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02: ClinTrials -ClinOps [clear filter]
Monday, June 24
 

10:10am

#102 EE: The Female Perspective on the Clinical Trial Patient Experience: A Live Focus Group
Component Type: Workshop
Level: Basic

This workshop will discuss the factors that create a positive patient experience for the female clinical trial participant with regard to protocol design and clinical trial participation.

Learning Objectives

Elucidate the factors that create a positive patient experience for the female clinical trial participant – a historically underserved stakeholder group with regard to protocol design and clinical trial participation.

Chair

Bonnie A. Brescia


Speakers
avatar for Bonnie Brescia

Bonnie Brescia

Founding Principal, Corporate Planning Officer, BBK Worldwide
Bonnie A. Brescia has been a leader in patient recruitment and engagement for more than 35 years. Widely recognized for helping to shape the patient recruitment discipline and a preeminent voice for patient centricity, her insights regarding the global clinical research community... Read More →


Monday June 24, 2019 10:10am - 10:55am
E and E Area Exh Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

1:45pm

#132 CH: Advancing Trailblazing Research and Development: When to Speed Up, When to Slow Down
Component Type: Workshop
Level: Intermediate

Using a case study, participants will discuss a real-life example of a manufacturing roadblock and discuss problem-solving strategies, the importance of taking prudent risk, and building the right team for success.

Learning Objectives

Analyze risks and recognize trade-offs in preclinical development planning; Identify problem-solving strategies and formulate a plan to proceed accordingly in development planning; Apply case study-specific steps and learnings to any potential scenario; Apply best practices in participants’ own work.

Chair

Sandy Macrae, PhD


Speakers
avatar for Sandy Macrae

Sandy Macrae

Chief Executive Officer, Sangamo Therapeutics
Sandy Macrae serves as a member of the Company’s Board of Directors. He has twenty years of experience in the pharmaceutical industry most recently serving as the Global Medical Officer of Takeda Pharmaceuticals, where he established and led the Global Medical Office, which encompasses... Read More →


Monday June 24, 2019 1:45pm - 2:15pm
Content Hub Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

2:15pm

#138: Blockchain in Clinical Trials Demo: Truth or Dare
Component Type: Workshop
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-548-L04-P; CME 1.00; IACET 1.00; RN 1.00

Use blockchain to show the design and implementation of faster, less onerous user identification processes through permissioned access to a federated database pointing to a variety of traditionally siloed sources (inc. EMR, wearables, IoT etc).

Learning Objectives

Describe how a blockchain-powered health wallet could support greater efficiencies across the clinical trial process.

Chair

Adama Ibrahim, MBA

Speaker

Facilitator
Maria Palombini, MBA

Facilitator
Jim Nasr, MBA

Facilitator
Disa Lee Choun, MBA, RPh

Blockchain
Mathew Rose, MD, MS, MSc



Speakers
avatar for Disa Lee Choun

Disa Lee Choun

Head of Innovation, Global Clinical Services and Operations, UCB Celltech
Disa has years of experience working in technology and innovation especially in the pharmaceutical industry. In her current role as Director Head of Innovation within the Global Clinical Sciences & Operations at UCB, she is responsible for evaluating and piloting innovative solutions... Read More →
avatar for Adama Ibrahim

Adama Ibrahim

Associate Director, Clinical Operations| WIN UK Chapter Co-Lead, Biogen
An innovation award winning operational strategy collaborator, blockchain advocate, eCOA and patient engagement thought leader with over 17 years in the NHS on commission by the DOH and in Industry (Hoffman La-Roche, Amgen, ALMAC, ICON and Biogen). An R&D transformation change champion... Read More →
avatar for Jim Nasr

Jim Nasr

Founder, Acoer
avatar for Maria Palombini

Maria Palombini

Life Sciences Practice Lead, Global Business Strategy and Intelligence (GBSI), IEEE-Standards Association
Maria joined IEEE-SA with a directive to build communities and advance initiatives to develop standards for enterprise adoption of emerging technologies. Her area of focus includes research on challenges and opportunities in integrating cutting-edge technologies such as AI, IoT, ML... Read More →
avatar for Jim Nasr

Jim Nasr

Vice President, Technology and Innovation, Certara
Jim Nasr is the VP of Technology & Innovation at Certara. Jim leads the development of OpenPharma: modern, open technology healthcare platform—including: blockchain, open APIs, real-time data services and machine learning—to improve patient outcome and transform life sciences... Read More →
MR

Mathew Rose

Founder and Chief Executive Officer, SAAVHA Inc.
Dr. Rose is a Physician, Entrepreneur, and Blockchain Specialist, who strives to use cutting-edge technology to simplify secure user experiences that increase patient engagement and drive better health outcomes. He has more than 9 years working on Translational Medicine and Phase... Read More →


Monday June 24, 2019 2:15pm - 3:15pm
Room 9 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
 
Tuesday, June 25
 

10:00am

#227 CH: GCP for Contributing Investigator Versus Conducting Investigator-Initiated Trials in Emerging Regions
Component Type: Workshop
Level: Intermediate

Emerging regions are participating in clinical trials, but that only provides drug benefits to a small number of patients. Shifting to Investigator-initiated trials maximizes patient access, but requires more activities to be GCP compliant.

Learning Objectives

Define GCP for Investigator-Initiated trials; Discuss strategies for GCP compliance in emerging regions.

Chair

Terry Katz, MS


Speakers
avatar for Terry Katz

Terry Katz

Director, Head of Global Data Management and Statistics, Merck Animal Health
Terry Katz is Head of Data Management and Statistics at Merck Animal Health. Previously he was Head of Biometrics at ImClone Systems, Senior Manager of Analysis & Reporting for PRA, and a Statistician at Schering-Plough. He holds Accreditation as a Professional Statistician, and Certifications... Read More →


Tuesday June 25, 2019 10:00am - 10:30am
Content Hub Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

2:00pm

#258: Build-a-Bot Workshop: Design and Build a Conversational Agent that Speaks for You
Component Type: Workshop
Level: Basic
CE: ACPE 1.25 Application UAN: 0286-0000-19-625-L04-P; CME 1.25; IACET 1.25; RN 1.25

This workshop gives participants a hands-on experience with designing and building chat bots as service automation agents for their functional area. Participants will identify opportunities for Conversational AI and leave with a working prototype.

Learning Objectives

Identify specific opportunities to leverage automation to engage with internal and external customers; Discuss fundamentals of how bots are designed and how to think through the logic and use cases; Describe how to get hands-on experience designing and making a working prototype; Discuss how to put automation and chat bots into a real world practical context.

Chair

Bryan Hill


Speakers
avatar for Bryan Hill

Bryan Hill

Chief Technology Officer, Life Sciences, Cognizant
Bryan Hill serves as Chief Technology Officer responsible for Cognizant’s range of digital solutions and innovation within the Life Sciences industry. His focus is on identifying how emerging digital technologies can help life sciences companies increase innovation in clinical development... Read More →


Tuesday June 25, 2019 2:00pm - 3:15pm
Room 9 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Intermediate
  • Featured Topics What's Next
  • Featured Topics Artificial Intelligence,Student Programming
  • Credit Type ACPE, CME, IACET, RN
  • Tags Workshop
 
Wednesday, June 26
 

2:00pm

#358: Improving the Trial Experience for Rare Disease Patients: Identifying and Overcoming Obstacles
Component Type: Workshop
Level: Intermediate
CE: ACPE 1.25 Application UAN: 0286-0000-19-697-L04-P; CME 1.25; IACET 1.25; RN 1.25

Participants will engage in an “overcoming obstacles” activity designed to encourage collaboration among rare disease patients, trial sponsors, and advocates. You will identify obstacles to trial participation and work to develop creative solutions.

Learning Objectives

Describe valuable and detailed input from patients on clinical trial design; Design patient interactions that encourage collaboration among patients, sponsors, and advocacy group; Explain how to optimize clinical trials to ensure they meet the needs of rare disease patients.

Chair

Kelly Franchetti, RN

Speaker

Patient Perspective
Kim Stephens, PhD, MA

Industry Perspective
Kelly Franchetti, RN

Academic Perspective
Ellyn Getz



Speakers
avatar for Kelly Franchetti

Kelly Franchetti

RN, CCRN, CEN Vice President, Global Head Patient Insights & Engagement, ICON plc.
Kelly has a diverse background comprised of nursing, advocacy & clinical research. She is also the mother of a child with a rare disease. This gives her a unique 360 degree view of patients’ & caregiver’s perspectives in the realm of disease management, treatment and burden. As... Read More →
avatar for Ellyn Getz

Ellyn Getz

Associate Director, Development and Community Engagement, CISCRP
Ellyn Getz is the Associate Director of Development and Community Engagement at CISCRP. She is responsible for directing CISCRP’s educational and outreach initiatives, including AWARE for All: Clinical Research Education Days, MT Pharmacy and Journey to Better Health mobile experiential... Read More →
avatar for Kim Stephens

Kim Stephens

President, Project Alive - Hunter Syndrome
Dr. Kim Stephens is the President of Project Alive, a nonprofit organization whose mission is to cure Hunter Syndrome/Mucopolysaccharidosis II through research and advocacy. Having a son with Hunter Syndrome herself, this is also a personal mission for Dr. Stephens. Dr. Kim Stephens... Read More →


Wednesday June 26, 2019 2:00pm - 3:15pm
Room 9 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

3:15pm

#376 EE: Assessing Medical Adherence in a Clinical Trial Setting: Challenges and Solutions
Component Type: Workshop
Level: Intermediate

This workshop will provide a dynamic environment for participants to share experiences related to medication adherence in drug development, and to learn new approaches for collecting, analyzing, and reporting adherence data.

Learning Objectives

Describe the extent of challenges with medication adherence across all phases of drug development; Identify where risk of medication non-adherence with a drug may arise: initiation, implementation and discontinuation; Evaluate strategies to collect, analyze, and report medication adherence across phase 2-3 clinical trial settings.

Chair

Sarah Clifford, PhD, MSc

Speaker

Facilitator
Lina Eliasson, PhD



Speakers
avatar for Sarah Clifford

Sarah Clifford

Senior Principal, Patient-Centered Outcomes, ICON Clinical Research, Inc
Sarah Clifford is Senior Principal and Division Leader for ICON’s Patient Centered Outcomes’ West Coast Division, where she oversees the development and execution of the PCO scientific strategy. She has 20 years of experience in patient-reported outcomes and health-services research... Read More →
avatar for Lina Eliasson

Lina Eliasson

Founding Director, Sprout Behaviour Change Ltd
As a Behavioral Psychologist, I specialize in understanding, measuring and improving treatment adherence, in clinical trials and in the real world. My experience spans the worlds of academic research, and the commercial sector. I worked as a post-doc researcher at Imperial College... Read More →


Wednesday June 26, 2019 3:15pm - 4:00pm
E and E Area Exh Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

4:15pm

#394: Demystifying Basic Statistical Concepts for Anyone Involved with Clinical Trials
Component Type: Workshop
Level: Basic
CE: ACPE 1.25 Application UAN: 0286-0000-19-710-L04-P; CME 1.25; IACET 1.25; RN 1.25

Not a statistician? Then this workshop is for you!

Group activities and slide-based learning will be used to introduce commonly used statistical concepts using real clinical trial results from publicly posted FDA reviews.

Learning Objectives

Explain basic statistical concepts such as randomization, blinding, hypothesis testing, p-values, the challenges of false positives and adjusting for multiplicity, and approaches to handling missing data; Identify the appropriate statistical analysis for a given outcome; Discuss assumptions and limitations of analysis methods with a study team; Assess the clinical importance of statistical results.

Chair

Matt Baldwin, MS

Speaker

Facilitator
Stephen Corson, PhD

Facilitator
Munish Mehra



Speakers
avatar for Matt Baldwin

Matt Baldwin

Senior Biostatistician, Advance Research Associates, Inc (ARA)
Matt Baldwin is a Senior Biostatistician who works with Advance Research Associates to advance clinical solutions through analysis. Matt’s various positions have provided experience in randomization, generic and new drugs, statistical clinical development, DMC support, and analysis... Read More →
avatar for Stephen Corson

Stephen Corson

Senior Statistician, Phastar
I am a Senior Statistician working at Phastar, a specialist CRO offering statistical consultancy, clinical trial reporting and data management services to pharmaceutical and biotech companies. Prior to this I spent 3 years working as a Consultant Statistician in the Department of... Read More →
avatar for Munish Mehra

Munish Mehra

Executive Director, Tigermed
Dr. Munish Mehra, is a drug development expert with Tigermed, providing services to Pharmaceutical and Biotechnology companies to design, analyze and report on Phase 2 and 3 studies. He has represented several sponsors at pre-IND, End of Phase 2 and pre-NDA meetings. He is a frequent... Read More →


Wednesday June 26, 2019 4:15pm - 5:30pm
Room 11B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA