Accenture Live Presentation
Accelerating New Product Introduction and batch release times using effective Digital Transformation in a post COVID era
Presenter: Mark Fish, Managing Director at Accenture’s Scientific Informatics Services Business
Mark Fish is a Managing Director in Accenture’s Scientific Informatics Services Business. Mark has over 20 years of experience in various leadership roles delivering innovative solutions to the pharmaceutical sector and is passionate about drug discovery and development, translation research and precision medicine, digital transformation, agile software development and analytical quality control automation.
Presenter: Barry Heavey Managing Director at Accenture’s Digital Manufacturing and Quality
Barry is a Managing Director based in Dublin, Ireland and leads Accenture’s Digital Manufacturing and Quality offering for life sciences in Europe. He has over 20 years of experience in the pharmaceutical industry and holds a PhD in Genetics from the University of Vienna.
The life sciences industry is in a state of transition as it shifts toward increasingly complex, targeted and diverse therapeutic and prophylactic modalities. This pivot to New Science creates compressive disruption not only in R&D, but also in supply chain operations, manufacturing and quality assurance and control. We will examine the impact of New Science on the key processes of New Product Introduction and Manufacturing/release Operations, and explore how a Holistic Approach to Digital Innovation in supply chain, manufacturing and laboratory operations can deliver outstanding value compared to traditional siloed approaches.
As companies adapt to managing smaller production batches and a wider portfolio of products & modalities, managing supply chain down to the level of individual patients, while still ensuring fast progress from NDA to BLA or fulfilment from order to delivery, current thinking and systems are just not ready for this New Agile Normal. Time from process to patient is money; ensuring effective and efficient filing of new drug applications; technology transfer to manufacturing; release of batches by managing CPPs and CQAs are all data driven processes that can be facilitated with modern digital solutions. This is especially important where delays of even a day for a blockbuster product can equate to millions of dollars of lost opportunity and cases where CMC is on the critical path for launch are emerging. To manage supply chain risk caused by long and variable end-to-end make/release cycle times companies are holding ever increasing levels of expensive inventories of raw materials, intermediates/WIP and finished goods, trapping billions of dollars of working capital.
Too many organizations still rely on laborious manual processes and static records for collecting, storing, and sharing critical supply chain, quality and manufacturing data. The result is unnecessary complexity, ineffective knowledge transfer and inefficiency from not taking learning from development into manufacturing and vice versa. From a user experience perspective this creates untold stress and frustration as scientists, engineers and are bogged down in repetitive and unfulfilling work and required to undertake repeated “herculanean effort” at times of peak activity in new product launch, CMC changes or ramp up in supply. We will explore opportunities for Digital Transformation in supply chain operation, manufacturing and laboratory operations in post COVID Time.
Where scientific innovation meets leading-edge technology
We combine scientific and laboratory informatics expertise with strategic and business consulting capabilities, industry platforms, innovation approach and global scale to revolutionize how scientific and laboratory processes are conducted. We work with our clients to streamline technology and processes, and harness the power of data, to remain competitive within today’s changing scientific informatics ecosystem