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Agenda

Global Disclosure Mandates • Data Sharing • Plain Language Summaries • Data & Document Anonymization • Medical & Regulatory Writing

January 22-24, 2020
  • Coral Gables, FL

Agenda

Want more agenda details? Download the brochure.

DAY ONE WEDNESDAY, JANUARY 22, 2020

7:15

Registration and Continental Breakfast

8:15

Chairperson’s Welcome and Opening Remarks

Delve Into the Evolution of Global Clinical Trial Transparency Regulations

8:30

KEYNOTE ADDRESS Discuss Ethical and Moral Imperatives to Increase Clinical Transparency and
Data Sharing in Response to Clear Needs and Expectations from Patients

Jessica S. Scott, MD, JD
Head of R&D Patient Engagement Office
Takeda Pharmaceutical Company

9:15

Bridge the Gap — Working Together to Enhance Clinical Data Disclosure, Dissemination and Discoverability

Richard White
Chief Operating Officer
Oxford PharmaGenesis

10:00

Networking and Refreshment Break

10:30

Clinical Document Anonymization and Disclosure, a Global Perspective

Jean-Marc Ferran
Director
Qualiance

REMOTE ADDRESS Health Canada Update

Melissa Jean
Scientific Reviewer – Public Release of Clinical Information
Health Canada

Followed by an Open Q&A Discussion Facilitated by:

Paul Ngai
Co-Founder and CEO
Xogene

11:45

Produce Quality Records on ClinicalTrials.gov

Laura Troast, MS
Director, Clinical Trial Registration & Results Disclosure,
Clinical Data Disclosure & Transparency (CDD&T)
Merck & Co., Inc

12:15

Networking Luncheon

1:30

CHOOSE FROM THREE CONCURRENT TRACKS (A-C)

TRACK A CLINICAL DISCLOSURE & ANONYMIZATION

1:30

Track Chair's Opening Remarks

Oladayo Oyelola, PhD, SC (ASCP)
Director, Clinical Trial Information Disclosure Regulatory Management Operations
Daiichi Sankyo, Inc.

1:45

Achieving Balance — Approaching Anonymization with Quantified Risk

Cathal Gallagher
Senior Life Sciences Consultant
d-Wise

2:45

Delve into Prospective and Retrospective Analyses of Clinical Disclosure and Data Sharing Requirements

Nirpal Virdee
Global Head, Transparency and Disclosure
Synchrogenix, A Certara Company

3:45

Networking and Refreshment Break

4:15

CASE STUDY Examine the Evolution of Clinical Disclosure and Transparency in Japan

Jenny Petersen
Director
Alnylam

TRACK B PLAIN LANGUAGE SUMMARIES &
DISSEMINATION STRATEGIES

1:30

Track Chair's Opening Remarks

Behtash Bahador, MS
Associate Director, Relationship Management and Development
Center for Information & Study on Clinical Research Participation (CISCRP)

1:45

Delve Into the Complexities of Pediatric Lay Summaries and Determine
Best Practices

Kelsey Brown
Medical Writing Manager
TransPerfect

2:45

Discover Patient Perspective of Clinical Research and Plain Language Summaries

Vidhi Vashisht
Associate Director
Kinapse, a Syneos Health Company

3:45

Networking and Refreshment Break

4:15

Explore New Technology and Advancements for Clinical Trial Transparency and Health Literacy

Behtash Bahador, MS
Associate Director, Relationship Management and Development
Center for Information & Study on Clinical Research Participation (CISCRP)

TRACK C REGULATORY & MEDICAL WRITING

1:30

Track Chair's Opening Remarks

Jo Anne-Marie Blyskal
Head of Global Regulatory Medical Writing & Data Transparency and Disclosure
Teva

1:45

Explore Lean Medical Writing and Other Opportunities to Streamline Processes

Jo Anne-Marie Blyskal
Head of Global Regulatory Medical Writing & Data Transparency and Disclosure
Teva

2:45

Identify Best Practices in Compliant Writing for Regulatory Documents

Speaker TBA

3:45

Networking and Refreshment Break

4:15

Leverage Innovative Tools and Visuals to Optimize Medical Writing

Speaker TBA

5:00

Close of Day One

Networking, Wine & Cheese Reception immediately following the final session on day one

DAY TWO THURSDAY, JANUARY 23, 2020

8:00

Continental Breakfast

8:30

Chairperson’s Review of Day One

8:45

PANEL Patient Perspectives on Clinical Data Sharing, Disclosure and Dissemination

MODERATOR:

Deborah Collyar
Founder & President
Patient Advocates in Research (PAIR)

CONVERSATION CONTRIBUTORS:

Jamie Tyrone
CEO and Founder
Beating Alzheimer's By Embracing Science (B.A.B.E.S.)

Amy Leitman
Director, Policy & Research
NTM Info & Research

9:30

KEYNOTE ADDRESS Discuss Ethical Standards for Clinical Research and the Responsibilities of the
Life Sciences Industry

Jennifer Miller
Founder, Bioethics International | Good Pharma Scorecard;
Assistant Professor, Yale University School of Medicine

10:15

Networking and Refreshment Break

10:45

PANEL Analyze the Evolution Clinical Disclosure and Transparency and the Potential for Harmonization of Global Standards

MODERATOR:

Julie Holtzople
Director, Clinical Trial Transparency Operations
AstraZeneca

PANELISTS:

Nate Root
Associate Director, Clinical Disclosure and Transparency
Ionis Pharmaceuticals

Deborah Collyar
Founder & President
Patient Advocates in Research (PAIR)

11:30

Elevate Patient Engagement through Improved Access of Clinical Information

Thomas Wicks
Chief Strategy Officer
TrialScope

12:30

Networking Luncheon

1:30

CHOOSE FROM THREE CONCURRENT SESSIONS (1-3)

1 Disclosure 101

Iwona Bucior
Director, Medical Communications
Myokardia

2 Explore Advances in Transparency through TransCelerate’s Clinical Research Access Initiative

Chris Pfitzer, MA
Transparency Operations Lead
UCB Biosciences

3 Global Harmonization of CTT requirements — Opportunities, Challenges and Ideas

Julie Holtzople
Director, Clinical Trial Transparency Operations
AstraZeneca

Nate Root
Associate Director, Clinical Disclosure and Transparency
Ionis Pharmaceuticals

2:30

CHOOSE FROM THREE CONCURRENT SESSIONS (4-6)

4 Disclosure 102

Oladayo Oyelola, PhD, SC (ASCP
Director, Clinical Trial Information Disclosure Regulatory Management Operations
Daiichi Sankyo, Inc.

5 Advance Disclosure of Biostatistics through Streamlined Programming and Processes

Paul Ngai
Co-Founder and CEO
Xogene

6 Analyze Disclosure and Registry Challenges in
Socio-Behavioral Studies

Yolanda P. Davis
Clinical Disclosure Manager
University of Miami

3:30

Networking and Refreshment Break

3:00

CHOOSE FROM THREE CONCURRENT SESSIONS (7-9)

7 Changing Processes and Attitudes Towards
Risk-assessment and Anonymization after Implementation of Health Canada PRCI

Shalini Dwivedi
Director
Kinapse, a Syneos Health Company

8 EMA Policy 0070 —
An Exploratory Review of Data Utility in
Clinical Study Reports for Academic Research

Jean-Marc Ferran
Director
Qualiance

9 Rare Disease Working Group —
Explore the Challenges of Disclosure and Transparency in Small Populations

Nate Root
Associate Director, Clinical Disclosure and Transparency
Ionis Pharmaceuticals

5:00

Close of Day Two

Networking, Wine
and Cheese Reception
immediately following the final session on day two

DAY THREE FRIDAY, JANUARY 24, 2020

7:45

Continental Breakfast

8:15

Chairperson’s Review of Day Two

8:30

Upcoming Changes in The NIH Review Process and Recommendation for Preparedness

Sonali Parmar
Senior Manager
Kinapse, a Syneos Health Company

9:15

Discuss the Challenges of Managing, Sharing and Disclosing Biostatistics and Biomarker Data

Jamie Tyrone
CEO and Founder
Beating Alzheimer's By Embracing Science (B.A.B.E.S.)

9:45

Explore Effective Ways to Engage with Patients through TransCelerate’s Patient Experience Initiative

Sean Ludlam
Clinical Trial Registries
Allergan

10:30

Networking and Refreshment Break

11:00

Partnering with Patients and Participants to Develop Clinical Research Materials and Plain Language Summaries Language Summaries

Sylvia Baedorf Kassis, MPH
Program Manager
Multi-Regional Clinical Trials Center of
Brigham and Women’s Hospital and Harvard

11:45

Elevate the Quality of Clinical Submissions and Documentation through Strategic Medical Writing

Jo Anne-Marie Blyskal
Head of Global Regulatory Medical Writing & Data Transparency and Disclosure
Teva

12:30

Chairperson’s Closing Remarks and Close of Conference

Agenda

Want more agenda details? Download the brochure.

Want more agenda details? Download the brochure.

DAY ONE WEDNESDAY, JANUARY 22, 2020

7:15

Registration and Continental Breakfast

8:15

Chairperson’s Welcome and Opening Remarks

Delve Into the Evolution of Global Clinical Trial Transparency Regulations

8:30

KEYNOTE ADDRESS Discuss Ethical and Moral Imperatives to Increase Clinical Transparency and
Data Sharing in Response to Clear Needs and Expectations from Patients

Jessica S. Scott, MD, JD
Head of R&D Patient Engagement Office
Takeda Pharmaceutical Company

9:15

Bridge the Gap — Working Together to Enhance Clinical Data Disclosure, Dissemination and Discoverability

Richard White
Chief Operating Officer
Oxford PharmaGenesis

10:00

Networking and Refreshment Break

10:30

Clinical Document Anonymization and Disclosure, a Global Perspective

Jean-Marc Ferran
Director
Qualiance

REMOTE ADDRESS Health Canada Update

Melissa Jean
Scientific Reviewer – Public Release of Clinical Information
Health Canada

Followed by an Open Q&A Discussion Facilitated by:

Paul Ngai
Co-Founder and CEO
Xogene

11:45

Produce Quality Records on ClinicalTrials.gov

Laura Troast, MS
Director, Clinical Trial Registration & Results Disclosure,
Clinical Data Disclosure & Transparency (CDD&T)
Merck & Co., Inc

12:15

Networking Luncheon

1:30

CHOOSE FROM THREE CONCURRENT TRACKS (A-C)

TRACK A CLINICAL DISCLOSURE & ANONYMIZATION

1:30

Track Chair's Opening Remarks

Oladayo Oyelola, PhD, SC (ASCP)
Director, Clinical Trial Information Disclosure Regulatory Management Operations
Daiichi Sankyo, Inc.

1:45

Achieving Balance — Approaching Anonymization with Quantified Risk

Cathal Gallagher
Senior Life Sciences Consultant
d-Wise

2:45

Delve into Prospective and Retrospective Analyses of Clinical Disclosure and Data Sharing Requirements

Nirpal Virdee
Global Head, Transparency and Disclosure
Synchrogenix, A Certara Company

3:45

Networking and Refreshment Break

4:15

CASE STUDY Examine the Evolution of Clinical Disclosure and Transparency in Japan

Jenny Petersen
Director
Alnylam

TRACK B PLAIN LANGUAGE SUMMARIES &
DISSEMINATION STRATEGIES

1:30

Track Chair's Opening Remarks

Behtash Bahador, MS
Associate Director, Relationship Management and Development
Center for Information & Study on Clinical Research Participation (CISCRP)

1:45

Delve Into the Complexities of Pediatric Lay Summaries and Determine
Best Practices

Kelsey Brown
Medical Writing Manager
TransPerfect

2:45

Discover Patient Perspective of Clinical Research and Plain Language Summaries

Vidhi Vashisht
Associate Director
Kinapse, a Syneos Health Company

3:45

Networking and Refreshment Break

4:15

Explore New Technology and Advancements for Clinical Trial Transparency and Health Literacy

Behtash Bahador, MS
Associate Director, Relationship Management and Development
Center for Information & Study on Clinical Research Participation (CISCRP)

TRACK C REGULATORY & MEDICAL WRITING

1:30

Track Chair's Opening Remarks

Jo Anne-Marie Blyskal
Head of Global Regulatory Medical Writing & Data Transparency and Disclosure
Teva

1:45

Explore Lean Medical Writing and Other Opportunities to Streamline Processes

Jo Anne-Marie Blyskal
Head of Global Regulatory Medical Writing & Data Transparency and Disclosure
Teva

2:45

Identify Best Practices in Compliant Writing for Regulatory Documents

Speaker TBA

3:45

Networking and Refreshment Break

4:15

Leverage Innovative Tools and Visuals to Optimize Medical Writing

Speaker TBA

5:00

Close of Day One

Networking, Wine & Cheese Reception immediately following the final session on day one

DAY TWO THURSDAY, JANUARY 23, 2020

8:00

Continental Breakfast

8:30

Chairperson’s Review of Day One

8:45

PANEL Patient Perspectives on Clinical Data Sharing, Disclosure and Dissemination

MODERATOR:

Deborah Collyar
Founder & President
Patient Advocates in Research (PAIR)

CONVERSATION CONTRIBUTORS:

Jamie Tyrone
CEO and Founder
Beating Alzheimer's By Embracing Science (B.A.B.E.S.)

Amy Leitman
Director, Policy & Research
NTM Info & Research

9:30

KEYNOTE ADDRESS Discuss Ethical Standards for Clinical Research and the Responsibilities of the
Life Sciences Industry

Jennifer Miller
Founder, Bioethics International | Good Pharma Scorecard;
Assistant Professor, Yale University School of Medicine

10:15

Networking and Refreshment Break

10:45

PANEL Analyze the Evolution Clinical Disclosure and Transparency and the Potential for Harmonization of Global Standards

MODERATOR:

Julie Holtzople
Director, Clinical Trial Transparency Operations
AstraZeneca

PANELISTS:

Nate Root
Associate Director, Clinical Disclosure and Transparency
Ionis Pharmaceuticals

Deborah Collyar
Founder & President
Patient Advocates in Research (PAIR)

11:30

Elevate Patient Engagement through Improved Access of Clinical Information

Thomas Wicks
Chief Strategy Officer
TrialScope

12:30

Networking Luncheon

1:30

CHOOSE FROM THREE CONCURRENT SESSIONS (1-3)

1 Disclosure 101

Iwona Bucior
Director, Medical Communications
Myokardia

2 Explore Advances in Transparency through TransCelerate’s Clinical Research Access Initiative

Chris Pfitzer, MA
Transparency Operations Lead
UCB Biosciences

3 Global Harmonization of CTT requirements — Opportunities, Challenges and Ideas

Julie Holtzople
Director, Clinical Trial Transparency Operations
AstraZeneca

Nate Root
Associate Director, Clinical Disclosure and Transparency
Ionis Pharmaceuticals

2:30

CHOOSE FROM THREE CONCURRENT SESSIONS (4-6)

4 Disclosure 102

Oladayo Oyelola, PhD, SC (ASCP
Director, Clinical Trial Information Disclosure Regulatory Management Operations
Daiichi Sankyo, Inc.

5 Advance Disclosure of Biostatistics through Streamlined Programming and Processes

Paul Ngai
Co-Founder and CEO
Xogene

6 Analyze Disclosure and Registry Challenges in
Socio-Behavioral Studies

Yolanda P. Davis
Clinical Disclosure Manager
University of Miami

3:30

Networking and Refreshment Break

3:00

CHOOSE FROM THREE CONCURRENT SESSIONS (7-9)

7 Changing Processes and Attitudes Towards
Risk-assessment and Anonymization after Implementation of Health Canada PRCI

Shalini Dwivedi
Director
Kinapse, a Syneos Health Company

8 EMA Policy 0070 —
An Exploratory Review of Data Utility in
Clinical Study Reports for Academic Research

Jean-Marc Ferran
Director
Qualiance

9 Rare Disease Working Group —
Explore the Challenges of Disclosure and Transparency in Small Populations

Nate Root
Associate Director, Clinical Disclosure and Transparency
Ionis Pharmaceuticals

5:00

Close of Day Two

Networking, Wine
and Cheese Reception
immediately following the final session on day two

DAY THREE FRIDAY, JANUARY 24, 2020

7:45

Continental Breakfast

8:15

Chairperson’s Review of Day Two

8:30

Upcoming Changes in The NIH Review Process and Recommendation for Preparedness

Sonali Parmar
Senior Manager
Kinapse, a Syneos Health Company

9:15

Discuss the Challenges of Managing, Sharing and Disclosing Biostatistics and Biomarker Data

Jamie Tyrone
CEO and Founder
Beating Alzheimer's By Embracing Science (B.A.B.E.S.)

9:45

Explore Effective Ways to Engage with Patients through TransCelerate’s Patient Experience Initiative

Sean Ludlam
Clinical Trial Registries
Allergan

10:30

Networking and Refreshment Break

11:00

Partnering with Patients and Participants to Develop Clinical Research Materials and Plain Language Summaries Language Summaries

Sylvia Baedorf Kassis, MPH
Program Manager
Multi-Regional Clinical Trials Center of
Brigham and Women’s Hospital and Harvard

11:45

Elevate the Quality of Clinical Submissions and Documentation through Strategic Medical Writing

Jo Anne-Marie Blyskal
Head of Global Regulatory Medical Writing & Data Transparency and Disclosure
Teva

12:30

Chairperson’s Closing Remarks and Close of Conference