Speech at the XIV Jornades Normes de Correcta Fabricació de Medicaments i Principis Actius

Big Data & Industry 4.0

Speech with Ana Ripoll and Juan Núñez describing how the new technologies based on big data and cloud can provide a new dimension to the Pharma Manufacturing under the Industry 4.0 concept.


Program available in this link.
Press Release: Red Tecnologías Sanitarias

Speech at the Anticoagulation Seminar organized by Boehringer Ingelheim, Sevilla 8th of October

Big Data & Clinical Practice

Speech with Pep Gubau about how the Big Data and Cloud Technologies are managing the new age of the health.
During the seminar, a lot of questions arose from the attendant physicians. Doubts about the patient data usage,  research options based on the new technologies, ethics, present and future, differences among USA and EU, are a sample of the concerns presented during the presentation.

Speech at the CPhI, Barcelona 6th of October

Industry 4.0 + Innovation = Challenge for the Pharma Industry
How the cloud and big data solve the equation

After describing how the Pharma Industry can evolve to a new model based on the statistical science of its processes, the main discussion was focused on the regulatory challenge. Lot of interest, expectation and curiosity.
See the program with the rest of speeches.

Speech at BioPhorum, Seattle 21st of September

Cloud Technologies for regulated environments. 
Speech with Pep Gubau.
An important upcoming face-to-face meeting for the BPIT 'Compliance for the Digital Age' workstream is taking place in Seattle on 20-22 September.  This workstream was set up to develop efficient means of ensuring regulatory compliance of IT systems that are appropriate for new ways of developing and deploying IT systems. At the BPIT IT Leaders meeting in May, the Leaders prioritised two important scenarios that are the focus of the workstream - 'Ensuring Data Integrity of IT Systems' with a particular focus on 3rd-party/Cloud-based systems, and 'Agile Development Methods for GxP compliant systems'. (Ref:BioPhorum)

Speech at the 1PDA Europe Annual Meeting in Berlin: Manufacturing & Big Data: Approaches for Pharma

Some sentences detailed in the conference:

• Requirements to make science in Pharma under a big data point of view: Rigorous and Compliance 
• The knowledge of real processes in Pharma have to consider the variability. The multiple factors involved in the variability only can be managed in the cloud (addressed to PAT and QbD) 
• Big data and cloud computing offer the power of the aggregation and this is the first step to discover knowledge 
• The pharma processes are complex and consist in the combination of CQA, CPP and the rest of variables that are not considered critical, but physically, are part of the reality. bigengine is able to normalize processes and extract knowledge from the aggregation that raise over the complexity. 

The presentation can be downloaded from this link

Speech at IL3: “Industry 4.0: the next generation of the pharma manufacturing through the big data”

Curso coordinado por Jesús Beneyto.

Objetivos del curso:

Proporcionar una visión clara de las posibilidades que permite la aplicación de las metodologías LEAN Manufacturing y SIX Sigma para la mejora y control de los procesos farmacéuticos durante todo el Ciclo de Vida de los productos, tal como lo requieren los nuevos conceptos del Sistema de Calidad Farmacéutico que describe el Capítulo 1 de las GMP de la UE, como en la verificación continua de los procesos que requiere el nuevo Anexo 15 de las GMP de la UE, que entró en vigor en octubre de 2015. 

Se hace un énfasis especial en el uso de los Sistemas IT para optimizar el aprovechamiento de la información obtenida durante todo el Ciclo de Vida y la transformación de esta información en conocimiento.

Speech at Genentech: Approach to the Industry 4.0 concept and the personalized medicines

The Industry 4.0, also known as Smart Industry, provides powerful tools to acquire knowledge from the manufacturing processes. Personalized medicine can also benefit from the resources offered by the power of information under a regulated environment. The new technologies are good drivers to allow the knowledge acquisition from the diversity around the sick.
Speech at Genentech SFO, February 21st,  2016