The Forces of Change: From Passenger to Driver’s Seat

Has the global pandemic disrupted our journey or cleared the path for us in advancing clinical research? Hear from Oracle Health Sciences SVP and General Manager, Henry McNamara, as he explores the answer to this question.

• Henry Mcnamara

  SVP and GM, Oracle Health Sciences

Gene-Related Therapies: New Future for Pharma in the Post-Covid Era?

With the advent of mRNA & DNA vaccines for COVID-19, the field of gene-related therapies has been fast-tracked by a decade. Before the paradigm shifted from chemical drugs to gene therapies, “mRNA, PCR & genomic variants” had already started to become household names.

Although there are approximately 10,000 known drugs for the treatment of 500 medical conditions, over 6,000 conditions remain unmet, many of which can be attributed to dysfunctional genes that have the possibility of correction. With the establishment of CAR-T for cancer after its first approval by FDA in 2017, and over 3500 gene therapy clinical trials ongoing, what will the future of pharma look like? Will the COVID crisis galvanize and fast-forward some of these pathbreaking therapies? Join Dr. Dhananjay Bakhale, the Executive Vice President of Medical Research at Lupid Ltd., for a session that gazes into the bright future of pharma.

• Dr Dhananjay Bakhale

  Executive Vice President Medical Research, Lupin Ltd

The Importance of the Unified Platform Approach

This session will review the differences between a unified platform and an integrated eClinical platform in detail and why a unified platform brings greater quality and innovation to both the front end and back end office.

• Jim Streeter

  Global Vice President, Life Sciences Product Strategy, Oracle Health Sciences

• Greg Jones

  Enterprise Strategy Architect, Oracle Health Sciences

• Steve Lyons

  Vice President, Development, Oracle Health Sciences

Next Generation Trial Management: CRO & Sponsor Collaboration

Panel session discussing next generation clinical trial management needs, and how sponsors and CROs can collaborate on trial management and oversight within the same platform, eliminating data redundancy, integrations and status reporting needs.

• Nicole Stansbury

  VP, Global Clinical Monitoring, Central Monitoring Services, Syneos Health

• Jamie Toth

  CPM, MS, Senior Director, Clinical Systems & Records, Global Clinical Operations & Planning, Daiichi Sankyo, Inc.

• Jennifer Bush

  Director, Life Sciences Product Strategy, Oracle Health Sciences

Decentralized Trials – No Going Back

Decentralized trials are fast becoming the new norm. This session will explore decentralized trials and the impact on Patients, Sites and Sponsors, as well as examine how can we simplify adoption and maximize this new approach to accelerate research.

• Yvonne Lungershausen

  CEO, Avance Clinical

Accelerated Adoption and Enhanced GxP Compliance of Oracle Health Sciences Cloud Solutions

In this session, learn how to enhance compliance, fast-track innovation, and unlock the full potential of the Oracle Health Sciences cloud solutions by leveraging Techsol's integrated add-on technologies, and process & validation/ assurance accelerators.

• Anshuman Misra

  Associate Director, Client Partner, SEA & ANZ, Techsol

• Sriram Varma

  Vice President, Global Service Operations, Techsol

The Safety One Evolution

Hear our latest strategy to evolve our suite of safety products (Argus, Empirica, and Safety One Intake) to modernize the industry-leading safety applications and bring them closer to Clinical One to form one source of truth across clinical and safety.

• Bruce Palsulich

  Vice President, Safety Product Strategy, Oracle Health Sciences

Safety Regulatory Updates

Our Regulations and Audits Working Group stays on top of all of the regulatory impacts facing our customers. In this session, we will present the latest updates covering global safety regulators.

• Lavanya Sathish

  Principal Product Manager, Oracle Health Sciences

Safety Customer Panel - Future of Pharmacovigilance

Join us for a discussion with the leading drug safety industry experts about the challenges and future of pharmacovigilance operations and systems.

• Dr. Vivek Ahuja

  VP, Medical Affairs & Head Global PV, Sun Pharma

• Dr. Avinash Kakade

  SGM Global Head – PV, Lupin Ltd

• Dr. Anju Agarwal

  Director Global Patient Safety, Advanz Pharma

• Jeyaseelan Jeyaraj

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