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Trial Master File Summit 2021 has ended
Monday, October 25
 

8:00am CDT

Registration and Continental Breakfast
Monday October 25, 2021 8:00am - 9:00am CDT
  Networking! - In-Person Only

9:00am CDT

Working with TMF Vendors
Speakers
avatar for Gillian Gittens

Gillian Gittens

Director, e-Clinical Strategy & Solutions, TransPerfect
Gillian is Director of eClinical Strategy and Solutions for Trial Interactive, TransPerfect’s eClinical platform. A career Trial Master File and eTMF subject matter expert with over 20 years of experience, she has a wide range of experience across operations, implementation... Read More →
avatar for Laurel-Ann Schrader

Laurel-Ann Schrader

Director, Client Solutions, TransPerfect
As Director, Client Solutions at TransPerfect Life Sciences, Laurel-Ann Schrader is a resident TMF subject matter expert.Her expertise includes TMF inspection readiness, preparation, and support, best practices for clinical document processes, procedures and clinical operations, eTMF... Read More →

Monday October 25, 2021 9:00am - 12:00pm CDT
  Workshop Day - Available to Virtual Audience Only

9:00am CDT

TMF Management Plan Workshop
Speakers
avatar for Marion Mays

Marion Mays

Vice President, Expert Services and Consulting Solutions, PHLEXGLOBAL
Marion Mays in an industry leader in Information Management with over 28 years of experience in the Pharmaceutical industry.  An advocate for essential information management practices; competent training for all contributors and consumers of the documentation which supports the... Read More →
avatar for Jamie Marie Toth, CPM, MS,

Jamie Marie Toth, CPM, MS,

Senior Director, Clinical Systems & Records, Global Clinical Operations & Planning, Daiichi Sankyo, Inc.
Jamie Marie Toth, Senior Director Clinical Systems & Records at Daiichi Sankyo Inc, USA.Ms. Toth has been with Daiichi Sankyo, Inc. since 2016, and is the business owner for the eTMF system, the SNL IB solution, and the CTMS system. Her department oversees TMF Operations, clinical... Read More →

Monday October 25, 2021 9:00am - 12:00pm CDT
  Workshop Day - In-Person Only

12:00pm CDT

Networking Luncheon
Monday October 25, 2021 12:00pm - 1:00pm CDT
  Networking! - In-Person Only

1:00pm CDT

Inspection Readiness: TMF Quality Review Workshop
Speakers
avatar for Sondra Pepe

Sondra Pepe

Associate Vice President, Clinical and Regulatory Product Management, ArisGlobal
Associate Vice President, Clinical and Regulatory Product Management, ArisGlobalSondra Pepe leads product management for ArisGlobal’s Clinical and Regulatory solution portfolios. In this role, she is responsible for defining product strategies and roadmaps, and overseeing the growth... Read More →

Monday October 25, 2021 1:00pm - 4:00pm CDT
  Workshop Day - Available to Virtual Audience Only

1:00pm CDT

Turning Your Processes and Systems into Strategic Assets
How to turn your TMF Management processes and systems into a strategic asset instead of an afterthought. This workshop will discuss best practices in identifying compliance and operational inefficiency gaps in TMF processes and technology. This workshop will include strategies for leveraging gap assessment data to gain leadership support for optimization. Discuss approaches to ensuring that your business processes and technology align with an emphasis on prioritization, optimization, and ultimately systems implementations.
Speakers
avatar for Donna Dorozinsky

Donna Dorozinsky

President/CEO, Just in Time GCP
30 years experience in drug development and clinical compliance, Founded Just in Time GCP in 2005, Extensive experience in supporting organizations through successful regulatory inspection preparation.
avatar for Jamie O’Keefe

Jamie O’Keefe

VP, Business & Technology, Just in Time GCP
20 years of business and technology consulting expertise, leading large scale, and biotech transformation programs, with a focus on Clinical Operations.

Monday October 25, 2021 1:00pm - 4:00pm CDT
  Workshop Day - In-Person Only
 
Tuesday, October 26
 

8:00am CDT

Networking Breakfast and Registration
Tuesday October 26, 2021 8:00am - 9:00am CDT
  Networking! - In-Person Only

9:00am CDT

Chairperson’s Opening Remarks
Speakers
avatar for Chris Englerth

Chris Englerth

Head, Global Marketing, Phlexglobal
Chris Englerth is the Head of Global Marketing at Phlexglobal where he creates and implements strategic programs to increase Phlexglobal’s brand awareness and market share across the Life Sciences industry. Prior to Phlexglobal, Chris was Vice President of Marketing at Bioclinica... Read More →
avatar for Jamie Marie Toth, CPM, MS,

Jamie Marie Toth, CPM, MS,

Senior Director, Clinical Systems & Records, Global Clinical Operations & Planning, Daiichi Sankyo, Inc.
Jamie Marie Toth, Senior Director Clinical Systems & Records at Daiichi Sankyo Inc, USA.Ms. Toth has been with Daiichi Sankyo, Inc. since 2016, and is the business owner for the eTMF system, the SNL IB solution, and the CTMS system. Her department oversees TMF Operations, clinical... Read More →
avatar for Grace Crawford

Grace Crawford

Global Head, Clinical Quality & Compliance, AstraZeneca R&D
Grace Crawford is an accomplished quality and compliance leader with over 27 years of experience working with international clinical trials, quality systems, regulatory compliance, and computer systems validation in the pharmaceutical, medical device, and biotech industries across GxP’s (GCP/GLP/cGMP). Her... Read More →
avatar for Karen Roy

Karen Roy

Chief Strategy Officer, PHLEXGLOBAL
Karen Roy has been responsible for the development of the TMF business at Phlexglobal since 2007, with a focus on creating solutions for our Clients’ TMF challenges. She started in Business Development, moving to Client Solutions, and now her focus is on strategy. In her role as... Read More →
avatar for Wendy Beeby

Wendy Beeby

Director, Clinical Document Management and Trial Support, Takeda Pharmaceuticals
Wendy Beeby is Director of Clinical Document Management and Inspection Readiness at Takeda, responsible for the strategic direction of clinical document management and working in collaboration with functional leads to implement effective inspection readiness and support plans.  With... Read More →

Tuesday October 26, 2021 9:00am - 9:30am CDT
  General Session - Live Streamed to Virtual Audience

9:30am CDT

Fireside Chat: Essential Documents – Review the Conduct and Management of a Clinical Trial
Moderators
avatar for Wendy Beeby

Wendy Beeby

Director, Clinical Document Management and Trial Support, Takeda Pharmaceuticals
Wendy Beeby is Director of Clinical Document Management and Inspection Readiness at Takeda, responsible for the strategic direction of clinical document management and working in collaboration with functional leads to implement effective inspection readiness and support plans.  With... Read More →

Speakers
avatar for Azhar Bisle, MSM-HCA, BSc.

Azhar Bisle, MSM-HCA, BSc.

Clinical Compliance Manager, Clinical Operations, Arena Pharmaceuticals, Inc
Azhar Bisle is a Clinical Compliance Manager at Arena Pharmaceuticals, responsible for Clinical Trial Compliance, Trial Oversight, and providing cross-functional clinical support to all clinical staff. Azhar has worked with various Trial Master File systems, legacy paper to most eTMF... Read More →

Tuesday October 26, 2021 9:30am - 10:00am CDT
  General Session - Live Streamed to Virtual Audience

10:00am CDT

Everything You Need to Know About Audit Trails
Speakers
avatar for Gillian Gittens

Gillian Gittens

Director, e-Clinical Strategy & Solutions, TransPerfect
Gillian is Director of eClinical Strategy and Solutions for Trial Interactive, TransPerfect’s eClinical platform. A career Trial Master File and eTMF subject matter expert with over 20 years of experience, she has a wide range of experience across operations, implementation... Read More →

Tuesday October 26, 2021 10:00am - 10:30am CDT
  General Session - Live Streamed to Virtual Audience

10:30am CDT

Networking Break
Tuesday October 26, 2021 10:30am - 11:00am CDT
  Networking! - In-Person Only

11:00am CDT

When is the right time to Archive your TMF?
Now that we are working in a more fully digital world, we are faced with the new challenge of how to manage our electronic content and keep these records safe, secure, and accessible for their lifetime. This means that the electronic documents and data collected during trials needs to be maintained for 25 years or longer.
  • Have you mapped out a strategy for how this is going to be done?
  • What if your system changes, are you going to migrate and if so, how can you be sure to preserve the integrity of the data?
  • What if the software that generated your data is now obsolete, have you considered transforming?
The big question is always “When is the right time to move to an Archive”.
Speakers
avatar for Marion Mays

Marion Mays

Vice President, Expert Services and Consulting Solutions, PHLEXGLOBAL
Marion Mays in an industry leader in Information Management with over 28 years of experience in the Pharmaceutical industry.  An advocate for essential information management practices; competent training for all contributors and consumers of the documentation which supports the... Read More →

Tuesday October 26, 2021 11:00am - 11:30am CDT
  General Session - Live Streamed to Virtual Audience

11:30am CDT

Panel Discussion: Risk-Based Approach to Periodic Review
Moderators
avatar for Jason King-Andreini

Jason King-Andreini

Senior Manager, TMF Operations, Eidos Therapeutics, a Bridge Bio Company

Speakers
avatar for Masoom Patel

Masoom Patel

Senior Clinical Document Management Specialist, Takeda
avatar for Traci Wendler

Traci Wendler

Sr. Manager, TMF Study Lead Line Head, Bristol-Myers Squibb
Traci has worked in Regulatory & Compliance for the past 16 years, focusing on clinical research trials, specifically the TMF for the last 10 years. Her career history includes working for 2 major pharmaceutical companies, a TMF vendor, the NIH and Stony Brook Research Foundation... Read More →
avatar for Christa Lewiski

Christa Lewiski

Associate Director, Records & Information Management (TMF Head), Akebia Therapeutics
Christa Lewiski is the TMF Head, Associate Director Records Information Management at Akebia Therapeutics, Inc. She is the owner of Akebia's TMF system and also responsible for all TMF processes. Christa has 20 years experience in TMF/clinical document management within the biopharmaceutical... Read More →

Tuesday October 26, 2021 11:30am - 12:15pm CDT
  General Session - Live Streamed to Virtual Audience

12:15pm CDT

eTMF Pep Talk
  • Simplifying the eTMF Experience
  • Brightening the Future of eTMF: AI + ML
  • Seeing the Entire eTMF Field of Play
  • Deepening your eTMF Bench
Speakers
avatar for Kevin Seeley

Kevin Seeley

Associate Director US Sales, IQVIA Technologies
Having spent the last 13 years in life sciences, Kevin has worked with globally mature sponsors such as Daiichi Sankyo, Boston Scientific, Zimmer Biomet & Nuvasive.More recently Kevin has dedicated his career towards consulting the life sciences industry – inclusive of biotechs... Read More →

Tuesday October 26, 2021 12:15pm - 12:30pm CDT
  General Session - Live Streamed to Virtual Audience

12:30pm CDT

Networking Lunch Sponsored by IQVIA
Tuesday October 26, 2021 12:30pm - 1:30pm CDT
  Networking! - In-Person Only

1:30pm CDT

Improve TMF Quality Through Metrics
Speakers
avatar for Daniel Bennett

Daniel Bennett

Trial Master File Manager, Shionogi Europe
Daniel has worked in various TMF roles for large pharma companies and small biotech, with a full-service CRO and a niche TMF provider. Having seen the issues from all sides he is a convert to the idea that the TMF is a key part of a quality approach to clinical trial management. He... Read More →

Tuesday October 26, 2021 1:30pm - 2:00pm CDT
  TMF Strategy - Live Streamed to Virtual Audience

2:00pm CDT

TMF Completeness, Quality and Timeliness: A Deep Dive
  • Understand the main challenges to determining TMF completeness
  • Measuring TMF quality: beyond QC failures
  • The many ways of calculating TMF timeliness
  • The perfect as the enemy of the good
Speakers
avatar for Kathie Clark

Kathie Clark

Product Director, CTMS and eTMF, Ennov
Kathie is Director, eTMF and CTMS for Ennov. She provides thought leadership for the industry and is the author of many white papers, journal articles and blog posts on eTMF, eClinical and regulatory topics. She is a member of the TMF Reference Model steering committee and has chaired... Read More →

Tuesday October 26, 2021 2:00pm - 2:30pm CDT
  TMF Oversight - Live Streamed to Virtual Audience

2:45pm CDT

Panel: Dive Into eTMF Implementation: Review Lessons Learned
Speakers
avatar for Grace Crawford

Grace Crawford

Global Head, Clinical Quality & Compliance, AstraZeneca R&D
Grace Crawford is an accomplished quality and compliance leader with over 27 years of experience working with international clinical trials, quality systems, regulatory compliance, and computer systems validation in the pharmaceutical, medical device, and biotech industries across GxP’s (GCP/GLP/cGMP). Her... Read More →
avatar for Martin Frid-Nielsen

Martin Frid-Nielsen

Vice President, Document Solutions, Medidata, a Dassault Systemes Company
Martin Frid-Nielsen is the VP of Document Solutions & Services at Medidata, a Dassault Systemes company. In this role, he oversees the company's R&D efforts for Rave eTMF and other document-based products and services that are used by a broad global audience. Prior to joining Medidata... Read More →
avatar for Jason King-Andreini

Jason King-Andreini

Senior Manager, TMF Operations, Eidos Therapeutics, a Bridge Bio Company
avatar for Liz Farrell

Liz Farrell

Director, Trial Master File, Agios Pharmaceuticals

Tuesday October 26, 2021 2:45pm - 3:30pm CDT
  TMF Oversight - Live Streamed to Virtual Audience

3:30pm CDT

Networking Break
Tuesday October 26, 2021 3:30pm - 4:00pm CDT
  Networking! - In-Person Only

4:00pm CDT

Have You Seen These Documents in your TMF?
The focus of this presentation will be on key documents like ICFs, FDFs, 1572s and other key inspections readiness documents teams tend to over look in the TMF until the last minute.

Speakers
avatar for Adriana Robinson

Adriana Robinson

Sr. TMF Specialist, Clinical Records & Systems, Global Clinical Operations & Planning, Daiichi Sankyo, Inc.

Tuesday October 26, 2021 4:00pm - 4:30pm CDT
  Operations & Collaboration - Live Streamed to Virtual Audience

4:30pm CDT

TMF Challenges: Thinking Strategically to Achieve Results
Do you need new perspectives to employ when tackling TMF challenges? Sometimes stepping back is the first step in preparing to launch forward. This interactive session will provide practical approaches to achieve engagement in the TMF management process.
  • Bring your real-world frustrations and situations
  • Let’s use new ways of thinking to achieve results
Speakers
avatar for Laura Wiggins, MBA

Laura Wiggins, MBA

Project Manager, Just in Time GCP
Laura Wiggins is a TMF Services Project Manager at Just in Time GCP with over 15 years of experience in the clinical research industry. She coordinates TMF management activities and works with clients to analyze, develop, and implement processes that support business use of electronic... Read More →

Tuesday October 26, 2021 4:30pm - 5:00pm CDT
  Operations & Collaboration - Live Streamed to Virtual Audience

5:00pm CDT

Develop, Communicate, and Maintain Best Practices with Sites – TMF Collaboration
Speakers
avatar for Aryn Knight, BS, CCRP

Aryn Knight, BS, CCRP

Administrative Director, Center for Clinical Research, Texas Heart Institute
Aryn Knight, CCRP, is Administrative Director at Texas Heart Institute, Center for Clinical Research in Houston, TX. She is a Certified Clinical Research Professional (CCRP) with more than 20 years of direct experience in clinical research in academia and hospital environments. Since... Read More →
avatar for Matt Lowery, ACRP-CP, CCRC

Matt Lowery, ACRP-CP, CCRC

Director of Clinical Research, Suncoast Neuroscience Associates, Inc.
Matt holds the ACRP-CP and CCRC certifications through ACRP and is a member of SCRS, ACRP, MAGI, and SoCRA. He has over 14 years of experience in clinical research on both the site and sponsor level. On the site side, Matt has worked as a study coordinator, site manager, director... Read More →

Tuesday October 26, 2021 5:00pm - 5:30pm CDT
  TMF Oversight - Live Streamed to Virtual Audience

5:30pm CDT

Roundtable Discussions
Tuesday October 26, 2021 5:30pm - 6:00pm CDT
  Roundtable Discussion - Hybrid

6:15pm CDT

Chairperson's Closing Remarks
Speakers
avatar for Jamie Marie Toth, CPM, MS,

Jamie Marie Toth, CPM, MS,

Senior Director, Clinical Systems & Records, Global Clinical Operations & Planning, Daiichi Sankyo, Inc.
Jamie Marie Toth, Senior Director Clinical Systems & Records at Daiichi Sankyo Inc, USA.Ms. Toth has been with Daiichi Sankyo, Inc. since 2016, and is the business owner for the eTMF system, the SNL IB solution, and the CTMS system. Her department oversees TMF Operations, clinical... Read More →
avatar for Grace Crawford

Grace Crawford

Global Head, Clinical Quality & Compliance, AstraZeneca R&D
Grace Crawford is an accomplished quality and compliance leader with over 27 years of experience working with international clinical trials, quality systems, regulatory compliance, and computer systems validation in the pharmaceutical, medical device, and biotech industries across GxP’s (GCP/GLP/cGMP). Her... Read More →
avatar for Karen Roy

Karen Roy

Chief Strategy Officer, PHLEXGLOBAL
Karen Roy has been responsible for the development of the TMF business at Phlexglobal since 2007, with a focus on creating solutions for our Clients’ TMF challenges. She started in Business Development, moving to Client Solutions, and now her focus is on strategy. In her role as... Read More →
avatar for Wendy Beeby

Wendy Beeby

Director, Clinical Document Management and Trial Support, Takeda Pharmaceuticals
Wendy Beeby is Director of Clinical Document Management and Inspection Readiness at Takeda, responsible for the strategic direction of clinical document management and working in collaboration with functional leads to implement effective inspection readiness and support plans.  With... Read More →
avatar for Chris Englerth

Chris Englerth

Head, Global Marketing, Phlexglobal
Chris Englerth is the Head of Global Marketing at Phlexglobal where he creates and implements strategic programs to increase Phlexglobal’s brand awareness and market share across the Life Sciences industry. Prior to Phlexglobal, Chris was Vice President of Marketing at Bioclinica... Read More →

Tuesday October 26, 2021 6:15pm - 6:30pm CDT
  General Session - Live Streamed to Virtual Audience

6:30pm CDT

Networking Cocktail Reception
Tuesday October 26, 2021 6:30pm - 7:30pm CDT
  Networking! - In-Person Only

7:30pm CDT

Conference Day One Concludes
Tuesday October 26, 2021 7:30pm - 7:30pm CDT
 
Wednesday, October 27
 

8:00am CDT

Networking Breakfast
Wednesday October 27, 2021 8:00am - 9:00am CDT
  Networking! - In-Person Only

9:00am CDT

Chairperson’s Opening Remarks
Speakers
avatar for Chris Englerth

Chris Englerth

Head, Global Marketing, Phlexglobal
Chris Englerth is the Head of Global Marketing at Phlexglobal where he creates and implements strategic programs to increase Phlexglobal’s brand awareness and market share across the Life Sciences industry. Prior to Phlexglobal, Chris was Vice President of Marketing at Bioclinica... Read More →
avatar for Jamie Marie Toth, CPM, MS,

Jamie Marie Toth, CPM, MS,

Senior Director, Clinical Systems & Records, Global Clinical Operations & Planning, Daiichi Sankyo, Inc.
Jamie Marie Toth, Senior Director Clinical Systems & Records at Daiichi Sankyo Inc, USA.Ms. Toth has been with Daiichi Sankyo, Inc. since 2016, and is the business owner for the eTMF system, the SNL IB solution, and the CTMS system. Her department oversees TMF Operations, clinical... Read More →
avatar for Grace Crawford

Grace Crawford

Global Head, Clinical Quality & Compliance, AstraZeneca R&D
Grace Crawford is an accomplished quality and compliance leader with over 27 years of experience working with international clinical trials, quality systems, regulatory compliance, and computer systems validation in the pharmaceutical, medical device, and biotech industries across GxP’s (GCP/GLP/cGMP). Her... Read More →
avatar for Karen Roy

Karen Roy

Chief Strategy Officer, PHLEXGLOBAL
Karen Roy has been responsible for the development of the TMF business at Phlexglobal since 2007, with a focus on creating solutions for our Clients’ TMF challenges. She started in Business Development, moving to Client Solutions, and now her focus is on strategy. In her role as... Read More →
avatar for Wendy Beeby

Wendy Beeby

Director, Clinical Document Management and Trial Support, Takeda Pharmaceuticals
Wendy Beeby is Director of Clinical Document Management and Inspection Readiness at Takeda, responsible for the strategic direction of clinical document management and working in collaboration with functional leads to implement effective inspection readiness and support plans.  With... Read More →

Wednesday October 27, 2021 9:00am - 9:15am CDT
  General Session - Live Streamed to Virtual Audience

9:15am CDT

Internal Stakeholder Collaboration: Explore Functional Areas
Speakers
avatar for Leila Ponce

Leila Ponce

Sr Manager, Clinical Systems & Records Management, Seagen

Wednesday October 27, 2021 9:15am - 9:45am CDT
  Operations & Collaboration - Live Streamed to Virtual Audience

9:45am CDT

Digital Disruption and TMF Health
Speakers
avatar for Sondra Pepe

Sondra Pepe

Associate Vice President, Clinical and Regulatory Product Management, ArisGlobal
Associate Vice President, Clinical and Regulatory Product Management, ArisGlobalSondra Pepe leads product management for ArisGlobal’s Clinical and Regulatory solution portfolios. In this role, she is responsible for defining product strategies and roadmaps, and overseeing the growth... Read More →

Wednesday October 27, 2021 9:45am - 10:15am CDT
  Emerging Technology - Live Streamed to Virtual Audience

10:15am CDT

Sponsor Oversight – Process and Technology
Speakers
avatar for Suliat Oyelami-Davies

Suliat Oyelami-Davies

Associate Director, Clinical Operations Inspection Readiness, Eidos Therapeutics, a Bridge Bio Company
avatar for Jason King-Andreini

Jason King-Andreini

Senior Manager, TMF Operations, Eidos Therapeutics, a Bridge Bio Company

Wednesday October 27, 2021 10:15am - 10:45am CDT
  TMF Oversight - Live Streamed to Virtual Audience

10:45am CDT

Networking Break
Wednesday October 27, 2021 10:45am - 11:15am CDT
  Networking! - In-Person Only

11:15am CDT

TMF Health Scoring with a Deep Dive on TMF Completeness
  • Define what metrics contribute to overall TMF Health
  • How to develop a single TMF Health score
  • Deep Dive into the creation of a high-quality TMF Completeness metric
Speakers
avatar for Jason Weinstein

Jason Weinstein

Sr Manager TMF Systems and Partner Management, Regeneron Pharmaceuticals, Inc.
Jason Weinstein has worked in the pharmaceutical industry for 10 years. He transitioned to TMF and Records Management in 2014, and is currently the eTMF/CTMS Business Lead at Regeneron Pharmaceuticals Inc. In his position, Jason works closely with the various system stakeholders to... Read More →
avatar for Soraya Nossoughi

Soraya Nossoughi

TMF Lead, Regeneron Pharmaceuticals, Inc.
Soraya Nossoughi has worked in the pharmaceutical industry for 10 years. Starting in Clinical Operations and Translational Sciences, she quickly began working in pre-clinical and bioanalytical archives as well as TMF management and oversight. In her current position at Regeneron Pharmaceuticals... Read More →

Wednesday October 27, 2021 11:15am - 11:45am CDT
  Emerging Technology - Live Streamed to Virtual Audience

11:45am CDT

Building a Digital Site Footprint for the Future of Patient-First Clinical Trials
In this session, you will learn how pharmaceutical sponsors, medical device companies, biotechs, and CROs are building digital site footprints integrated with their eTMF to support the patient-first clinical trials of tomorrow, today. Real-world examples will be shared of how a global digital network of sites powered COVID vaccine trials on a global level and kept 10,000 study sites operational. During this session, you'll discover how to build a technology strategy and product stack that enables you to bridge the digital divide between sponsors and sites and drive operational effectiveness, quality, completeness, and timeliness while turning on always-on remote access.
Speakers
avatar for Blake Adams

Blake Adams

VP of Marketing, Florence
Blake is VP of Marketing for Florence and Host of "The Next Phase: Exploring Innovations in Clinical Trials" Podcast. At Florence, Blake has helped to position the company to solve global site access and operational challenges over the past four years. Florence is now the leading digital site technology in use by 10,000 study sites in 27 countries and accessed monthly by every top 100 pharma company. On "T... Read More →

Wednesday October 27, 2021 11:45am - 12:15pm CDT
  Emerging Technology - Live Streamed to Virtual Audience

12:15pm CDT

Panel: Use a Data Driven eTMF to Improve Quality, Timeliness, and Completeness, With Contributors
Moderators
avatar for Suliat Oyelami-Davies

Suliat Oyelami-Davies

Associate Director, Clinical Operations Inspection Readiness, Eidos Therapeutics, a Bridge Bio Company

Speakers
avatar for Gabrielle Gauger

Gabrielle Gauger

Program Manager, TMF Operations, Syneos Health
avatar for Joanne Malia

Joanne Malia

Director, Clinical Documentation Management, Regeneron
Joanne Malia is Director, Clinical Documentation Management at Regeneron Pharmaceuticals and responsible for the TMF group and Clinical Archives and is the Business Process Owner for the eTMF.  Throughout her 25+ year career in life sciences she has worked for diagnostic, biotech... Read More →
avatar for Leila Ponce

Leila Ponce

Sr Manager, Clinical Systems & Records Management, Seagen

Wednesday October 27, 2021 12:15pm - 1:00pm CDT
  TMF Strategy - Live Streamed to Virtual Audience

1:00pm CDT

Networking Luncheon
Wednesday October 27, 2021 1:00pm - 2:00pm CDT
  Networking! - In-Person Only

2:00pm CDT

Establish Processes for System Enhancements That Benefit Global End-Users
  • Leverage Clinical System Framework for system enhancement projects
  • Capture relevant KPI to measure system performance
  • Engage with end users – keep them informed and listen to their feedbacks
Speakers
avatar for Keith Win, MS

Keith Win, MS

Manager, Clinical Systems (eTMF), Clinical Systems & Records, Global Clinical Operations & Planning, Daiichi Sankyo, Inc.
Keith Win, MS, is a Manager Clinical Systems (eTMF) for Clinical Systems & Records group at Daiichi Sankyo, Inc. (DSI) where he facilitates system enhancement change control projects, data migrations, and metric generation for the eTMF application. Prior to DSI, Keith worked for... Read More →

Wednesday October 27, 2021 2:00pm - 2:30pm CDT
  Emerging Technology - Live Streamed to Virtual Audience

2:30pm CDT

Optimizing your TMF Plan
Speakers
avatar for Traci Wendler

Traci Wendler

Sr. Manager, TMF Study Lead Line Head, Bristol-Myers Squibb
Traci has worked in Regulatory & Compliance for the past 16 years, focusing on clinical research trials, specifically the TMF for the last 10 years. Her career history includes working for 2 major pharmaceutical companies, a TMF vendor, the NIH and Stony Brook Research Foundation... Read More →

Wednesday October 27, 2021 2:30pm - 3:00pm CDT
  TMF Strategy - Live Streamed to Virtual Audience

3:00pm CDT

Migration Best Practices
Speakers
avatar for Ashlyn Deshaies

Ashlyn Deshaies

Associate Director, Clinical and TMF Operations, TG Therapeutics, Inc.
Ashlyn Deshaies serves as the Associate Director of Clinical and TMF Operations at TG Therapeutics overseeing the planning and execution of TMF processes, quality reviews, and TMF scoped deliverables. Ashlyn has driven implementation TMF maintenance guidelines based on the "three... Read More →

Wednesday October 27, 2021 3:00pm - 3:30pm CDT
  General Session - Live Streamed to Virtual Audience

3:30pm CDT

Panel Discussion: Enhance Collaboration Between Sponsor, Sites, and CROs to Improve TMF Quality
Moderators
avatar for Azhar Bisle, MSM-HCA, BSc.

Azhar Bisle, MSM-HCA, BSc.

Clinical Compliance Manager, Clinical Operations, Arena Pharmaceuticals, Inc
Azhar Bisle is a Clinical Compliance Manager at Arena Pharmaceuticals, responsible for Clinical Trial Compliance, Trial Oversight, and providing cross-functional clinical support to all clinical staff. Azhar has worked with various Trial Master File systems, legacy paper to most eTMF... Read More →

Speakers
avatar for Caroline Nielson

Caroline Nielson

Manager, Records Management, Ultragenyx
avatar for Aryn Knight, BS, CCRP

Aryn Knight, BS, CCRP

Administrative Director, Center for Clinical Research, Texas Heart Institute
Aryn Knight, CCRP, is Administrative Director at Texas Heart Institute, Center for Clinical Research in Houston, TX. She is a Certified Clinical Research Professional (CCRP) with more than 20 years of direct experience in clinical research in academia and hospital environments. Since... Read More →
avatar for Tonia Huggins

Tonia Huggins

Director, TMF Operations, Syneos Health
Tonia Huggins is a Director of TMF Operations at Syneos Health. Tonia has over 10 years dedicated TMF management experience that includes working with multiple CROs across various TMF platforms, process development and implementation, system migrations, and client relationships.At... Read More →
avatar for Seneca Harrison

Seneca Harrison

Vice President, Quality Clinical Research Inc.
Seneca Harrison is the Vice President of Operations and CEO of Quality Clinical Research, an expanding research facility catering to residents of the Midwest for nearly 20 years. Mr. Harrison has served as CEO since 2008 and has since made it his mission to diversify clinical trials... Read More →

Wednesday October 27, 2021 3:30pm - 4:15pm CDT
  General Session - Live Streamed to Virtual Audience

4:15pm CDT

Chairperson's Closing Remarks
Speakers
avatar for Chris Englerth

Chris Englerth

Head, Global Marketing, Phlexglobal
Chris Englerth is the Head of Global Marketing at Phlexglobal where he creates and implements strategic programs to increase Phlexglobal’s brand awareness and market share across the Life Sciences industry. Prior to Phlexglobal, Chris was Vice President of Marketing at Bioclinica... Read More →
avatar for Jamie Marie Toth, CPM, MS,

Jamie Marie Toth, CPM, MS,

Senior Director, Clinical Systems & Records, Global Clinical Operations & Planning, Daiichi Sankyo, Inc.
Jamie Marie Toth, Senior Director Clinical Systems & Records at Daiichi Sankyo Inc, USA.Ms. Toth has been with Daiichi Sankyo, Inc. since 2016, and is the business owner for the eTMF system, the SNL IB solution, and the CTMS system. Her department oversees TMF Operations, clinical... Read More →
avatar for Grace Crawford

Grace Crawford

Global Head, Clinical Quality & Compliance, AstraZeneca R&D
Grace Crawford is an accomplished quality and compliance leader with over 27 years of experience working with international clinical trials, quality systems, regulatory compliance, and computer systems validation in the pharmaceutical, medical device, and biotech industries across GxP’s (GCP/GLP/cGMP). Her... Read More →
avatar for Karen Roy

Karen Roy

Chief Strategy Officer, PHLEXGLOBAL
Karen Roy has been responsible for the development of the TMF business at Phlexglobal since 2007, with a focus on creating solutions for our Clients’ TMF challenges. She started in Business Development, moving to Client Solutions, and now her focus is on strategy. In her role as... Read More →
avatar for Wendy Beeby

Wendy Beeby

Director, Clinical Document Management and Trial Support, Takeda Pharmaceuticals
Wendy Beeby is Director of Clinical Document Management and Inspection Readiness at Takeda, responsible for the strategic direction of clinical document management and working in collaboration with functional leads to implement effective inspection readiness and support plans.  With... Read More →

Wednesday October 27, 2021 4:15pm - 4:30pm CDT
  General Session - Live Streamed to Virtual Audience

4:30pm CDT

Conference Concludes
Wednesday October 27, 2021 4:30pm - 4:30pm CDT
 
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Monday, October 25
Tuesday, October 26
Wednesday, October 27
  • Emerging Technology - Live Streamed to Virtual Audience
  • General Session - Live Streamed to Virtual Audience
  • Networking! - In-Person Only
  • Operations & Collaboration - Live Streamed to Virtual Audience
  • Roundtable Discussion - Hybrid
  • TMF Oversight - Live Streamed to Virtual Audience
  • TMF Strategy - Live Streamed to Virtual Audience
  • Workshop Day - Available to Virtual Audience Only
  • Workshop Day - In-Person Only