinformatics function within Translational Medicine at MedImmune. He has 15+ years of industry experience in biomarker development within indications of oncology, autoimmunity, inflammation, CNS, and transplantation. He has a PhD in Computational Biology and... Read More →
MT

Marc Theoret

Associate Director of Immunotherapeutics, OHOP, OND, CDER, FDA
Dr. Theoret is a medical oncologist and the Associate Director of Immunotherapeutics in the Office of Hematology and Oncology Products, CDER, FDA. In his role as Associate Director, Dr. Theoret is leading initiatives in immuno-oncology product development—regulatory, scientific... Read More →


Monday June 27, 2016 10:45am - 12:00pm
108B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
 
Tuesday, June 28
 

10:30am

#212: Special Populations in Clinical Pharmacology Studies
Limited Capacity seats available

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



Chair
avatar for William Smith

William Smith

CEO, Alliance for Multispecialty Research/NOCCR
William B. Smith, MD, FACC, is a Professor of Medicine at the University of Tennessee Medical Center in Knoxville, Tennessee. Dr. Smith is board certified in Nephrology, Internal Medicine, Cardiology and Critical Care. Dr. Smith is the President of New Orleans Center for Clinical... Read More →

Speakers
avatar for Harry Alcorn

Harry Alcorn

Chief Scientific Officer, DaVita Clinical Research
Chief Scientific Officer for DaVita Clinical Research a CRO, located in Minneapolis Minnesota and Lakewood Colorado. He has served as PI on over 150 protocols and Sub Investigator on over 300 protocols which have included Renal (Full and Adaptive), Hepatic and Pulmonary, along with... Read More →
RK

Robert Kleiman

Chief Medical Officer and Vice President, Global Cardiology, ERT
Dr. Kleiman is a cardiac electrophysiologist who has performed research in both basic and clinical electrophysiology and practiced clinical electrophysiology for 12 years before joining ERT in 2003. Dr. Kleiman is currently ERT’s Chief Medical Officer, and works with pharmaceutical... Read More →
avatar for Richard Scheyer

Richard Scheyer

Vice President, Medical, Medpace
Dr. Richard Scheyer is VP Medical at Medpace. Prior to Medpace, he led Experimental Medicine, BM, and PGx functions at Daiichi Sankyo. He served in leadership roles at Sanofi-Aventis and CMO at Neurotrope Bioscience. Dr. Scheyer received his BS Physics from Stanford, MD from SUNY... Read More →


Tuesday June 28, 2016 10:30am - 11:45am
113A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

4:00pm

#260: A Risk-Benefit Approach to Planning Early Clinical Development
Limited Capacity seats available

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



Chair
avatar for Howard Greenberg

Howard Greenberg

Medical Safety Officer, Janssen Research and Development, LLC
Dr. Greenberg is a Medical Safety Officer for Janssen Pharmaceuticals R&D, and Adjunct Associate Professor in the Department of Pharmacology & Experimental Therapeutics of Thomas Jefferson University. He is a Clinical Pharmacologist with education and experience in chemical engineering... Read More →

Speakers
avatar for Donna Dorozinsky

Donna Dorozinsky

President, Just In Time GCP
Donna is a business consultant who has over 25 years of experience in study operations that includes clinical operations, safety, data management, biostatistics, clinical supply management, and TMF management. She encourages strategic thinking and implementation of solutions not only... Read More →
avatar for Mattheus Van Iersel

Mattheus Van Iersel

Senior Director, Scientific Affairs - Clinical Pharmacology, PRA Health Sciences
Dr van Iersel is an MD with 25 years of experience in clinical development. He is trained in Clinical Pharmacology in the UK and the Netherlands. Currently he is a Senior Director of Science at PRA. Previously he worked as Researcher at Urology and as Principal Investigator, Medical... Read More →
avatar for Gopalan Narayanan

Gopalan Narayanan

Biologics and Advanced Therapies Expert, NDA Group
Trained in Internal Medicine. Currently providing strategic support and advice to Biotech/Pharma companies on regulatory science primarily in Biotechnology, Cell and Gene Therapy. Previously Head of Biotechnology Unit, MHRA, UK and Expert Medical Assessor; Member of Committee for... Read More →


Tuesday June 28, 2016 4:00pm - 5:15pm
113C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
 
Wednesday, June 29
 

10:30am

#312: Human Tissue Models: A Look into the Future of Safety Pharmacology Studies
Limited Capacity seats available

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



Chair
avatar for Michelle Beharry

Michelle Beharry

Senior Non-Clinical Assessor, Medicines and Healthcare products Regulatory Agency (MHRA)
Michelle spent 4 years in the pharmaceutical Industry as a regulatory/investigative toxicologist, then joined the MHRA and is now a Senior Pharmaco-Toxicologist. Principally, this involves the assessment of nonclinical data for Clinical Trials and Marketing Authorisation applications... Read More →

Speakers
AH

Anthony Holmes

Head, Technology Development, NC3Rs
Anthony Holmes is Head of Technology Development at the NC3Rs. He oversees a programme of work focusing on the interface between academia and industry and the acceleration of technologies out of the science base and in to application to reduce animal use and address scientific and... Read More →


Wednesday June 29, 2016 10:30am - 11:30am
113C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

2:00pm

#338: Evolving Methods in Pain Trials: Evaluating Abuse Deterrence, Drug Interactions, and Appropriate Patient Selection
Limited Capacity seats available

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



Chair
avatar for Beatrice Setnik

Beatrice Setnik

Vice President, Clinical Pharmacology, Early Phase, INC Research
Dr. Setnik has been working in the area of CNS research and clinical drug development for over 16 years and is an expert in the area of abuse and dependence potential evaluation of drugs. Dr. Setnik is currently the Vice President of Clinical Pharmacology at INC Early Phase and oversees... Read More →

Speakers
avatar for Galina Bernstein

Galina Bernstein

Director of Pharmacometrics, Early Phase, INC Research
Dr Galina Bernstein received PhD in Biochemistry from Moscow State University, postdoctoral training from College of Pharmacy, U of Michigan, and pharmacokinetics training at Pfizer GRD PDM department. She has 15+ years’ experience in analytics, PK and PK/PD modeling for IVD, small... Read More →
AW

Andrew Whiles

Director, Regulatory Affairs, Pfizer Ltd
Andrew Whiles has 29 years’ regulatory experience in researching , registering and maintaining pharmaceuticals and devices on the market. Over the last four years he has focused on early development regulatory strategies from Phase 1 through to Proof of concept studies within the... Read More →


Wednesday June 29, 2016 2:00pm - 3:15pm
201A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

4:00pm

#360: Biomarkers and Sample Stability: Bottlenecks in Study Planning, Ensuring Sample Stability as the Key for Reliable Lab Results
Limited Capacity seats available

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



Chair
HS

Hermann Schulz

Executive Vice President, Synlab Pharma Institute
Before founding INTERLAB in 1994, Hermann Schulz held senior R&D positions in Pharma for 12 years. He was a Board member of the German Society of Pharmaceutical Medicine for 6 years, is visiting professor for applied clinical pharmacology and has written more than 35 scientific publications... Read More →

Speakers
avatar for Paul Travis

Paul Travis

Exec. Director, Medpace Global Labs, Medpace
Paul Travis MSc, Executive Director of Global Business Strategy at Medpace Laboratories. +25 years of Experience in R&D within the pharma and contract research industries. Attained MSc in Biomedical Science & began career with Ciba Geigy UK, working in early research and development... Read More →


Wednesday June 29, 2016 4:00pm - 5:00pm
105AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
 
Thursday, June 30
 

10:45am

#405: Hot Button Protocol and Operational Issues Between Sponsors and Sites in Clinical Pharmacology Studies
Limited Capacity seats available

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



Chair
avatar for Gary Steinman

Gary Steinman

President, Medexetech
Gary Steinman has degrees in Electrical & Systems Engineering from RPI where he also served on the faculty and as Director of the Center for Biomedical Engineering. He then joined the Stanford Cardiology Division, launched Pharmiya Medical Technologies in the People’s Republic of... Read More →

Speakers
avatar for William Smith

William Smith

CEO, Alliance for Multispecialty Research/NOCCR
William B. Smith, MD, FACC, is a Professor of Medicine at the University of Tennessee Medical Center in Knoxville, Tennessee. Dr. Smith is board certified in Nephrology, Internal Medicine, Cardiology and Critical Care. Dr. Smith is the President of New Orleans Center for Clinical... Read More →
avatar for Mary Westrick

Mary Westrick

Adjunct Professor, University of Wisconsin
Dr. Mary Westrick holds a BS in Chem, and MS & PhD degrees in pharmacology from Purdue University. She has held leadership positions in Global Clinical Pharmacology at Covance, Astellas and Quintiles and currently teaches Project Management and Leadership in the MS Program in Biotechnology... Read More →


Thursday June 30, 2016 10:45am - 12:00pm
107AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA