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Join us in Boston, MA to Discuss How to Advance Life Sciences R&D

With Innovation, Automation, and Intelligent Analytics.

October 3rd, 2022

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About Breakthrough 2022

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

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 & Opening Keynote; Data and Analytics Role in Life Sciences

- Mike Gordon, CEO of ArisGlobal

Panel Discussion: The Future of Safety.
Are you ready?

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

Panel Discussion: Trends in Regulatory Affairs

- Jim Hilferty, ArisGlobal
- Steve Gens, Gens and Associates
- Kelly Hnat, 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 Collborating 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

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
Mike Gordon - Breakthrough2022 Speaker

Mike Gordon

Chief Executive Officer, ArisGlobal Chairman of the Board

With more than 18 years of experience, Mike Gordon has held several senior-level global leadership roles of increasing scope and responsibility, mainly within technology-focused organizations. Mr. Gordon’s most recent corporate leadership role was with Callcredit Information Group as Chief Executive Officer, where he oversaw a successful transformation of the business and an eventual sale to Transunion. Mr. Gordon also currently serves on the board of directors of three technology companies, Fintech, Hometrack and Constructonline.

Prior to Callcredit Information, Mr. Gordon served as FICO’s Executive Vice President of Sales, Services, and Marketing, after serving in various roles of increasing responsibility across the company’s banking, insurance, retail, health care and pharmaceutical markets. Before joining FICO in 2005, Mr. Gordon 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.

Mr. Gordon 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

With more than 18 years of experience, Mike Gordon has held several senior-level global leadership roles of increasing scope and responsibility, mainly within technology-focused organizations. Mr. Gordon’s most recent corporate leadership role was with Callcredit Information Group as Chief Executive Officer, where he oversaw a successful transformation of the business and an eventual sale to Transunion. Mr. Gordon also currently serves on the board of directors of three technology companies, Fintech, Hometrack and Constructonline.

Prior to Callcredit Information, Mr. Gordon served as FICO’s Executive Vice President of Sales, Services, and Marketing, after serving in various roles of increasing responsibility across the company’s banking, insurance, retail, health care and pharmaceutical markets. Before joining FICO in 2005, Mr. Gordon 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.

Mr. Gordon 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.

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.

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.

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.

Daniel Berglund

Board Member, Partner at 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, Partner at 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.

Khaudeja Bano headshot

Khaudeja Bano

Vice President of Combination Product Quality, Amgen

Khaudeja is a Physician with a Masters in Clinical Research, Pharmaceutical engineering Certification, a Database Administrator and a certified Project Management Professional.

Khaudeja has more than 25 years’ professional experience, including clinical practice. She has held several global medical positions at Guidant, Abbott, AbbVie Inc and now Amgen. Her career includes global medical / clinical and safety leadership roles in devices, diagnostics, pharmaceuticals and combination products.

She currently serves as the chair for the Post Marketing Safety working group for the Combination Product Coalition (CPC).

Khaudeja Bano headshot
Khaudeja Bano

Vice President of Combination Product Quality, Amgen

Khaudeja is a Physician with a Masters in Clinical Research, Pharmaceutical engineering Certification, a Database Administrator and a certified Project Management Professional.

Khaudeja has more than 25 years’ professional experience, including clinical practice. She has held several global medical positions at Guidant, Abbott, AbbVie Inc and now Amgen. Her career includes global medical / clinical and safety leadership roles in devices, diagnostics, pharmaceuticals and combination products.

She currently serves as the chair for the Post Marketing Safety working group for the Combination Product Coalition (CPC).

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.

 

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.

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.

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.

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.

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

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.

Ali Faruqi

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

 

Ali Faruqi

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

 

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

Breakthrough 2022 JOIN US IN BOSTON ON OCT 3        REGISTER TODAY