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Tuesday, June 28
 

10:30am EDT

#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 EDT
113A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 04: Preclin Transl-Early Clin Dev, Symposium

4:00pm EDT

#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 EDT
113C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 04: Preclin Transl-Early Clin Dev, Symposium
 
Wednesday, June 29
 

2:00pm EDT

#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 EDT
201A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 04: Preclin Transl-Early Clin Dev, Symposium
 
Thursday, June 30
 

10:45am EDT

#403: Running Personalized Medicine Trials: Facts and Figures
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-516-L01-P; CME 1.25; IACET 1.25; RN 1.25

Personalized medicine is a hot topic in drug development. But how exactly do you run trials with a personalized medicine target in mind? Is there a different way to plan for trial operations when you must include only those patients who express a biomarker? What are the implications to running a trial when you're testing a biomarker hypothesis in the trial itself, instead of using a validated biomarker? And how do you effectively partner with CROs to execute these plans? This session will offer industry-wide data on current trends and findings and insights on the pitfalls and opportunities of personalized medicine trials, as well as share experiences of running many trials with the goal of developing truly personalized medicines.

Learning Objectives

Define personalized medicine and share industry-wide data about the use of personalized medicine strategy in clinical trials; Describe regulatory insights and perspectives on operationalizing trials with personalized medicine objectives; Discuss lessons learned and tips to successfully run trials with personalized medicine endpoints.

Chair

Jane E. Myles, MS

Speaker

Challenge and Change in Personalized Medicines: A Survey of Industry Perspectives
Christopher Paul Milne

FDA Perspective
Michael Pacanowski, PharmD, MPH

Clinical Operations Perspective
Caoimhe Vallely Gilroy



Chair
avatar for Jane Myles

Jane Myles

Head, Decentralized Trials Implementation, Covance
Jane is driving the global impmenentation of decentralized trials at Covance with a team of tech and trial experts. She is the Founder of JemTech consulting and the former Head, Operational Intelligence and Innovation for Roche, working at Genentech. Her passion is driving innovation... Read More →

Speakers
avatar for Caoimhe Vallely Gilroy

Caoimhe Vallely Gilroy

Biomarker Operations Therapeutic Area Leader, I2ON, Roche
Caoimhe is a Biomarker Operations Therapeutic Area Leader in immunology, infectious diseases, ophthalmology and neuroscience at Roche UK, leading a team of biomarker operational experts in the execution of late stage clinical trials, with complex biomarker strategies. Caoimhe has... Read More →
avatar for Christopher Milne

Christopher Milne

Director of Research and Research Associate Professor, Tufts Center for the Study of Drug Development
Dr. Milne is currently Director of Research at Tufts CSDD, Research Associate Professor at Tufts Univ. School of Medicine, Innogen Center Associate (Univ. of Edinburgh), as well as a member of the editorial boards of DIA’s journal (TIRS) and Pharma Focus Asia. His research interests... Read More →
MP

Michael Pacanowski

Associate Director for Genomics and Targeted Therapy, OCP, CDER, FDA
Dr. Pacanowski is the Associate Director for Genomics and Targeted Therapy in the Office of Clinical Pharmacology at FDA. His team of translational scientists works to advance the use of pharmacogenomics and other biomarker innovations in drug development through review of investigational... Read More →


Thursday June 30, 2016 10:45am - 12:00pm EDT
108B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 01: Clinical Operations, Session

10:45am EDT

#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 EDT
107AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 04: Preclin Transl-Early Clin Dev, Forum