Business Wire

MA-VERISTAT

29.5.2024 14:43:32 CEST | Business Wire | Press release

Share
Veristat Appoints Gabriela Rosu, M.D., to Lead Growing Medical Affairs Team

Veristat, the Science-First Full Service CRO and Consultancy, is pleased to announce that Gabriela Rosu, M.D., has joined as Senior Director, Global Medical Affairs.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240529939891/en/

To view this piece of content from mms.businesswire.com, please give your consent at the top of this page.

Gabriela Rosu, MD Senior Director, Global Medical Affairs Veristat (Photo: Business Wire)

Dr. Rosu is a seasoned professional with over twenty years of experience in scientific and clinical fields, having significantly contributed to the planning and execution of pivotal activities that have led to the approval and commercialization of groundbreaking therapies.

Her appointment is timely, coming just before the American Society of Clinical Oncology’s (ASCO, #ASCO24) Annual Meeting, an event where Dr. Rosu has historically made impactful contributions through numerous abstracts.

Patrick Flanagan, CEO of Veristat, praised Dr. Rosu's dedication, "Dr. Rosu’s fervent commitment to collaboration enhances our ability to make informed decisions, crucially improving patient experiences in clinical trials and ensuring favorable outcomes. Her profound insight into the nuances of oncology therapy development is invaluable, particularly as we continue to focus on optimizing treatment strategies in this area."

Veristat’s Medical Affairs team is at the forefront of evaluating scientific data to address the increasing complexity of biotherapeutic compounds and diverse patient demographics in clinical trials. The team is instrumental in fostering communication and generating essential evidence to support patient safety and optimize treatment outcomes, especially for those with rare and complex diseases (#oncology, #cancer, #raredisease).

In her new role, Dr. Rosu will oversee the global expansion of the medical and safety/pharmacovigilance teams. Her extensive background includes senior medical affairs positions at leading global CROs, where she oversaw medical monitoring for various oncology trials, advised on protocol development, risk mitigation strategies, and strategic development with a focus on patient safety and patient outcomes. Dr. Rosu's experience is particularly notable in immuno-oncology, focusing on managing compound toxicity.

Before transitioning to the CRO industry, Dr. Rosu held significant roles such as Chief Medical Officer at IMV Inc. and Global Medical Advisor at Novo Nordisk Healthcare, where she led clinical developments in oncology and coagulation disorders, among other responsibilities.

Dr. Rosu earned her Doctor of Medicine degree in Romania and has maintained active participation in prestigious organizations such as the American Society for Clinical Oncology (ASCO, #ASCO) and the European Society for Medical Oncology (ESMO, #ESMO).

Reflecting on her new position, Dr. Rosu stated, "I am honored to lead as Senior Director, Global Medical Affairs at Veristat, aligning with the company’s strategic vision to pioneer the development and commercialization of innovative treatments for rare diseases. My dedication to enhancing patient experiences in clinical trials and fostering the development of safe and effective therapies remains unwavering. I look forward to contributing to Veristat’s dynamic team and its noble mission."

About Veristat

Veristat is the Science-First CRO and Consultancy that integrates full service clinical trial execution, regulatory affairs and safety, and strategic advisor services to rapidly advance the development, approval, and commercialization of novel therapies (#NovelTherapies) around the globe. With 30 years of experience solving sponsors' unique and complex clinical, statistical, and regulatory challenges, #Veristat Science-First experts deliver timely, quality-driven results with solutions that are tailored to the needs of patients, clinical trial sites, regulators, sponsor teams, and key stakeholders.

Veristat's focus on novel drug development has led to success when handling any unknown that arises, from the simplest to most complex, across numerous therapeutic areas including rare/ultra-rare disease, advanced therapies, oncology, and biologics including cell and gene therapies (#cellandgenetherapy), enabling sponsors to succeed in extending and saving patients’ lives. Sponsors collaborate with Veristat Science-First experts who care— like they do. It is not just business for Veristat, it’s personal.

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240529939891/en/

About Business Wire

Business Wire
Business Wire
101 California Street, 20th Floor
CA 94111 San Francisco

http://businesswire.com
DK

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

FDA Issues Modified Risk Tobacco Product Orders for 20 ZYN Nicotine Pouch Products30.6.2026 18:19:00 CEST | Press release

FDA’s decision makes ZYN the first nicotine pouch product to receive MRTP orders authorizing reduced-risk claims versus cigarettes Philip Morris International Inc. (PMI) (NYSE: PM) today announced that the U.S. Food and Drug Administration (FDA) issued Modified Risk Tobacco Product (MRTP) orders for 20 variants of ZYN nicotine pouch products. These are the first MRTP orders granted for nicotine pouches, allowing PMI U.S. to market the following claim for the authorized ZYN products: “Using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.” “FDA’s decision is an important moment for the more than 45 million legal-age nicotine consumers in America,” saidStacey Kennedy, PMI U.S. CEO. “Today’s news ensures these adultshave access to accurate, science-based information, including FDA-authorized evidence that switching from cigarettes to ZYN reduces the risk of smoking-related diseases like heart disease

Caidya Announces Strategic Combination with Simbec-Orion Bridging Early Scientific Insight and Global Clinical Execution30.6.2026 17:00:00 CEST | Press release

Caidya today announced a strategic combination with Simbec-Orion designed to close the divide between early scientific insight and global clinical execution. The combination of Caidya and Simbec-Orion creates a differentiated specialty clinical CRO platform that enables programs to scale, maintaining focus, speed, and accountability. The strategic combination brings together complementary strengths to create a more complete development partner for innovative biopharma companies. With established operations across Europe, the Americas, APAC, and China, the combined organization provides meaningful expertise and execution capabilities in the regions that matter most. Simbec-Orion brings early-phase clinical pharmacology capabilities alongside deep therapeutic expertise for later stage complex oncology and rare disease trials, helping sponsors shape critical decisions early in the development lifecycle. Together, the organizations strengthen their ability to support complex, cross-border

Archer® Proves Purpose-Built AI Beats General-Purpose LLMs on Regulatory Change Management: 95% Verified Accuracy, 80x Faster, 92% Lower Cost30.6.2026 16:13:00 CEST | Press release

In a head-to-head benchmark, a leading general-purpose LLM was confidently wrong 35% of the time on regulatory dates. Archer Evolv™ shipped zero errors. For enterprises deploying AI in compliance, a wrong date is a missed deadline. The more dangerous failure is a wrong answer the model returns with high confidence, one that flows silently into a compliance calendar and is only discovered after the window has passed. Archer® today released results showing purpose-built AI beats a general-purpose large language model (LLM) on regulatory work, and it’s not close. This head-to-head test compared Archer’s purpose-built, vertical-specific AI and proprietary data sets against a leading general-purpose LLM, on a core compliance task: determining the publication, effective and comment-close dates of regulatory documents across six jurisdictions. General-purpose models are a genuine breakthrough, and this is no referendum on their quality. The question Archer set out to answer is narrower and mo

Altasciences Supports Key Development Milestone for Steel Therapeutics’ Lead Therapeutic Candidate, Fizurex™30.6.2026 16:08:00 CEST | Press release

Altasciences, a leading drug development organization, today announced a significant milestone in the development of Steel Therapeutics, Inc.’s pivotal toxicology study for its lead product candidate, Fizurex™, for the treatment of anal fissures. The successful completion of the study plays a significant role in the advancement of Fizurex™ toward first-in-human trials. The GLP-compliant study demonstrated a favorable safety profile, which has advanced Steel Therapeutics' plans to submit an Investigational New Drug (IND) application for Fizurex™ to the FDA in Q3 2026. Fizurex™, a patent-pending, single-use topical wipe, was designed to provide a standardized, accessible treatment option for a painful and often undertreated medical condition. The product builds on years of use through compounding pharmacy prescriptions and is now advancing toward clinical development and regulatory review. "We are proud to have supported Steel Therapeutics with the generation of the high-quality safety d

Interactive Brokers Expands Access to Korean Equities with Launch of Nextrade ATS30.6.2026 16:00:00 CEST | Press release

IB SmartRouting℠ Routes Orders to the Best Available Price Between KRX and Nextrade Interactive Brokers (Nasdaq: IBKR), an automated global broker, today announced the launch of select Korean equities through Nextrade, South Korea's first Alternative Trading System (ATS). The addition of Nextrade builds on Interactive Brokers' earlier launch of the Korea Exchange (KRX), through which it became the first major US-based broker to provide global investors with direct access to Korean equities. Clients trading on Nextrade benefit from significantly extended trading hours and access to additional liquidity. Interactive Brokers has enabled IB SmartRouting℠ across both the Korea Exchange (KRX) and Nextrade, automatically routing orders to the venue offering the best price. This helps clients achieve best execution while providing greater flexibility and more opportunities to participate in one of Asia's most dynamic equity markets. Korea's equity market ranks among the top global exchanges by

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye