August 26, 2020

Bigfinite Achieves ISO Certifications: ISO/IEC 27001/27017 for Information Security Management and ISO 9001 for Quality Management

SAN FRANCISCO, CA – (August 26, 2020) – Bigfinite, Inc. (Bigfinite), the leading manufacturing artificial intelligence (AI) and advanced analytics platform company for regulated industries, today announced that it has achieved certification to ISO 9001:2015 in recognition of its commitment to quality management systems (QMS) and ISO/IEC 27001:2013 for information security management (ISMS) including the extension ISO 27017 which includes security in cloud environments. These certifications validate Bigfinite’s ability to deliver reliable systems that align with industry best practices. The certifications were awarded by Lloyd’s Register.

Pere Merino, Chief Operating Officer, Bigfinite, said, “Bigfinite has remained focused on developing Pharma 4.0 technologies in the highly regulated pharma and biotech communities. Acquiring our ISO 9001 and ISO/IEC 27001/27017 certification demonstrates our relentless commitment to bringing technology innovation while upholding the highest quality and security standards.”

The ISO/IEC 27001/27017 is the international standard for activities concerning the management of information security risks and the certification ensures that Bigfinite continuously maintains information security. The ISO 9001 corroborates Bigfinite’s ability to produce consistent, high quality products and experiences for customers. Given the company’s overall focus on regulation and compliance, these certifications are both important milestones for the business.

ISO 9001 and ISO/IEC 27001/27017 are both published by the International Standardization Organization (ISO) and are globally recognized for the qualification of companies’ quality management processes.

About Bigfinite, Inc.

Bigfinite is a software provider that transforms manufacturing operations with the use of advanced analytics, artificial intelligence, and pharma 4.0 technologies focused on optimizing pharmaceutical and biotech companies. The Bigfinite analytics platform seamlessly integrates unlimited sources of structured and unstructured data to deliver actionable insights across all manufacturing sites. Bigfinite offers an intuitive way to gain meaningful operational intelligence with data by enabling real-time visibility and predictive insights in a GxP compliant manner with end-to-end data integrity. Founded in 2014, the company is based in San Francisco, California and also has a European office in Barcelona, Spain.

May 13, 2020

Bigfinite Announces Additions to Executive Team

SAN FRANCISCO, CA – (May 13, 2020) – Bigfinite, Inc. (Bigfinite), the leading manufacturing data analytics platform company for regulated industries, today announced that Brian Sweeney, Lawrence Baisch and Glenn Griffin have been added to the leadership team.

Brian Sweeney has been named Chief Revenue Officer and brings over 35 years of experience in senior executive roles in Sales, Customer Care and Operations across geographies and leading teams selling solutions using data analytics, CRM, information services and other B2B technology products and services to grow with both public and private companies. Previously, Sweeney served as Chief Revenue and Customer Officer at IHS Markit where he led a worldwide organization targeting global and interconnected capital-intensive industries including Energy, Chemical, Automotive and Aerospace and Defense. Before IHS, Sweeney held senior executive positions at HP Software, LexisNexis, Oracle, Siebel Systems and IBM.

Lawrence Baisch joins Bigfinite as the Chief Customer Success Officer. Baisch brings over twenty-five years of domestic and international business expertise in information technology and strategy to Bigfinite. He is a proven technology strategy and customer solution expert, having launched and scaled several companies and by being a thought leader in terms of digital transformation. He recently was Founder & CEO of Luminous Systems and prior was an Enterprise Architect for Salesforce Inc., leading engagements with some of the largest pharma and medical device companies in North America. Baisch has led global customer support and professional services with Precise Software, Encover Inc., Oracle Consulting and Wells Fargo.

Glenn Griffin joins Bigfinite as the new Senior Vice President of Global Alliances. He brings multi-functional executive experience running Alliances, Business Development, and Channel Sales teams across the globe. Griffin has a strong history of driving sales acceleration and market expansion via partner ecosystems for SaaS based enterprise solutions. Previously, Glenn Griffin served as the Vice President of Partnerships at disruptive high growth companies such as Optimizely, DocuSign, and NetSuite.

“Brian, Lawrence, and Glenn are world-class executives who have been at the forefront of technology innovation their entire careers,” said John Vitalie, CEO of Bigfinite. “They bring the right mix of executive experience, operational excellence and possess the integrity that will help propel our growth and lead us to a new level of market leadership for Bigfinite. We are very fortunate to have them joining the leadership team at this critical juncture.”

About Bigfinite, Inc.

Bigfinite is a software provider that transforms manufacturing operations with the use of advanced analytics, artificial intelligence, and pharma 4.0 technologies focused on optimizing pharmaceutical and biotech companies. The Bigfinite analytics platform seamlessly integrates unlimited sources of structured and unstructured data to deliver actionable insights across all manufacturing sites. Bigfinite offers an intuitive way to gain meaningful operational intelligence with data by enabling real-time visibility and predictive insights in a GxP compliant manner with end-to-end data integrity. Founded in 2014, the company is based in San Francisco, California and also has a European office in Barcelona, Spain.

April 6, 2020

Bigfinite Announces Senior Leadership Additions

SAN FRANCISCO, CA – (April 6, 2020) – Bigfinite, Inc. (Bigfinite), the leading manufacturing data analytics platform company for regulated industries, today announced that John Vitalie has been named Chief Executive Officer (CEO) and has been elected to the Board of Directors. David Merino has been named Chief Financial Officer (CFO) of Bigfinite. Other recent additions to the Bigfinite leadership team include Crystal Black, VP of Marketing; Cristian Marfà, VP of Technical Sales; and Daniel Voicu, VP of Security.

“John is a first-class executive with a proven track record of success and we’re excited to welcome him to the Bigfinite family,” said Pep Gubau, former CEO and current Executive Chairman and Chief Technology Officer (CTO) of Bigfinite. Gubau will transition from the CEO role he has held for the last five years, since the founding of the company, to the Executive Chairman and retain his role as CTO. “When we started Bigfinite, we had one clear aspiration: to become the market leader in advanced analytics in AI in the pharma and biotech industry. His tremendous experience in sales and accelerated growth will propel us into this new phase of Bigfinite.”

Previously, John Vitalie served as Senior Vice President of NAA CX Sales for Oracle where he led Oracle’s front office application sales and drove several key CX categories while driving higher growth. Before Oracle, John led the entire go-to-market organization as the Senior Vice President of the Healthcare and Life Sciences vertical for North America at Salesforce, Inc. He comes from a strong corporate leadership background including serving as CEO at Precise Software Solutions, President and CEO of Encover, Inc., Corporate Vice President for NASDAQ Stock Exchange and established Siebel Systems as the global market leader of the Life Science Industry as VP of Sales.

“I’m honored to lead this team and to join their mission of helping bring lifesaving drugs to market more quickly, safely and efficiently,” said Vitalie. “Bigfinite has pioneered the application of artificial intelligence, predictive analytics and automation for pharmaceutical and biotech manufacturing processes. We are well positioned to help customers drive their digital transformation while significantly reducing the time to market for their products at a time when this is increasingly important for all stakeholders. Bigfinite is poised for significant growth going forward.”

Before joining Bigfinite as CFO, David Merino was the Managing Director for Novartis Integrated Services Limited, a global service center offering technical and business services to the Global Novartis Manufacturing division after spending five years as part of their Corporate CFO Leadership program. Prior to that, he served as CFO for Novartis Ringaskiddy Limited, one of the largest API manufacturing sites in the Novartis network, driving an ambitious productivity agenda.

“I truly believe Bigfinite’s SaaS platform can drive biotech and pharma manufacturing to new levels of efficiency, quality and regulatory compliance,” said Merino. “I’m excited to be a part of Bigfinite’s new growth phase.”

Other recent additions to the leadership team bring decades of experience in pharma and technology: Crystal Black, VP of Marketing; Cristian Marfà, VP of Technical Sales; and Daniel Voicu, VP of Security.

About Bigfinite, Inc.

Bigfinite is a software provider that transforms manufacturing operations with the use of advanced analytics, artificial intelligence, and pharma 4.0 technologies focused on optimizing pharmaceutical and biotech companies. The Bigfinite analytics platform seamlessly integrates unlimited sources of structured and unstructured data to deliver actionable insights across all manufacturing sites. Bigfinite offers an intuitive way to gain meaningful operational intelligence with data by enabling real-time visibility and predictive insights in a GxP compliant manner with end-to-end data integrity. Founded in 2014, the company is based in San Francisco, California and also has a European office in Barcelona, Spain.

July 7, 2019

Bigfinite and NNE Partnership

San Francisco, California, July 9, 2019 — Bigfinite and NNE announced a strategic partner program agreement to collaborate around accelerating digital transformation within manufacturing operations at the world’s leading pharmaceutical and biotech manufacturers.

This collaborative effort is based on Bigfinite’s SaaS platform leveraging Industry 4.0 technologies like artificial intelligence (AI) and machine learning to improve manufacturing operations combined with NNE’s unique pharma domain expertise.  The Bigfinite platform will be able to successfully monitor and optimize NNE’s customer’s operations, identifying and eliminating the root causes of operational issues, enhancing operating performance – all while ensuring GxP compliance and inherent data integrity.  Members from both organizations will work side-by-side to combine NNE’s strong knowledge in pharma operation, automation, and regulations with Bigfinite’s big data, industry, and advanced technological experience.

Pep, CEO of Bigfinite, said, “Partnering with NNE is a tremendous opportunity to accelerate the deployment of our platform and make ‘Pharma 4.0’ a reality.”

While several of these digital technologies have been available for some time, the Pharmaceutical industry has moved slowly and cautiously into the digital world due to heavy regulations.  But as the pressure to reduce cost, raise quality, and the demand for personalized medicine increases, companies must evolve to changing requirements to stay ahead.

Pharma manufacturers in the US alone wastes $50 billion each year and 70% of manufacturing data is never used.  This partnership will help improve those statistics – empowering pharma companies to see their fullest potential with the use of the Bigfinite platform and NNE’s expertise.

According to Mogens Larsson, Vice President (VP), Automation & IT of NNE, “We are excited to partner with Bigfinite Inc., a joined effort to bring market-leading technology that is purpose-built for the industry to our customers, for real and impactful improvements on how to create value from manufacturing and GxP data.”

    

About NNE: NNE is an international company specialised in pharma engineering. We help pharmaceutical companies bring products to market by providing flexible, compliant and future-proof solutions. We have close to 1,000 professionals delivering global knowledge and best practices, all dedicated to supporting our customers globally and on local sites.

About Bigfinite Inc.: Bigfinite is a cloud-based SaaS platform for the Life Sciences Industry that transforms manufacturing operations with the use of advanced analytics, artificial intelligence, and IoT technologies.  Founded in 2014 by a veteran team that possesses over 30 years of expertise in Pharma and IT, Bigfinite offers an intuitive way to gain process and operational intelligence so you can improve manufacturing operations in a GxP compliant manner.  Our mission is to advance manufacturing operations so pharma and biotech companies can provide patients with the right medicine, at the right time, and at the right price.

October 5, 2018

Welcome to the Bigfinite Blog!

Just like many startups in Silicon Valley, Bigfinite started out as a disruptive idea: solve the current Pharma inefficiencies with the newest AI and cloud technologies. Following this idea, we were imprisoned for 9 months writing patents and creating a Minimum Valuable Product (MVP) that could be validated by the Industry (Pep in the technologies, Pere in the Pharma business knowledge, Toni in the science, and Llorenç in the code).  We started from scratch, an idea full of challenges that turned into a side project inside one of our co-founder’s Silicon Valley garage.

Since then, Bigfinite has turned into two “real” offices and over 50 employees. As we continue our growth, we are very excited to spread the word about our advanced analytics SaaS platform (AI and Big Data) for the life sciences industry. Our platform just released version 1.6 and includes some impressive features that will help bring the life sciences industry (particularly the Pharma and biotech manufacturing industries) into the new area of Pharma 4.0.

In this blog, we will discuss some interesting topics ranging from product features, regulatory advances, best practices, and our thoughts about the industry and related technologies.  We hope to convey this in an open and direct format – this is our perspective on the state of the industry and how Bigfinite helps. We pledge to keep it interesting and exciting and we are looking forward to seeing your comments, opinions, and beginning discussions.

Our Founders (left to right) Toni, Pep and Pere, the day they officially founded Bigfinite Inc. (October 20th 2014).