2014
Horizon
Michelle Blake, Senior Regulatory Affairs Executive at DLRC Ltd
Michelle is described as a very driven individual with a need to pursue her goals irrespective of personal setbacks. She has made significant contributions to all projects she has been involved with over the last 3 years, spanning early stage clinical trials through to marketed products.
Costantino Congiatu, Senior Regulatory Affairs Specialist at PPD
Costantino began in a biotech start-up company, and moved to PPD in 2013. Within a few months he was running projects to a high standard. His strengths lie with his scientific understanding and excellent communication skills.
Sophie Viollet, Senior Regulatory Associate at Eli Lilly and Company
Since joining Eli Lilly Sophie has been instrumental in building capabilities for regulatory intelligence in Europe, United States, and China along with leading regulatory product strategies for several compounds in development.
The winner of the 2014 Horizon Award was Costantino Congiatu
Inspiration
Graham Burton, Former Senior Vice President, Celgene, USA
Dr. Graham Burton has been an inspirational leader in the field of Regulatory Affairs in Europe and the USA for over 30 years. He is a physician who worked at the UK Agency and was a member of the team that developed the MEDRA Dictionary. Graham moved into the pharma industry in 1988 as a VP at Pharmacia & Upjohn, then worked at J&J and latterly at Celgene.
Gillian Gregory, Consultant
Gillian has also worked in regulatory affairs for over 30 years. She has twice set up and developed strong teams of regulatory consultants in small consultancy companies, both of which were then successfully sold. She recruited people with limited regulatory affairs experience, but helped everyone become proficient in all aspects of regulatory affairs - many have since gone on to work in senior posts in the industry.
Lucy Rose, President, Lucy Rose and Associates, USA
As former head of the Division of Drug Marketing, Advertising and Communications in the FDA, Lucy is considered one of the foremost authorities on evolving regulations on sales and marketing. She is now an independent consultant conducting training courses aimed at preparing teams and individuals for successful interactions with health authorities.
The winner of the 2014 Inspiration Award was Gillian Gregory
Innovation
Antje Behring, Federal Joint Committee (Healthcare), Germany
Antje Behring has been the main driver in the German drug regulatory field for a European multilateral scientific advice procedure with EMA and HTA-Agencies. She works very closely with EMA, with national HTA agencies, with EUnetHTA and EFPIA. She has made a significant contribution in promoting this European approach in the German healthcare scene, with relentless optimism and creativity.
Benny Ons, Director Regulatory Affairs Europe, Becton Dickinson and Company, Belgium
The EU Commission challenged Benny and others to establish controls to mitigate the risk associated with labelling of medical devices in many languages. This has been one of the most difficult concept changes in IVD regulatory history and took several years of discussion with the various stakeholders until the final concept was agreed.
The winner of the 2014 Innovation Award was Benny Ons
Futures
Greer Deal, Global Regulatory Services
Greer and her company GRS work on a range of innovative projects, including novel concepts for medical device classification, for herbals as food supplement, in foods with special medicinal purposes, or even standard pharmaceutical medicines looking to enter the market as generic biosimilars.
Professor Jean Hugues Trouvin, University of Paris Descartes, France
Prof Trouvin has chaired the Biologics Working party at EMA and is the CAT member for the French Authority. In these roles he has been at the forefront of many developments in the modern regulation of innovative products.
Alison Wilson, Celldata Services
Alison is a specialist in regulatory affairs of gene and cell therapies and tissue engineered medicinal products, and is an authority in this difficult regulatory and technological area. As an example of her involvement with state- of-the- art medical technology, Alison is actively involved in the development and regulatory strategy for a tissue engineered human trachea ready for clinical trial.
The winner of the 2014 Futures Award was Alison Wilson
Education
Gabriele Dallmann, Founder of EUCRAF, Germany
Gabriele was one of the first to introduce a specialized education programme in biopharmaceutical-related regulatory affairs in Germany. She has successfully established EUCRAF as a centre of excellence in providing professional networking and educational programs in the regulatory affairs community.
Detlef Hold, Global Head, Regulatory Learning and Development, F. Hoffmann-La Roche
By fostering fit-for-purpose individual, team and organisational learning, Detlef has set the culture for a passionate learning organisation in Roche, and so set the basis for developing highly skilled, influential and effective regulatory talent.
Genpact Pharmalink Regulatory Operations
Successfully achieving ‘Investors in People’ accreditation, Genpact has shown a commitment to fostering the potential in entry level graduates. Since taking on their first in 2013 the company has applied a robust, innovative and comprehensive approach tailored to each individual.
Susana Vázquez and Dora Isolabella, University of Buenos Aires, Argentina
In 2011, Susana and Dora teamed up and approached the University with the idea of producing an entirely new post-graduate online course on regulatory affairs, covering the complex regulations of their local agency. Since then, they have produced an annual course 4 times for 300 students across Argentina, Venezuela and Spain, among other countries.
The winner of the 2014 Education Award was Gabriele Dallmann
Support
Lorna Griffin, Regulatory Resources Group, Surrey
Lorna and her RRG team were contracted to provide project management and regulatory assistance to Orbona Pharmaceuticals, who nominated them. The overall quality of the support in all disciplines has been excellent as was the ability to provide additional experienced resource to the project when needed.
Sarah Ware, Regulatory Manager, JensonR+, Exeter
Nominated by their client, Internis Pharmaceuticals, Sarah and her team were described as a ‘stellar example’ of how a consultancy should meet the needs of clients, and who also go the extra mile with professionalism and innovative thinking.
Voisin Consulting Life Sciences (VCLS), Paris, France
As part of a collaboration with Pierre Fabre, Voisin Life Sciences demonstrated abilities that were critical success factors, including creativity, pro-activity and offering appropriate solutions to problems.
Lisa Jenkins and Regulatory Team, Virtual Regulatory Solutions, Philadelphia, USA
Lisa Jenkins was described in her nomination as an exceptional regulatory professional. She helps individuals and teams navigate complex regulatory processes by combining a disciplined understanding of the regulatory framework with a persistent willingness to help and a commitment to her clients’ success.
The winner of the 2014 Support Award was Voisin Consulting Life Sciences
Contribution
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Lyn Ferguson, Regulatory Resources Group
Lyn has worked uninterrupted in regulatory affairs for nearly 40 years. During this time she has worked in industry, for the regulatory authorities and most significantly in consultancy for over 30 years. She has actively encouraged and mentored many senior and experienced professionals, while providing clients with strong, confident regulatory support.
Sue Harris, MHRA
Since she first joined the UK Department of Health in 1986, Sue Harris has made a significant contribution to public health, the profession of regulatory affairs and to TOPRA. She has contributed to many of the milestones in medicines regulation, from the UK Product Licence Review to the introduction of the regulation on traditional herbal medicines, spanning legislative development through to practical implementation
Eva Kopecna, TEVA
In the past three years Eva, a qualified physician, has successfully set up the Global central OTC team for TEVA which now employs 85 staff. She has also made a major contribution to the MSc Regulatory Affairs as a Module Leader and providing support on several other modules . She is the author of several publications, including one book on GCP and clinical trials.
Christian Redondo-Müller, NDA, Germany
Christian has over 20 years’ experience in the regulatory affairs field. He’s worked for leading pharmaceutical companies across a variety of regulatory affairs and project management roles. Most recently, he’s spent over six years at NDA Group, showing consistent commitment, dedication and passion for every project he has worked on.
The winner of the 2014 Contribution Award was Sue Harris
Lifetime achievement
The winner of the 2014 Lifetime Achievement Award was Dr Murray Lumpkin
Prior to entering the medical profession, Murray Lumpkin studied German linguistics at the University of Marburg. As a medical student he worked in a refugee camp in Bangladesh. His post-graduate studies majored in two areas: paediatrics and tropical medicine, and he studied the latter in the UK at the London School of Hygiene and Tropical Medicine.
He then worked in the US as a specialist in paediatric infectious diseases before taking up a post in industry, at Abbott Laboratories, to help lead the development of a new antimicrobial agent.
In light of these early interests it is perhaps not unexpected that our winner has become known for his dedicated public service, his enthusiastic work to act as a bridge between the EU and US regulatory communities and, most recently, his commitment to improving healthcare in low and middle income countries.
He was recruited to the FDA in 1989 as Director of the Division of Anti-Infective Drug Products in the Center for Drug Evaluation and Research. From 1994 he served as Deputy Center Director for CDER where his main responsibilities included oversight and management of the Offices of Drug Evaluation and their new drug review divisions.
He was one of the initial members of FDA’s representation to the International Conference on Harmonization (a position he maintained for 10 years) ; and he was FDA’s representative for 9 years to the World Health Organization’s CIOMS working groups on drug safety issues.
He has represented FDA in numerous bilateral initiatives with governments across the globe. In 2000, he spent three months working at the European Medicines Agency in London on a special initiative that encouraged bilateral exchanges of senior level leaders from both regulatory organisations.
In 2013, after a period as a special adviser to Commissioner Hamburg, it was announced that he would take up a role as a senior fellow of the Gates Foundation, a global health foundation founded by Microsoft co-founder Bill Gates, one of the world's wealthiest individuals. His work there is wide-ranging: supporting the development of global regulatory systems, providing assistance to foreign regulatory training programs, contributing to a regional regulatory hub located within the Pan American Health Organization and developing new pharmacovigilance systems in Africa and Asia.
Despite all these achievements and the many awards and honours that have been bestowed on him, he remains one of the nicest, most modest and approachable guys in the regulatory world.