Health Science Connect Agenda

Agenda

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Sunday, April 7

3:00
p.m.
Registration
Atrium, Third Floor
3:00 p.m.
7:00 p.m.

Monday, April 8

7:00
a.m.
Registration
Atrium, Third Floor
7:00 a.m.
7:00 p.m.

Tuesday, April 9

7:00
a.m.
Registration
Atrium, Third Floor
7:00 a.m.
6:00 p.m.
Networking Breakfast
Ormandy Ballroom, Lobby Level
7:00 a.m.
8:15 a.m.
8:30
a.m.
Health Sciences General Session

Change Is Certain, Growth Is Optional: Are You Ready?
The digital clinical trial—incorporating new data sources and modernizing processes—is here. And innovative technology to support such trials is available. So what’s holding us back? Uncertainty, inexperience, choice overload? In this keynote learn how Oracle customers have embraced change to spur growth, and gain perspective on how you can do the same.

Steve RosenbergSenior Vice President and General Manager, Health Sciences Global Business Unit, Oracle
Industry Keynote
Symphony Ballroom, Third Floor
8:30 a.m.
10:00 a.m.
10:00
a.m.
Break
Atrium, Third Floor
10:00 a.m.
10:30 a.m.
Connect Zone Networking
Overture, Third Floor
10:00 a.m.
6:00 p.m.
10:30
a.m.
How Oracle Health Sciences Clinical One Can Optimize Digital Data Collection

An overview and demo of Clinical One, a unified, central location for all stakeholder access to data that only has to be captured once, as well as a simple-to-use, scalable, and flexible eClinical environment with common tools that can be used across all processes.

Andy AlassoVice President, Product Management, Oracle
Jim StreeterGlobal Vice President, Life Sciences Product Strategy, Oracle
Liam WoodVice President, Clinical One Product Management, Oracle
Symphony Ballroom, Third Floor
10:30 a.m.
11:30 a.m.
11:30
a.m.
Empathy and Expertise: Patient Centricity in the Digital Age

In this session learn how patients and pharma are working together to improve research results, clinical trials, and patient outcomes.

Tommy BramleyPresident, Lash Group
Derek PollockManaging Director, Accenture
Symphony Ballroom, Third Floor
11:30 a.m.
12:00 p.m.
12:00
p.m.
Networking Lunch
Ormandy Ballroom, Lobby Level
12:00 p.m.
1:15 p.m.
Connect Zone Networking
Overture, Third Floor
12:00 p.m.
1:15 p.m.
12:40
p.m.
Connect Zone Innovation Theater

How Will mHealth Help Take Something Great and Make It Better?
IoT technology is moving at pace and Oracle Internet of Things/mHealth is at the forefront. Now we’ve seen it in action, what do we need to do to optimize our outcomes from it? Attend this session to learn more.

Andy GreenbergPresident, Accenture
Overture, Third Floor
12:40 p.m.
1:00 p.m.
Sponsored by
1:15
p.m.
Finding a Pragmatic Approach to Information Governance

Hear a panel of experts discuss their approach to information governance. In this session learn how some of the largest organizations have approached implementation of standards and overall information governance strategies. Learn about some of the challenges they experienced as well as how they addressed these challenges.

Wade FairbanksDirector, Clinical and Technical Data Management, Pfizer
Brooke HinksonDirector, Global Clinical Data Standards, Merck
Linda LanderDirector of Data Standards, GSK
Symphony Ballroom, Third Floor
1:15 p.m.
2:15 p.m.
How AI Will Optimize Safety Case Management

Though safety budgets have remained flat, safety caseloads have continued to increase year over year. Learn how artificial intelligence can optimize safety case management by not only processing safety workflows more quickly and cheaply, but also by freeing safety team members for more important activities.

Rave HarpazSenior Director Research and Data Science, Oracle
Stefan KnoldAssociate Director and Head of Pharmacovigilance Technology, Ferring Pharmaceuticals
Bruce PalsulichVice President of Product Strategy, Oracle
Aria, Third Floor
1:15 p.m.
2:15 p.m.
Study Startup Optimization: PPD and goBalto

Hear how PPD streamlined its global site selections, implementations, and activations from launch to business-as-usual using goBalto solutions. In this session PPD reviews its approach and lessons learned scaling hundreds of users globally, improving the overall business process, and establishing study startup quality and efficiencies.

Malcolm HorsleySenior Director, Site Intelligence and Activation, PPD
Chris KomelaskySenior Director, Strategic Feasibility, PPD
Concerto, Third Floor
1:15 p.m.
2:15 p.m.
2:15
p.m.
Optimizing Site Activation with Oracle Health Sciences Siebel CTMS and goBalto Activate Solutions

Hear from Covance on how Oracle Siebel CTMS and goBalto Activate work together to deliver a comprehensive, end-to-end, and integrated site activation process. Topics include: an overview of Siebel CTMS and Activate implementations and scope of use, highlights of integrations in-place between the two solutions, and how the combined solution benefits businesses and users overall.

Nadine BrownProject Director, Covance
Annie B. HarrisDirector, Clinical Trial Management Systems, Covance
Symphony Ballroom, Third Floor
2:15 p.m.
3:15 p.m.
Compliance and Multivigilance Across the Product Lifecycle

The regulatory landscape for safety has changed dramatically over the last four years and shows no signs of slowing down any time soon. Get an update of the situation worldwide and a preview of what the next five years will bring. Hear customer perspectives on using Argus and Empirica to meet regulatory requirements.

Dr. Vivek AhujaVice President of Medical Affairs and Global Head of Pharmacovigilance, Sun Pharma
Michael Braun-BoghosDirector of Safety Analytics, Oracle
Elena DavisonDirector of Pharmacovigilance Informatics, Sunovion
Aria, Third Floor
2:15 p.m.
3:15 p.m.
The Role of AI and Contactless Sensors in Passive, In-Home, Patient Monitoring

The large scale deployment of mHealth devices and sensors in clinical trial programs will result in a data tsunami for clinical teams. This session explores how artificial intelligence and machine learning can address this data deluge and improve the patient experience with passive monitoring and the capacity to understand new, descriptive, digital biomarkers that are more reliable than current, gold-standard measures.

Hariharan RahulMassachusetts Institute of Technology
Concerto, Third Floor
2:15 p.m.
3:15 p.m.
3:15
p.m.
Break
Atrium, Third Floor
3:15 p.m.
3:30 p.m.
3:30
p.m.
Transformational Platforms for Clinical Data Management: From Source to Submission

Increasing clinical trial activity across a variety of therapeutic areas is driving the collection of new and voluminous data streams. Collecting and using data from sensors, omics analysis, and unstructured electronic health and medical records provides an opportunity to shrink both the cost and time associated with clinical trials. In this session learn how clinical data management can transform into a new clinical data pipeline, taking source data to submission-ready deliverables in a more scalable, robust, secure, and regulatory-compliant manner.

Linda Amato-SmithDirector, Pfizer
Nate BlevinsR&D IT Program Manager, GSK
Ken BengtsonDirector, Pfizer
Maria PerkinsonDirector, Kinapse
Ralph RussoSenior Director, Database Management, Pfizer
Linda ThibeaultIT Risk Management and Compliance Senior Manager, Pfizer
Moderator: Srinivas KarriSenior Director, Product Strategy, Oracle
Symphony Ballroom, Third Floor
3:30 p.m.
4:30 p.m.
Making the Move to the CTMS Cloud

Customers who have recently implemented their first cloud-based clinical trial management system (CTMS) share experiences on the key capabilities that are helping them organize and report on important clinical trial events. Get the details on the new features that are must haves for CTMS, as well as the integration points and workflows that are critical for enhancing business processes.

Sher-ree BeekmanDirector, Research Project Management, GE Healthcare
April CobbClinical System Analyst II, Rho
Dr. John MollerChief Executive Officer, Novotech
Dr. Nicholas PoulsonClinical Team Lead, Rho
Mark RewersDirector, Product Owner, Pfizer
Kate YorkSenior Clinical Systems Analyst, Rho
Moderator: Jennifer BushDirector Life Sciences Product Strategy, Oracle
Aria, Third Floor
3:30 p.m.
4:30 p.m.
4:30
p.m.
Connect Zone Networking
Overture, Third Floor
4:30 p.m.
6:00 p.m.
5:00
p.m.
Connect Zone Innovation Theater

The Connected Trial: From Concept to Global Deployment
This session offers a short demonstration of how HCL and Oracle can support scaling digital trials from simple proof of concept to global rollout.

Veselka IlievaSenior Director, Clinical Operations, HCL
Neeraj KaushlendraPractice Director, R&D Solutions, HCL
Overture, Third Floor
5:00 p.m.
5:30 p.m.
Sponsored by
7:00
p.m.
Customer Appreciation Reception
R2L, 50 South 16th Street, 37th Floor
7:00 p.m.
10:00 p.m.
Sponsored by

Wednesday, April 10

7:30
a.m.
Registration
Atrium, Third Floor
7:30 a.m.
4:30 p.m.
7:30
a.m.
Networking Breakfast
Ormandy Ballroom, Lobby Level
7:30 a.m.
8:30 a.m.
8:30
a.m.
Breakthrough Study Startup – goBalto

An overview and demonstration of how goBalto study startup solutions can save time and money by providing a solution for site selection and site activation.

Andrea SimVice President of Product Management, Oracle
Elliot ZimmermanVice President, Consulting, Oracle
Symphony Ballroom, Third Floor
8:30 a.m.
9:15 a.m.
9:15
a.m.
Customer Success Stories: Oracle Health Sciences Clinical One Randomization and Supplies Management (ORS)

Hear from customers as they share their experiences using Clinical One ORS for building, running, and closing studies. Gain perspective on validation and acceptance-testing practices implemented for Clinical One studies. Learn how mid-study changes were handled in hours, as well as other advantages customers experienced with Clinical One ORS.

Kristen StrifflerAssociate Director, Clinical Development, Oyster Point Pharma, Inc.
Liam WoodVice President, Clinical One Product Management, Oracle
Symphony Ballroom, Third Floor
9:15 a.m.
10:15 a.m.
ICON Streamlines Site Activation

Learn how ICON utilizes goBalto Activate to encourage transformational process change. In this session ICON executives detail how they use Activate to drive clinical quality/efficiency/compliance, provide cycle-time visibility, and reduce risk.

Dr. Diane FranciscoDirector of Process, Program Management Office, ICON
Dr. Helen YeardleySenior Vice President, Global Head of Feasibility, Site ID and Study Start-Up, ICON
Aria, Third Floor
9:15 a.m.
10:15 a.m.
The Value of the Cloud for Safety

Even large companies are now moving to the Oracle Health Sciences Safety Cloud because it offers true SaaS that reduces operating costs, speeds implementations and upgrades, and increases security and privacy protections. Learn how the cloud reduces the total cost of ownership over three to five years.

Michael Braun-BoghosDirector of Safety Analytics, Oracle
John D’AntonioGlobal Head of Consulting, Navitas Health Sciences
Concerto, Third Floor
9:15 a.m.
10:15 a.m.
10:15
a.m.
Break
Atrium, Third Floor
10:15 a.m.
10:30 a.m.
Connect Zone Networking
Overture, Third Floor
10:15 a.m.
4:15 p.m.
10:30
a.m.
Adopting Digital Trials: Real World Experiences and Strategies

Clinical teams discuss how they are digitally transforming their clinical research, from connecting a patient to a medical sensor, to collecting high-quality, objective, real world data, to discovering new therapies. Learn how they are utilizing their clinical opportunities, challenges, and strategies to incorporate digital innovation, from acquisition, to patient engagement, to real world insight.

Raj PallapothumHealth Global Lead, Business Operations, Bayer
Jonathan PalmerSenior Director, Product Strategy, Digital Trials, Oracle
Jeremy WyattChief Technology Officer and Senior Vice President of Product Development, ActiGraph
John YonchukManager, Digital Clinical Trials, GSK
Symphony Ballroom, Third Floor
10:30 a.m.
11:30 a.m.
Key Takeaways from Pfizer’s Oracle Cloud Implementation

Pfizer, one of the world’s largest pharmaceutical companies, used a homegrown clinical trial management system (CTMS) for many years. Learn about the strategy, challenges, and process behind the company’s recent migration from this in-house, on-premises system to Oracle’s Siebel Clinical Trial Management System in the Oracle Cloud. Hear tips from Pfizer and Perficient on implementation and additional considerations.

Mark RewersDirector, Product Owner, Pfizer
Param SinghDirector, Clinical Operations Solutions, Perficient
Aria, Third Floor
10:30 a.m.
11:30 a.m.
A Better Experience in Signal Detection and Management

The Oracle UX team has reimagined the Oracle Health Sciences Empirica UI to provide a brand new, dynamic, and modern experience for users. The new interface will help safety professionals to do their work more quickly with fewer steps and clicks. Get a preview of the new design in a live demonstration.

Bruce PalsulichVice President of Product Strategy, Oracle
Lee RussellPrinciple Solutions Consultant, Oracle
Concerto, Third Floor
10:30 a.m.
11:30 a.m.
11:30
a.m.
Human and Machine: The Future of Digital Health

The distance between human and machine is evaporating and the vision surrounding how we use technology has never been more important. Attend this session to learn more.

Andy GreenbergPresident, Accenture
Symphony Ballroom, Third Floor
11:30 a.m.
12:15 p.m.
Integrating EDC and Safety: An Advanced Approach Using Oracle Health Sciences InForm and Oracle Argus

Members of a customer team share how they integrated Oracle Health Sciences InForm and Oracle Argus by using a new process. Learn why the new process was important, the value of the approach for users and the overall business, and tips for other companies that intend to execute this same innovative integration method.

Dr. Anil DhiriConsulting Technical Manager, Oracle
Sagar ShahConsulting Practice Director, Oracle
Concerto, Third Floor
11:30 a.m.
12:15 p.m.
12:15
p.m.
Networking Lunch
Ormandy Ballroom, Lobby Level
12:15 p.m.
1:15 p.m.
Connect Zone Networking
Overture, Third Floor
12:15 p.m.
1:15 p.m.
12:40
p.m.
Connect Zone Innovation Theater

Medical Coding with Artificial Intelligence
It can be challenging to find medical coders with the appropriate skills and attitude required to process a large number of terms on a daily basis. In this session discover how machine learning and AI can be used for medical coding without adding human resources and impacting quality.

Rudolf CoetzeeDirector of Strategic Accounts, Perficient
Ormandy Ballroom, Third Floor
12:40 p.m.
1:00 p.m.
Sponsored by
1:15
p.m.
Defining Pharmacogenomics Decision Support for Clinical Trials

In this session hear a customer presentation on the opportunities and challenges of developing genomic assays for clinical decision support and clinical trials. The discussion focuses on the new, emerging genomic technologies that are being used to define pharmacogenomics and the need for comprehensive, longitudinal clinical profiles for accurate reporting.

John ChristophersonTechnology and Operations, MolecularDx
Dr. John KriakPharmD, Clinical Business Consultant for Goldblat Systems, MolecularDx
Dr. Laura Voeghtly, PhDChief Scientist and Director of Laboratory Operations, MolecularDx
Symphony Ballroom, Third Floor
1:15 p.m.
2:15 p.m.
Facilitating an Effective Training, Change Management and Support Program for your Global Study Startup Implementation

Hear a panel of study startup experts share their experiences and lessons learned from global implementations. Panelists will address the need for a well thought out change management plan and support processes that will scale. Panelists will also address prepared questions on the do’s and don’ts with the initial rollout and upgrades.

Leila CukicBusiness and Configuration Lead, PPD
Lorena GomezDirector, Global Study Start-Up and Essential Documents, Allergan
Jennifer WeaverAssociate Director, Clinical Operations Lead, CSL Behring
Aria, Third Floor
1:15 p.m.
2:15 p.m.
Reducing End-To-End Trial Planning, While Optimizing Costs, Timelines, and Resources

Today, organizations need to plan, forecast, and provide resources for clinical trials faster and with greater accuracy than ever before. This session presents an in-depth discussion on challenges and strategies for improving the end-to-end clinical trial planning and outsourcing processes.

Liz KhachadoorianAssociate Director in Clinical Business Operations, Imbrium Therapeutics
Jason WaclawekSenior Manager, Study Planning, Abbott
Concerto, Third Floor
1:15 p.m.
2:15 p.m.
2:15
p.m.
Next Generation Clinical Data Disruption: Clinical Data Management in 2023

New advances in managing clinical data and real-world evidence for analytical, scientific, and regulatory needs in artificial intelligence, predictive analytics, and big data offer new opportunities for innovation. In this session gain insight into the technology disruptors for clinical data management and clinical R&D over the next five years and what the single biggest disruptor could be.

Jennifer DuffManaging Director, Life Sciences, Accenture
Bruce NovickSenior Manager, Accenture
Prabha RanganathanDirector, Life Sciences Data Warehousing and Analytics, Perficient
Symphony Ballroom, Third Floor
2:15 p.m.
3:15 p.m.
Optimizing the Site Activation Contracting Process with goBalto Activate

Allergan reviews how goBalto Activate and Analyze solutions are supporting its global site contracting process for study start-up. Learn how the company is using the goBalto solutions to track, manage, report and analyze the contracting processing including identification of bottlenecks and measurement of cycle times.

Dave PosseltGlobal Director, Contract Management and Global Monitoring Operations, Allergan
Aria, Third Floor
2:15 p.m.
3:15 p.m.
Connected Trials: From Ideas to Execution

In this session learn why despite acknowledging how mHealth technology can dramatically impact the clinical trials process, many pharmas fail to expand beyond pilot or proof of concept stages. See how HCL and Oracle combined their technology and global services to help customers plan, execute, and scale the next generation of digital trials.

Sunil AgarwalAssociate Vice President and Global Head, R&D Business Process Consulting, HCL
Joseph FlemingVice President of Information Technology, R&D, Allergan
Jonathan PalmerSenior Director, Product Strategy, Digital Trials, Oracle
Jim StreeterGlobal Vice President, Life Sciences Product Strategy, Oracle
Anil VermaVice President, Life Sciences Solutions, HCL
Concerto, Third Floor
2:15 p.m.
3:15 p.m.
3:15
p.m.
Enriching Clinical Trials Data with Electronic Health Records

Provider adoption of electronic health records (EHRs) create an enormous opportunity to accelerate clinical research by supplying a rich source of available, de-identified, patient data for clinical studies. This session discusses a number of issues associated with bringing EHR data to clinical trials including: managing patient EHRs as an additional key data source, addressing site EHR data challenges, exploring the TransCelerate eSource Working Group, and examining the emerging HL7 FHIR Standard.

Timothy JoySenior Director, Pfizer
Prasann MehtaMerck
Symphony Ballroom, Third Floor
3:15 p.m.
4:15 p.m.