Pharmaceutical companies are conducting more clinical trials than ever before, in order to spur growth, maintain profit margins and replenish shrinking pipelines. The rising costs, complexity, as well as regulatory challenges caused by the increasingly global nature of these clinical trials presents significant challenges for pharmaceutical companies seeking to effectively manage the clinical supply chain.
R&D and clinical supply leaders must face these challenges with a flexible, cost effective approach that accounts for the complexity of the global distribution of the clinical trial supplies.
We will discuss:
- Regulatory and global trade requirements and implications for shipment into key clinical trial markets.
- The challenges facing global importers and exporters in a post 9/11 world.
- How to manage a “time and temperature” sensitive supply chain.
- How other government agencies affect the supply chain – US Customs is not your only hurdle at the time of import/export.
- Critical Documents Required.
- The significance of study start-up.
- Key activities to ensure seamless supply of clinical materials such as labeling management, labeling requirements in different countries, translation management of labels and inserts.
- The basic requirements of the QP process.
- Differences between IMPs and commercial products.
- Considerations to make the QP release process as quick and easy as possible.
- Application of USP General Chapter <1079> Good Storage and Shipping/Practices to Clinical Supply Chain Management.
- Revision of <1079> – Progress and Timeline.
Dr. Michael N. Eakins, Principal Consultant, Eakins & Associates
After 23 years in the pharmaceutical industry, Michael formed Eakins & Associates to provide consulting services to the pharmaceutical and medical packaging component industries. Within packaging, Michael specializes in the development of products in pre-filled syringes, the selection and incorporation of anti-counterfeiting technologies into primary and secondary packaging, counterfeiting in the supply chain, packaging QbD and speaks worldwide on these topics.
Michael joined the Squibb Research Institute in the USA in 1980 after spending 5 years with the MRC Cyclotron Unit at Hammersmith Hospital, London. He became Director of Diagnostics Development with Bristol-Myers Squibb responsible for the non-clinical development of all diagnostic products before moving to Bracco. At Bracco, Michael was Senior Director within R&D and then in the Worldwide Sales and Marketing Group responsible for packaging strategic initiatives.
Michael is an active member of the Parenteral Drug Association, being Chair for the 2007 Annual Meeting Program Planning Committee, Chair for the 2006 and 2007 Pharmaceutical Anti-Counterfeiting Forum and is the Vice-Chair of the USP Packaging and Storage Expert Committee for 2005-2010 cycle. He holds a Ph.D. from London University and has contributed to 52 publications and 8 USA patents.
Martin Page, General Manager, Catalent Pharma Solutions
Martin Page is General Manager, for Catalent Pharma Solutions. In this role Martin is responsible for planning, direction and controlling all activities of the Bolton UK facility. Martin joined Catalent, which was then Unipack in 1989. By using his past clinical expertise, Martin was key in establishing the clinical trial division. With over 25 years of experience in clinical supplies, Martin performs the duties as a Qualified Person in relation to the manufacture for export or importation of investigational Medicinal Products (IMP’S) under the transitional arrangements in accordance with Article 13(5) of Directive 2001/20/EC.
Prior to joining Catalent, Martin was a Medical Research Associate for Ciba-Geigy Pharmaceuticals and then a Clinical Research Executive for Smith & Nephew Pharmaceuticals. Martin holds a BSc (Hons) Biochemistry degree from Liverpool Polytechnic.
Andrew Willis, VP of Regulatory Affairs, Catalent Pharma Solutions
Andrew Willis is the VP of Regulatory Affairs, for Catalent Pharma Solutions. He currently leads a global team of internal and external regulatory affairs consultants for Catalent Pharma Solutions, which is the World’s leading Contract Manufacturing, Development and Consulting group, providing multiple support for innovative formulations.
Andrew is a qualified Chemist from the University of Glamorgan, after which he furthered his understanding of pharmaceutical development, working as a research chemist with Parke Davis. He has 8 years manufacturing and analytical experience prior to entering regulatory affairs as a Senior Executive Officer with responsibility for submission of European MAA’s and project management of development programs. Extensive knowledge was gained during this time in the development and manufacture of multiple dosage forms.
He has been an active member of BIRA (initially) and now TOPRA, presenting at symposiums and training seminars. Additional publications and presentations include: –
- ACRPI Presentation – EU Clinical Trials, Present and Future 2000
- ACRPI Handbook Chapter ( Drug Regulations in 21st Century) 2000 (issue 2001)
- Additional numerous internal / external training presentations.
- IIR – Mastering Abridged Application – Fast Track Approach (Lead Trainer)
- GOR – European Clinical Trials (Present and Future)
He also has significant experience in both OTC and generic development, presenting and providing advice to multiple clients on such developments. In addition, he is considered as an expert in life-cycle management, including management of life-cycles for products with global turnover in excess of $1.5bn. Particular experience has been gained in developing Clinical Study Start-up processes within a CRO environment lead to start-up systems for clinical trials in excess of 40 countries.
Phil Wilson, Director of Global Trade Operations, Supply Chain and Corp. Security, Catalent Pharma Solutions
Phil Wilson is the Director of Global Trade Operations, Supply Chain and Corp. Security for Catalent Pharma Solutions since joining Catalent in 2005. With over 18 years of experience in supply chain logistics for the Pharmaceutical Industry, Phil is responsible for the logistics of importing and exporting of pharmaceutical product globally. Since joining Catalent, Phil has assisted with achieving C-TPAT and AEO status. Phil is licensed by the US Treasury Department as a Customs House Broker and is an active participant in the Department of Homeland Security critical infrastructure program. He is also co-chair of the Healthcare Industries Committee in Washington, DC for the American Association of Exporters and Importers and an active member of the American Society for Industrial Security (ASIS).
Prior to joining Catalent, Phil held the position of Regional Manager of International Operations for CEVA Logistics and was also the Manager of Import Logistics for Expeditors International.
Who Should Attend?
Senior level executives in R&D and Clinical Supply functions for pharmaceutical/biotech companies worldwide.
Catalent Pharma Solutions is an industry leader with 25 years of experience and resources in the clinical supplies industry. Catalent has a proven track record in worldwide logistics management and regulatory affairs. Catalent provides an integrated, comprehensive, full-service operation for clinical trials materials preparation in support of Phase I through Phase IV studies, covering virtually all dosage forms. Our clinical supply services are cGMP compliant and include established clinical trial material and material management SOPs with QA oversight.
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