Maintaining Data Integrity In Digital Transformation Strategies


The life sciences industry is undergoing a period of widespread digital transformation, pushed forward by initiatives such as Pharma 4.0 and progress in embedding artificial intelligence (AI), machine learning (ML) and robotic process automation (RPA) into pharma operations and medical devices. However, while human intervention in some routine processes may be minimized, there is an enhanced need to scrutinize data to ensure quality standards are maintained and compliance requirements adhered to. 

This roundtable discussion will consider how drug developers must create a nexus of the right workforce skillsets, technologies, quality systems and culture for successful data integrity strategies in a time of digital evolution.

Discussion points will include:
    Challenges in embedding AI, ML and RPA into drug development
    Regulatory considerations and the importance of data integrity for agencies
    The data benefits of embedding new technologies into drug development
    Key considerations for building a successful digital transformation strategy 
     How to build sustainable data governance
     What does the future of data look like as digital potential evolves?


Speakers:

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Scott Deckebach, M.B.A.

Director

Lachman Consultant Services, Inc.


Scott Deckebach, M.B.A., is a Director in the Compliance Practice at Lachman Consultant Services, Inc. with more than 25 years of experience in the life sciences including APIs, pharmaceuticals (RX and OTC) biopharmaceuticals, aseptics, and medical devices. Mr. Deckebach has extensive quality systems design and remediation experience. He develops IT strategies and solutions and is a Computer Systems Validation Subject Matter Expert who has led global cross-functional Information Systems (IS) projects and built a culture of technology innovation. He is familiar with FDA and EMEA regulations including cGMP, ISO, MDSAP, EU MDR 2017/745, Occupational Health, Drug Enforcement, Environmental Production Compliance, and other industry regulations and guidances.

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Patrick Day, M.S.

Principal Consultant

Lachman Consultant Services, Inc.


Patrick Day, M.S. is a Principal Consultant in the Compliance Practice at Lachman Consultant Services, Inc. and an established pharmaceutical executive and practitioner with proven leadership in proactive risk identification, deployment of strategies to enhance compliance controls, and implementation of detection systems to eliminate blind spots. He is skilled in policy deployment as well as in leading the rollout of computer validation for vaccines, aseptic antibiotic, and cytotoxic operations. Mr. Day is well versed in FDA and MHRA regulations. He has trained FDA field inspectors for facility inspection techniques and has delivered talks on deployment of risk strategies and modern signal detection. His expertise includes in-house execution as well as outsourcing and governance of FM and laboratory services across US/UK and Asia-Pacific.

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Fausto Artico

Global R&D Tech Head and Director of Innovation and Data Science

GSK plc


Fausto has a double PhD (Information Technology and Computer Science), earning his second master’s and PhD at the University of California, Irvine. Fausto also holds multiple certifications from MIT, Columbia University, London School of Economics and Political Science and soon also from Kellogg School of Management, University of Cambridge and University of California, Berkeley. He has worked in multi-disciplinary teams and has over 20 years of experience in academia and industry.

As a Physicist, Mathematician, Engineer, Computer Scientist, and High-Performance Computing (HPC) and Data Science expert, Fausto has worked on key projects at European and American government institutions and with key individuals, like Nobel Prize winner Michael J. Prather. After his time at NVIDIA corporation in Silicon Valley, Fausto worked at the IBM T J Watson Center in New York on Exascale Supercomputing Systems for the US government (e.g., Livermore and Oak Ridge Labs).

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Priya Durvasula, Ph.D.

Associate Vice President – Digital Quality

Eli Lilly and Company


Priya joined Eli Lilly & Co. in 2019 as Associate Vice President, Digital Quality, Drug Product & Devices where she has been accountable for providing quality leadership and partnership in the identification, selection, and deployment of applications of technology to implement connected health solutions that enable Lilly’s Connected Care & digital strategy. Most recently, she led the quality team in enabling the Tempo Smart Button CE Marking through integration with a couple of OUS digital app partners. In Nov, 2022, Priya will transition to a newly created role of Associate Vice President, Information Systems Quality with a broader global remit. In this role, she will be accountable for the design, execution, and monitoring of information systems quality management. Priya will also be responsible for Manufacturing and Quality data governance and will partner across functions to drive innovative approaches to information systems to meet compliance expectations. Priya has a Ph.D. in Civil & Systems Engineering from the University of Virginia and is an alumna of the Harvard Business School from the Executive Education program. She also holds a Masters in Civil Engineering from UNLV. She is a published author in peer reviewed journals.

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Marty Smyth

Senior Vice President of Go-To-Market Strategy

MasterControl


As the senior vice president of go-to-market strategy, Marty Smyth is responsible for designing and implementing a customer-first, integrated, go-to-market strategy to drive MasterControl’s evolution to a cloud-based business model. He brings 15 years in technology sales, support, and marketing to bear in leading strategic planning, integrated marketing, and sales enablement for Fortune 500 companies.

In his last role as senior vice president of customer experience for MRM//McCann, Smyth led strategic marketing and customer experience management assignments for Cisco, Mastercard, Panasonic, and Verizon, including facilitating marketing transformation initiatives and leading omni-channel engagement. Prior to joining MRM//McCann, he worked in enterprise sales and operations support for AT&T. Smyth is a University of Notre Dame alumnus.


Hosted by

Maire Gerrard

Managing Editor, Custom Content

Pharma Intelligence

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