People
- More than 30years experience in industry and consultancy in Europe, the USA, Asia and Latin America
- Worked on controversial substances with major companies in chemicals, metals, pharmaceuticals, plant protection products, food and beverages
- Experienced in product defence strategies, advocacy tools and the interfaces between science and policy, politics and the media
- Widely recognised for his strategic and innovative approaches, his networks and ability to deliver solutions
- Worked on a number of very large assignments in the fields of clinical trials, epidemiology, toxicology and risk
Joseph Huggard is a chemical engineer with over 30 years experience gained in manufacturing, environment- and health-related consulting. He began his career working in manufacturing and plant design and construction for Exxon Chemicals and GlaxoSmithKline. Moving into consultancy, he is credited with developing the projects at Lloyds Register on which the ISO 14000 and EMAS environmental management systems are based.
He has extensive science and policy experience in Europe, the United States and Latin America. He understands with the workings of the key European Institutions as these impact on environment, occupational health, consumer protection and industry. He has designed and implemented numerous product defence strategies for major international industries and is pre-eminent in assembling scientific expert panels to assist clients.
He is engaged in the monitoring of major European and international administrations and agencies on behalf of clients. He has also organized landmark conferences on the correct calculation, use and communication of environmental and health risks in the EU and Latin America.
Mr. Huggard has worked extensively in the field of regulatory impact analysis (RIA) and the application of econometric modelling to predict likely the short- and medium-term impacts of potential regulatory decisions on business sectors and how these create societal consequences.
He also works on the interaction between science and public policy and the challenges that these interactions pose for industry communications. He gives workshops, presentations and seminars on how industry should address these issues.
He holds a degree in Chemical Engineering and is a former adjunct professor at the Sacred Heart University Luxembourg Campus of the John F. Welsh College of Business MBA course where he taught ethics, leadership and contemporary management.
- Former Secretary General of the European Association of Research and Technology Organisations (EARTO) in Brussels
- Former member of numerous scientific committees
- Former professor at University of Xiamen (China) and adjunct at university in Kassel (Germany)
- Sworn in expert for environmental analytics and scientific editor of the Fresenius Environmental Bulletin
- Currently Secretary General of the advisory board (European Advisory Committee) to the Fujian Association for the Promotion of International Economic and Technological Cooperation (FAPET)/China
- Excellent links to European Commission, Parliament and national governments
- Long experience in consulting in scientific affairs, product defense and sustainability
- Preeminent in the engagement of key experts across a broad range of scientific issues
Dr. Schlesing has a Ph.D. in Analytical Chemistry (University of Bonn). He is author and co-author of many scientific and policy publications including co-author of “Responsible Partnering” between Research and Business.
He is fluent in German, English, French, and Italian.
- 30 years experience in biological, chemical and social-policy aspects of environmental and public health protection in the United States and Europe
- Served on two national Academy Science Committees, numerous USFDA and USEPA peer review panels and chaired several US Army Science Advisory Board Committees
- Executive director of the Presidential/Congressional Commission on Risk Assessment and Risk Management
- Former director of the Toxicology and Risk Assessment Program at the National Academy of Sciences/National Research Council
- Serves on the National Academy of Sciences Board on Environmental Studies and Toxicology
- Lifetime fellow and past president of the Society for Risk Analysis
- PhD in toxicology from MIT
Dr. Gail Charnley is an internationally recognized scientist specializing in environmental health risk assessment and risk management science and policy. She has 30 years of experience in the biological, chemical, and social policy aspects of environmental and public health protection, writing and speaking extensively on issues related to the roles of science and democracy in environmental and public health decision-making. Dr. Charnley focuses on the strategic risk management of complex scientific issues related to, for example, the design and implementation of regulatory programs in the United States and Europe, and on promoting a role for science and analysis in regulatory agendas worldwide.
She recently served on two National Academy of Sciences committees, one convened to improve the regulation of low-level nuclear waste disposal and one convened to provide guidance to the US Environmental Protection Agency on the future of toxicity testing and risk analysis. She has also served on and chaired several US Army Science Advisory Board committees that evaluated science- and technology-based policies and practices in the Army and on numerous peer review panels convened by the Environmental Protection Agency, the Food and Drug Administration, and Health and Welfare Canada.
From 1994-1997 she was executive director of the Presidential/Congressional Commission on Risk Assessment and Risk Management, mandated by Congress to evaluate the roles that risk assessment and risk management play in federal regulatory programs. Before her appointment to the Commission, she served as director of the Toxicology and Risk Assessment Program at the National Academy of Sciences/National Research Council, where she also served as the project director for several Academy committees convened to evaluate and make recommendations concerning science-based public policy matters.
She lectures frequently on science policy issues and is the author of numerous reports evaluating the toxicity of chemical exposures, environmentally related impacts on public health, the management of risks to health and the environment, children’s environmental health, and democratic science-based public policy and decision-making. She is a lifetime fellow and a past president of the international Society for Risk Analysis, for which she has also served as councillor, Sigma Xi distinguished lecturer, and chair of the public policy committee. She holds an AB in biochemistry from Wellesley College and a PhD in toxicology from MIT.
- Over 20 years experience in developing science-based defence of products in legal and public settings
- Performed in-depth safety evaluations of major pharmaceutical and medical device products
- Worked with major companies on projects involving pharmaceuticals, medical devices, food and beverages, dietary supplements, metals, and chemical exposures
- Experienced in product support strategies, advocacy tools and the interface between science, policy, and the law
- Worked on a number of very large assignments in the fields of clinical trials, epidemiology, toxicology and risk
- Developed strategic and tactical support in Daubert motions involving multi-million dollar, mass tort litigation
Dr. Schwartz heads the Liability Support Practice at Innovative Science Solutions, having secured his reputation in science-based defence of products in both legal and public settings. He has significant expertise in the design of programs that critically review the scientific foundation of the adversary’s case. Dr. Schwartz honed this skill as Director of Scientific Litigation Support for the legal firm, McCarter and English, where he led on the evaluation of the safety of antidepressants. Since then, he has guided clients in applying rigorous scientific principles to products before, during, and after launch. Over the course of is career, Dr. Schwartz has supported the science-based defence of a host of scientific products, including breast implants (allegations of autoimmune disease and cancer), diet drugs (allegations of cardiotoxicity), cellular telephones (allegations of brain cancer), antipsychotic medications (allegations of diabetes), and non-steroid anti-inflammatory drugs (allegations of toxic skin conditions).
Dr. Schwartz received a Ph.D. in neuroscience from Princeton University and postdoctoral training in neuropharmacology and neurophysiology from the Center for Molecular and Behavioral Neuroscience at Rutgers University.
- 30 years international experience in industry and consulting on the impact of public policy on business performance
- Focus on competitiveness, innovation and entrepreneurship, and Regulatory Impact Analysis
- Worked for pharmaceuticals, specialty chemicals, consumer products, oil refining, telecoms, retailing, biotechnology and metals industries, the OECD, European Commission, national governments
- Held senior management positions at BP in Finance, Corporate Planning, and Marketing, including Finance Director and Deputy Managing Director responsible for BP’s extensive investments in Switzerland
- Graduate in Modern History from Oxford University and a Fellow of the Association of Chartered Certified Accountants (FCCA)
- Clients include the OECD, the European Commission, national governments, trade associations, the European Roundtable of Industrialists, UNICE, and a wide range of major international corporations
At BDL, Richard Meads has, for the past 15 years, undertaken significant work in the area of socio-economic impact analysis in a wide range of sectors including pharmaceuticals, specialty chemicals, consumer products, oil refining, telecoms, retailing, biotechnology and metals. Amongst the assignments he has recently completed is a global benchmarking study for the animal health sector, which examined the socio-economic impact of the industry, as well as the impact of government policy on competitiveness. It was carried out in Australia, Canada, Europe, Japan, and the USA. He has also worked widely on other themes including competitiveness, innovation and entrepreneurship, and Regulatory Impact Analysis.
He has carried out business critical studies for the mining and metal industries related to multi-billion dollar acquisitions. His work has formed the basis for numerous industry initiatives to communicate to key stakeholders the economic and societal benefits that their products and services deliver.
Before to founding BDL, Richard Meads spent twelve years working for British Petroleum. He held senior management positions in Finance, Corporate Planning, and Marketing, including Finance Director and Deputy Managing Director responsible for BP’s extensive investments in Switzerland.
Richard Meads was a Senior Policy Advisor to The European Policy Centre and Rapporteur of its Risk Forum between 2004 and 2007. He is now a founding member of the European Risk Forum; an EU-level think tank focused on regulatory policy, management of risk, and regulatory reform. He has written extensively on regulatory policy and risk management.
He is a graduate in Modern History from Oxford University and is also a Fellow of the Association of Chartered Certified Accountants (FCCA).
- Over 25 years experience in the global pharmaceutical industry
- Has played a key role in the successful development and commercialisation of more than 60 medicinal products
- Has wide experience with the development of both small molecules and biologics including recombinant proteins
- Has held Vice President and Director level appointments in several major pharmaceutical companies with responsibility for European Development and Regulatory Strategies
- Has performed due diligence for both product and corporate acquisitions and for partnering
Dr. Peter Cooper has worked for a total of over 35 years in the pharmaceutical industry with experience that includes the management and co-ordination of new product development, manufacturing and international regulatory affairs. His expertise covers the development and regulatory approval of both small molecules and biologics (human derived and recombinant molecules). He has played a key role in the development and commercialisation of more than 60 new products in therapeutic areas including cardiovasculars, anti-cancers, anti-infectives, CNS, respiratory, vaccines, intravenous nutrition and recombinant technology (EPO, alpha interferon, G-CSF and GM-CSF and human growth hormone).
Holding a variety of senior level positions at Medeva, Amgen, Schering-Plough, KabiVitrum, ICI Pharmaceuticals (AstraZeneca) and Boehringer Ingelheim, Dr. Cooper has led numerous assignments in the development and commercialisation of new molecules, line extensions and prescription to OTC switches. In these organisations, he has also been responsible for regulatory compliance in the EU and in other regions. He has also performed technical due diligence for product and corporate acquisitions, assessed in-licensing opportunities and gained approval for a new manufacturing facility. He has managed external projects such as establishing joint research programmes with academic units and joint ventures with the National Health Service in the UK for specialised pharmacy services.
In his role as a consultant, and as an Interim Manager, he has continued to perform technical due diligence exercises and to carry out projects such as the restructuring of international regulatory affairs functions and establishing effective strategic regulatory input into multidisciplinary project teams.
One of his major contributions to successful development and commercialisation programmes is managing the interfaces between the various disciplines and functional areas involved.
He holds a BSc (Pharmacy), PhD (Metabolism and protein binding of drugs) and is a Member of the Royal Pharmaceutical Society and a Fellow of TOPRA (The Organisation for Professionals in Regulatory Affairs).
- Recognised expert with over 30 years experience in the pharmaceutical field
- Manufacturing experience includes blood products, small and large volume parenterals, transfusion and dialysis equipment
- Contract research experience covers overall programme management for numerous new products from small synthetic chemicals to complex proteins manufactured in animal cell lines and in bacterial fermentation systems
- Responsible for clinical trial applications and marketing authorisation applications in both Europe and the USA in a number of therapeutic areas
- Extensive experience of interacting with the regulatory agencies including EMA, FDA and national agencies
- B.Sc.(Biochemistry), Chartered Biologist, Member of Society of Biology, Member of The Organisation for Professionals in Regulatory Affairs
As a recognized expert with over 30 years experience in human pharmaceutical manufacture and registration, Mr Cameron has advised companies on all aspects of drug development from early non-clinical testing through Phases I to III in man and on to marketing authorisation applications. His areas of expertise include NCEs, recombinant DNA products, monoclonal antibodies, biologically derived products and “borderline” products. Mr Cameron has extensive experience of clinical trial applications across the European Union and has submitted designation applications for a number of orphan medicinal products.
This experience has been gained, initially, in the manufacture and quality control of human plasma products and crystalloid solutions. Angus Cameron followed this as Senior Scientific Officer at Baxter Laboratories Ltd, where he was responsible for providing a regulatory affairs service on a range of products including blood components, anticoagulant solutions, parenteral nutrition and dialysis solutions. This included handling clinical trial applications and product licence submissions in UK and Ireland, maintaining existing licences, participation in hearings before CSM and setting up and monitoring of clinical trials in the UK on novel blood products.
As Regulatory Affairs Manager for lnveresk Research (now Charles River), Angus Cameron provided a complete regulatory service to groups within this large contract research organisation and to external customers. In this role, he prepared European clinical trial and marketing authorisation applications for new and established substances, including biological and biotechnological products, IND and NDA packages for submission to the US–FDA and designed pre-clinical and clinical testing strategies for new products.
He now provides expert advice in the areas of non-clinical and clinical development strategies, clinical trial submissions and scientific advice procedures, with particular expertise in the areas of orphan medicines and advanced therapies. He also offers strategic advice to companies involved in drug development and has led on the preparation of development strategies and regulatory submissions to the European and US regulatory agencies.
Angus Cameron provides training and gives presentations on regulatory affairs topics at symposia and to companies in UK, USA and Japan.
Angus Cameron holds a B.Sc. (Biochemistry) and is a Chartered Biologist, Member, Society of Biology and Member of The Organisation for Professionals in Regulatory Affairs.
Phil has explored the nexus of science, politics and society throughout his career, from journalism to senior management in an international setting. He specializes in strategies that convey the complexity, contributions and challenges of scientific enterprise while fostering public approval and supportive policy, the essence of reputation management.
- Phil’s expertise spans major project engineering, chemical, pharmaceutical and health science sectors, in addition to agriculture, food and nutrition. Phil adds the capacity to cultivate cooperative international relations. His contributions include the development of Olympic and Paralympic Sport.
- Phil has held leadership positions in both corporate and government sectors nationally and internationally. He has headed communications and public affairs in three major government departments, the Lottery Corporation, the Pharmaceutical Association and the European Crop Protection Association. Immersed in issues related to food security, safety, biodiversity, industrial chemistry, the environment, risk management, health care and associated policy, he presents a compelling voice for sustainable productivity with wide exposure in global media.
- Phil came to Europe in 2006 as Press Chief for the Canadian Team at the Torino Olympic and Paralympic Winter Games. He stayed to develop a cross industry platform for marketing and advocacy communications on behalf of Bayer, BASF, Syngenta, DuPont and Dow Chemical within a highly charged political environment.
- Previously the Adviser for Science and Ethics within the European Commission’s Bureau of European Policy Advisers, which reports directly to the President of the European Commission
- President of the International Council on Amino Acid Science (ICAAS) and Chair of the International Glutamate Technical Committee (IGTC)
- Has published extensively on the role of the precautionary principle in technological risk management under scientific uncertainty and is co-editor of the book “The Reality of Precaution” which compares precaution in risk management in the US and the EU.
- Has a PhD in physics from the University of Wales and is a visiting professor at the University of Tokyo (School of Public Policy)
Dr. Michael Rogers is a consultant working on subjects at the interface between risk, ethics and law for a variety of clients in academia, foundations and private companies. Dr. Michael Rogers has had a wide range of national and international experience in government service, academia and industry
Previously, he was the Adviser for Science and Ethics within the European Commission’s Bureau of European Policy Advisers, which reports directly to the President of the European Commission. Within this multidisciplinary group, Dr. Rogers was responsible for advice concerning science and society and was Secretary of the European Group on Ethics in Science and New Technologies. Before joining the European Commission, he was for five years a member of HM Diplomatic Service in Tokyo. He also spent a year as Counsellor (Science and Technology) at the EC Office in San Francisco.
He is President of the International Council on Amino Acid Science (ICAAS) and Chair of the International Glutamate Technical Committee (IGTC).
Dr. Rogers has a PhD in physics from the University of Wales. During 1999-2000, he was the EU Visiting Fellow at Duke University, North Carolina. He is a visiting professor in the School of Public Policy of the University of Tokyo. He has published a number of papers on the role of the Precautionary Principle in technological risk management under scientific uncertainty. He is co-editor of “The Reality of Precaution” which compares precaution in risk management in the US and the EU.