DLRC Regulatory Consultancy

Wow, what a night for DLRC at the TOPRA Awards for Regulatory Excellence 2024! We couldn’t be more proud to share that the DLRC team has been recognised in two categories, taking home the Support and Contribution awards! We’re delighted to celebrate Michelle Blake, Associate Director and Senior Consultant, with the incredible achievement of winning the Contribution Award. Michelle’s dedication, positive attitude, and ability to inspire and support her colleagues embody the very best of DLRC’s values. From mentoring new and senior team members to guiding clients through complex regulatory challenges, Michelle’s leadership, expertise, and genuine care make her an indispensable asset and a true role model for us all. Following Michelle’s win, the DLRC Aligos Therapeutics Team received the Support Award! The winning team consists of consultants from our UK, EU, and US offices and includes Greg Dombal, Wafa Bouaziz, Roy Pengilley, Sharon Robinson, Jo Brady, Sowjanya Pushpala, Carolina De La Portilla, Tiankun Ren and Rose Prizzi. Their determination, innovative approach, and commitment to excellence have consistently exceeded expectations, delivering high-quality outcomes under tight timelines. The team's collaborative spirit and impactful contributions set a benchmark for success, making them truly deserving of this recognition. In addition to our winners, Wafa Bouaziz secured a finalist position in the Inspiration category, and Anuya Aras is a finalist in the Horizon category—two very deserving finalists chosen for their impactful contributions to regulatory affairs. It was an absolute pleasure to spend the evening celebrating excellence in our profession. The evening was an inspiring recognition of the life-changing impact of regulatory affairs professionals' work in advancing global health care. Thank you to TOPRA - The Organisation for Professionals in Regulatory Affairs for hosting another great awards evening, and congratulations to all of the worthy finalists and category winners! #RegAwards24 #RegulatoryAffairs #RegulatoryExcellence #Pharma #PharmaAwards

Last week, Greg Dombal, President of DLRC’s US office, participated in the inaugural meeting of Accelerator Hub, VITAL – A BARDA BAN Hub!   VITAL supports the development and acceleration of next-generation #therapeutic and #vaccine platforms and technologies.   Greg delivered an interactive seminar on the regulatory process in the US and strategies for engaging the #FDA to the ten pioneering companies taking part in #VITAL.   The companies had specific questions about #INTERACT Meetings, special designations, what questions to ask the FDA and when, and how to bring external #regulatory expertise into their teams.    The 90-minute discussion touched on how the FDA works with sponsors and highlighted DLRC's experiences in collaborative work with the agency and its clients. Greg will continue to support VITAL as a strategic regulatory sounding board to help innovators align their regulatory strategies with their business objectives. Are you an anti-infective or anti-viral company ready to bring your therapeutic or vaccine innovations to market?   Email us at hello@dlrcgroup.com to discover how DLRC’s strategic expertise can maximise your impact. #RegulatoryAffairs #RegulatoryStrategy #Biotech #Pharma

It’s now less than a month until Stuart Hunter, Business Development Lead, will be in San Francisco for RESI JPM 2025, with partnering for RESI open now! RESI is an annual conference held concurrently with JPM week, which Stuart will also be attending with Claire Meadowcroft, Chief Business Officer. Stuart will be attending the in-person event only, held on January 14th. This day will include partnering meetings, as well as a variety of panels and workshops on topics including early stage therapeutics, women’s health, medical devices, oncology investment, and paediatrics. The event typically draws over a thousand attendees including investors, innovators, and industry experts, many of whom are also in the city attending #JPMWeek. If you will also be in San Francisco and would like to discuss with Stuart how our experts at DLRC can support your company and products, search for DLRC in the RESI partnering system, or email us at hello@dlrcgroup.com #PharmaEvents #RegulatoryAffairs #RESIJPM2025 #BioTech #SanFrancisco

It’s the final day of #DDL2024, and our experts Claire Meadowcroft, Chief Business Officer, Ian Ashurst, Principal Regulatory Consultant, and Catherine Flynn, Principal Regulatory Consultant, are excited to see what the last day has in store for them! Yesterday, Ian and Catherine attended Session 4, ‘Advances in Nasal Drug Delivery’, with some of their key take-aways from this session including; 🔵 An epinephrine nasal inhaler was approved in the US which is an important alternative to the auto-injectors. 🔵 There are many benefits to nasal drug delivery such as non-invasive, rapid onset of action, easy administration of the dose and bypass of 1st pass metabolism. 🔵 Nose to brain pathways were highlighted and reviewed and it was clear that different options are available to the developer. 🔵 Vaccines are an important target as 27% of deaths world-wide are due to communicable diseases. Current work shows promising results including good stability with dry powder formulations. 🔵 Untranslated administration is growing at about 6-7% per year driven by a patient preference for self-administration of doses. 🔵 Choice of species for non-clinical modelling of nasal drug delivery can depend on several elements including compound type, biological target, formulation and intended volume. 🔵  Delivery of drugs through the nasal membranes can be complicated by low volumes, poor retention, poor mucoadhesion and efficient mucociliary clearance. 🔵 Effective droplet formation in the delivery nasal sprays depends on adequate shear rate and velocity during atomisation. Devices currently in development offer an optimised fluid path that is able to cope with more viscous solutions and may be further fine-tuned. After this, the team got glammed up Christmas style – Santa hats and all - ready to attend the DDL 2024 Gala Dinner, held at the National Museum of Scotland. The event featured a delicious meal, great networking, and Claire even got to take a selfie with Dolly the sheep! If you are also attending DDL 2024 today, don’t forget to check out Stand 107 on Floor -2 for more conference talk, and to discuss with Claire, Ian and Catherine how our experts at DLRC can support your pulmonary and nasal drug delivery products! Alternatively, you can also email us at hello@dlrcgroup.com #PharmaEvents #RegulatoryAffairs #NasalDrugDelivery #NationalMuseumofScotland #GalaDinner

DLRC experts Catherine Flynn and Ian Ashurst are having an interesting time at #DDL2024, particularly enjoying Session 1 of DDL on the transition to new low global warming potential (#LGWP) propellants in pressurised metered dose inhalers (#pMDIs). This topic is of special interest to DLRC, who have written a white paper co-authored with Koura on the regulatory requirements for the transition, which you can find here: https://lnkd.in/epfGVxHy During the session, Maureen Hardwick, legal counsel and secretariat of the IPAC organisation gave an excellent presentation covering the multiplicity of regulations governing the transition and focused on how a multi-stakeholder approach was key to a successful transition - key stakeholder groups need to work together to ensure patients are not disadvantaged. Sara Panigone, a device expert from Chiesi, then examined three key questions which need to be addressed during the transition: 🔵 When will the new propellants be available? 🔵 How do we develop them into drug products? And 🔵 What is the view of the regulators? She then went on to describe how a beclometasone / formoterol / glycopyrridonium triple combination product has been developed in HFA-152a and has been shown to be therapeutically equivalent to its HFA-134a equivalent. It is fascinating to see that the first new drug product that may be approved with a novel LGWP propellant could be a triple combination product! Finally, John Bell, a pharmacologist from AstraZeneca, presented on the current solutions and future threats. It was highlighted that HFO-1234ze may be challenged by upcoming plans to restrict the use of PFAS (polyfluorinated alkylated substances). HFA-152a may also be challenged by the EU phaseout and AIM phase down regulations due to its higher global warming potential than HFO-1234ze, although it still has an order of magnitude reduced global warming potential than that of the HFAs. The session was concluded with a Q&A where a number of challenging ideations were raised, including the challenges of redeveloping all of the current pMDI portfolio – there is a long way to go. It was postulated that some products could be lost in the transition as some of the lower value products may not be redeveloped. The drive to greater sustainability is critical but it is also important to remember that a suitable range of therapeutics – that work – needs to be available, as the ‘greenest’ patient is a patient with well controlled disease. If you are also attending DDL 2024, don’t forget to check out Stand 107 on Floor -2 for more DDL insights, and to discuss with Claire, Ian and Catherine how our experts at DLRC can support your pulmonary and nasal drug delivery products! Alternatively, you can also email us at hello@dlrcgroup.com #DDL2024 #PharmaEvents #RegulatoryAffairs #MedicinesForInhalation

Our experts Claire Meadowcroft, Chief Business Officer, Ian Ashurst, Principal Regulatory Consultant, and Catherine Flynn, Principal Regulatory Consultant, had a busy first day at #DDL2024, and are looking forward to seeing what Day 2 has to offer! The DLRC stand has seen lots of interest, and Ian, Catherine and Claire were also able to check out some of the sessions on offer. Ian and Catherine particularly enjoyed Session 1, ‘Transition to New Propellants – Current Solution and Future Threat’, which focussed on the transition to new low global warming potential (#LGWP) propellants in pressurised metered dose inhalers (#pMDIs), a topic which DLRC has particular expertise in. If you are also attending DDL 2024 today, don’t miss the chance to say ‘Hi’ – head to Stand 107 on Floor -2 to discuss with our experts how DLRC can utilise its considerable experience in pulmonary and nasal drug delivery products to help your company and products. Alternatively, you can also email us at hello@dlrcgroup.com #DDL2024 #PharmaEvents #RegulatoryAffairs #MedicinesForInhalation

Today marks an exciting milestone for DLRC!   Greg Dombal, President of DLRC’s US office, is honoured to participate in the inaugural meeting of Biomedical Advanced Research and Development Authority (BARDA)'s Accelerator Hub, #VITAL.   Led by the Global Startup Accelerator Start2 Group in collaboration with Advise Connect Inspire, LLC (ACI) and BioLabs, VITAL welcomes ten pioneering companies into its first-ever biotech accelerator cohort.   These innovators are at the forefront of revolutionising #health and #biotech, with ground-breaking work spanning #respiratory #therapeutics, #vaccine platforms, and more.   Meet the trailblazing cohort: 🔵 Auravax Therapeutics, Inc. 🔵 Avocet Bio GmbH 🔵 Cryptyx Bioscience 🔵 Cutanos GmbH 🔵 Immunyx Pharma 🔵 Macrotope Inc. 🔵 Grant Knappe at Bathe BioNanoLab 🔵 Nitro Biosciences 🔵 Sagitta Biotech 🔵 Thylacine Biotherapeutics   DLRC is proud to support this transformative initiative. Greg will be delivering a session today on US #regulatory pathways and FDA engagement, emphasising the critical role of a well-defined regulatory strategy in securing funding. Beyond this, Greg will mentor these companies throughout the accelerator process, offering invaluable #strategic insights.   Find out more about the VITAL – A BARDA BAN Hub and DLRC’s contributions below 👇   Are you an anti-infective or anti-viral company ready to bring your therapeutic or vaccine innovations to market?   Email us at hello@dlrcgroup.com to discover how DLRC’s strategic expertise can maximise your impact, or go to www.dlrcgroup.com for more information. #RegulatoryAffairs #BiotechStartups #Pharma

It’s officially started! This morning, our experts Claire Meadowcroft, Chief Business Officer, Ian Ashurst, Principal Regulatory Consultant, and Catherine Flynn, Principal Regulatory Consultant, have arrived in beautiful #Edinburgh for the first day of Drug Delivery to the Lungs 2024! After registration and the opening of the conference, today, Ian, Claire and Catherine have a busy programme of lectures and panels presented by individuals working in the area of inhalational drugs from various research institutes and pharmaceutical companies. The sessions include ‘Transition to New Propellants – Current Solution and Future Threat’, ‘Inhalation Across the Ages’, and ‘Gene Therapy and Biologics for the Lungs’, before a welcome drinks reception to finish the day. In addition to this fantastic agenda, there will also be a large industry exhibition, with DLRC having a stand for the duration of this years 35th anniversary event! If you will also be attending, don’t forget to check out Stand 107 on Floor -2 for chocolate, Christmas spirit, and of course to discuss with Claire, Ian and Catherine how our experts at DLRC can support your pulmonary and nasal drug delivery products! Alternatively, you can also email us at hello@dlrcgroup.com #DDL2024 #PharmaEvents #RegulatoryAffairs #MedicinesForInhalation

Last week, our Regulatory Consultant Carolina De La Portilla, attended the BioM Dinner and had the opportunity to talk and discuss with members of different #Munich based Biotech Companies! For over two decades, BioM Biotech Cluster Development GmbH has been the driving force behind Bavaria’s #biotechnology ecosystem. Commissioned by the Bavarian Ministry of Economic Affairs, #BioM connects innovators, fosters collaboration, and accelerates growth in one of Europe’s leading biotech hubs. Supporting over 520 companies in the #Bavarian #Biotech Cluster, BioM plays a pivotal role in advancing: 🔵 Innovative Therapeutics 🔵 Diagnostics 🔵 Enabling Technologies for personalised medicine Munich continues to be a central hub for further Biotech Development, and DLRC's EU team is happy to have been invited to participate in this lovely dinner on a perfect Munich evening. #PharmaEvents #RegulatoryAffairs #BavarianBiotech

As the global focus on climate change intensifies, the #pharmaceutical industry must transition to more sustainable practices. Making the shift to low global warming potential (#LGWP) #propellants in pressurised metered dose inhalers (#pMDIs) is not only timely but essential for #environmental stewardship and regulatory compliance. Our most recent whitepaper, written in partnership with Koura, a global leader in the development, manufacture and supply of #Fluoroproducts, delves into the vital regulatory requirements surrounding this change. Focusing on European #regulations, we explore the context of this transition, reflecting on the lessons learned from previous changes and the reasons driving this important evolution. We will unpack the intricate #regulatory landscape, detailing the requirements for #quality, #nonclinical, and #clinical data when a new LGWP propellant is introduced, ensuring an understanding of what’s needed for this transition. Finally, we’ll provide a brief update on the current status of the move toward LGWP propellants, highlighting the progress made and what lies ahead. Read the full whitepaper for free: https://lnkd.in/epfGVxHy Want to meet the authors and discuss your inhaled products in person? DLRC and Orbia Fluor & Energy Materials (Koura) will be exhibiting at the Drug Delivery to the Lungs Conference (DDL) in #Edinburgh this week, from December 11th to the 13th. To request a meeting at #DDL, email our regulatory experts at hello@dlrcgroup.com, or find the DLRC team at stand 107. DLRC has significant experience in #inhaled products and has helped clients develop, write, submit, and approve inhaled submissions for #DPIs and #Nebules and subsequently manage post-approval regulatory activities. To find out more about DLRC's award-winning #regulatory services, email us at the address above or visit the www.dlrcgroup.com website. #InhaledProducts #RegulatoryAffairs #DDL2024