Last updated: 17 January 2025
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.
Introduction and Scope
QbDVision, Inc. (formerly known as CherryCircle Software, Inc.), QbDvision Holdings Ltd., and QbDvision Operating Company Ltd. (collectively referred to as “QBV”, “Company”, “we”, “us”, or “our” in this privacy policy) takes the protection of personal data very seriously. This privacy policy aims to give you information on how QBV collects and processes your personal data through your use of our QbDVision website (“QbDVision”).
We also comply with the EU-U.S. Data Privacy Framework (EU-U.S. DPF), the UK Extension to the EU-U.S. DPF, and the Swiss-U.S. Data Privacy Framework (Swiss-U.S. DPF) as set forth by the U.S. Department of Commerce regarding the collection, use, and retention of personal information transferred from the European Union, the United Kingdom (and Gibraltar), and Switzerland to the United States.
This privacy policy applies to the information we obtain through your use of our QbDVision website.
This privacy policy does not apply to personal data we collect by any other means, such as personal data we receive directly through our product, or personal data arising from QBV’s employment-related activities. Except to the extent that a third party provides services on our behalf (such as a SaaS vendor), this privacy policy also does not apply to the practices of third parties to which we may link or otherwise refer you, such as other websites.
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.
Data Privacy Frameworks
QBV complies with the EU-U.S. Data Privacy Framework (EU-U.S. DPF), the UK Extension to the EU-U.S. DPF, and the Swiss-U.S. Data Privacy Framework (Swiss-U.S. DPF) as set forth by the U.S. Department of Commerce. QBV has certified to the U.S. Department of Commerce that it adheres to the EU-U.S. Data Privacy Framework Principles (EU-U.S. DPF Principles) with regard to the processing of personal data received from the European Union and the United Kingdom (and Gibraltar) in reliance on the EU-U.S. DPF and the UK Extension to the EU-U.S. DPF. QBV has certified to the U.S. Department of Commerce that it adheres to the Swiss-U.S. Data Privacy Framework Principles (Swiss-U.S. DPF Principles) with regard to the processing of personal data received from Switzerland in reliance on the Swiss-U.S. DPF.
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If there is any conflict between the terms in this privacy policy and the EU-U.S. DPF Principles and/or the Swiss-U.S. DPF Principles, the Principles shall govern. To learn more about the Data Privacy Framework (DPF) program, and to view our certification, please visit https://www.dataprivacyframework.gov/s/.
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QBV is subject to the investigatory and enforcement powers of the Federal Trade Commission (FTC).
Controllership : QBD is the controller and responsible for your personal data.
We have appointed a data privacy officer responsible for overseeing questions concerning 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: 7801 N. Capital of Texas Hwy, Ste 380, Austin, TX 78731-1187
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.
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:
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. The submission of sensitive personal data, including clinical or patient data and sensitive employment information (e.g. trade union affiliation) is strictly prohibited. By using this site, you agree not to submit any sensitive personal data.Â
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.
We may collect your personal data using different methods, including through:
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:
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Automated technologies or interactions. As you interact with our website, we will automatically collect Technical Data about your activity (including your login information). We collect this personal data by using cookies and other similar technologies. Please see the section titled “Cookies” below, or see our cookie policy (http://qbdvision.com/cookie-policy) for further details.
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Third parties or publicly available sources. We will receive personal data about you from various third parties as set out below:
Lawful Bases of ProcessingÂ
We must have a valid reason to use your personal data. This is called the “lawful basis for processing”. QBV will only use personal data when the law allows us to. Most commonly, we will use personal data in the following circumstances:
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Purposes for which we will use personal data
We have set out below, in a table format, a description of all the ways QBV uses 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 legal basis 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 provide you with the services you or your employer contracted for in QbDVision, including tracking user activity in completing required training |
(a) Identity (b) Contact (c) Employment (d) Technical (e) Profile (f) Usage |
(a) Performance of a contract with you
(b) Necessary for our legitimate interests (to provide our main business product) |
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 the QbDVision product (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 develop our business and to inform our marketing strategy) |
To comply with auditing and tracking requirements of the US 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 |
(a) Identity (b) Contact (c) Profile (d) Usage |
Necessary for us to comply with a legal obligation |
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 http://qbdvision.com/opt-out-preferences.
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.
QBV may share your personal data with the parties set out below for the purposes set out in the table above.
We require all third parties to respect the security of your personal data and to treat it in accordance with the law. All third parties are required to implement and maintain reasonable security controls to protect the confidentiality, integrity, and availability of the personal data we transfer to them. 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.
Some of these third parties may be located outside of the United States. However, before transferring your personal data to these third parties, we will either ask for your explicit consent, or require the third party to maintain at least the same level of privacy and data security for your personal data that we do. QBV remains liable for the protection of your personal data that we transfer to our service providers, except to the extent that we are not responsible for the event giving rise to any unauthorized or improper processing.
In addition, some of these third parties may be outside of the European Economic Area, Switzerland, and the United Kingdom. In some cases, the European Commission or the relevant authorities of your country may not have determined that the countries’ data protection laws provide a level of protection equivalent to European Union law. We will only transfer your personal data to third parties in these countries when proper safeguards are in place. Such safeguards include the 2021 European Commission approved standard contractual data protection clauses and appropriate technical, contractual, and organizational supplemental measures to ensure the safety of the personal data.
Other disclosures of your personal data
We may disclose your personal data to the extent required by law, or if we have a good-faith belief that we need to disclose it in order to comply with official investigations or legal proceedings (whether initiated by governmental/law enforcement officials or private parties). In the unlikely event that we must disclose your personal data to governmental/law enforcement officials, we may not be able to ensure those officials will maintain the privacy and security of your personal data.
We may also disclose your personal data if we sell or transfer all or some of our company’s business interests, assets, or both, or in connection with a corporate restructuring. Finally, we may disclose your personal data to our subsidiaries or affiliates, but only if necessary for business purposes, as described in the section above.Â
We reserve the right to use, transfer, sell, and share aggregated, anonymous data for any legal purpose. Such data does not include any personal data. The purposes may include analyzing usage trends or seeking compatible advertisers, sponsors, and customers.
Automated Decision-Making
We do not engage in automated decision-making activities, such as profiling.
QBV has implemented and will maintain reasonable security controls to protect the confidentiality, integrity, and availability of personal data we process. 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.
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.
QBV 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, 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 as soon as possible, or in some cases, as described below, we will anonymize it.Â
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.
If we process your personal data, you may have the right to request access to (or to update, correct, or delete) such personal data. You may also have the right to ask that we limit our processing of such personal data, as well as the right to object to our processing of such personal data. You may also have the right to data portability. If you are a user of the QbDVision product, you may log in to the product to see and manage the personal data stored in your user profile, and to request access to any other personal data we have about you (to the extent we have any).
If we have received your personal data in reliance on our Data Privacy Framework certification, you may also have the right to opt out of having your personal data shared with third parties, and to revoke your consent to our sharing your personal data with third parties. You may also have the right to opt out if your personal data is used for any purpose that is materially different from the purpose(s) for which it was originally collected or which you originally authorized.
An individual may request to access their information, or otherwise correct, amend, or delete their information in line with the EU-U.S. (and its UK Extension) and Swiss-U.S. Data Privacy Framework Principles by contacting us at dpm@qbdvision.com. Please note that we may not be able to honor all requests, especially those that relate to deletion or alteration of data stored in your user profile, due to our conflicting legal obligations. By way of example only, our legal obligations include, but are not limited to, audit trail requirements of the US 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. If we are unable to honor your request, we will explain the legal basis for our inability to do so. Â
Moreover, we are subject to certain legal obligations with regard to maintaining electronic records created through computerized systems handling data related to Good Manufacturing Practices (e.g., the tracking, storage, and archiving of users and their actions on such systems). As such, pursuant to Articles 6(1)(c) and 89 of the General Data Protection Regulation (“GDPR”) and other applicable laws, we may process your personal data without your knowledge or consent and, provided we have implemented appropriate safeguards, are not required to abide by a request by you to access, correct, erase, restrict the processing of, or transfer your personal data maintained on our systems. To learn more information, please consult with QBV’s customer who is the data controller of your personal data. Â
Because QBV may have limited ability to access data our customers submit to our services, if you wish to request access, limit use or disclosure, or otherwise manage the data you think one of our customers has submitted about you (primarily because you act as one of their suppliers), please provide the name of the QBV customer who submitted your data to our services. We will refer your request to that customer, and will support them as needed in responding to your request.
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Data Privacy Frameworks
With respect to personal data processed in the scope of this privacy policy, QBV complies with the EU-U.S. Data Privacy Framework (“EU-U.S. DPF”), and the UK Extension to the EU-U.S. DPF, and the Swiss-U.S. Data Privacy Framework (“Swiss-U.S. DPF”) as set forth by the U.S. Department of Commerce. Â
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QBV has certified to the U.S. Department of Commerce that it adheres to the EU-U.S. Data Privacy Framework Principles (“EU-U.S. DPF Principles”) with regard to the processing of personal data received from the European Union and the United Kingdom in reliance on the EU-U.S. DPF and the UK Extension to the EU-U.S. DPF. QBV has certified to the U.S. Department of Commerce that it adheres to the Swiss-U.S. Data Privacy Framework Principles (“Swiss-U.S. DPF Principles”) with regard to the processing of personal data received from Switzerland in reliance on the Swiss-U.S. DPF. Â
If there is any conflict between the terms in this privacy policy and the EU-U.S. DPF Principles and/or the Swiss-U.S. DPF Principles, the Principles shall govern. Â
To learn more about the Data Privacy Framework, and to view QBV’s certification, please visit https://www.dataprivacyframework.gov/s/ and https://www.dataprivacyframework.gov/s/participant-search.Â
QBV is subject to the investigatory and enforcement powers of the United States Federal Trade Commission.
Dispute Resolution
If a privacy complaint or dispute relating to personal data received in reliance on the Data Privacy Framework (or any of its predecessors) cannot be resolved through our internal processes, we have agreed to participate in the VeraSafe Data Privacy Framework Dispute Resolution Procedure. Subject to the terms of the VeraSafe Data Privacy Framework Dispute Resolution Procedure, VeraSafe will provide appropriate recourse free of charge to you. To file a complaint with VeraSafe and participate in the VeraSafe Data Privacy Framework Dispute Resolution Procedure, please submit the required information here: https://www.verasafe.com/privacy-services/dispute-resolution/submit-dispute/
Binding Arbitration
If your dispute or complaint related to your personal data that we received in reliance on the Data Privacy Framework cannot be resolved by us, nor through the dispute resolution program established by VeraSafe mentioned above, you may have the right to require that we enter into binding arbitration with you pursuant to the Data Privacy Framework’s Recourse, Enforcement and Liability Principle and Annex I of the Data Privacy Framework.
European Union Supervisory Authority Oversight
If we process your personal data and you are not satisfied with how we process your personal data, you may also have the right to lodge a complaint with a data protection regulator. For example, under the GDPR, you can file a complaint with a data protection authority in one or more of the European Union Member States. In particular, you may have the right to file a complaint with the data protection authority in the European Union Member State where you reside, work, or where you believe there has been an infringement of the GDPR.Â
Privacy of Children
Our QbDVision product is not intended for use by children under the age of 18 and we do not knowingly collect data relating to children. If you believe your child may have provided us with personal data, you can contact our Data Privacy Officer using the information in the “How to contact us” section of this privacy policy below, and we will delete the data.
Changes to the privacy policyÂ
QBV keeps its privacy policy under regular review. This version was last updated on the last updated date. Historic versions can be obtained by contacting us. If we make any material change to this policy, we will post the revised policy to this web page and update the “last updated” date. We will also inform you on the new version when you login next to QbDVision. By continuing to use QbDVision after we post any of these changes, you accept the modified policy.
How to contact us
If you have any questions regarding this policy, or if you would like to exercise your privacy rights, please contact our Data Privacy Officer at dpm@qbdvision.com, or by regular mail addressed to:
QbDVision, Inc.
7801 N. Capital of Texas Hwy
Ste 380
Austin, TX 78731-1187
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Please allow us up to four weeks for us to reply.Â
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.
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.
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VP of CMC
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.
A Data Solution Architect working at ZÆTHER who strives to grow and develop cutting edge solutions in industrial automation and life science. Andy has 5+ years of experience within the software automation field providing innovative solutions to customers which improve process efficiency.
A great opportunity to connect with like-minded professionals in the pharma industry who are passionate about digital tools like QbDVision. Learning about advancements in Digital CMC, tech transfer, and AI in the pharma sector broadened my understanding and inspired me to explore innovative approaches in my work.
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.
Board Director, QbDVision
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.
RAÂ CMCÂ Director, Novartis
Life Sciences Innovation Lead, Accenture
CSO, Zifo
Chief Architect of Healthcare and Life Sciences at Amazon Web Services
Scientific Assistant, Biological Development, Downstream, Bayer AG
Global Head TRD Data Assets & Insights, Novartis
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Board Director, QbDVision
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.
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.
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.)
Speaker’s Pretty Long Title, Specialty, and Business
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