MA-VERISTAT
29.5.2024 14:43:32 CEST | Business Wire | Press release
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/
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
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
International Human Rights Lawyer Jared Genser and Former White House Counsel Lanny J. Davis Join Legal and Advocacy Team Supporting Cambodian Businessman Yim Leak, Seiden Law LLP Announces18.9.2026 19:52:00 CEST | Press release
Jared Genser, one of the world's most recognized international human rights lawyers, and Lanny J. Davis, an adviser to former presidents George W. Bush and Bill Clinton, join the legal and advocacy team for Cambodian businessman Yim Leak and challenge what they call a coordinated smear campaign in Thailand. International human rights lawyer Jared Genser and Lanny J. Davis, who has close ties to two former US presidents and a worldwide reputation for defending those under attack with lies and smears, and for repairing the damage done to their reputations, have joined the legal and advocacy team supporting Cambodian businessman Yim Leak, Seiden Law LLP, which serves as Yim Leak's chief global counsel, announced today. Their first move is to hold the Thai government accountable, framing its conduct as either complicit in or willfully blind to a sustained smear campaign against Yim. Genser is Managing Director of Perseus Strategies, an international law firm. Over more than two decades, he
Ningbo FEED Meeting Confirms Full Confidence in Q1 2027 FID for Allied Biofuels’ US$6.1 Billion Presidential Decree-Backed SAF and e-SAF Project18.9.2026 17:38:00 CEST | Press release
Allied Biofuels has held a major Front-End Engineering Design (FEED) meeting at Sinopec’s office in Ningbo, China, bringing together Allied Biofuels, Sinopec Engineering Group Co., Ltd. of China, Topsoe A/S of Denmark, Sasol South Africa Limited, and Plug Power of the United States — the principal international engineering and technology providers supporting its US$6.1 billion Presidential Decree-backed Sustainable Aviation Fuel (SAF) and e-SAF project in Uzbekistan. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260918708077/en/ FEED Meeting - Ningbo, China At the joint FEED meeting of the project’s core engineering and technology stakeholders, the discussions established clear alignment on engineering responsibilities, technology interfaces, design deliverables, project integration and the coordinated execution programme required to advance the project through FEED. All stakeholders working on the project expressed full co
Corcept Announces CHMP Opinion Recommending EU Marketing Authorization for Lifyorli® (Relacorilant)18.9.2026 14:00:00 CEST | Press release
Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended that the European Commission (EC) should approve relacorilant, combined with the chemotherapy drug nab-paclitaxel, for the treatment of patients with platinum-resistant ovarian cancer. The CHMP’s recommendation is based on positive data from Corcept’s Phase 2 and pivotal Phase 3 ROSELLA trials, in which patients receiving relacorilant combined with nab-paclitaxel experienced improved progression-free and overall survival compared to patients who received nab-paclitaxel alone. The safety profile of relacorilant plus nab-paclitaxel in these trials was consistent with the safety profile of nab-paclitaxel monoth
Enhertu® Recommended for Approval in the EU by CHMP as Adjuvant Treatment for Patients with Residual Disease After Neoadjuvant Treatment for HER2 Positive Early Breast Cancer18.9.2026 14:00:00 CEST | Press release
Recommendation based on DESTINY-Breast05 phase 3 trial results that showed Enhertu reduced the risk of invasive disease recurrence or death by 53% versus T-DM1 Daiichi Sankyo and AstraZeneca’s Enhertu has the potential to become a new standard of care in this early breast cancer setting Enhertu® (trastuzumab deruxtecan) has been recommended for approval in the European Union (EU) as a monotherapy for the adjuvant treatment of adult patients with resected HER2 positive breast cancer who have residual invasive disease after neoadjuvant taxane-based and HER2 targeted treatment. Enhertu is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/NYSE: AZN). The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on results from the DESTINY-Breast05 phase 3 trial presented at th
CHMP Recommends EU Approval of New Indication for Alfasigma’s Jyseleca® (filgotinib), Treatment of Adults With Axial Spondyloarthritis18.9.2026 12:58:00 CEST | Press release
The information contained within this press release is for the purpose of scientific exchange.It is intended for scientific, financial and investor media only.If approved, Jyselecawill be indicated for the treatment of patients with active axial spondyloarthritis (axSpA), both non-radiographic and radiographic forms of the disease, who have responded inadequately to conventional therapy.Despite the availability of multiple treatment options, nearly half of people living with axSpA do not respond adequately to current therapies, and just 10-20% reach inactive disease within 16-24 weeks of initiating treatment.CHMP’s positive opinion is based on findings from the OLINGUITO Phase 3 study, where improvements in the signs and symptoms of axSpA with filgotinib were observed early and maintained over 52 weeks of treatment.Jyselecais already approved in Europe and the United Kingdom, for the treatment of moderate to severe rheumatoid arthritis and ulcerative colitis. Alfasigma S.p.A, a global
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
