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Breakthrough Regulatory 2024

Lisbon, Portugal

September 4-5, 2024

Breakthrough Regulatory 2024 is the must-attend event for Regulatory leaders across life sciences. Over two days, engage in the brightest, forward-looking industry conversations and hear the latest developments with LifeSphere Regulatory products.

ArisGlobal will bring together experts and executives to discuss the strategic and practical implications of next-generation technologies for Regulatory Affairs.

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Agenda

Day 1

September 4th

14:00-17:00

Focus on intelligent automation and GenAI for Regulatory Operations, including:

  • Drawing on the latest GenAI and LLM Regulatory applications powered by NavaX and lessons learned from recent Private Preview
  • Industry look on how they're prioritizing and deploying advanced automation and GenAI within their organizations
  • Practical implications on how to get started with advanced technologies, like GenAI and LLMs, presented by partners
  • >

Day 2

September 5th

9:00-13:00

Dedicated and detailed LifeSphere Regulatory topics, including:

  • Implementation success, migration, and best practices
  • Compliance as a top priority
  • What to expect in the next six months from LifeSphere Regulatory

Travel & Venue Information

We are proud to bring Breakthrough Regulatory to the beautiful city of Lisbon on September 4-5.

  • Tivoli Avenida Liberdade Lisboa Hotel
    Av. da Liberdade 185, 1269-050 Lisboa, Portugal

Dates & Times:

  • Main Session begins Wednesday, Sept 4th from 14:00-17:00
  • Cocktail & Standing Dinner Reception on Wednesday, Sept 4th at 18:30
  • Main Session continues Thursday, Sept 5th from 9:00-13:00
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Mike Murphy

Head of PV Operations team within Global Patient Safety at Amgen

Mike Murphy leads the PV Operations team within Global Patient Safety at Amgen, a position he has held since April 2019. Responsibilities include overseeing and managing teams accountable for adverse event case processing and medical review, periodic reporting, safety reporting obligations for clinical, commercial/marketing programs, and oversight of the safety technologies. Mike has over 23 years of experience within the pharmaceutical industry, focused within pharmacovigilance, with expertise in change management, process excellence and safety systems.

Mike Murphy

Head of PV Operations team within Global Patient Safety at Amgen

Mike Murphy leads the PV Operations team within Global Patient Safety at Amgen, a position he has held since April 2019. Responsibilities include overseeing and managing teams accountable for adverse event case processing and medical review, periodic reporting, safety reporting obligations for clinical, commercial/marketing programs, and oversight of the safety technologies. Mike has over 23 years of experience within the pharmaceutical industry, focused within pharmacovigilance, with expertise in change management, process excellence and safety systems.

Hans van Leeuwen

Global Head of Regulatory Operations, Astellas

Hans van Leeuwen has over 20 years of experience in Regulatory Operations. He has managed global regulatory operations groups with responsibilities including regulatory information management, submission management, labeling, regulatory planning, change control and regulatory intelligence. On the IT side his experience includes global responsibility for (pre-) clinical, regulatory and pharmacovigilance systems such as clinical trial management, document management and adverse event reporting systems.
Hans has a strong interest in the use of data standards in regulatory submissions and has served on multiple representative committees promoting the use of standards in regulatory.
His previous employers include Organon Biosciences, Schering-Plough and MSD and he is currently at Astellas as head of RA Data & Systems Excellence. Prior to working in regulatory, Hans held management and research positions in multiple disciplines including analytical chemistry, statistics and data analysis. Hans holds a Ph.D. in Chemistry.

Hans van Leeuwen

Global Head of Regulatory Operations, Astellas

Hans van Leeuwen has over 20 years of experience in Regulatory Operations. He has managed global regulatory operations groups with responsibilities including regulatory information management, submission management, labeling, regulatory planning, change control and regulatory intelligence. On the IT side his experience includes global responsibility for (pre-) clinical, regulatory and pharmacovigilance systems such as clinical trial management, document management and adverse event reporting systems.
Hans has a strong interest in the use of data standards in regulatory submissions and has served on multiple representative committees promoting the use of standards in regulatory.
His previous employers include Organon Biosciences, Schering-Plough and MSD and he is currently at Astellas as head of RA Data & Systems Excellence. Prior to working in regulatory, Hans held management and research positions in multiple disciplines including analytical chemistry, statistics and data analysis. Hans holds a Ph.D. in Chemistry.

Sridhar (Sri) Mantha

Director of the Office of Business Informatics at the Center for Drug Evaluation and Research at the FDA

Sridhar (Sri) Mantha is currently Director of the Office of Business Informatics (OBI) at the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration. As the Director of OBI, Sri is charged with leading informatics development to modernize CDER’s drug regulatory operations. Prior to joining CDER in Dec 2020, Sri spent 25 years in the Lifesciences industry spanning Drugs, Biologics and Medical Device products. Sri held operational and leadership roles across Clinical Regulatory Informatics, Drug Safety, Quality Assurance and Information technology functions. Sri has masters degree in Environmental Systems Engineering from Clemson University, MBA from the University of Virginia’s Darden School of Business and is graduating in spring 2024 with a masters degree in Data Science from the Eastern university.

Sridhar (Sri) Mantha

Director of the Office of Business Informatics at the Center for Drug Evaluation and Research at the FDA

Sridhar (Sri) Mantha is currently Director of the Office of Business Informatics (OBI) at the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration. As the Director of OBI, Sri is charged with leading informatics development to modernize CDER’s drug regulatory operations. Prior to joining CDER in Dec 2020, Sri spent 25 years in the Lifesciences industry spanning Drugs, Biologics and Medical Device products. Sri held operational and leadership roles across Clinical Regulatory Informatics, Drug Safety, Quality Assurance and Information technology functions. Sri has masters degree in Environmental Systems Engineering from Clemson University, MBA from the University of Virginia’s Darden School of Business and is graduating in spring 2024 with a masters degree in Data Science from the Eastern university.

Claudia Lehmann

Vice President of Global Patient Safety and Pharmacovigilance Operations & Systems for Boehringer Ingelheim

Claudia Lehmann serves as Vice President of Global Patient Safety and Pharmacovigilance Operations & Systems for Boehringer Ingelheim. Her passion lies in patient safety, process design and efficiency and breaking down complex situations into manageable pieces that can be addressed in an agile and comprehensible way, never losing sight of the overall purpose of the task and the big picture. Prior to this role, she was leading Biostatistics and Data Management Europe within Boehringer Ingelheim.
Claudia has been trained in medical information management at an affiliation of the University of Ulm, Germany.

Claudia Lehmann

Vice President of Global Patient Safety and Pharmacovigilance Operations & Systems for Boehringer Ingelheim

Claudia Lehmann serves as Vice President of Global Patient Safety and Pharmacovigilance Operations & Systems for Boehringer Ingelheim. Her passion lies in patient safety, process design and efficiency and breaking down complex situations into manageable pieces that can be addressed in an agile and comprehensible way, never losing sight of the overall purpose of the task and the big picture. Prior to this role, she was leading Biostatistics and Data Management Europe within Boehringer Ingelheim.
Claudia has been trained in medical information management at an affiliation of the University of Ulm, Germany.

Hans-Jörg Römming

Head of Global Patient Safety Operations at Merck

Dr Hans-Jörg Römming is the Head of Global Patient Safety Operations at Merck. A physical chemist by training, Hans-Jörg started his career in a bio- and cheminformatics startup company and joined Merck Global Patient Safety in 2004. He was Head of Safety Systems and leading several major safety IT projects before being promoted Head of GPS Operations.

He currently oversees the end-to-end ICSR management with teams in Germany, USA, and India. He is passionate about further automating PV processes and is a member of the CIOMS working group XIV about AI in PV.

Hans-Jörg Römming

Head of Global Patient Safety Operations at Merck

Dr Hans-Jörg Römming is the Head of Global Patient Safety Operations at Merck. A physical chemist by training, Hans-Jörg started his career in a bio- and cheminformatics startup company and joined Merck Global Patient Safety in 2004. He was Head of Safety Systems and leading several major safety IT projects before being promoted Head of GPS Operations.

He currently oversees the end-to-end ICSR management with teams in Germany, USA, and India. He is passionate about further automating PV processes and is a member of the CIOMS working group XIV about AI in PV.

Steve Gens

Founder and Managing Partner of Gens & Associates Inc.

Steve Gens (MSOD) is the Founder and Managing Partner of Gens & Associates Inc., a Life Science benchmarking and advisory firm specializing in regulatory benchmarking, performance improvement, regulatory information management, and organizational transition. His early career was spent at Johnson and Johnson in a variety of management positions and then transitioned to consulting where he led global Life Science consulting practices for First Consulting Group and Booz Allen Hamilton.

His organization is well known for their insightful industry benchmarks, World Class RIM industry performance standard, and thought leadership. Steve has a Bachelor of Science in Business Computer Science and a Master in Organizational Development. He is a frequent speaker, has many publications, and was named both to the 2017 PharmaVoice 100 and the 2021 innovators for Pharmaceutical Development for his contributions to industry.

Steve Gens

Founder and Managing Partner of Gens & Associates Inc.

Steve Gens (MSOD) is the Founder and Managing Partner of Gens & Associates Inc., a Life Science benchmarking and advisory firm specializing in regulatory benchmarking, performance improvement, regulatory information management, and organizational transition. His early career was spent at Johnson and Johnson in a variety of management positions and then transitioned to consulting where he led global Life Science consulting practices for First Consulting Group and Booz Allen Hamilton.

His organization is well known for their insightful industry benchmarks, World Class RIM industry performance standard, and thought leadership. Steve has a Bachelor of Science in Business Computer Science and a Master in Organizational Development. He is a frequent speaker, has many publications, and was named both to the 2017 PharmaVoice 100 and the 2021 innovators for Pharmaceutical Development for his contributions to industry.

Jorge Carmona

Global Product Line Lead for PSRMI at Roche

Jorge Carmona is an outcome-driven leader with an exceptional track record in business and team development within diverse industries. With more than 13 years of expertise in Biotech and over a decade in spearheading Business Technology strategies, Jorge has cultivated a vast experience in building, managing, and leading high-performance, multicultural teams across Europe, America and Asia.

In his current role as Global Product Line Lead for Patient Safety Risk Management Informatics Jorge partners closely with the Global Pharma Development Safety Organization to drive Patient Safety Technology at Roche. Through operational rigor, his team implements modern cloud solutions, enables process automation, and the use of artificial intelligence and analytics capabilities. All of this with the ultimate goal of maximizing the value that Safety creates for Roche and its Patients.

Jorge Carmona

Global Product Line Lead for PSRMI at Roche

Jorge Carmona is an outcome-driven leader with an exceptional track record in business and team development within diverse industries. With more than 13 years of expertise in Biotech and over a decade in spearheading Business Technology strategies, Jorge has cultivated a vast experience in building, managing, and leading high-performance, multicultural teams across Europe, America and Asia.

In his current role as Global Product Line Lead for Patient Safety Risk Management Informatics Jorge partners closely with the Global Pharma Development Safety Organization to drive Patient Safety Technology at Roche. Through operational rigor, his team implements modern cloud solutions, enables process automation, and the use of artificial intelligence and analytics capabilities. All of this with the ultimate goal of maximizing the value that Safety creates for Roche and its Patients.

Marina Suvakov

Global Head, Product Safety Surveillance at PMI Life Sciences

Marina is a passionate, experienced, and motivated professional with over 13 years of experience in the pharmaceutical industry, particularly safety surveillance. Her expertise and experience in pharmacovigilance and quality activities, combined with her innovative thinking style and enthusiasm has helped many companies and departments propel through their transformation journeys. Her expertise are in process optimization and ensuring standards and compliance within the GVP guidelines. Marina holds a master’s degree in pharmaceutical sciences from Greenwich University and a bachelor’s degree in medical biochemistry from Brunel University.

Marina Suvakov

Global Head, Product Safety Surveillance at PMI Life Sciences

Marina is a passionate, experienced, and motivated professional with over 13 years of experience in the pharmaceutical industry, particularly safety surveillance. Her expertise and experience in pharmacovigilance and quality activities, combined with her innovative thinking style and enthusiasm has helped many companies and departments propel through their transformation journeys. Her expertise are in process optimization and ensuring standards and compliance within the GVP guidelines. Marina holds a master’s degree in pharmaceutical sciences from Greenwich University and a bachelor’s degree in medical biochemistry from Brunel University.

Mitesh B. Rao

Founder and CEO of OMNY Health

Dr. Mitesh B. Rao, MD, MHS is the Founder and CEO of OMNY Health, a venture-backed company revolutionizing how healthcare organizations collaborate and advance science through the common language of data. Encompassing timely and comprehensive real-world data from direct partnerships with IDNs, AMCs, specialty networks, and other providers across the US, OMNY Health’s proprietary platform provides the foundation for stakeholders across the healthcare ecosystem to compliantly and efficiently share data and insights, as well as pursue broader data-driven partnerships. Prior to founding OMNY Health, Dr. Rao developed a national reputation as a leader in healthcare safety. A Board-Certified Emergency Medicine Physician and Assistant Professor of Emergency Medicine at Stanford, he most recently served as the Chief Patient Safety Officer for Stanford Healthcare where he led Patient Safety, Quality, and System Redesign for the Enterprise. Dr. Rao also served as Director of the Center for Advancing Patient Safety at Northwestern Memorial Hospital, which focused on implementing new innovations in the fields of Patient Safety and Quality Improvement. Dr. Rao began his career as a Fellow in the Robert Wood Johnson Clinical Scholars Program at Yale University.

Mitesh B. Rao

Founder and CEO of OMNY Health

Dr. Mitesh B. Rao, MD, MHS is the Founder and CEO of OMNY Health, a venture-backed company revolutionizing how healthcare organizations collaborate and advance science through the common language of data. Encompassing timely and comprehensive real-world data from direct partnerships with IDNs, AMCs, specialty networks, and other providers across the US, OMNY Health’s proprietary platform provides the foundation for stakeholders across the healthcare ecosystem to compliantly and efficiently share data and insights, as well as pursue broader data-driven partnerships. Prior to founding OMNY Health, Dr. Rao developed a national reputation as a leader in healthcare safety. A Board-Certified Emergency Medicine Physician and Assistant Professor of Emergency Medicine at Stanford, he most recently served as the Chief Patient Safety Officer for Stanford Healthcare where he led Patient Safety, Quality, and System Redesign for the Enterprise. Dr. Rao also served as Director of the Center for Advancing Patient Safety at Northwestern Memorial Hospital, which focused on implementing new innovations in the fields of Patient Safety and Quality Improvement. Dr. Rao began his career as a Fellow in the Robert Wood Johnson Clinical Scholars Program at Yale University.

Franziska Rathjens

DQP for Pharmacovigilance and DL Safety Officer at B. Braun Melsungen AG

Dr. Franziska Rathjens is a pharmacist and holds a Master’s and doctoral degree in Molecular Medicine. She joined B. Braun Melsungen AG in 2019 as a Deputy Qualified Person for Pharmacovigilance and Deputy Local Safety Officer for Germany.
After initiating and managing the establishment of new and improvement of existing processes from 2020 to 2022 within B. Braun’s Global Pharmacovigilance & Patient Safety Department, she built and now leads a team responsible for Business Process Management & Pharmacovigilance Tools. This team is in charge of the applications used in pharmacovigilance at B. Braun, especially of the pharmacovigilance database Lifesphere Multivigilance. In close collaboration with the teams responsible for case processing, periodic safety reporting and signal management automations have and are being implemented to bring value to the business users.

Franziska Rathjens

DQP for Pharmacovigilance and DL Safety Officer at B. Braun Melsungen AG

Dr. Franziska Rathjens is a pharmacist and holds a Master’s and doctoral degree in Molecular Medicine. She joined B. Braun Melsungen AG in 2019 as a Deputy Qualified Person for Pharmacovigilance and Deputy Local Safety Officer for Germany.
After initiating and managing the establishment of new and improvement of existing processes from 2020 to 2022 within B. Braun’s Global Pharmacovigilance & Patient Safety Department, she built and now leads a team responsible for Business Process Management & Pharmacovigilance Tools. This team is in charge of the applications used in pharmacovigilance at B. Braun, especially of the pharmacovigilance database Lifesphere Multivigilance. In close collaboration with the teams responsible for case processing, periodic safety reporting and signal management automations have and are being implemented to bring value to the business users.

Scott Skellenger

Vice President - DTI - Research and Development Informatics & Global Infrastructure Services at Amgen

Scott Skellenger leads Digital, Technology, and Innovation (DTI) for Amgen’s Research and Development (R&D) function as well as Global Infrastructure Services (GIS) and serves on the DTI and R&D leadership teams. In his role, Scott ensures the reliability and resiliency of Amgen’s technology, infrastructure, scientific technology, and data assets across R&D and Business Development.

Scott started his career at Amgen in the late 1990’s, leaving in 2008 to lead and scale the information systems function at Illumina as Next Generation Sequencing (NGS) was gaining traction. After 5 years at Illumina, Scott spent the next several years company building as the senior technology executive developing health and life sciences commercial products in startup companies at the intersection of genomics and oncology. He is applying his product development experiences and industry knowledge in artificial intelligence, deep learning, real world data, phenotype/omics data integration and analysis, and precision oncology laboratory operations to accelerate the innovation and delivery of differentiated digital capabilities at Amgen.

Since returning to Amgen in 2019, Scott has had key leadership roles in building the next generation platforms across R&D including AI/ML portfolio creation and execution. Scott leads technology integration for Mergers and Acquisitions cross functionally, as well as critical product filing and launch support, and key digital transformation. Scott holds a Bachelor of Science degree in Computer Information Systems and a Master of Business Administration degree in Information Technology Management from California Lutheran University.

Scott Skellenger

Vice President - DTI - Research and Development Informatics & Global Infrastructure Services at Amgen

Scott Skellenger leads Digital, Technology, and Innovation (DTI) for Amgen’s Research and Development (R&D) function as well as Global Infrastructure Services (GIS) and serves on the DTI and R&D leadership teams. In his role, Scott ensures the reliability and resiliency of Amgen’s technology, infrastructure, scientific technology, and data assets across R&D and Business Development.

Scott started his career at Amgen in the late 1990’s, leaving in 2008 to lead and scale the information systems function at Illumina as Next Generation Sequencing (NGS) was gaining traction. After 5 years at Illumina, Scott spent the next several years company building as the senior technology executive developing health and life sciences commercial products in startup companies at the intersection of genomics and oncology. He is applying his product development experiences and industry knowledge in artificial intelligence, deep learning, real world data, phenotype/omics data integration and analysis, and precision oncology laboratory operations to accelerate the innovation and delivery of differentiated digital capabilities at Amgen.

Since returning to Amgen in 2019, Scott has had key leadership roles in building the next generation platforms across R&D including AI/ML portfolio creation and execution. Scott leads technology integration for Mergers and Acquisitions cross functionally, as well as critical product filing and launch support, and key digital transformation. Scott holds a Bachelor of Science degree in Computer Information Systems and a Master of Business Administration degree in Information Technology Management from California Lutheran University.

Lucinda Smith

Global Head of Safety Operations at Roche

Lucinda is an experienced leader with over 20 years experience in Pharmacovigilance.  Lucinda began her PV career processing ICSRs and subsequently moved to more senior positions, and has experience in various areas including process development, implementation of regulatory changes, strategy development, system implementation, audits and inspections, mergers and acquisitions.  Lucinda is now the Global Head of Safety Operations at Roche and is accountable for the acquisition of safety data, delivery of ICSR and device safety reports, management of safety agreements with business partners, delivery of data for aggregate reports and management of vendors supporting operations activities.

Lucinda Smith

Global Head of Safety Operations at Roche

Lucinda is an experienced leader with over 20 years experience in Pharmacovigilance.  Lucinda began her PV career processing ICSRs and subsequently moved to more senior positions, and has experience in various areas including process development, implementation of regulatory changes, strategy development, system implementation, audits and inspections, mergers and acquisitions.  Lucinda is now the Global Head of Safety Operations at Roche and is accountable for the acquisition of safety data, delivery of ICSR and device safety reports, management of safety agreements with business partners, delivery of data for aggregate reports and management of vendors supporting operations activities.

Jennifer Manochio

Senior Director of Global Safety Systems at Bristol Myers Squibb

Jennifer is Senior Director of the Global Safety Systems team within the World Wide Patient safety organization at Bristol Myers Squibb. In her 18 year tenure with BMS, she has led two Global Safety Database implementations and built the dedicated team that provides stewardship of the organization’s systems, while actively driving system roadmaps. Jennifer is passionate about the possibilities of safety organizations improving their business value, quality, and ultimately empowering more effective and efficient patient safety through standardization of systems and process.

Prior to joining the Pharmaceutical industry, Jennifer worked as an Oncology nurse for Princeton Medical Center.

Jennifer Manochio

Senior Director of Global Safety Systems at Bristol Myers Squibb

Jennifer is Senior Director of the Global Safety Systems team within the World Wide Patient safety organization at Bristol Myers Squibb. In her 18 year tenure with BMS, she has led two Global Safety Database implementations and built the dedicated team that provides stewardship of the organization’s systems, while actively driving system roadmaps. Jennifer is passionate about the possibilities of safety organizations improving their business value, quality, and ultimately empowering more effective and efficient patient safety through standardization of systems and process.

Prior to joining the Pharmaceutical industry, Jennifer worked as an Oncology nurse for Princeton Medical Center.

Claudia Schaffer

Head of Case and Vendor Management at Merck Healthcare KGaA- Global Patient Safety

Claudia is an accomplished leader with over 17 years of experience in pharmacovigilance. Her journey started with handling ICSRs and quickly progressed to leadership roles where she gained expertise in diverse areas such as vendor management, business process management, system implementation, audits and inspections.

Currently, Claudia holds the position of Head Case and Vendor Management at Merck Healthcare KGaA- Global Patient Safety. In this role, she leads the management of ICSRs, oversees Global Patient Safety vendor partnerships, and drives the evolution of the safety platform to ensure regulatory compliance. In addition, Claudia is actively leading the ICSR automation strategy.

Claudia Schaffer

Head of Case and Vendor Management at Merck Healthcare KGaA- Global Patient Safety

Claudia is an accomplished leader with over 17 years of experience in pharmacovigilance. Her journey started with handling ICSRs and quickly progressed to leadership roles where she gained expertise in diverse areas such as vendor management, business process management, system implementation, audits and inspections.

Currently, Claudia holds the position of Head Case and Vendor Management at Merck Healthcare KGaA- Global Patient Safety. In this role, she leads the management of ICSRs, oversees Global Patient Safety vendor partnerships, and drives the evolution of the safety platform to ensure regulatory compliance. In addition, Claudia is actively leading the ICSR automation strategy.

Andrea Rogers

Head of Digital, Technology, and Innovation (DTI) teams at Amgen

Andrea Rogers leads the Digital, Technology, and Innovation (DTI) teams who provide technology solutions for Amgen’s Global Patient Safety, Global Development, and Global Medical organizations. Andrea has spent more than 30 years working in Information Technology supporting Healthcare, first working for payers within the US, and for the last 17+ years at Amgen.
During her tenure at Amgen, Andrea has held numerous roles of increasing scope and responsibility, including in Enterprise Technology groups focused on data and analytics, and for the past eight years in the R&D Informatics organization. In addition to her current role supporting Patient Safety, Development, and Medical, Andrea has also led the teams supporting Commercialization and Business Development. Andrea is the R&D technology integration lead for Amgen’s acquisition of Horizon Therapeutics and in 2024 will lead an effort to transform the technology ecosystem for Global Patient Safety. Andrea holds a Bachelor of Arts degree from UC Santa Cruz, and a Master of Arts from UC Davis.

Andrea Rogers

Head of Digital, Technology, and Innovation (DTI) teams at Amgen

Andrea Rogers leads the Digital, Technology, and Innovation (DTI) teams who provide technology solutions for Amgen’s Global Patient Safety, Global Development, and Global Medical organizations. Andrea has spent more than 30 years working in Information Technology supporting Healthcare, first working for payers within the US, and for the last 17+ years at Amgen.
During her tenure at Amgen, Andrea has held numerous roles of increasing scope and responsibility, including in Enterprise Technology groups focused on data and analytics, and for the past eight years in the R&D Informatics organization. In addition to her current role supporting Patient Safety, Development, and Medical, Andrea has also led the teams supporting Commercialization and Business Development. Andrea is the R&D technology integration lead for Amgen’s acquisition of Horizon Therapeutics and in 2024 will lead an effort to transform the technology ecosystem for Global Patient Safety. Andrea holds a Bachelor of Arts degree from UC Santa Cruz, and a Master of Arts from UC Davis.

Samuel Wallis

Senior Director and Head of Case Management at Bristol Myers Squibb

Sam Wallis is Senior Director and Head of Case Management within the World Wide Patient Safety organization at Bristol Myers Squibb. During his tenure with BMS, he has led the harmonization, integration and evolution of ICSR Processes and Safety Systems and developed the Case Management Organization which provides global leadership and oversight in adverse event processes.

Sam is committed to progressing the discipline of pharmacovigilance and adverse event processing through process optimization and technology to enhance safety data management to drive predictive patient safety to bring value to customers and safeguard patients.

Prior to joining BMS Samuel was Head of Case Management and Medical Evaluation and deputy to the EU Qualified Person for Pharmacovigilance at Celgene Europe Ltd where he also held roles as Head of Pharmacovigilance for the UK and Ireland and roles in Global Drug Safety and Risk Management.

Samuel Wallis

Senior Director and Head of Case Management at Bristol Myers Squibb

Sam Wallis is Senior Director and Head of Case Management within the World Wide Patient Safety organization at Bristol Myers Squibb. During his tenure with BMS, he has led the harmonization, integration and evolution of ICSR Processes and Safety Systems and developed the Case Management Organization which provides global leadership and oversight in adverse event processes.

Sam is committed to progressing the discipline of pharmacovigilance and adverse event processing through process optimization and technology to enhance safety data management to drive predictive patient safety to bring value to customers and safeguard patients.

Prior to joining BMS Samuel was Head of Case Management and Medical Evaluation and deputy to the EU Qualified Person for Pharmacovigilance at Celgene Europe Ltd where he also held roles as Head of Pharmacovigilance for the UK and Ireland and roles in Global Drug Safety and Risk Management.

Priyank Agarwal

Senior IT Director, OCMO, Johnson & Johnson IM

A highly accomplished business technology leader, with a rich professional background spanning more than twenty years, renowned for incubating and scaling strategic initiatives within Johnson & Johnson Innovative Medicine. His extensive expertise encompasses spearheading various technological endeavors across Regulatory, Clinical, and Early Development sectors.

Currently serving in a pivotal capacity within the Office of Chief Medical Officer, he is entrusted with the mission of championing the adoption of transformative technologies across the pharmacovigilance value chain. His overarching goal is to harness these innovations to optimize the benefit-risk profiles of therapies, elevate patient outcomes, and elevate the overall patient experience.

Priyank Agarwal

Senior IT Director, OCMO, Johnson & Johnson IM

A highly accomplished business technology leader, with a rich professional background spanning more than twenty years, renowned for incubating and scaling strategic initiatives within Johnson & Johnson Innovative Medicine. His extensive expertise encompasses spearheading various technological endeavors across Regulatory, Clinical, and Early Development sectors.

Currently serving in a pivotal capacity within the Office of Chief Medical Officer, he is entrusted with the mission of championing the adoption of transformative technologies across the pharmacovigilance value chain. His overarching goal is to harness these innovations to optimize the benefit-risk profiles of therapies, elevate patient outcomes, and elevate the overall patient experience.

Bhupesh Chadha

Head of Healthcare LifeSciences ISVs Industry vertical at Amazon Web Services

Bhupesh has over 17 years of experience leading various industry verticals like Telecom, CSP and MarTech. In his current role at Amazon Web Services, Bhupesh leads the Healthcare LifeSciences ISVs Industry vertical. In his near 5 years tenure at AWS, he has led multiple large migration projects including ArisGlobal DC exit and migrating 1000s of servers and TBs of data to AWS.

He has also led multiple modernization projects involving monolith to microservices modernization, containerization, migration to opensource, analytics, AI/ML and GenAI resulting in reduction of overheads, improvement in performance and availability and finally reduction of cost.

Prior to joining AWS, he worked at Hewlett Packard Enterprise and Dell. He holds a master’s degree in business administration and likes to play badminton, read about capital markets and spend time with family in his free time.

Bhupesh Chadha

Head of Healthcare LifeSciences ISVs Industry vertical at Amazon Web Services

Bhupesh has over 17 years of experience leading various industry verticals like Telecom, CSP and MarTech. In his current role at Amazon Web Services, Bhupesh leads the Healthcare LifeSciences ISVs Industry vertical. In his near 5 years tenure at AWS, he has led multiple large migration projects including ArisGlobal DC exit and migrating 1000s of servers and TBs of data to AWS.

He has also led multiple modernization projects involving monolith to microservices modernization, containerization, migration to opensource, analytics, AI/ML and GenAI resulting in reduction of overheads, improvement in performance and availability and finally reduction of cost.

Prior to joining AWS, he worked at Hewlett Packard Enterprise and Dell. He holds a master’s degree in business administration and likes to play badminton, read about capital markets and spend time with family in his free time.

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About

ArisGlobal’s annual Breakthrough is a one-of-a-kind event that brings together key leaders of the life sciences to provide unique insights around the innovation, processes, talent and technology to drive greater efficiency, strategy and results for businesses. Breakthrough 2024 will feature sessions and keynotes by leading voices from across the industry, aimed at sharing ideas, experiences and best practices. You will also have the opportunity to visit the Innovation Center where live demonstrations across the LifeSphere platform will be available, plus time to network with ArisGlobal’s preferred partners as part of our open ecosystem.

Travel & Info

Venue

We are excited to bring Breakthrough 2024 to London, England on March 19-20, 2024.

Leonardo Royal London St Paul’s
10 Godliman St
London - EC4V 5AJ

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