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Conference Agenda

Day One

09:00 - 09:15
Opening address from chairwoman and event director
09:15 - 09:45
A holistic approach: hear from TransCelerate member companies about how the future of technology and patient experience will be inseparable
  • Learn from the experience of TransCelerate member companies about how to identify areas in which there is pent up demand for innovation and ways to take a holistic approach to systems, process, and people in the implementation of various eSource modalities
  • Keep overall drivers in mind such as improving patient safety, or improving site and patient experience of clinical trials
  • Review alternatives from the TransCelerate eSource team to overcome obstacles to optimal eSource implementation

Speaker Logo Aman Thukral Assistant Director, Strategy and Innovation AbbVie

09:45 - 10:15
View stakeholder engagement strategically to optimize decisions and collaboration across matrix organizations
  • Utilize the principles of Strategic Thinking to achieve alignment for clinical trials and research partnerships
  • Achieve more targeted and impactful outcomes by building inclusive insights from key stakeholders into engagement strategies and trial design
  • Learn how disruptive technologies and use of devices are changing patient care and stakeholder engagement within Pharma
  • "One size does not fit all": Moving towards a more cohesive decision making approach to adapt to a changing healthcare environment

Speaker Logo Melva Covington Principal and CEO AGAPE Strategic Solutions, LLC

10:15 - 10:45
Coffee Break
10:45 - 11:15
Allow your sites to focus on patient relationships by considering the operational burden of technologies
  • Involve your sites in the implementation of new technologies to assess if it’s something they’re going to be able to work with
  • Case study. Co-creation: using key learnings from sites and patients to build meaningful strategies.

Speaker Logo Robin Heiskell Associate Director, Strategic Clinical Relationships Bristol-Myers Squibb

11:15 - 11:45
Leverage big data analytics to enhance clinical trials from planning to execution
  • How to analyze data to uncover and address cost and timeliness factors in clinical trials
  • Discover the key to enriching key data assets by leveraging a bridge to the real world
  • Live Demos: Clinical Development Analytics (Study Monitoring) & Clinical Development Feasibility

Saama Nikhil Gopinath Senior Solutions Engineer Saama

11:45 - 12:30
Panel: A guide to collecting data. Make better, faster decisions
  • Create a single internal platform for gathering and analysing data
  • Build the data standards up front to allow for faster, more accurate reporting
  • Learn about the benefits of implementing these platforms to CDISC industry standards to prepare yourself for an increasingly industry approach

Moderator: Sam Hume Sam Hume Head of Data Exchange Technologies CDISC

Speaker Logo Jeremy Wyatt CTO and Sr. VP of Product Development ActiGraph

Speaker Logo Raj Nimmagadda Director, Global Head - Data Sciences & Standards, Analytics Novartis

Jaydev Thakkar Jaydev Thakkar Director, Technology Strategy and Innovation Amgen

12:30 - 13:30
Lunch Break
13:30 - 14:15
Panel: Recognize why patients are engaging with their own health and how you can become a trusted partner in this
  • Improve the care of a patient at the same time as gathering important medical data via the use of apps
  • Understand any obstacles that exist to implementing a fully digital engagement strategy

Moderator: Speaker Logo Edward Miseta Executive Editor Clinical Leader and Life Science Leader

Speaker Logo Sarah Krüg CEO Cancer101

Speaker Logo Ide Mills Lung cancer survivor, patient advocate, health educator and patient communication specialist

Speaker Logo Jaydev Thakkar Director, Technology Strategy and Innovation Amgen

14:15 - 14:45
Improve data accuracy and timeliness in your trials with the use of Electronic Health Records as eSource
  • Find out how far the needle has moved since the FDA released their eSource guidance in 2013 with the results of their demonstration project
  • Learn about different models of implementation – and which would be most suited for your clinical trials
  • Understand the obstacles that still need to be overcome in order to achieve higher quality data, and more efficient, cost-effective trials

OmniComm Systems, Inc. Ken Light EVP, Transformation and Professional Services OmniComm Systems, Inc.

14:45 - 15:30
Panel: Better engage patients by designing trials that fit in with the patient’s own experience of their disease
  • Incorporate key learnings about the particular symptoms of a disease by tapping into online patient forums/engagement points.
  • Understand the overall patient experience of clinical trials via social media listening, so you can build strategies to overcome the general pain points in your protocol designs
  • Engage with/collaborate with third-party, patient-centric organizations that are in regular dialogue with patient communities to expand reach of clinical trial information and heighten awareness of participation opportunities

Moderator: Speaker Logo Edward Miseta Executive Editor Clinical Leader and Life Science Leader

Speaker Logo Esther Schorr Co-Founder/COO Patient Power

Speaker Logo Cynthia Chmielewski Blood cancer survivor, trained mentor, advocate and Patient Ambassador

Speaker Logo Robin Heiskell Associate Director, Strategic Clinical Relationships Bristol-Myers Squibb

Speaker Logo Ron Bartek FARA

15:30 - 16:00
Coffee Break
16:00 - 16:30
The 24/7 pharma company: absorb and gain insights from the wealth of consumer health data coming your way
  • With greater use of wearable and sensor devices in clinical trials providing feedback around the clock, our new challenge is to effectively integrate this data and gain insights
  • Hear from representatives of AbbVie’s leading Data Science group on how to effectively manage the data chain in wearable data integration
  • Accommodate trials of the future by creating a wearable-device-agnostic environment

Speaker Logo Brooks Fowler Global Head of Data Sciences AbbVie

Speaker Logo Aman Thukral Assistant Director, Strategy and Innovation AbbVie

16:30 - 17:00
“Beginning to end”: see your clinical trial data as one continuous life cycle
  • Learn how CDISC SHARE contributes to the availability of standards that work together across the clinical research data lifecycle
  • Learn how to improve traceability across the full clinical research data lifecycle to include useful visualizations
  • Hear about the important work CDISC has been doing on the CTR-XML standard to more efficiently submit to clinical trial registries

Sam Hume Sam Hume Head of Data Exchange Technologies CDISC

17:00 - 19:30
Networking Drinks

Day Two

08:00 - 08:55
Registration
08:55 - 09:00
Opening address from day 2 chairman
09:00 - 09:30
Understand the value to better understand the potential of new technologies
  • Avoid investing in one-off point solutions: think about systems, process; platforms; and people holistically
  • Get the buy-in: keep overall drivers in mind such as improving patient safety, or improving site and patient experience of clinical trials
  • Calculate the business case when the value is incalculable

Speaker Logo Christopher Pitcherella Director, Clinical Trial Innovation Teva Pharmaceuticals

09:30 - 10:15
Co-presentation: Maintain control and ensure greater transparency of data through the emerging standardization of core industry platforms
  • Partner with industry peers to build and run common clinical data and clinical management platforms
  • Case study: See how Amgen/ Cognizant are helping to bring together pharma to simplify internal processes and drive efficiencies and speed

Speaker Logo Aditi Kumar Executive Director, Clinical Systems Amgen

Speaker Logo Bhaskar Sambasivan Senior Vice President & Global Head of Markets – Life Sciences Cognizant

10:15 - 10:45
Move towards a more app-centred way of working for more flexible and cost-effective trials
  • Learn how the first App based new generation clinical data suite can help you to run more efficient and cost-effective trials by giving access to Apps that have been purpose built to deliver the key functionalities your trial needs
  • Discover how new methods of data collection and real-time clinical data analytics can improve data visibility and reduce the number of Protocol violators in your trial.
  • Work more effectively with your investigators by increasing the transparency of your trials

CMED Research Ami Israel VP, Clinical Operations CMED Research

10:45 - 11:15
Coffee Break
11:15 - 12:00
Panel: Maximize resource allocation through innovative trial design
  • Adapt to risks as the trial progresses to gain better quality data about the optimal dosage before approval
  • Reduce the number of patients needed to gain approval by only enriching arms where the drug is shown to be working

Moderator: Speaker Logo Jeremy Wyatt CTO and Sr. VP of Product Development ActiGraph

Speaker Logo Kannan Natarajan Global Head of Biometrics and Data Management Pfizer

Speaker Logo Melva Covington Senior Director, Head of Field Based Medical Strategy Sanofi

Alkermes Jyotsna Mehta Director, Economics Value Evidence and Outcomes Alkermes, Inc.

12:00 - 13:00
Panel: How to design (more) patient centric trials including technology: lessons from the Aurora Benchmarking Project
  • Learn from the experience of clinical and medical affairs peers in the types of patient centric approaches to trial design including the use of technology from the largest survey ever undertaken in the industry
  • Case Study: Rethinking clinical supplies - how Sanofi makes it possible for patients to engage through direct shipment and QR codes
  • Case Study: The use of a patient controlled digital tool for data collection, sharing and monetization - how Portable Genomics' platform will change the patient to pharma relationship and accelerate the discovery process.

Moderator: Aurora Project Anita Burrell Founder of the Aurora Project and Principal Anita Burrell Consulting LLC

Portable Genomics Patrick Merel Founder and CEO Portable Genomics

Sanofi Michael Sparozic TSOM, Leader, Clinical Supplies Chain Operations – Distribution Sanofi US

Cystic Fibrosis.com Jeanne Barnett Founding Member of Aurora Project and President/Founder of CysticFibrosis.com CysticFibrosis.com

13:00 - 14:00
Lunch Break
14:00 - 14:30
Don’t let anyone misinterpret your patient’s experience of a trial. Improve the quality of data by going direct to the patient
  • Using mobile devices to gain real-time insights into how patients are progressing in their trials
  • Learn how this data can supplement PROs
  • Increasing understanding of your product and its benefits earlier in the drug development process to make better commercial decisions like price later on

Speaker Logo Pablo Lapuerta Executive Vice President and Chief Medical Officer Lexicon Pharmaceuticals

14:30 - 15:00
E-consent: communicate the value of your trial directly to the patient
  • Discover innovative ways of implementing multimedia tech to give the patient a complete overview of the study
  • Gain access to previously difficult to reach patient populations

Speaker Logo Mohammed Ali Director, R&D Operations and Innovation Leader Janssen

15:00 - 15:30
The Consumer-Directed Path to Data Exchange and its Implications for Clinical Trials
  • Discover the policy, technical, and emerging business model trends that are enabling consumers to take a more active role in connecting their health data with the applications and services they trust
  • Evaluate the implications for clinical trials and benchmark your strategies to assemble longitudinal patient records for trial recruitment, enrolment and real-world evidence

NavHealth Aneesh Chopra President and former (and first) U.S. Chief Technology Officer NavHealth

15:30 - 16:00
Save time for your investigators by eliminating dual data entry
  • Make life easier for your sites: permit your investigators to work into their own EMR systems and pulling the requisite data directly from those
  • Avoid human intervention with data to minimise errors

Speaker Logo Tesheia Johnson COO / Associate Director for Clinical Research YCCI / Yale School of Medicine

Coffee to go or stay!

Day One

09:00 - 09:15
Opening address from chairwoman and event director
09:15 - 09:45
A holistic approach: hear from TransCelerate member companies about how the future of technology and patient experience will be inseparable
  • Learn from the experience of TransCelerate member companies about how to identify areas in which there is pent up demand for innovation and ways to take a holistic approach to systems, process, and people in the implementation of various eSource modalities
  • Keep overall drivers in mind such as improving patient safety, or improving site and patient experience of clinical trials
  • Review alternatives from the TransCelerate eSource team to overcome obstacles to optimal eSource implementation

Speaker Logo Aman Thukral Assistant Director, Strategy and Innovation AbbVie

09:45 - 10:15
View stakeholder engagement strategically to optimize decisions and collaboration across matrix organizations
  • Utilize the principles of Strategic Thinking to achieve alignment for clinical trials and research partnerships
  • Achieve more targeted and impactful outcomes by building inclusive insights from key stakeholders into engagement strategies and trial design
  • Learn how disruptive technologies and use of devices are changing patient care and stakeholder engagement within Pharma
  • "One size does not fit all": Moving towards a more cohesive decision making approach to adapt to a changing healthcare environment

Speaker Logo Melva Covington Principal and CEO AGAPE Strategic Solutions, LLC

10:15 - 10:45
Coffee Break
10:45 - 11:15
Allow your sites to focus on patient relationships by considering the operational burden of technologies
  • Involve your sites in the implementation of new technologies to assess if it’s something they’re going to be able to work with
  • Case study. Co-creation: using key learnings from sites and patients to build meaningful strategies.

Speaker Logo Robin Heiskell Associate Director, Strategic Clinical Relationships Bristol-Myers Squibb

11:15 - 11:45
Leverage big data analytics to enhance clinical trials from planning to execution
  • How to analyze data to uncover and address cost and timeliness factors in clinical trials
  • Discover the key to enriching key data assets by leveraging a bridge to the real world
  • Live Demos: Clinical Development Analytics (Study Monitoring) & Clinical Development Feasibility

Saama Nikhil Gopinath Senior Solutions Engineer Saama

11:45 - 12:30
Panel: A guide to collecting data. Make better, faster decisions
  • Create a single internal platform for gathering and analysing data
  • Build the data standards up front to allow for faster, more accurate reporting
  • Learn about the benefits of implementing these platforms to CDISC industry standards to prepare yourself for an increasingly industry approach

Moderator: Sam Hume Sam Hume Head of Data Exchange Technologies CDISC

Speaker Logo Jeremy Wyatt CTO and Sr. VP of Product Development ActiGraph

Speaker Logo Raj Nimmagadda Director, Global Head - Data Sciences & Standards, Analytics Novartis

Jaydev Thakkar Jaydev Thakkar Director, Technology Strategy and Innovation Amgen

12:30 - 13:30
Lunch Break
13:30 - 14:15
Panel: Recognize why patients are engaging with their own health and how you can become a trusted partner in this
  • Improve the care of a patient at the same time as gathering important medical data via the use of apps
  • Understand any obstacles that exist to implementing a fully digital engagement strategy

Moderator: Speaker Logo Edward Miseta Executive Editor Clinical Leader and Life Science Leader

Speaker Logo Sarah Krüg CEO Cancer101

Speaker Logo Ide Mills Lung cancer survivor, patient advocate, health educator and patient communication specialist

Speaker Logo Jaydev Thakkar Director, Technology Strategy and Innovation Amgen

14:15 - 14:45
Improve data accuracy and timeliness in your trials with the use of Electronic Health Records as eSource
  • Find out how far the needle has moved since the FDA released their eSource guidance in 2013 with the results of their demonstration project
  • Learn about different models of implementation – and which would be most suited for your clinical trials
  • Understand the obstacles that still need to be overcome in order to achieve higher quality data, and more efficient, cost-effective trials

OmniComm Systems, Inc. Ken Light EVP, Transformation and Professional Services OmniComm Systems, Inc.

14:45 - 15:30
Panel: Better engage patients by designing trials that fit in with the patient’s own experience of their disease
  • Incorporate key learnings about the particular symptoms of a disease by tapping into online patient forums/engagement points.
  • Understand the overall patient experience of clinical trials via social media listening, so you can build strategies to overcome the general pain points in your protocol designs
  • Engage with/collaborate with third-party, patient-centric organizations that are in regular dialogue with patient communities to expand reach of clinical trial information and heighten awareness of participation opportunities

Moderator: Speaker Logo Edward Miseta Executive Editor Clinical Leader and Life Science Leader

Speaker Logo Esther Schorr Co-Founder/COO Patient Power

Speaker Logo Cynthia Chmielewski Blood cancer survivor, trained mentor, advocate and Patient Ambassador

Speaker Logo Robin Heiskell Associate Director, Strategic Clinical Relationships Bristol-Myers Squibb

Speaker Logo Ron Bartek FARA

15:30 - 16:00
Coffee Break
16:00 - 16:30
The 24/7 pharma company: absorb and gain insights from the wealth of consumer health data coming your way
  • With greater use of wearable and sensor devices in clinical trials providing feedback around the clock, our new challenge is to effectively integrate this data and gain insights
  • Hear from representatives of AbbVie’s leading Data Science group on how to effectively manage the data chain in wearable data integration
  • Accommodate trials of the future by creating a wearable-device-agnostic environment

Speaker Logo Brooks Fowler Global Head of Data Sciences AbbVie

Speaker Logo Aman Thukral Assistant Director, Strategy and Innovation AbbVie

16:30 - 17:00
“Beginning to end”: see your clinical trial data as one continuous life cycle
  • Learn how CDISC SHARE contributes to the availability of standards that work together across the clinical research data lifecycle
  • Learn how to improve traceability across the full clinical research data lifecycle to include useful visualizations
  • Hear about the important work CDISC has been doing on the CTR-XML standard to more efficiently submit to clinical trial registries

Sam Hume Sam Hume Head of Data Exchange Technologies CDISC

17:00 - 19:30
Networking Drinks

Purchase the Post-Conference Materials

Event Presentations • Event Audio • On Demand Subscription

Day Two

08:00 - 08:55
Registration
08:55 - 09:00
Opening address from day 2 chairman
09:00 - 09:30
Understand the value to better understand the potential of new technologies
  • Avoid investing in one-off point solutions: think about systems, process; platforms; and people holistically
  • Get the buy-in: keep overall drivers in mind such as improving patient safety, or improving site and patient experience of clinical trials
  • Calculate the business case when the value is incalculable

Speaker Logo Christopher Pitcherella Director, Clinical Trial Innovation Teva Pharmaceuticals

09:30 - 10:15
Co-presentation: Maintain control and ensure greater transparency of data through the emerging standardization of core industry platforms
  • Partner with industry peers to build and run common clinical data and clinical management platforms
  • Case study: See how Amgen/ Cognizant are helping to bring together pharma to simplify internal processes and drive efficiencies and speed

Speaker Logo Aditi Kumar Executive Director, Clinical Systems Amgen

Speaker Logo Bhaskar Sambasivan Senior Vice President & Global Head of Markets – Life Sciences Cognizant

10:15 - 10:45
Move towards a more app-centred way of working for more flexible and cost-effective trials
  • Learn how the first App based new generation clinical data suite can help you to run more efficient and cost-effective trials by giving access to Apps that have been purpose built to deliver the key functionalities your trial needs
  • Discover how new methods of data collection and real-time clinical data analytics can improve data visibility and reduce the number of Protocol violators in your trial.
  • Work more effectively with your investigators by increasing the transparency of your trials

CMED Research Ami Israel VP, Clinical Operations CMED Research

10:45 - 11:15
Coffee Break
11:15 - 12:00
Panel: Maximize resource allocation through innovative trial design
  • Adapt to risks as the trial progresses to gain better quality data about the optimal dosage before approval
  • Reduce the number of patients needed to gain approval by only enriching arms where the drug is shown to be working

Moderator: Speaker Logo Jeremy Wyatt CTO and Sr. VP of Product Development ActiGraph

Speaker Logo Kannan Natarajan Global Head of Biometrics and Data Management Pfizer

Speaker Logo Melva Covington Senior Director, Head of Field Based Medical Strategy Sanofi

Alkermes Jyotsna Mehta Director, Economics Value Evidence and Outcomes Alkermes, Inc.

12:00 - 13:00
Panel: How to design (more) patient centric trials including technology: lessons from the Aurora Benchmarking Project
  • Learn from the experience of clinical and medical affairs peers in the types of patient centric approaches to trial design including the use of technology from the largest survey ever undertaken in the industry
  • Case Study: Rethinking clinical supplies - how Sanofi makes it possible for patients to engage through direct shipment and QR codes
  • Case Study: The use of a patient controlled digital tool for data collection, sharing and monetization - how Portable Genomics' platform will change the patient to pharma relationship and accelerate the discovery process.

Moderator: Aurora Project Anita Burrell Founder of the Aurora Project and Principal Anita Burrell Consulting LLC

Portable Genomics Patrick Merel Founder and CEO Portable Genomics

Sanofi Michael Sparozic TSOM, Leader, Clinical Supplies Chain Operations – Distribution Sanofi US

Cystic Fibrosis.com Jeanne Barnett Founding Member of Aurora Project and President/Founder of CysticFibrosis.com CysticFibrosis.com

13:00 - 14:00
Lunch Break
14:00 - 14:30
Don’t let anyone misinterpret your patient’s experience of a trial. Improve the quality of data by going direct to the patient
  • Using mobile devices to gain real-time insights into how patients are progressing in their trials
  • Learn how this data can supplement PROs
  • Increasing understanding of your product and its benefits earlier in the drug development process to make better commercial decisions like price later on

Speaker Logo Pablo Lapuerta Executive Vice President and Chief Medical Officer Lexicon Pharmaceuticals

14:30 - 15:00
E-consent: communicate the value of your trial directly to the patient
  • Discover innovative ways of implementing multimedia tech to give the patient a complete overview of the study
  • Gain access to previously difficult to reach patient populations

Speaker Logo Mohammed Ali Director, R&D Operations and Innovation Leader Janssen

15:00 - 15:30
The Consumer-Directed Path to Data Exchange and its Implications for Clinical Trials
  • Discover the policy, technical, and emerging business model trends that are enabling consumers to take a more active role in connecting their health data with the applications and services they trust
  • Evaluate the implications for clinical trials and benchmark your strategies to assemble longitudinal patient records for trial recruitment, enrolment and real-world evidence

NavHealth Aneesh Chopra President and former (and first) U.S. Chief Technology Officer NavHealth

15:30 - 16:00
Save time for your investigators by eliminating dual data entry
  • Make life easier for your sites: permit your investigators to work into their own EMR systems and pulling the requisite data directly from those
  • Avoid human intervention with data to minimise errors

Speaker Logo Tesheia Johnson COO / Associate Director for Clinical Research YCCI / Yale School of Medicine

Coffee to go or stay!

Purchase the Post-Conference Materials

Event Presentations • Event Audio • On Demand Subscription