Has eCTD outlived its usefulness?
The eCTD format provides large amounts of unstructured text in PDF format which leads to lengthy and redundant reviews because the key information is buried in the documents.
Day: October 2, 2018
The eCTD format provides large amounts of unstructured text in PDF format which leads to lengthy and redundant reviews because the key information is buried in the documents.
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Managing Director, Life Sciences Strategy, Accenture
Tina is a Managing Director in Accenture’s Life Sciences Strategy practice with over 15 years experience in the industry.Â
Tina is a transformation leader and helps her clients to architect and implement complex enterprise programs, including digital and process transformations, strategic cost take-out programs, change management and process re-design & engineering.
2019 Philadelphia Business Journal Minority Business Leader Award, 2023 Healthcare Business Association Rising Star Honoree, 2025 Bryn Mawr Health Foundation Board Member.
Life Sciences Strategy & Consulting, Accenture
Whitney has dedicated her career to helping large biopharma companies accelerate new product introduction with Digital CMC and PLM capabilities.
Her passion lies within the democratization of data; enabling powerful product and process knowledge to seamlessly span early discovery through commercial manufacturing and quality.
Digital Technical Manager, AbbVie
Experienced Technical Leader with many years of GMP pharmaceutical experience in multiple roles such as Technology Transfer Lead, Process Chemistry, Process engineering, Validation and QC analytical.
Delivery of NPI technology transfers and commercial product continuous improvement projects working with all levels within an organization.
Passionate about maximizing the use of data and digital tools to support pharmaceutical manufacturing and tech transfer.
Vice President, Head of Sustainability and Technology, R&D, Takeda
Christoph Pistek is a senior pharmaceutical executive with 20 years of experience across the full continuum of the pharmaceutical product lifecycle. With an interdisciplinary engineering background, deep expertise in technology operations, and a strong foundation in business administration, he applies a holistic and strategic approach to pervasive change.
As Vice President, Head of Sustainability and Technology, R&D at Takeda, Christoph currently is accountable for large-scale global innovation, advancing emerging capabilities and novel approaches in drug discovery and development, while ensuring alignment with Takeda’s Net-Zero objectives.
His career is defined by end-to-end transformation across Research, CMC, Manufacturing, Quality, Regulatory, and Supply Chain, seamlessly integrating business excellence principles and technological advancements to accelerate efficient and scalable pharmaceutical operations.
CRO at Datahow LLC.
Kevin Healy brings over three decades of Pharmaceutical process development and manufacturing ranging from process optimization in plants, design-build of end-to-end bioprocesses from R&D through manufacturing scale to this topic of hybrid process modeling. Over the last decade he has taken his real-world process knowledge and applied it to the digitalization of Pharmaceutical and other related Life Sciences processes. Â
Kevin has an MS in engineering from Drexel University and is currently the CRO for DataHow. DataHow has pioneered the development of AI-powered bioprocess models and methods and applied them to bioprocess development objectives.
Head of Strategy, Product, & Partnerships, Thermo Fisher Scientific – Digital Science
Devendra has enjoyed a rich career on both the sell and buy sides of technology products and services, primarily within the life and laboratory sciences sectors.
Currently with Thermo Fisher Scientific, Devendra leads strategy, product management, marketing, and strategic partnerships for Digital Science. In this role, Devendra focuses on delivering innovative solutions to the biopharmaceutical industry, developed by Thermo Fisher as well as through a robust partner ecosystem, aimed at accelerating scientific progress and enhancing productivity from molecule discovery to medicine development.
Before joining Thermo Fisher Scientific, Devendra held leadership positions including GM for AlinIQ Global Services & Support at Abbott Diagnostics, leader of the Scientific Informatics practice in Boston at Accenture, Executive Director for Global Research IT at Merck, and VP and GM for PerkinElmer Informatics.
Digital CMC Specialist, QbDVision
Pharmaceutical scientist and expert in drug development & manufacturing across various therapeutic areas. Currently a Digital CMC Specialist at QbDVision, helping global pharma/biotech companies streamline CMC workflows to accelerate therapy delivery.
Principal Engineer – TS/MS Digital Strategy, Eli Lilly and Company
Mike Greene is currently Principal Engineer – Technical Services Digital Strategy at Eli Lilly and Company where he serves as the technical subject matter expert on Product Lifecycle Management (PLM), bringing together his expertise in process control strategy across modalities and networks with his passion for transformational digital initiatives. Previously, he worked on various global cross-functional initiatives supporting Quality, Manufacturing and Technical Services including data criticality assessments for multiple modalities of API, Drug Product, Device Assembly, and Packaging processes across over 10 sites. He began his career as a frontline Technical Services engineer supporting mAb API production and SME on select unit operations and instruments. Mike graduated from Purdue University with his bachelor’s degree in Chemical Engineering and in his free time enjoys hiking and exploring the wilderness with his friends and family as well as on solo adventures.
Associate Director of Data Science, AskBio
Bill has worked in the pharmaceutical industry for over 15 years in R&D and process development at Merck, Novartis, and AskBio. In his current role as Associate Director of Data Science, he leads a company-wide effort in creating digital road maps and connecting data sources within pre-clinical manufacturing, process development, and MSAT. His efforts are meant to improve communication and collaboration through digitalization and promote data-driven decision-making.
PhD, Executive Director, TS/MS New Modalities and Data Strategy, Eli Lilly and Company
Victor is the Executive Director of Technical Services New Modalities and Data Strategy at Eli Lilly and Company. Leveraging his 35 years of industry experience in developing and commercializing nine novel medicines to enhance the exchange of knowledge needed to speed delivery of new medicines to patients. Previous to Lilly, he held process development, manufacturing support, and laboratory automation roles at Merck and holds a BS in chemical engineering from Stanford University and a PhD in chemical and biochemical engineering from the University of Pennsylvania.
MSAT USP Senior Scientist, Viralgen Vector Core
Isabel currently works at Viralgen Commercial Therapeutic Vector Core as an MSAT Scientist part of the Technology Transfer team. She has years of experience in molecular biology, cell culture and fermentation research with industrial experience as an Upstream Technician responsible for batch record writing and reviewing.
VP of CMC
Vijay currently leads CMC activities to deliver on Pioneering Medicines portfolio. The portfolio is built on Flagship Pioneering’s bio-platforms covering multiple modalities (small molecules, biologics, cell & gene therapies). Vijay was previously in technical leadership roles at Novartis.
Data Solution Architect, ZAETHER
A Data Solution Architect working at ZAETHER who strives to grow and develop cutting edge solutions in industrial automation and life science. Andy has 5+ years of experience within the software automation field providing innovative solutions to customers which improve process efficiency.
Associate Vice President, Manufacturing and Quality Tech, Eli Lilly and Company
Ravi Medandravu is a seasoned healthcare executive with over 20 years of experience in the pharmaceutical and medical device industries, specializing in global market access and health economics. He has successfully led teams to develop and implement strategies that enhance patient access to innovative therapies worldwide.
A great opportunity to connect with like-minded professionals in the pharma industry who are passionate about digital tools like QbDVision. Learning about advancements in Digital CMC, tech transfer, and AI in the pharma sector broadened my understanding and inspired me to explore innovative approaches in my work.
COO, QbDVision
A veteran technologist and company leader with a global CV, Luke currently oversees the core business operations across QbDVision and its teams. Before joining QbDVision, he developed, grew, and led key practices for international agency Brand Networks, and spent six years deploying technology and business strategies for PricewaterhouseCoopers’ CIO Advisory consulting unit.
Board Director, QbDVision
President & CEO, QbDVision
Yash Sabharwal is an accomplished inventor, entrepreneur, and executive specializing in the funding and growth of early-stage technology companies focused on life science applications. He has started 3 companies and successfully exited his last two, bringing a wealth of strategic and tactical experience to the team.
RAÂ CMCÂ Director, Novartis
Life Sciences Innovation Lead, Accenture
CSO, Zifo
Chief Architect of Healthcare and Life Sciences at Amazon Web Services
Scientific Assistant, Biological Development, Downstream, Bayer AG
Global Head TRD Data Assets & Insights, Novartis
Global Head of Process Engineering CoE, CSL Behring
Fran Leira is a biopharma Professional with over 20 years of experience in QC, MSAT/Tech Ops at companies like Genentech, GSK, Merck, and Lonza where he supported Product and Process Lifecycle Management at site-based and global roles. He is currently the Global Head of Process Engineering CoE at CSL Behring.
Lab Head, Biological Development, Bayer AG
Florian has a B. Sc. and M. Sc. in pharmaceutical biotechnology with a focus on bioprocess engineering. Since 2018, he’s worked at Bayer AG in Biological Development, concentrating on portfolio program management and tech transfer.
Global Head, Digital Science Business Operations, Thermo Fisher Scientific
Devendra Deshmukh currently leads Global Business Operations for Digital Science Solutions at Thermo Fisher Scientific. In this role he oversees operations broadly for the business across its product portfolio and leads the global professional services, technical support, and product education teams.
Managing Director, Scientific Informatics, Accenture
Mark Fish is Managing Director and Global Lead for Accenture’s Scientific Informatics Services Business. Mark has over 25 years of experience in leadership roles in Accenture, Brooks Life Sciences and Thermo Fisher Scientific delivering innovative solutions to the pharmaceutical sector and is passionate about drug discovery and development, translation research and manufacturing transformation. Mark has extensive experience in agile software development, data strategy, process engineering and robotic automation for research, analytical development and quality control in Life Sciences.
Solution Architect, Digital & Data, Zaether
Chris is a Solution Architect with Zaether, focusing on delivering next-generation digital and data solutions for GxP Life Sciences customers. Chris has previously held technical operations roles within multiple gene therapy manufacturers, including Thermo Fisher Scientific’s CDMO organization where he supported various capital projects including the design, build, and startup of new GxP manufacturing capacity.
Executive Director, TS/MS New Modalities and Data Strategy, Eli Lilly and Company
Victor Goetz, Ph.D. is the Executive Director of Technical Services New Modalities and Data Strategy at Eli Lilly and Company. He has over 35 years of industry experience in developing and commercializing nine novel medicines to enhance the exchange of knowledge needed to speed the delivery of new medicines to patients. Dr. Goetz holds a BS in chemical engineering from Stanford University and a PhD in chemical and biochemical engineering from the University of Pennsylvania.
Director of Manufacturing Systems Automation and Digital Strategy, Vertex Pharmaceuticals
Rachelle is the Director of Manufacturing Systems Automation and Digital Strategy for Vertex’s Small Molecule Manufacturing Center. She oversees the site Automation Engineering function and has co-led Vertex’s global Digital Manufacturing Transformation program since 2019. She leads several initiatives related to data integrity, data management, and employee education. Rachelle is a graduate of Tufts University and the University of Connecticut where she has degrees in Chemical Engineering and a PhD in Process Control.
Vice President, CMC Management, Flagship Pioneering
Vijay currently leads CMC activities to deliver on Pioneering Medicines portfolio. The portfolio is built on Flagship Pioneering’s bio-platforms covering multiple modalities (small molecules, biologics, cell & gene therapies). Vijay was previously in technical leadership roles at Novartis.
Head of cGMP Strategic Supply & Operations, mRNA Center of Excellence, Sanofi
Greg serves as Head of cGMP Strategic Supply and Operations at the mRNA Center of Excellence at Sanofi, where he is responsible for all aspects of clinical production and raw material supply chain. He joined Sanofi via acquisition of Translate Bio, where he was Chief Manufacturing Officer and responsible for Technical Operations. Over his 20+ year career in the drug delivery field, Greg had various roles leading the pharmaceutical development of complex formulations, including numerous nano- and microparticle based systems. Greg received his MSE and BS in Biomedical Engineering from The Johns Hopkins University and was elected and inducted into the American Institute for Medical and Biological Engineering (AIMBE) College of Fellows in 2020 for recognition of his accomplishments in drug delivery.
Senior Vice President Manufacturing, Quality, and Operations, SalioGen
Pat is a Biotechnology technical operations executive with 30+ years of experience leading and managing technical operations functions at numerous innovative companies in the biotech and life sciences industries. He has a passion for advancing and implementing best practices in pharmaceutical manufacturing.
Associate Director, Data & Digital Strategy, AbbVie
Diana is the Associate Director, Data & Digital Strategy in S&T-Biologics Development and Launch leading the organization’s Digital Transformation since October 2021. She joined AbbVie in 2012 in the R&D-Discovery Biologics group focused on antibody and multi-specific protein screening and engineering, leading multiple programs to the cell line development stage. In 2017 she joined Information Research and led a team of IT professionals who supported AbbVie’s Discovery Scientists in Biotherapeutics, Chemistry, Immunology and Neuroscience. She has a PhD in Molecular Biology from The Scripps Research Institute and Bachelor of Science in Chemistry from The University of Northern Iowa.
Director Digital Quality Systems, Thermo Fisher Scientific
Robert Dimitri is a Director of Digital Quality Systems in Thermofisher’s Pharma Services Group. Previously he was a Digital Transformation and Innovation Lead in Takeda’s Business Excellence for the Biologics Operating Unit while leading Digital and Data Sciences groups in Manufacturing Sciences at Takeda’s Massachusetts Biologics Site.
Global Head, Digital Science Business Operations, Thermo Fisher Scientific
Devendra Deshmukh currently leads Global Business Operations for Digital Science Solutions at Thermo Fisher Scientific. In this role he oversees operations broadly for the business across its product portfolio and leads the global professional services, technical support, and product education teams.
Sr. Dir. Manufacturing Science and Technology, VernalBio
Grant Henderson is the Senior Director of Manufacturing Science and Technology at Vernal Biosciences. He has years of expertise in pharmaceutical manufacturing process development/characterization, advanced design of experiments, and principles of operational excellence.
Life Sciences Global Sales Director, Rockwell Automation
Ryan Nielsen is the Life Sciences Global Sales Director at Rockwell Automation. He has over 17 years of industry experience and a passion for collaboration in solving complex problems and adding value to the life sciences space.
Head of Quality Manufacturing Informatics, Zifo
Shameek Ray is the Head of Quality Manufacturing Informatics and Zifo and has extensive experience in implementing laboratory informatics and automation for life sciences, forensics, consumer goods, chemicals, food and beverage, and crop science industries. With his background in services, consulting, and product management, he has helped numerous labs embark on their digital transformation journey.
Lab Data Automation Practice Manager, Zifo
Max Petersen is the Lab Data Automation Practice Manager at Zifo responsible for developing strategy for their Lab Data Automation Solution (LDAS) offerings. He has over 20 years of experience in informatics and simulation technologies in life sciences, chemicals, and materials applications.
Board Director, QbDVision
Head of Digital Pioneering Medicines & Regulatory Systems, Flagship Pioneering
Matt Schulze is a Senior Director in the Flagship Digital, IT, and Informatics team, where he leads and manages the digital evolution for Pioneering Medicines. His role is pivotal in ensuring that digital strategies align with the overall goals and objectives of the Flagship Pioneering initiative.
His robust background in digital life sciences includes expertise in applications, informatics, data management, and IT/OT management. He previously spearheaded Digital Biomanufacturing Applications at Resilience, a CDMO start-up backed by Arch, where he established a team responsible for implementing global manufacturing automation systems, Quality Assurance applications, laboratory systems, and data management applications.
Matt holds a B.S. in Biology and Biotechnology from Worcester Polytechnic Institute and an M.B.A. from the Boston University Questrom School of Business, where he focused on Strategy and Innovation.
Founder and President, Axendia
Daniel R. Matlis is the Founder and President of Axendia, an analyst firm providing trusted advice to life science executives on business, technology, and regulatory issues. He has three decades of industry experience spanning all life science and is an active contributor to FDA’s Case for Quality Initiative. Dan is also a member of the FDA’s advisory council on modeling, simulation, and in-silico clinical trials and co-chaired the Product Quality Outcomes Analytics initiative with agency officials.
CEO, The Henrici Group
Kir is a life science consultant working domestically and internationally for over 12 years in support of quality and compliance for pharma and biotech. Her deep belief in adopting digital technology and data analytics as the foundation for business excellence and life science innovation has made her a key member of PDA and ISPE – she currently serves on the PDA Regulatory Affairs/Quality Advisory Board
VP & Head of Biotech Data Science & Digitalization, Bayer Pharmaceuticals
Oliver Hesse is the current VP & Head of Biotech Data Science & Digitalization for Bayer, based in Berkeley, California. He has a degree in Biotechnology from TU Berlin and started his career in a Biotech start-up in Germany before joining Bayer in 2008 to work on automation, digitalization, and the application of data science in the biopharmaceutical industry.
Director of Manufacturing Sciences, Sanofi mRNA Center of Excellence
With over 18 years of process engineering experience, John is an expert in the application of process engineering and operational technology in support of the production of life science therapeutics. His work includes plant capability analysis, functional specification development, and the start-up of drug substance manufacturing facilities in Ireland and the United States.
Business Development Executive, Life Sciences and Healthcare at AWS
As a Business Development Executive at Amazon Web Services, Chris leads teams focused on tackling customer problems through digital transformation. This experience includes leading business process intelligence and data science programs within the global technology organizations and improving outcomes through data-driven development practices.
Digital Life Science Operations, ZAETHER
Tim Adkins is a Director of Digital Life Sciences Operations at ZAETHER, serving the life science industry by assisting companies reach their desired business outcomes through digital IT/OT solutions. He has 30 years of industry experience as an IT/OT leader in global operational improvements and support, manufacturing system design, and implementation programs.
Manufacturing Sciences Data Manager, Sanofi
At Sanofi’s mRNA Center of Excellence, Blake Hotz focuses on developing data ingestion and cleaning workflows using digital tools. He has over 5 years of experience in biotech and holds degrees in Chemical Engineering (B.S.) and Biomedical Engineering (M.S.) from Tufts University.
Offering Manager, Rockwell Automation
Anthony has over 14 years of experience in the life science industry focusing on process development, operational technology (OT) implementation, technology transfer, CMC and cGMP manufacturing in biologics, cell therapies, and regenerative medicine.
Data Solution Architect, ZÆTHER
Andy Zheng is a Data Solution Architect at ZÆTHER who strives to grow and develop cutting-edge solutions in industrial automation and life science. His years of experience within the software automation field focused on bringing innovative solutions to customers which improve process efficiency.
Phorum Director, Regulatory CMC, Biophorum
Sue Plant is the Phorum Director of Regulatory CMC at BioPhorum, a leading network of biopharmaceutical organizations that aims to connect, collaborate, and accelerate innovation. With over 20 years of experience in life sciences, regulatory, and technology, she focuses on improving access to medicines through innovation in the regulatory ecosystem.
President & CEO, QbDVision
Yash Sabharwal is an accomplished inventor, entrepreneur, and executive specializing in the funding and growth of early-stage technology companies focused on life science applications. He has started 3 companies and successfully exited his last two, bringing a wealth of strategic and tactical experience to the team.
Director of Product Management, QbDVision
Joschka Buyel is the Director of Product Management at QbDVision. He was previously responsible for the rollout and integration of QbDVision at Bayer and worked on various late-stage projects as a Quality-by-Design Expert for Product & Process Characterization, Process Validation, and Transfers. Joschka has a Ph.D. in Drug Sciences from Bonn University and a M.S. and B.S. in Molecular and Applied Biotechnology from the RWTH University.
COO, QbDVision
A veteran technologist and company leader with a global CV, Luke currently oversees the core business operations across QbDVision and its teams. Before joining QbDVision, he developed, grew, and led key practices for international agency Brand Networks, and spent six years deploying technology and business strategies for PricewaterhouseCoopers’ CIO Advisory consulting unit.
Head of Global Consultancy, Business Platforms | Ph.D., Biosystems Engineering
Gloria Gadea-Lopez is the Head of Global Consultancy at Business Platforms. Using her prior extensive experience in the biopharmaceutical industry, she supports companies in developing strategies and delivering digital systems for successful operations. She holds degrees in Chemical Engineering, Food Science (M.S.), and Biosystems Engineering (Ph.D.)
Speaker’s Pretty Long Title, Specialty, and Business
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