Daniela Drago’s Post

What a fantastic experience at #ASGCT24 yesterday! During my talk, I addressed five common questions that I get from academic entrepreneurs who are working on their first Investigational New Drug Application (IND): 🔹 What is an INTERACT meeting with the #FDA and should I consider one? 🔹 How does an INTERACT meeting differ from a pre-IND meeting? 🔹 How do I assess if I am ready for an INTERACT meeting? 🔹 What are some best practices for a successful FDA meeting? 🔹 What are some regulatory mechanisms to expedite the development process? A heartfelt thank you to American Society of Gene & Cell Therapy for hosting a wonderful conference and for the kind invitation. What a great opportunity to connect with friends and colleagues and share insights on navigating the regulatory landscape. #drugdevelopment #regulatoryaffairs #CellTherapy #GeneTherapy

I am delighted to be in the final stages of preparing for my upcoming lecture on US #FDA regulation at the University of Sydney. A heartfelt thank you to Orin Chisholm for extending her kind invitation. I’m putting together a talk that I hope will be both informative and engaging, and I’m really looking forward to exchanging ideas with the bright minds there. It’s such a rewarding experience to discuss topics I am passionate about with students and colleagues. Looking forward to this opportunity for professional exchange and learning. Thank you, Orin, for making this possible! #drugdevelopment #education #career #regulatoryaffairs https://lnkd.in/dSagNxb6

𝗙𝗗𝗔 𝗛𝘂𝗺𝗮𝗻 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗣𝗿𝗼𝗱𝘂𝗰𝘁 𝗨𝘀𝗲𝗿 𝗙𝗲𝗲 𝗣𝗿𝗼𝗴𝗿𝗮𝗺𝘀 𝗘𝘅𝗽𝗹𝗮𝗶𝗻𝗲𝗱 The Congressional Research Service recently updated its report on the US FDA human medical product user fee programs. For those that might not be familiar with it, CRS is a service unit of the Library of Congress. It analyzes legislative and oversight issues of interest to the US Congress. CRS’s services are nonpartisan and produce excellent resources. This report provides a broad overview of user fee programs. Specifically, it describes: 🔹 Prescription Drug (Brand) User Fee Program (PDUFA) 🔹 Medical Device User Fee Program (MDUFA) 🔹 Generic Prescription Drug User Fee Program (GDUFA) 🔹 Biosimilar User Fee Program (BsUFA)

𝗥𝗲𝗳𝗹𝗲𝗰𝘁𝗶𝗼𝗻𝘀 𝗼𝗻 𝗖𝗼𝗻𝘁𝗿𝗼𝗹, 𝗖𝗼𝗺𝗺𝘂𝗻𝗶𝗰𝗮𝘁𝗶𝗼𝗻, 𝗮𝗻𝗱 𝗡𝗮𝘃𝗶𝗴𝗮𝘁𝗶𝗻𝗴 𝗧𝘂𝗿𝗯𝘂𝗹𝗲𝗻𝗰𝗲 I was reflecting on a recent high-stakes meeting, and one truth stands out vividly: exceedingly few things are within our control. However, the choice of our words is an important exception. This is a powerful tool. Often people don't just listen to us — they might need to rely on us. Every word counts, echoing far beyond the walls of a conference room or the borders of a Zoom screen. Reflecting on this, I recall moments of turbulence on flights — analogy for unexpected challenges in life and business. I've noticed two types of responses from pilots. In the first scenario, the pilot calmly informs us about the rough patch ahead, reassuring passengers with clear instructions. This transparency helps prepare and stay calm. In contrast, a silent cockpit during a rough flight can cause panic and fear. Leadership is similar. Whether steering a team through economic downturns, organizational changes, or a big or small crisis without a clear end, the essence of good leadership is consistent communication. Like the pilot who doesn't leave his passengers in the dark, a good leader provides guidance even when the path isn't clear. They reassure the team: "We are in this together. It might get tough, but here's our plan to mitigate the impact." So, let's all remember: let's be the pilot who picks up the PA system and doesn't leave everyone guessing. Let's be clear and keep people in the loop. People might not remember everything we say, but they'll remember how we helped them feel secure when things got rocky.

𝟵 𝗤&𝗔𝘀 𝗼𝗻 𝗕𝗶𝗼𝗹𝗼𝗴𝗶𝗰𝘀 𝗣𝗿𝗼𝗺𝗼𝘁𝗶𝗼𝗻 𝗮𝗻𝗱 𝗔𝗱𝘃𝗲𝗿𝘁𝗶𝘀𝗶𝗻𝗴 𝗶𝗻 𝘁𝗵𝗲 𝗨𝗦   Hot off the press - The US #FDA published a revised draft guidance to answer questions about promotional communications for prescription biologics including reference products, biosimilars, and interchangeable biosimilars. This revised document fulfills the Biosimilar User Fee Amendments of 2022 commitment to publish draft guidance on promotional labeling and advertising considerations for interchangeable biosimilar products. It replaces the 2020 draft guidance, “Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products: Questions and Answers.” Changes from the 2020 draft guidance include: 🔹  Additional recommendations 🔹  An example of an interchangeable biosimilar product, and 🔹  Clarifying editorial changes #drugdevelopment #regulatoryaffairs #biopharma #biosimilars

𝗙𝗗𝗔'𝘀 𝗤𝘂𝗮𝗻𝘁𝗶𝘁𝗮𝘁𝗶𝘃𝗲 𝗠𝗲𝗱𝗶𝗰𝗶𝗻𝗲 𝗖𝗲𝗻𝘁𝗲𝗿 𝗼𝗳 𝗘𝘅𝗰𝗲𝗹𝗹𝗲𝗻𝗰𝗲: 𝗪𝗼𝗿𝗸𝘀𝗵𝗼𝗽 𝗠𝗮𝘁𝗲𝗿𝗶𝗮𝗹𝘀 𝗡𝗼𝘄 𝗔𝘃𝗮𝗶𝗹𝗮𝗯𝗹𝗲 Hot off the press -The US #FDA just posted meeting materials for its upcoming virtual workshop titled 𝘚𝘵𝘳𝘦𝘢𝘮𝘭𝘪𝘯𝘪𝘯𝘨 𝘋𝘳𝘶𝘨 𝘋𝘦𝘷𝘦𝘭𝘰𝘱𝘮𝘦𝘯𝘵 𝘢𝘯𝘥 𝘐𝘮𝘱𝘳𝘰𝘷𝘪𝘯𝘨 𝘗𝘶𝘣𝘭𝘪𝘤 𝘏𝘦𝘢𝘭𝘵𝘩 𝘵𝘩𝘳𝘰𝘶𝘨𝘩 𝘘𝘶𝘢𝘯𝘵𝘪𝘵𝘢𝘵𝘪𝘷𝘦 𝘔𝘦𝘥𝘪𝘤𝘪𝘯𝘦: 𝘈𝘯 𝘐𝘯𝘵𝘳𝘰𝘥𝘶𝘤𝘵𝘪𝘰𝘯 𝘵𝘰 𝘵𝘩𝘦 𝘊𝘋𝘌𝘙 𝘘𝘶𝘢𝘯𝘵𝘪𝘵𝘢𝘵𝘪𝘷𝘦 𝘔𝘦𝘥𝘪𝘤𝘪𝘯𝘦 𝘊𝘦𝘯𝘵𝘦𝘳 𝘰𝘧 𝘌𝘹𝘤𝘦𝘭𝘭𝘦𝘯𝘤𝘦. The workshop, scheduled for April 25, 2024, will be the debut event hosted by the newly launched CDER Quantitative Medicine Center of Excellence (QM CoE). Quantitative Medicine uses models and simulations from various data sources to enhance drug development, regulatory processes, and patient care. The workshop aims to outline the QM CoE’s vision, current projects, and future goals. The meeting is free and open to the public, but registration is required. #drugdevelopment #regulatoryaffairs #biopharma

𝗦𝗲𝗻𝘀𝗶𝘁𝗶𝘃𝗶𝘁𝘆 𝘃𝘀. 𝗦𝗽𝗲𝗰𝗶𝗳𝗶𝗰𝗶𝘁𝘆 Have you wondered 𝘸𝘩𝘢𝘵'𝘴 𝘵𝘩𝘦 𝘥𝘪𝘧𝘧𝘦𝘳𝘦𝘯𝘤𝘦 𝘣𝘦𝘵𝘸𝘦𝘦𝘯 𝘴𝘦𝘯𝘴𝘪𝘵𝘪𝘷𝘪𝘵𝘺 𝘢𝘯𝘥 𝘴𝘱𝘦𝘤𝘪𝘧𝘪𝘤𝘪𝘵𝘺? In this short video, I answer this question. ____________________________________ 𝘉𝘦𝘭𝘪𝘦𝘷𝘦 𝘺𝘰𝘶𝘳 𝘯𝘦𝘵𝘸𝘰𝘳𝘬 𝘮𝘪𝘨𝘩𝘵 𝘧𝘪𝘯𝘥 𝘵𝘩𝘪𝘴 𝘷𝘢𝘭𝘶𝘢𝘣𝘭𝘦? 𝘏𝘪𝘵 𝘳𝘦𝘱𝘰𝘴𝘵 𝘞𝘢𝘯𝘵 𝘵𝘰 𝘸𝘰𝘳𝘬 𝘵𝘰𝘨𝘦𝘵𝘩𝘦𝘳? 𝘏𝘦𝘳𝘦 𝘪𝘴 𝘢 𝘭𝘪𝘯𝘬 𝘵𝘰 𝘴𝘤𝘩𝘦𝘥𝘶𝘭𝘦 𝘢 𝘤𝘢𝘭𝘭: https://rb.gy/dizmuu

𝗨𝗦 𝗙𝗗𝗔'𝘀 𝗢𝗻𝗰𝗼𝗹𝗼𝗴𝘆 𝗖𝗲𝗻𝘁𝗲𝗿 𝗼𝗳 𝗘𝘅𝗰𝗲𝗹𝗹𝗲𝗻𝗰𝗲 𝗣𝗿𝗼𝗷𝗲𝗰𝘁 𝗔𝘀𝗵𝗮 The US #FDA's Oncology Center of Excellence has launched Project Asha in partnership with the White House Cancer Moonshot Program to enhance oncology clinical trial access in India. The primary focus is to expand clinical trials, offer training for early career researchers, provide regulatory guidance, and improve patient-centered approaches in low-resource settings with support from Indian pharmaceuticals. Project Asha will also foster international research collaborations, ensuring inclusive participation and robust privacy protections. Despite India's large population representing nearly 20% of the global total, only 1.5% of worldwide clinical trials are conducted there. Addressing this disparity, Project Asha aims not only to improve health outcomes in India but also to enhance global cancer research. #Oncology #ClinicalTrials #GlobalHealth #CancerCare

𝗘𝗨 𝗣𝗮𝗿𝗹𝗶𝗮𝗺𝗲𝗻𝘁 𝗔𝗱𝗼𝗽𝘁𝘀 𝗟𝗮𝗻𝗱𝗺𝗮𝗿𝗸 𝗣𝗵𝗮𝗿𝗺𝗮𝗰𝗲𝘂𝘁𝗶𝗰𝗮𝗹 𝗥𝗲𝗳𝗼𝗿𝗺𝘀 𝗔𝗺𝗶𝗱 𝗜𝗻𝗱𝘂𝘀𝘁𝗿𝘆 𝗖𝗼𝗻𝗰𝗲𝗿𝗻𝘀 This week, the European Parliament has voted to adopt a significant update to the EU's pharmaceutical regulations, the first in 20 years. By a substantial majority, the Parliament adopted new legislation that seeks to balance drugmaker incentives and medication access. The pharmaceutical industry expressed concerns that the changes might stifle innovation by reducing incentives, especially in areas like orphan drug and pediatric medication development. The new Parliament will revisit the legislation post the June 6-9 European elections, and the European Council must endorse the package before final negotiations can proceed. #drugdevelopment #biopharma #regulatoryaffairs

𝗥𝗲𝗮𝗹-𝗧𝗶𝗺𝗲 𝗢𝗻𝗰𝗼𝗹𝗼𝗴𝘆 𝗥𝗲𝘃𝗶𝗲𝘄 (𝗥𝗧𝗢𝗥) Have you wondered 𝘸𝘩𝘢𝘵 𝘪𝘴 𝘵𝘩𝘦 𝘍𝘋𝘈'𝘴 𝘖𝘯𝘤𝘰𝘭𝘰𝘨𝘺 𝘊𝘦𝘯𝘵𝘦𝘳 𝘰𝘧 𝘌𝘹𝘤𝘦𝘭𝘭𝘦𝘯𝘤𝘦 𝘙𝘦𝘢𝘭-𝘛𝘪𝘮𝘦 𝘖𝘯𝘤𝘰𝘭𝘰𝘨𝘺 𝘙𝘦𝘷𝘪𝘦𝘸 (𝘙𝘛𝘖𝘙) 𝘱𝘳𝘰𝘨𝘳𝘢𝘮? In this short video, I answer this question. #drugdevelopment #pharmaceuticals #biopharma #regulatoryaffairs ____________________________________ 𝘉𝘦𝘭𝘪𝘦𝘷𝘦 𝘺𝘰𝘶𝘳 𝘯𝘦𝘵𝘸𝘰𝘳𝘬 𝘮𝘪𝘨𝘩𝘵 𝘧𝘪𝘯𝘥 𝘵𝘩𝘪𝘴 𝘷𝘢𝘭𝘶𝘢𝘣𝘭𝘦? 𝘏𝘪𝘵 𝘳𝘦𝘱𝘰𝘴𝘵 𝘞𝘢𝘯𝘵 𝘵𝘰 𝘸𝘰𝘳𝘬 𝘵𝘰𝘨𝘦𝘵𝘩𝘦𝘳? 𝘏𝘦𝘳𝘦 𝘪𝘴 𝘢 𝘭𝘪𝘯𝘬 𝘵𝘰 𝘴𝘤𝘩𝘦𝘥𝘶𝘭𝘦 𝘢 𝘤𝘢𝘭𝘭: https://rb.gy/dizmuu