COMPLIANT BIG DATA ANALYTICS

SAAS platform for the acquisition, record, visualization and knowledge generation from manufacturing data for the optimization of industrial processes in a simple, regulated and traceable way.

Our 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.”

bigfinite foundational statement

Vision

Getting knowledge from ensuring total traceability through simple IT solutions.

Mission

To provide 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.

Values

Efficiency, collaboration, interdisciplinary, joy, respect, transparency & commitment.

bigfinite Management & Advisory Team
Pere Merino

Pere Merino

Chairman of the board & COO

Pere is a visionary Entrepreneur and Investor. With more than 30 years in the biotech & pharma software industry, Pere co-founded M2R SA in the mid '80s pioneering this industry. M2R was acquired by Aspen Technology Inc. in 2000. He co-founded a second company, SVS, in the late '90s, that became the global reference for GMP compliance knowledge for pharma and biotech processes. SVS was bought by Azbil Corporation (Japan) in 2013. Pere is an active investor in diverse ventures, but bigfinite is his main focus of attention from the beginning and he is now actively working in the company as Chairman. Pere is Chemical Engineer by the IQS.

Pep Gubau

Pep Gubau

Chief Executive Officer & CTO

Pep is an IT entrepreneur and has been working in IT for the last 25 years, being pioneer in Linux adoption in the 90s, cloud in the 2000s and big data in the last years. Although having a theoretical economics and maths profile, his early career was as a software developer for the chemical industry. He later was CTO & COO of an IT consulting firm, leading a team of more than 200 engineers until 2003 when Pep co-founded his first IT company. Two more followed. In 2013 Pep brought to his lifelong profesional career partners Pere and Toni the inception of bigfinite, a third iteration of their accumulated knowledge and expertise, using the new technologies now available. Pep is Economist (University of Barcelona) with an engineering background.

Toni Manzano, Ph.D.

Toni Manzano, Ph.D.

Chief Scientist Officer

Toni previously was head of R+D+i at Telstar. Quality Manager in Labware, Group Telstar. Since 1996 Toni managed software projects for international pharma industries along all the supply chain process (R+D, clinical phase, manufacturing, quality, equipments, warehousing and logistics), projects to implement the 3 ICH (Q8, Q9 and Q10) and was also involved in audits and validation tasks (he's an ISO 9001 auditor). Toni pioneered the introduction of applications to manage the electronic quality of the manufacturing processes in the pharma an biotech market. He is also a postgraduate in Quality Systems in Industry and Pharmaceutical Research. Toni doctorate in Astrophysics at Barcelona University.

Llorenç Domingo, Ph.D.

Llorenç Domingo, Ph.D.

Chief Data Scientist

Llorenç is doctor in chemical engineering by the IQS. He started his professional career already linked to the science applied IT working at IBM on Research on Quantum Chemistry and Parallel Computation. He later was technical manager and owner at M2R until it was acquired by Aspen Technologies, where he became Senior Principal Engineer. He has an extremely extensive activity in publications and an intensive activity in regulatory organizations (ISA, ISPE).

Rodolfo Díaz, Ph.D.

Rodolfo Díaz, Ph.D.

Solutions Director

Rodolfo graduated as an Electronic Engineer at the Universidad de Buenoas Aires and later specialized in Lasers and Metrology at the Université de Paris Nord. Rodolfo has a broad experience in Instrumentation, Control and Automation and is a referent in the Pharmaceutical and Biotech Industry in Latin America in PAT.
Rodolfo is the CEO of Hitec SRL, a company dedicated to Industrial Automation & Instrumentation with a high level of expertise in the Pharmaceuticals field, involved in relevant PAT projects.
Hitech is also sales representatives of several major brands like Mettler Toledo Process Division, Thornton Inc, Alfa Laval Instrument Division, Setra, Sensydine, Lorenz Messtechniks, etc. and is a Rockwell Software / Allen Bradley Engineering Solution Providers and Siemens System Integrator.

Stephan Zeler

Stephan Zeler

Financial Advisor

Stephan is Chief Financial Officer at Novartis Vaccines in China & Tianyuan Bio-Pharma. With more than 17 years of experience in the Pharmaceutical industry Stephan gained deep international experience spanning Middle East, China, Africa, and Europe/US, covering all financial aspects of a Pharma company – from R&D, to Production to Sales in corporate, regional and local roles. Stephan is a trained MBA/Chemical Engineer (Wirtschaftingenieur) and received further education in Finance and Legal at MIT, UIUC and the University of Liverpool.

Thomas Unger, Ph.D.

Thomas Unger, Ph.D.

Science Advisor

Thomas has held a number of positions at Pfizer Inc., most recently within the Development Operations and Worldwide Regulatory Strategy organization. Prior to these roles, he was the Head of Strategy for Pfizer’s Biotherapeutics and Bioinnovation Center (BBC). He joined Pfizer as Development Strategy Lead, Strategic Management Group (SMG) within Pfizer Global Research and Development (PGRD). While at Pfizer, Thomas was responsible for initiating a number collaborative innovation initiatives, including that as a co-founding member of MIT/NEWDIGS. He currently serves on the Advisory Boards of a number of emerging biotech companies and foundations. Thomas obtained his Ph.D. in Biological Chemistry from the California College of Medicine, University of California, Irvine.and his M.B.A. from the Marshall School of Business, University of Southern California. He currently serves on the Advisory Boards of a number of emerging biotech companies, foundations and the Center for Biomedical Innovation at MIT.

Mark Wheeler

Mark Wheeler

Technology Advisor

Mark is Technology Director at Genentech. Previously he was general manager of the Life Sciences and Specialty Chemicals division at Aspen Technology and before at Sequencia as vice president of sales and marketing. Previously he had more than 15 years of experience in control and automation of batch processes, first as a process control engineer at GE Plastics and Hoechst-Celanese and later as director of project engineering for PID. Mark holds a B.S. in chemical engineering from the University of California at Santa Barbara.

Professor Wim de Bruyn

Professor Wim de Bruyn

Market Advisor

Wim was one of the founders of COMPEX and was in charge to develop the international business in LIMS, PLM and MES and setting up the international offices. Because of Compex high tech and organization capabilities the group was acquired by Siemens headquarter in 2001, to include COMPEX MES, LIMS, PLM and Research Suite solutions in the SIEMENS portfolio. He has a large experience in the software industry for pharma and biotech and several publication and European and international projects in this sector. He also advises several tech companies in the area of software solutions for the regulated industry. Wim is engineer, Master in applied sciences, Physics, Electronics, Information & Communication Technology by the University of Gent, where he is also professor of ICT management.

logo_bigengine_blanc_small

is a SAAS platform for the acquisition, record, visualization and knowledge generation of industrial processes data in a simple, regulated and traceable way.

Utilizing our IoT, Big Data, Cloud based solution, customers are discovering process optimizations, realizing new economic efficiencies, lowering manufacturing-quality issues, and improving regulatory compliance.

bigengine can be quickly implemented, without having to adapt or change the currently existing systems and with a typical ROI under 6 months.

Simple

bigengine does not require new hardware or new infrastructures, neither new software. The system implementation allows to start capturing info in three simple steps, incorporating primary data to a regulated repository in an intuitive way and accessible through the the web.

Compliant

The system ensures the information, records and data source traceability. Where there is interaction with users, APIs provide the 21 CFR part 11 environment for the legally required data management and processing: uploads, downloads and maintenance (storage, modifications under changes control).

Transversal

All required phases for the creation, production and drug administration generate GxP information deemed relevant. Product design (R & D), clinical stage, scale-up, production, packaging, distribution and dispensing, as well as new ways of drug licensing management (eg Adaptive Licensing), personalized medicine, etc. require to manage information on a shared basis to ensure concepts like e-pedigree, full traceability and studies of continuous improvement. But it’s essential to establish transversal safety criteria (data privacy, information security and integrity, validable repository, etc.).

bigengine at a glance
Contact

156 2nd Street – San Francisco – CA – 94105 – USA

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