ESGBERT/base_data · Datasets at Hugging Face

sentence stringlengths 1 23.5k ⌀
We also provide free medicines to patients who do not have insurance and cannot afford the cost of the drug.
We are a different kind of biotech company, with a distinct ethos of ‘Doing Well By Doing Good’ and a focus on homegrown R&D capabilities.
One way we demonstrate our commitment to doing the right thing and to applying our technologies effectively is through our efforts to respond to public health challenges like infectious disease outbreaks.
It was a perfect opportunity to pair our desire to improve global health with our proprietary VelociSuite® of drug discovery and development technologies.
Working with the U.S. government’s BARDA, we used our rapid response approach to generate potent Ebola antibodies at an unprecedented speed, moving from preclinical to clinical research in a matter of months instead of years.
Thankfully that outbreak ended before our triple-antibody cocktail reached clinical development.
Instead, we tested the investigational medicine in a healthy-volunteer Phase demonstrating its safety in humans.
We worked with the WHO, U.S. FDA and other global organizations to have our medicine, REGN-EBcompassionate use protocol and included in the four-arm PALM clinical trial.
In August stopped early when our Ebola treatment was deemed superior to the previous antibody treatment standard of care.
We continued to provide this important treatment for free through the PALM trial and compassionate use to ensure access for people in need.
We were relieved to learn in Spring the DRC appears to be winding down.
Building on our Ebola and Middle East Respiratory Syndrome (MERS) coronavirus experience and using the same VelociSuite® technologies, we are collaborating to rapidly develop a novel antibody cocktail that could be used as a preventative or treatment to combat this latest significant global health risk.
“THE LIFE-SAVING RESULTS SEEN WITH OUR INVESTIGATIONAL EBOLA THERAPY IN IMPACT OF REGENERON’S RAPID RESPONSE PLATFORM FOR ADDRESSING EMERGING OUTBREAKS.
AT EVERY STAGE, POSITIONING REGENERON TO RESPOND QUICKLY AND EFFECTIVELY TO NEW PATHOGENS.
To meet patients’ unmet medical needs, we are compelled to act with integrity, seeking excellence in all we do.
Our employees are crucially important to achieving our mission.
Through their passion, entrepreneurial spirit and high ethical standards, we are able to repeatedly bring important new medicines to people in need.
These shared values and behaviors guide our efforts to recruit and retain the best and brightest from today’s talent marketplace.
INTEGRITY & EXCELLENCE Ethical conduct builds trust in our company and is essential to our business.
Regeneron sets high standards for our employees, officers and directors, which are underpinned by sound corporate governance and overseen by the Board of Directors and its Corporate Governance and Compliance Committee.
Our culture of integrity informs how we approach all areas of our business, from R&D and product quality and safety, through to sales and marketing and supply chain management.
Corporate Compliance Leadership and Oversight The Chief Compliance Officer and management’s Compliance Committee lead our compliance program.
The Chief Compliance Officer is responsible for developing and providing oversight on policies and procedures to ensure that employees, suppliers and contractors comply with applicable laws and regulations.
The Chief Compliance Officer chairs the Compliance Committee, which is made up of cross- functional senior leaders.
Code of Business Conduct and Ethics Our Code of Business Conduct and Ethics sets out Regeneron’s key policies and expectations for employees, third-party contractors and suppliers to ensure that we are always acting in accordance with applicable laws and regulations.
All employees are trained on the Code when they are hired and then annually thereafter.
Employees are required to acknowledge that they have read, understood and will abide by the Code when they complete the training.
Any breach or failure to report a violation of the Code may result in disciplinary action, up to and including termination of employment.
ETHICS AND COMPLIANCE Regeneron’s commitment to high ethical standards goes beyond the required elements of a good corporate compliance program.
Members of the compliance team are integrated with the business units they support to ensure that compliance resources are available at the point of decision.
Our Chief Compliance Officer speaks frequently at employee gatherings to reinforce our culture of integrity.
And senior leaders throughout the business reinforce the company’s expectations of compliance and integrity to their own organization.
Compliance is a team activity at Regeneron and we all have a role to play.
https://www.regeneron.com/sites/default/files/Code_of_Business_Conduct_and_Ethics.pdf Global Interactions with Healthcare Professionals We are dedicated to the advancement of medical science and the development of healthcare products that will improve patient care.
We recognize that healthcare professionals are uniquely positioned to understand the needs of patients, the performance of medicines in the clinical setting and unmet treatment needs.
Therefore, we are committed to collaborating with physicians and healthcare professionals in a manner that does not have, or appear to have, any undue influence on medical judgment, prescription or product recommendations.
Transparency We believe greater transparency helps the public understand how we collaborate with the medical community to deliver safe and effective therapies and helps patients make more informed healthcare decisions.
We are committed to full compliance with all relevant transparency laws and policies requiring pharmaceutical manufacturers to track and report payments and other transfers of value to healthcare professionals.
Anti-Bribery and Anti-Corruption Regeneron’s anti-bribery and anti-corruption policy provides guidance to ensure compliance with anti-bribery and anti-corruption laws, including the U.S. Anti-Kickback Law, the U.S. Foreign Corrupt Practices Act and the United Kingdom Bribery Act.
All employees, third-party contractors and suppliers are required to complete training on global anti-bribery and anti-corruption.
Regeneron does not tolerate any type of corruption, including bribery, facilitation or “grease” payments, or the offering of any improper payments or benefits, regardless of local customs or rationales for the payments or benefits.
Non-Retaliation and Open-Door Policy Noncompliance with laws or our policies can pose serious risks for patients, shareholders, employees and our business.
Our opendoor policy encourages people to raise any concerns or questions with their supervisor or manager, by contacting the Head of Human Resources or Chief Compliance Officer or by making anonymous reports through our EthicsPoint hotline (877-RGN-ETHX) or website.
Regeneron protects employees who report concerns in good faith with non-retaliation, confidentiality policies and mechanisms to file reports anonymously.
https://www.regeneron.com/sites/default/files/Code_On_Global_Interactions.pdf https://www.regeneron.com/sites/default/files/Code_On_Global_Interactions.pdf https://secure.ethicspoint.com/ SNAPSHOT / Award-Winning Security Innovation As part of our cybersecurity efforts, Regeneron is among the first to use robotic automation to resolve computer malware infections.
CSOdemonstrate outstanding business value and thought leadership Information Security and Data Privacy Cybersecurity is critical to companies operating in our increasingly digital world, where sensitive data, personal information and intellectual property are vulnerable to theft or damage.
For us to retain trust and continue to grow, we need to ensure we are maintaining robust systems to protect against threats, both technological and human.
Our patients, colleagues, partners and other stakeholders trust Regeneron to protect the privacy of their personal data and we treat this responsibility with the utmost seriousness.
Privacy is a legal landscape that is rapidly expanding, and we are continually analyzing new and changing laws to ensure our compliance.
We updated our online Privacy Policy and put controls in place to align with new regulations, such as the EU General Data Protection Regulation (GDPR), which has been in place since the California Consumer Privacy Act, which came into effect on January 1, 2020.
“REGENERON HAS SUCH A UNIQUE CULTURE WHERE PEOPLE ARE FOCUSED ON SCIENCE AND PATIENTS— AND DOING THE RIGHT THING IS AT THE CORE OF OUR VALUES.
PRIVACY IS A PART OF THAT, AND EACH OF US PLAYS AN IMPORTANT ROLE IN PRIVACY AND COMPLIANCE.
As a general matter, this support is made to office holders and candidates who hold views that are consistent with, or will further, the legislative, regulatory and public policy goals of our company, patients and community.
We adhere to the highest ethical standards in our activities, respecting and following all applicable federal, state and local laws.
In of national trade associations, including the Biotechnology Innovation Organization (BIO) and Healthcare Distribution Alliance.
Our government affairs and public policy teams help Regeneron navigate and interact with legislative and regulatory bodies in a responsible, and civic-minded way.
We believe it is our responsibility to engage on public health matters, and we are focused on supporting Regeneron’s mission to bring important new medicines to people living with serious diseases.
Substantiated and scientifically sound Healthcare professionals should prescribe Regeneron products only when their use is clinically appropriate.
We believe branded television commercials can help provide patients with information to learn more about their condition and about a potential treatment option to help manage their disease.
Regeneron aired our first branded television commercials in the U.S. in 2018.
We have received feedback from doctors saying they appreciate that our television commercials help eligible patients know there is a potential treatment for their disease.
Patients are best served when they and their physicians are given consistent, accurate and balanced information about our medicines.
Our policies provide clear requirements for promotional materials and communications to employees, contingent workforce and vendors who communicate with the healthcare community.
Customer-facing colleagues receive annual and extensive training regarding regulations and our policies.
We have implemented processes and policies to ensure our clinical trial practices comply with laws and regulations and meet our high ethical standards.
• Our Protocol Review Committee confirms that ethics and patient safety considerations are fully integrated into all of our trial protocols.
• Our Clinical Review Committee reviews all patient-facing clinical trial recruitment material prior to Ethics Committee or Institutional Review Board submission to confirm they are easily understood by patients and free of coercive or unduly influential language, meet our quality standards and comply with applicable laws and regulations.
• Our Standard Operating Procedures outline the processes that are in place to ensure that enrolled participants (or their legal representatives) give their free and informed consent before any study procedure is undertaken or data is collected.
• Our Data Privacy Office has developed processes to ensure the privacy protections of participants in our clinical trials.
When we outsource studies to contract research organizations (CROs), our Good Clinical Practices (GCP) audit program reviews clinical trials and associated internal systems, vendors and clinical investigators to confirm they meet our quality and safety standards and are compliant, and to identify meaningful corrective and preventive actions.
Our audit program, which includes site visits by our Quality Assurance & Auditing team, is designed to cover clinical trials conducted in various countries and regions around the world.
When we engage CROs in our studies, part of the CRO’s role, through its monitors/research associates, is to ensure that the clinical trials align with pre-established criteria.
At the end of patient volunteers in 53 countries.
We hold the CROs we engage to the same high standards we have for our internally-managed projects.
If and when we identify issues related to contracted services or GCP standards, the issues are managed through a formal escalation pathway and triaged for appropriate action and resolution.
If improvements are not made within a defined period of time, or if repeat occurrences are noted and unsatisfactorily remediated, we will limit and possibly cease future award opportunities with the vendor until the issues have been fully remediated.
We are also subject to external audits by health authority inspectors that verify that we are complying with ethical standards and applicable laws and regulations.
Over the course of inspected by regulatory authorities 13 times.
Neither did any FDA-sponsored inspections result in required voluntary or official actions.
In line with the Sustainability Accounting Standards Board (SASB) recommended disclosures, we disclose the amount of monetary losses incurred as a result of legal proceedings associated with clinical trials in developing countries.
Diversity in Clinical Trials Increasing diversity in clinical trials is important as different patient populations may be impacted differently by their disease and have varying responses to the same treatment.
We believe clinical trials should represent the people living with the disease and we have always strived to be inclusive.
As part of this effort, in of processes and controls to increase awareness and incorporate diversity considerations into the design and placement of our clinical studies.
We will continue to develop this framework during measures to track our progress.
Data Transparency We are committed to sharing data from our clinical research and clinical trials in a responsible manner.
Regeneron is a member of the Biotechnology Innovation Organization (BIO) and endorses their principles on the responsible sharing of truthful and non-misleading information about medicines with healthcare professionals and payers.
We support data transparency that advances science and medicine, protects participant privacy and is in the best interest of individuals who use our products and providers who prescribe them.
Regardless of study outcome, Regeneron seeks to publish its Phase studies and its hypothesis testing/confirming Phase 1 and 2 studies; post-approval clinical studies conducted to meet a regulatory requirement; post-approval observational studies with predefined hypotheses that involve a Regeneron product; and any other clinical trial or study that provides important information on the safety and/or efficacy/ effectiveness of the agent under investigation.
Regeneron is committed to timely publication by submitting the primary findings within a year of completion of analysis.
Qualified researchers may request access to individual patient or aggregate-level data from a Regeneron-sponsored study by submitting a research proposal to https://vivli.org/. Animal Welfare Regeneron is committed to and abides by all ethical requirements related to animal welfare in research, teaching and testing.
Research involving the use of live animals must be approved by the Regeneron Institutional Animal Care and Use Committee (IACUC), a requirement of U.S. federal and state laws.
In addition, we comply with the “Three Rs” (Replacement, Reduction and Refinement), widely accepted ethical principles that are now embedded in the conduct of animal-based science in many countries around the world.
Regeneron has earned accreditation from AAALAC International, a non-profit that assesses organizations that use animals in research, teaching or testing.
More than government agencies and other research institutions in 49 countries have been accredited through AAALAC’s rigorous program and site evaluation review.
recognition of its culture of continuous improvement and manufacturing excellence.
QUALITY AND SAFETY Our ability to meet patients’ unmet needs depends on providing safe, high-quality products that people can trust.
The safety of our patients is our top priority and critical to delivering on our mission. products.
We take seriously our legal and ethical obligations to collect product technical compliance and adverse events related to our medications so that we can monitor their safe use throughout the product lifecycle.
We are committed to our responsibility for timely reporting of safety information to the FDA and other regulatory authorities, in compliance with regulations and global expectations.
In order to ensure full transparency to our expectations, we provide annual training on adverse event reporting for employees, contractors and suppliers.

We also provide free medicines to patients who do not have insurance and cannot afford the cost of the drug.

We are a different kind of biotech company, with a distinct ethos of ‘Doing Well By Doing Good’ and a focus on homegrown R&D capabilities.

One way we demonstrate our commitment to doing the right thing and to applying our technologies effectively is through our efforts to respond to public health challenges like infectious disease outbreaks.

It was a perfect opportunity to pair our desire to improve global health with our proprietary VelociSuite® of drug discovery and development technologies.

Working with the U.S. government’s BARDA, we used our rapid response approach to generate potent Ebola antibodies at an unprecedented speed, moving from preclinical to clinical research in a matter of months instead of years.

Thankfully that outbreak ended before our triple-antibody cocktail reached clinical development.

Instead, we tested the investigational medicine in a healthy-volunteer Phase demonstrating its safety in humans.

We worked with the WHO, U.S. FDA and other global organizations to have our medicine, REGN-EBcompassionate use protocol and included in the four-arm PALM clinical trial.

In August stopped early when our Ebola treatment was deemed superior to the previous antibody treatment standard of care.

We continued to provide this important treatment for free through the PALM trial and compassionate use to ensure access for people in need.

We were relieved to learn in Spring the DRC appears to be winding down.

Building on our Ebola and Middle East Respiratory Syndrome (MERS) coronavirus experience and using the same VelociSuite® technologies, we are collaborating to rapidly develop a novel antibody cocktail that could be used as a preventative or treatment to combat this latest significant global health risk.

“THE LIFE-SAVING RESULTS SEEN WITH OUR INVESTIGATIONAL EBOLA THERAPY IN IMPACT OF REGENERON’S RAPID RESPONSE PLATFORM FOR ADDRESSING EMERGING OUTBREAKS.

AT EVERY STAGE, POSITIONING REGENERON TO RESPOND QUICKLY AND EFFECTIVELY TO NEW PATHOGENS.

To meet patients’ unmet medical needs, we are compelled to act with integrity, seeking excellence in all we do.

Our employees are crucially important to achieving our mission.

Through their passion, entrepreneurial spirit and high ethical standards, we are able to repeatedly bring important new medicines to people in need.

These shared values and behaviors guide our efforts to recruit and retain the best and brightest from today’s talent marketplace.

INTEGRITY & EXCELLENCE Ethical conduct builds trust in our company and is essential to our business.

Regeneron sets high standards for our employees, officers and directors, which are underpinned by sound corporate governance and overseen by the Board of Directors and its Corporate Governance and Compliance Committee.

Our culture of integrity informs how we approach all areas of our business, from R&D and product quality and safety, through to sales and marketing and supply chain management.

Corporate Compliance Leadership and Oversight The Chief Compliance Officer and management’s Compliance Committee lead our compliance program.

The Chief Compliance Officer is responsible for developing and providing oversight on policies and procedures to ensure that employees, suppliers and contractors comply with applicable laws and regulations.

The Chief Compliance Officer chairs the Compliance Committee, which is made up of cross- functional senior leaders.

Code of Business Conduct and Ethics Our Code of Business Conduct and Ethics sets out Regeneron’s key policies and expectations for employees, third-party contractors and suppliers to ensure that we are always acting in accordance with applicable laws and regulations.

All employees are trained on the Code when they are hired and then annually thereafter.

Employees are required to acknowledge that they have read, understood and will abide by the Code when they complete the training.

Any breach or failure to report a violation of the Code may result in disciplinary action, up to and including termination of employment.

ETHICS AND COMPLIANCE Regeneron’s commitment to high ethical standards goes beyond the required elements of a good corporate compliance program.

Members of the compliance team are integrated with the business units they support to ensure that compliance resources are available at the point of decision.

Our Chief Compliance Officer speaks frequently at employee gatherings to reinforce our culture of integrity.

And senior leaders throughout the business reinforce the company’s expectations of compliance and integrity to their own organization.

Compliance is a team activity at Regeneron and we all have a role to play.

https://www.regeneron.com/sites/default/files/Code_of_Business_Conduct_and_Ethics.pdf Global Interactions with Healthcare Professionals We are dedicated to the advancement of medical science and the development of healthcare products that will improve patient care.

We recognize that healthcare professionals are uniquely positioned to understand the needs of patients, the performance of medicines in the clinical setting and unmet treatment needs.

Therefore, we are committed to collaborating with physicians and healthcare professionals in a manner that does not have, or appear to have, any undue influence on medical judgment, prescription or product recommendations.

Transparency We believe greater transparency helps the public understand how we collaborate with the medical community to deliver safe and effective therapies and helps patients make more informed healthcare decisions.

We are committed to full compliance with all relevant transparency laws and policies requiring pharmaceutical manufacturers to track and report payments and other transfers of value to healthcare professionals.

Anti-Bribery and Anti-Corruption Regeneron’s anti-bribery and anti-corruption policy provides guidance to ensure compliance with anti-bribery and anti-corruption laws, including the U.S. Anti-Kickback Law, the U.S. Foreign Corrupt Practices Act and the United Kingdom Bribery Act.

All employees, third-party contractors and suppliers are required to complete training on global anti-bribery and anti-corruption.

Regeneron does not tolerate any type of corruption, including bribery, facilitation or “grease” payments, or the offering of any improper payments or benefits, regardless of local customs or rationales for the payments or benefits.

Non-Retaliation and Open-Door Policy Noncompliance with laws or our policies can pose serious risks for patients, shareholders, employees and our business.

Our opendoor policy encourages people to raise any concerns or questions with their supervisor or manager, by contacting the Head of Human Resources or Chief Compliance Officer or by making anonymous reports through our EthicsPoint hotline (877-RGN-ETHX) or website.

Regeneron protects employees who report concerns in good faith with non-retaliation, confidentiality policies and mechanisms to file reports anonymously.

https://www.regeneron.com/sites/default/files/Code_On_Global_Interactions.pdf https://www.regeneron.com/sites/default/files/Code_On_Global_Interactions.pdf https://secure.ethicspoint.com/ SNAPSHOT / Award-Winning Security Innovation As part of our cybersecurity efforts, Regeneron is among the first to use robotic automation to resolve computer malware infections.

CSOdemonstrate outstanding business value and thought leadership Information Security and Data Privacy Cybersecurity is critical to companies operating in our increasingly digital world, where sensitive data, personal information and intellectual property are vulnerable to theft or damage.

For us to retain trust and continue to grow, we need to ensure we are maintaining robust systems to protect against threats, both technological and human.

Our patients, colleagues, partners and other stakeholders trust Regeneron to protect the privacy of their personal data and we treat this responsibility with the utmost seriousness.

Privacy is a legal landscape that is rapidly expanding, and we are continually analyzing new and changing laws to ensure our compliance.

We updated our online Privacy Policy and put controls in place to align with new regulations, such as the EU General Data Protection Regulation (GDPR), which has been in place since the California Consumer Privacy Act, which came into effect on January 1, 2020.

“REGENERON HAS SUCH A UNIQUE CULTURE WHERE PEOPLE ARE FOCUSED ON SCIENCE AND PATIENTS— AND DOING THE RIGHT THING IS AT THE CORE OF OUR VALUES.

PRIVACY IS A PART OF THAT, AND EACH OF US PLAYS AN IMPORTANT ROLE IN PRIVACY AND COMPLIANCE.

As a general matter, this support is made to office holders and candidates who hold views that are consistent with, or will further, the legislative, regulatory and public policy goals of our company, patients and community.

We adhere to the highest ethical standards in our activities, respecting and following all applicable federal, state and local laws.

In of national trade associations, including the Biotechnology Innovation Organization (BIO) and Healthcare Distribution Alliance.

Our government affairs and public policy teams help Regeneron navigate and interact with legislative and regulatory bodies in a responsible, and civic-minded way.

We believe it is our responsibility to engage on public health matters, and we are focused on supporting Regeneron’s mission to bring important new medicines to people living with serious diseases.

Substantiated and scientifically sound Healthcare professionals should prescribe Regeneron products only when their use is clinically appropriate.

We believe branded television commercials can help provide patients with information to learn more about their condition and about a potential treatment option to help manage their disease.

Regeneron aired our first branded television commercials in the U.S. in 2018.

We have received feedback from doctors saying they appreciate that our television commercials help eligible patients know there is a potential treatment for their disease.

Patients are best served when they and their physicians are given consistent, accurate and balanced information about our medicines.

Our policies provide clear requirements for promotional materials and communications to employees, contingent workforce and vendors who communicate with the healthcare community.

Customer-facing colleagues receive annual and extensive training regarding regulations and our policies.

We have implemented processes and policies to ensure our clinical trial practices comply with laws and regulations and meet our high ethical standards.

• Our Protocol Review Committee confirms that ethics and patient safety considerations are fully integrated into all of our trial protocols.

• Our Clinical Review Committee reviews all patient-facing clinical trial recruitment material prior to Ethics Committee or Institutional Review Board submission to confirm they are easily understood by patients and free of coercive or unduly influential language, meet our quality standards and comply with applicable laws and regulations.

• Our Standard Operating Procedures outline the processes that are in place to ensure that enrolled participants (or their legal representatives) give their free and informed consent before any study procedure is undertaken or data is collected.

• Our Data Privacy Office has developed processes to ensure the privacy protections of participants in our clinical trials.

When we outsource studies to contract research organizations (CROs), our Good Clinical Practices (GCP) audit program reviews clinical trials and associated internal systems, vendors and clinical investigators to confirm they meet our quality and safety standards and are compliant, and to identify meaningful corrective and preventive actions.

Our audit program, which includes site visits by our Quality Assurance & Auditing team, is designed to cover clinical trials conducted in various countries and regions around the world.

When we engage CROs in our studies, part of the CRO’s role, through its monitors/research associates, is to ensure that the clinical trials align with pre-established criteria.

At the end of patient volunteers in 53 countries.

We hold the CROs we engage to the same high standards we have for our internally-managed projects.

If and when we identify issues related to contracted services or GCP standards, the issues are managed through a formal escalation pathway and triaged for appropriate action and resolution.

If improvements are not made within a defined period of time, or if repeat occurrences are noted and unsatisfactorily remediated, we will limit and possibly cease future award opportunities with the vendor until the issues have been fully remediated.

We are also subject to external audits by health authority inspectors that verify that we are complying with ethical standards and applicable laws and regulations.

Over the course of inspected by regulatory authorities 13 times.

Neither did any FDA-sponsored inspections result in required voluntary or official actions.

In line with the Sustainability Accounting Standards Board (SASB) recommended disclosures, we disclose the amount of monetary losses incurred as a result of legal proceedings associated with clinical trials in developing countries.

Diversity in Clinical Trials Increasing diversity in clinical trials is important as different patient populations may be impacted differently by their disease and have varying responses to the same treatment.

We believe clinical trials should represent the people living with the disease and we have always strived to be inclusive.

As part of this effort, in of processes and controls to increase awareness and incorporate diversity considerations into the design and placement of our clinical studies.

We will continue to develop this framework during measures to track our progress.

Data Transparency We are committed to sharing data from our clinical research and clinical trials in a responsible manner.

Regeneron is a member of the Biotechnology Innovation Organization (BIO) and endorses their principles on the responsible sharing of truthful and non-misleading information about medicines with healthcare professionals and payers.

We support data transparency that advances science and medicine, protects participant privacy and is in the best interest of individuals who use our products and providers who prescribe them.

Regardless of study outcome, Regeneron seeks to publish its Phase studies and its hypothesis testing/confirming Phase 1 and 2 studies; post-approval clinical studies conducted to meet a regulatory requirement; post-approval observational studies with predefined hypotheses that involve a Regeneron product; and any other clinical trial or study that provides important information on the safety and/or efficacy/ effectiveness of the agent under investigation.

Regeneron is committed to timely publication by submitting the primary findings within a year of completion of analysis.

Qualified researchers may request access to individual patient or aggregate-level data from a Regeneron-sponsored study by submitting a research proposal to https://vivli.org/. Animal Welfare Regeneron is committed to and abides by all ethical requirements related to animal welfare in research, teaching and testing.

Research involving the use of live animals must be approved by the Regeneron Institutional Animal Care and Use Committee (IACUC), a requirement of U.S. federal and state laws.

In addition, we comply with the “Three Rs” (Replacement, Reduction and Refinement), widely accepted ethical principles that are now embedded in the conduct of animal-based science in many countries around the world.

Regeneron has earned accreditation from AAALAC International, a non-profit that assesses organizations that use animals in research, teaching or testing.

More than government agencies and other research institutions in 49 countries have been accredited through AAALAC’s rigorous program and site evaluation review.

recognition of its culture of continuous improvement and manufacturing excellence.

QUALITY AND SAFETY Our ability to meet patients’ unmet needs depends on providing safe, high-quality products that people can trust.

The safety of our patients is our top priority and critical to delivering on our mission. products.

We take seriously our legal and ethical obligations to collect product technical compliance and adverse events related to our medications so that we can monitor their safe use throughout the product lifecycle.

We are committed to our responsibility for timely reporting of safety information to the FDA and other regulatory authorities, in compliance with regulations and global expectations.

In order to ensure full transparency to our expectations, we provide annual training on adverse event reporting for employees, contractors and suppliers.