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18: InnovTheater [clear filter]
Monday, June 24
 

10:15am

#103 IT: Advanced Clinical Innovation Theater: Raising the Bar on Clinical Oversight to Reduce Risk and Ensure Inspection Readiness
Component Type: Session

As a result of increasing compliance requirements like ICH E6 R2, competition and more - many sponsor organizations do not have the resources to provide proper oversight on outsourced clinical trials. Advanced Clinical will present a case study that features a successful sponsor-FSP oversight program using a winning combination of resources, processes and a data-driven decision-making platform that helped a client demonstrate regulatory obligations and inspection readiness while minimizing risk.

Chair

Advanced Clinical


Speakers
avatar for Graham Belgrave

Graham Belgrave

Sr. Vice President, Head of European Operations, Advanced Clinical
avatar for Cheryle Evans

Cheryle Evans

SVP Clinical and Medical Ops, Advanced Clinical
avatar for Julie Ross

Julie Ross

President, Advanced Clinical
Ms. Ross, President of Essential Patient Recruitment and CRO, has a BS in Nuclear Medicine and has served the research industry for 23 years. She has comprehensive knowledge in all facets of clinical research and is a leader in patient recruitment, research operations and business... Read More →


Monday June 24, 2019 10:15am - 10:45am
Theater 1 Exhibit Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

10:15am

#104 IT: ArisGlobal Innovation Theater: Can Blockchain Technology Change Life Sciences?
Component Type: Session

How can the life sciences industry take advantage of the Blockchain technology? We will have a conversation about how the inherent characteristics of BlockChain and a Blockchain network can change the traditional models of exchanging data? What are some of the potential impacts from these changes?

Chair

ArisGlobal, LLC


Speakers
EB

Emmanuel Belabe

Associate Vice President, Safety Business Unit, ArisGlobal


Monday June 24, 2019 10:15am - 10:45am
Theater 2 Exhibit Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

12:15pm

#123 IT: IQVIA Innovation Theater: When Context is Hard to Come By – The Emerging Value of External Comparators
Component Type: Session

Today more pharmaceutical products are being evaluated based on data from a single-arm trial design. However, single-arm trials do not have an internal comparator to enable understanding of study results and overall patient impact. External comparators derived from real-world data can help to address this evidence gap, augmenting submissions to regulators and payers, and enabling better value articulation for healthcare stakeholders.

Chair

IQVIA


Speakers
avatar for IQVIA

IQVIA

IQVIA
avatar for Christina Mack

Christina Mack

VP, Epidemiology, IQVIA
Dr. Mack is Sr. Director of Epidemiology and Clinical Evidence and Head of the Surveillance and Analytics team at IQVIA, where she oversees development of large evidence platforms and novel studies that augment primary data collection with existing data. She also holds an academic... Read More →
TW

Tawana Wester

Director, Clinical Development, Bioventus


Monday June 24, 2019 12:15pm - 12:45pm
Theater 1 Exhibit Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

12:15pm

#124 IT: Parexel Innovation Theater: Transforming the Drug Development Journey Through the Patient’s Eyes
Component Type: Session

Since the 2018 DIA where PAREXEL launched The Innovation Imperative: The Future of Drug Development, research conducted by the Economist Intelligence Unit and commissioned by PAREXEL, we have convened global roundtables with key industry influencers on how to enable innovation to transform the drug development journey. We now want to share the insights gleaned and explain how leveraging multi-stakeholder input – and multiple innovations working together – can ultimately benefit the patient.

Chair

Parexel


Speakers
avatar for Alberto Grignolo

Alberto Grignolo

Corporate Vice President, Parexel
Alberto Grignolo, PhD is a Corporate Vice President at Parexel, and established the firm's Japan Consulting Services during a two-year assignment in Tokyo. Dr. Grignolo has served as an adviser on human subject protection in clinical trials to the Institute of Medicine of the National... Read More →
avatar for Sy Pretorius

Sy Pretorius

Executive Vice President, Chief Medical & Scientific Officer, PAREXEL
Sy has been with PAREXEL 20+ years, closely collaborating with global clients to design and optimize drug/device development strategies and plans, as well as find, evaluate & purchase assets. As a member of PAREXEL’s executive leadership team, Sy is responsible for overall leadership... Read More →


Monday June 24, 2019 12:15pm - 12:45pm
Theater 2 Exhibit Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

1:00pm

#127 IT: Veeva Systems Innovation Theater: Annual Industry Report: Trends, Insights, and Strategies to Improve Study Execution
Component Type: Session

Hear new results from the Veeva 2019 Unified Clinical Operations survey. By gathering the experiences and opinions of more than 350 clinical operations professionals from around the globe, the goal of the annual research is to understand the challenges and advances in today’s clinical operating model. Topics include the industry’s progress towards streamlining clinical systems and processes, improving collaboration, and reducing complexity to improve trial performance.

Chair

Veeva Systems, Inc.


Speakers
avatar for Veeva Systems, Inc.

Veeva Systems, Inc.

NA
Veeva Systems Inc. is a leader in cloud-based software for the global life sciences industry. From compliant promotional content management to best-in-class multichannel marketing, Veeva provides innovative marketing solutions to more than 200 pharmaceutical and biotech companies... Read More →
avatar for Jim Reilly

Jim Reilly

VP, Vault Clinical, Veeva Systems Inc.
Jim Reilly is a Director of Product Strategy at Veeva Systems, where he is responsible for defining the market approach for the Vault Regulatory suite of products. For the last 15 years, he has held a variety of senior positions in Regulatory publishing, software delivery, consulting... Read More →


Monday June 24, 2019 1:00pm - 1:30pm
Theater 1 Exhibit Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

1:00pm

#128 IT: WIRB-Copernicus Group Innovation Theater: Getting the Most Out of Your Site Selection Strategy
Component Type: Session

When it comes to site selection, the decisions made will have the largest impact on the study timelines. In fact, the combination of utilizing predictive data, performance analytics, and creating meaningful relationships with sites are the perfect ingredients for timely startup and ultimate success. In this 30min. presentation, we will discuss moving your site selection strategy from a transactional approach to a portfolio-level approach to help accelerate enrollment timelines by 30%.

Chair

WIRB-Copernicus Group


Speakers
SC

Suzanne Caruso

Vice President, Clinical Solutions, WCG


Monday June 24, 2019 1:00pm - 1:30pm
Theater 2 Exhibit Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

1:45pm

#133 IT: Cognizant Innovation Theater: Shared Investigator Platform: Innovating Clinical Trials Feasibility and Study Start Up
Component Type: Session

The Shared Investigator Platform (SIP), the industry's only open clinical ecosystem, is changing the way that sites and sponsors interact with each other across the clinical trials life cycle. Learn how clinical trials feasibility and study start up are being managed more efficiently, reducing administrative burden and accelerating cycle times.

Chair

Cognizant


Speakers
avatar for Cognizant

Cognizant

Cognizant Technology Solutions Corporation
Cognizant partners with companies to develop strategies and apply solutions to healthcare challenges. Products such as Cognizant Protocol Creator and Shared Investigator Platform are digitizing interactions between sponsors, investigators, CROs, patients, and regulators across every... Read More →
avatar for Larissa Comis

Larissa Comis

Shared Investigator Platform, Product Lead, Cognizant
Larissa Comis is Cognizant’s Product Leader for the Shared Investigator Platform. She works closely with sponsors, investigators, CROs, and technology partners to drive adoption across the clinical ecosystem. Larissa has extensive experience in clinical trial informatics and technology... Read More →


Monday June 24, 2019 1:45pm - 2:15pm
Theater 1 Exhibit Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

1:45pm

#134 IT: SAS Institute Inc Innovation Theater: Smarter Clinical Trial Enrollment with Real World Data and Simulation Analytics
Component Type: Session

Real world data is transforming the way therapies are discovered, developed and delivered to market. In this fast-paced symposium, learn about how real world data can help inform smarter clinical trial enrollment. Real world data gives you richer, more accurate data on the patients involved to make your enrollment simulations more accurate and therefore more valuable. From there, discrete event simulation can be used to identify the optimal enrollment plan.

Chair

SAS Institute Inc.


Speakers
JB

Jim Box

Principal Pre-Sales Solutions Architect, SAS Institute Inc
avatar for Sherrine Eid

Sherrine Eid

Principal Industry Consultant, SAS Institute Inc
Sherrine Eid is an Industry Consultant with Health and Life Sciences at SAS. She has over 20 years of experience in Real-World Evidence, Epidemiology and Biostatistics. Previous positions include both private sector and public service roles, including work for USAID, CDC, the City... Read More →
avatar for SAS Institute Inc.

SAS Institute Inc.

SAS Institute Inc


Monday June 24, 2019 1:45pm - 2:15pm
Theater 2 Exhibit Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

4:45pm

#173 IT: Appian Innovation Theater: Accelerating the Regulatory Information Management Journey with Intelligent Automation
Component Type: Session

In this session we will cover: -Overview of key Life Sciences trends and the drivers for innovation. -How to realize a new innovative approach to Regulatory Information Management. -Leveraging intelligent automation, with Business Process Management (BPM), to accelerate product development and commercialization life cycle. -The vision for world-class regulatory information further leveraging approaches such as BPM.

Chair

Appian


Speakers
avatar for Evi Cohen

Evi Cohen

Vice President, Global Life Sciences and Healthcare, Appian
Evi is an experienced pharmaceutical executive with extensive background in developing global business portfolios with emphasis on new products, technologies, and IP. He is a skilled innovation management professional with experience managing global business process transformations... Read More →
RM

Rohit Malhotra

GSRS Quality & Operations - Head of Submission Sciences, Biogen


Monday June 24, 2019 4:45pm - 5:15pm
Theater 1 Exhibit Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

4:45pm

#174 IT: Deloitte Consulting Innovation Theater: Reimagining Patient Safety
Component Type: Session

Innovation is a term that has been thrown around in Pharmacovigilance for years associated with a promise to change the entire PV paradigm, reduce costs, and optimize patient safety outcomes. No longer a distant concept, cognitive automation and a consolidated data repository are now strategic initiatives leveraged by firms globally. These advanced strategies could allow regulators and sponsors to leverage new tools to improve identification of important safety signals and generate more meaningful health care insights. So, what does this actually mean? What are the benefits? What are the risks? And where do we start? Hear from Deloitte as we provide a perspective on how patient safety is being reimagined through the cooperation and lessons learned of industry, regulators, investigators, HCPs, and patients.

Chair

Deloitte Consulting


Speakers
avatar for Amanda Bowles

Amanda Bowles

Life Sciences Specialist Leader, Deloitte
Amanda has over 14 years of life sciences experience including over 11 years specializing as a pharmacovigilance and drug safety subject matter advisor. Her experience spans drug safety and regulatory affairs, including extensive experience in PV operations strategy consulting, global... Read More →
avatar for Glenn Carroll

Glenn Carroll

Principal, Life Sciences Strategy, Deloitte
Glenn is a Principal in Deloitte’s Life Science practice with over 15 years of Pharmaceutical and Biotechnology consulting experience delivery strategic and operating model engagements. He has significant consulting experience in Compliance, R&D, Medical Affairs and Pharmacovigilance... Read More →


Monday June 24, 2019 4:45pm - 5:15pm
Theater 2 Exhibit Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

5:30pm

#176 IT: Statistics & Data Corporation Innovation Theater: Artificial Intelligence and Machine Learning: Innovations in Clinical Trial Data Automation
Component Type: Session

With a focus toward achieving faster time to market, reducing R&D costs, and increasing clinical trial success rates, Artificial Intelligence (AI) and Machine Learning (ML) capabilities are quickly becoming the next frontier in clinical research. In this presentation, SDC will share an overview of AI/ML applications in clinical trials, a case study featuring AI/ML deployment in clinical data services, and several lessons learned to help you integrate AI/ML capabilities in your clinical trials.

Chair

Statistics & Data Corporation


Speakers
avatar for Richard Abelson

Richard Abelson

President & CEO, SDC
avatar for Dale Usner

Dale Usner

CSO & Sr. VP, Strategic Scientific Consulting, SDC
Dale Usner is the VP of Biostatistics & Data Management at SDC, joining in September 2011. Prior to his position with SDC, he worked at AVI and ZymoGenetics as the head of statistics and data management, at Bausch & Lomb as the global head of statistics and data management, and at... Read More →
avatar for Statistics & Data Corporation

Statistics & Data Corporation

Statistics & Data Corporation


Monday June 24, 2019 5:30pm - 6:00pm
Theater 1 Exhibit Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

5:30pm

#177 IT: Syneos Health Innovation Theater: Dialing In the Optimal FSP Solution
Component Type: Session

The functional service provider (FSP) model has evolved beyond traditional approaches to accommodate a wide spectrum of needs within the pharma, biotech and medical device sectors. The FSP approach, in any iteration, delivers cost savings and time efficiencies while freeing sponsor resources to advance other product development goals. This presentation will describe the latest FSP models and their benefits in more detail.

Chair

Syneos Health


Speakers
avatar for Eleanore Doyle

Eleanore Doyle

Executive Vice President, FSP Strategic Solutions, Syneos Health
Eleanore Doyle, Executive Vice President, FSP Strategic Solutions at Syneos Health, is responsible for building and maintaining long-term relationships with sponsors, ensuring exceptional customer service, and increasing market reputation. With more than two decades of functional... Read More →
avatar for Shaun Williams

Shaun Williams

Vice President, Investigator Management Solutions, Syneos Health


Monday June 24, 2019 5:30pm - 6:00pm
Theater 2 Exhibit Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
 
Tuesday, June 25
 

9:45am

#225 IT: DiagnoSearch Life Sciences Innovation Theater: Disruptive Innovation: ‘Wide-Angle-Data’ – Fully Integrated Platform with Advanced Analytics and Customized Algorithms for Real Time Safety and Risk Management
Component Type: Session

Conventional approach to risk management and patient safety is often fraught with review delays which can lead to reduced regulatory compliance. Fully integrated data sciences platform (W-A-D) with intuitive customized algorithms, smart data reduction, advanced analytics & visualization facilitates real-time ‘signal detection & adjudication’ and comprehensive risk management while ensuring review efficiency. 'Operational & predictive analytics' and machine learning give full control over data.

Chair

DiagnoSearch Life Sciences


Speakers
avatar for Vasudeo Ginde

Vasudeo Ginde

President & Managing Director, DiagnoSearch Life Sciences
A physician by training, Dr. Vasudeo Ginde is an eminent clinical research thought leader in India. After playing a pivotal role in setting up Eli Lilly’s Indian clinical research infrastructure in early 1990s, he co-founded the full-service CRO DiagnoSearch in 1995 & currently... Read More →


Tuesday June 25, 2019 9:45am - 10:15am
Theater 1 Exhibit Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

9:45am

#226 IT: Covance Innovation Theater: Fixing the Patient Recruitment "Leaky Funnel"
Component Type: Session

Patient recruitment has long been considered the primary pain point in clinical trials. We lose potential patients in 4 key stages: pre-screen failures, consent declines, screen failures and post randomization drop-outs. To increase efficiencies and stop the "leaky" patient recruitment funnel, we need to address these challenges with a new approach. In this presentation, we will share how Covance leverages its proprietary data sources and assets to "seal" the leaks to produce better outcomes.

Chair

Covance Inc.


Speakers
avatar for Covance Inc.

Covance Inc.

Covance Inc.
avatar for Michelle Jones

Michelle Jones

Senior Director, Data and Technology Organization, Covance
Michelle has more than 30 years of experience in pharmaceutical research and development. She currently leads Covance’s global Clinical Informatics group, which uses the latest methods and creates new ones to statistically and computationally analyze and model Real World Data and... Read More →
avatar for Kate Reese

Kate Reese

Executive Director, Site and Patient Centricity, Covance
Kate has spent more than 20 years in the Pharmaceutical Industry and has broad experience in Project management and Clinical Operations, including several years in project feasibility strategy, within the CRO, Pharmaceutical, and Device company arenas. Throughout her career she has... Read More →
avatar for Kate Reese

Kate Reese

Clinical Research Pharmacist in Charge, Celerion
Kate has spent more than 20 years in the Pharmaceutical Industry and has broad experience in Project management and Clinical Operations, including several years in project feasibility strategy, within the CRO, Pharmaceutical, and Device company arenas. Throughout her career she has... Read More →


Tuesday June 25, 2019 9:45am - 10:15am
Theater 2 Exhibit Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

11:40am

#248 IT: Veeva Systems Innovation Theater: Shortening Database Builds by 40-60%
Component Type: Session

Radical time savings aren’t possible with incremental process improvements. However, inefficient processes for database builds are often the byproduct of EDC limitations. An agile EDC enables process transformation that shortens the database build process by 40-60%. Veeva describes the technology-enabled process changes that produce those savings, including spec-less design, risk-based UAT, and a live UAT roundtable.

Chair

Veeva Systems, Inc.


Speakers
HC

Hugo Cervantes

VP, Vault CDMS, Veeva Systems Inc.
DC

Dan Crawford

Senior Director, Vault CDMS Strategy, Veeva Systems Inc.


Tuesday June 25, 2019 11:40am - 12:25pm
Theater 1 Exhibit Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

11:40am

#249 IT: ArisGlobal Innovation Theater: Getting More Value From Your Data Through A Unified Regulatory Platform
Component Type: Session

As the industry moves toward unified regulatory platforms, an important aspect which cannot be overlooked is the data in such systems. In this session, ArisGlobal will highlight use cases where automation can be used to improve business processes to enhance data quality in your unified solution.
In addition, we will explore how a unified platform can reach beyond regulatory, and how the platform and data can be used to add value across the entire organization.

Chair

ArisGlobal, LLC


Speakers
avatar for Wim Cypers

Wim Cypers

SVP Regulatory, ArisGlobal
Wim Cypers has been with ArisGlobal for 23 years. In his current role, he heads all business unit operations for our regulatory domain, including overall product vision, strategy, implementation, and success of ArisGlobal’s Regulatory Solution Suite. Wim has long standing experience... Read More →


Tuesday June 25, 2019 11:40am - 12:25pm
Theater 2 Exhibit Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

12:40pm

#251 IT: AMPLEXOR Innovation Theater: The Great Regulatory Catch-up: Lessons From Big Pharma as Medical Device Manufacturers Succumb to New Reporting Rigor
Component Type: Session

Medical device manufacturers rarely like to be compared to their life sciences industry cousins in pharmaceuticals. Yet they could learn a thing or two from the sector which, for the last 14 years, has been subject to the sorts of rigorous electronic reporting standards device producers will now be subjected to. Today, the 2 affiliated industries have a great deal more in common than they realise, and to ignore the parallels and start from scratch with MDR and other standards now being imposed by international authorities, will double the work companies face. AMPLEXOR’s David Gwyn charts the similarities and distils some takeaway best practices.

Chair

AMPLEXOR


Speakers
avatar for David Gwyn

David Gwyn

Global Solutions Architect, AMPLEXOR Life Sciences
With more than 25 years of experience in the Life Sciences industry, David Gwyn is a seasoned executive with extensive experience delivering solutions to clients, with a particular focus in the areas of content management and collaboration. As a global solution architect for AMPLEXOR... Read More →


Tuesday June 25, 2019 12:40pm - 1:25pm
Theater 1 Exhibit Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

12:40pm

#252 IT: Bioclinica Innovation Theater: When EDC is not Enough: Automating Multi-Country Data Collection and Complex Workflows
Component Type: Session

Have multi-step data processing/review despite EDC?
Hear how innovation lets you:
  • Automate multi-country data collection and complex workflows;
  • Comply with privacy regulations;
  • Auto-manage multi-country data routing pathways for patient eligibility, endpoint adjudication, independent data review, and treatment planning- while eliminating errors and transparency issues that can lead to violations and invalidation.
See case studies on cloud-based applications and AI-enabled data screening.


Chair

Bioclinica


Speakers
avatar for Janine  Jones

Janine Jones

Clinical Solutions Specialist, BioClinica
Janine Jones, a registered nurse by training, works as a Clinical Solutions Specialist at Bioclinica. There she performs product demonstrations, is a subject matter expert in endpoint adjudication, and serves on the adjudication services team. She brings her adjudication expertise... Read More →


Tuesday June 25, 2019 12:40pm - 1:25pm
Theater 2 Exhibit Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

1:40pm

#253 IT: UBC Innovation Theater: Standardizing and Enhancing Registry Data to Improve Evidence Generation
Component Type: Session

UBC will show the value of standardizing diverse registry data into a common structure to assemble real-world evidence to complement ad hoc observational research. This HIPAA-compliant ‘universal-registry’ approach efficiently improves evidence generation to enable better insight into disease natural history and treatment patterns, particularly for rare diseases. Data linkage through HealthVerity’s tokenization process to enhance registry data with other healthcare information will be included.

Chair

UBC


Speakers
U

UBC

United BioSource Corporation
avatar for Irene Cosmatos

Irene Cosmatos

Senior Research Specialist, Database Analytics Automation, UBC
Ms. Cosmatos is an experienced epidemiology database analyst who supports product training & development within UBC’s Database Analytics Automation team. Irene leads UBC’s retrospective database analytic service activities, which include conducting global database feasibility... Read More →
avatar for Andrew Kress

Andrew Kress

Chief Executive Officer, HealthVerity, Inc.
Andrew is the CEO of HealthVerity, a company that operates a healthcare data marketplace using novel technologies to connect data at the patient level from a broad set of external data partners. Previously, he was SVP, Healthcare Value Solutions for IMS Health, responsible for real... Read More →
avatar for Annette Stemhagen

Annette Stemhagen

SVP & Chief Scientific Officer, UBC
Dr. Annette Stemhagen is an epidemiologist with more than 30 years of public health research experience, including 20 years in safety surveillance of pharmaceutical, biotechnology, and vaccine products. She is the SVP of Safety, Epidemiology, Registries and Risk Management within... Read More →


Tuesday June 25, 2019 1:40pm - 2:00pm
Theater 1 Exhibit Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

1:40pm

#254 IT: IBM Watson Health Innovation Theater: Real World Insights and Collaboration in Protocol Development
Component Type: Session

IBM Watson Health will discuss trends in the application of real world data in clinical development and review the opportunity to introduce real world insights earlier in clinical trial design.

Chair

IBM Watson Health


Speakers
avatar for Robert DiCicco

Robert DiCicco

Deputy Chief Health Officer, IBM Watson Health
Rob DiCicco is a Deputy Chief Health Officer for IBM Watson Health where he focuses on Life Sciences. Rob joined IBM in 2018 after a long career in Pharmaceutical R&D spanning nearly 30 years. His area of expertise includes clinical pharmacology and experimental medicine, clinical... Read More →


Tuesday June 25, 2019 1:40pm - 2:00pm
Theater 2 Exhibit Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

3:30pm

#279 IT: PPD Innovation Theater: Have you Considered Market Access in Your Trial Design
Component Type: Session



Chair

PPD, Inc.


Speakers

Tuesday June 25, 2019 3:30pm - 4:00pm
Theater 1 Exhibit Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

3:30pm

#280 IT: Parexel and Microsoft Innovation Theater: Change The Way You Work: Transforming Regulatory Processes with Parexel and Microsoft
Component Type: Session

Parexel and Microsoft are looking at the human factors of Regulatory processes and designing solutions to help optimize patient, clinical, and regulatory workflows. Through system automation, machine learning, and “smart” templates, we are bringing exciting productivity innovations for the users of Parexel’s InSight® Regulatory Information Management solution. Along with our special guest customer, we will be discussing the latest integrations of InSight with Microsoft’s Office 365®.

Chair

Parexel


Speakers
avatar for Daniel Carchedi

Daniel Carchedi

Director of Business Development and Strategy, Microsoft Health & Life Sciences
Daniel leads the development & implementation of strategic plans for new product/partner offerings in Life Sciences. He was a founding member & Director of Business Development & Strategy for Microsoft Genomics and led a cross vertical (Payer, Provider, Health and Life Sciences, HHS... Read More →
CL

Chris Lee

Vice President, Global Regulatory Affairs Operations and Quality Management, Merck & Co., Inc.
avatar for Matt Neal

Matt Neal

Senior Director, Product Management, Parexel
Matt Neal joined PAREXEL in 2016 as the Senior Director of Product Management for Regulatory Solutions. Before joining PAREXEL, Matt was a Director of Regulatory & Safety Operations at Amgen, Inc. (2003-2016) and prior to that he was one of the pioneering members of the Regulatory... Read More →


Tuesday June 25, 2019 3:30pm - 4:00pm
Theater 2 Exhibit Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
 
Wednesday, June 26
 

9:45am

#324 IT: Salesforce Innovation Theater: Digital R&D: Accelerating intelligent innovation with IQVIA’s Orchestrated Clinical Trials Platform, powered by Salesforce Health Cloud
Component Type: Session

Life science companies must accelerate R&D timelines and carefully manage resources to stay competitive amidst pricing pressures, patent expirations, and the new era of personalized medicine. Learn how IQVIA is leveraging the Salesforce Customer Success Platform to deliver innovative clinical, compliance, and safety applications while ensuring collaboration, transparency, intelligence, and integration, all backed up by the World’s #1 Most Trusted Enterprise Cloud.

Chair

Salesforce


Speakers
avatar for MaryAnne Rizk

MaryAnne Rizk

SVP, Digital R&D Strategy, IQVIA
Dr. Rizk has been a rising global digital technology lifescience executive for the past 20+ years, transforming the way the biopharmaceutical industry manages digital health to improve patient outcomes. Effective in building enterprise alliance programs, She has forged clinical outsourcing... Read More →
avatar for Michael Schwartz

Michael Schwartz

Senior Director, Industry Go To Market, Salesforce
Michael Schwartz is Senior Director, Life Sciences at Salesforce. As part of the Healthcare and Life Sciences team, Michael works to bring customer success to biopharmaceutical, medical device, and diagnostic companies. He brings 15 years of industry experience ranging from product... Read More →


Wednesday June 26, 2019 9:45am - 10:15am
Theater 1 Exhibit Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

9:45am

#325 IT: SAS Institute Inc JMP Innovation Theater: Semi-automation of the Narrative Section of the Clinical Study Report for Oncology Studies
Component Type: Session

The quantity and complexity of the study data associated with oncology adverse event narratives puts a high burden on the writer to be accurate, consistent and discerning as to which information to include for these individuals. Fortunately, software now allows the medical writer to choose from a variety of options as to which content to present as well as how the grammar for each adverse event is written within the paragraphs and tabulated data belonging to each participant.

Chair

SAS Institute Inc. JMP Division


Speakers
avatar for SAS Institute Inc. JMP Division

SAS Institute Inc. JMP Division

JMP, A Business Unit of SAS
avatar for Geoff Mann

Geoff Mann

JMP Life Sciences Principal Product Manager, SAS Institute Inc., JMP Division
Geoffrey Mann is JMP Product Manager for the health & life sciences industry. In this role, he explores needs for visual & statistical discovery software in the clinical segment of the pharmaceutical & healthcare industries. After joining SAS in 2000, he helped develop software for... Read More →


Wednesday June 26, 2019 9:45am - 10:15am
Theater 2 Exhibit Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

11:40am

#346 IT: IQVIA Innovation Theater: Clinical Development Innovation Through the Lens of Data Science
Component Type: Session

Data science is transforming both the approach to and execution of clinical development. But the amounts of clinical data require time and resources to manage and gain meaningful insights. Data-as-a-Service is an emerging capability that provides fast access to highly curated data, and the methodologies to use and interpret it. Explore how data science is powering better approaches to help sponsors make more informed decisions, reach milestones faster, and deliver treatments to patients.

Chair

IQVIA


Speakers
avatar for IQVIA

IQVIA

IQVIA
avatar for Luke Dunlap

Luke Dunlap

Senior Principal, IQVIA
Luke Dunlap is the head of IQVIA’s Data Science Cloud and leads organizational programs that provide highly curated global healthcare data to data scientists through one of the largest private data clouds in the world. Luke has 20 years of experience in Life Science and R&D technology... Read More →
avatar for Cynthia Verst

Cynthia Verst

President, R&D Solutions Development & Design Innovation, IQVIA
Cynthia L. Verst, PharmD, MS, is President of Design and Delivery Innovation for Research and Development Solutions at IQVIA, responsible for accelerating growth through innovative solutions powered by rich data assets, advanced predictive analytics, integrated technology capabilities... Read More →


Wednesday June 26, 2019 11:40am - 12:25pm
Theater 1 Exhibit Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

11:40am

#347 IT: ZS Innovation Theater: Designing With Confidence
Component Type: Session

What if we had more confidence in our clinical trials and more control over a trial’s success? Through a dynamic Design Center—a suite of tools that help design a better clinical protocol and accelerate timelines—companies can better understand feasibility, site selection, patient burden analysis and other important aspects of clinical programs such as overall strategy and costs. In this session, we will share how companies are evolving their approach to clinical trials in a profound way.

Chair

ZS


Speakers
avatar for Venkat Sethuraman

Venkat Sethuraman

Associate Principal, ZS Associates
Venkat Sethuraman is the global clinical lead within ZS's R&D excellence practice. Venkat has nearly 20 years of experience in R&D drug development life cycle with deep expertise in biostatistics, clinical trial design strategy, clinical trial optimization and regulatory approval... Read More →
avatar for ZS

ZS

NA
ZS is the world’s largest firm focused exclusively on helping companies improve overall performance and grow revenue and market share through end-to-end solutions—from customer insights and strategy, to analytics, to operations and technology. More than 5,000 ZS professionals... Read More →
avatar for Qin Ye

Qin Ye

Associate Principal, ZS Associates
As head of Global Real World Evidence at ZS, Qin leads the development of our RWE team, oversees the product development of our RWE technology and delivery of advanced real world analytics services. He works directly with clients on RWE programs across clinical, HEOR, medical, and... Read More →


Wednesday June 26, 2019 11:40am - 12:25pm
Theater 2 Exhibit Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

12:40pm

#350 IT: IQVIA Innovation Theater: The Digital Patient Experience
Component Type: Session

The world of clinical development has changed. IQVIA Orchestrated Clinical Trials is a more strategic, technology-driven clinical development innovation that drives healthcare forward by powering clinical trials from the patient’s perspective. Real-world examples will highlight how OCT automates study processes by connecting previously siloed applications for a seamless trial management experience for the sponsor, while supporting improved patient engagement & retention, and better outcomes.

Chair

IQVIA


Speakers
avatar for IQVIA

IQVIA

IQVIA
avatar for MaryAnne Rizk

MaryAnne Rizk

SVP, Digital R&D Strategy, IQVIA
Dr. Rizk has been a rising global digital technology lifescience executive for the past 20+ years, transforming the way the biopharmaceutical industry manages digital health to improve patient outcomes. Effective in building enterprise alliance programs, She has forged clinical outsourcing... Read More →
avatar for Josh Rose

Josh Rose

Vice President, Global Head of Strategy, IQVIA
As Vice President and Global Head of Strategy for the R&D Solutions business unit at IQVIA, Josh Rose is responsible for building the overarching strategy for the clinical development business, establishing and governing strategic initiatives, and leading the identification of acquisition... Read More →
avatar for Josh Rose

Josh Rose

VP, Strategic Planning, IQVIA
As Vice President and Global Head of Strategy for the R&D Solutions business unit at IQVIA, Josh Rose is responsible for building the overarching strategy for the clinical development business, establishing and governing strategic initiatives, and leading the identification of acquisition... Read More →


Wednesday June 26, 2019 12:40pm - 1:25pm
Theater 1 Exhibit Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

12:40pm

#350.1 IT: Oracle Health Sciences Innovation Theater: The AI Revolution in Multivigilance
Component Type: Session

As the resources needed to develop new drugs, medical devices, vaccines and combination products skyrockets, and ensuring patient safety remains critical, managing the complex responsibility of multivigilance has become a crucial challenge. Additionally safety caseloads continue to increase while safety budgets remain flat. Learn how AI can help optimize safety caseload management, processing safety workflows more quickly and cheaply, freeing clinical teams to focus on more important activities.

Chair

Oracle Health Sciences


Speakers
BP

Bruce Palsulich

Global Vice President of Product Strategy, Oracle
avatar for Oracle Health Sciences

Oracle Health Sciences

Oracle Systems Corporation


Wednesday June 26, 2019 12:40pm - 1:25pm
Theater 2 Exhibit Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

1:40pm

#353.1 IT: Tata Consultancy Services: Enabling Perpetual Digital Transformation in Research & Development
Component Type: Session



Chair

Tata Consultancy Services



Wednesday June 26, 2019 1:40pm - 2:00pm
Theater 1 Exhibit Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

1:40pm

#354 IT: PRA Health Sciences Innovation Theater: The Importance and Impact of Age Specific Content in Pediatric Studies
Component Type: Session

PRA Health Sciences and Jumo Health embarked on an ambitious effort to ensure all pediatric studies are designed with children in mind from the beginning of the study design. PRA's Center for Pediatric and Vaccine Clinical Development (CPCVD) is the focal point and repository for PRA’s global pediatrics knowledge. We understand development of treatments for the pediatric population is complex and requires a multi-faceted approach to address the inherent challenges of conducting clinical trials in children. Jumo Health develops age¬ appropriate, educational resources for patients and caregivers for use throughout their medical journey. With the belief that an informed patient is a capable patient, Jumo Health designs its solutions for outcomes. Studies may require many years of follow-up that may continue from infancy to adulthood. This timeline presents issues of evolving assent; providing progressively more complex information to patients and caregivers; the transition to adulthood and consent; and the challenges of ensuring data privacy. The CPVCD has expertise with each of these complexities. With experience in more than 50 countries, covering more than 200 topics, Jumo’s mixed media solutions range from comic books to animated and live action videos, activity and appreciation items, and much more. During this session PRA’s Center for Pediatric and Vaccine Clinical Development and Jumo Health will highlight how focused and age specific recruitment and retention tools have an impact on results.

Chair

PRA Health Sciences


Speakers
CH

Chris Heimerle

Executive Director, Jumo Health
Chris is Area Vice President of Strategic Solutions for Jumo Health and manages a portfolio of pediatric clinical trials that span over 30 countries around the world. Chris has over 20 years of experience working in the pharma/biotech industry. Chris holds a degree in Communication... Read More →
MS

Mark Sorrentino

VP, Center for Pediatrics, PRA Health Sciences
Dr Sorrentino has 20 years of experience in the pharmaceutical and biotech industries doing pediatric drug development. Having earned his medical and master's degrees in clinical nutrition from the Chicago Medical School, Dr Sorrentino completed a residency in pediatrics and a fellowship... Read More →


Wednesday June 26, 2019 1:40pm - 2:00pm
Theater 2 Exhibit Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA