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 15+ years in the pharmaceutical industry. Aidan 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 Biologics (a Johnson & Johnson company). His current role is Senior Process Validation Engineer in Technical Operations at Janssen Biologics, Cork. His responsibilities include supporting the assessment and use of disposable technologies throughout Janssen. He represents Janssen Biologics in 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.
Arminda O. Montero
Arminda Montero has worked in the pharmaceutical industry over 15 years. She is the distribution quality assurance program manager for the global pharmaceutical products division. Her current responsibilities include the development and implementation of strategies and quality systems for distribution, with specialized focus on cold chain management. Arminda holds a Bachelor of Science in Chemical Engineering from the University of Illinois at Urbana-Champaign.
Neritan Mustafa is Associate Director at Genzyme A Sanofi Company. He is the leader of the Supply Chain Operations Engineering & Performance for Genzyme Industrial Organization. Neritan's focus for the past 13 years has been understanding the requirements of the Global Cold Chain process, lead, manage and support key activities achieving business excellence aligned to strategy based on robust science, risk management while meeting global regulatory requirement.Neritan received his Bachelors of Science in Chemical Engineering with a Minor in Chemistry from the University of Massachusetts Lowell, USA, and his Masters of Arts in Business Administration from Framingham State University, Framingham Massachusetts, USA.Neritan is an active member of ISPE and PDA and contributing member of Industry Working Groups.
Humberto has gained 7 years of experience in quality system, cold chain process and project of continuous improvement, during his previous position as quality assurance inspector at Wyeth Pharmaceutical. His current position is a quality coordinator and Pfizer, based in Peru. He holds extensively knowledge in the different worldwide tendencies in cold chain in USA, Europe and Latin-America and has experience in maintaining the cold chain in places without electricity, available roads and extreme weather. Knowledge about ISO 9000, PMBOK, Six Sigma, 6S, Poka Yoke, Risk Management and all the activities regarding to Good Manufacturing Practices including validations. Red Belt and Trainer Certification.
Benjamin Romero is a Senior Engineer in the Pharmaceutical & Packaging Engineering department of Genentech. He has over 12 years of regulated packaging experience, most of which focused in the field of thermal package design, validation and manufacturing for the biopharma industry. He has been deeply involved in most areas of cold chain packaging including insulation, phase change material science, electronic temperature monitors, and predictive simulation. His work in the field of cold chain has yielded a US patent, as well as peer recognition in the form of a 2004 IOPP Ameristar, and WPO Worldstar awards in the pharmaceutical category. He has a BS in mechanical engineering from Stevens Institute of Technology, and is a CPP (IOPP Certified Packaging Professional).
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.
Saddam Huq is QA Senior Manager, Global Logistics and Cold Chain at GSK Vaccines in Belgium. Previously Cold Chain Technology lead at Wyeth Biotech/Pfizer in the UK, Saddam is a Subject Matter Expert for Cold Chain Shipment, Road Freight, Air Freight, Controlled Temperature Storage and Temperature Excursion Management. He held previously positions at Fresenius Kabi as a QA Officer and at Tycohealthcare as Process Engineer. Saddam as a BSC in Chemical Engineering.
Richard Ellinger is Principal at Temperature Assurance Group, a Cold Chain Research, Training, Consulting and Packaging Solutions organization. He has been active as a Cold Chain Supplier since 2005 working first with ThermoSafe Brands and now with TAG. His supplier experience includes global management responsibility for lab services, product development, business development, marketing, sales and customer service. His current research study involves discovering the best 'track and trace', 'chain of custody' and full-service logistics services; and his current training program is dedicated to suppliers so they might improve their ability to win business by maintaining a high-quality, regulatory compliant service or product while working within the framework of the ColdChain decision-making process.
A veteran journalist with 28 years of trade publication experience, including 23 in packaging, Jim Butschli is responsible for editorial planning, writing, and editing for print, Web, and electronic publications produced by Healthcare Packaging and Packaging World, published by Chicago-based Summit Media Group. Jim has served as Editor-in-Chief of Healthcare Packaging magazine since its inception as an electronic publication in 2004. He also serves as Features Editor with Packaging World magazine, where he started in 1994. Jim has attended recent Cold Chain for Pharmaceuticals events in Philadelphia, is an active member of the Institute of Packaging Professionals, is experienced in speaker acquisition, and has served as a moderator and/or speaker at packaging-focused events. Jim has visited numerous plants throughout the U.S., Canada, and Europe to report on packaging machinery and material applications, focusing primarily on pharmaceutical, medical device, and biologics issues and trends, including cold chain distribution issues.
Kevin O’Donnell is Senior Partner at Exelsius Cold Chain Management - US an international provider of consulting, research and training services to manufacturers, airlines, forwarders and other stakeholders in the life science logistics sector. With its unique cross-sector knowledge of the industry, Exelsius has been consulted on a diverse range of projects around the world including in-house and public training, logistics product development, Quality Management System introduction and facility design. Mr. O’Donnell’s contributions to industry are widely recognized. He is internationally respected as an advocate, author, blogger, educator, training developer, and champion of good distribution and logistics practices for temperature-sensitive drugs. His involvement with industry spans such organizations as the International Air Transport Association, where he serves at Chair of the Time & Temperature Task Force; the World Health Organization, as a temporary advisor; the United States Pharmacopeia, as a member of the 2010-2015 Expert Committee on Packaging; and the Parenteral Drug Association, as a founding member of the PCCIG, co-author of Technical Report #39, and training co-developer. Prior to joining Exelsius, Mr. ODonnelll was Director and Chief Technical Advisor to Industry at ThermoSafe Brands. He retired in 2005 as a Principle Packaging Engineer after a 26-year career at Abbott Laboratories.
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 : email@example.com
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.
Nicole Goodwin is the global head of the Pharma IQ online community. Responsible for the strategic direction and development of the portal, Nicole manages a talented team of producers, marketers and editors who all have a single goal – to make it easier for the pharma and bio community to connect in a meaningful way.Coming from a journalistic and event s background, Nicole has spent her time at Pharma IQ working with industry to create innovative content and meetings that help pharma and bio professionals benchmark their current strategies and solve their most pressing challenges. It is this practical approach that helped boost the community to 22 000 members in its first year.
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.