Ash is a co‐founder and managing director of COUCH Medical Communications. Ash has over 10 years’ experience in pharma marketing and has delivered activities across UK, Europe, US, Canada and Latin America. His areas of expertise include behaviour change, self-management, patient outcomes, medical communications, stakeholder development, digital engagement strategies. As a creative communicator he enjoys finding interesting ways to engage wide audiences in an effective manner. Ash has worked with clients in the pharma, healthcare, NHS and public sector, so he truly understands the need to discuss patient advocacy from a number of perspectives.Areas of clinical focus include: oncology, COPD, neurologic and psychiatric disorders, amongst others.
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Gilles Jr Grégoire joined Pharmascience in 2013 as a Distribution Manager but as of 2015, he holds the position of Global Transportation Manager. He obtained a Bachelor’s Degree in Industrial Engineering and a Masters of Engineering from École de Technologie Supérieure in Montreal, Québec. Gilles Jr likes to describe his job as “as soon as something is not within the four walls of Pharmascience it falls under my responsibility”. Gilles Jr’s responsibilities include qualification of transportation lanes, passive and active solutions, managing external warehouses and worldwide distribution networks, and leveraging global supply chain opportunities through different logistic models, all while preventing any compromise to the quality of Pharmascience’s product. His passion for statistics, thermodynamics, and logistics allows him to address the toughest supply chain challenges that can be found in todays regulated and cost pressurized environment.
Mr. Johnson joined Entegris in March 1996 as a project engineer. He entered his current role in 2014. His primary responsibilities include managing technical activities related to the expansion of Entegris products, services and technologies in the life sciences market.Over the last 20 years, Mr. Johnson has held various positions at Entegris including project engineer, application engineer and global product marketing manager. Through these roles Mr. Johnson has established himself as a subject matter expert on high-purity fluid handling of critical process fluids. His efforts have resulted in over 10 patents, including a beadless welding apparatus designed to meet the requirements of cGMP piping systems. Mr. Johnson has also written multiple articles for industry publications and is a frequent speaker at bioprocessing conferences.Mr. Johnson is a member of ISPE, PDA, ASTM and BPSA. He is also Chair of the ASME-BPE Standards sub-committee on polymeric materials as well as the ASME-BPE Project Leader for the Polymeric Hygienic Union task group and the Particulates in Single-Use Systems task group. Mr. Johnson received his bachelor of science engineering degree from the University of Minnesota’s College of Science and Engineering.
Dr. Aidan Sexton
Dr. Aidan Sexton has a Bachelor of Science in Industrial Chemistry and a Doctorate in Catalysis/Physical Chemistry, both from the University of Limerick. He has more than 25 years of experience; 10 years in research and development and 16+ years in the pharmaceutical industry. He has held a number of senior roles in the areas of Validation, Quality Assurance and Engineering. These roles have been in biopharmaceutical, sterile fill finish and API manufacturing organisations, including Pfizer and Janssen Sciences Ireland (a Johnson & Johnson company). His current role is Senior Process Validation Engineer in Technical Operations at Janssen Sciences Ireland UC, Cork. His responsibilities include supporting the assessment and use of disposable technologies throughout Janssen. He represents Janssen on the Extractables and Leachables work stream in the BioPhorum Operations Group (BPOG), an industry collaboration body. Aidan is the Janssen corporate vote holder in the ASTM E55.04 General Biopharmaceutical Standards subcommittee. He also lectures in three modules for an MEngSc program in Pharmaceutical and Biopharmaceutical Engineering, at University College Cork.
Geoffrey Glauser is a K.W. Tunnell Contractor in support of the Manufacturing, Facilities, and Engineering Division of the Biomedical Advancement Research Development Authority (BARDA) in the Office of the Assistant Secretary for Preparedness and Response (ASPER) within the U.S Department of Health and Human Services (HHS). This division supports the development, contracting and supply of vaccines, antivirals, diagnostics, therapeutics and ancillary products. As a subject matter expert in supply chain functions for biologicals and pharmaceuticals, Geoff works in support of the development, testing, and manufacture of Pandemic Influenza vaccines, antiviral compounds and Radiological, Nuclear and Chemical vaccines and therapeutics. Geoff reviews contract proposals and related documents for product development, manufacturing processes, logistics, storage and distribution issues. He provides assessment and guidance reports on contract issues involving product delivery, quality, regulatory compliance, oversight of facility design, construction, and monitoring contract progress. Geoffrey Glauser has previously worked with Pfizer Pharmaceuticals (formerly Wyeth) in the Global Packaging Technology group supporting biotech, vaccine, consumer and nutritionals with temperature controlled shipping expertise and solutions. In previous industrial positions, he has directed supply chain, biological, sterile and chemical manufacturing activities with Merck & Co. Inc. (25 years) and Fisher Clinical Services for in-line, new product and clinical biological and pharmaceutical entities both domestically and internationally. A former US Navy officer and engineer, Mr. Glauser has a microbiology degree from Indiana University. As an active member of the PDA, ISPE, and APICS, Geoff speaks and writes for industry forums on supply chain issues.
Tomas Skacel was previously Medical Director at Amgen International. His past experience includes, International Medical Director at Amgen International, Zug Switzerland, Clinical Resarch Physician at Eli Lilly Regional Medical Ctr, Vienna, Austria, Product manager, Oncology at Eli Lilly Czech Republic and Physician at University Hospital Olomouc, Czech Republic.
David P. Elder has over 32 years experience in the pharmaceutical industry working for Sterling, Syntex, SmithKline Beecham and GlaxoSmithKline, where he has worked at various director level positions. He is currently a director in the Externalization group (SCINOVO). He obtained a BSc degree in Applied Chemistry in 1977 from Northumbria University, Newcastle upon Tyne, UK, an MSc in Analytical Chemistry investigating polymorphic transitions from the same institute in 1982. He obtained a PhD in crystallography from Edinburgh University, UK in 1992. He is a member of the BP-Committee PCY: Pharmacy. He is a committee member of the Joint Pharmaceutical Analysis Group (JPAG). He is a member of the Chartered Quality Institute, a fellow of the Royal Society of Chemistry (RSC), a Chartered Chemist, a Chartered Scientist, a Chartered Quality Professional and is a Qualified Person. Dr Elder has lectured worldwide on a variety of topics including externalization and solid state chemistry. He is a member of EfPIA and PhRMA genotoxic impurities interest groups. He has authored two book chapters and is in the process of authoring a further four book chapters. In addition he has presented more than 60 technical and review articles on a variety of subjects. He has 7 patents to his name.
André Bourgouin was previously the Vice-President of Corporate Intellectual Property of Ipsen Pharma which he joined in 1996. He began his career in the Patent Department of Roussel Uclaf and then joined Pasteur Merieux Connaught (now Sanofi Pasteur) where he held the position of Director, Corporate Intellectual Property. André holds a Doctorate degree in Organic Chemistry and studied law at the University of Paris (Licence en droit and DESS degrees). He graduated from the CEIPI and is a registered French and European patent attorney and a European Trade mark attorney.
Ronaldo Galvão is the Quality Operations Director -GPSG Brazil at Janssen-Cilag. A role he has held since 2007. Ronaldo's responsibilities include, providing leadership and direction for ANVISA issues for GPSG and J&J site, supporting new product launches in the Brazilian market, and providing leadership for BBC (Behavior Based Compliance) concept introduction to all employees.
Stephen Brown was previously CTO and co-manager of CMO activities for Vivalis, based in Nantes, Western France. He has worked in the biopharmaceutical industry for 31 years. Prior to Vivalis, Dr Brown was Director, Biological Process Development for Merial and before that, responsible for the Gene Vector Manufacturing site at Transgène, France. Stephen Brown held a postdoctoral position at the ETH Zurich, Switzerland and received his Ph.D. in Fermentation Technology from the University of Kent at Canterbury, UK and holds a B.Sc. in Microbiology from the University of Wales (University College Cardiff), UK. Steve is an active member of the Parenteral Drug Association, where he is a member of the PDA Biotechnology Advisory Board and several technically oriented task forces.Stephen Brown Chief Technical Officer Vivalis 6 rue Alain Bombard 44800 Saint Herblain Nantes France Telephone : +33.228.07.37.10 Fax : +33.228.07.37.11 Email : firstname.lastname@example.org
Melissa Mudrick, JD, is Director of Drug Safety and Risk Management at Biogen Idec. In this capacity she is responsible for oversight of global compliance for Drug Safety, through management of corrective actions, auditing, oversight of training and documentation control, and fostering continuous quality improvement worldwide. Melissa has over 8 years of experience in Drug Safety at Biogen Idec with experience in management of operations, oversight of CROs, establishing a CQI program for Drug Safety, and management of contracts and budget. Melissa joined Biogen Idec in 2002, and has been Director, Drug Safety Quality since November 2009. Prior to joining Biogen Idec Melissa has supported research in various roles at the Boston University Medical Campus and the Veterans Affairs Medical Center. Melissa received her B.A. degree in Psychology from Dickinson College, Carlisle, Pennsylvania and her law degree at Suffolk University Law School in Boston, Massachusetts. She is a member of both the New Hampshire and Massachusetts bar.
Sheraz is Head of Assay Development & Screening at the Fraunhofer Institute for Molecular Biology and Applied Ecology – ScreeningPort. In his role, he is responsible for the management and development of Assay Development and Medium and High Throughput Screening activities for partners across the world. He has 23 years’ experience in both academia (University of London) and industry (GlaxoSmithKline Pharmaceuticals). This has ranged from the detailed study of catalysis by biological catalysts (enzymes and catalytic antibodies) to the design and development of assays for High Throughput Screening for the major drug target classes. He is the co-author of numerous papers, chapters and the Enzyme Assays: Essential Data handbook.He now works for the Fraunhofer Institute - one of the largest applied research organisations in Europe employing around 23,000 staff.
Dr Steven Bradshaw
Steve Bradshaw leads the life sciences consultancy firm, Valid Insight. He is an experienced leader with expertise gained from a career spanning market access consultancy and healthcare roles.Steve has comprehensive experience and knowledge of market access and pricing dynamics and of healthcare systems and pharmaceutical policy affairs across Europe, the US and the emerging markets. Qualified as a MD, trained as an Eye Surgeon, elected as a National Guideline Development Group Committee Member, appointed as Editor at Nature and with life science consultancy experience in all key therapy areas, plus experienced in health economics and outcomes research, including real-world evidence and publication strategy. In the consultancy sector Steven worked with United Biosource Corporation (UBC), Evidera, and he built up and led European capabilities for MKTXS until 2016 prior to launching Valid Insight. Steven has a first-class BSc (Hons.) in Biochemistry, MD from Cambridge, and specialist Diploma from the Royal College of Ophthalmologists. He is an active member of the market access community: he presents widely, is a frequent attender at panel sessions and congresses and has over 30 publications. His research interests focus on policies for innovative medicines, particularly regenerative medicines for rare disease.Steve is an expert reviewer for clinical and industry journals and ISPOR, an Advisory Board Member and regular contributor at Pharma-IQ, an Advisor to AuthorAID and has been quoted in publications such as BioPharm Insight, Hospital Pharmacy Europe, Pharmiweb and Reuters.
As well as being affiliated with the Novartis Institute of Biomedical Research, Dean is also affiliated with the Institute of the University of Basel.