Current position and relevant professional experience:
Current Position:
ALAN BOYD CONSULTANTS LIMITED
Associate Director, Regulatory Affairs February 2023 – present
My most current role has been a transition from leading the Regulatory Affairs function at Albumedix, to becoming a more highly skilled technical and strategic regulatory professional at Alan Boyd Consultants. The level of responsibility within my current role, differs from that of my previous role with regards to taking on more responsibility for the delivery of operational and strategic regulatory support for Boyds’ customers. Alongside the delivery of regulatory projects for a diverse range of applications, product types and phases of development, I also maintain line management responsibility. I have taken on additional responsibility during my time in this role to initiate the creation and delivery of a regulatory and scientific podcast, which supports the business efforts of the company in addition to providing an educational resource for members of the regulatory community and wider profession. I have also taken on responsibility for thought leadership in the area of Genome Editing Technologies, through the initiation of a PhD in the topic and creation of multiple peer reviewed articles.
Relevant Professional Experience:
PODCAST INITIATIVE (CONVERSATIONS IN DRUG DEVELOPMENT) September 2023- Present
The podcast is aimed at members of the drug development industry, including regulatory affairs professionals. The goals and objectives of the podcast are to engage and educate professionals working drug development, providing an accurate and informative resource in an alternative way of communication. The opportunity to listen in to a regulatory focussed episode that provides the opportunity for listeners to learn more about a particular topic, without the need to read a journal article, could allow a wider audience to be reached. The podcast has already received multiple positive feedback from members of the profession, in addition to non-industry members and the general public, demonstrating its value.
PHD CANDIDATE January 2024 onwards (pre-work from January 2023 including a publication in May 2023)
The research I have already undertaken as part of my PhD research has resulted in a publication in Regulatory Rapporteur, which directly benefits other regulatory professionals as a source of information and learning. The work I intend to undertake throughout my PhD will provide a valuable resource to other regulatory professionals and anyone working in the field of genome editing technologies. There are currently gaps in existing legislation and guidance to support developers of genome editing technologies and therefore my research aims, not only to identify the gaps, but also provide recommendations and opportunities to improve existing legislation which should directly benefit anyone working in this field.
PUBLICATIONS 2017 onwards:
2024: The Year of the GET (Genome Editing Technology)? Cell & Gene Therapy Insights, 2024 (in publication)
Has COVID-19 changed the future of pharmaceutical regulation?”2021, International Journal of Regulatory Science 9 (2)
“Navigating the Regulatory Landscape for Advanced Therapies and Regenerative Medicines – Part 3: Japan” 2022, Regulatory Rapporteur 19 (3)
“Advanced Therapies and Regenerative Medicines Regulation – Part II: The US” 2021 Regulatory Rapporteur 18 (2)
“An overview of Advanced Therapy Regulation – Part I: The EU” 2020, Regulatory Rapporteur 17 (10)
“A comparison of UK versus US submission processes for Phase I trial applications” 2017 Regulatory Rapporteur 14 (4)
“Comparisons between US and UK Regulatory Environments for Conducting Phase I Clinical Research” 2016 Poster 04M1230 Presented by Dr. Peter Scholes at AAPS November 2016
Previous Position (relevant experience)
ALBUMEDIX LIMITED May 2019 – January 2023
Head of Regulatory Affairs & Enhanced Services April 2021- January 2023
Director, Global Regulatory Affairs, Sales & Business Development APAC April 2020 – April 2021
Director, Regulatory Affairs May 2019 – April 2020
My first role at Albumedix was an increased level of responsibility from my final role at my previous company. As the Director of Regulatory Affairs, I became responsible for leading all regulatory activities on behalf of the company, including communications internally to other departments and externally to clients and Regulatory Agencies. At Director level, I was expected to provide strategic input not only to the regulatory department, but also feed into the company strategy and support company objectives through the delivery of the Regulatory Affairs departments’ goals and objectives.
Key achievements during my time as Director of Regulatory Affairs included:
Increased number of Albumedix’ regulatory dossiers, through new submissions complying with applicable regulatory standards and guidance for biological products, expanding into new territories including China and Japan. This was a direct result of my responsibility for creating the strategy and objectives for the Regulatory Department.
Developed and implemented a formal regulatory strategy for new products as well as for the life cycle management of registered products.
Implemented continued process development and improvement across the department, through assessing the impact of new regulations and guidance documents externally and investing in training and mentoring for employees.
Provided regulatory support for Albumedix’ customers in variety of therapeutic applications including representing the company at customers’ meetings with the regulatory agencies.
Presented regulatory topics on behalf of Albumedix at international conferences and meetings and continued to influence externally through working with relevant pharmaceutical industry organisations to influence regulators with regards to improving the regulatory environment to support biopharmaceutical product innovation.
The achievements and executed responsibilities in this role, led to a successful promotion to Director, Global Regulatory Affairs, Sales & Business Development APAC. The level of responsibility increased significantly during my time in this dual-responsibility role as I remained solely responsibility for the continued success of the regulatory department, in addition to taking on additional responsibility for the growth of a new business territory (APAC). I took on this additional role, as the commercial business success in this new territory would be highly dependent on the regulatory success in this area, through new filings and regulatory support for products in the APAC territory (something that had not previously existed before I took on the role).
Key achievements included:
Increased the regulatory support offering by >100%, more than doubling the number of regulatory filings held at Albumedix since starting at the company in 2019
Authored dossiers to support the products manufactured by Albumedix
Implemented new ways of working to improve efficiency and productivity, focussing on strengths, and addressing areas for improvement within the regulatory department
Ensured the department was abreast of new regulations and guidance documents which may impact not only Albumedix’ direct filings, but also customer’s application areas including ATMPs, medical devices, biologics and vaccine to ensure the regulatory team could advise on and implement any changes that may be required to support the company goals and customer applications.
Acting as the main point of contact both internally across the organisation within various cross-functional teams and project deliveries to provide regulatory input, advice and strategy
Implemented regulatory strategy to continue growth within the department and manage the growing lifecycle maintenance
Increased awareness of Albumedix through regulatory thought leadership including authoring a number of peer reviewed publications
Successfully negotiated two large distributor agreements in the APAC region, carefully balancing cultural differences and ensuring all parties were satisfied with the outcome to build Albumedix’ global reach and grow business in this territory
Formalised and introduced new ways of working for the business development activities in APAC to align with more established territories with dedicated full-time employees
My final role at Albumedix became my most senior role in the company, progressing to Head of Regulatory Affairs and Enhanced Services. As the Head of Regulatory Affairs, I took on a more senior leadership position within the company, maintaining my leadership role within the Regulatory Affairs department whilst simultaneously increasing personal responsibility and visibility across the company. As a member of the senior leadership team, I was responsible for ensuring the Regulatory department supported overall business goals and objectives through development of new regulatory strategies and regulatory consultancy services to increase the overall company offering and ultimately value, which contributed to a increased valuation as part of the company acquisition by Sartorius.
Key achievements as Head of Regulatory Affairs included:
Defining and subsequently leading and executing the global regulatory strategy for Albumedix, ensuring that all correspondence and submissions presented to external parties (regulators and/or customers) are of an appropriate professional quality, compliant with the applicable regulations and scientifically sound
Continuing to act as the primary contact for all regulatory agencies for which Albumedix has filed submission including FDA, Health Canada, PMDA, CDE (NMPA), MedSafe and TGA, including meetings, teleconference and written communication. Additionally lobbying with EMA and volunteering to be part of a pilot scheme whereby Albumedix’ product dossiers would serve as an example for review on whether new systems should be in place for DMF’s across the EU
Maintained successful regulatory department despite a significant increase in additional responsibilities, delivering on customer applications to achieve successful approvals, increasing the regulatory support offering and broadening the dossiers for which Albumedix is the applicant
Continued to grow the department through implementation of new business procedures, SOPs and resource management to ensure the function is efficient, successful and well-supported.
Supported numerous customers across their IND, CTA, BLA, MAA applications from both a practical and strategic perspective, inputting directly to their applications and corresponding with regulators on their behalf including a high profile COVID-19 vaccine with both EMA and MHRA, medical device challenges across the EU and ATMP applications within US, EU and JP territories
Maintaining a hands-on approach to regulatory department, supporting project delivery and authoring regulatory documentation in addition to providing strategic leadership to the department.
Continuation of excellent regulatory support to a wide variety of customers across many territories, liaising with regulators, developing regulatory strategies and providing bespoke support depending on the phase of development (ranging from pre-clinical to post-commercialisation) across many applications spanning advanced therapies (cell and gene therapies), medical devices, diagnostics, proteins/peptides and small molecules
Successful introduction of a new business unit within the company, implementing regulatory consultancy/contract support services (“enhanced services”) from concept and strategic planning, branding, coordinating marketing and communication and promotion of the function internally and externally through to creation of business processes and procedures to support the function of the unit.
Mentoring new employees and acting as a support back up for the Chief Commercial Officer (and later VP Commercial Operations) when they were unavailable.
Current or previous involvement in TOPRA activities:
FTOPRA
Fellow of TOPRA awarded May 2024
TOPRA/European Science Council
Chartered and Registered Scientist Assessor Feb 2024 - Present
This role is required to support new CSci applicants achieve their chartered status through review of their applications, ensuring that applicants are awarded their chartership (or registered status) if they meet the assessment criteria. This helps members of the profession with their continued professional development and supports in furthering career progression. I was approached by TOPRA to undertake the necessary training required to become a qualified assessor (after being a chartered scientist myself for 2 years). This role is additional to my other TOPRA volunteer roles and to my current employed role.
TOPRA/Regulatory Rapporteur
Commentary Editor for Regulatory Rapporteur May 2023 - present
Member of the Editorial Panel/Consultant Editor for Regulatory Rapporteur January 2022 - present
I am a TOPRA volunteer and have been part of the Editorial panel for Regulatory Rapporteur since 2022. Whilst maintaining this position, I have also taken on additional responsibility and a more active role as a core board member for Regulatory Rapporteur and most recently, the Commentary Editor for the online digital journal. The additional role as commentary editor has provided an opportunity to take on additional responsibility through the coordination and compilation of commentary articles for the journal. I am required to organise the commentary pipeline in addition to commissioning articles and peer-reviewing the commentary submissions.
TOPRA Awards Winner
Communications Award 2021
In recognition for the work I undertook to educate and provide impartial information regarding COVID-19 during the pandemic, where information was scarce. The communications were aimed at everyone, not specifically people within the regulatory field, but those who did not have access to information or a scientific knowledge to understand available information. My streams on social media platforms amassed tens of thousands of views and provided a reliable and factual source of information for laypeople to understand the development of COVID-19 vaccines. I also spoke to many school children during virtual meetings to try and educate them about COVID-19 and also about regulatory affairs and science in general. I was recognised for all of this work during 2020 and 2021 with the winning of the TOPRA Communications award in 2021
Personal statement:
I have proven experience in various leadership positions across different areas of regulatory affairs, but my strengths lie in communication and strategic thinking. I am most enthusiastic about improving the visibility of our profession to engage and inspire others as well as attract new talent.
I have been an active member of TOPRA over the last decade including board member at Regulatory Rapporteur and CSci assessor. I have personally benefitted greatly from many TOPRA initiatives, and see the value this has added to my own career. Therefore, I can give a well-rounded view of how TOPRA can support the continued development of our sector.
Nomination information
Proposer: Julie Warner; Seconders: Vickie Goff, Shalini Gupta