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Committee & Speaker Biographies

Committee & Speaker Biographies

2020 PDA Pharmaceutical Manufacturing Data Science Workshop

April 2, 2020

  • Arne Zilian

    Arne Zilian, PhD

    Novartis

    Arne has 20 years of experience in the Pharmaceutical Industry. He has worked in Analytical Development, Chemical Development, Pharmaceutical Development, Manufacturing Operational Excellence and Manufacturing Science and Technology.

    In Novartis, he is the global program lead for ‘Predictive Processing’ and for Continued Process Verification. He serves as the lead author for the corporate quality standards for process validation and for CPV. Over the last years, he was instrumental in building the Manufacturing Science and Technology organization.

    In PDA, he is engaged in the interest groups for CPV and Manufacturing Intelligence.

    Arne holds a Ph.D. in Analytical Chemistry and a Master in Chemistry. He is also a Agile/ Scrum master and certified Kepner Tregoe trainer for situation, decision and problem analysis.

  • Crystal Black

    Crystal L. Black, MA

    Bigfinite

    As Director of Marketing for Bigfinite, Crys Black owns and directs the marketing strategy for Bigfinite's award-winning AI-informed data analytics solutions for the life sciences industry. She is responsible for building the marketing analytics infrastructure, processes, and dashboards that inform B2B marketing decisions across the organization, and is deeply involved in brand strategy, promotions, content calendar, and strategic partnerships to support Bigfinite's AI platform offerings. Her accumulated experience spans partner/channel marketing, martech/marketing, automation/ABM, web and search marketing, event planning, yearly planning, branding and identity, global marketing, and contract negotiations.

    Functionally, her background is extensive with experience in partner/channel marketing, martech/marketing, automation/ABM, web and search marketing, event planning, yearly planning, branding and identity, global marketing, and contract negotiations.

    She earned her B.A. and M.A. in English from Virginia Polytechnic Institute and State University and is a talented nature photographer and Jeep enthusiast.

  • Frank Gorski

    Frank L. Gorski

    Merck & Co., Inc.

    Frank leads the GMP Technology Audit organization within Merck's Manufacturing Division (MMD). His team independently monitors MMD’s internal and external IT control environment to ensure compliance of Merck's digital assets. These assets include Merck's data centers, enterprise applications, shop floor and laboratory systems as well as suppliers of software and managed IT services.

    Frank began his career at Merck as an Automation Engineer supporting vaccine and sterile operations. A pre-approval inspection changed his career trajectory towards quality and compliance. This interest led him to Wyeth Pharmaceuticals as a GxP IT Quality Auditor. At Wyeth he moved on through various quality, compliance and leadership roles that included managing product quality complaints and global quality systems for the manufacturing division. After Pfizer’s acquisition of Wyeth, he built and managed the Pfizer global IT audit program in support of Sarbanes-Oxley, Data Privacy, Information Security, and GxP regulations.

    He holds a Bachelor of Science in Electrical & Computer Engineering from Drexel University and has a Six-Sigma Greenbelt certification.

  • Ghada N. Haddad, PhD

    Merck & Co., Inc.

    Ghada Haddad is currently an Executive Director, leading the Global cGMP and Compliance Auditing Organization at Merck & Company. Prior to that she was the Head of the Global Quality Risk Management Center of Excellence, building a team of experts to develop and implement a robust and sustainable QRM program. She holds a chemistry degree and a PhD and an MBA with over 22 years of experience, working in the Biotech and Pharmaceutical industries in the areas of Quality Risk Management (QRM), Validation, Quality Systems and Regulatory, including research, management (people and projects), process development, auditing, regulatory agency inspection, change control and validation. Haddad was the chair of the Paradigm Change in Manufacturing (PCMO) initiative: QRM in Packaging and Labeling, QRM for the Design, Qualification, and Operation of Manufacturing Systems task forces, co-chaired the Aging Facilities Points to Consider and co-chaired the 2018 and 2019 Annual PDA Conferences and the 2019 PDA Quality Week. She is also a faculty member for PDA’s Training and Research Institute and a Science Advisory Board member and a member of the PDA Board of Directors.

  • Richard Love

    Richard N. Love

    HarborView LLC

    Richard Love is the founder of HarborView LLC (www.harborview.com) which provides Business Intelligence (BI) consulting services and products for FDA regulated industries. HarborView clients include L7 Informatics, Genentech/Roche, Ligand, Amgen, Kite Pharma, Baxter. HarborView is also working with St Gallen to develop an advanced analytics app for their OPEX benchmarking database.

    Richard has a BS Chemical Engineering from Cornell University and has held Global Technical Operations and Quality positions in the Bio/Pharmaceutical industry, most recently for GlaxoSmithKline.

    At GlaxoSmithKline, Richard was immersed in Lean principles, tools and culture and has since incorporated Lean in his business to provide real value to his clients. He takes a 5S for Data approach in building his management and shop floor analytics reports. This approach enables clients to dramatically improve information flow within the value stream—traditionally a difficult lift.

    His skill set/experience includes Power BI, dimensional modeling, systems analysis, business intelligence report design/implementation, database design/implementation, GxP, 21CFR211, 21CFR820, process, computer, facility validation, supply chain management, protein chemistry, manufacturing process development and scale-up, Quality by Design, Design of Experiments, Lean Quality/Operations, Six Sigma. VBA Expert, MS Access, Excel. He recently developed and deployed a Quick Base app for a global pharma-client.

  • Toni Manzano

    Toni Manzano, PhD

    Bigfinite

    Toni Manzano is Cofounder and CSO of Bigfinite, a SaaS company that is transforming manufacturing operations with the use of AI and IIoT technologies for pharmaceutical and biotech companies. For over two decades, he has led software projects for international pharmaceutical companies covering the entire production process and supply chain. Today, Toni is a part of the scientific committee with PDA Europe and with the AI Xavier Manufacturing team. He worked as a researcher at the University of Barcelona as a physicist and teaches big data and artificial intelligence in postgraduate courses at the UAB. He is also a member of the Science Experts in the Spanish Parliament on big data and artificial intelligence. He has written numerous articles and holds a dozen international patents related to the encryption, transmission, storage, and processing of large volumes of data for regulated environments in the cloud.

  • Vasu Rangadass

    Vasu Rangadass, PhD

    L7 Informatics, Inc.

    Dr. Vasu Rangadass, PhD is the CEO at L7 Informatics, Inc. provides software and services that enable synchronized solutions for science + health. L7’s novel Enterprise Science Platform (ESP) is a scientific process and data management (SPDM) solution that enables life science and healthcare companies to connect people, processes, and systems to accelerate discoveries and drive precision healthcare.

    Prior to L7 Informatics, Dr. Rangadass was the Chief Strategy Officer at NantHealth following its acquisition of Net.Orange, the company he founded to provide an enterprise-wide platform - Clinical Operating System (cOS) to simplify and optimize care delivery processes in health systems. As CEO of Net.Orange, Vasu is patented and developed an innovative healthcare framework (cOS™ - Clinical Operating System™) that results in superior performance for Healthcare Organizations and revolutionized the way healthcare IT systems are architected.

    Holding several patents in “Master Data Management” (MDM), Enterprise "Operating Systems", and Workflow Management (as well as extensive process experience in the Life Sciences, Healthcare, Automotive, High-Tech, Consumer Packaged Goods and Retail industries), Vasu has extraordinary proven experience in large-scale enterprise transformation. 

  • Frank Gorski

    Frank L. Gorski

    Merck & Co., Inc.

    Frank leads the GMP Technology Audit organization within Merck's Manufacturing Division (MMD). His team independently monitors MMD’s internal and external IT control environment to ensure compliance of Merck's digital assets. These assets include Merck's data centers, enterprise applications, shop floor and laboratory systems as well as suppliers of software and managed IT services.

    Frank began his career at Merck as an Automation Engineer supporting vaccine and sterile operations. A pre-approval inspection changed his career trajectory towards quality and compliance. This interest led him to Wyeth Pharmaceuticals as a GxP IT Quality Auditor. At Wyeth he moved on through various quality, compliance and leadership roles that included managing product quality complaints and global quality systems for the manufacturing division. After Pfizer’s acquisition of Wyeth, he built and managed the Pfizer global IT audit program in support of Sarbanes-Oxley, Data Privacy, Information Security, and GxP regulations.

    He holds a Bachelor of Science in Electrical & Computer Engineering from Drexel University and has a Six-Sigma Greenbelt certification.

  • Richard Love

    Richard N. Love

    HarborView LLC

    Richard Love is the founder of HarborView LLC (www.harborview.com) which provides Business Intelligence (BI) consulting services and products for FDA regulated industries. HarborView clients include L7 Informatics, Genentech/Roche, Ligand, Amgen, Kite Pharma, Baxter. HarborView is also working with St Gallen to develop an advanced analytics app for their OPEX benchmarking database.

    Richard has a BS Chemical Engineering from Cornell University and has held Global Technical Operations and Quality positions in the Bio/Pharmaceutical industry, most recently for GlaxoSmithKline.

    At GlaxoSmithKline, Richard was immersed in Lean principles, tools and culture and has since incorporated Lean in his business to provide real value to his clients. He takes a 5S for Data approach in building his management and shop floor analytics reports. This approach enables clients to dramatically improve information flow within the value stream—traditionally a difficult lift.

    His skill set/experience includes Power BI, dimensional modeling, systems analysis, business intelligence report design/implementation, database design/implementation, GxP, 21CFR211, 21CFR820, process, computer, facility validation, supply chain management, protein chemistry, manufacturing process development and scale-up, Quality by Design, Design of Experiments, Lean Quality/Operations, Six Sigma. VBA Expert, MS Access, Excel. He recently developed and deployed a Quick Base app for a global pharma-client.

  • Toni Manzano

    Toni Manzano, PhD

    Bigfinite

    Toni Manzano is Cofounder and CSO of Bigfinite, a SaaS company that is transforming manufacturing operations with the use of AI and IIoT technologies for pharmaceutical and biotech companies. For over two decades, he has led software projects for international pharmaceutical companies covering the entire production process and supply chain. Today, Toni is a part of the scientific committee with PDA Europe and with the AI Xavier Manufacturing team. He worked as a researcher at the University of Barcelona as a physicist and teaches big data and artificial intelligence in postgraduate courses at the UAB. He is also a member of the Science Experts in the Spanish Parliament on big data and artificial intelligence. He has written numerous articles and holds a dozen international patents related to the encryption, transmission, storage, and processing of large volumes of data for regulated environments in the cloud.

  • Vasu Rangadass

    Vasu Rangadass, PhD

    L7 Informatics, Inc.

    Dr. Vasu Rangadass, PhD is the CEO at L7 Informatics, Inc. provides software and services that enable synchronized solutions for science + health. L7’s novel Enterprise Science Platform (ESP) is a scientific process and data management (SPDM) solution that enables life science and healthcare companies to connect people, processes, and systems to accelerate discoveries and drive precision healthcare.

    Prior to L7 Informatics, Dr. Rangadass was the Chief Strategy Officer at NantHealth following its acquisition of Net.Orange, the company he founded to provide an enterprise-wide platform - Clinical Operating System (cOS) to simplify and optimize care delivery processes in health systems. As CEO of Net.Orange, Vasu is patented and developed an innovative healthcare framework (cOS™ - Clinical Operating System™) that results in superior performance for Healthcare Organizations and revolutionized the way healthcare IT systems are architected.

    Holding several patents in “Master Data Management” (MDM), Enterprise "Operating Systems", and Workflow Management (as well as extensive process experience in the Life Sciences, Healthcare, Automotive, High-Tech, Consumer Packaged Goods and Retail industries), Vasu has extraordinary proven experience in large-scale enterprise transformation. 

  • Arne Zilian

    Arne Zilian, PhD

    Novartis

    Arne has 20 years of experience in the Pharmaceutical Industry. He has worked in Analytical Development, Chemical Development, Pharmaceutical Development, Manufacturing Operational Excellence and Manufacturing Science and Technology.

    In Novartis, he is the global program lead for ‘Predictive Processing’ and for Continued Process Verification. He serves as the lead author for the corporate quality standards for process validation and for CPV. Over the last years, he was instrumental in building the Manufacturing Science and Technology organization.

    In PDA, he is engaged in the interest groups for CPV and Manufacturing Intelligence.

    Arne holds a Ph.D. in Analytical Chemistry and a Master in Chemistry. He is also a Agile/ Scrum master and certified Kepner Tregoe trainer for situation, decision and problem analysis.