Editorial Board

Leslie Dowling

Leslie Dowling – Editor-in-Chief

Leslie has been a regulatory professional since 1997, working mostly as a regulatory consultant/team leader in the CRO/consultancy space, although she has also worked in pharma and a medical device company. She has a special interest in early clinical phase development, and has been Editor in Chief of Regulatory Rapporteur since 2011.

Davina Steveson

Davina Stevenson – Deputy Editor

Davina has expertise in global regulatory strategy across the product lifecycle, and also process and system improvement. Regulatory experience spans oncology, analgesia and liver disease therapeutic areas, orphan and generic drug development. Davina is a Chartered Scientist, TOPRA Fellow and holds a Regulatory Affairs MSc with focus on Regulatory Intelligence. Davina is Regulatory Rapporteur Deputy Editor and Continuing Professional Development (CPD) Editor.

Joan Boren

Joan Boren

Joan provides regulatory strategy and advice on global product development and marketing strategies, being involved in interactions with regulatory authorities worldwide to agree on a successful pathway. His area of focus is on oncology products, with expertise in ATMPs and biologics. He holds a PhD in biochemistry and molecular biology.

 

 

 

 

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Pascale Canning

Pascale has worked at knoell for over ten years, overseeing regulatory procedures and carrying out regulatory intelligence research for clients in the animal health industry. She is also involved in knoell’s marketing activities, and has organised regulatory affairs training courses. With previous employment in publishing and educational environments, Pascale is a current TOPRA editorial board member.

 

 

 

 

Mike Day

Mike Day

As Senior Director Regulatory Science and Head of Complex Biologics at Voisin Consulting Life Sciences (VCLS), Michael (Mike) is responsible for providing both regulatory strategy and CMC consulting services to clients for global product development ranging from small molecule drugs to biologics and advanced therapies.

 

 

 

 

Marie Deneux

Marie Deneux

 Marie Deneux is in charge of defining and executing the regulatory strategy for the development and registration of Lysogene’s gene therapy products. Prior to joining Lysogene in 2019, Marie spent 15+ years in consulting. Involved in the development of biotech products, NCEs and repurposed drugs, Marie has extensive experience in interactions with FDA, EMA and national health authorities.

 

 

 

Stephen Dew

Stephen Dew

Steve has extensive experience in Healthcare Regulatory Affairs, Quality Assurance, Project Management, Design and Development. Experienced in various medical technologies including drug/device combination delivery systems, borderline drug/devices, In-Vitro Diagnostics/companion diagnostics, general medical devices, medical electrical equipment, software medical devices, digital health including ‘Apps’, cosmetics, consumer health products and food supplements.

 

 

Daniela-Drago

Daniela Drago

Dr. Daniela Drago is an Expert Consultant at NDA Partners. She has significant global expertise in the development of small molecules, biologics, cell & gene therapies, and combination products in multiple rare and common disease areas, including ophthalmology, neurology, and oncology. She also serves on the Regulatory Affairs Certification’s Board of Directors, the Executive Committee of the American Course on Drug Development and Regulatory Science (ACDRS), and the Regulatory Affairs Committee of the American Society of Gene and Cell Therapy (ASGCT). She is a TOPRA fellow (FTOPRA) and a fellow of the Regulatory Affairs Professional Society (FRAPS). Daniela has received several awards, including the TOPRA Award for Regulatory Excellence.

Victoria Goff

Victoria Goff

Victoria graduated from university with a BSc in Chemistry with analytical science and began working as a quality control operative for ProSynth Ltd.Victoria joined Mundipharma in 2021 as the Head of Regulatory CMC and in this role and is responsible for the team providing regulatory CMC strategy across all the portfolios to maintain global compliance and support commercial opportunities.

 

 

 

Kornelia Grein

Kornelia Grein

Kornelia Grein has an extensive career which includes 20 years in management positions with responsibilities for veterinary medicines at the EMA. Currently she provides services to the animal health industry and other organizations concerned with the development and authorization of veterinary medicines as independent consultant.

 

 

 

 

Richard Huckle

Richard Huckle

Richard Huckle (Regulatory Affairs Director, Healx) has 30 years’ experience in drug development coming from pharmaceutical, biotech and CRO industries. Healx leverage artificial intelligence technologies in drug discovery to develop new treatments for rare diseases. Prior to Healx, he was a Senior Director for Huron (Pope Woodhead), with CROs PPD and Gregory Fryer Associates, managing global clinical trial submissions and lifecycle strategy. Richard has also managed teams at Actelion, Axovan (Basel), Chiroscience and authored 30+ peer-reviewed publications.

 

 

 

Patricia Hurley

Patricia Hurley

Patricia Hurley PhD is Vice President and head of regulatory affairs at F-star Therapeutics. She is responsible for overseeing the regulatory strategy for F-star’s innovative bispecific antibodies in immuno-oncology. A pharmacologist by training, Patricia spent several years in the global CRO and regulatory product development space.

 

 

 

Leah Kleylein

Leah Kleylein

Leah’s function is Life Sciences and Regulatory Intelligence within Accenture’s Life Sciences practice, with over 20 years of experience. Leah monitors the Life Sciences regulatory environment for regulations, innovations and trends. Previously Leah worked for global pharmaceutical companies in Regulatory and has deep technical experience in electronic submission standards.

 

 

 

James McCormick

James McCormick

James is a Senior Director within Regulatory affairs and with more than 40 years of experience in Research and Development he supports clients across the full spectrum of regulatory development. He mentors staff and clients with the delivery of their development strategies and maximisation of the global market.

 

 

 

Satish Muchakayala

Satish Muchakayala

Satish has 16 years of experience covering development and life cycle maintenance of both small and large molecules. Currently he is supporting the development of nucleic acid based vaccines and providing CMC regulatory advice for partners to enable the utility of doggybone DNA technology in vaccines and advanced therapy applications.

 

 

 

Sobhey Nassar

Sobhey Nassar

Sobhey is Head of Regulatory Affairs at Bausch and Lomb, managing the activities of a large portfolio of products authorised in the UK and Ireland, as well as having Medical and PV oversight. He has extensive industry experience, having worked in a number of manufacturing site, regional and global roles. Sobhey has been a member of TOPRA since 2006 and joined the Editorial Board in early 2014.

 

 

 

Ilse-Maria Nolan

Ilse-Maria Nolan

Ilse-Maria is Senior Director of Global Regulatory Affairs at PPD, leading PPD’s Regulatory Intelligence, Policy & Advocacy function. She is an Industrial Microbiologist and Pharmacologist by training with extensive industry experience from her time in pharmaceutical and contract research organizations. Ilse-Maria is a long-standing member of TOPRA and joined the Editorial Board in 2020.

 

 

 

Kasia Nowok

Kasia Nowok

Kasia has been working in the pharmaceutical industry, since 2006 in various regulatory affairs roles. Prior to her current Regulatory Intelligence position at UCB, Kasia had diverse responsibilities in European Human Regulatory Affairs lifecycle and development. Kasia received her master’s degree in chemistry from the University of Opole, Poland in 2004.

 

 

Jillian-Stewart

Jillian Stewart

Jillian has more than 15 years’ experience in regulatory affairs and quality, including more than 10 years working with a leading global generic pharmaceutical company. Jillian has gained expert knowledge in both medical devices and pharmaceuticals – specialising in the Irish and Maltese markets in particular – and now operates as the Principal Consultant of Jillian Stewart Regulatory Solutions.

Julie Warner

Julie Warner

Julie has been involved in regulatory affairs since 2003, gaining significant pre- and post-authorisation experience in disease areas ranging from oncology to cardiovascular and infectious diseases. She has a special interest in advanced therapies, orphan drugs, oncology, clinical trials and marketing authorisations.