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Trial Master File Summit 2021
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Monday, October 25
 

8:00am CDT

9:00am CDT

TMF Management Plan Workshop
Speakers
avatar for Laura Naranjo

Laura Naranjo

Associate Director, TMF Operations, Daiichi Sankyo, Inc.
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

9:00am CDT

Working with Vendors Workshop
Monday October 25, 2021 9:00am - 12:00pm CDT

12:00pm CDT

Networking Luncheon
Monday October 25, 2021 12:00pm - 1:00pm CDT

1:00pm CDT

Afternoon Workshop – TBA
Monday October 25, 2021 1:00pm - 4:00pm CDT

1:00pm CDT

Inspection Readiness: TMF Quality Review Workshop
Monday October 25, 2021 1:00pm - 4:00pm CDT
 
Tuesday, October 26
 

8:00am CDT

9:00am CDT

Chairperson’s Opening 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 →


Tuesday October 26, 2021 9:00am - 9:30am CDT

9:30am CDT

10:00am CDT

Reviewing 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 →
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 →


Tuesday October 26, 2021 10:00am - 10:30am CDT

10:30am CDT

Networking Break
Tuesday October 26, 2021 10:30am - 11:00am CDT

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

11:30am CDT

Panel Discussion: Risk-Based Approach to Periodic Review
Speakers
avatar for Laura Naranjo

Laura Naranjo

Associate Director, TMF Operations, Daiichi Sankyo, Inc.


Tuesday October 26, 2021 11:30am - 12:15pm CDT

12:15pm CDT

12:30pm CDT

Networking Luncheon
Tuesday October 26, 2021 12:30pm - 1:30pm CDT

1:30pm CDT

1:30pm 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


Tuesday October 26, 2021 1:30pm - 2:00pm CDT

2:00pm CDT

Panel: Discuss the Use of the TMF as a Central Repository
Moderators
avatar for Priya Chaturvedi, PhD.

Priya Chaturvedi, PhD.

VP, Clinical Quality Assurance, Eisai, Inc.
Priya Chaturvedi is currently the VP and Head of Global Clinical Quality Assurance at Eisai. Prior to joining, Eisai Inc., Priya served as Executive Director, Clinical Quality Assurance at Merck. Prior to Merck, Priya was at Pfizer in the Quality oversight roles in Clinical and Med... Read More →

Tuesday October 26, 2021 2:00pm - 2:45pm CDT

2:00pm CDT

Panel: Dive Into eTMF Implementation: Review Lessons Learned
Speakers
avatar for Liz Farrell

Liz Farrell

Director, Trial Master File, Agios Pharmaceuticals


Tuesday October 26, 2021 2:00pm - 2:45pm CDT

2:45pm CDT

Networking Break
Tuesday October 26, 2021 2:45pm - 3:15pm CDT

3:15pm CDT

3:15pm CDT

Partner Presentation by Ennov
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 3:15pm - 3:45pm CDT

3:45pm 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 3:45pm - 4:15pm CDT

3:45pm 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.


Tuesday October 26, 2021 3:45pm - 4:15pm CDT

4:15pm CDT

4:15pm CDT

4:30pm CDT

Networking Cocktail Reception
Tuesday October 26, 2021 4:30pm - 5:30pm CDT

5:30pm CDT

Conference Day One Concludes
Tuesday October 26, 2021 5:30pm - 5:30pm CDT
 
Wednesday, October 27
 

8:00am CDT

Networking Breakfast
Wednesday October 27, 2021 8:00am - 9:00am CDT

9:00am CDT

9:00am CDT

9:15am CDT

9:15am CDT

Improve TMF Quality Through Metrics [VIRTUAL]
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 →


Wednesday October 27, 2021 9:15am - 9:45am CDT

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

9:45am CDT

10:15am CDT

TMF Health Scoring with a Deep Dive on TMF Completeness
Speakers
avatar for Jason Weinstein

Jason Weinstein

Sr Manager TMF Systems and Partner Management, Regeneron Pharmaceuticals, Inc.
avatar for Soraya Nossoughi

Soraya Nossoughi

TMF Lead, Regeneron Pharmaceuticals, Inc.


Wednesday October 27, 2021 10:15am - 10:45am CDT

10:15am CDT

Panel: Use a Data Driven eTMF to Improve, Quality, Timeliness, and Completeness, With Contributors
Speakers
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

Manager, Clinical Trials, Seagen


Wednesday October 27, 2021 10:15am - 11:00am CDT

11:00am CDT

Networking Break
Wednesday October 27, 2021 11:00am - 11:30am CDT

11:30am 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 11:30am - 12:00pm CDT

11:30am 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 11:30am - 12:00pm CDT

12:00pm 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 12:00pm - 12:30pm CDT

12:00pm CDT

12:30pm CDT

Networking Luncheon
Wednesday October 27, 2021 12:30pm - 1:30pm CDT

1:30pm 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 1:30pm - 2:00pm CDT

2:00pm CDT

Panel Discussion: Enhance Collaboration Between Sponsor, Sites, and CROs to Improve TMF Quality
Speakers
avatar for Etienne Hinton

Etienne Hinton

Clinical Trial Coordinator I, Duke Clinical Research Institute
An experienced professional with over 13 years of knowledge and experience in the CRO industry. During that spending time at both CROs and currently at an ARO. I contain a vast depth of experience and knowledge in drug safety, clinical affairs and site relationship management across... Read More →
avatar for Tonia Huggins

Tonia Huggins

Director, TMF Operations, Syneos Health


Wednesday October 27, 2021 2:00pm - 2:45pm CDT

2:45pm 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 →


Wednesday October 27, 2021 2:45pm - 3:00pm CDT

3:00pm CDT

Conference Concludes
Wednesday October 27, 2021 3:00pm - 3:00pm CDT