Voisin Consulting Life Sciences (VCLS)

"[𝗥]𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘀 𝗮𝗻𝗱 𝗵𝗲𝗮𝗹𝘁𝗵 𝘁𝗲𝗰𝗵𝗻𝗼𝗹𝗼𝗴𝘆 𝗮𝘀𝘀𝗲𝘀𝘀𝗺𝗲𝗻𝘁 𝗯𝗼𝗱𝗶𝗲𝘀... 𝗿𝗲𝗰𝗼𝗴𝗻𝗶𝘇𝗲 𝘁𝗵𝗲 𝗶𝗺𝗽𝗼𝗿𝘁𝗮𝗻𝗰𝗲 𝗼𝗳 𝗶𝗻𝘁𝗲𝗴𝗿𝗮𝘁𝗶𝗻𝗴 𝗽𝗮𝘁𝗶𝗲𝗻𝘁𝘀' 𝗮𝗻𝗱 𝗰𝗮𝗿𝗲𝗴𝗶𝘃𝗲𝗿𝘀' 𝗽𝗲𝗿𝘀𝗽𝗲𝗰𝘁𝗶𝘃𝗲𝘀 𝗶𝗻 𝘁𝗵𝗲𝗶𝗿 𝗱𝗲𝗰𝗶𝘀𝗶𝗼𝗻-𝗺𝗮𝗸𝗶𝗻𝗴 𝗽𝗿𝗼𝗰𝗲𝘀𝘀𝗲𝘀." 🎤 VCLS expert Anne Thorez, Senior Director of Patient Engagement, speaks on the ways patient centricity is shaping the future of healthcare, and health authorities' approaches to patient engagement. 🔗Learn more about how we support the amplification of patient voices at every stage of the product lifecycle: https://lnkd.in/dGvtxTza Anne Thorez, Valérie Saugnieux #QandA #PatientCentricity #PatientEngagement #DrugDevelopment

At VCLS, we understand the common challenges HealthTech companies face when looking to enter the EU market: ➡️ Complex regulatory and reimbursement landscapes, especially for innovative and combination products. ➡️ Difficulty aligning development plans with regulatory & payer requirements across different regions. ➡️ Limited experience in interacting with regulators & payers. We provide integrated solutions all along the development journey, to help #biotech, #medtech, and #pharma companies bring their innovative products to the patients who need them. From preclinical, to early- and late-stage clinical development, and through registration to the post-approval phase, our seasoned, multidisciplinary teams are ready to support you along the path to the EU and beyond. Learn more: https://lnkd.in/emacNVEb #EU #ProductDevelopment Christelle Fasano, Kate Noble, Tom Beach, Henrik Dörge Ph.D, M.Sc, MBA, Kenneth Hollmén, Lori Kaiser, Paul Toscano, Sébastien Giraudier, PhD

The FDA recently released draft guidance titled “Frequently Asked Questions — Developing Potential Cellular and Gene Therapy Products,” aimed at assisting developers in understanding the regulatory landscape of cellular and gene therapy (CGT) products. The document provides guidance on product development, regulatory collaboration, and non-clinical & clinical development. Our new blog post, authored by VCLS expert Victoria Quiroga, Associate Director, CMC, provides all the details: https://lnkd.in/eJHNWQWq Here's a quick summary⤵️ 1️⃣ 𝗣𝗿𝗼𝗱𝘂𝗰𝘁 𝗗𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁 𝗖𝗼𝗻𝘀𝗶𝗱𝗲𝗿𝗮𝘁𝗶𝗼𝗻𝘀: The FDA guidance stresses the importance of donor eligibility, robust traceability, disease screenings, and early identification of Critical Quality Attributes (CQAs). 2️⃣ 𝗠𝗮𝗻𝘂𝗳𝗮𝗰𝘁𝘂𝗿𝗶𝗻𝗴 & 𝗣𝗿𝗼𝗰𝗲𝘀𝘀 𝗩𝗮𝗹𝗶𝗱𝗮𝘁𝗶𝗼𝗻: Sponsors must use scaled-down models for process validation, provide stability data, and assess comparability for process changes. 3️⃣ 𝗙𝗗𝗔 𝗜𝗻𝘁𝗲𝗿𝗮𝗰𝘁𝗶𝗼𝗻: Early FDA engagement through INTERACT and pre-IND meetings, as well as expedited pathways like rolling reviews, help streamline development. 4️⃣ 𝗕𝗟𝗔 𝗣𝗿𝗲𝗽𝗮𝗿𝗮𝘁𝗶𝗼𝗻: Manufacturing processes must be fully validated with data on safety, purity, potency, and stability for Biologics License Application (BLA) submission. 5️⃣ 𝗪𝗵𝘆 𝗶𝘁 𝗠𝗮𝘁𝘁𝗲𝗿𝘀: The FDA emphasizes early quality focus and strong communication to expedite the approval of safe, effective therapies. Comments on the draft guidance are open until February 18, 2025. #CellTherapy #GeneTherapy #ATMP #FDA #Guidance

Today is the 𝗜𝗻𝘁𝗲𝗿𝗻𝗮𝘁𝗶𝗼𝗻𝗮𝗹 𝗗𝗮𝘆 𝗼𝗳 𝗪𝗼𝗺𝗲𝗻 𝗮𝗻𝗱 𝗚𝗶𝗿𝗹𝘀 𝗶𝗻 𝗦𝗰𝗶𝗲𝗻𝗰𝗲 (IDWGS) and we're proud to support the United Nations in highlighting the need to close the gender gap in scientific careers. At VCLS, we know that science transforms lives. We partner with many women-led companies from across the HealthTech industry, for the benefit of patients around the world. In addition, women make up two thirds of our staff, taking on roles across the company - from our Founder & CEO Emmanuelle Voisin, PhD to our leadership team, consultants, and support functions. 👩🔬 Let's celebrate this 10th anniversary of #IDWGS and keep moving forward toward gender equity in science! #WomenInSTEM #Biotech #Medtech #Growth

"𝗔 𝗽𝗮𝘁𝗶𝗲𝗻𝘁-𝗰𝗲𝗻𝘁𝗿𝗶𝗰 𝗮𝗽𝗽𝗿𝗼𝗮𝗰𝗵 𝘁𝗼 𝗱𝗿𝘂𝗴 𝗱𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁 𝗶𝘀 𝗻𝗼𝘁 𝗷𝘂𝘀𝘁 𝗯𝗲𝗻𝗲𝗳𝗶𝗰𝗶𝗮𝗹 𝗳𝗼𝗿 𝗽𝗮𝘁𝗶𝗲𝗻𝘁𝘀 - 𝗶𝘁'𝘀 𝗼𝗳 𝗶𝗺𝗺𝗲𝗻𝘀𝗲 𝘃𝗮𝗹𝘂𝗲 𝘁𝗼 𝗽𝗵𝗮𝗿𝗺𝗮 𝗰𝗼𝗺𝗽𝗮𝗻𝗶𝗲𝘀, 𝘁𝗼𝗼." We asked VCLS expert Anne Thorez, Senior Director of Patient Engagement, for her thoughts on including patients in clinical trial protocol design. ▶️ Watch this video to learn more about how patient engagement is the cornerstone of successful clinical trial design. Anne Thorez, Valérie Saugnieux #QandA #PatientCentricity #DrugDevelopment #ClinicalTrial #ProtocolDesign

Last week, we got a little bit closer as a company with our interactive "Meet Your Colleagues" event. From Cambridge, MA to Shanghai, China, employees logged into a speed dating-style online platform where they were able to get to know coworkers from around the world that they might not have the chance to interact with on a regular basis. At VCLS, People are our first core value. This "Meet Your Colleagues" event was just one way in which we empower individuals and teams by providing them with an environment to grow and succeed. Learn more about how we live our values of People, Innovation, Passion and Excellence: https://lnkd.in/e4rfEC5n #people #HR #LifeAtVCLS Mireille Blaess

VCLS has been recognized for our sustainability initiatives for two years in a row, receiving the EcoVadis Silver Medal for our sustainability assessment. With above average scores in the Environment, Labor & Human Rights, Ethics, and Sustainable Procurement assessment sections, we've earned a spot among the 𝘁𝗼𝗽 𝟭𝟱% 𝗼𝗳 𝗰𝗼𝗺𝗽𝗮𝗻𝗶𝗲𝘀 evaluated by EcoVadis. In 2024, we nearly scored high enough to earn a gold medal - let's see what we can achieve in 2025! 🌍 Learn more about our ESG commitments: https://lnkd.in/ebpcDgxZ #ESG #sustainability Mireille Blaess

𝗛𝘂𝗴𝗲 𝘁𝗵𝗮𝗻𝗸𝘀 to everyone who came out on Wednesday for our first afterwork event of 2025! Olivier Delaunay from In Extenso Innovation Croissance presented a great overview of fundraising across the healthtech sector in 2024, with data prepared alongside Rana El Sabeh that provided context for the types of discussions happening at JPM 2025. Our amazing panelists - Clément Bertholet, Pierre Courteille, Rodolphe Clerval, and Thibaut Roulon – had a lively, insightful conversation on the trends they observed at the conference. We hope everyone left with a sense of the major takeaways from JPM, the current fundraising environment for #healthtech companies, and one or two new connections from across the Neighborhood #community. #biotech #medtech #innovation #JPM

🇺🇸 The US is the single largest healthcare market, comprising 45% of the global market overall. We can help you achieve US success for all types of #healthtech products, across all stages of development, leveraging regulatory strategy, FDA submission compliance, and effective partnering with the FDA. Learn more: https://lnkd.in/emsEGynj Lori Kaiser, Paul Toscano, Christelle Fasano, Pauline Lestringant, Michael Day #Biotech #Medtech #US #FDA #RegulatoryStrategy

✨🐍 Wishing our partners, clients, and colleagues prosperity and success in the Year of the Snake! Learn more about our presence in China: https://lnkd.in/eh64y2tT