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Monday, June 27
 

8:30am EDT

#102: Digital Health Debate
Limited Capacity seats available

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

The Digital Debate will bring together expert representatives from sponsor, site, CRO and marketing perspectives to debate the merits of digital media for patient recruitment and retention. We will discuss the challenges and optimal scenarios for utilizing digital channels to recruit patients.

Learning Objectives

Discuss insights from sponsors, CROs, and sites on their past and planned use of digital media for patient recruitment; Describe the challenges faced in implementing digital media for patient recruitment; Address issues in coordinating digital media campaigns among the entities and in integrating digital with traditional campaigns; Identify possible methods to overcome organizational barriers to effectively implement digital campaigns for patient recruitment.

Chair

Nariman Nasser

Speaker

Move from Pilot to Platform: Four Strategies to Enable Digital Health Approaches to Scale in Research Programs
John Reites

mHealth in Clinical Research and Development: Is It All Hype?
Brett Villagrand

Site Perspective
Joshua R. Korzenik, MD



Chair
avatar for Nariman Nasser

Nariman Nasser

Digital Strategist, Operational Intelligence and Innovation, Roche
Nariman Nasser is Digital Strategist of Operational Intelligence and Innovation at Roche/Genentech. She previously was the Senior Director of Participant Recruitment & Study Management Services at UCSF's Clinical & Translational Science Institute. Ms. Nasser’s prior experience also... Read More →

Speakers
JK

Joshua Korzenik

Director, Crohn's and Colitis Center, Brigham and Women's Hospital
avatar for John Reites

John Reites

Senior Director, Head of Digital Health Acceleration, Quintiles Inc.
As the Head of Digital Health Acceleration, John Reites is focused on partnering and executing digital health innovation programs with biopharmaceutical companies, established innovators, start-ups and VC firms. Mr. Reites is a speaker and author of various publications, providing... Read More →
avatar for Brett Villagrand

Brett Villagrand

Principal, Carethings
Brett’s passion is for how innovation in technology can impact outcomes for patients. Most of his career was with Pharmaceutical companies Novartis and Genentech in product development and marketing roles. Until recently, was hired as an industry subject matter expert at Oracle... Read More →


Monday June 27, 2016 8:30am - 9:45am EDT
113A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 01: Clinical Operations, Forum

8:30am EDT

#109: EHR in Clinical Research: Heralding a New Era
Limited Capacity seats available

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

This session will focus on the work completed by the CDISC EHR-to-CDASH (E2C) team mapping data from EHR into EDC as eSource. Ongoing studies will be profiled. Representatives from a sponsor, academia, and EDC vendor will present.

Learning Objectives

Identify the components of EHR systems; Discuss complexities associated with EHR to EDC data transfer; Describe data standards and proper mapping between systems; Describe regulatory implications; Discuss how this will be able to help clinical research sites.

Chair

Trisha D Simpson

Speaker

EHR to EDC Data Transfer: Experiences and Lessons
Ian Sparks

The eSource Stakeholders Group and Next Steps
Michael A. Ibara, PharmD

EHR-EDC Integration Case Study: The Good, the Bad, and the Beautiful
Sue Dubman, MA



Chair
avatar for Trisha Simpson

Trisha Simpson

Director, Global Biometry Standards, UCB Biosciences, Inc.
Trisha is currently the Director of Global Integrated Standards at UCB. She’s been in the pharma industry for over 20 years. Her work at UCB includes standards governance; overseeing a Metadata Repository (MDR) build; and initiating an Electronic Healthcare Record (EHR) data retrieval... Read More →

Speakers
avatar for Sue Dubman

Sue Dubman

Director, IT and Informatics Innovation, University of California San Francisco (UCSF)
20+ yrs. experience. Sr. Dir, IT Innovation, at UCSF. Part of a multi-disciplinary team to innovate changes in care & research. Previously Sue was Sr. Dir, Genzyme, strategy, standards and arch. Before that, served as Dir, NCI Informatics Initiatives & VP/CIO at 2 biopharmas. At NCI... Read More →
avatar for Michael Ibara

Michael Ibara

Managing Partner, Fathom Digital Healthcare Consulting
20+ years’ experience in clinical R&D. Previously Head of Digital Healthcare for CDISC. Prior to that 15 yrs at Pfizer, leading implementations of global systems. Pioneered ASTER - the first time AEs were retrieved directly from an EHR and sent to FDA. Current work FDA project to... Read More →
avatar for Ian Sparks

Ian Sparks

Senior Director, Research Science, Medidata Solutions Worldwide
Ian Sparks is a Senior Director in Medidata Labs, an innovation group focused on evaluating new technologies and data integrations. Ian's recent work has been in integrating wearable sensors and Electronic Health Records with EDC using CDISC and HL7 standards. Ian holds a bachelors... Read More →


Monday June 27, 2016 8:30am - 9:45am EDT
201C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 07: Tech-Data- Records-Subs, Session

8:30am EDT

#112: The Upcoming European Clinical Trials Regulation
Limited Capacity seats available

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

This session will give an opportunity to understand the requirements of the new European Clinical Trial Regulation, the IT developments for its implementation, and to discuss the expectations and preparedness for implementation by global sponsors.

Learning Objectives

Recognize the requirements of the new clinical trial regulation; Discuss major information technology developments required for its implementation; Describe the impact of the regulation for the main stakeholders; Identify the expectations and challenges to be faced by global sponsors.

Chair

Anabela Marcal, PharmD

Speaker

The EU Portal and Database: A Pillar of the Clinical Trial Regulation
Anabela Marcal, PharmD

Getting Ready for the Changes: A Sponsor Perspective
Nick Sykes, MS

Transparency in Clinical Trials: A European Update
Marie-Agnes Heine, MA



Chair
avatar for Anabela Marcal

Anabela Marcal

EMA Liaison Official to FDA, European Medicines Agency, Netherlands
Anabela holds a degree in pharmacy and a professional certification in hospital pharmacy. Anabela had joined the EMA in 1999. During her career at the Agency she held a number of roles in various areas and she is currently Head of Committees and Inspections Department.

Speakers
avatar for Marie-Agnes Heine

Marie-Agnes Heine

Head of Communication Department, Stakeholders and Communication Division, European Medicines Agency, European Union
Marie-Agnes Heine is Head of Communication Department at the European Medicines Agency, London. She is a senior external relations and communications specialist with 25 years of experience in communications strategy development and implementation, journalism, advocacy and media campaigns... Read More →
avatar for Nick Sykes

Nick Sykes

Senior Director, Worldwide Regulatory Strategy, Pfizer Ltd.
Currently working in Europe and International regulatory policy and strategy group in Pfizer. Been working for Pfizer for 17 years. My main focus - lead a small team providing regulatory policy and strategy to Pfizer organisation. Previous employment includes SmithKline Beecham, Scrip... Read More →


Monday June 27, 2016 8:30am - 9:45am EDT
204C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 08: Reg Affairs, Session

10:00am EDT

#122: DBMS Consulting/Clinical Ink Innovation Theater: Accelerating Clinical Trial Innovation: Technology Case Studies for Improving Data Collection, Monitoring, and Medical Coding Processes
Limited Capacity seats available

Component Type: Session
Level: Intermediate

Standardization supports efficiency but usually with a lack of flexibility. Make the introduction of new technologies less challenging by limiting the scope of change. Learn how one top 5 pharmaceutical company is replacing EDC with eSource by mapping data into their existing processes and clinical database. Learn solutions for expiring dsNavigator support and how a centralized medical coding model can eliminate coding discrepancies by integrating safety systems with RDC, Rave and InForm via Oracle's TMS.

Chair

DBMS Consulting


Chair
Monday June 27, 2016 10:00am - 10:30am EDT
Exhibit Hall B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 20: Innov Theater, Session

10:45am EDT

#131: IDMP Update
Limited Capacity seats available

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

CBER provided critical leadership and technical expertise to the development of IDMP standards and currently continues leading international efforts to delineate a common approach for their implementation and to consider their future application. This session will provide an update on this initiative.

Learning Objectives

Discuss the status of IDMP implementation.

Chair

Vada A. Perkins

Speaker

ISO IDMP: Benefits Beyond Compliance
Niels Gronning, MSc

Interoperability and Standardization Within the Life Sciences: Justification, Mechanisms, and Opportunities
Tom Macfarlane, RAC



Chair
VP

Vada Perkins

Senior Advisor for Regulatory Science, IDMP Topic Lead, CBER, FDA
Capt. Vada A. Perkins, MSc, BSN, RN, is the Deputy Associate Director for Review Management (acting) with the FDA's Center for Biologics Evaluation and Research, Office of the Director. He received his MSc. in Bioscience Regulatory Affairs from The Johns Hopkins University and his... Read More →

Speakers
avatar for Niels Gronning

Niels Gronning

Principal Consultant, NNIT A/S
With a professional and academic bacground within the pharmaceutical industry Niels Grønning possesses extensive knowledge within the area of IT & Life Sciences. His area of expertise is predominantly found within regulatory affairs, IT (strategy, architecture & compliance) and more... Read More →
avatar for Tom Macfarlane

Tom Macfarlane

Director, Life Sciences, Accenture Accelerated R&D Services
A Neuroscientist by training, Tom has worked in most therapeutic areas during time at Ipsen, Parexel and as a freelance consultant. Now at Accenture, he continues to represent clients to EMA and to facilitate drug development strategies; but also works with emergent technologies/concepts... Read More →


Monday June 27, 2016 10:45am - 12:00pm EDT
204B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 07: Tech/Data/ Records/Subs, Session

10:45am EDT

#137: Using Technology to Make Trials Accessible to More Clinical Trial Participants
Limited Capacity seats available

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

As clinical care moves toward increasingly patient-centric models, research must also account for the participant’s perspective in order to maximize clinical trial recruitment, enrollment, adherence, and completion. Quality indicators that capture information about participant preferences and challenges can be used to inform clinical trial feasibility. Leveraging mobile technologies, in particular, can potentially empower a participant population, while emphasizing participant understanding of the commitment involved and, simultaneously, easing burdens on sites and study staff. This session will explore mobile applications, including eConsent, and at-home clinical trials, as potential tools—even providing the capacity to conduct remote trials—to spur participation through increased participant engagement, convenience, and satisfaction.

Learning Objectives

Identify emerging technologies and methods for both achieving efficiencies and optimizing effectiveness in clinical trial design; Evaluate quality metrics related to participant satisfaction and challenges associated with study implementation; Assess technologies and methods for their impact on clinical trial feasibility from a participant-focused perspective; Describe how to create an integrated plan, leveraging available technologies and methods, to improve the success of clinical trials.

Chair

Linda M Coleman, Esq, JD

Speaker

Mobile Clinical Trial Technologies: Use Cases and GCP Compliance Considerations
Philip J. Coran, Esq

Mobile Technology in Research: A Compliance and Ethics Review Perspective
Linda M Coleman, Esq, JD

Mobile Health Applications and eConsent: A Sponsor’s Perspective
Kevin Hudziak, MS



Chair
LC

Linda Coleman

Director, Human Research Protection Program, Yale University
Ms. Coleman is the Director of the Human Research Protection Program at Yale University. Prior to joining Yale, she was the Vice President of Regulatory and Legal Affairs at Quorum Review and an attorney at Bennett Bigelow & Leedom. Ms. Coleman has experience in research ethics, regulatory... Read More →

Speakers
avatar for Philip Coran

Philip Coran

Principal, Global Compliance and Strategy, Medidata Solutions
Phil Coran is a Principal of Global Compliance & Strategy at Medidata. Prior to joining Medidata, Phil was at Pfizer for 12 years in the Medical Quality Assurance and Internal Audit groups. From 1999-2001, Phil was an IT Risk Consultant at Deloitte & Touche & Arthur Andersen accounting... Read More →
avatar for Kevin Hudziak

Kevin Hudziak

Consultant, Innovation Lead, Eli Lilly and Company
Kevin works in the Clinical Innovation group at Lilly as an Innovation Lead focused on implementing eConsent and other technologies across the Lilly portfolio. Kevin participated in the CTTI Informed Consent project and is currently a member of the TransCelerate eConsent project... Read More →


Monday June 27, 2016 10:45am - 12:00pm EDT
204A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 11: Quality in CT/GCP, Session

12:15pm EDT

#146: Tata Consultancy Services Innovation Theater: Data Transparency Initiative: An Innovative Solution
Limited Capacity seats available

Component Type: Session
Level: Intermediate

With a growing commitment in the pharma world to data transparency, we require an innovative technology-driven solution using newly developed digital tools to make data and document sharing solutions achievable, scalable, and cost-effective. Metadata analytical algorithms will be used for de-identification and anonymization of data. This will ensure a greater control of the quality and reduction in overall process time.

* Presented by: Helle-Mai Gawrylewski, Sr. Director Regulatory Medical Writing, Janssen R&D. Titusville, NJ, USA
* Supported by: Arghya Chattopadhyay, Vice President, Biostatistics and Statistical Programming, Tata Consultancy Services

Chair

Tata Consultancy Services


Chair
Monday June 27, 2016 12:15pm - 12:45pm EDT
Exhibit Hall B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 20: Innov Theater, Session
 
Tuesday, June 28
 

9:45am EDT

#206: Covance Innovation Theater: Leveraging Patient Data and Historical Investigator Performance Data to Realize Faster Patient Recruitment
Limited Capacity seats available

Component Type: Session
Level: Intermediate

Patient recruitment and enrollment is one of the most critical opportunities to improve the clinical trial execution process. Twenty to 60 percent of the total clinical development timeline is spent on identifying and recruiting the right patients. Through Covance’s proprietary Xcellerate® knowledgebase with over 175,000 individual investigators and our LabCorp patient database with over 70 million de-identified patients, we are able to leverage the two databases to significantly increase our site optimization towards faster patient enrollment.

Chair

Covance Inc.


Chair
CI

Covance Inc.

Covance Inc.

Tuesday June 28, 2016 9:45am - 10:15am EDT
Exhibit Hall B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

10:30am EDT

#217: Electronic Submissions Gateway: Next Generation
Limited Capacity seats available

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

Electronic Submissions Gateway (ESG) is an FDA solution for accepting electronic regulatory submissions. It has been in production since 2006. This session will provide an update and Q&A on its status and the technology and process enhancements.

Learning Objectives

Discuss the Electronic Submissions Gateway (ESG) process and solutions for submission of regulatory; Describe the technology and process enhancements planned for ESG._x000D_


Chair

Ron D. Fitzmartin, PhD, MBA

Speaker

FDA eCTD v4.0 Two-Way Communication
Mark A. Gray

Panelist
Virginia Hussong

Panelist
La Misha Fields



Chair
avatar for Ron Fitzmartin

Ron Fitzmartin

Senior Informatics Advisor, Office of the Director, CBER, FDA, United States
Ron Fitzmartin is Senior Informatics Advisor, Office of the Director, Center for Biologics Evaluation and Research, Food and Drug Administration. In this role Ron provides policy and strategy consultation and support on a wide range of topics focused on electronic regulatory submissions... Read More →

Speakers
avatar for La Misha Fields

La Misha Fields

IT Program Manager, Electronic Submissions Gateway, OIMT, OC, FDA
La Misha Fields is the Program Manager of the FDA’s Electronic Submissions Gateway (ESG) under the Office of Information Management and Technology located in Rockville, MD. She is an informatics and technology professional with over 6 years of FDA experience, including 5+ years... Read More →
avatar for Mark Gray

Mark Gray

Senior Project Manager, BSS, CBER, FDA
Mark has over 30 years experience in Information Management including; software developer/project manager in CBER; Director of Applications Development & Services in CDER; and PDUFA IT Program Director. Mark currently work’s for CBER’s Bioinformatics Support Staff. His responsibilities... Read More →
avatar for Virginia Hussong

Virginia Hussong

Director, Div. of Data Management Services & Solutions, OBI, OSP, CDER, FDA
Ginny Hussong has over 20 years of experience in the pharmaceutical industry, of which the past 10 have been in CDER. As Acting Director of the Division of Data Management Services and Solutions, she supports the receipt, processing and archive of electronic regulatory submissions... Read More →
avatar for Virginia Hussong

Virginia Hussong

Chief, Data Standards Program, CBER, FDA
Ginny Hussong is Chief of CBER’s Data Standards Program, and has been with FDA for 14 years. She was previously Director of Data Management Services and Solutions within CDER. As Chair of CBER’s Data Standards Committee, Ginny’s recent projects include creating a new joint data... Read More →


Tuesday June 28, 2016 10:30am - 11:45am EDT
201C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

10:30am EDT

#216: Implementing a Successful Metadata Repository: The Journey of a Thousand Milestones Begins with a Single Step
Limited Capacity seats available

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

During this session, the value of metadata repositories will be discussed, and the audience will be provided with real-world practical experience regarding the traps to avoid, and the process to follow, to enable a successful metadata repository implementation.

Learning Objectives

Describe the complexities associated with defining metadata repository requirements; Discuss how to develop a methodology for implementing a successful metadata repository.

Chair

David Handelsman

Speaker

Semantic Metadata Repository at the Core of E2E eClinical Solutions
Isabelle M de Zegher

Implementing a Metadata Repository Based on Value and Not Technology
David Handelsman

Metadata Repositories: From the Outside In
Wayne R. Kubick, MBA



Chair
avatar for David Handelsman

David Handelsman

Senior Director, Industry Strategy, d-Wise
Dave Handelsman is a life sciences expert with 25 years of industry, software and management experience. As Senior Director of Strategy and Product Development at d-Wise, Dave is responsible for d-Wise’s growth and evolution, and for further establishing d-Wise as the go-to partner... Read More →

Speakers
avatar for Wayne Kubick

Wayne Kubick

Chief Technology Officer, HL7
Mr. Kubick is CTO for Health Level Seven International, intent on improving clinical research through technology and data standards. He was formerly CTO and a Board member for CDISC, and has 2+ decades in a variety of leadership roles in clinical R&D with BBN, Parexel International... Read More →
avatar for Isabelle de Zegher

Isabelle de Zegher

Vice President, PAREXEL Informatics
Isabelle de Zegher is Vice President, Integrated Solutions at PAREXEL Informatics where she is responsible for engineering strategy around Big Data, BI and Advanced Analytics. She has 25 years’ experience in Life Sciences, including extensive work on cross-industry forum on integration... Read More →


Tuesday June 28, 2016 10:30am - 11:45am EDT
204C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 07: Tech/Data/ Records/Subs, Session

12:40pm EDT

#232: PRA Innovation Theater: Transforming EMR to EDC
Limited Capacity seats available

Component Type: Session
Level: Intermediate

Disparate EMR systems and lack of CFR 21-11 compliance have hamstrung efforts streamlining data entry for research. PRA's Predictivv platform reduces the duplicate data entry by transforming EMR to EDC in real time.

"Predictivv is the foundation of PRA and our drive towards evidence driven healthcare and research."

Jane Quigley, Vice President of Medical Informatics

Chair

PRA Health Sciences


Chair
Tuesday June 28, 2016 12:40pm - 1:10pm EDT
Exhibit Hall B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 20: Innov Theater, Session

2:00pm EDT

#239: Cloud Compliance: Clinical Software Challenges and Vendor Auditor Views
Limited Capacity seats available

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

We will share practical experience and tips for addressing the compliance challenges for clinical solutions using cloud technology and auditing vendors of IaaS, PaaS, and SaaS services. Benefits, challenges, and possible remediation are discussed.

Learning Objectives

Identify infrastructure issues related to data integrity and system security for SaaS, IaaS, and PaaS services; Discuss audit compliance issues related to cloud based software solutions; Identify how to check for critical quality evidence based on 50+ audits of IT suppliers.

Chair

Teri Stokes, PhD, MS, MT

Speaker

Software as a Service (SaaS) and Cloud Provider Qualification: An Auditor's Perspective
Calvin H Kim, MS

Maintaining the Validation Status of Software as a Service (SaaS) in a Regulated Environment
Anu Virkar

Are You Cloud Compliant? Practical Considerations for Managing Clinical Data in the Cloud
Srinivas Karri, MSc



Chair
avatar for Teri Stokes

Teri Stokes

Director, Quality Assurance Compliance, Cytel Inc.
Dr. Stokes worked 11 years as a Medical Technologist in hospital, research, and central medical laboratories. Then 16 years at Digital Equipment Corporatin (DEC) first in the Large Computer Group, second in the Laboratory Data Products Group, and finally at DEC in Basel, Switzerland... Read More →

Speakers
avatar for Srinivas Karri

Srinivas Karri

Senior Director, Clinical Warehousing Cloud Strategy, Oracle Corporation
As an industry strategy lead for clinical data cloud based applications, I help identify, define and create new services to support management of clinical data using cloud based technologies and capabilities. I have over 20 years experience with developing, implementing, selling and... Read More →
avatar for Calvin Kim

Calvin Kim

Senior GxP IT Auditor, Bayer
Calvin is a seasoned IT auditor with over 20 years of experience in various sectors of GxP regulated industries. As a core member of a global QA organization responsible for quality oversight and regulatory compliance assessment of computerized systems (CS) and technologies used in... Read More →
avatar for Anu Virkar

Anu Virkar

Vice President, Quality and Compliance, eClinical, IBM Watson Health
Anu Virkar, MS, MA, PMP is the VP of Q&C. Anu has been in the SQA field for over 23 years, & has focused on clinical trial mgmt and Med device industry for over 15 yrs. She has extensive experience in software QA, SDLC, project mgmt as well as policy development, implementation. She... Read More →


Tuesday June 28, 2016 2:00pm - 3:15pm EDT
201C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 07: Tech/Data/ Records/Subs, Symposium

4:00pm EDT

#257: Mobile Apps for Clinical Trials: DIY or AMAZON Strategy? When to Build, When to Buy
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-514-L04-P; CME 1.25; IACET 1.25; RN 1.25

The use of apps every day is a way of life, but in biopharmaceutical companies, teams struggle with how and when to use them. We will share DIY (build in house) and Amazon (off the shelf) case studies, their outcomes, and learnings.

Learning Objectives

Discuss the current landscape of clinical trial apps and health apps; Explain user adoption and outputs from use of mobile apps in trials; Describe cases from two companies who have built apps in-house or bought “off the shelf” apps for use in clinical trials, including successes and challenges in implementation, adoption and execution.

Chair

Jane E. Myles, MS

Speaker

Implementing Mobile Technology from the Site Perspective
James Kremidas

Build, Inspire, or Spin Off: Case Studies on Tech Develoment in Clinical Research
Joseph Kim

Own or Lease: Lessons Learned from a Platform Owner
Jeffrey Lee, MBA



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 Joseph Kim

Joseph Kim

Senior Advisor, Clinical Innovation, Eli Lilly and Company
Joseph Kim serves as a Senior Advisor in Clinical Innovation at Lilly, focusing on innovative patient engagement solutions. He has spent over 17 years in the Pharma industry, recognized as one of “Top 100 individuals on the 2015 MedicineMakers Power List, and “20 Innovators Changing... Read More →
avatar for James Kremidas

James Kremidas

Executive Director, Association of Clinical Research Professionals (ACRP)
Jim Kremidas is Executive Director for ACRP, a not-for-profit association that represents the clinical research enterprise. He was Senior Vice President, Patient Recruitment, at two different large CROs for over six years where he and his team were responsible for developing and implementing... Read More →
avatar for Jeffrey Lee

Jeffrey Lee

Chief Executive Officer, mProve Health
Jeff is Founder of mProve Health, his 4th entrepreneurial venture. After a decade of experience in the mobile industry, with clients ranging from HBO/Disney/Fox to Barack Obama, Mr Lee formed mProve to leverage mobile technologies in the clinical research field. Omniscience has risen... Read More →


Tuesday June 28, 2016 4:00pm - 5:15pm EDT
113A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 01: Clinical Operations, Session

4:00pm EDT

#264: FDA Update on Data Standards
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-538-L04-P; CME 1.25; IACET 1.25; RN 1.25

This session will include information on required data standards in regulatory submission and FDA's efforts to develop, test, and support therapeutic area data standards. Discussion will include FDA's participation in and status of international data standards initiatives such as IDMP.

Learning Objectives

Discuss required data standards in NDAs, BLAs, INDs and ANDAs 2; Summarize FDA's efforts to develop, test and support therapeutic area data standards; Describe FDA's participation in and status of international data standards initiatives, such as IDMP.

Chair

Mary Ann Slack

Speaker

OCP Update
Eileen E. Navarro Almario

CDER Perspective
Colleen Ratliffe, MS, PMP

FDA Update
Stephen E. Wilson, DrPH



Chair
avatar for Mary Ann Slack

Mary Ann Slack

Director, Office of Strategic Programs, CDER, FDA, United States
Ms. Slack has 30+ years extensive leadership and management experience in both the public and private sectors, developing informatics strategy and implementing business solutions. She currently serves as Director of FDA CDER Office of Strategic Programs, which plays a lead role in... Read More →

Speakers
avatar for Eileen Navarro Almario

Eileen Navarro Almario

Lead Medical Officer, OCS, OTS, CDER, FDA
Eileen Navarro is Associate Director for Clinical Affairs in the Office of Computational Science, OTS, CDER, where she leads a team of analysts in providing regulatory review and training support to medical officers, statisticians, and safety evaluators. She is a Fellow of the American... Read More →
avatar for Colleen Ratliffe

Colleen Ratliffe

Project Management Officer, Office of Strategic Programs, CDER, FDA
Colleen Ratliffe is a project management officer on the Data Standards team within the Office of Strategic Programs, CDER. The data standards team’s core functions include coordinating and leading projects that support and promote the development of data standards and policy and... Read More →
avatar for Stephen Wilson

Stephen Wilson

Director, Division of Biometrics III, Office of Biostatistics, OTS, CDER, FDA
Dr. Wilson has worked as a Statistical Reviewer and Supervisory Mathematical Statistician in FDA/CDER for 28 years and is currently the Director of the Division of Biometrics III and a Captain in the USPHS. He received his doctorate in Biostatistics from UNC/Chapel Hill in 1984.


Tuesday June 28, 2016 4:00pm - 5:15pm EDT
204B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 07: Tech/Data/ Records/Subs, Session
 
Wednesday, June 29
 

8:00am EDT

#301: The Future of Big Data
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: CME 1.50; IACET 1.50; RN 1.50

Just how BIG will Big Data be? Understanding how innovators plan to use it to disrupt drug development and advance new health care offerings across delivery systems will be HUGE for everyone involved in innovation.

Come hear from top thought-leaders about what innovations are in the pipeline that will both generate and harness BIG DATA. Learn how innovators will use Big Data to disrupt the health care system. This dynamic forward-focused session will bring together industry, technology innovators, academia, and government agencies to paint a colorful picture of how they will drive advances in health care founded on big data platforms.

Learning Objectives

Discuss how big data will impact innovation in health care; Describe the way academia, industry, government agencies, and technology innovators are advancing health care utilizing big data.

Chair

Nancy Bradish Myers, JD

Speaker

Panelist
Luciana Borio, MD

Panelist
Kara N. Dennis

Panelist
Michael J Doherty

Panelist
Brad Hirsch, MD

Panelist
Sally A. Howard, JD



Chair
avatar for Nancy Myers

Nancy Myers

President and Founder, Catalyst Healthcare Consulting, Inc
Nancy Bradish Myers, JD is President/Founder of Catalyst Healthcare Consulting, a boutique regulatory advisory firm that helps innovators navigate FDA and policy circles. She served as a senior advisor in FDA's Office of the Commissioner and held senior positions at PhRMA, BIO and... Read More →

Speakers
avatar for Luciana Borio

Luciana Borio

Acting Chief Scientist, Office of the Chief Scientist, OC, FDA
Dr. Luciana Borio is FDA’s acting chief scientist. In this capacity, she is responsible for leading and coordinating FDA's cross-cutting scientific and public health efforts. The Office of the Chief Scientist works closely with FDA’s product centers, providing strategic leadership... Read More →
avatar for Kara Dennis

Kara Dennis

Managing Director, Mobile Health, Medidata Solutions Worldwide
As managing director of mobile health, Kara leads Medidata’s efforts to support mobile-enabled clinical trials and launched mobile health (mHealth) as a new business unit in 2015. Prior to this, Kara served as chief of staff to the company's CEO and president, and a vice president... Read More →
avatar for Michael Doherty

Michael Doherty

Head, Strategic Innovation, Pharma Dev; Exec Advisor, Foundation Medicine Inc., Hoffmann-La Roche Ltd.
Head of regulatory affairs at Roche and Genentech from 2002 to 2016. Currently head of strategic innovation at Roche and Executive adviser to Foundation Medicine.
avatar for Brad Hirsch

Brad Hirsch

Senior Medical Director, Flatiron Health
Dr. Hirsch is a practicing medical oncologist with Texas Oncology in Dallas. At Flatiron Health, he helps to lead multiple efforts including value based care initiatives, collaborations with life sciences companies, and the development of novel research capabilities. Prior he served... Read More →
avatar for Sally Howard

Sally Howard

Head of Regulatory Affairs and Policy, Human Longevity, Inc.
Has more than two decades of health policy and regulatory expertise, leads all efforts related to federal and state regulatory oversight. She comes from the FDA where she served most recently as Senior Advisor and Acting Chief of Staff to the FDA Commissioner. She also spent two years... Read More →


Wednesday June 29, 2016 8:00am - 9:30am EDT
103ABC Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 19: DIAmond, Forum

10:30am EDT

#314: Transforming Clinical Protocols into a Digital Platform: Driving Quality and Efficiency End-to-End
Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-16-539-L04-P; CME 1.00; IACET 1.00; RN 1.00

A panel of experts will discuss novel approaches to developing and implementing a machine-readable protocol. Representatives from the clinical development, data standards, and regulatory affairs disciplines will review the impact of traceability.

Learning Objectives

Discuss the evolution of a protocol from a document to a digital platform; Describe an end-to-end traceability model from protocol to analysis; Describe the approach to automate reuse of protocol level information.

Chair

Robert A. DiCicco, PharmD

Speaker

Panelist
Eileen E. Navarro Almario

Panelist
Rebecca D. Kush, PhD

Panelist
Christine Pierre, RN



Chair
avatar for Robert DiCicco

Robert DiCicco

Vice President, Clinical Innovation and Digital Platforms, GlaxoSmithKline
Rob DiCicco is the Vice President of Clinical Innovation and Digital Platforms at GSK. He is the Work Stream Leader for the Common Protocol Template Project sponsored by TransCelerate and one of the Team Leads on CTTI’s Mobile Clinical Trials Novel Endpoints Project. He has over... Read More →

Speakers
avatar for Eileen Navarro Almario

Eileen Navarro Almario

Lead Medical Officer, OCS, OTS, CDER, FDA
Eileen Navarro is Associate Director for Clinical Affairs in the Office of Computational Science, OTS, CDER, where she leads a team of analysts in providing regulatory review and training support to medical officers, statisticians, and safety evaluators. She is a Fellow of the American... Read More →
avatar for Rebecca Kush

Rebecca Kush

President and Chief Executive Officer, CDISC
Rebecca Daniels Kush, Ph.D. is a Founder and the President and CEO of the Clinical Data Interchange Standards Consortium (CDISC). Dr. Kush has worked for the NIH, academia, a global CRO and pharmaceutical companies in the U.S. and Japan. Dr. Kush earned a Ph.D. in Physiology and Pharmacology... Read More →
avatar for Christine Pierre

Christine Pierre

President, Society for Clinical Research Sites
Christine is the President of the Society for Clinical Research Sites, a global trade organization representing over 9,000 sites in 47 countries committed to providing sites a community and voice for site sustainability. Christine is an internationally recognized expert on the global... Read More →


Wednesday June 29, 2016 10:30am - 11:30am EDT
203AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 07: Tech/Data/ Records/Subs, Forum

4:00pm EDT

#357: The Internet of Things and Clinical Research: Privacy, Security, and Ethical Aspects
Limited Capacity seats available

Component Type: Session
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-515-L04-P; CME 1.25; IACET 1.25; RN 1.25

The Internet of Things (IoT) refers to objects simultaneously producing data in an automated way. It is revolutionary to clinical research and pushes the limits of current policy, requiring us to examine regulation that could limit its potential.

Learning Objectives

Describe potential advantages and benefits of the Internet of Things (IoT) in clinical research, and the complexities and barriers to adoption; Summarize the impacts and issues involved in leveraging the IoT within health care and clinical research in particular.

Chair

Ellen Kelso

Speaker

Does “Big Data” for Enhanced Recruiting Invade Patient Confidentiality?
Lea Studer



Chair
avatar for Ellen Kelso

Ellen Kelso

Executive Director, Chesapeake IRB
Founder, managing member & CEO of Goodwyn IRB, Ellen Kelso is recognized for her experience & expertise in clin. trial mgt & reg. affairs. Has provided educ., consultation & services to the pharma industry supporting clinical research & regulatory strategies, submissions & compliance... Read More →

Speakers
avatar for Lea Studer

Lea Studer

Senior Vice President of Marketing Communications, SCORR Marketing
Studer is an accomplished marketing and communications professional with more than 20 years of experience developing and implementing compelling, award-winning marketing and communication strategies and tactics in the global life sciences industry.


Wednesday June 29, 2016 4:00pm - 5:15pm EDT
108B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 01: Clinical Operations, Session

4:00pm EDT

#359: Addressing Dysfunction in Provider Prequalification: A New Model to Streamline Processes, Improve Quality, and Reduce Risk
Limited Capacity seats available

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

This forum will present data on industry challenges related to prequalification of technical service providers. Industry leading initiatives to standardize requirements and processes, and regulatory, sponsor and provider perspectives will be shared.

Learning Objectives

Identify risks, challenges, issues and industry dysfunction related to prequalifying technical service providers; Describe new industry standards/processes/approaches for prequalification of technical providers; Explain sponsor/provider/regulator perspectives regarding implications for standardizing and centralizing prequalification to ensure high quality, efficiency and confidence in processes and results.

Chair

Dawn M Niccum, BSN, MS, RN, PMP

Speaker

Panelist
Marta Haley Fields, MBA

Panelist
Mitchell A. Katz, PhD

Panelist
Dennis Salotti, MBA, MS

Panelist
Sean Y. Kassim, PhD



Chair
avatar for Dawn Niccum

Dawn Niccum

Associate Director, Quality, Endocyte
Dawn Niccum is the associate director of quality at Endocyte, where she is responsible for GCP compliance, SOP development, computer system validation oversight, and training. With over 20 years of pharmaceutical experience, Ms. Niccum holds a Master’s Degree in Regulatory Affairs... Read More →

Speakers
avatar for Marta Fields

Marta Fields

Senior Director, Research & Development Quality, Seattle Genetics, Inc.
Marta joined Seattle Genetics in 2008 as Sr Director of Compliance and Quality Systems after 21 years at Amgen where she served as Director of Clinical Compliance. Ms Fields has a BS in Speech from Northwestern University and an MBA in Healthcare Management from California Lutheran... Read More →
avatar for Sean Kassim

Sean Kassim

Director, Office of Study Integrity and Surveillance, OTS, CDER, FDA
Sean serves as the Director of the Office of Study Integrity and Surveillance, CDER/FDA. He oversees the bioavailability/bioequivalence (BA/BE) and GLP inspection programs that inspect and review conduct of regulated pharmaceutical premarket bioanalytical and non-clinical researc... Read More →
avatar for Mitchell Katz

Mitchell Katz

Head of Clinical Research and Drug Safety Operations, Purdue Pharma L.P.
Dr. Mitchell Katz is Head of Clinical Research and Drug Safety Operations at Purdue Pharma L.P. In this position, he is responsible for leading all operational activities across Purdue’s multinational clinical programs. Dr. Katz has 28 years’ experience in the pharmaceutical and... Read More →
avatar for Dennis Salotti

Dennis Salotti

Chief Operating Officer, The Avoca Group
With 20 years in the pharmaceutical industry as a sponsor, provider, and consultant, Dennis Salotti's experience spans preclinical research, clinical operations, data management, quality assurance, eClinical, business operations, and strategic management. Prior to Avoca, he was Director... Read More →


Wednesday June 29, 2016 4:00pm - 5:15pm EDT
111AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

4:00pm EDT

#369: Innovative and Emerging Technologies
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-607-L04-P; CME 1.25; IACET 1.25; RN 1.25

Recent technological advances in manufacturing, product delivery, and control provide opportunities and challenges to improve quality assurance. Improved regulatory understanding of continuous manufacturing, product delivery, and control should enable and encourage adoption of novel technologies. This session will focus on emerging innovative technology and approaches to developing quality products.

Learning Objectives

Discuss emerging innovative technology and how quality assurance can be improved.

Chair

Daniel Blackwood

Speaker

Process Validation for Lyophilized Drug Products: Developing a Program for Continued Process Verification
Karen Bossert

Portable, Continuous, Miniature, and Modular: An Integrated Development and Manufacturing System for Solid Oral Dossage Forms
Daniel Blackwood

API Particle Engineering: Bridging Primary and Secondary Processes for Continuous Oral Solid Dose Manufacturing
Sonja A. Sharpe, PhD



Chair
avatar for Daniel Blackwood

Daniel Blackwood

Director, Pharm Science Technology and Innovation, Pfizer Inc
Daniel O. Blackwood is a Director, Technology & Innovation, within PharmaTherapeutics Pharmaceutical Sciences at Pfizer. He received his BS in Mechanical Engineering from Cornell University in Ithaca NY, and his MS in Industrial Engineering from Columbia University in New York City... Read More →

Speakers
KB

Karen Bossert

Vice President, Scientific Affairs, Lyophilization Technology, Inc.
Karen Bossert is the Vice-President, Scientific Affairs at Lyophilization Technology, Inc. She has over 25 years of experience in pharmaceutical manufacturing and development. She received her Bachelor of Science degree in Pharmacy and her Doctorate in Pharmaceutics. Karen has authored... Read More →
avatar for Sonja Sharpe

Sonja Sharpe

Director, Technology Development, Advanced Manufacturing Technologies, GlaxoSmithKline
Sonja leads a global team responsible for developing novel secondary (drug product) manufacturing technologies with the goal of streamlining and simplifying drug product process development and manufacturing. She has over 11 years of experience in the area of process engineering and... Read More →


Wednesday June 29, 2016 4:00pm - 5:15pm EDT
109AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 12: Pharm Quality, Session
 
Thursday, June 30
 

10:45am EDT

#407: Successful Application of Wearables and Remote Monitoring in Clinical Trials: Lessons Learned and Future Progress
Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-16-537-L04-P; CME 1.00; IACET 1.00; RN 1.00

The usage of wearables can be a challenge in the regulated and traditionally risk adverse pharmaceutical industry. This session reviews a case study of utilizing wearables from planning, to IRB, to final report in a large pharma clinical sub-study.

Learning Objectives

Describe the importance of reviewing standard processes when inserting wearables into a clinical trial; Discuss the support structure necessary for combining traditional clinical research with emerging technologies; Demonstrate an understanding of the change management necessary to run a successful wearables trial.

Chair

John H. Bunch

Speaker

Internet of Medical Things (IoMT) and Clinical Development: Challenges and Opportunities
Yury Rozenman

How to Get From Unknown Unknowns to Known Unknowns
Tilo Hache, MBA



Chair
avatar for John Bunch

John Bunch

Senior Innovation Project Manager, PPD
John Bunch is a PMP, Six Sigma, and Proci certified project manager now focused on pharmaceutical and CRO innovation projects intended to positively impact patient trial experience, improve data frequency and reliability, and bend the cost time curve for drug development. Mr. Bunch... Read More →

Speakers
avatar for Tilo Hache

Tilo Hache

Work Stream Leader Mobile Patient Data, Novartis Pharma AG
Tilo's career career started in Roche, developing and implementing large corporate IT platforms for more than 50'000 employees. Since 2003, he had positions with increasing responsibility in Novartis IT and Sourcing, for example to operate the global Personal Computer environment... Read More →
avatar for Yury Rozenman

Yury Rozenman

Director, Business Development, Qualcomm Life
Yury Rozenman leads Qualcomm Life pharmaceutical business development organization. Yury has considerable experience of working in and consulting to the pharmaceutical industry, strategic studies, new product and business development and manufacturing across the healthcare and life... Read More →


Thursday June 30, 2016 10:45am - 11:45am EDT
111AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA

10:45am EDT

#408: Securing Internet-Driven Collaboration in Drug Development
Limited Capacity seats available

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

This session covers the current role of global SAFE-BioPharma standard for identity and access management trust and EngageZone, Merck's initiative enhancing collaboration between it and hundreds of partner organizations. _x000D_


Learning Objectives

Evaluate risk associated with Internet-based collaboration; Discuss approaches to develop secure, trust-based information sharing; Define critical terminology such as multi-factor authentication, federation, and identity and access management.

Chair

Mollie Shields-Uehling

Speaker

Industry Perspective
Andrew Porter



Chair
avatar for Mollie Shields-Uehling

Mollie Shields-Uehling

President and Chief Executive Officer, Safe-BioPharma Association
The SAFE-BioPharma standard assures the identity trust inherent in implementation of the TransCelerate Shared Investigator Portal, in Merck’s EngageZone portal, and in other industry collaboration portals. Digital signature applications certified compliant with the SAFE-BioPharma... Read More →

Speakers
avatar for Andrew Porter

Andrew Porter

Director of Enterprise Architecture, IT Planning & Innovation, Applied Tech, Merck & Co., Inc.
His expertise includes creating the architectures for Identity and Access Management (IAM) and Enterprise Knowledge Management (EKM) solutions that support Merck's External Partner Program (EPP) and clinical trials initiatives. Mr. Porter has also provided architectural alignment... Read More →


Thursday June 30, 2016 10:45am - 11:45am EDT
109AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA