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Oracle Health Sciences Connect—India, Australia, and South East Asia

April 26, 2022


Why attend Oracle Health Sciences Connect?

With programs specifically developed for Oracle’s regional customer communities, this multifaceted event provides compelling sessions led by Oracle customers and industry thought leaders.

Meet with your peers and gain perspective on industry trends from leading experts on artificial intelligence, cloud-based research, innovative study-site selection/activation/analytics, and additional advances that are transforming and streamlining clinical development.

Agenda

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Keynote fireside chat - Embrace the future: innovation at the speed of science

The ongoing pandemic has resulted in the compression of often decades-long digital transformation roadmaps in the way clinical trials are planned and conducted. This immediate impact is now being overshadowed by the opportunities it presents to reimagine and reinvigorate studies. Drug development models and processes, artificial intelligence/machine learning, drug safety, decentralized trials, and direct-to-patient services are only some of the options being investigated and deployed.

The stage is set for those who can accelerate their digital transformation roadmaps and embrace innovative approaches to overcome adversity. Reaping significant benefits now – and in the future.

  • Moderator-Henry McNamara

    Senior Vice President and General Manager, Oracle Health Sciences

  • Maimah Karmo

    Founder and CEO, Tigerlily Foundation

  • Patricia Leuchten

    Founder and CEO, WCG Avoca and Chief Change Officer WCG

  • Craig Lipset

    Co-Chair, DTRA (Decentralized Trials and Research Alliance)

  • Casey Orvin

    Chief Commercial Officer, CenExel Centers of Excellence and Former President of SCRS (Society of Clinical Research Sites)

  • Pamela Tenaerts

    Chief Scientific Officer, Medable

  • Susan Winckler

    CEO, Reagan-Udall Foundation for the FDA

Future of clinical research in the post pandemic world

In this keynote presentation we will discuss the post pandemic future of clinical trials and how patient safety, recruiting new participants into trials, and data collection and management are changing.

How to maximize data-driven decisions and GxP compliance with Oracle Health Sciences applications

With increased adoption of next generation SaaS based technology, Oracle’s Clinical One and Safety One applications are gaining significant traction across Clinical R&D organizations, as well as CROs. In this session, Techsol, an Oracle Strategic Partner, will present best practices and examples for how your enterprise can optimize the operational efficiency of your drug safety and clinical trial processes, while ensuring regulatory compliance and mitigating regulatory risks.

  • Sriram Varma

    Vice President of Operations, Techsol Corporation

Digital clinical trials - prepare for the future of clinical trials

In this panel discussion we will discuss:

  • Hybrid and decentralized clinical trials
  • The benefits and challenges of decentralized trials
  • What the future holds for decentralized trials
  • Ways to optimize new clinical trial technologies

Integrating sensor generated data to power clinical research and patient care

The use and reuse of reliable data to make better and faster decisions across drug development and care delivery will require an understanding of all stakeholder needs and the implementation of best practices to ensure that these needs are met. Learn how the Digital Medicine Society launched a new multi stakeholder Sensor Data Integration Tour of Duty to address these challenges and provide a clear direction on how sensor data can fulfill its potential to enhance patient lives.

Innovations in Safety

In this presentation, we will focus on recent innovations across the Oracle safety portfolio, including Argus, Empirica, and Safety One Intake, and how all of these innovations are building toward a unified safety platform.

State of AI in safety

In this presentation, we will discuss where artificial intelligence (AI) is making an impact in safety, how those impacts are deployed, and what our next priorities will be for AI.

Future of Monitoring

In this panel we will discuss:

  • Changes in monitoring that customers have seen over the past 18 months
  • How experience with increased remote monitoring will impact the approach to monitoring in the future
  • How the advent of greater digital data collection will affect monitoring
  • How CRAs can interact more effectively with sites for monitoring and managing protocol deviations
  • What would most assist CRAs in conduct of monitoring as next generation CTMS systems are designed

RWD - beyond the trials

In this presentation, we will discuss how the 2+ year old industry consortium Project Vulcan is using EHR data sources and the HL7 FHIR Standard to develop novel approaches to using EHRs data sources to get new, safe therapies to patients faster.

  • Jeyaseelan Jeyaraj

    Senior Director, Solutions Consulting, Asia Pacific, Oracle Health Sciences

Unified analytics with Oracle Analytics Cloud (OAC)

In this presentation, we will explore doing away with traditional siloed analysis views of data sources. Learn about the delivery of unified clinical & safety analytics based on the real-time data flows from all systems providing data sources for each study and modern technologies such as Oracle Analytics Cloud (OAC).

Clinical Closing Summary

Safety in the post pandemic world

In this panel we will discuss:

  • Safety changes in the post pandemic world
  • Regulator response to the change
  • The possible uptake of vaccine AE reporting (AEFI)
  • Why countries like India still has very low AE cases reported
  • The presence of an efficient mechanism for patient self-reporting of AE
  • The role of technology (NLP/AI) in PV innovation

COVID-19 signalling research

In this presentation, we will discuss the outcome of the research work in analysing COVID-19 VAERS data for signals of interest, and how masking and different algorithms where considered in producing this work.

  • Rob van Manen

    Master Principal Solutions Consultant, Oracle Health Sciences

Elevating Argus Analytics

In this presentation, we will focus on driving a reporting strategy utilizing the next generation of Oracle Analytics with Argus.

  • Mary Ma

    Principal Solutions Consultant, Oracle Health Sciences

Safety Closing Summary

Featured speakers

Maimah Karmo
Maimah Karmo Founder and CEO, Tigerlily Foundation

Maimah Karmo is the Founder and CEO of the Tigerlily Foundation (Tigerlily) and a fifteen-year survivor of breast cancer. On February 28, 2006, at 4:45 p.m., Maimah was diagnosed with Stage 2 breast cancer. She had no family history and was 32-years old. While undergoing her second round of chemotherapy, she made a promise to God that if she survived, she would create an organization to educate, empower, advocate for, and support young women affected by breast cancer. After her second treatment, Tigerlily Foundation was born. Tigerlily provides breast health, educational, empowerment wellness, and transformational programs to young women; and works to end disparities of age, stage, and color.

Visit https://www.tigerlilyfoundation.org to learn about how you can support young women – before, during and after breast cancer, and collaborate to end disparities of age, stage and color. You can find Maimah on Twitter @maimah, on Instagram @maimah and on Facebook @maimahkarmoofficial.

Patricia Leuchten
Patricia Leuchten Founder and CEO, WCG Avoca; Chief Change Officer, WCG

With more than 30 years of experience in the pharmaceutical industry, Patricia Leuchten is a leading authority on global clinical outsourcing, strategic alliances, and driving change in clinical trial execution through collaboration.

In 1999, she founded The Avoca Group, a consulting and research firm focused on the elevation of quality in clinical trial execution. The Avoca Group has played an important role in the industry as the first consulting firm to track trends in clinical research and clinical outsourcing and to measure the health of relationships between sponsors and CROs. In 2011, Patricia launched the Avoca Quality Consortium a member-based, pre-competitive collaborative comprised of clinical operations, quality, and outsourcing professionals from pharma, biotech, CROs, and clinical service providers. Since its inception, the rapidly growing Avoca Quality Consortium is transforming clinical development by driving efficiency, improving quality, and mitigating risk in clinical trial execution.

Patricia is a frequent speaker and writer on topics surrounding clinical outsourcing, strategic alliances, quality management, and relationship management in the pharmaceutical industry. She has a dual role leading WCG Avoca and serving as Chief Change Officer, supporting WCG’s mission to drive efficiency and quality, at scale, in clinical trial execution.

Craig Lipset
Craig Lipset Co-Chair, DTRA (Decentralized Trials & Research Alliance)

Craig Lipset is an advisor, educator, advocate, and innovator focused on novel solutions for clinical trials and medicine development. He is the Founder of Clinical Innovation Partners, providing advisory and board leadership with pharma, tech, and investors. Craig is Co-Chair for the Decentralized Trials & Research Alliance, Vice Chair of the MedStar Health Research Institute, and Vice President of the Foundation for Sarcoidosis. He is Adjunct Assistant Professor in Health Informatics at Rutgers University.

Craig was previously the Head of Clinical Innovation and Venture Partner at Pfizer, and on the founding management teams for two successful startup ventures.

Henry McNamara
Henry McNamara Senior Vice President and General Manager, Oracle Health Sciences

Responsible for all aspects of the global business, Henry McNamara has dedicated his career to advancing the adoption and positive impact of technology on the Healthcare and Life Sciences industries. Motivated by working with companies dedicated to improving people’s lives, he is credited with driving significant technological progress in the areas of clinical research and patient care.

During his 15-plus years at Oracle, McNamara has expanded the Oracle Health Sciences business and continues to be instrumental in technology transformation in the world’s largest pharmaceutical companies.

Among his many industry contributions, McNamara currently serves on the Board of Directors for the Association of Clinical Research Organizations, a collaborative that fosters efficient, effective, and safe clinical research.

Casey Orvin
Casey Orvin Chief Commercial Officer, CenExel

Casey has a long and exemplary career history in the pharmaceutical research industry. Most recently, serving as President and then as Honorary President of the Society for Clinical Research Sites (SCRS), a global organization representing nearly 10,000 sites in 47 countries. Prior to SCRS, he was on the executive team of several large site management organizations including Radiant and Synexus. With Casey’s guidance, Synexus (now AES) expanded to over 200 sites in 15 countries.

Casey is passionate about representing the site voice within the industry while ensuring every research patient’s journey is a positive one. In 2020, he was recognized in PharmaVoice as one of the 100 Most Inspiring People in the Industry.

Pamela Tenaerts
Pamela Tenaerts Chief Scientific Officer, Medable

Dr. Pamela Tenaerts is on a mission to improve evidence generation in medicine. She believes new models are needed to facilitate and scale the evidence generation system for health by creating re-usable, responsible, and more effective ways to understand and treat diseases. Dr. Tenaerts has over 30 years of experience in clinical trials, as a researcher and academic, in medical device research operations, a hospital-based site administrator, and physician, most recently serving as Executive Director of the Clinical Trials Transformation Initiative (CTTI) at Duke University. She sits on the board of the Society of Clinical Trials, the Scientific Leadership Council of the Digital Medicine Society, participates on the Good Clinical Trial Collaborative, and is a member of the National Academies of Science and Medicine: Forum on drug discovery, development, and translation. She received her MD from the Catholic University in Leuven and her MBA from the University of South Florida.

Susan Winckler
Susan Winckler CEO, Reagan-Udall Foundation for the FDA

Susan C. Winckler, RPh, Esq., is CEO of the Reagan-Udall Foundation for the Food and Drug Administration. The Foundation is the non-profit organization created by Congress to advance the mission of the FDA.

Prior to accepting the Foundation post in May of 2020, Ms. Winckler served as President of Leavitt Partners Solutions. As President and Chief Risk Management Officer for the Leavitt Partners family of businesses, Ms. Winckler advised corporate executives on policy and business matters. As CEO of the Food & Drug Law Institute, she provided attorneys, regulators, industry leaders, and consumers with a neutral forum to address domestic and global issues.

As FDA Chief of Staff from 2007-2009, Ms. Winckler managed the Commissioner’s office; served as his/her senior staff adviser; analyzed policies; and represented FDA before myriad government and external stakeholders. She simultaneously led FDA’s Offices of Legislation, External Relations, Public Affairs, and Executive Secretariat.

As APhA Vice President Policy/Communications and Staff Counsel, she served as the association’s lead spokesperson and senior liaison to Congress, the executive branch, state associations, and allied groups. Ms. Winckler earned a BS from the University of Iowa College of Pharmacy and her JD magna cum laude from Georgetown University Law Center. She is an APhA Fellow, an elected member and Chair of the United States Pharmacopeial Convention (USP) Board of Trustees (2015-2020, 2020-2025), a member of the Purgo Scientific, LLC board, and a member of the Virginia Commonwealth University School of Pharmacy National Advisory Council.

Dr. Kanokwan Pornprasit
Dr. Kanokwan Pornprasit CEO, Clinixir

Dr. Kanokwan Pornprasit is currently CEO of Clinixir, a Thailand-based Contract Research Organization offering end-to-end clinical research services. Dr. Kanokwan received degrees in Medicine specialized in OB&GYN. She also holds degrees in Economics and Finance. She has over 15 years of experience in pharmaceutical industry at country and above country level, in the field of clinical research, regulatory affairs and HEOR. Prior to Clinixir, she was General Manager of IQVIA (Thailand) for 8 years. In her role, Dr. Kanokwan works with clients in both public and private sectors to support commercial and non-commercial projects particularly in the areas of clinical research and real-world evidence.

Matty Culbreth-Notar
Matty Culbreth-Notaro BSN, RN Chief Operating Officer, Obvio Health

Matty Culbreth-Notaro is the Chief Operating Officer at Obvio Health. She has nearly 30 years of experience in clinical research, first as a critical care nurse and later, in leadership roles developing and implementing clinical research programs for multi-therapeutic area practices and hospitals across the country. She has managed advanced research programs specializing in phases I-IV, device, post-approval, interventional and observational trials. Matty has been at the heart of Obvio Health’s development as a pioneering decentralized clinical trial provider since her arrival in 2018. She has worked with the digital development team to ensure clinically sound implementation of fully virtual and hybrid trials and has recruited, trained, and overseen the growth of the company’s clinical operations team, putting in place policies and procedures to ensure the safe and efficient accomplishment of program and sponsor objectives.

Dr. Deepa Chodankar
Dr. Deepa Chodankar Head, GENESIS Unit, Sanofi, India

Dr Deepa Chodankar is heading the GENESIS unit at Sanofi. She has more than 13 years of experience both in healthcare and in pharmaceutical industry, managing both Global and Indian clinical studies. Chair of the Real-World Evidence (RWE) council of the Indian Society of Clinical Research (ISCR) and has worked across therapy areas in different phases of drug development as well as in RWE studies.

Working as a clinical study director for clinical studies, she is involved in development of clinical study protocols and other essential clinical study documents. She is section editor for RWE section of peer reviewed Journal: Perspectives in Clinical Research and has publications in national and international journals. She holds a MBBS degree from Goa Medical College and a masters in public health from Wollongong University, Australia.

Dr. Tapan K. Raval
Dr. Tapan K. Raval Director, Medical Devices Science & Technology, Strategic Solutions, IQVIA

With a background in medicine and clinical research education, Dr. Raval has more than 18 years of experience working in the CRO industry managing centralized cardiac safety operations, data management operations, as well as creating end-to-end solutions for using medical devices as part of the safety and efficacy end points for clinical trials.

Dr. Raval’s current focus is on selection of medical devices fit for purpose for the trial as well as technology integration to capture, harmonize, and produce the required result. In his current role, he works in enabling decentralized clinical trials, through remote data capture.

Nelson Wong
Nelson Wong Founder & CEO, CSI Medical

Nelson Wong is the CEO and co-founder of CSI Medical Research. He has over 20 years of clinical research experience with more than 10 years of his career with a major CRO. Nelson started his clinical research career as a study coordinator at Singapore General Hospital before joining Clinical Research Organization (CRO) as a Clinical Research Associate. During his time at CRO, Nelson had been exposed to many roles that allowed him to cover various regions. Some of his recent assignments are General Manager of Vietnam, Singapore & Malaysia Operations and most recently the Research & Development process excellence lead for SEA. These exposures have enabled him to appreciate the different efficient processes adopted by different countries or sites and share their best practices to his teams. Equipped with such experiences, Nelson has been successful in transforming a small start-up and steering it to a regional provider for clinical development.

Abby Abraham
Abby Abraham Global Head Data Science, India, George Clinical

Abby Abraham is the Head of Global Data Science and a co-chair for the Centre for Innovation at George Clinical. He is a proponent of adopting data and technology to improve the execution and monitoring of clinical research. Abby has multi-faceted experience of 22 years that commenced in clinical monitoring and project management. He went on to handle operational management and strategic initiatives and technology adoption for clinical monitoring and management in large global CROs. Prior to joining George Clinical, Abby was an early co-founder at Algorics, which specialized in risk-based monitoring, data analytics, and enabling organizations to be compliant to ICH-E6 R(2). He is a pharmacologist and has healthcare management credentials. He actively contributes in various forums such as DIA and SCDM.

Edsel Pereira
Edsel Pereira Global Vice President of IT, Glenmark

Edsel Pereira is group CIO accountable for enabling IT to achieve objectives such as high system availability, process improvement, increased levels of automation, digital in an ever increasing regulatory and compliance framework. Responsibilities include ensuring security compliance for IT infrastructure by adopting industry best practices and industry proven technologies, and ensuring reduced operational costs through automation, digital and higher customer satisfaction for the overall Glenmark firm.

Charles Anthony Suarez
Charles Anthony Suarez Regulatory Affairs and Pharmacovigilance Manager, PiVOT CRO Philippines

Charles Anthony Suarez is a registered pharmacist with 12 years of experience in the clinical research industry taking on various roles from head of clinical trial support services, regulatory affairs and pharmacovigilance manager, local pharmacovigilance manager, pharmacovigilance team lead, patient recruitment & retention specialist and clinical trial monitoring for pharmaceutical companies (Boehringer-Ingelheim, Novartis Healthcare and Pfizer), contract research organizations (PiVOT , IQVIA, EPS International and Innovative Trials UK), knowledge process outsourcing company (Cognizant) and international JCI accredited hospital (Dr. Erfan and Bagedo General Hospital, Jeddah KSA).

Charles helped in the formation of PiVOT, a Filipino contract research organization in 2018. Currently leading the Clinical Trial Support Services (CTSS) cluster, which includes regulatory affairs and study startup, pharmacovigilance, clinical data management, and non-interventional studies. He is also the project lead of the WHO Solidarity Trial Vaccines Pilipinas.

Danny Soon
Danny Soon Chief Executive Officer, Consortium for Clinical Research and Innovation Singapore, Executive Director, Singapore Clinical Research Institute

Dr. Danny Soon is Chief Executive Officer at the Consortium for Clinical Research and Innovation, Singapore (CRIS) and concurrent Executive Director at the Singapore Clinical Research Institute (SCRI). As the inaugural CEO, Danny has the responsibility of bringing together five research programs and platforms under the auspices of CRIS, promulgating synergies and strategies, building corporate functions to service the entire entity.

Danny was previously the Executive Director of Biomedical Research Council (BMRC) in A*STAR. His team in BMRC was responsible for incepting and coordinating efforts and programs in drug development, precision medicine, medical technology and biomanufacturing. Previously, Danny also held the role of founding and Acting CEO of the Experimental Biotherapeutics Centre. In this role, where he and his team were responsible for setting up a brand new center for biotherapeutics development.

Danny has long experience in drug development, having worked at Eli Lilly and Company for 15 years, where he headed up the Lilly-NUS Centre for Clinical Pharmacology (LNUS). As the Managing Director and Principal Investigator, Danny had responsibility and oversight for all clinical Phase 1 studies conducted and operations in the unit. Studies conducted included first-in-human studies, biomarker development work, human physiology investigations and pivotal registration PK studies, in neuroscience, diabetes, musculoskeletal and cardiovascular therapeutic areas.


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