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What a fantastic day in Boston!

Many thanks to all our speakers, attendees, and everyone who made Breakthrough2022 the exciting event that it was.

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About Breakthrough 2022

ArisGlobal’s Breakthrough2022 event brought together key members of the life sciences and digital health community to provide insights into innovation, AI and digital transformation. This year’s event featured sessions and keynotes by leading voices from across the industry, aimed at sharing ideas, experiences, and best practices.

See our full library of resources including webinars, guides and more available here

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October

3rd, 2022

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Boston

Massachusetts, United States

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In-person

Event

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Free

To register and attend

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Who Attended Breakthrough2022?

Breakthrough2022 is designed for anyone interested in understanding how technology is transforming the future for humanity. Sessions will be geared towards a variety of audiences, such as life sciences and digital health professionals, automation and innovation advocates, and health technology journalists.

Who Should Attend

Breakthrough2022 is designed for anyone interested in understanding how technology is transforming the future for humanity. Sessions will be geared towards a variety of audiences, such as life sciences and digital health professionals, automation and innovation advocates, and health technology journalists.

Breakthrough2022 Agenda

The day’s sessions will leave you with a better understanding of new technology, and how data and analytics can immediately impact your clinical development and patient safety programs.

Arrivals & Welcome Reception

Attendees are encouraged to arrive throughout the day and join us for a welcome reception and Networking opportunity.

Full Day of Programming

Refer to Agenda Overview Below
Evening Group Outing to Follow

Welcome to Breakthrough2022

10:00AM

- Mike Gordon, CEO, ArisGlobal

- Heidi Hattendorf, VP - Head of Marketing, ArisGlobal

Harnessing the Power of Innovation in Life Sciences

- Mike Gordon, CEO, ArisGlobal

The LifeSphere Platform and Vision

10:30AM

- Pat Jenakanandhini, Chief Product Officer, ArisGlobal

- John Landy, Chief Technology Officer, ArisGlobal

Fireside Chat: The Impact of Digital Transformation on the Pharmaceutical Industry

10:45AM

- Priyank Agarwal, Head of IT Global Medical Safety, Johnson & Johnson

- Aman Wasan, Chief Commercial Officer, ArisGlobal

LifeSphere Safety: The Future Is Now - Advancing Patient Safety Through Innovation

11:05AM

- Beena Wood, VP, Safety & Medical Affairs, ArisGlobal

The Value of Data to Drive Drug Discovery and Development

11:40AM

- Dr. Isabel Klör, Lead Risk Management Physician and Product Owner, Boehringer Ingelheim

- Elizabeth Smalley, Principal Product Manager, ArisGlobal

The Future of Life Sciences and Healthtech Through Data

12:05PM

- Daniel Berglund, Partner, Nordic Capital

Lunch and Networking Break

12:25 - 1:30PM

Fireside Chat: Out of the Box Implementation Discussion with Bristol-Myers Squibb

1:30PM

- Jennifer Manochio, Senior Director, Global Safety Systems WorldWide Patient Safety, Bristol-Myers Squibb

- Swetha Kannan, Vice President, Business Transformation, ArisGlobal

Breaking Away From Traditions - The Current and the Future of Pharmacovigilance

1:45PM

- Beena Wood, VP, Safety & Medical Affairs, ArisGlobal

- Richard Wolf, Head of PV Operations, CSL Behring

- Claudia Lehmann, VP Head of Pharmacovigilance Operations and Systems, Boehringer Ingelheim

- Jane Carroll, VP Global Medical Excellence & Pharmacovigilance Operations, Moderna

- Bethann Riley, Senior Director PV Process Excellence and Learning Strategy & Case Management Business Operations, Bristol-Myers Squibb

Regulatory Trends and the Evolving Role of Regulatory Affairs

2:30PM

- Steve Gens, Managing Partner, Gens & Associates

- Jim Hilferty, AVP, Product Management, ArisGlobal

- Kelly Hnat, Principal, K2 Consulting, Gens & Associates

- Robin Schilling, Product Manager, ArisGlobal

Main Plaza Ballroom
Track A

Innovation Through Collaboration

3:10PM

- Zhiyi Chen, Director, Global Procurement, Astellas

Track A

Designing and Future-proofing a Global Safety Program Delivering Value Day 1 with Efficiency Gains

3:30PM

- Marina Suvakov, Global Head Product Safety Surveillance, Phillip Morris International

Track A

Vaccine Story and Large Case Processing

3:50PM

- Humaira Qureshi, CEO, Qinecsa Solutions

Seaport B
Track B

Partnerships - The Future of Data Sharing

3:10PM

- Karen De Jong, Executive Director GPV Global Case Management, Boehringer Ingelheim

Track B

One Patient Voice - Unifying and Innovating How We Work For More Total Patient Care

3:40PM

- Chet Bhatt, Executive Director, Amarin

- Ali Faruqi, Global Medical Affairs Systems & Processes (Strategic Ops), Amarin

Seaport A
Track C

Small Group Setting - Roundtable on Regulatory Needs / Technology as a Lever

3:10PM

- Robin Schilling, Product Manager, ArisGlobal

- Kevin Smith, SVP, Global Specialty Sales, ArisGlobal

- Gary Wilson, Managing Director & Co-Founder of CorrIT and creator of the SPORIFY web application

Seaport C
Track D

Safety Document Distribution - Clinical

3:10PM

- Hosted by ArisGlobal

Highlights from our Life Sciences Industry Report - Your Voice

4:30PM

- Heidi Hattendorf, VP, Head of Marketing, ArisGlobal

Customer All-Star Awards

4:40PM

- Aman Wasan, Chief Commercial Officer, ArisGlobal

CEO Closing Comments and Thank You

4:50PM

- Mike Gordon, CEO, ArisGlobal

Breakthrough2022 Agenda

Arrivals & Welcome Reception

Attendees are encouraged to arrive throughout the day and join us for a welcome reception and networking opportunity.

Morning: Opening Keynote

All Day: Individual Sessions

Details to be announced closer to the
event!

Afternoon: Closing Remarks

Evening: Group Outing

The day’s sessions will leave you with a better understanding of new technology, and how data and analytics can immediately impact your clinical development and patient safety programs.

Data and analytics are disrupting the life sciences. Are you ready?

  • Mike Gordon, CEO of ArisGlobal

Panel Discussion: The Future of Safety

  • Beena Wood, ArisGlobal
  • Richard Wolf, CSL Behring
  • Priyank Agarwal, Johnson & Johnson

Panel Discussion: Trends in Regulatory Affairs

  • Jim Hilferty, ArisGlobal
  • Steve Gens and Kelly Hnat of Gens and Associates

 

The Value of De-Siloing Patient Data to Create Safer, Better Patient Outcomes

  • Chet Bhatt and Ali Faruq, Amarin

Breaking Down Barriers: Building a Data Strategy to Deliver Safe, Effective Pharmaceuticals by Collaborating with Life Science Partners

  • Karen De Jong, Boehringer Ingelheim

How AI and Automation Enables PMI to Globally Scale their PV Program

  • Marina Suvakov, PMI Life Sciences
Priyank Agarwal

Priyank Agarwal

IT Director, Medical Safety for Johnson & Johnson

Priyank Agarwal is currently the IT Director, Medical Safety for Johnson & Johnson based in NJ. He has been part of J&J R&D IT for over 18 years and has led various technology efforts across Regulatory, Clinical and Early Development. In his current role he responsible for implementing transformative technologies across pharmacovigilance value chain to enhance patient outcomes and experiences.

Prior to joining J&J he worked as a Software Engineer and has made many significant contributions in various technologies through his product development work with large multinational companies.

Priyank Agarwal
Priyank Agarwal

IT Director, Medical Safety for Johnson & Johnson

Priyank Agarwal is currently the IT Director, Medical Safety for Johnson & Johnson based in NJ. He has been part of J&J R&D IT for over 18 years and has led various technology efforts across Regulatory, Clinical and Early Development. In his current role he responsible for implementing transformative technologies across pharmacovigilance value chain to enhance patient outcomes and experiences.

Prior to joining J&J he worked as a Software Engineer and has made many significant contributions in various technologies through his product development work with large multinational companies.

Daniel Berglund

Board Member and Partner, Nordic Capital

Daniel Berglund is a member of ArisGlobal’s Board of Directors and a Partner at Nordic Capital, having joined the firm in January 2010. Daniel has served on the boards of nine Nordic Capital portfolio companies. Daniel focuses on investment situations within Technology and Payments as well has Healthcare IT. Before joining Nordic Capital, Daniel worked at Bain & CO from 2007 to 2009, most recently as a Senior Associate. Daniel holds an MSc in Economics from the Stockholm School of Economics and Business Administration from the Ross School of Business at the University of Michigan.

Daniel Berglund

Board Member and Partner, Nordic Capital

Daniel Berglund is a member of ArisGlobal’s Board of Directors and a Partner at Nordic Capital, having joined the firm in January 2010. Daniel has served on the boards of nine Nordic Capital portfolio companies. Daniel focuses on investment situations within Technology and Payments as well has Healthcare IT. Before joining Nordic Capital, Daniel worked at Bain & CO from 2007 to 2009, most recently as a Senior Associate. Daniel holds an MSc in Economics from the Stockholm School of Economics and Business Administration from the Ross School of Business at the University of Michigan.

Chet Bhatt

Executive Director, Global Medical Operations and Strategic Programs, Amarin Pharma Inc.

 

Chet Bhatt

Executive Director, Global Medical Operations and Strategic Programs, Amarin Pharma Inc.

 

Jane Carroll

Jane Carroll

Vice President, Global Medical Excellence and PV Operations, Moderna

Jane joined Moderna in March 2021 as Vice President, Global PV Operations and in Jan 2022 assumed responsibility for Global Medical Excellence.

Jane is a pharmacovigilance and medical affairs executive with ~20 years of experience with increasing degrees of accountability motivated to design and implement high quality solutions for patients, caregivers, and healthcare professionals to support appropriate use of medications.

She specializes in large scale strategy development and change management and development of systems compliant with health authority regulations.

Jane Carroll
Jane Carroll

Vice President, Global Medical Excellence and PV Operations, Moderna

Jane joined Moderna in March 2021 as Vice President, Global PV Operations and in Jan 2022 assumed responsibility for Global Medical Excellence.

Jane is a pharmacovigilance and medical affairs executive with ~20 years of experience with increasing degrees of accountability motivated to design and implement high quality solutions for patients, caregivers, and healthcare professionals to support appropriate use of medications.

She specializes in large scale strategy development and change management and development of systems compliant with health authority regulations.

Zhiyi Chen

Zhiyi Chen

Global Procurement Director Software and Digital, Astellas

Experienced Multi Industry Procurement Leader with a demonstrated history of driving innovation and change within organizations. Experienced in digital and IT procurement and transformation. Believes in driving Value beyond cost and highly passionate about enabling innovation through collaboration.

Zhiyi Chen
Zhiyi Chen

Global Procurement Director Software and Digital, Astellas

Experienced Multi Industry Procurement Leader with a demonstrated history of driving innovation and change within organizations. Experienced in digital and IT procurement and transformation. Believes in driving Value beyond cost and highly passionate about enabling innovation through collaboration.

Karen S. De Jong

Executive Director Global Case Management, Patient Safety & Pharmacovigilance Boehringer Ingelheim Pharmaceuticals

Karen is a pharmacovigilance expert with 21 years of experience in end to end Pharmacovigilance, health care, clinical research, as well as business process and Organizational transformation design. Karen is leading the Global Case Management organization within Boehringer Ingelheim PV Operations & Systems

Karen has experience with USA, Europe, and Japan regulatory, operations and safety surveillance activities in pharmaceutical companies. Provided subject matter expertise, leadership, oversight, and global project coordination to clients in risk management, periodic reporting, signaling, ICSR handling, PV and risk management training, system implementations, and business process analysis. Led the Product Management team in the next generation PV Platform designed with automation and artificial intelligence as well as build a PV department (operations, surveillance, and vendor management) from the bottom-up within 8 months.

Karen S. De Jong

Executive Director Global Case Management, Patient Safety & Pharmacovigilance Boehringer Ingelheim Pharmaceuticals

Karen is a pharmacovigilance expert with 21 years of experience in end to end Pharmacovigilance, health care, clinical research, as well as business process and Organizational transformation design. Karen is leading the Global Case Management organization within Boehringer Ingelheim PV Operations & Systems

Karen has experience with USA, Europe, and Japan regulatory, operations and safety surveillance activities in pharmaceutical companies. Provided subject matter expertise, leadership, oversight, and global project coordination to clients in risk management, periodic reporting, signaling, ICSR handling, PV and risk management training, system implementations, and business process analysis. Led the Product Management team in the next generation PV Platform designed with automation and artificial intelligence as well as build a PV department (operations, surveillance, and vendor management) from the bottom-up within 8 months.

Ali Faruqi

Project Manager, Global Medical Affairs Systems & Processes, Amarin Pharma Inc.

 

Ali Faruqi

Project Manager, Global Medical Affairs Systems & Processes, Amarin Pharma Inc.

 

Steve Gens

Steve Gens

Founder, Gens & Associates

Steve is the founder of Gens & Associates, a boutique Life Science information management and organizational consultancy specializing in strategic planning, industry benchmarking, regulatory information management, and organizational transition management. His company is actively working with over 90 organizations (benchmarking and consulting practices) consisting of medicinal, device, consumer product, agricultural and regulatory software /service providers that support them.

Steve has over 30 years of business experience with his early career was spent at Waterford Crystal and Johnson & Johnson before moving into consulting where he managed several global healthcare consulting practices for Booz Allen Hamilton and First Consulting Group. He has deep strategy formulation, organization development , industry benchmarking, and information management strategy expertise. Steve holds a Bachelor of Science degree in Business Computer Science, a Master of Science in Organization Development with distinction for his field work from American University. Steve is a sought out speaker, has several publications, is quoted in many trade journals and provider announcements, and was named in the 2017 PharmaVoice 100 and 2021 innovators for Pharmaceutical Development for his contribution to the industry.

Steve Gens
Steve Gens

Founder, Gens & Associates

Steve is the founder of Gens & Associates, a boutique Life Science information management and organizational consultancy specializing in strategic planning, industry benchmarking, regulatory information management, and organizational transition management. His company is actively working with over 90 organizations (benchmarking and consulting practices) consisting of medicinal, device, consumer product, agricultural and regulatory software /service providers that support them.

Steve has over 30 years of business experience with his early career was spent at Waterford Crystal and Johnson & Johnson before moving into consulting where he managed several global healthcare consulting practices for Booz Allen Hamilton and First Consulting Group. He has deep strategy formulation, organization development , industry benchmarking, and information management strategy expertise. Steve holds a Bachelor of Science degree in Business Computer Science, a Master of Science in Organization Development with distinction for his field work from American University. Steve is a sought out speaker, has several publications, is quoted in many trade journals and provider announcements, and was named in the 2017 PharmaVoice 100 and 2021 innovators for Pharmaceutical Development for his contribution to the industry.

Mike Gordon - Breakthrough2022 Speaker

Mike Gordon

Chief Executive Officer, ArisGlobal Chairman of the Board

Mike Gordon is the CEO of ArisGlobal, a global life sciences technology provider with innovative and market leading solutions. He also serves as Chairman of its Board since 2020. Mike is a seasoned professional with a well-established background in global leadership roles, mainly within technology-focused organizations. Prior to taking Arisglobal’s CEO role in 2022 he was CEO of Altus Group, a public company in the Commercial Real Estate sector, where he led its transformation into a cloud-based software, data, and analytics company through a renewed focus on sales, reworking solutions, and improving customer retention and satisfaction. Preceding Altus Group, Mike served on the leadership team at Callcredit Information Group as CEO, where he oversaw a successful transformation of the business and an eventual sale to Transunion. Before Callcredit Information, Mike served as FICO’s Executive Vice President of Sales, Services, and Marketing, after working in various roles of increasing responsibility across the company’s banking, insurance, retail, health care and pharmaceutical markets. Before joining FICO in 2005, he spent more than 13 years in the financial services industry. As a vice president at Capgemini (formerly Ernst & Young Consulting LLP) his competency was in providing strategic and operational solutions to banking and insurance providers, leading the Insurance Center of Excellence and Solutions.
Mike also currently serves on the board of directors of three technology companies, Fintech, Hometrack, and Constructonline. He received a BS in Industrial Engineering / Operations Research from Northwestern University and an MBA in Finance and Business Economics from The University of Chicago Graduate School of Business.

Mike Gordon - Breakthrough2022 Speaker
Mike Gordon

Chief Executive Officer, ArisGlobal Chairman of the Board

Mike Gordon is the CEO of ArisGlobal, a global life sciences technology provider with innovative and market leading solutions. He also serves as Chairman of its Board since 2020. Mike is a seasoned professional with a well-established background in global leadership roles, mainly within technology-focused organizations. Prior to taking Arisglobal’s CEO role in 2022 he was CEO of Altus Group, a public company in the Commercial Real Estate sector, where he led its transformation into a cloud-based software, data, and analytics company through a renewed focus on sales, reworking solutions, and improving customer retention and satisfaction. Preceding Altus Group, Mike served on the leadership team at Callcredit Information Group as CEO, where he oversaw a successful transformation of the business and an eventual sale to Transunion. Before Callcredit Information, Mike served as FICO’s Executive Vice President of Sales, Services, and Marketing, after working in various roles of increasing responsibility across the company’s banking, insurance, retail, health care and pharmaceutical markets. Before joining FICO in 2005, he spent more than 13 years in the financial services industry. As a vice president at Capgemini (formerly Ernst & Young Consulting LLP) his competency was in providing strategic and operational solutions to banking and insurance providers, leading the Insurance Center of Excellence and Solutions.
Mike also currently serves on the board of directors of three technology companies, Fintech, Hometrack, and Constructonline. He received a BS in Industrial Engineering / Operations Research from Northwestern University and an MBA in Finance and Business Economics from The University of Chicago Graduate School of Business.

Heidi Hattendorf

VP- Head of Marketing, ArisGlobal

Heidi Hattendorf is the Vice President, Head of Marketing at ArisGlobal, building and delivering a world-class integrated brand and marketing strategy. Heidi brings a strong blend of technology and commercial experience with deep expertise in GTM/Go-to-Market strategies, SaaS/Cloud models, digital transformation and innovation. Prior to ArisGlobal, she oversaw Marketing efforts at an influential intelligent automation company. Before that, she held leadership roles at Motorola in various business lines across Product, Marketing and Business Development. Heidi has extensive international expat experience and holds two patents in software. In addition to her professional accolades, Heidi holds a Bachelor’s in Marketing, plus MBA, and is certified in Digital Transformation. She is passionate about translating market needs into real solutions that improve lives and deliver results.

Heidi Hattendorf

VP- Head of Marketing, ArisGlobal

Heidi Hattendorf is the Vice President, Head of Marketing at ArisGlobal, building and delivering a world-class integrated brand and marketing strategy. Heidi brings a strong blend of technology and commercial experience with deep expertise in GTM/Go-to-Market strategies, SaaS/Cloud models, digital transformation and innovation. Prior to ArisGlobal, she oversaw Marketing efforts at an influential intelligent automation company. Before that, she held leadership roles at Motorola in various business lines across Product, Marketing and Business Development. Heidi has extensive international expat experience and holds two patents in software. In addition to her professional accolades, Heidi holds a Bachelor’s in Marketing, plus MBA, and is certified in Digital Transformation. She is passionate about translating market needs into real solutions that improve lives and deliver results.

Jim Hilferty Headshot

Jim Hilferty

AVP, Regulatory Product, ArisGlobal

Jim has 20+ years of experience in life sciences performing multiple roles within regulatory product and services. He has a well-rounded understanding of the drug management process, with focus in regulatory management, publishing, and authoring. His experience includes leading regulatory product, technical services, partnership programs, and designing products, processes, and integrations across departments and organizations.

Jim Hilferty Headshot
Jim Hilferty

AVP, Regulatory Product, ArisGlobal

Jim has 20+ years of experience in life sciences performing multiple roles within regulatory product and services. He has a well-rounded understanding of the drug management process, with focus in regulatory management, publishing, and authoring. His experience includes leading regulatory product, technical services, partnership programs, and designing products, processes, and integrations across departments and organizations.

Kelly Hnat

Kelly Hnat

Principal, K2 Consulting

Kelly is a recognized industry leader in RIM and IDMP with over 20 years experience in the pharmaceutical industry, the last 11 focused on Regulatory Affairs. She has led both IT and RIM/Reg Ops organizations in several companies and has overseen implementation of large-scale global systems and processes. Kelly is passionate about the possibilities for pharma companies to improve productivity and compliance through process-focused management of critical data. She is an industry leader on the EMA SPOR Task Force and its PMS subteam and is also involved in ISO TC/215.

Kelly Hnat
Kelly Hnat

Principal, K2 Consulting

Kelly is a recognized industry leader in RIM and IDMP with over 20 years experience in the pharmaceutical industry, the last 11 focused on Regulatory Affairs. She has led both IT and RIM/Reg Ops organizations in several companies and has overseen implementation of large-scale global systems and processes. Kelly is passionate about the possibilities for pharma companies to improve productivity and compliance through process-focused management of critical data. She is an industry leader on the EMA SPOR Task Force and its PMS subteam and is also involved in ISO TC/215.

Pat Jenakanandhini

Pat Jenakanandhini

Chief Product Officer, ArisGlobal

Pat Jenakanandhini serves as ArisGlobal’s Chief Product Officer, where he oversees all product strategy and management functions. Prior to ArisGlobal, Pat served as Senior Vice President of Products at Accruent and Chief Technology Officer at BlueCielo, acquiring several years of experience building and delivering SaaS products including serving. During his tenure at Accruent, the company completed 5 acquisitions, built a strong product strategy driving growth that eventually led to Accruent being acquired by Fortive, a large publicly listed company. At BlueCielo, Pat was responsible for driving the transformation of the product, the business and the culture of product & engineering teams to focusing on SaaS. Pat is passionate about building great software that delights users, solves real business problems and provides a superior user experience. Pat lives just outside Boston, MA with his wife, 2 kids and dog. Pat loves building things, home automation, playing video games, and traveling the world. He has an MBA in Finance and dual degrees in Computer Science and Process & Piping Design.

Pat Jenakanandhini
Pat Jenakanandhini

Chief Product Officer, ArisGlobal

Pat Jenakanandhini serves as ArisGlobal’s Chief Product Officer, where he oversees all product strategy and management functions. Prior to ArisGlobal, Pat served as Senior Vice President of Products at Accruent and Chief Technology Officer at BlueCielo, acquiring several years of experience building and delivering SaaS products including serving. During his tenure at Accruent, the company completed 5 acquisitions, built a strong product strategy driving growth that eventually led to Accruent being acquired by Fortive, a large publicly listed company. At BlueCielo, Pat was responsible for driving the transformation of the product, the business and the culture of product & engineering teams to focusing on SaaS. Pat is passionate about building great software that delights users, solves real business problems and provides a superior user experience. Pat lives just outside Boston, MA with his wife, 2 kids and dog. Pat loves building things, home automation, playing video games, and traveling the world. He has an MBA in Finance and dual degrees in Computer Science and Process & Piping Design.

Swetha Kannan

Vice President of Business Transformation, ArisGlobal

Swetha Kannan is the Vice President of Business Transformation with ArisGlobal. She has been with the company for just under 5 years and has held various roles and portfolios, living in different global locations. She established and continues to manage the Global Organizational Readiness Center of Excellence, providing Organizational Change Management, Training, Business Process Reengineering & Documentation support for customers. She currently lives in Budapest where she moved in 2019 from the USA to be our Head of Professional Services for Europe & UK. Most recently she heads up the Business Transformation function for the company leading specific initiatives focused on quality, improved services delivery, and evolution of the culture of ArisGlobal through improved employee and customer experiences. In this capacity she also heads up Learning & Development for ArisGlobal.

Prior to joining ArisGlobal, Swetha has held transformational change portfolios across various health systems & medical services organizations in different parts of the globe including, the Ministry of Health Holdings in Singapore, the Royal College of Physicians & Surgeons of Canada, and with NYU Langone Health Center in Manhattan. She has also worked for SaaS organizations supporting their growth, transformation, and acquisition pursuits with companies including Orion Health based out of New Zealand, and Edifecs Inc., based in Seattle.

Swetha was the first of 500 globally Certified Change Management Professionals in 2018, is AMIA Certified in Medical Informatics, is a Canadian Board Certified Psychometrist, and holds a Masters Degree in Psychology from Rhodes University in South Africa.

Swetha Kannan

Vice President of Business Transformation, ArisGlobal

Swetha Kannan is the Vice President of Business Transformation with ArisGlobal. She has been with the company for just under 5 years and has held various roles and portfolios, living in different global locations. She established and continues to manage the Global Organizational Readiness Center of Excellence, providing Organizational Change Management, Training, Business Process Reengineering & Documentation support for customers. She currently lives in Budapest where she moved in 2019 from the USA to be our Head of Professional Services for Europe & UK. Most recently she heads up the Business Transformation function for the company leading specific initiatives focused on quality, improved services delivery, and evolution of the culture of ArisGlobal through improved employee and customer experiences. In this capacity she also heads up Learning & Development for ArisGlobal.

Prior to joining ArisGlobal, Swetha has held transformational change portfolios across various health systems & medical services organizations in different parts of the globe including, the Ministry of Health Holdings in Singapore, the Royal College of Physicians & Surgeons of Canada, and with NYU Langone Health Center in Manhattan. She has also worked for SaaS organizations supporting their growth, transformation, and acquisition pursuits with companies including Orion Health based out of New Zealand, and Edifecs Inc., based in Seattle.

Swetha was the first of 500 globally Certified Change Management Professionals in 2018, is AMIA Certified in Medical Informatics, is a Canadian Board Certified Psychometrist, and holds a Masters Degree in Psychology from Rhodes University in South Africa.

Dr. Isabel Kloer, MD MSc

Dr. Isabel Klör, MD MSc

Lead Patient Safety Physician,
Boehringer Ingelheim International GmbH

Isabel is a physician with 7 years of clinical experience in inpatient internal medicine, oncology, and intermediate/intensive care, and holds an MSc in Biology with a focus on developmental neuroscience. In 17 years in the pharmaceutical industry, she has held roles in Medical Imaging Methods/Software Development, Clinical Development, and Pharmacovigilance.

She joined Boehringer Ingelheim (BI) Global Pharmacovigilance in 2015. As Lead Patient Safety Physician, she was responsible for pharmacovigilance risk management for a variety of products in respiratory indications. Within the Strategic Data Analysis group of Patient Safety and Pharmacovigilance, she is currently Product Owner of a software solution for Benefit-Risk analysis, developed by BI in an agile framework.​ She is a member of efpia’s PV Data Analytics Subgroup.

Isabel is an enthusiast for data analysis that keeps in mind the complexities of the patients behind them and loves bringing together insights and people from various fields. Her research interests include digital health, data visualization, and causal inference.

Dr. Isabel Kloer, MD MSc
Dr. Isabel Klör, MD MSc

Lead Patient Safety Physician,
Boehringer Ingelheim International GmbH

Isabel is a physician with 7 years of clinical experience in inpatient internal medicine, oncology, and intermediate/intensive care, and holds an MSc in Biology with a focus on developmental neuroscience. In 17 years in the pharmaceutical industry, she has held roles in Medical Imaging Methods/Software Development, Clinical Development, and Pharmacovigilance.

She joined Boehringer Ingelheim (BI) Global Pharmacovigilance in 2015. As Lead Patient Safety Physician, she was responsible for pharmacovigilance risk management for a variety of products in respiratory indications. Within the Strategic Data Analysis group of Patient Safety and Pharmacovigilance, she is currently Product Owner of a software solution for Benefit-Risk analysis, developed by BI in an agile framework.​ She is a member of efpia’s PV Data Analytics Subgroup.

Isabel is an enthusiast for data analysis that keeps in mind the complexities of the patients behind them and loves bringing together insights and people from various fields. Her research interests include digital health, data visualization, and causal inference.

John Landy

Chief Technology Officer

Prior to joining ArisGlobal, John has held CTO positions at other SaaS-based companies and has almost 30 years of experience in the software industry. Most recently, John was the CTO at Sovos, a privately held global tax and compliance software company. During his 5 1/2 year tenure, John was responsible for Product Development, Cloud Operations, and Security. John helped grow the Sovos business by nearly 200%. Prior to Sovos, John was the CTO at Intralinks, a provider of secure workspaces serving the M&A market as well as offering products in Life Sciences for Study Startup and Safety Document Distribution.

John Landy

Chief Technology Officer

Prior to joining ArisGlobal, John has held CTO positions at other SaaS-based companies and has almost 30 years of experience in the software industry. Most recently, John was the CTO at Sovos, a privately held global tax and compliance software company. During his 5 1/2 year tenure, John was responsible for Product Development, Cloud Operations, and Security. John helped grow the Sovos business by nearly 200%. Prior to Sovos, John was the CTO at Intralinks, a provider of secure workspaces serving the M&A market as well as offering products in Life Sciences for Study Startup and Safety Document Distribution.

Jennifer Manochio

Jennifer Manochio

Senior Director | Global Safety Systems, WorldWide Patient Safety, BMS

Jennifer is Senior Director of the Global Safety Systems team within the World Wide Patient safety organization at Bristol Myers Squibb. In her 17 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
Jennifer Manochio

Senior Director | Global Safety Systems, WorldWide Patient Safety, BMS

Jennifer is Senior Director of the Global Safety Systems team within the World Wide Patient safety organization at Bristol Myers Squibb. In her 17 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.

Humaira Qureshi

Humaira Qureshi

CEO, Qinecsa Solutions

Humaira has over 20 years’ strategic and operational experience in clinical and post-marketing drug safety solutions. As CEO of Qinecsa, Humaira is spearheading a movement to bring together scientific expertise with technology and create world-leading solutions that address the challenges faced by the pharmacovigilance industry and advance drug safety solutions to the next level of innovation, expertise and customer excellence. Prior to 2022 Humaira led a number of global pharmacovigilance businesses, delivering growth through customer excellence she has implemented sustainable operating models to support and manage PV operational solutions for many of our diverse clients.

Humaira has a bachelor’s degree in Medicinal Biochemistry from Royal Holloway, University of London and a diploma in leadership from the Said Business School, University of Oxford. She is frequently invited to lecture, having presented on a range of pharmacovigilance topics at industry and academic events in the US, EU, and Asia, and has participated on a number of Global PV forums focusing on technology, sourcing, and process enablement.

Humaira Qureshi
Humaira Qureshi

CEO, Qinecsa Solutions

Humaira has over 20 years’ strategic and operational experience in clinical and post-marketing drug safety solutions. As CEO of Qinecsa, Humaira is spearheading a movement to bring together scientific expertise with technology and create world-leading solutions that address the challenges faced by the pharmacovigilance industry and advance drug safety solutions to the next level of innovation, expertise and customer excellence. Prior to 2022 Humaira led a number of global pharmacovigilance businesses, delivering growth through customer excellence she has implemented sustainable operating models to support and manage PV operational solutions for many of our diverse clients.

Humaira has a bachelor’s degree in Medicinal Biochemistry from Royal Holloway, University of London and a diploma in leadership from the Said Business School, University of Oxford. She is frequently invited to lecture, having presented on a range of pharmacovigilance topics at industry and academic events in the US, EU, and Asia, and has participated on a number of Global PV forums focusing on technology, sourcing, and process enablement.

Robin Schilling

Global Product Manager, IDMP, ArisGlobal

With 15+ years experience managing the strategic development and implementation of global technology programs, Robin is experienced in regulatory affairs, publishing support and technology operations, including leading and collaborating with diverse, international teams. Her passion is helping individuals and organizations grow and excel by identifying opportunities to create value and optimize process efficiencies while remaining compliant with regulatory expectations and good ethical practices. She is a member of EMA SPOR Task Force and an active participant in the IRISS IDMP Working Group.

Robin Schilling

Global Product Manager, IDMP, ArisGlobal

With 15+ years experience managing the strategic development and implementation of global technology programs, Robin is experienced in regulatory affairs, publishing support and technology operations, including leading and collaborating with diverse, international teams. Her passion is helping individuals and organizations grow and excel by identifying opportunities to create value and optimize process efficiencies while remaining compliant with regulatory expectations and good ethical practices. She is a member of EMA SPOR Task Force and an active participant in the IRISS IDMP Working Group.

Russ Schreiber

Chief Operating Officer, ArisGlobal

Based out of New York City, Russ is focused on our Professional Services organization along with multiple operational areas of the company in his newly created role of Chief Operating Officer.

Prior to joining ArisGlobal, Russ served as the Chief Operating Officer for the Altus Group’s Global Property Tax business.  A former Big 4 consulting partner, executive and technology sales leader, Russ has held P&L responsibility for large divisions, implemented compliance and productivity measures, turned around challenged businesses and projects.  He has held senior leadership roles with Altus, FICO, Swiss Re, and Ernst & Young in a career spanning close to 3 decades.

Russ Schreiber

Chief Operating Officer, ArisGlobal

Based out of New York City, Russ is focused on our Professional Services organization along with multiple operational areas of the company in his newly created role of Chief Operating Officer.

Prior to joining ArisGlobal, Russ served as the Chief Operating Officer for the Altus Group’s Global Property Tax business.  A former Big 4 consulting partner, executive and technology sales leader, Russ has held P&L responsibility for large divisions, implemented compliance and productivity measures, turned around challenged businesses and projects.  He has held senior leadership roles with Altus, FICO, Swiss Re, and Ernst & Young in a career spanning close to 3 decades.

Marina Suvakov

Global Head Product Safety Surveillance, 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, 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.

Aman Wasan

Chief Commercial Officer, ArisGlobal

 

Aman Wasan

Chief Commercial Officer, ArisGlobal

 

Gary Wilson

Managing Director & Co-Founder of CorrIT and creator of the SPORIFY web application.

Gary holds a BSc (Hons) in Computer Science from Griffith College Dublin and has over 18 years industry and consultancy experience. Since the launch of SPORIFY in 2017, CorrIT have assisted many pharma organisations and regulators with their implementation and integration of SPOR Master Data Services and Controlled Vocabularies as they move towards their implementation of IDMP.

Gary Wilson

Managing Director & Co-Founder of CorrIT and creator of the SPORIFY web application.

Gary holds a BSc (Hons) in Computer Science from Griffith College Dublin and has over 18 years industry and consultancy experience. Since the launch of SPORIFY in 2017, CorrIT have assisted many pharma organisations and regulators with their implementation and integration of SPOR Master Data Services and Controlled Vocabularies as they move towards their implementation of IDMP.

Rich Wolf

Global Head of Pv Operations, Global Clinical Safety & Pharmacovigilance (GCSP), CSL Behring

Rich Wolf is the Executive Director, Pv Operations in the GCSP group at CSL Behring.  He directs Case Management, Medical Evaluation, Manufacturing Site Pharmacovigilance Representative, Pv Business Process and Technology, and Pv Combination Products & Device Center of Excellence groups.

Rich has been with CSL for the past 7 years having spent the prior 12 years working across many areas in Global Medical Safety at Johnson and Johnson.

Prior to joining the pharmaceutical industry Rich spent 5 years at Accenture and was an Airborne Ranger qualified Infantry Officer.  He earned his undergraduate degree from the University of Richmond and MBA from Rutgers University.

CSL Behring is a global leader in the plasma protein biotherapeutics industry.  They research, develop, manufacture and market biotherapies that are used to treat serious and rare conditions.

Rich is an advocate for Project Healing Waters Fly Fishing – Project Healing Waters Fly Fishing, Inc. is dedicated to the physical and emotional rehabilitation of disabled active military service personnel and disabled veterans through fly fishing and associated activities including education and outings.

Rich Wolf

Global Head of Pv Operations, Global Clinical Safety & Pharmacovigilance (GCSP), CSL Behring

Rich Wolf is the Executive Director, Pv Operations in the GCSP group at CSL Behring.  He directs Case Management, Medical Evaluation, Manufacturing Site Pharmacovigilance Representative, Pv Business Process and Technology, and Pv Combination Products & Device Center of Excellence groups.

Rich has been with CSL for the past 7 years having spent the prior 12 years working across many areas in Global Medical Safety at Johnson and Johnson.

Prior to joining the pharmaceutical industry Rich spent 5 years at Accenture and was an Airborne Ranger qualified Infantry Officer.  He earned his undergraduate degree from the University of Richmond and MBA from Rutgers University.

CSL Behring is a global leader in the plasma protein biotherapeutics industry.  They research, develop, manufacture and market biotherapies that are used to treat serious and rare conditions.

Rich is an advocate for Project Healing Waters Fly Fishing – Project Healing Waters Fly Fishing, Inc. is dedicated to the physical and emotional rehabilitation of disabled active military service personnel and disabled veterans through fly fishing and associated activities including education and outings.

Beena Wood

VP, Safety Product Management, ArisGlobal

Beena Wood has been in the Information technology space building products for over 26 years, with experience across multiple domains. She has led Engineering as well as Product Management teams. She comes from Oracle where she was in the Pharmacovigilance space for over 15 years, leading their Argus Safety Product Management teams, and most recently from Anju Software leading their Medical Affairs space, and loves building solutions to keep patients safe.

She is excited to be part of ArisGlobal team and feels fortunate being part of something that matters to human lives. Beena lives in Portland in the beautiful Pacific NW, with her husband, a young daughter who loves to read, write, and dance, and a mini labradoodle. Beena’s passion, apart from being part of Life sciences solutions that keeps patients safe, is to help kids that doesn’t have the means to have better access to education, loves the ocean and hikes with her family, and to meditate.

Beena Wood

VP, Safety Product Management, ArisGlobal

Beena Wood has been in the Information technology space building products for over 26 years, with experience across multiple domains. She has led Engineering as well as Product Management teams. She comes from Oracle where she was in the Pharmacovigilance space for over 15 years, leading their Argus Safety Product Management teams, and most recently from Anju Software leading their Medical Affairs space, and loves building solutions to keep patients safe.

She is excited to be part of ArisGlobal team and feels fortunate being part of something that matters to human lives. Beena lives in Portland in the beautiful Pacific NW, with her husband, a young daughter who loves to read, write, and dance, and a mini labradoodle. Beena’s passion, apart from being part of Life sciences solutions that keeps patients safe, is to help kids that doesn’t have the means to have better access to education, loves the ocean and hikes with her family, and to meditate.

Breakthrough by the Numbers

50+

Top Biopharmas Represented

100's

Life Science Leaders Attending

25+

Inspiring Speakers

Hear from past attendees

Johnson and Johnson logo

Johnson & Johnson

“This is a great opportunity to connect and build a bigger partnership with life sciences peers and regulators”

Boehringer Ingelheim logo

Boehringer Ingelheim

“A tremendous event to learn from industry thought leaders and move life sciences forward”

Breakthrough 2021 Highlights

  • Listen to leading voices in life sciences across two days of thought-provoking conversations
  • Learn directly from ArisGlobal customers and product leaders as they share R&D technology best practices and successes
  • Complimentary attendance for members of the life sciences industry

Contact Us

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