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15: Engage-Exchange [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

12:15pm

#125 EE: ICH E2B IND Safety Reporting to FDA Adverse Event Reporting System (FAERS)
Component Type: Workshop
Level: Intermediate

FDA is preparing to receive IND safety reports in ICH E2B format to FDA Adverse Events Reports System (FAERS). During this session the implementation plan for E2B(R2) IND safety reporting will be discussed in use case-based scenarios.

Learning Objectives

Recognize that FDA is preparing to receive IND safety reports in ICH E2B format to FDA Adverse Event Reporting System (FAERS); Describe several E2B R2 data elements, including regional elements that are key for premarket safety reporting.

Chair

Meredith K. Chuk, MD, MHS

Speaker

Facilitator
Suranjan De



Speakers
MC

Meredith Chuk

Acting Associate Director for Safety, OHOP, CDER, FDA
avatar for Suranjan De

Suranjan De

Deputy Director, Regulatory Science, OSE, CDER, FDA
Mr. De is the Deputy Director of CDER’s Office of Surveillance and Epidemiology, Regulatory Science Staff at FDA. He provides expert advice and technical direction on regulatory science for developing new tools, standards, and approaches to assess the safety, efficacy, quality... Read More →
MC

Meredith Chuk

Acting Associate Director for Safety, OHOP, CDER, FDA
Dr. Meredith Chuk is the Acting Associate Director for Safety in the Office of Hematology and Oncology Products in CDER at the FDA.


Monday June 24, 2019 12:15pm - 1:00pm
E and E Area Exh Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

1:15pm

#129 EE: The Potential Value of Shared Decision Making (SDM) in Clinical Trial Consideration and Participation
Component Type: Workshop
Level: Intermediate

Shared decision making is a form of collaborative communication to help patients and their providers consider various care options and potential clinical trials. Through facilitated discussion and small group activity, participants will examine the value of SDM from the point of view of people living with different disease types, from common, chronic diseases, such as diabetes, to various stages of cancer and rare diseases. They will also consider a study design with patient-centered outcome measures related to decision-making and patient experience.

Learning Objectives

Explore the application of SDM in discussions including clinical trials as options; Examine examples from clinical development operations, assess them for their suitability for decision support; Discuss the challenges of implementation Explain a study design that could help demonstrate the potential of SDM to transform traditional clinical trial recruitment into patient-centered decision support.

Chair

Mary Stober Murray, MBA

Speaker

Facilitator
Diana Pankevich, PhD

Facilitator
T.J. Sharpe, PMP



Speakers
avatar for Mary Murray

Mary Murray

Associate Director, Diversity and Patient Engagement, Bristol-Myers Squibb Company
As an Associate Director for Diversity and Patient Engagement at Bristol-Myers Squibb, Mary facilitates collaborations with disease-specific and community-based organizations to bring relevant clinical trial options to patients and representative populations. Mary has co-chaired the... Read More →
DP

Diana Pankevich

Director,Innovation Policy, Pfizer Inc
avatar for T.J. Sharpe

T.J. Sharpe

Patient Advocate, Starfish Harbor LLC
T.J. Sharpe is a Stage IV melanoma patient who shares his journey through cancer in the Patient #1 Blog.  He was diagnosed in August 2012 with melanoma tumors in multiple organs, only four weeks after his second child was born. Since then, he has undergone six surgeries and four... Read More →


Monday June 24, 2019 1:15pm - 2:00pm
E and E Area Exh Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

5:15pm

#175 EE: Data Analytics Use in Quality Processes
Component Type: Workshop
Level: Advanced

Roche is using data analytics as a key component for planning and conducting audits and providing ongoing support to our study teams. A brief overview will be given, and participants will be invited to share their experiences.

Learning Objectives

Discuss how Roche is integrating data analytics into issue/audit management; Describe how other companies are/will be using data analytics in support of their quality processes.

Chair

Eileen Magruder, DrMed, MD

Speaker

Facilitator
Alaina Barros



Speakers
avatar for Alaina Barros

Alaina Barros

Principal Auditor/Quality Program Lead, Genentech, A Member of the Roche Group
Alaina Barros has worked within the pharmaceutical industry for 17+ years in the areas of manufacturing, clinical operations and quality. She is currently employed with Genentech, a member of the Roche Group, as a Quality Program Lead/Principal Auditor.
avatar for Eileen Magruder

Eileen Magruder

Senior Auditor, Product Development Quality- PDQ-AFM, Genentech, A Member of the Roche Group
Eileen E. Magruder, MD has over 20 years of experience as a GCP and PV auditor. She is currently a senior auditor for the Product Development Quality - Audit and Finding Management team at Genentech, Inc., a member of the Roche Group.


Monday June 24, 2019 5:15pm - 6:00pm
E and E Area Exh Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
 
Tuesday, June 25
 

9:30am

#222 EE: The Negotiation Game: Learn What you Never Knew About Negotiation in a Fun, Interactive, Collaborative Game
Component Type: Workshop
Level: Basic

This is an interactive game for people who want to build negotiating skills, and we ALL negotiate, for everything, all day long regardless of your role or title. Guaranteed to be thought provoking, fun, and talked about!

Learning Objectives

Describe team collaboration- how do we negotiate with other teams to our greatest benefit; Discuss collaboration in the context of competition.

Chair

Sheila Mahoney Jewels, MBA


Speakers
avatar for Sheila Mahoney Jewels

Sheila Mahoney Jewels

CEO, Reg/Clin Ops SME Independent Consultant, LifeSciHub
Sheila has over 25 years of experience in reg/clin ops, having operated as an SME on both the sponsor and vendor sides. Her current focus as an independent consultant (IC) is advocating for the independent workforce, and helping sponsors engage with them. Sheila has spent the last... Read More →


Tuesday June 25, 2019 9:30am - 10:15am
E and E Area Exh Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

2:00pm

#274 EE: Pharma Powered by the Digital
Component Type: Workshop
Level: Basic

Pharma companies are experimenting with a range of digital health initiatives. This workshop will help the audience appreciate the complexity of implementing digital solutions through mock cases and interactive discussions about key challenges.

Learning Objectives

Identify opportunities and challenges associated with digital health technologies; Discuss approaches and strategies to more effectively engage in digital healthcare initiatives; Apply best practices to future digital health implementation.

Chair

Fabian D'Souza, MD, MBA


Speakers
avatar for Fabian D'Souza

Fabian D'Souza

Founder and President, Boston Strategic Partners, Inc.
Dr. D’Souza is the Founder and President of Boston Strategic Partners, Inc. a consultancy dedicated to serving pharma-biotech, devices/ diagnostics, and Health-IT through different practices: business and clinical strategy, HEOR, and medical communications. He has also led projects... Read More →


Tuesday June 25, 2019 2:00pm - 3:00pm
E and E Area Exh Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

3:15pm

#275 EE: Access to Investigational Drugs Outside of Clinical Trials: What's Fair?
Component Type: Workshop
Level: Basic

Requests for investigational drugs are increasing, posing ethical, regulatory, and logistical challenges for companies. After discussing a fictional case, participants will understand these challenges and be better prepared to address them.

Learning Objectives

Discuss ethical, legal, and practical concerns surrounding patient requests for access to investigational drugs outside of clinical trials (preapproval access); Apply this knowledge to a fictitious case study; Analyze the pros and cons of different possible responses in real world scenarios.

Chair

Alison Bateman-House, PhD, MA, MPH

Speaker

Facilitator
Beverly L Harrison



Speakers
avatar for Alison Bateman-House

Alison Bateman-House

Assistant Professor, Division of Medical Ethics, NYU Langone Health
Alison Bateman-House, PhD, MPH, MA, is an assistant professor in the Division of Medical Ethics at NYU Langone Health's School of Medicine. She is co-chair of the Working Group on Compassionate Use and Preapproval Access (CUPA), an academic group that studies ethical issues concerning... Read More →
avatar for Beverly Harrison

Beverly Harrison

Head, Patient Support, Janssen Pharmaceutical Companies of Johnson & Johnson
Leading the Patient Support Group @ Janssen R&D (a J&J Co.), reporting directly to the Chief Medical Officer, Beverly focuses on developing strategies for patients’ needs by working with internal/external stakeholders & engaging patient advocacy organizations. She is a R&D & nonprofit... Read More →


Tuesday June 25, 2019 3:15pm - 4:15pm
E and E Area Exh Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
 
Wednesday, June 26
 

9:30am

#321 EE: One Size Does NOT Fit All: Know How to Adapt your Communication Style to be Effective Communicating Up, Down and Peer-to-Peer
Component Type: Workshop
Level: Basic

This interactive workshop will allow participants to discover their communication style, and to make a plan for when and how to adapt that style to most effectively communicate with managers, subordinates, or peers who possess a different style.

Learning Objectives

Identify their own communication style(s) by completing a communication style inventory (e.g., DOPE assessment); Discuss (via role play) the communication styles of their subordinates, peers, and manager(s); Recognize how to create an action plan for more effective communication with 3 chosen individuals (in the workplace, at home, or other).

Chair

Margaret Richards, PhD

Speaker

Facilitator
Donny Chen, MBA



Speakers
avatar for Donny Chen

Donny Chen

Executive Director, Registries and Prospective Studies, Evidera
Donny Chen, executive director of registries and prospective studies at Evidera/PPD, has spent the last 20 years designing and spearheading observational research studies in a variety of therapeutic areas, with particular expertise in strategy, analysis and project management. Mr... Read More →
avatar for Margaret Richards

Margaret Richards

Executive Director, Scientific Affairs, Real-World Solutions, PRA Health Sciences
Dr. Meg Richards has over 25 years' experience as an epidemiologist in the public health, biopharmaceutical, and contract research sectors. Prior to joining PRA as Executive Director of Scientific Affairs, Dr. Richards worked for 8 years at Mapi (ICON plc) and PPD-Evidera. Dr. Richards... Read More →


Wednesday June 26, 2019 9:30am - 10:15am
E and E Area Exh Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

12:30pm

#349 EE: Regulatory Affairs Governance: Benchmarking and Sharing of Best Practices
Component Type: Workshop
Level: Intermediate

Gain a deeper understanding of governance in regulatory affairs through this discussion-based workshop where you’ll be teamed with peers to share your experiences and assess your company’s procedures to encourage efficient decision-making processes.

Learning Objectives

Describe how to benchmark internal governance within Regulatory Affairs in other pharmaceutical companies by engaging in peer discussion -Identify the importance and benefits of a well-functioning governance model; Explain how to utilize learnings to identify potential areas of improvement within your own company.

Chair

Benjamin Sugden, PharmD


Speakers
avatar for Benjamin Sugden

Benjamin Sugden

Assistant Director Regulatory Affairs, North America Regional Operations, Bayer U.S. Pharmaceuticals
Benjamin Sugden, Pharm.D., is currently the Assistant Director of Regulatory Affairs, North America Regional Operations for Bayer U.S. Pharmaceuticals. Dr. Sugden has previously served within Regulatory Affairs as a Senior Information Scientist. Before joining Bayer in 2017, he gained... Read More →


Wednesday June 26, 2019 12:30pm - 1:30pm
E and E Area Exh Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

2:00pm

#374 EE: Enabling Patient-Centric Clinical Studies: TransCelerate’s Patient Engagement Tools
Component Type: Workshop
Level: Intermediate

TransCelerate BioPharma is a collaboration of 19 of the world’s leading pharmaceutical organizations that has undertaken a Patient Experience initiative to enable greater patient engagement and partnership between patient and sponsors.

Learning Objectives

Describe TransCelerate’s Patient Experience Initiative and the toolkits; Recognize the value of patient engagement in the development of clinical study protocols; Identify the clinical study participant experience as a valuable outcome measure; Appreciate the opportunity for embedding these practices into the development process.

Chair

Mary Elmer, BSN, MSN, RN

Speaker

Facilitator
Lani Hashimoto

Facilitator
Anne Marie L. Inglis, PhD

Facilitator
Christina Cantrell, MSc



Speakers
avatar for Mary Elmer

Mary Elmer

Director, Patient Caregiver, Consumer Experience, Merck
Mary Elmer is the director of the Patient, Caregiver and Consumer experience at Merck. This group seeks to create an experience that engages consumers and patients in optimizing their health, wellbeing, and healthcare outcomes. She also leads a team for global patient engagement... Read More →
CC

Christina Cantrell

Senior Patient Insights Leader, Genentech, A Member of the Roche Group
Christina has worked for over 15 years in clinical research, always with a focus on the patient’s experience and primarily in outcomes research and insights gathering. She has worked at both large and community hospitals, health technology vendors, and she currently works at Roche... Read More →
LH

Lani Hashimoto

Clinical Trial Intelligence Manager, Novartis Pharmaceuticals Corporation
LH

Lani Hashimoto

Clinical Program Benchmark Manager, Novartis Pharmaceuticals Corporation
avatar for Anne Marie Inglis

Anne Marie Inglis

Director, US Clinical Operations, Development Clinical Operations, Pharma R&D, GlaxoSmithKline
Dr. Inglis has over 20+ years of experience in clinical research, spanning all phases of research, specializing in clinical operations. Most recently, she was Head of US Pharma Clinical Operations for GSK, where she was responsible for operational delivery of US Clinical Trials. Currently... Read More →


Wednesday June 26, 2019 2:00pm - 3:00pm
E and E Area Exh Hall 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