2013
Innovation
Diamond BioPharm, Harlow, UK
The regulatory team led by Dr Maureen Graham (Managing Director of Diamond BioPharm), working closely with the biopharmaceutical company developing the product played an integral part in achieving regulatory approval of the first gene therapy medicinal product, Glybera, in Europe in November 2012.
RIMtrack (Regulatory Information Management & Tracking), NJ, USA
In order to make tracking easy for all stakeholders, MakroCare developed RIMtrack (Regulatory Information Management & Tracking). This application helps pharma companies to monitor Dossiers and Projects in a time effective way. As a management tool developed exclusively for regulatory submissions, it is built on compliance process.
On-course®, IMI EMTRAIN team, Medical University of Vienna and University of Manchester
To address the problem of finding training programmes of the right quality, content, location and price, EMTRAIN has developed the on-course® portal. Having created a list of 65 scientific and therapeutic areas as search options, on-course® provides the most specific search options for biomedical courses to date.
The winner of the 2013 Innovation Award was Diamond BioPharm
Horizon
Andrea Quaye, Regulatory Affairs Consultant, Pfizer, Surrey, UK
As a highly motivated and positive member of the regulatory affairs team at Pfizer, Andrea has shown passion and enthusiasm for her field from the onset. Volunteering to take on responsibility for a large number of products, her deliverables are to a standard usually expected from more experienced colleagues.
Kathryn Parsley, Senior Regulatory Affairs Specialist, PPD, Cambridge, UK
Kathryn began her regulatory career at PPD in December 2011 after a transition into regulatory affairs from the clinical research environment where she specialized in the area of gene therapy. She has developed rapidly within her regulatory affairs role at PPD, applying her scientific background to its maximal advantage to progress her career in this field.
Sarah Bentouati, Regulatory Program Manager, Roche, Basel, Switzerland
Sarah was introduced to regulatory at Roche as part of her work experience placement for her University degree in 2010. Following a traineeship, as a permanent employee Sarah has been working on two development projects, covering meeting post approval commitments, safety work, development work and also is the regulatory lead for paediatric work.
The winner of the 2013 Horizon Award was
Sarah Bentouati
Support
Triskel team, Triskel Integrated Services, Geneva, Switzerland
Jean-Yves le Cotonnec, Founder and CEO, Triskel
Aarti Naik, Senior Scientific Consultant, Triskel
Jean-Yves le Cotonnec and Aarti Naik from Triskel have supported the RA team at Baxter for many years. Their services have been used for the most critical and challenging projects requiring their many years of expertise, resources and diplomacy. Their high quality of work is not only limited to excellent output but to a very proactive, open, questioning and friendly working style.
Gillian Traynor, Director, Albany Regulatory Consulting, Cambridge, UK
As freelance regulatory consultant, Gillian has provided extensive European regulatory support for two start-up US headquartered biotech companies (Pharmion and Clovis Oncology). Gillian has been flexible to the changing needs of start up businesses, and along with being viewed as part of the internal team she is highly regarded both in the UK and by US regulatory and clinical colleagues.
Regulis Consulting Regulatory Team, Regulis, Hertfordshire, UK
Within the past year, Regulis has played a key role in obtaining approval of two Article 8(3) Marketing Authorisation Applications (MAAs) submitted via the Decentralised Procedure (DCP). For both MAAs an ERA was produced by Regulis, and they were able to provide expert input on the potential issues and devise an appropriate strategy.
The winner of the 2013 Support Award was the
Triskel team
Inspiration
Gert Bos, Head of Regulatory and Clinical Affairs, British Standards Institution, UK
Dr. Gert Bos has worked in Notified Bodies for approximately 10 years (KEMA and BSI). He has also represented Notified Bodies in the Commissions Medical Device Expert Group (MDEG) and in many of its working groups, always presenting the views of Notified Bodies very articulately and with great professional expertise.
Chris Griffett, New Jersey, US
As a Chartered Biologist, graduating with an Honours Degree in Biology in 1975, Chris has spent his entire career in the pharmaceutical industry and has worked for 35 years in the field of regulatory affairs both in Europe and the US. He was Chairman of TOPRA's predecessor body the British Institute of Regulatory Affairs, was a member of the leadership board and founder of TOPRA in North America.
Sushma Sanger, Regulatory Affairs Manager, Pfizer, Surrey, UK
Sushma is a strong leader and mentor, with a passion for regulatory affairs. She has a desire for team success and takes immense pride in her reports’ professional and personal achievements. Sushma has been a Manager in Worldwide Regulatory Strategy (WRS) UK & Ireland PCOs at Pfizer for almost 7 years and manages a team of about 12 colleagues.
The winner of the 2013 Inspiration Award was
Chris Griffett
Education
Tony Cartwright, Independent Regulatory Affairs Adviser, Hertfordshire, UK
Tony’s extensive regulatory background is founded on his accumulated experience in the pharmacopoeia industry, the British Pharmacopoeia Commission and with the Medicines Control Agency (MCA). Tony has lectured and trained colleagues both within and outside a regulatory agency. He is currently researching and writing a book on the history of the British Pharmacopoeia on its 150th anniversary, due for publication next year.
F.Hoffmann - La Roche, Basel, Switzerland
Stéphané André, Head of EU/International Regulatory Affairs Division
Mark Hope, Global Head of the Neuroscience and Cardiovascular-Metabolism Regulatory Affairs Division
Lieke Kusters, Team Leader of EU Regulatory Professionals in the Cardiovascular-Metabolism Therapeutic area
Petra Piosik, Team Leader of Regulatory Managers in the Oncology Therapeutic area
Seema Shah, EU lead for a development project within Oncology
Stéphanie Capo-Chichi, EU/International Regulatory Affairs Manager for Neuroscience projects
The regulatory team at F.Hoffmann-La Roche has been instrumental in developing, supporting and managing the international trainee programme in regulatory affairs in Basel, Switzerland. This programme has become a successful pathway for recent post-graduates to learn more about the pharmaceutical field of registration and legislation, allowing them to flourish into proficient regulatory affairs professionals.
Anne Tomalin, Managing Director, OptumInsight, Ontario, Canada
Anne Tomalin has dedicated her career exclusively in the area of regulatory affairs since 1971. Actively engaged in one of her passions, teaching regulatory affairs, Anne is an advisor to Humber College assisting in the curriculum for the post-graduate certificate Regulatory Affairs program. Anne has also been an ongoing contributor to the Fundamentals of Regulatory Affairs with RAPS.
The winner of the 2013 Education Award was the F Hoffmann-La Roche Regulatory Team
Communication
Gavin Edwards, Manager, Integrated Product Development, PAREXEL Consulting, Uxbridge, UK
Dr Edwards is a regulatory and product development professional specialising in all aspects of quality (CMC) in respect of recombinant proteins, and in particular, biosimilar medicinal products. Whilst at Parexel, Gavin has designed and implemented a training course focused on the development and regulation of biologics; leading 5 of the 13 course modules himself.
Sue Harris, Unit Manager, MHRA, London, UK
Throughout her career, Sue has trained and mentored new members of staff within the MHRA. Having lectured on the TOPRA Spring Introductory Course for the last 16 years, both as a lecturer and as a case study helper, Sue has regularly trained new regulatory professionals receiving consistently positive feedback.
Auditgraph team led by Mauricha Marcussen, CEO, Agano Solutions, Ohio, US
The Auditgraph team, led by Mauricha Marcussen, designed a global label alignment program that significantly improves global compliance communications. The team has identified the benefits of improved existing communications and continues to find new and different ways to access, compile and present newly available knowledge for use across the organisation.
The winner of the 2013 Communication Award was the Auditgraph team led by Mauricha
Lifetime achievement
Professor Kjell Strandberg was the delighted recipient of the 2013 Lifetime Achievement Award, saying it as good as ‘receiving an Oscar’.
Professor Strandberg has devoted most of his 36-year professional career to improving the regulatory process. Recognising the need for high calibre in-house staff, he advanced the Medical Products Agency (MPA) in Sweden to become one of Europe’s most respected and frequently used agencies. He also served as the Chairman of the EFTA Pharmaceutical Committee which was responsible for achieving harmonisation of national pharmaceutical legislations compatible with the EEC, thus creating a platform for the new system for approval of marketing authorisation applications to be put in force in January 1995. Professor Strandberg is currently chair of the NDA Advisory Board.
The Awards programme recognises the excellent contributions of regulatory professionals from across the board at all stages of their careers: from practitioners to educators and communicators; from innovators and service providers; and a combination of all the above.