Nikki Whitfield

Thanks Rizwan Chaudhrey for the great chat with Almac Sciences' Tom Moody at #CPHINA. Learn more about our expertise, investment and stability in the video below:

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*GSK sells off remaining stake in Haleon* Sale of 4.2% holding raises £1.25bn for pharmaceutical group as it shifts focus to high-value drugs GSK has sold its remaining stake in Haleon, the consumer healthcare company it spun off and listed in London in July 2022, raising £1.25bn and underscoring how pharmaceutical groups are streamlining their businesses to focus on high-value drugs. The sale of the 4.2 per cent stake marks the end of the FTSE 100 company’s links to the maker of Panadol painkillers and Sensodyne toothpaste. GSK on Friday said it had sold more than 385mn shares at 324p a share, representing a 2.6 per cent discount to its closing price of 332.4p on Thursday. The British pharmaceutical company’s exit from Haleon was anticipated. The group had made three previous stock disposals since May 2023, when it held 12.9 per cent of the spin-off’s shares. The company said its exit was “consistent with its previous commitments to monetise its holding in a disciplined manner.” In total, stock disposals over the past year have helped GSK raise just under £4bn, which can be redirected to reducing debt or for mergers and acquisitions. Haleon was formed in 2019 as a joint venture of Pfizer and GSK’s consumer health assets. The decision to list the division in 2022 marked the largest public offering in London in a decade. It came after years of pressure from shareholders, with activist investor Elliott Advisors building a stake in the UK drugmaker and pushing GSK to speed up the process. https://lnkd.in/du4hdZg3

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Departmentalisation, Specialisation and Outsourcing Opportunities in Pharmaceutical Development Organisations Join our FREE breakfast session on 29th May, 2024 at 9am GMT (UK time) All organisations are looking to maximise returns on R&D spending whilst at the same time ensuring a high-quality product succeeds through to commercialisation. There are choices as to how to set up internally/externally and how to achieve the correct balance between speed, cost, quality, flexibility and dependability. We will briefly cover the principles of Departmentalisation, Specialisation and Outsourcing. We will then discuss examples from participants and what decisions participants have been faced with and overall outcomes. We will present two examples the moderator has initiated and led from his experience as a leader within a global analytical R&D department. We will discuss pros/cons and challenges, along with some ideas and suggestions as to how to overcome the latter. Register now through the 🔗 in the comments below. See you there! --------------------------------------------------------- Want to see more of our content? Join our FREE High Performance Life Science Organisation (HPLSO) Community https://lnkd.in/eYneyABd to get access to FREE events and content. 🔝 Connect with me Ring the 🔔 on my Profile Head to my featured content section 📈   👍 You want to improve your organisation and/or develop the potential of your products and people? 👍 You have a complex business issue you have to deal with? 👍 You need specific biopharma expertise? 👍 You are looking for operational / interim management support? 👍 You are looking for a customised training session? 👍 You have an urgent hiring need? 🤔 Then pop me a DM 💬 and let's have a chat 😁 OR use the contact form on our website: https://lnkd.in/ey2q3QzU or book a call https://lnkd.in/eyF-QrZy 😉.

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The MHRA have communicated that only 20% of Windsor Framework submissions have been made. With implementation due by 1st Jan 2025, if you haven’t started planning your submissions and artwork updates, you are putting either compliance or supply at risk. Reach out to discuss how Fusion Pharma Limited can support you as we have/are with many companies. #windsorframework #mhra

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ICH announces plans to develop Addendum to ICH M7 to deal with Nitrosamines The ICH press release (12 June 2024) states “An Addendum to the Multidisciplinary Guideline M7 on “Assessment and Control of DNA Reactive (mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk” to address safety assessment and establishment of appropriate controls for nitrosamine impurities through a staged approach, leveraging the Formal ICH Procedure, as well as to develop a harmonised set of acceptable intakes (AIs) leveraging the M7 Maintenance Procedure”. It is expected that the Addendum will deal with the application of ICH M7 principles to nitrosamines, including derivation of acceptable intake (AI), concept of less-than-life-time (LTL), structure-activity relationship and read-across methodologies, protocol for in vitro Ames test and follow-up in vivo tests, in the toxicological risk assessment of nitrosamine impurities. It is really a welcome move and a major milestone in the safety evaluation of “cohort of concern” chemicals, such as nitrosamines. #nitrosamines #ICHM7 #genotoxicity #mutagenicity #toxicology #riskassessment #acceptableintake #PDE #permitteddailyexposure #nonclinicaldevelopment #clinicaldevelopment #CMC #impurityqualification #ICHQ3A #ICHQ3B #ICHQ3C #firstinhumantrial #drugdevelopment #clinicaltrial #toxicity #carcinogenicity

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The pharmaceutical industry must adapt to the updated European Union’s Annex 1 sterile product manufacturing guidelines to work within the EU or service EU-based clients. CRB's Christa Myers is joined by Nadiyra Walker Speight, Senior Director of Drug Product & Finished Goods Manufacturing at FUJIFILM Doisynth Biotechnologies, for an interview with Pharmaceutical Technology at INTERPHEX. They discuss: • Alignment status with Annex 1 • Challenges facing the industry with Annex 1 implementation • Changes necessary due to Annex 1 updates Watch their interview at the link below. #LifeSciences #Pharma #INTERPHEX2024 #Annex1

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At #ASCO24, we are delighted to share the key findings from sunvozertinib’s global pivotal WU-KONG1B study that has met its primary endpoint in EGFR exon20ins NSCLC. https://lnkd.in/eYZiT7jf #exon20ins #nsclc #oncology

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Shares in Redx Pharma (“Redx”) (https://lnkd.in/ecPbsk48) have been admitted to trade on JP Jenkins share dealing platform.   Redx (JPJ: REDX) is a clinical-stage biotechnology company focused on the discovery and development of novel, small molecule, targeted therapeutics for the treatment of fibrotic disease and cancer.   JP Jenkins provides a share trading venue for unlisted or unquoted assets in companies, enabling shareholders and prospective investors to buy and sell equity on a matched bargain basis. JP Jenkins is a trading name of InfinitX Limited and Appointed Representative of Prosper Capital LLP (FRN453007).   Shareholders wishing to trade these securities can do so through their stockbroker. Trades will be conducted at a level that JP Jenkins is able to match a willing seller and a willing buyer. Trades can be conducted, and limits can be accepted, during normal business hours. Shareholders or potential investors can place limits via their existing UK regulated stockbroker.   The indicative pricing for the ordinary shares (ISIN: GB00BSNB6S51), as well as the transaction history, will be available on the JP Jenkins website at (https://jpjenkins.com/)   Peter Collum, Chief Financial Officer, Redx Pharma said “We are pleased to be able to offer our shareholders the ability to continue trading Redx shares on the JP Jenkins platform as a private company following the delisting from AIM. The JP Jenkins platform allows buying and selling of shares through a structured secondary market using brokers in the same manner as trading a listed security. This will allow us to focus on the execution of our corporate strategy, driving forward our pipeline of differentiated, novel drug candidates and ultimately delivering shareholder returns.” Veronika Oswald, Commercial Director of JP Jenkins said: “Redx’s move from AIM to the JP Jenkins venue represents a significant step forward in our journey towards accessibility and liquidity for their investors. This transition underscores our commitment to fostering a dynamic and thriving investment environment. We're thrilled to embark on this new chapter with Redx, confident in the opportunities it will unlock for both companies. See full article here: https://lnkd.in/dXmWaYwG

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Island Pharmaceuticals is pleased to report highly positive pharmacokinetic (PK) data for ISLA-101 from its 24-subject Single Ascending Dose clinical study. The new data shows that the required levels of ISLA-101 concentration in the blood were observed after only a single dose. PK data is critical for determining how the drug acts in the body and for establishing appropriate dosing regimens for Island's planned Phase 2a clinical trial. CEO Dr David Foster said, “This new pharmacokinetic data reinforces our strong confidence in ISLA-101. The data has shown us that even following a single dose, we are achieving blood concentrations that have previously been shown to be effective against dengue fever infections. This is exactly the outcome we hoped for - it provides a critical datapoint to underpin our dosing regimen as we prepare for the Phase 2 clinical study, which will include dosing for multiple days.” For further information, refer to the full ASX Announcement here: https://shorturl.at/nqyO8 #ILA #DengueFever #MosquitoBorneViruses

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The FDA has just approved two biosimilars to Regeneron's blockbuster eye injection Eylea: Biocon Biologics' Yesafili and Samsung Bioepis/Biogen's Opuviz. These biosimilars, designed for conditions like wet age-related macular degeneration and diabetic retinopathy, are set to offer high-quality, affordable alternatives with the FDA's interchangeability designation, meaning they can be used in place of Eylea without needing prescriber consultation. This move underscores the rigorous review process that confirmed these biosimilars' efficacy, safety, and similarity to Eylea. With the potential to lower costs and increase accessibility, biosimilars like Yesafili and Opuviz are poised to be a win for patients. Follow Warman O'Brien for all the latest updates in the life sciences industry. #HealthcareInnovation #Biosimilars #PatientCare #FDAApproval #EyeHealth

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Closed Loop Medicine's exclusive #SaMD is aiming to personalise and optimise drug therapy by partnering up with Teva Pharmaceuticals to combine digital care with tailored drug doses. 💊 Merging the technology from Closed Loop Medicine with Teva's pharmaceutical products will allow for the prescription of #digitalsolutions 📱 alongside traditional medications. Recent trials have shown promising results in drug therapy for hypertension, enhancing medication adherence, and minimising side effects. 👨‍⚕️Closed Loop Medicine's CEO commented: “This commercial partnership is an example of the potential and scalability of our SaMD technology platform, demonstrating the value that can be added by integrating software to well-known and trusted brands to improve disease management and patient outcomes at an individual level.” Read more here 👉 https://lnkd.in/dEw9S7Nv #HealthTech #MedTech #Compliance

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How do you ensure a major separation delivers two world leading companies on time and with minimal disruption to either business? We're delighted to have been nominated for the Management Consultancies Association awards for our close work with GSK functions over more than two years to scope, mobilise and deliver their complex, high-profile transformation. You can take a read of the full case study here: https://lnkd.in/gXRgTqHr #MCAawards #businesstransformation #MeaningfulChange

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Tom Hegarty shares his knowledge with International Pharmaceutical Industry Journal on the complexities of #paediatric drug development and manufacturing and how to best address these challenges. Read more: https://hubs.li/Q02t8k4L0

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I attended Reuters Events Pharma https://lnkd.in/e76Qt259 2024 #REpharma2024 in Barcelona last week, for an exciting and insightful few days of presentations, panel discussions and networking. Some of my key themes and take-home thoughts include: The importance of collaboration across the industry. This was kicked off by Daniel Baker, introducing the whole conference with the analogy of a rowing team, pulling together, and emphasizing how we need to work together to accelerate the delivery of much-needed treatments to patients. Patient centricity was an important thread, with industry leaders talking about how to access and include patient voice and other stakeholder views into clinical trial planning and execution, as well as post-market communications. Ben Geelan and Ken Getz talked about Roche’s triad framework to balance trail performance, patient burden, and complexity. And Andrew Binns gave a provocative keynote on how it's crucial speak a common language and connect more with our patients. And of course, the impact of large language models and innovative AI. For me there were two outstanding “visionary” talks, one from Aaron Bjork at Microsoft and one from Marco Andre, global head of AI excellence for Novartis. Aaron Bjork reminded us not to underestimate the power of AI. For instance, ChatGPT has amassed 100 million users in just 2 months, a milestone that took Netflix 10 years to achieve. Marco Andre talked about FOBO – fear of becoming obsolete, but ended with the message that AI can give us superpowers; folks working with AI will be more effective than folks working without. Many of the speakers across the 3 days, and the coffee and networking chats, tended to be more pragmatic, and how folks were getting value from genAI for smaller scale tasks e.g. writing emails, summarising meetings, finding internal information; saving time and being more effective with these new tools. Overall, the energy and enthusiasm for advancing healthcare through collaboration, novel technology, and patient focus were truly inspiring. What a great few days!

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We caught up with Makarand Bagul, MBBS MBA, Senior Medical and Technical Director at Teva UK, to find out a bit more about his involvement in some of the #Pride month initiatives that have been happening here at Teva: “I’ve been with Teva for just short of two years and what has struck me most since day one is the really strong sense of inclusion that we have here; doing the right thing and being able to bring your true self to work, without judgement. As well as having an enjoyable job, the culture of an organisation is important to me. That’s why I have become involved in the Diversity and Inclusion work that’s a core pillar of our business. I’m sponsor of the race workstream and am also a vocal member of the gender group, participating in some Pride events – both locally and globally. Just last week, I took part in a Pride panel discussion as I think it is important for people to share their personal experiences. “I’m fortunate that I have never really faced any discrimination either for my sexuality or race. But I know others aren’t so lucky, and that’s why I think it is important for me to be an ally – a kind of ‘ally from within’. Everyone has different experiences, and it is our job to create an environment that provides psychological safety. Therefore, by making my voice heard, if one person feels more comfortable with who they are then, for me, that is a success.” Thanks to Makarand for his insight and all the work he and the Diversity and Inclusion groups do. Click here to read more about how we’ve been celebrating Pride at Teva: https://ow.ly/BCtM50Srw9y #TevaUK #Pride #DiversityAndInclusion

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The fastest growing drug market serves obesity and type 2 diabetes. Standard Fmoc-based peptide synthesis in organic solvents will never be an economically viable approach. Initially we need to move to peptide synthesis in water and ultimately we may need to replace Fmoc with lower molecular weight protection. At Spheritech we’re tackling the first issue and working on the second. We can dissolve Fmoc protected amino acids in water and we now have a new water compatible activating agent to overcome the coupling issues with EDCI and DMTMM.

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On Clinical Trials Day 2024, as we celebrate the crucial role of clinical trials in advancing medical science and improving patient outcomes, it's a perfect moment to reflect on the inspiring stories shared at Pharma IQ’s Clinical Trial Supply Forum last week. We were privileged to close the conference with a patient case study from Carol Jarvis. Carol's journey underscores the vital importance of clinical trials and the continuous efforts of researchers and healthcare professionals. Let's continue to support and recognize the life-changing work being done in clinical research. #ClinicalTrialsDay #ClinicalTrials #HodgkinsLymphoma #Pharma #ClinicalResearch #MedicalInnovation #PatientStories #PharmaIQ #ClinicalTrialSupplyForum

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Just how much has Annex 13 changed? Well, here's an overview of it 👇 Our latest blog post delves into the recent changes introduced in PIC/S Annex 13 for the Manufacture of Investigational Medicinal Products. Gain valuable insights and stay informed about the evolving regulatory landscape! Link in the comments! #GMP #PICS #pharmaceuticals

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