Ming Ewe’s Post

What a wonderful, generous opportunity! MedTech is one great area to get into in case anyone in my network is interested! Sian Kneller, MSc, CMPP and Katy Barber spread the word! #innovation #career #interns #lifesciences

𝐖𝐚𝐜𝐤𝐢𝐧𝐞𝐬𝐬, 𝐢𝐧𝐧𝐨𝐯𝐚𝐭𝐢𝐨𝐧 𝐚𝐧𝐝 𝐜𝐫𝐞𝐚𝐭𝐢𝐯𝐢𝐭𝐲! Thanks to SCi Partners and Mills & Reeve for hosting a lovely #LquidlifeSciences networking event earlier this week where I met Soreya Senior as well as Dafydd Wright with a couple of members from his team, Mark Johnson and Mital Jethwa, MSc who work closely with the advanced therapies sector. From our conversations and my reflections:   💰 𝘐𝘯𝘷𝘦𝘴𝘵𝘰𝘳𝘴 𝘢𝘳𝘦 𝘯𝘰𝘸 𝘨𝘦𝘵𝘵𝘪𝘯𝘨 𝘪𝘯𝘷𝘰𝘭𝘷𝘦𝘥 𝘭𝘢𝘵𝘦𝘳 𝘢𝘵 𝘴𝘦𝘳𝘪𝘦𝘴 𝘉 i.e. taking less risk and wanting to see more concrete proof of concept   📈 𝘙𝘦𝘨𝘶𝘭𝘢𝘵𝘰𝘳𝘺 𝘊𝘔𝘊 𝘪𝘴 𝘴𝘵𝘪𝘭𝘭 𝘩𝘪𝘨𝘩 𝘪𝘯 𝘥𝘦𝘮𝘢𝘯𝘥 Clients need to be flexible and do a good sell in being able to attract good candidates/consultants. It’s also a great career choice! 👯 𝘗𝘳𝘰𝘨𝘳𝘢𝘮 𝘔𝘢𝘯𝘢𝘨𝘦𝘮𝘦𝘯𝘵 𝘢𝘯𝘥 𝘙𝘦𝘨𝘶𝘭𝘢𝘵𝘰𝘳𝘺 𝘢𝘳𝘦 𝘷𝘪𝘵𝘢𝘭 𝘵𝘰 𝘺𝘰𝘶𝘳 𝘴𝘶𝘤𝘤𝘦𝘴𝘴! What’s helped to make some startups successful is having Program Management in the earliest round of hires. The same is true of Regulatory. When both are paired together, it makes for a formidable duo driving collaboration and strategy across the organisation! 𝑊𝑎𝑐𝑘𝑖𝑛𝑒𝑠𝑠, 𝑖𝑛𝑛𝑜𝑣𝑎𝑡𝑖𝑜𝑛 𝑎𝑛𝑑 𝑐𝑟𝑒𝑎𝑡𝑖𝑣𝑖𝑡𝑦! The key to innovation is having allowing ourselves to have those mad, goofy ideas and to have fun! Sometimes it’s not just about facts and data but the freedom of expression and creativity, which enables us to become more authentic, intuitive leaders especially when we’re now in times of uncertainty and complexity. 𝑾𝒉𝒂𝒕 𝒂𝒅𝒗𝒊𝒄𝒆 𝒅𝒐 𝒚𝒐𝒖 𝒉𝒂𝒗𝒆 𝒕𝒉𝒂𝒕 𝒄𝒐𝒖𝒍𝒅 𝒉𝒆𝒍𝒑 𝒐𝒕𝒉𝒆𝒓 𝒂𝒅𝒗𝒂𝒏𝒄𝒆𝒅 𝒕𝒉𝒆𝒓𝒂𝒑𝒚 𝒔𝒕𝒂𝒓𝒕𝒖𝒑𝒔? #innovation #networking #ceos #founders #regulatoryaffairs --- --- --- --- --- --- --- --- --- --- --- --- --- --- --- --- --- --- --- --- --- If you're a biotech/advanced therapy start-up, DM to see how I can help with my consulting and coaching services. I now have availability 😀

𝐅𝐫𝐞𝐞 𝐨𝐧𝐥𝐢𝐧𝐞 𝟐 𝐝𝐚𝐲 𝐠𝐥𝐨𝐛𝐚𝐥 𝐞𝐯𝐞𝐧𝐭 𝐨𝐧 𝐍𝐎𝐖 𝐟𝐨𝐫 𝐰𝐨𝐦𝐞𝐧 𝐰𝐨𝐫𝐤𝐢𝐧𝐠 𝐢𝐧 𝐚𝐝𝐯𝐚𝐧𝐜𝐞𝐝 𝐭𝐡𝐞𝐫𝐚𝐩𝐢𝐞𝐬 Having been to a couple of female leadership events this year like BioIndustry Association (BIA)'s Women in Biotech and last month's The CGT Circle organized by the lovely Christina Giakou, I'm excited about the Women in Advanced Therapies (WIAT) Global event where they'll be covering: 💥Diversity and Collaboration 💥Inclusivity and Leadership 💥Empowerment and Mentorship 💥Regional Spotlights Just in case anyone wants to join see link below. There's also a LinkedIn group you can join. Thanks to Mital Jethwa, MSc for sharing! #wiatglobal #advancedtherapies #womeninstem #networking #innovation

𝐇𝐨𝐰 𝐭𝐨 𝐝𝐞𝐯𝐞𝐥𝐨𝐩 𝐚𝐧 𝐞𝐧𝐭𝐫𝐞𝐩𝐫𝐞𝐧𝐞𝐮𝐫𝐢𝐚𝐥 𝐦𝐢𝐧𝐝𝐬𝐞𝐭? 🎯 Set a clear vision, mission and goals ⏱ Make time to develop your longer-term strategy aligned with your vision 👯 Surround yourself with other like-minded entrepreneurs 😍 Have good aspirational role-models and mentors 👱♀️ Get a leadership coach 💝 Be kind to yourself – it takes time! 𝑾𝒉𝒂𝒕 𝒐𝒕𝒉𝒆𝒓 𝒂𝒅𝒗𝒊𝒄𝒆 𝒅𝒐 𝒚𝒐𝒖 𝒉𝒂𝒗𝒆? #innovation #startups #biotech #leadership --- --- --- --- --- --- --- --- --- --- --- --- --- --- --- --- --- --- --- --- --- If you're a biotech start-up and are struggling with your regulatory strategy or mindset, DM to see how I can help with my consulting and coaching services.

𝗛𝗼𝘄 𝗰𝗮𝗻 𝗜 𝘁𝗲𝗹𝗹 𝘄𝗵𝗶𝗰𝗵 𝗯𝗶𝗼𝘁𝗲𝗰𝗵 𝘀𝘁𝗮𝗿𝘁-𝘂𝗽 𝗰𝗹𝗶𝗲𝗻𝘁𝘀 𝘄𝗶𝗹𝗹 𝗯𝗲 𝘀𝘂𝗰𝗰𝗲𝘀𝘀𝗳𝘂𝗹? When you’re developing an innovative, complex drug in a fast-paced, ever-changing scientific, regulatory and commercial environment, it’s crucial to have more of an entrepreneurial mindset vs an employee mindset.   You need:   ⏲ 𝑇𝑖𝑚𝑒 You can’t immediately leap from a large company to a small start-up whether you’re permanent or interim.   👁 𝑆𝑒𝑙𝑓-𝑎𝑤𝑎𝑟𝑒𝑛𝑒𝑠𝑠 If you’re doing the start-up on the side while being employed, you need to be aware when switching between either modes. Note: a lot of investors don't like part-time CEOs as it looks like you're not committed.   👯 𝐴𝑙𝑖𝑔𝑛𝑒𝑑 𝑙𝑒𝑎𝑑𝑒𝑟𝑠ℎ𝑖𝑝 Founders/CEO and their team must be aligned to avoid dysfunctional decision-making and company culture.   𝑾𝒉𝒊𝒄𝒉 𝒎𝒊𝒏𝒅𝒔𝒆𝒕 𝒂𝒓𝒆 𝒚𝒐𝒖 𝒊𝒏 𝒎𝒐𝒔𝒕 𝒐𝒇 𝒕𝒉𝒆 𝒕𝒊𝒎𝒆? #innovation #startups #biotech #leadership --- --- --- --- --- --- --- --- --- --- --- --- --- --- --- --- --- --- --- --- --- If you're a biotech start-up and are struggling with your regulatory strategy or mindset, DM to see how I can help with my consulting and coaching services. 

𝐔𝐊 𝐠𝐞𝐧𝐞𝐫𝐚𝐥 𝐞𝐥𝐞𝐜𝐭𝐢𝐨𝐧 𝐯𝐨𝐭𝐞𝐫𝐬! 𝐁𝐞𝐰𝐚𝐫𝐞! Be careful to check whether your polling station will accept your postal vote! I went to my nearest but because the boundaries have changed, I had to go elsewhere! #UK #UKelection #vote

𝐊𝐞𝐞𝐩𝐢𝐧𝐠 𝐩𝐚𝐜𝐞 𝐰𝐢𝐭𝐡 𝐢𝐧𝐧𝐨𝐯𝐚𝐭𝐢𝐨𝐧; 𝐚𝐧 𝐞𝐭𝐡𝐢𝐜𝐚𝐥 𝐝𝐢𝐥𝐞𝐦𝐦𝐚 Last month’s 13th Annual Global Pharma Regulatory Summit in Mumbai supported by TOPRA - The Organisation for Professionals in Regulatory Affairs, explored how regulation can keep pace with innovation while ensuring patient safety, accessibility and affordability. I spoke on ATMPs and was joined by Valentin Plouchard, Shaila Choi, Meritxell Sabidó-Espin and Mark Birse who covered inspections, real world evidence, clinical trials, medical devices and AI. My additional reflections: 𝑬𝑼 𝑷𝒉𝒂𝒓𝒎𝒂 𝒍𝒆𝒈𝒊𝒔𝒍𝒂𝒕𝒊𝒐𝒏 - 𝑹𝒆𝒈𝒖𝒍𝒂𝒕𝒐𝒓𝒚 𝒅𝒂𝒕𝒂 𝒑𝒓𝒐𝒕𝒆𝒄𝒕𝒊𝒐𝒏 (𝑹𝑫𝑷)  More favourable for drug developers now that: ✅ RDP baseline has been adjusted from the previous proposal of 6+4y to 7.5+3 years (currently 8+2y). ✅ The previous carrot/stick proposal of gaining an extra 2y RDP if launched in all EU markets has been reduced to 6m, noting it may take up to 17m to secure pricing and reimbursement (EFPIA, 2023).   𝑨𝑰: 𝑸𝒖𝒂𝒍𝒊𝒕𝒚 𝒗𝒔 𝒔𝒑𝒆𝒆𝒅 Given the risk-based approach that FDA/EMA/MHRA have adopted, it emphasizes the importance of Quality to ensure good data quality and data integrity. Quality is already a major reputational issue for India, given the suspension of more than 350 generic drugs tested by Synapse Labs, an Indian CRO, due to deficient/insufficient data to show bioequivalence following a GCP inspection (EMA 2023 Annual Report). Anecdotally the EMA is concerned about 15 other Indian CROs.    𝑼𝑲 𝒍𝒂𝒈𝒈𝒊𝒏𝒈? Lack of resources at MHRA have resulted in fewer overseas inspections given the high staff turnover and Brexit. This is matched by anecdotal reports of scientific advice taking 3-12 months! In contrast, FDA conduct the majority of their inspections overseas supported by their local presence in China and India.   𝑪𝑮𝑻 – 𝒉𝒐𝒍𝒚 𝒈𝒓𝒂𝒊𝒍 𝒇𝒐𝒓 𝑰𝒏𝒅𝒊𝒂? I was impressed how Yogananth Rajendran M.Pharm.RAC at Immuneel Therapeutics Pvt. Ltd. had licensed the first-ever commercial CAR-T in India within an immature ATMP regulatory system at that time. However seeing the world's most expensive home - the Ambani family’s Mumbai tower, Antilia ($1 billion), in contrast to widespread poverty where basic healthcare and sanitation are lacking for many, it's made me wonder:   ❓ 𝑰𝒔 𝒊𝒕 𝒓𝒊𝒈𝒉𝒕 𝒇𝒐𝒓 𝒍𝒐𝒘𝒆𝒓-𝒎𝒊𝒅𝒅𝒍𝒆 𝒊𝒏𝒄𝒐𝒎𝒆 𝒄𝒐𝒖𝒏𝒕𝒓𝒊𝒆𝒔 𝒍𝒊𝒌𝒆 𝑰𝒏𝒅𝒊𝒂 𝒕𝒐 𝒇𝒐𝒄𝒖𝒔 𝒐𝒏 𝑨𝑻𝑴𝑷𝒔? ❓ 𝑾𝒉𝒂𝒕’𝒔 𝒕𝒉𝒆 𝒎𝒐𝒓𝒂𝒍 𝒓𝒆𝒔𝒑𝒐𝒏𝒔𝒊𝒃𝒊𝒍𝒊𝒕𝒚, 𝒊𝒇 𝒂𝒏𝒚, 𝒐𝒏 𝑨𝑻𝑴𝑷 𝒅𝒆𝒗𝒆𝒍𝒐𝒑𝒆𝒓𝒔 𝒊𝒏 𝒓𝒊𝒄𝒉𝒆𝒓 𝒄𝒐𝒖𝒏𝒕𝒓𝒊𝒆𝒔 𝒇𝒐𝒓 𝒎𝒂𝒌𝒊𝒏𝒈 𝒕𝒉𝒆𝒎 𝒂𝒄𝒄𝒆𝒔𝒔𝒊𝒃𝒍𝒆 𝒇𝒐𝒓 𝒅𝒊𝒔𝒆𝒂𝒔𝒆𝒔 𝒘𝒉𝒆𝒓𝒆 𝒕𝒉𝒆 𝒎𝒂𝒋𝒐𝒓𝒊𝒕𝒚 𝒐𝒇 𝒑𝒂𝒕𝒊𝒆𝒏𝒕𝒔 𝒂𝒓𝒆 𝒊𝒏 𝒅𝒆𝒗𝒆𝒍𝒐𝒑𝒊𝒏𝒈 𝒄𝒐𝒖𝒏𝒕𝒓𝒊𝒆𝒔 𝒂𝒏𝒅 𝒄𝒂𝒏’𝒕 𝒂𝒇𝒇𝒐𝒓𝒅 𝒊𝒕?   Until the cost is significantly reduced, ATMPs may only be the preserve of the rich. #innovation #biotech #advancedtherapies #ai #india

𝐂𝐳𝐞𝐬́𝐜́ 𝐟𝐫𝐨𝐦 𝐖𝐚𝐫𝐬𝐚𝐰! Taking a break this week after the busyness of last week's conference in Mumbai, I bumped into a statue of Marie Curie in Warsaw. Marie Curie (1867-1934) was a Polish and naturalised-French physicist and chemist who conducted pioneering research on radioactivity including discovering polonium and radium. This resulted in the development of mobile radiography units to provide X-ray services to field hospitals during World War I. I remembered reading about her at school. I didn't appreciate until now how much she was ahead of her time. She was: 🥇The first woman to win a Nobel Prize, jointly with her husband, Pierre Curie. 🥇The first person to win a Nobel Prize twice (1903 & 1911). 🏆The only person to win a Nobel Prize in two scientific fields (physics and chemistry). Normal service will resume next week! Until then, enjoy your weekend wherever you are! #femaleleaders #innovation #inspiration #stem

𝐖𝐚𝐢𝐭𝐢𝐧𝐠 𝐢𝐧 𝐭𝐡𝐞 𝐰𝐢𝐧𝐠𝐬... I've lost count how many times my Perfectionist has popped up including in the middle of the night! It's like cramming for an exam! 🙏🙏