Frank DeVecchis’ Post

Only one day left until the first ever BBJ Pharma CEO Breakfast at the Anantara New York Palace Budapest Hotel. This special event is dedicated to those involved in one of the most dynamic industrial sectors, which faces unique challenges and touches all kinds of areas, from supporting everyday well-being to developing new medicines and treatments and, of course, supporting the healthcare system and keeping hospitals running. The breakfast will start with two 15-minute presentations by (Dora Szerencses and Zsolt Bibity), shedding light on different aspects of the pharma sector in Hungary. After the presentation, there will be a roundtable, featuring (Judit Bidló, Katalin Szaloki, Dr., Wolfgang Wallisch, Matt Zeller, Robin Marshall MBE), delving into some of the crucial challenges in more depth. How will Hungary survive this critical year? How can budgetary overspending be financed? What are the likely next steps for the pharma industry in Hungary? How can Hungarian patients gain better access to cutting-edge medicines? How can Hungarian firms get involved in international clinical trials? We'll find out tomorrow!

𝐃𝐈𝐀 𝐉𝐚𝐩𝐚𝐧 𝐀𝐧𝐧𝐮𝐚𝐥 𝐌𝐞𝐞𝐭𝐢𝐧𝐠 – Early Bird Extended ❗❗  November 5-7, 2023  Venue: Ariake Central Tower Hall & Conference  Rebuilding Drug Development through Society 5.0: The Fusion of Knowledge and Technology that Transcends Time and Space     ✨ 𝐂𝐨𝐧𝐭𝐞𝐧𝐭𝐬 𝐇𝐢𝐠𝐡𝐥𝐢𝐠𝐡𝐭 ✨   ◾ 𝘒𝘦𝘺𝘯𝘰𝘵𝘦 𝘈𝘥𝘥𝘳𝘦𝘴𝘴 1️⃣: Futuristic Vision for Disease Prediction and Prevention at Ultra-Early Stages: Moonshot Research & Development Program  Gen Sobue, MD, PhD (Aichi Medical University) ◾ 𝘒𝘦𝘺𝘯𝘰𝘵𝘦 𝘈𝘥𝘥𝘳𝘦𝘴𝘴 2️⃣: Regulatory Innovation in Oncology Drug Development  Richard Pazdur, MD, PhD (Food and Drug Administration) ◾ 𝘋𝘐𝘈𝘮𝘰𝘯𝘥 𝘚𝘦𝘴𝘴𝘪𝘰𝘯 1️⃣: China Townhall  With the pandemic over, China has been actively participating in events outside the country this year.   At this year's Japan Annual Meeting, we have “China Townhall” with Director General of CCFDIE (China Center for Food and Drug International Exchange), CDE (Center of Drug Evaluation) and DFDI (Center for Food and Drug Inspection) of NMPA (National Medical Products Administration), and executives from the pharma industry in China.   They will share information with Japanese leaders in the form of a panel discussion on the progress made since their participation in ICH and on the prospects for the grand goal of making the leap to a pharmaceutical superpower.   This is the first time for the Japan Annual Meeting to have a session with Chinese regulators, and this session is very promising, especially since it will be conducted face-to-face. ◾ 𝘚𝘱𝘦𝘤𝘪𝘢𝘭 𝘚𝘦𝘴𝘴𝘪𝘰𝘯 1️⃣: Orphan Drug Development Update - Issues and Measures for Global Cooperation    Register by October 24 to benefit from the extended early bird rate: https://bit.ly/47dtq4x.

An interesting local national development in Germany........

Central & Southern Europe multi country organization (MCO) unifies 8 countries that works as one👍 : Hungary, Czechia, Slovakia, Poland, Ukraine, Romania, Greece and Israel. Our continuous learning culture and opportunities that span specialisms, sectors and products mean there are endless possibilities to progress. Meet Sanofians who share their career stories! 💬 Liat Livne: I joined Sanofi's Rare Disease Business Unit back in 2020 and later on, as part of my Individual Development Plan, received additional responsibilities as Patient Program Lead. It has been such an enriching journey so far, with me being able to lead a portfolio of solutions that is fast growing, as well as contributing to the development of a program that addresses both Health Care Professionals' and patients' needs to ensure an adequate treatment. 🎉🎉🎉 As a Sanofian, I get to benefit from endless possibilities to learn and grow as a professional, as well as experience diverse opportunities to sharpen my leadership skills and prepare myself for my next challenge. 👌 What will be my next step? I don't know yet, but I know for sure it will be here. 🌟 🌟 🌟 You'll be surprised what you can achieve at Sanofi. Discover your future here: https://lnkd.in/du5S_HvU Pursue Progress. Discover Extraordinary. #Sanofi #PursueProgress #DiscoverExtraordinary #SanofiCareers

Looks really interesting. I wish it could be held in a decent time for Japan🥲 "The Duke-Margolis Center for Health Policy, under a cooperative agreement with the U.S. Food and Drug Administration, is convening a two-day hybrid Public Workshop on March 19-20 to identify these barriers and potential strategies across all stakeholders. The goals of this workshop are to identify key challenges and opportunities in clinical trial modernization efforts around the following topics: -Regulatory and Compliance Considerations -Patient-Centricity and Recruitment Innovations -Clinical Trial Infrastructure and Organizational Culture" https://lnkd.in/gVCVh4Qg

What a way to start the week! Presenting about Centrus and "Enhancing Translational Safety Assessment" first thing! To find out more about the webinar, or about Centrus, DM me. #translationalscience #safetyassessment #womeninstem

I am delighted to be welcoming Medicines for Europe to Ireland for their annual conference on June 12th and 13th. This year is the 30th anniversary of Medicines for Europe and our conference comes at a critical time for the sustainability and security of supply of medicines across Europe. The agenda and the speaker line up reflects the importance of these topics and this promises to be a really valuable meeting. #MedsforEU24 #accessforall #genericsmedicines #valueaddedmedicines #biosimilars #MedicinesForIreland #MedicinesForEurope

With 3 weeks to go, the team here is ready for #WODC on Oct 31 – Nov 2. We have the Mighty team of Dennis Akkaya, Jasmin Schelhaas, Eline Heidenrijk and Angela Sarmiento Betancourt all attending in Barcelona 🇪🇸   We look forward to our CCO Dennis hosting a panel discussion on Oct 31 at 16:10 with recognized experts Ramona Reichenbach (Novartis), Pedro Franco (Merck Serono), and François Houÿez (Eurodis) as they delve into ‘Compassionate Use in the EU: Challenges and the Path to Harmonization’, discussing the current landscape and a path forward.      Under the moderation of Dennis, the dialogue will provide an insightful overview on:    🛤 A Comprehensive Overview: Journey through the historical to current regulations of compassionate use in the EU.  🏔 Challenges Unveiled: Active discussion about the hurdles and bottlenecks in the EU Compassionate use process.  💡 Actionable Insights: Learn about real-world pathways and solutions to harmonize compassionate use practices. Are you attending? 😃 Visit us at our booth 86 and speak with our team about our expertise in #CompassionateUse, #ExpandedAccess programs, and #RWD collection as well as our, #CTRecruitment offering and to learn more about the latest developments within pre-approval access for BioPharma.    Follow myTomorrows and World Orphan Drug Congress Europe for more. #raredisease #orphandrug 🗒 https://lnkd.in/esU7EFd  

Join me for an insightful panel discussion at the BIO International Convention in San Diego on June 5. Our session, "Evolution of the IRA: A New-Year, a Potential New Administration, Yet Tackling the Same Access and Affordability Challenges," will feature expert panelists like William Roth, Gerry Gleeson, Albert Thigpen, and William Sarraille. They will demystify how IRA will change the landscape for emerging pharmaceutical companies and put recent developments in plain language. Don't miss out on this opportunity to stay ahead of the curve in the ever-changing world of drug pricing and Medicare negotiation. #BIO2024 #IRA #drugpricing #medicarenegotiation

Patient access to effective and affordable medicines is the goal that brings all ATMP stakeholders together. Products in clinical use prior to these regulations have slowly died out due to a disconnect in clinical and commercial needs. The EMA is recognising the need for supporting hospital driven product development, where market approved medicines do not exist for a patient group. This ATMP world tour 2024 session is hosted by Peter Tropp from Region Örebro län (Örebro University Hospital) and we are very pleased to have Manel Juan from Hospital Clínic de Barcelona presenting. This duo will address the needs of the volume of patients outside of the clinical trial eligibility criteria of existing market approved ATMPs and in using hospital GMP functions to fill the gap where commercial options are not possible. The session also begins to explore the implications of obtaining autologous start material 'under duress' and the ownership of these autologous cells and data. We look forward to a lively discussion with access to effective and affordable medicines for patients in focus. https://lnkd.in/ggS_UR6V