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Monday, June 20
 

12:15pm CDT

#104 CH: What Do Patients Want From Digital Solutions? Considerations for Access, Self Determination of Their Data and Portability
Component Type: Workshop
Level: Intermediate

This content hub will share feedback from Patient Advocates on the clinical research experience and what technologies can address their needs. The unique role that digital solutions can play in facilitating clinical research will also be explored.

Learning Objectives

Reassess the perspective of the patient as we advance our use of digital solutions in clinical research; Compare the experience gained in the clinical research community over the last 2 years on digital solutions with patient needs; Describe the adoption of digital solutions and trends in patient behavior and explore impact on clinical research strategy.

Chair

Michelle Hoiseth

Speaker

Facilitator
Joy Bhosai, MD, MPH


Speakers
avatar for Michelle Hoiseth

Michelle Hoiseth

Chief Data Officer, Parexel, United States
Michelle has been working in the drug and device development industry for 30 years. She has enjoyed a variety of positions that allowed her to create product development plans, run study operations, and support product commercialization objectives. Michelle presently serves Parexel... Read More →
avatar for Michelle Hoiseth

Michelle Hoiseth

Chief Data Officer, Parexel, United States
Michelle has been working in the drug and device development industry for 30 years. She has enjoyed a variety of positions that allowed her to create product development plans, run study operations, and support product commercialization objectives. Michelle presently serves Parexel... Read More →

Monday June 20, 2022 12:15pm - 12:45pm CDT
Room 470 B McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  15: Content Hubs, Workshop |   05: Patient Engagement, Workshop

2:30pm CDT

#123 CH: Mastering the Science of Medical Writing Communications
Component Type: Workshop
Level: Intermediate

Medical writers don't just write documents, we are also strategic planners, mediators and conflict resolvers and need to be effective communicators. This session aims to give MWs hands on tools for better communication with their team members.

Learning Objectives

Identify key communication errors; Share examples of best practices for good planning and communication; Discuss how to train reviewers.

Chair

Mitali Purohit, PhD, MS

Speakers
avatar for Mitali Purohit

Mitali Purohit

Associate Director, Immunology TA Lead, CSL Behring, United States

Monday June 20, 2022 2:30pm - 3:00pm CDT
Room 470 B McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  15: Content Hubs, Workshop |   04: MedAffairs-SciComm, Workshop

4:00pm CDT

#135: Demystifying the Delivery of Healthcare Economic Information (HCEI) by Medical Affairs and Market Access Personnel
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-528-L04-P ; CME 1.00; RN 1.00

Focus is on the exchange of healthcare economic information to the payor audiences. Since FDAMA 114 was instituted, many changes have occurred in the pharmaceutical industry regarding the what, the when, and the who around this information exchange.

Learning Objectives

Describe health economic and outcomes research and potential consumers of this research; Examine how healthcare economic information (HCEI) is communicated and how the customer segments in this area are expanding; Discuss a case study on the benefits and challenges of communicating health economics and outcomes research to a variety of customer segments.

Chair

J. Lynn Bass, PharmD, RPh

Speaker

Panelist
Iris Tam, PharmD

Panelist
Jeff Lee, PharmD

Panelist
Dara S. Katcher Levy, JD


Speakers
avatar for Jeff Lee

Jeff Lee

Vice President, US Value Strategy and Services, Lumanity, United States
Jeff is a senior HEOR leader, with a focus on generating and communicating value evidence for payor audiences. Jeff led the Global Health Outcomes and Payer MSL teams at Allergan after several years as International Director of Pharmacoeconomics at Glaxo. Jeff is an ACCP Fellow, led... Read More →
avatar for Iris Tam

Iris Tam

Vice President and Head, Medical Affairs and HEOR, Coeus Consulting Group, United States
Iris Tam, PharmD, FAMCP, has over 28 years of experience in health care, including hospital pharmacy administration, managed care pharmacy, and 17 years in the biopharmaceutical industry. She is Senior Director & Head of HEOR, Patient Access and Value at Coeus Consulting Group, a... Read More →
avatar for Dara Katcher Levy

Dara Katcher Levy

Director, Hyman Phelps & McNamara P.C., United States
Dara Levy helps pharmaceutical and medical device companies on a wide range of issues relating to product communications. Dara assists clients with products in all stages of development to design engaging communications compliant with FDA legal and regulatory requirements. In the... Read More →
avatar for Iris Tam

Iris Tam

Vice President and Head, Medical Affairs and HEOR, Coeus Consulting Group, United States
Iris Tam, PharmD, FAMCP, is Vice President & Head of Medical Affairs and HEOR at Coeus Consulting Group with over 30 years of experience in health care, including hospital pharmacy, managed care pharmacy, and the biopharmaceutical industry. In previous industry roles, she led Medical... Read More →

Monday June 20, 2022 4:00pm - 5:00pm CDT
Room 470 B McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  04: MedAffairs-SciComm, Forum
 
Tuesday, June 21
 

9:00am CDT

#206: The Future of Content Authoring and Web Portal Technology, Publishing Stability Calculators: Challenges for Pushing Automation
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-545-L04-P ; CME 1.00; RN 1.00

This session will discuss the digitization and on-line medical information resources.

Learning Objectives

Describe the value and purpose around defining and architecting content for multi-channel use; Evaluate the capabilities of new technology for Self Service and MI Portals; Discuss questions around what is permissible within a regulatory framework; Identify artificial Intelligence capabilites in Medical Information Portals.

Chair

Joe Pierce

Speaker

The Future of Content Authoring and Web Portal Technology
Joe Pierce

Publishing Stability Calculators: Challenges for Pushing Automation
Graham Harding, PharmD

Content Formatting for Multi-Channel use
John Jones, MBA


Speakers
avatar for Graham Harding

Graham Harding

Senior Operations Manager, PPD, Part of Thermo Fisher Scientific, United States
Graham Harding, PharmD is a senior operations manager in Medical Information at PPD, part of Thermo Fisher Scientific. He has more than a decade of experience in health care including retail pharmacies and the biopharmaceutical industry. Within Medical Information, he has assisted... Read More →
JJ

John Jones

Technology Director, PhactMI, United States
John Jones is an experienced IT Strategist focused on developing innovative technology solutions for unmet business needs in Life Sciences. John is currently the Founder and CEO of Entitech Solutions, a Life Sciences focused IT Software and Consulting firm. Prior to starting his company... Read More →
avatar for Joe Pierce

Joe Pierce

CEO, SciMax Global, United States
Joe Pierce has worked with pharmaceutical and biotech companies since 1995, specifically in the area of medical information and medical affairs. He was VP of Sales and Marketing for Online Business Applications, leading that company’s core product IRMS, to become the most widely... Read More →

Tuesday June 21, 2022 9:00am - 10:00am CDT
Room 470 B McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  04: MedAffairs-SciComm, Session

11:00am CDT

#221: Complying with the EU-CTR Disclosure Standards in the Era of GDPR
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-557-L04-P ; CME 1.00; RN 1.00

Hear from disclosure experts about their organizations’ approaches to EU-CTR disclosure requirements while complying with GDPR and how EU-CTR disclosure compares with EMA CDP (EMA Policy 0070) disclosure.

Learning Objectives

Identify the disclosure requirements and standards as written in the European Union (EU) – Clinical Trial Regulation (CTR); Evaluate how the disclosure standards for EU-CTR align with the requirements of the EU General Data Publication (GDPR); Describe how the disclosure standards in the EU-CTR compare to the standards of the Clinical Data Publication (CDP; aka EMA Policy 0070).

Chair

Robin Whitsell

Speaker

Preparing for EUCTR
Lora Killian, MBA

Influences in Transparency Approach for EU CTIS
Julie G. Holtzople

Lessons Learned for EU CTIS Submissions
Wendy M Wimmer, MS


Speakers
avatar for Julie Holtzople

Julie Holtzople

Senior Director Clinical Transparency and Data Sharing, AstraZeneca, United States
Julie Holtzople is the Sr. Director of Clinical Transparency & Data Sharing for AstraZeneca and co-lead of the CREG CTT group. Julie received her Bachelors of Science in Business Administration at Virginia Polytechnic Institute. Julie has been with AstraZeneca for 14 years. Prior... Read More →
avatar for Lora Killian

Lora Killian

Clinical Trial Transparency and Disclosure Lead, Pfizer Inc, United States
Lora has 20+ years of business experience, including more than a decade of pharmaceutical industry experience. She started her career in the military serving four years of active duty in the Medical Service Corp for the U.S. Army. In her first pharmaceutical industry position, Lora... Read More →
avatar for Wendy Wimmer

Wendy Wimmer

Director, Clinical Data Disclosure and Transparency, Merck & Co., Inc., United States
Wendy Wimmer is a Director in the Clinical Data Disclosure & Transparency department at Merck Sharp & Dohme. She has over 25 years of clinical research experience and over the last 6 years has created and currently manages a centralized document transparency functional area for her... Read More →

Tuesday June 21, 2022 11:00am - 12:00pm CDT
Room 470 B McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  04: MedAffairs-SciComm, Session |   08: RD Quality-Compliance, Session |   09: Regulatory, Session

12:45pm CDT

#237.1 CH: Emerging Editorial Policies, Researcher, and Author Standards in Promoting Diversity, Inclusion, and Equity in Cancer Research
Component Type: Workshop
Level: Basic

Medical journals are addressing systemic inequities in healthcare via new editorial policies requiring demographic reporting in published research. The workshop will explore stakeholder considerations, actions and metrics as these policies evolve.

Learning Objectives

Identify how to ensure transparent demographic, sexual orientation and gender identity (SOGI), and social determinants of health (SDoH) collection and reporting for inclusive research programs; Describe how to advocate for demographic collection and reporting in the research and clinical trial process with internal and external partner organizations, including Journal editors.

Chair

Jeanne Regnante

Speakers
JR

Jeanne Regnante

Chief Health Equity Advisor, Tiger Lily Foundation, United States
Jeanne M. Regnante is Tigerlily Foundation’s Strategic Health Equity Advisor. Previous to this position, Jeanne was the Chief Health Equity and Diversity Officer at the LUNGevity Foundation, the Senior Vice President of Community Engagement for NMQF where she launched the Cancer... Read More →

Tuesday June 21, 2022 12:45pm - 1:15pm CDT
Room 470 B McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  15: Content Hubs, Workshop |   04: MedAffairs-SciComm, Workshop

1:45pm CDT

#246: Project Management Across the Healthcare Continuum
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-572-L04-P ; CME 1.00; PDU 1.00 PMI 2166M0HPR0; RN 1.00

This session will cover skills project management professionals need to develop and learn – regardless of which function you belong to deliver success delivery project outcomes.

Learning Objectives

Discuss what is it to be a project manager from three different functions across drug development life cycle in a pharma company; Assess if you are a practicing project manager or a new project manager and wondering – how does the project manager role look like to lead initiatives to deliver business results vary from Discovery to Pharmacovigilance to Commercial function.

Chair

Erin Mulrooney, MSc, PMP

Speaker

Project Management in Discovery
Erin Mulrooney, MSc, PMP

Project Management: New Market Development
Nancy Watanabe, MS, PMP

Project Management: Pharmacovigilance
Jeffrey Mohr, PhD


Speakers
avatar for Hetal Doshi

Hetal Doshi

Director, Business Operations and Strategy, AbbVie, Inc., United States
Hetal Doshi has over 15 years of experience in leading global business transformation initiatives in pharmaceutical and healthcare industry. Her experience span across leading strategic initiatives in Pharmacovigilance & Patient Safety, Regulatory, Technology and Digital Health initiatives... Read More →
avatar for Jeffrey Mohr

Jeffrey Mohr

Director, Global Strategic Safety Initiatives and Portfolio Management, AbbVie, United States
Jeffrey Mohr is a Director in the Pharmacovigilance and Patient Safety division of AbbVie R&D where he manages Strategic Initiatives and Global Portfolio Management, focused on driving business transformation. Prior to joining AbbVie, Jeffrey was the Senior Director, Portfolio Simplification... Read More →
avatar for Nancy Watanabe

Nancy Watanabe

Executive Director, New Market Development Project Leadership, BeiGene, Inc., United States

Tuesday June 21, 2022 1:45pm - 2:45pm CDT
Room 470 B McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  07: ProjectManagement-StrategicPlanning, Forum |   13: ProfDevelopment, Forum

3:30pm CDT

#262 CH: Mentoring 101
Component Type: Workshop
Level: Basic

Mentoring experts will discuss key relationships that can influence the trajectory of your career. Your relationships with your network, coach, mentor and sponsor will be explored. A provided tool will be used to manage these relationships.

Learning Objectives

Differentiate a network, coach, mentor and sponsor; Discuss how using a provided tool, define their plan for managing their career relationships.

Chair

Leslie Sam

Speaker

Mentoring Update
Tywnia Brewton


Tuesday June 21, 2022 3:30pm - 4:00pm CDT
Room 470 B McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  15: Content Hubs, Workshop |   13: ProfDevelopment, Workshop

4:15pm CDT

#273: IMPALA (IntercoMPany quALity Analytics) Industry Group: Data Science Development and Other Collaboration Updates
Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-586-L04-P ; CME 1.00; RN 1.00

This forum will cover data science models that have been shared across companies, learnings from the testing and deployment of those models across companies, and prompt discussion on how further collaborative efforts could accelerate data-driven Q&C.

Learning Objectives

Discuss examples of R&D quality data science models that are developed and shared across companies; Discuss other sharing opportunities including Health Authority engagement, how to expand the collaborative efforts in order to drive data and digital transformation of R&D quality; Discuss potential to further advance risk-based and data-driven collaborative approaches.

Chair

Robert Studt

Speaker

Panelist
Jennifer Emerson, PhD, MPH, RN, PMP

Panelist
Michael Torok, PhD

Panelist
Ronojit Adyanthaya, MS


Speakers
avatar for Ronojit Adyanthaya

Ronojit Adyanthaya

Senior Director, QA Analytics and Insights, Merck & Co., Inc., United States
Senior Director, Analytics & Insights for Merck Research Labs (MRL) Quality Assurance group. Responsible for leading Analytics, and Data Science initiatives for QA business. Prior to joining Merck, he worked for various pharmaceutical and medical device companies within the Quality... Read More →
avatar for Jennifer Emerson

Jennifer Emerson

Head Quality Analytics & Risk Management, Boehringer Ingelheim, Germany
Clinical research professional with more than 20 years' experience in Quality Management, Project Management, Monitoring & Pharmacovigilance. PhD in Public Health - Epidemiology, Project Management Professional (PMP) Certified, ISO 9001:2015 certified Auditor. Current role: Head of... Read More →
avatar for Robert Studt

Robert Studt

Head of Quality Analytics, BioResearch Quality and Compliance, Janssen, United States
Rob is currently the head of Quality Analytics in Johnson & Johnson's BioResearch Quality & Compliance. He began his career as a drug discovery chemist, and has worked in leadership roles in Drug Discovery, R&D IT, and Quality & Compliance. Current interests are in applications of... Read More →
avatar for Michael Torok

Michael Torok

Senior Director, Clinical Quality Assurance, Astellas, United States
Michael Torok, Ph.D. is a Senior Director in Clinical Quality Assurance at Astellas. He currently leads Astellas’ CQA Process Improvement, Operational Excellence, and Audit Center of Excellence groups. He is passionate about leveraging quality analytics to enhance risk and issue... Read More →

Tuesday June 21, 2022 4:15pm - 5:15pm CDT
Room 470 B McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  08: RD Quality-Compliance, Forum |   11: Statistics, Forum
 
Wednesday, June 22
 

9:00am CDT

#304: Transformation of the Data Manager to the Data Scientist
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-596-L04-P ; CME 1.00; RN 1.00

This session will share perspectives and examples of digitally-enabled data processes and how they can accelerate timelines. Utilizing data during the clinical trial budgeting process is very important and allows for a strategic and compliant approach to your financial management.

Learning Objectives

Outline ways digitally enabled data processes can streamline and reduce cycle times for data management; Identify lessons learned for data management during the pandemic and how they can be applied to the future state; Assess what might stay the same and where the most realistic advantages are to be had for data management to see progress; Describe how to utilize data to gain complete control and visibility into your trial budgeting.

Chair

Katrina Rice, MS

Speaker

What the Future State Really Looks Like for Clinical Data Leaders
Katrina Rice, MS

How Data Scientists Bring Insights and Visibility to Clinical Trial Budgeting
Shelley Douros


Speakers
SD

Shelley Douros

Senior Director, Product Management, Clinical Trial Financial Management, Medidata, a Dassault Systèmes company, United States
avatar for Katrina Rice

Katrina Rice

Chief Delivery Officer, Data Services, eClinical Solutions, United States
Katrina Rice is an accomplished Chief Delivery Officer with an impressive career that spans over 20 years and includes advancement into increasingly demanding leadership roles. With a solid history of leading business transformations and managing global portfolios, she is as much... Read More →

Wednesday June 22, 2022 9:00am - 10:00am CDT
Room 470 B McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  03: Data-Tech in Clinical Trials, Session |   02: ClinTrials -ClinOps, Session

12:45pm CDT

#336 CH: Reviewing FDA's Draft Guidance on PROs in Oncology Trials: How This Affects Future Measurement Strategy and Study Designs
Component Type: Workshop
Level: Intermediate

In June '21, FDA issued draft guidance on core PROs in cancer trials. This provides insight into regulatory thinking, and may lead to more future PRO-based labeling. This session explores how the guidance might affect study design and PRO selection.

Learning Objectives

Identify if existing gold standard measures are fit for purpose; Explore the impact of the guidance on PRO selection and adaptation; Discuss how to optimize study designs to meet the requirements of the guidance, and what this means practically for patients and sites.

Chair

Bill Byrom, PhD

Wednesday June 22, 2022 12:45pm - 1:15pm CDT
Room 470 B McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  15: Content Hubs, Workshop |   02: ClinTrials -ClinOps, Workshop

1:45pm CDT

#346: New Global Team: Building and Leading Remote Teams and Non-Fulltime Equivalents (FTEs)
Component Type: Session
Level: Intermediate

This session will discuss the unique challenges associated with leading a remote global team and discuss the characteristics of high performing teams and practical actions and strategies for modern leaders to drive engagement and team performance. We will explore the need to tailor management approach for the individual and discuss improving retention of high achieving team members.

Learning Objectives

Recognize the unique challenges inherent with leading a team based remotely (home based, different geographies); Outline basic strategies for meeting the challenges and encouraging the desired team characteristics; Demonstrate an understanding of how to tailor leadership strategies for the needs of the individual.

Chair

Catherine Edwards

Speaker

The New Global Team: Building and Leading Engaged and High Performing Remote Teams to Meet Today’s Business Challenges
Catherine Edwards

Become a Virtual Classroom Training Whiz: The 6 Ps for Success!
Liz Wool, BSN

Working with Non FTEs: The Do's and Don'ts of Working with Consultants and Contractors
Sheila Mahoney Jewels, MBA


Speakers
avatar for Catherine Edwards

Catherine Edwards

Senior Director, Regulatory Consulting, Syneos Health, United Kingdom
Catherine is currently the Head of Europe for Syneos Health's Global Regulatory Affairs group and is based in the UK. Catherine has 20 years’ experience in the Pharmaceutical Industry with both sponsor companies and CROs. She started in drug development and clinical trial support... Read More →
avatar for Liz Wool

Liz Wool

President, Wool Consulting Group Inc., United States
Liz Wool CCRA, CID, CMT, is President, Wool Consulting Group. Inc. Liz possesses 28 years in the product development with expertise in CRO-Vendor Oversight, GCP compliance, SOP gap analyses and development, development and delivery of training programs (live, webinar, virtual classroom... Read More →

Wednesday June 22, 2022 1:45pm - 2:45pm CDT
Room 470 B McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  13: ProfDevelopment, Session |   07: ProjectManagement-StrategicPlanning, Session

3:15pm CDT

#361 CH: Separating the AI Hype From Reality: A Primer on NLP (Natural Language Processing)
Component Type: Workshop
Level: Intermediate

The promise of AI is incredible, but clarity has been a challenge for drug development operations. This Content Hub will provide an educational primer on NLP, the most advanced form of AI commercially available for widespread adoption today.

Learning Objectives

Acquire practical knowledge with which to recognize NLP’s potential for efficiency gains, and more effectively collaborate with internal IT groups to manifest operational innovation via this emerging technology.

Chair

Walter Bender, MS

Speakers
avatar for Walter Bender

Walter Bender

Chief Technology Officer, Sorcero, United States
Walter Bender is a technologist, entrepreneur, and free software advocate. As CTO and Co-founder of Sorcero, Walter leverages technology to enhance the learning capabilities of humans and machines. Walter was a founding member of the MIT Media Lab where he held the Alexander W. Dreyfoos... Read More →

Wednesday June 22, 2022 3:15pm - 3:45pm CDT
Room 470 B McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  15: Content Hubs, Workshop |   04: MedAffairs-SciComm, Workshop

4:15pm CDT

#377: Choosing the Most Convincing Clinical Endpoints in Cancer Clinical Trials: How to Balance Different Perspectives?
Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-645-L04-P ; CME 1.00; RN 1.00

The choice of endpoints for oncology trials requires balancing multiple and often competing objectives, like validity, feasibility, etc. In this session we’ll explore strategies for optimal endpoint selection from different perspectives.

Learning Objectives

Identify different estimands and attributes for efficacy endpoints in cancer clinical trials; Describe the different perspectives and trade-offs involved in the choice of endpoints; Discuss strategies for optimizing the choice of endpoint based on a survey of decision makers and examples of global cancer drug development.

Chair

Francesco Pignatti, MD

Speaker

Results of the EMA Survey on PFS as a Clinical-Benefit Endpoint
Douwe Postmus, PhD, MSc

Endpoint Selection Strategies to Address the Needs of Multiple Decision Makers Globally
Amy McKee, MD

Trial Objectives and Endpoint Selection Considerations in the Cancer Drug Development
Rajeshwari Sridhara, PhD


Speakers
avatar for Amy McKee

Amy McKee

CMO and Global Head, Oncology Center of Excellence, Parexel International, United States
Dr. McKee worked for over 10 years at the U.S. Food and Drug Administration most recently in the role of Deputy Center Director, Oncology Center of Excellence (OCE) and Supervisory Associate Director, OHOP, CDER. Dr. McKee was the signatory authority for products within Office of... Read More →
avatar for Francesco Pignatti

Francesco Pignatti

Scientific Adviser for Oncology, European Medicines Agency, Netherlands
Francesco Pignatti graduated as Medical Doctor at the University of Rome La Sapienza, Italy. In 1995 he became Research Fellow at the EORTC Data Center in Brussels, Belgium In 1997 he obtained a Master of Science degree in Biostatistics from the University of Limburg, Belgium. In... Read More →
avatar for Douwe Postmus

Douwe Postmus

Assistant Professor & Seconded National Expert, University Medical Center Groningen & EMA, Netherlands
Dr Douwe Postmus is employed as an assistant professor at the Department of Epidemiology of the University Medical Center Groningen, The Netherlands. His research focuses on applying quantitative modeling techniques to decision making problems in health care, including regulatory... Read More →
avatar for Rajeshwari Sridhara

Rajeshwari Sridhara

Senior Biostatistician Consultant, Oncology Center of Excellence, FDA, FDA, United States
Rajeshwari Sridhara, Ph.D. is the Division Director of Division of Biometrics V, Office of Biostatistics which supports Office of Hematology Oncology Products in the Oncology Center of Excellence and Center for Drug Evaluation and Research. As a leader in the field, she routinely... Read More →

Wednesday June 22, 2022 4:15pm - 5:15pm CDT
Room 470 B McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  11: Statistics, Session |   02: ClinTrials -ClinOps, Session |   05: Patient Engagement, Session
 
Thursday, June 23
 

10:00am CDT

#414: Optimizing the Pharma Workforce for Trial Success in the Digital Era
Component Type: Forum
Level: Basic

Digital tools are increasingly central for success across clinical development. This session will focus on target skills, best practices and educational opportunities for pharma workforce development for more efficient and successful clinical trials.

Learning Objectives

Define key skills necessary for digital success at different stages of clinical development; Define best practices for pharma workforce development strategies that support the successful adoption of digital health solutions; Discuss future trends and enablers for the pharma workforce to optimize the impact of digital health on trial inclusivity, patient centricity, speed, and success.

Chair

Claire Meunier, MBA

Speaker

Panelist
Chris Benko, MBA

Panelist
Jordan Brayanov, PhD

Panelist
Maria I. Florez, MA


Speakers
avatar for Chris Benko

Chris Benko

Chief Executive Officer, Koneksa Health, United States
Chris Benko is the CEO and co-founder of Koneksa Health, the leading patient-centric digital biomarker company for the pharmaceutical and biotechnology industries that develops end-to-end solutions for remotely collected clinical data. Prior to founding Koneksa, Chris was a vice president... Read More →
JB

Jordan Brayanov

Senior Director, Digital Strategy, Takeda Pharmaceutical Company Limited, United States
Jordan Brayanov, PhD is a Senior Director, Digital Strategy, within the Data Sciences Institute at Takeda Pharmaceuticals. In this role, he oversees the strategic development and deployment of Digital Health Solutions within clinical programs across the R&D organization. Prior to... Read More →
avatar for Maria Florez

Maria Florez

Senior Consultant, Tufts Center For the Study of Drug Development, Tufts Univers, United States
Maria Florez studies the practices, strategies, attitudes, and incentives driving innovation in the pharmaceutical R&D process, as well as the impact of digital transformation in clinical research. Maria has been a researcher, consultant, and advisor in the healthcare sector for over... Read More →
avatar for Claire Meunier

Claire Meunier

Chief Operating Officer, Digital Medicine Society (DiMe) , United States
Claire Meunier is the Chief Operating Officer of the Digital Medicine Society (DiMe), a non-profit organization dedicated to advancing digital medicine to optimize human health. Claire is the head of DiMe’s partnerships team, and leads market strategy and infrastructure development... Read More →

Thursday June 23, 2022 10:00am - 11:00am CDT
Room 470 B McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  13: ProfDevelopment, Forum |   07: ProjectManagement-StrategicPlanning, Forum
 
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Virtual
  • 00: Plenary
  • 01 - Clinical Safety and Pharmacovigilance
  • 01: ClinSafety-PV
  • 02: ClinTrials -ClinOps
  • 03: Data-Tech in Clinical Trials
  • 04: MedAffairs-SciComm
  • 05: Patient Engagement
  • 06: PreClinical Dev-EarlyPhaseCR
  • 06 - Translational Sciences and Precision Medicine
  • 06: TranslationalScience-PrecisionMedicine
  • 07: ProjectManagement-StrategicPlanning
  • 08: RD Quality-Compliance
  • 09: Regulatory
  • 10: RegCMC-Product Quality
  • 11: Statistics
  • 12: Value-Access
  • 13: ProfDevelopment
  • 14: DIAmond
  • 15: Content Hubs
  • 16: Community Rounds
  • 17: Networking Opportunities
  • 18: Posters
  • 19: InnovationTheaters
  • 20: Short Courses
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  • AI and Machine Learning
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  • Decentralized Trials
  • Digital
  • Diversity Equity and Inclusion
  • Innovative Trial Design
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  • Remote Work
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