Public Website Privacy Policy

Last updated: 25 May 2023

Introduction

Welcome to the privacy policy of QbDVision, Inc. (formerly known as CherryCircle Software, Inc.) for its public website. QbDVision, Inc. respects your privacy and is committed to protecting your personal data. This privacy policy will inform you as to how we look after your personal data when you visit our website (regardless of where you visit it from), and tell you about your privacy rights and how the law protects you. This privacy policy is provided in a layered format so you can click through to the specific areas set out below. Please also use the Glossary below to understand the meaning of some of the terms used in this privacy policy.

Important information and who we are

Purpose of this privacy policy

This privacy policy aims to give you information on how QbDVision, Inc. collects and processes your personal data through your use of this website, including any data you may provide through this website when you sign up for and/or purchase our products and/or services. 

 

This website is not intended for children and we do not knowingly collect data relating to children. It is important you read this privacy policy together with any other privacy policy or fair processing policy we may provide on specific occasions when we are collecting or processing personal data about you so you are fully aware of how and why we are using your data. This privacy policy supplements other notices and privacy policies and is not intended to override them.

Controller

QbDVision, Inc. is the controller and responsible for your personal data (collectively referred to as “Company”, “we”, “us”, or “our” in this privacy policy).

 

We have appointed a data privacy officer who is responsible for overseeing questions in relation to this privacy policy. If you have any questions about this privacy policy, including any requests to exercise your legal rights, please contact the data privacy officer using the details below.

 

Contact details

If you have any questions about this privacy policy or our privacy practices, please contact our data privacy officer:

 

Full name of data privacy officer: Luke Guerrero

Email address: dpm@qbdvision.com

Postal address: 2301 West Anderson Lane, Suite 101, Austin, TX 78757

 

You have the right to make a complaint at any time to any appropriate governmental or regulatory body in  any applicable jurisdiction concerning this privacy policy. We would, however, appreciate the chance to deal with your concerns beforehand, so please contact us in the first instance.

 

Changes to the privacy policy and your duty to inform us of changes

We keep our privacy policy under regular review. This version was last updated on the date listed above at the top of the first page. Historic versions can be obtained by contacting us.

 

It is important the data we hold about you is accurate and current. Please keep us informed if your data changes during your relationship with us.

 

Third-party links

This website may include links to third-party websites, plug-ins, and applications. Clicking on those links or enabling those connections may allow third parties to collect or share data about you. We do not control these third-party websites and are not responsible for their privacy statements. When you leave our website, we encourage you to read the privacy policy of every website you visit.

The data we collect about you

Personal data, or personal information, means any information about an individual from which that person can be identified. It does not include data where the identity has been removed (anonymous data). We may collect, use, store, and transfer different kinds of personal data about you which we have grouped together as follows:

 

  • Identity Data includes first name, maiden name, last name, username or similar identifier, title, and name of organization.
  • Contact Data includes billing address, delivery address, email address, and telephone numbers.
  • Financial Data includes bank account and payment card details.
  • Transaction Data includes details about payments to and from you and other details of products and services you have purchased from us.
  • Technical Data includes internet protocol (IP) address, your login data, browser type and version, time zone setting and location, browser plug-in types and versions, operating system and platform, and other technology on the devices you use to access this website.
  • Profile Data includes your username and password, purchases or orders made by you, your interests, preferences, feedback, and survey responses. 
  • Usage Data includes information about how you use our website, products, and services.
  • Marketing and Communications Data includes your preferences in receiving marketing from us and our third parties and your communication preferences.

 

We also collect, use, and share Aggregated Data such as statistical or demographic data for any purpose. Aggregated Data could be derived from your personal data, but is not considered personal data in law, as this data will not directly or indirectly reveal your identity. For example, we may aggregate your Usage Data to calculate the percentage of users accessing a specific website feature. However, if we combine or connect Aggregated Data with your personal data so it can directly or indirectly identify you, we treat the combined data as personal data which will be used in accordance with this privacy policy.

 

We do not collect any Special Categories of Personal Data about you (this includes details about your race or ethnicity, religious or philosophical beliefs, sex life, sexual orientation, political opinions, trade union membership, information about your health, and genetic and biometric data). Nor do we collect any information about criminal convictions and offenses.

 

If you fail to provide personal data

Where we need to collect personal data by law, or under the terms of a contract we have with you, and you fail to provide that data when requested, we may not be able to perform the contract we have or are trying to enter into with you (for example, to provide you with services). In this case, we may have to cancel a service you have with us, but we will notify you if this is the case at any time.

How your personal data is collected

 

Direct interactions. You may give us your Identity, Contact, and Financial Data by filling in forms or by corresponding with us by post, phone, email, or otherwise. This includes personal data you provide when you:

 

  • apply for our products or services;
  • create an account on our website;
  • subscribe to our service or publications;
  • request marketing to be sent to you; or
  • give us feedback or contact us.

 

Automated technologies or interactions. As you interact with our website, we will automatically collect Technical Data about your equipment, browsing actions, and patterns. We collect this personal data by using cookies, server logs, and other similar technologies. We may also receive Technical Data about you if you visit other websites employing our cookies. Please see our cookie policy (https://login.qbdvision.com/terms/cookiePolicy.html) for further details.

 

Third parties or publicly available sources. We will receive personal data about you from various third parties as set out below:

    

  • Technical Data from the following parties:
    • analytics providers such as Google;
    • advertising networks; and
    • search information providers.
  • Contact, Financial, and Transaction Data from providers of technical, payment, and delivery services.
  • Identity and Contact Data from data brokers or aggregators.
  • Identity and Contact Data from publicly available sources.

How we use your personal data

We will only use personal data when the law allows us to. Most commonly, we will use personal data in the following circumstances:

 

  • Where we have obtained consent to the processing of personal data for one or more specific purposes;
  • Where we need to perform the contract we are about to enter into or have entered into with you.
  • Where it is necessary for our legitimate interests (or those of a third party) and your interests and fundamental rights do not override those interests.
  • Where we need to comply with a legal obligation. By way of example only, our legal obligations include, but are not limited to, audit  trail requirements of the FDA and the EU for systems handling data related to Good Manufacturing Practices, which, among other things, call for the tracking, storage, and archiving of certain users and their actions.
  • Where processing is necessary in order to protect the vital interests of a data subject or of another person.
  • Where processing is necessary for the performance of a task to be carried out in the public interest or in the exercise of official authority vested in the Company.
  • Where processing is necessary for the purposes of the legitimate interests pursued by the Company or by a third party, except where such interests are overridden by the interests or fundamental rights and freedoms of a data subject which require protection of personal data, in particular where the data subject is a child.
  • Generally, we do not rely on consent as a legal basis for processing your personal data, although we will get your consent before sending third party direct marketing communications to you via email or text message. You have the right to withdraw consent to marketing at any time by contacting us.

Purposes for which we will use personal data

We have set out below, in a table format, a description of all the ways we plan to use personal data, and which of the legal bases we rely on to do so. We have also identified what our legitimate interests are, where appropriate.

 

Note we may process personal data for more than one lawful ground, depending on the specific purpose for which we are using such data. Please contact us if you need details about the specific legal ground we are relying on to process personal data, where more than one ground has been set out in the table below.

Purpose/Activity Type of data Lawful basis for processing including basis of legitimate interest
To register you as a new customer (a) Identity
(b) Contact
Performance of a contract with you
To process and deliver your order including:
(a) Manage payments, fees and charges
(b) Collect and recover money owed to us
(a) Identity
(b) Contact
(c) Financial
(d) Transaction
(e) Marketing and Communications
(a) Performance of a contract with you
(b) Necessary for our legitimate interests (to recover debts due to us)
To manage our relationship with you which will include:
(a) Notifying you about changes to our terms or privacy policy
(b) Asking you to leave a review or take a survey
(a) Identity
(b) Contact
(c) Profile
(d) Marketing and Communications
(a) Performance of a contract with you
(b) Necessary to comply with a legal obligation
(c) Necessary for our legitimate interests (to keep our records updated and to study how customers use our products/services)
To enable you to complete a survey (a) Identity
(b) Contact
(c) Profile
(d) Usage
(e) Marketing and Communications
(a) Performance of a contract with you
(b) Necessary for our legitimate interests (to study how customers use our products/services, to develop them and grow our business)
To administer and protect our business and this website (including troubleshooting, data analysis, testing, system maintenance, support, reporting and hosting of data) (a) Identity
(b) Contact
(c) Technical
(a) Necessary for our legitimate interests (for running our business, provision of administration and IT services, network security, to prevent fraud and in the context of a business reorganization or group restructuring exercise)
(b) Necessary to comply with a legal obligation
To deliver relevant website content and advertisements to you and measure or understand the effectiveness of the advertising we serve to you (a) Identity
(b) Contact
(c) Profile
(d) Usage
(e) Marketing and Communications
(f) Technical
Necessary for our legitimate interests (to study how customers use our products/services, to develop them, to grow our business and to inform our marketing strategy)
To use data analytics to improve our website, products/services, marketing, customer relationships and experiences (a) Technical
(b) Usage
Necessary for our legitimate interests (to define types of customers for our products and services, to keep our website updated and relevant, to develop our business and to inform our marketing strategy)
To make suggestions and recommendations to you about goods or services that may be of interest to you (a) Identity
(b) Contact
(c) Technical
(d) Usage
(e) Profile
(f) Marketing and Communications
Necessary for our legitimate interests (to develop our products/services and grow our business)

Marketing

We strive to provide you with choices regarding certain personal data uses, particularly around marketing and advertising. We have established the following personal data control mechanisms:

 

Promotional offers from us

We may use your Identity, Contact, Technical, Usage, and Profile Data to form a view on what we think you may want or need, or what may be of interest to you. This is how we decide which products, services, and offers may be relevant for you (we call this marketing).

 

You will receive marketing communications from us if you have requested information from us or purchased goods or services from us and you have not opted out of receiving that marketing.

 

Third-party marketing

We will get your express opt-in consent before we share your personal data with any third party for marketing purposes.

 

Opting out

You can ask us or third parties to stop sending you marketing messages at any time by following the opt-out link on any marketing message sent to you, or by contacting us at any time. Where you opt out of receiving these marketing messages, this will not apply to personal data provided to us as a result of a product/service purchase, warranty registration, product/service experience, or other transactions.

 

Cookies

You can set your browser to refuse all or some browser cookies, or to alert you when websites set or access cookies. If you disable or refuse cookies, please note some parts of this website may become inaccessible or not function properly. For more information about the cookies we use, please see https://login.qbdvision.com/terms/cookiePolicy.html.

 

Change of purpose

We will only use your personal data for the purposes for which we collected it, unless we reasonably consider that we need to use it for another reason, and that reason is compatible with the original purpose. If you wish to get an explanation as to how the processing for the new purpose is compatible with the original purpose, please contact us.

 

If we need to use your personal data for an unrelated purpose, we will notify you and explain the legal basis which allows us to do so. Please note we may process your personal data without your knowledge or consent, in compliance with the above rules, where this is required or permitted by law.

Disclosure of personal data

We may share your personal data with the parties set out below for the purposes set out in the table above.

  • External third parties as set out in the Glossary below.
  • Third parties to whom we may choose to sell, transfer, or merge parts of our business or our assets. Alternatively, we may seek to acquire other businesses or merge with them. If a change happens to our business, then the new owners may use your personal data in the same way as set out in this privacy policy.
  • We require all third parties to respect the security of your personal data and treat it in accordance with the law. We do not allow our third-party service providers to use your personal data for their own purposes and only permit them to process your personal data for specified purposes and in accordance with our instructions.

Data security

We have put in place appropriate security measures to prevent your personal data from being accidentally lost, used, or accessed in an unauthorized way, altered, or disclosed. In addition, we limit access to your personal data to those employees, agents, contractors, and other third parties who have a business need to know. They will only process your personal data on our instructions, and they are subject to a duty of confidentiality.

 

We have put in place procedures to deal with any suspected personal data breach, and will notify you and any applicable regulator of a breach where we are legally required to do so.

Data retention

How long will you use my personal data for?

We will only retain your personal data for as long as reasonably necessary to fulfill the purposes we collected it for, including for the purposes of satisfying any legal, regulatory, tax, accounting, or reporting requirements. We may retain your personal data for a longer period in the event of a complaint, or if we reasonably believe there is a prospect of litigation in respect to our relationship with you.

 

To determine the appropriate retention period for personal data, we consider the amount, nature, and sensitivity of the personal data, the potential risk of harm from unauthorized use or disclosure of your personal data, the purposes for which we process your personal data, and whether we can achieve those purposes through other means, and the applicable legal, regulatory, tax, accounting, or other requirements.

 

When the purposes of processing are satisfied, we will securely delete the personal data, or in some cases, as described below, anonymize it. 

 

In some circumstances, we will anonymize personal data (so it can no longer be associated with a particular individual) for research or statistical purposes, in which case we may use this information indefinitely without further notice to you and/or the individual.

Under certain circumstances, you have rights under data protection laws in relation to your personal data. See Section 9 below for more information about these rights:

  • Request access to your personal data.
  • Request correction of your personal data.
  • Request erasure of your personal data.
  • Object to processing of your personal data.
  • Request restriction of processing your personal data.
  • Request transfer of your personal data.
  • Right to withdraw consent.

 

If you wish to exercise any of the rights set out above, please contact us.

 

No fee usually required

You will not have to pay a fee to access your personal data (or to exercise any of the other rights). However, we may charge a reasonable fee if your request is clearly unfounded, repetitive, or excessive. Alternatively, we could refuse to comply with your request in these circumstances.

 

What we may need from you

We may need to request specific information from you to help us confirm your identity and ensure your right to access your personal data (or to exercise any of your other rights). This is a security measure to ensure personal data is not disclosed to any person who has no right to receive it. We may also contact you to ask you for further information in relation to your request to speed up our response.

 

Time limit to respond

We try to respond to all legitimate requests within one month. Occasionally, it could take us longer than a month, if your request is particularly complex or you have made a number of requests. In this case, we will notify you and keep you updated.

Glossary

LAWFUL BASIS

Legitimate Interest means the interest of our business in conducting and managing our business to enable us to give you the best service/product and the best and most secure experience. We make sure we consider and balance any potential impact on you (both positive and negative) and your rights before we process your personal data for our legitimate interests. We do not use your personal data for activities where our interests are overridden by the impact on you (unless we have your consent or are otherwise required or permitted to by law). You can obtain further information about how we assess our legitimate interests against any potential impact on you in respect of specific activities by contacting us.

Performance of Contract means processing your data where it is necessary for the performance of a contract to which you are a party, or to take steps at your request before entering into such a contract.

Comply with a legal obligation means processing your or others’ personal data where it is necessary for compliance with a legal obligation we are subject to.

THIRD PARTIES

External Third Parties are professional advisers acting as processors including lawyers, bankers, auditors, and insurers based in the United States, and any other countries where Company clients are located, who provide consultancy, banking, legal, insurance, and accounting services.

YOUR LEGAL RIGHTS

You have the right to:

  • Request access to your personal data (commonly known as a “data subject access request”). This enables you to receive a copy of the personal data we hold about you and to check we are lawfully processing it.
  • Request correction of the personal data we hold about you. This enables you to have any incomplete or inaccurate data we hold about you corrected, though we may need to verify the accuracy of the new data you provide to us.
  • Request erasure of your personal data. This enables you to ask us to delete or remove personal data where there is no good reason for us continuing to process it. You also have the right to ask us to delete or remove your personal data where you have successfully exercised your right to object to processing (see below), where we may have processed your information unlawfully, or where we are required to erase your personal data to comply with local law. Note, however, that we may not always be able to comply with your request of erasure for specific legal reasons which will be notified to you, if applicable, at the time of your request.
  • Object to processing of your personal data where we are relying on a legitimate interest (or those of a third party) and there is something about your particular situation which makes you want to object to processing on this ground, as you feel it impacts on your fundamental rights and freedoms. You also have the right to object where we are processing your personal data for direct marketing purposes. In some cases, we may demonstrate we have compelling legitimate grounds to process your information which override your rights and freedoms.
  • Request restriction of processing of your personal data. This enables you to ask us to suspend the processing of your personal data in the following scenarios:
    • If you want us to establish the data’s accuracy.
    • Where our use of the data is unlawful, but you do not want us to erase it.
    • Where you need us to hold the data even if we no longer require it, as you need it to establish, exercise, or defend legal claims.
    • You have objected to our use of your data, but we need to verify whether we have overriding legitimate grounds to use it.
  • Request the transfer of your personal data to you or to a third party. We will provide to you, or a third party you have chosen, your personal data in a structured, commonly used, machine-readable format. Note this right only applies to automated information which you initially provided consent for us to use, or where we used the information to perform a contract with you.
  • Withdraw consent at any time where we are relying on consent to process your personal data. However, this will not affect the lawfulness of any processing carried out before you withdraw your consent. If you withdraw your consent, we may not be able to provide certain products or services to you. We will advise you if this is the case at the time you withdraw your consent.

Luke Guerrero

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.

Michael Stapleton

Board Director, QbDVision

Michael Stapleton is a life sciences leader with success spanning leadership roles in software, consumables, instruments, services, consulting, and pharmaceuticals. He is a constant innovator, optimist, influencer, and digital thought leader identifying the next strategic challenge in life sciences, executing and operationalizing on high impact strategic plans to drive growth.

Yash Sabharwal​

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.

Laurent Lefebvre - Headshot

Laurent Lefebvre

RA CMC Director, Novartis

Laurent is the Director of RA GDD CMC at Novartis. With over 10 years of experience working as a worldwide Regulatory CMC Project Lead on blockbuster brands, he is an expert in the entire CMC product lifecycle in global regulatory environments. Laurent has been a core team member of the Novartis Regulatory Strategy and Intelligence for IDMP since 2014 and a member of the EFPIA ICH M4Q support team. He is involved in regular collaborations cross-industry (IDMP roundtables, Pistoia Alliance), digital initiatives (RIM structured authoring, master data & PLM), reviewer of the ISO IDMP guidelines and a Novartis contributor to regulatory intelligence discussions.
Laurent Lefebvre - Headshot

James Maxwell

Life Sciences Innovation Lead, Accenture

James Maxwell is an Innovation Lead at Accentures Global Centre for R&D and Innovation. He leads strategic innovation programs with global Life Sciences organizations to solve challenges, rapidly prototype and prove value for future solutions across the end-to-end Life Sciences value chain. With a background in design, research and innovation strategy he has worked with multiple organizations to take an innovation approach for solving challenges across CMC.
Paul Denny-Gouldson - Headshot

Paul Denny-Gouldson

CSO, Zifo

Paul is the CSO at Zifo RnD Solutions, a global specialist scientific and process informatics service provider working across research, development, manufacturing and clinical domains. He obtained his Ph.D. in Computational Biology from Essex University in 1996 and started his career as a Post Doc, and subsequently Senior Scientist at Sanofi-Synthelabo Toulouse (now Sanofi) for five years, where he managed a multidisciplinary molecular and cell biology department. He has also founded a number of companies focused on combining science, technology and business, and authored more than 25 scientific papers and book chapters.
Chris McCurdy

Chris McCurdy

Chief Architect of Healthcare and Life Sciences at Amazon Web Services

Chris McCurdy serves as Chief Architect of Healthcare and Life Sciences (HCLS) for Amazon Web Services (AWS), where he leads teams responsible for architecting cutting-edge services, unlocking data assets, and opening novel analytics capabilities for customers. With over 20 years of industry experience, Chris plays a key role in envisioning and developing innovative solutions and services that accelerate customer value while improving patient outcomes.
Isabell Hagemann Headshot - Digital CMC Basecamp - QbDVision

Isabell Hagemann

Scientific Assistant, Biological Development, Downstream, Bayer AG

Isabell Hagemann is a biochemical engineer by training and has worked at Bayer AG in the biological development downstream department in 2017. In that time, she has worked on process development, process characterization, and the technology transfers of several biologics using high-throughput development systems, modeling approaches, and knowledge management tools.

Ganga Kalidindi

Global Head TRD Data Assets & Insights, Novartis

As the Global Head TRD Data Assets and Insights at Novartis, Ganga Kalidindi brings a unique combination of Information Technology and Product Development expertise to delivering in a regulatory landscape. Throughout his career, he has striven to make direct positive impact on business providing leadership that creates cross-functional high-performing teams. Focusing on complex business and technical challenges, leading through change, and creating success that takes programs and companies to a winning status.
Fran Leira Headshot - Digital CMC Basecamp - QbDVision

Fran Leira

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.

Florian Aupert Headshot - Digital CMC Basecamp - QbDVision

Florian Aupert

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.

Devendra Deshmukh

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.

Mark Fish

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.

Chris Puzzo

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.

Victor Goetz, Ph.D

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.

Rachelle Howard

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.

Vijay Raju

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.

Greg Troiano

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.

Pat Sacco

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.

Diana Bowley

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.

Robert Dimitri, M.S., M.B.A.

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.

Devendra Deshmukh

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.

Grant Henderson

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.

Ryan Nielsen

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.

Shameek Ray

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.

Max Peterson​

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.

Michael Stapleton

Board Director, QbDVision

Michael Stapleton is a life sciences leader with success spanning leadership roles in software, consumables, instruments, services, consulting, and pharmaceuticals. He is a constant innovator, optimist, influencer, and digital thought leader identifying the next strategic challenge in life sciences, executing and operationalizing on high impact strategic plans to drive growth.

Matthew Schulze

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.

Daniel R. Matlis

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.

Kir Henrici

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

Oliver Hesse

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.

John Maguire

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.

Chris Kopinski

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.

Tim Adkins

Digital Life Science Operations, ZÆTHER

Tim Adkins is a Director of Digital Life Sciences Operations at ZÆTHER, 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.

Blake Hotz

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.

Anthony DeBiase

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.

Andy Zheng

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.

Sue Plant

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.

Yash Sabharwal​

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.

Joschka Buyel

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.

Luke Guerrero

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.

Gloria Gadea Lopez

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.)

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