Speech at IL3 (UB), November, 28th - 2017

From local serialization to global traceability: finding answers in the cloud.

The traceability of devices by means of a Unique Device Identification system (UDI system) based on international guidance should significantly enhance the effectiveness of the post-market safety-related activities for devices.
Transparency and adequate access to information, appropriately presented for the intended user, are essential in the public interest, to protect health, to empower patients and healthcare professionals and to enable then to make informed decisions, to provide a sound basis for regulatory decision-making and to build confidence in the regulatory system.

Regulation (EU) 2017/45 of the European Parliament of the Council of 5 April 2017

BioPhorum Development Group 21. Brussels, 17th - 19th October 2017

Speech in the BioPhorum Development Group 21. Brussels, 17th - 19th October 2017

Advanced Analytics on the Cloud: How to manage the big data under the Data Integrity perspective.

The different Smart Industry Maturity Levels are presented under the big data and cloud technologies:

• Monitoring: Traditional and basic level. Telemetry, SCADA,…
• Remote control and management: Bidirectional communications
• Efficiency, Productivity, Quality & Security Optimization: Optimization, Preventive maintenance, Fraud detection in spare parts replacements, unauthorized maintenances.
• Smart Automation: IIoT, Digital Twin, M2M
• Operational Data Spaces: MaaS, Equipment + Customer Operational Data in the cloud (advanced logbook), EOM Custom Solutions

Getting a new periodic table of elements using AI

White paper

The periodic table of elements is an atomic organisation based on two axis. The horizontal axis establishes an increasing order based on the atomic number (number of protons) of each element. The vertical arrangement is managed by the electronic configuration and presents a taxonomic structure designed by the electrons of their latest layer . Furthermore, four main blocks arrange the atoms by similar properties (gases, metals, nonmetals, metalloids).

Additionally to the number of protons and the electronic configuration, the atoms are characterised by other attributes that are not ascendant nor cyclic in the periodic table of elements. The values of these properties constitute a sample of numbers that represent different atomic magnitudes that distinguish in some how the chemical elements. In this experiment some of these chemical and physical dimensions have been involved in the training of a set of machine learning algorithms to obtain representative clusters of each element.

White paper published in:

• Data Science Foundation
• Data Science Central
• Data Science Association

Speech in the European Prefilled Syringes, Berlin, 7th of September 2017

Advanced Analytics on the Cloud: How to manage the big data under the Data Integrity perspective.

ACI’s European Prefilled Syringes Summit will explore the advancements in regulatory guidelines, product development, manufacturing processes, risk mitigation , portfolio management and answer some infinite industry questions such as; how the industry is responding to disruptive technology, connectivity, speed to market, and next generation syringes. There are several elements that pose a severe challenge to the growth of the global prefilled syringes market, the primary one being the high costs associated with temperature controlled packaging required for temperature-sensitive drugs. Other more traditional factors inhibiting the market include product recalls due to breakages and leachables, the potential risk of interaction between prefilled syringes and drugs, and needle stick prevention.
The main topics about how to start introducing Advanced Analytics tools on the Cloud are:

• AI/ML/big data in life‐sciences ‐ big data becoming a big topic
• Drivers of change
• Opportunities for AI/ML/data
• What are barriers? What are issues that are likely to impede uptake or experimentation?
• Challenges implement new tech & Best practice: evolution of processes, culture and capabilities
• How to start?

Speech in the ExpoFYBI 2017:

Industria 4.0 + Innovación = Un desafío para la Industria Farmacéutica

Sociedad Argentina de Farmacia y Bioquímica Industrial

¿Cómo se obtiene un proceso de fabricación robusto? Una respuesta teórica consideraría todas las variables involucradas, así como las constantes que determinan el sistema para establecer las ecuaciones de estado dinámico que caracterizan el proceso. Sin embargo, las leyes de la Física y la Ingeniería obligan a realizar aproximaciones debido a que no siempre se disponen de ecuaciones que

permitan una modelización exacta del proceso. Para añadir más dificultad a la respuesta, es importante recordar que la ciencia y la tecnología no avanzan al unísono. Tomar datos en tiempo real de todas las variables que deben ser tenidas en cuenta para aplicar el modelo teórico, resulta una tarea ardua si no imposible, debido a que la multitud de fuentes de información suelen no estar integradas.

Moderating the Big Data track in the PDA European Summit. Berlin, 12 - 14, June 2017

Sessions driven by:

• Sašo Jezernik, Ph.D. Solutions & Innovation Director at Altran

Digitalization & Innovation in Drug Delivery Systems
The IoT technologies are able to objectivize the diseases acquiring for instance vital signs. When AI is applied to these measures, a new medicine arises.

• Wim De Bruyn

Internet of Things for Predictive Analytics
The Shannon limit is the maximum amount of information that a system can manage. When we talk about devices we have to be realistic: their capacity is limited. What happens when the smart devices delegate the power of the information processes to the cloud? Which is the Shannon limit of the cloud?

Article in the 2017-May's edition of the PDA Letter:

Pharma Has its Head in the Cloud

Big Data is Leading Pharma Manufacturing to Greater Maturity

Yet from a regulatory perspective, there  are some risks that deserve special consideration.  ese are: the security and privacy  of the data, the commitment and quality  behind service level agreements, data  integrity, and disaster recovery processes.  Nevertheless, each of these elements can  be addressed by building on the strength  of cloud technologies. Many common  cloud platforms even feature their own  cybersecurity, such as Amazon, Google,  or Microsoft platforms. Now, consider a  manufacturer that has installed sensors  to feed data into an AI system to help  improve process performance. How can  that manufacturer address the risks?

Program available in this link.
www.pda.org/pdaletter. May 2017. Volume LIII, Issue 5

Speech at IL3: Reto de las nuevas tecnologías en la industria farmacéutica 4.0. Cómo acercar el big data a la realidad farmacéutica.

Risks, mitigations and challenges
La llamada "cuarta revolución industrial" ya está impactando a la Industria Farmacéutica en distintos niveles (industry 4.0, Big Data) y va a condicionar su futuro, en especial su competitividad.
La ponencia proporciona una visión clara de esta situación, planteando cómo puede una compañía iniciarse en la aplicación de dichos conceptos a los requerimientos que ya son actuales y que requieren tratamiento de gran volumen de datos, como pueden ser: confección continua de los PQR, mejora continua, revisión del espacio de diseño, verificación continua del proceso, transferencia del conocimiento, etc.
Asimismo, se describe cómo la nueva Guidance de la FDA sobre Data Integrity and Compliance With CGMP Guidance for Industry impacta en todo ello, y se aportará la visión de las herramientas adecuadas para el tratamiento de los Big Data. Se expusieron ejemplos prácticos de proyectos de éxito en la implantación en compañías de prestigio, con demostrada mejora en los recursos y respuestas a los diferentes problemas.

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

The chemical and pharmaceutical processes from the Big Data point of view: a truly innovation

Speech in PharmaProcess,  27th -October-2015
Professionals need a forum where disruptive technologies (like big data, IoT or cloud computing) and the impact they will have on current and future manufacturing supply chain strategies will be discussed in order to improve and maximize industry processes.
What are the challenges in adopting new technologies within regulated environments? How they can create real-time models which allow verification of the process before the outputs of the process are obtained? Could be considered as realistic process the Continuous Process Validation? How the batch manufacturing can be considered as a continuous process rather than a discrete process?

You can download the presentation from this link.

Speech at IL3: Continuous verification and protocols for process monitoring

Big data: The end of the utopy of the continuous process validation
Conference in the IL3 (University of Barcelona)
20th - October - 2015

A process is considered adequately known when:

• All critical sources of variability are identified and explained.
• The variability is managed from the process
• The quality of the product and its attributes can be predicted correctly in the design space established by the materials, the environment and other conditions involved in its manufacture.

Focus production in the knowledge of the processes involved reverts to a drastic reduction of the costs and burden of validation systems, since different options are provided to justify and qualify the different production processes.

Big data and regulated industry: the new paradigm

• Cloud environment can not be compared with traditional systems
• Security access is managed in a different way
• The owner of applications become the end user
• Pricing is by use and service, not by licensing
• The validation concept should evolve to the new reality (GAMP X?)
• The science of processes is not based just in pre-defined parameters (CPP & CQA). All inputs and data can participate.

Nowadays, big data is accepted by Pharma R+D when computing power is required.

Quality by Design (QbD) & Paperless Lab Consultancy

Big Data: New data structures for a new concept of regulated manufacturing

Representing to ISPE-Spain, Pep and I we are presenting a seminar in the PaperLess Academy Event on 14-15 of April - 2015 in Barcelona.

Big Data is the reference to systems that manage large data sets in the context of information technology and communications. Nowadays vast amounts of information are continuously generated and stored in multiple different systems: external and internal hard drives, virtual disks, network storage, pen-drives, e-drives, etc. Right now 1400000 GB = 1400 TB per minute are transferred to Internet.

The huge amount of the generated electronic information is directly related to the ease with which it can be stored. Without a multitude of elements and storage devices that allow quick access and low cost, it would not make sense to create much data. This factor, coupled with the high technology and high degree of penetration of the ICT in to the society, has favored the avalanche of information produced by the different areas of reality that surrounds us.

Today many areas and professional activities have based a fundamental part of their work on managing large amounts of data. Academic simulation environments (engineering, meteorology, astrophysics, physics of matter, environmental sciences), scientific institutions aimed to healthcare (genomics, biomedical research, epidemiology) and many sectors of different non-scientific applications (police investigation, social networks , smart cities, financial systems, marketing) need to mine Giga-bytes of information in a short period of time to extract knowledge in real time. The concept of big-data is inherent into all these scenarios. More and more appear new sectors that require tools for the analysis of large amounts of bytes by second.

Which is the challenge for the pharmaceutical industry? How the regulated industries should adapt its structures to the new concept of data?

Event
Seminar content

Estrategias para la implementación de las 3ICH en equipos dedicados a la fabricación de medicamentos

La introducción de las 3 ICH en el proceso productivo de medicamentos impacta no solamente sobre los procesos de fabricación. Su alcance se extiende a todas las herramientas, equipos, fases o acciones relacionadas con el diseño y la producción de fármacos. Bajo este marco de trabajo y desde la perspectiva de la utilización de equipos en entornos regulados, la implementación de las 3 ICH asegura una ventaja competitiva y cualitativa respecto a otros procesos y dispositivos que no dispongan de estas características.

Este artículo pretende ofrecer una estrategia en el despliegue de equipos en procesos de fabricación farmacéutica sobre los que requiera implementarse los patrones descritos en las 3 ICH. Por lo general no suele realizarse una implantación global de las ICH (Q8, Q9 y Q10) en la planta de forma simultánea, optándose por transiciones y objetivos focalizados en procesos y equipos.

El artículo está disponible íntegramente en este link.

Bigfinite: my new company, my dream

bigfinite is a company which goal is to be the global partner in providing simple solutions to the analysis and control complex needs of industrial processes in Biotech and Pharma, covering all the supply chain, from R+D to patient dispensing. By offering a SAAS application for industrial use, under the philosophy of “Internet of Things”, that can be quickly implemented, without having to adapt or change the currently existing systems and with a customer ROI under six months. With efficiency, collaboration, interdisciplinary, joy, respect, transparency & commitment.

www.bigfinite.com

Since the 1st of November I'm the CSO of this company. I expect to cover the needed functions that allow to grow the knowledge in the company and as in our customers as well.