Ana Serrato’s Post

📢 Avextra Announces the Approval of #NEUROBIS by the Italian Medicines Agency: A Phase II Clinical Trial Avextra is proud to announce that both the Italian Medicines Agency AIFA and the Italian Ministry of Health have granted formal #approval for a multi-centre #Phase II study to evaluate #safety, and #efficacy of an Avextra oral formulation in managing the symptoms of patients suffering from Amyotrophic Lateral Sclerosis (#ALS), #Alzheimer’s Disease and #Parkinson’s Disease. Avextra is partnering with the sponsor of NEUROBIS, the AOU Maggiore della Carità in Novara, Italy. #NEUROBIS is the second Phase 2 clinical trial supported by Avextra.   The study is funded by a grant from the Italian Ministry of Health signifying the support of regulators in gathering of clinical #evidence for #Cannabis-based medicines.   NEUROBIS is one of the few randomised, placebo controlled, double-blind trial with a Cannabis-based medicine to be conducted at multiple sites in #Italy and a study of this robust scientific nature aligns perfectly with Avextra’s clinical plan.   "We are excited to support a second Phase II clinical trial NEUROBIS in partnership with a leading university hospital in Italy, the AOU Maggiore della Carità Novara" said Dr. Bernhard Babel, CEO, at Avextra." With two active Phase II clinical trials in BELCANTO in Germany and NEUROBIS in Italy, Avextra is uniquely positioned with the necessary skills and capabilities to design clinical trials and develop pharmaceutical IP with Cannabis-based medicines with the potential to improve patient’s quality of life."   ➡️ For more information about NEUROBIS, please follow the link: https://lnkd.in/e2gGiQfM   ⬇️ Please find the Italian translation in the comments below. #AvextraIsExtra #Phase2ClinicalTrial #ClinicalTrial #NEUROBIS #Evidence #CannabisBasedMedicines #GeneratingEvidenceTogether #AvextraAlliance #Phase2ClinicalTrial #PatientFocus

🆕 #CANNABISFORUM NEWS 💚 MESA 4️⃣ 𝗦𝗲𝗴𝘂𝗿𝗶𝗱𝗮𝗱 𝘆 𝗲𝗳𝗶𝗰𝗮𝗰𝗶𝗮 𝗲𝗻 𝗺𝗲𝗱𝗶𝗰𝗮𝗺𝗲𝗻𝘁𝗼𝘀 𝗯𝗮𝘀𝗮𝗱𝗼𝘀 𝗲𝗻 𝗰𝗮𝗻𝗻𝗮𝗯𝗶𝘀. 𝗨𝗻 𝗽𝘂𝗻𝘁𝗼 𝗱𝗲 𝘃𝗶𝘀𝘁𝗮 𝗰𝗹í𝗻𝗶𝗰𝗼. Desde un punto de vista clínico, los medicamentos basados en cannabis presentan un potencial significativo en el tratamiento de ciertas condiciones y patologías. Sin embargo, a pesar del avance de la investigación científica, la evidencia clínica sobre su eficacia y seguridad sigue siendo limitada. En esta mesa abordaremos la importancia de los ensayos clínicos y real-world evidence, los retos regulatorios y el uso de herramientas como ensayos preclínicos y modelos animales. Y todo ello con la participación de grandes expertos en la materia: 👉 Viola Brugnatelli 👉 Roberto Algar 👉 Guillermo Moreno-Sanz Con la moderación de Ana Serrato, Chairwoman en European Medicinal Cannabis Association - EUMCA. ¡¡Te esperamos!! 😎 👀 El programa completo está disponible en la web de FARMAFORUM #medicalcannabis #biopharma #patients #regulation #quality #safety #efficacy #future #theplacetobe #Madrid #cantwait 🤗

La evidencia científica debe ser nuestro aliada y la investigación, su pilar. Para poder obtener medicamentos, con los API's del Cannabis, antes hay que lograr una sólida evidencia, durante la investigación clínica. Para contarnos los desafíos y retos durante ese proceso, tenemos la suerte de contar con una experta en esa materia, Ana Serrato. Conocela un poco mejor: Ana Serrato es una ejecutiva con más de 20 años de experiencia en la industria farmacéutica, con una dinámica trayectoria en áreas de biotecnología, enfermedades huérfanas y cannabinoides. Actualmente, se desempeña como Directora de Desarrollo Clínico en AVEXTRA desde 2021 y recientemente ha sido nombrada Presidenta de EUMCA. La experiencia de Ana es extensa en la que ha desempeñado roles fundamentales en diversas áreas terapéuticas en Pfizer, Sanofi y Merck, demostrando un profundo compromiso con la mejora de la vida de los pacientes y las comunidades. Con títulos en Microbiología y Gestión de Negocios Internacionales, Ana trae consigo una combinación de su conocimiento científico con el desarrollo estratégico corporativo. https://lnkd.in/dU5Pk3eY

Introducing our world class panel of experts who will be discussing "Challenges and Solutions in Clinical Trials" at The Cannabis Summit which is taking place in the Auditorium Maximum Jagiellonian University, Kraków, Poland on Friday 7th June 2024. The theme of the summit is "Revolutionising Healthcare | The Transformative Impact of Cannabis on Medicine and Pharma." The panel is being moderated by Prof. Dr Markus Veit | Managing Director of Alphatronics. Panelists include: Assi Rotbart - CEO, Panaxia Pharmaceutical Industries Dr. Ascher Shmulewitz MD, PhD | Chairman & CEO, MedGenesis Group Ana Maria Serrato - Head of Drug Development | Avextra This panel will delve into the intricacies of conducting clinical trials with cannabis. Panelists will evaluate the distinct challenges that arise in this burgeoning field, from navigating complex regulatory frameworks to grappling with ethical dilemmas. Gain invaluable insights into innovative strategies and solutions that pave the way for rigorous, ethical, and impactful research in cannabis-based medicine. Details concerning this important conference including tickets (€175 + Booking Fee) and accommodation in Kraków can be found at www.cannabis-summit.com #poland #polska #canabis #cannabisnews #medical #medicine #pharma #clinicaltrials #B2B #germany #industry #medicalcannabis #europe #may #cannabissummit #regulation #healthcare Eoin Long Dr. Malgorzata (Gosia) Meunier Alicia Zimmermann Jamie L. Pearson Beau Whitney Mike Sikorski Marion M. Jackie Grech Dr. Shabnam Sarshar, MBA Mariana L. Heidi Whitman Rachel Wright, CPA, MST Peter Su, CTP, CCBP, CCCE, GRCP, GRCA, IDPP, ACBP, CBE Lorna Donohoe Rebecca Abraham RN, BSN Sita Schubert Larysa Gorbunova Magda Wawrzyniak Marta Łanoch Boris Moshkovits Beatrice Spindler Christian Mey Curaleaf Adán de Salas Quiroga, PhD Christian B.

Exciting news! We are delighted to introduce our new chairwoman for the European Medicinal Cannabis Association: Ana Serrato.   With over 20 years of experience in both the cannabinoid-based medicine (CBM) and pharmaceutical industries, Ana will lead us into a dynamic era of growth and innovation.   With a strong commitment to patient-focused policies, we as EUMCA are ready to advocate for accessible and compassionate medical solutions across Europe and to continue to welcome also new members from the medical cannabis industry, pharmaceutical companies, patient, physician and industry associations, as well as academia.   Join us in welcoming Ana as we embark on this journey to shape an inclusive and progressive future for the CBM sector. Ana Maria Serrato European Medicinal Cannabis Association - EUMCA

🆕Breaking News: First patient enrolled in BELCANTO clinical trial   BELCANTO Phase 2 Clinical Trial Enrolls First Patient, Investigating Avextra's Balanced THC/CBD Extract for Early Palliative Care Oncology Patients, Sponsored by Kiel University.   Avextra Pharmaceuticals, in collaboration with the University of Kiel, is pleased to announce the enrollment of the first patient into the Belcanto Phase 2 clinical trial, a randomized, double-blind, placebo-controlled study. The trial focuses on early palliative care for oncology patients, employing Avextra's balanced 10 THC/10 CBD standardized cannabis extract. Besides University of Kiel, BELCANTO includes the participation of the oncology departments from Universities of Hamburg and Lübeck. Thus BELCANTO unifies the oncological power of northern Germany’s academia.   The primary objective of the BELCANTO trial is to rigorously examine and analyze the impact on the overall symptom burden in oncology patients treated with Avextra's balanced cannabis extract compared to a placebo control group. This collaboration with the Universities of Kiel, Hamburg and Lübeck under the lead by Professor Dr. med. Thomas Herdegen, adds academic rigor and expertise to the study, enhancing its scientific credibility and potential impact on patient care.   ~*~*~* Neueste Entwicklung: Erster Patient in BELCANTO-Studie eingeschlossen   Erste Patientenaufnahme in klinischer Phase-2-Studie BELCANTO, gesponsert von der Universität Kiel, zur Untersuchung des ausbalancierten THC/CBD-Extraktes von Avextra für onkologische Palliativpatient:innen im Frühstadium   Avextra und die Universität Kiel geben die Aufnahme des ersten Patienten in die gemeinsame klinische Phase-2-Studie BELCANTO bekannt, einer randomisierten, doppelblinden, Placebo-kontrollierten Studie. Die Studie konzentriert sich auf die Behandlung von onkologischen Palliativpatient:innen im Frühstadium mit dem ausbalancierten, standardisierten Cannabisextrakt 10 / 10 von Avextra. Neben der Universität Kiel umfasst BELCANTO auch onkologische Studienzentren der Universitäten Hamburg und Lübeck, also eine akademische Allianz der universitären Onkologie Norddeutschlands.   Hauptziel der Studie ist es, die Auswirkungen der Behandlung mit dem ausgewogenen Cannabisextrakt von Avextra auf die allgemeine Symptombelastung bei onkologischen Palliativpatient:innen zu untersuchen und zu analysieren – im Vergleich zu einer Placebo-Kontrollgruppe.   Die Zusammenarbeit mit der Universität Kiel, Hamburg und Lübeck unter der Leitung von Professor Dr. med.Thomas Herdegen verleiht der Studie eine profunde akademische Qualität und wissenschaftliche Expertise, was ihre wissenschaftliche Kredibilität und ihre potenziellen Auswirkungen auf die Patientenversorgung erhöht.   Prof. Dr. Juergen Dunst Prof. Dr. med. Anne Letsch Justus Domschikowski #medicalcannabis #RWE #Firstpatientin #oncology #palliativecare #CBM #AvextraisExtra #Generatingevidencetogether #RCT #Belcanto #AvextraAlliance

📢 Heute ist ein großer Tag für Avextra. Wir sind stolz, heute unsere #Avextra Allianz für Evidenz und unsere Unterstützung für BELCANTO, einer doppelblinden, placebokontrollierten klinischen Studie der Phase 2 für Onkologiepatient:innen vorstellen zu können! Die Avextra Allianz für evidenzbasierte Cannabis-Medizin ist eine #Kooperationsplattform für HCPs und Forschende. Ziel ist es, klinische Studien durchzuführen und Real-World Data zu generieren die als Grundlage für künftige #Zulassungsstudien mit unseren Cannabis-basierten Arzneimittel dienen können.  BELCANTO soll als Pilotprojekt der Allianz starten und wird die Veränderung der Symptomlast von onkologischen Palliativpatient:innen vs. Der Placebogruppe analysieren. Diese #Phase-2-Studie wurde von Prof. Dr. med. Thomas Herdegen vom Universitätsklinikum Schleswig-Holstein initiiert und ist sowohl vom Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) als auch von den zuständigen #Ethikkommissionen genehmigt. ➡️ Weitere Informationen über BELCANTO und die Allianz finden Sie unter dem nachfolgenden Link: https://lnkd.in/gqyRFYat EN: Today is a big day for Avextra as we introduce our Alliance for Evidence-Based Cannabis Medicine and its support of BELCANTO, a Phase 2, double-blind, placebo-controlled clinical trial for oncology patients.  Avextra’s Alliance for Evidence-based Cannabis medicine serves as a collaborative platform for healthcare professionals and researchers to conduct clinical trials and generate real-world patient data that can help inform and design future robust clinical trials with our cannabis-based medicines. The Alliances’ pilot project, BELCANTO, will examine changes to symptom burden in palliative care patients receiving a balanced cannabis extract vs. the placebo group. This phase 2 study, led by Prof. Dr. Med. Thomas Herdegen at the University Hospitals of Schleswig-Holstein, has received approval from The German Federal Institute for Drugs and Medical Devices (BfArM) and the responsible ethic committees. ➡️ For more information about BELCANTO and the alliance, follow the link below:  #GeneratingEvidenzTogether #AvextraAlliance #ClinicalTrial #AvextraisExtra #RWE #MedicalCannabis Bernhard Babel David R. Marla Luther Neil Smith Dr. Vicente Jakas Ana Maria Serrato Claudia Nemitz Dr. med. Dipl.-Chem. Konrad F. Cimander Dennis Stracke, PhD Universitätsklinikum Schleswig-Holstein Universitätsklinikum des Saarlandes Universitätsklinikum Hamburg Eppendorf

🆕Exciting news! Avextra has successfully exported medical cannabis extracts to Italy, one of our key markets in Europe.   With the second-largest patient population for cannabis-based medicines in the European Union, Italy is an important market for us. We are thrilled to be one of the few providers able to meet the needs of patients and healthcare professionals in this region.   This successful export is a testament to the quality and effectiveness of our cannabis-based medicines, as well as our unwavering commitment to meeting the needs of patients and healthcare professionals across Europe.   Stay tuned for more updates on our continued efforts to bring innovative, high-quality cannabis-based medicines to patients across Europe. #MedicalCannabis #AvextraisExtra #Italy #Patients https://lnkd.in/euThpUZv