Sanofi India Ltd.

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- ReNAgade Therapeutics, a company unlocking the limitless potential for RNA medicines, today announced the appointment of Paul Perreault to its Board of Directors, effective December 5, 2023. Mr. Perreault most recently served as Chief Executive Officer of CSL and brings over 40 years of leadership experience across the biotechnology industry. “Paul is a distinguished industry executive recognized for his extensive track record in drug development and was integral to the growth of CSL to become an international leader in the field. His leadership and extensive knowledge of the biotech industry will be an invaluable addition to our company as we continue to build our portfolio of novel RNA medicines,” said Amit D. Munshi, Chief Executive Officer of ReNAgade. “We are pleased to welcome Paul to the ReNAgade team and look forward to his contributions.” “I am thrilled to join ReNAgade at this exciting time for the company,” said Mr. Perreault. “ReNAgade is led by a world-class executive team, and its innovative technologies have the potential to drive the field of RNA medicines forward on an unprecedented scale in the coming years.” Mr. Perreault brings more than 40 years of experience in the global biotechnology and pharmaceutical industries, most recently as CEO and Managing Director of CSL. Within his 25-year career with CSL, he was responsible for operations in more than 40 countries, including major manufacturing sites in the U.S., Switzerland, Germany and Australia, and an extensive network of plasma collection centers throughout North America and Germany. He previously served in senior leadership roles at various companies in the space including Wyeth, Centeon, Aventis Bioservices and Aventis Behring, and served on the Board of Directors of the Pharmaceutical Research and Manufacturers of America (PhRMA). In 2019, Mr. Perreault was included in Harvard Business Review’s CEO 100 List and recognized as one of the best performing CEOs in the world. He earned his B.S. in Psychology from the University of Central Florida and completed advanced business management training at Kellogg School of Management and Wharton School of the University of Pennsylvania. About ReNAgade Therapeutics ReNAgade exists to unlock the potential for RNA medicines to treat disease anywhere in the body. We combine our novel RNA delivery platforms with a comprehensive RNA platform allowing for an all-RNA system for coding, editing, and gene insertion to develop new medicines. To accelerate the future of medicine, we bring together a team with deep RNA and delivery expertise to develop paradigm-shifting RNA medicines. ReNAgade Therapeutics—RNA Without Limits For more information about the company, its technologies, and its leadership, visit

DUBLIN, Oct. 18, 2022 /PRNewswire/ -- The "Data Integrity and Document Management Training Course" conference has been added to ResearchAndMarkets.com's offering. This concise course covers the background to data integrity, why it is important and how its requirements affect both paper-based and computer-based systems. Document management and data integrity are a key focus of regulatory inspections, with both EU and FDA inspectors increasingly observing violations during GxP inspections. It has become a critical issue in document governance and regulators expect staff working in GxP roles to have been trained in this important area. Ensuring data integrity is an important component of the pharma industry's responsibility to guarantee the safety, efficacy, and quality of drugs. Violations relating to document management and data integrity have led to numerous regulatory actions, including warning letters and critical inspection findings. To address these concerns, the FDA, EMA, MHRA and the World Health Organization (WHO) have all recently published data integrity guidelines. The programme will include discussion of the latest MHRA data integrity guide and EMA TMF guideline that should be considered by organisations involved in any aspect of the GxP pharmaceutical lifecycle (GCP, GMP, GLP and GvP). You will gain an understanding of the requirements for ensuring data integrity, review data integrity inspection findings, and get practical advice on defining and implementing an appropriate data governance process for compliance with data integrity requirements. Benefits of attending: Understand the importance of data integrity and good document practice Ensure you are compliant with the new EU trial master file (TMF) guideline Be aware of key regulations and guidelines Discuss QMS considerations for data integrity and document management Review document management and data integrity inspections to facilitate regulatory compliance Consider the requirements for document management and data integrity governance to prevent data integrity breaches Who Should Attend: This course is designed for managers and staff from all GxP areas in the pharmaceutical and medical device industries who are responsible for the creation, review, approval and/or reporting of data to ensure data integrity, in particular, those working in: Clinical trials Manufacturing Quality assurance/quality control Compliance Pharmacovigilance QA personnel from CROs/CMOs and GxP auditors responsible for carrying out audits and self-inspections or external audits will also benefit from the programme. Key Topics Covered: Principles of data integrity and good documentation practice What is data integrity? Why is data integrity important? ALCOA principles Good documentation practice including paper and electronic records Data integrity regulations and guidelines MHRA/WHO/FDA/EMA/PICS/ICHGCPR2 data integrity guidelines Group review and discussion of some key regulated documents including the latest MHRA data integrity guide Document management and data integrity inspection findings MHRA, EMA findings, EU non-compliance reports FDA findings Group discussion on inspection findings QMS considerations for Data integrity and documentation What are the elements of QMS for data integrity? Risk management considerations Data governance Discussion of participant's experience and best practice for QMS and data governance Data integrity for computer systems Computer system validation considerations What is expected for compliance for GxP systems? Discussion of document and data integrity issues Data integrity and digital signatures Certified copies/true copies Managing and preventing data integrity breaches Speakers Laura Brown Pharmaceutical QA and Training Consultant University of Cardiff Dr Laura Brown MBA, BSc,PhD, is a Pharmaceutical QA and Training Consultant, Course Director for the MSc in Clinical Research, School of Pharmacy at the University of Cardiff. She has more than 20 years' experience of quality assurance in the pharmaceutical industry and has worked for several companies, including GSKs Hoechst Marion Roussel, Farmitalia and Phoenix International. She has a particular expertise in quality assurance including risked based approaches to quality systems, data Integrity and project management in the pharmaceutical industry. She regularly writes on pharmaceutical regulatory issues including "The Planning of International Drug Development", in the Clinical Research Manual, Euromed and the "Impact of Brexit", RQA Journal 2017. For more information about this conference visit Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1904 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

SAN DIEGO, Sept. 02, 2021 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of novel therapeutics for rare endocrine diseases and endocrine-related tumors, today announced the appointment of Jeff E. Knight as chief operating officer. Mr. Knight will draw on his broad experience in pharmaceutical portfolio strategy, program management, and operations in this newly created role, in which he will be responsible for the strategic management of Crinetics' operations and infrastructure including program and portfolio management, alliance management, information technology, and facilities. Scott Struthers, Ph.D., founder and chief executive officer of Crinetics, stated, “Jeff’s intellectual curiosity and proven ability to grow into new roles makes him a natural fit for the Crinetics team. We look forward to applying his specific expertise in operational and organizational management as we continue to advance our pipeline and increase the staff and infrastructure necessary to support our growing clinical and commercial operations.” Prior to joining Crinetics, Mr. Knight was responsible for portfolio management and strategy, alliance management, quality and compliance, and corporate operations at Poseida Therapeutics, where he was a member of the executive leadership team. Between 2012 and 2018, Mr. Knight held various positions of increasing responsibility in clinical, development and corporate operations, and program and portfolio management at Amgen, Onyx Pharmaceuticals (a subsidiary of Amgen), and Halozyme Therapeutics. Earlier in his career, he gained valuable clinical development, program management, and regulatory affairs experience at Genentech, Hoechst Marion Roussel (now Sanofi), and PRA International. Mr. Knight earned a Bachelor of Science in nursing from the University of Kansas and a Bachelor of Arts in psychology followed by a Master of Public Health in biostatistics and epidemiology from the University of Oklahoma. Mr. Knight added, “Crinetics is undergoing a period of immense growth. Not only has the company embarked on registrational studies for their lead product candidate, paltusotine, but they’ve also advanced two new compounds into the clinic and have recently added over 40 new team members to support these programs. I am looking forward to working with this dynamic team to build an operational structure that allows these development efforts to accelerate with focus and efficiency.” About Crinetics Pharmaceuticals Crinetics Pharmaceuticals is a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of novel therapeutics for rare endocrine diseases and endocrine-related tumors. The company’s lead product candidate, paltusotine (formerly CRN00808), is an investigational, oral, selective nonpeptide somatostatin receptor type 2 biased agonist for the treatment of acromegaly, an orphan disease affecting more than 26,000 people in the United States. A Phase 3 program in acromegaly with paltusotine is underway. Crinetics also plans to advance paltusotine into a Phase 2 trial for the treatment of carcinoid syndrome associated with neuroendocrine tumors. The company is also developing CRN04777, an investigational, oral, nonpeptide somatostatin receptor type 5 (SST5) agonist for congenital hyperinsulinism, as well as CRN04894, an investigational, oral, nonpeptide ACTH antagonist for the treatment of Cushing’s disease, congenital adrenal hyperplasia and other diseases of excess ACTH. All of the company’s drug candidates are new chemical entities resulting from in-house drug discovery efforts and are wholly owned by the company. Contacts:Marc WilsonChief Financial OfficerIR@crinetics.com (858) 450-6464 Investors / Media:Corey DavisLifeSci Advisors, LLCcdavis@lifesciadvisors.com(212) 915-2577 Aline SherwoodScienta Communicationsasherwood@scientapr.com(312) 238-8957