Breakthrough by the Numbers

Lisa Arbogast is the Industry Principal for Life Sciences at Snowflake.  She has over 35 years of experience in the Life Science industry spanning the value chain.  Transformation and innovation have been and continue to be Lisa’s passion. Today, she is focused on unleashing data insights and analytics, by mobilizing data within the industry ecosystem, to accelerate collaboration and scientific innovation to improve the lives of patients everywhere.

Stella Chang, MPH is the Senior Vice President of Life Sciences at OMNY Health where she oversees partnerships with Life Sciences and research companies to leverage OMNY Health’s real world data and clinical research solutions. Ms. Chang has extensive experience in developing the strategy, design and support of real-world evidence and data analytics across the healthcare industry. Prior to joining OMNY Health, Stella was Vice President of Life Sciences Solutions at Veradigm, where she led the development of the largest EHR-sourced real-world data and managed a portfolio of clinical registries and SaaS solutions. At Truven Health Analytics, Stella managed several large program evaluation and analytics projects for Federal agencies (CMS, AHRQ, CDC, and state APCDs), and oversaw the MarketScan Database portfolio. At Veradigm and Truven, Ms. Chang was the lead researcher for the FDA Sentinel Operations and Innovation Center and lead these organizations’ collaboration with OMOP-OHDSI, FDA COVID-19 Accelerator, and other public-private initiatives in the use of real world data for drug safety and surveillance. Ms. Chang has an MPH from Yale School of Public Health and a BA in Biology from Johns Hopkins University.

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.

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 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.

Claudia Lehmann serves as Vice President of Patient Safety & Pharmacovigilance Operations & Systems for Boehringer Ingelheim. Prior to this role, she was leading Biostatistics and Data Management Europe within Boehringer Ingelheim, Claudia is a member of the ICH MedDRA Management Committee and an SME on the Eudravigilance EWG.

Claudia has been trained in medical information management at an affiliation of the University of Ulm, Germany

Petruta Manea is the Associate Director of Regulatory Operations at Astellas Pharma.  In her current role she supported the implementation of the LifeSphere RIMS and related data management processes, and is currently playing a critical role in leading several workstreams for the IDMP implementation project. Prior to Astellas, Petruta spent 14 years in the Medical Device industry, as the Principle Engineer of Quality and Labeling Development at CareFusion, where one of her responsibilities was to support the UDI implementation, leading the GUDID data gathering and management in preparation for the data submissions. Throughout her career in the pharmaceutical and medical device industry, Petruta’s passion has been centered around data management and ensuring high-quality data while adhering to compliance requirements. Petruta has a master’s in mechanical engineering and a bachelors in Mechanical Engineering for Precision Mechanics and Medical Devices.

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.

Nidhir leads the Safety Insights team in the Global Safety and Regulatory Sciences department at Biogen. The team provides safety data expertise, analytics, and reporting & solutions for pharmacovigilance.

He has over 14 years’ experience in the pharmaceutical industry leading complex transformation projects and process improvement initiatives across functions in R&D. Previously, Nidhir co-founded a consulting company that also developed a healthcare follow-up and risk management software for OB/GYN Health Centers to ensure timely patient recall.

Nidhir has a Bachelor of Science in Statistics, an MBA from Loyola University Chicago and a Master of Public Policy degree from The University of Chicago and is an ASQ Certified Six Sigma Black Belt.

Vanja Primorac is a seasoned Quality Assurance professional with over 10 years of experience in the field. Prior to joining the IT industry, Vanja worked in GlaxoSmithKline, where she held the position of Senior Quality Executive and Responsible Person.

In her current role as a Product Manager and Life Sciences Consultant, Vanja is responsible for contributing to the development and enhancement of software solutions, as well as providing expertise to clients.

Throughout her career, Vanja has been passionate about helping companies deliver high-quality products and services to their customers, whether they are patients in need of high-quality medicinal products or pharmaceutical companies in need of software solutions.

Mitesh Rao, MD is the Founder and CEO of OMNY Health, a venture-backed company revolutionizing how healthcare data is shared and valued. With a national network covering over 55M lives across 42 states, OMNY serves as the foundational informational layer to support real world data needs and build data-driven relationships across the healthcare continuum. OMNY’s infrastructure is a collaborative ecosystem, where data serves as the common language to accelerate healthcare innovation. As an Assistant Professor of Emergency Medicine at Stanford, prior to founding OMNY, Dr. Rao served as a physician executive at both Stanford Healthcare and Northwestern Medicine. As a physician leader, Dr. Rao has helped implement systems-level improvements for quality and safety in institutions across the country, as well as initiatives to advance healthcare quality on a national level. Throughout his career, Dr. Rao has helped implement and scale new technologies within the clinical venue and has served as an advisor to technology companies across the country to help guide the development of innovative solutions to sustainably impact patient care.

Renato Rjavec is Director of Product Management at Amplexor Life Sciences and is responsible for its product portfolio. Over the last sixteen years at the company, he has held various positions in delivery, development and finally product management organization, where he gained deep insight in the industry needs and extensive experience in the definition, development and implementation of end-to-end regulatory and quality solutions for the global life sciences industry. He is a strong advocate of holistic data-driven approach empowering the efficiency of the life sciences industry.

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.

Daniel Tripp is the VP of Compliance Strategy & Analytics, BRQC and is responsible for cross sector Pharmacovigilance Quality and Compliance oversight, including global Health Authority Adverse Event and Aggregate Report compliance and quality, non-conformance governance and oversight, process risk management, inspection support, and training and procedural document development.

Daniel joined Johnson & Johnson after fifteen years at Pfizer Inc. where he served in a variety of positions including most recently as Sr. Director Medical Quality Assurance. In this position Daniel was responsible for quality assurance and auditing activities for the Cardiovascular therapeutic area. Other roles at Pfizer included Director, Inspection Management where he led inspection preparation and management for global Pharmacovigilance and Good Clinical Practice inspections and Director, Quality Safety Alliances where he was responsible for development of a PV CAPA database, a compliance metrics reporting application and oversaw reporting of individual case safety reports to worldwide regulatory authorities and local safety offices.

Daniel began his career working at the Autistic Treatment Center in Dallas Texas. He has a Bachelor’s degree in Psychology from the University of North Texas, an MBA from Centenary College and a Six Sigma Black Belt Certificate from Villanova University. He lives in Chester, NJ with his wife Marisa and their three children – Phineas (18), Dashel (16) and Willow (11).

Wasan is an expert in general management and commercial leadership with a deep understanding and knowledge of drug safety and clinical research. Since joining ArisGlobal in 2018, Wasan has excelled in six different positions, most recently as Senior Vice President of Global Commercials, where he managed global enterprise business. Before joining the ArisGlobal team, Wasan worked for Bioclinica as the company’s Global Head of Safety and Regulatory Services.

Gary is Managing Director & Co-Founder of CorrIT and creator of the SPORIFY web application. Gary holds a BSc (Hons) in Computer Science and has over 18 years industry and consultancy experience. Since the launch of SPORIFY in 2017, CorrIT have assisted many organisations and regulators with their implementation and integration of SPOR Master Data Services as they move towards IDMP in Europe and has a sharp focus on a data first approach with global reference data management and interoperability of systems. Gary is a member of the SPOR Key Use Group and IDMP inter-association group.

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.

Kristy Wort serves as the Vice President of Clinical Operations for Total Diversity Clinical Trial Management (TOTAL). In this role, she has strategic oversight across clinical operations.

Before joining TOTAL in 2017, Wort started her career at a research site as a Recruitment Manager and eventually moved into a position as a Global Project Manager. She has more than 20 years of experience in operational delivery in clinical trials, including global regulations, cultures, and customs relevant to the successful implementation of projects in the clinical trial industry.

Wort has a vast array of therapeutic experience, including women’s health, dermatology, hematology/oncology, rare disease, nervous system and endocrine/metabolic just to name a few.

Kristy earned a Bachelor’s degree in marketing from the Intercontinental University in Atlanta. She holds a white belt certification in risk-based management.