Drug discovery and development is known to be a risky and expensive exercise. What is probably less well understood is the crucial role management of the clinical supply chain in the drug development process and specifically its impact on costs. With the growing importance of therapeutic biologics and industry's expansion into logistically-challenged high growth markets, companies are now recognising the strategic importance clinical supplies management.
On March 28th Scrip Intelligence hosted a roundtable discussion, chaired by editor-in-chief Mike Ward, involving Mr Harry Clark, managing director of SI Associates, Dr Steve Day, vice president of global demand and supply at GlaxoSmithKline, Dr Ken Getz, a senior research fellow at Tufts Center for the Study of Drug Development, and Dr Sean Smith, VP, Global Logistics at Fisher Clinical Services to discuss the challenges facing the industry and consider some of the potential solutions on offer.
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As part of the exploration of what market leaders need to be doing to manage the challenges associated with the clinical supply chain in today's environment, the participants introduce themselves and outline their interest in the discipline and explain briefly why pharma companies should pay more attention to its management. | How are pharmaceutical companies coping in the current and challenging business environment and what impact could tighter management of the clinical supply chain have on the economics of drug discovery and development? | Consolidation and globalisation are two factors shaping today's global pharma industry. With the acceptance that clinical supply chain management should now also be at the heart of a company's strategic planning, to what extent should this be reserved for in-house activity and when should it be outsourced to external specialists? |
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The centre of gravity is shifting from Western developed markets – where sales are stagnant – to high growth emerging markets. What impact is this likely to have on the clinical supply management process? How should companies approach potentially significant markets such as China? Should they go-it-alone? work with a global specialist? or with a local hero? | There is a trend in clinical trial design from huge fixed Phase III trials towards adaptive trials as well as increasing demands for both comparative efficacy and cost effectiveness. How are these trends affecting the dynamics of clinical supply management? | What can the regulators do to reduce the level of complexity in clinical supply chain management? |
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The roundtable participants reveal how they think clinical supply chain management is likely to evolve in the near future. | | |
 | | |  Harry Clark
Harry Clark is Managing Director of SI Associates Limited and CEO of SI Associates, Inc. SI is an international operations management consulting business working with technology-led companies. Following his postgraduate degree at The University of Liverpool he joined General Motors, spending several years in the automotive and transportation sectors before joining the Production Engineering Research Association (Pera). In 1993 he joined The Strathclyde Institute, the then parent organisation of SI, which was subsequently subject to an MBO from the Institute in 1995. Harry has a specific interest in design, development and commercialisation of new products to compress time to market and in the effective alignment of supply chain relationships around this objective. He is married with two boys and two girls and enjoys cycling, tennis and cinema. | | |  Steve Day Steve Day is Vice President of Global Demand & Supply at GlaxoSmithKline focussing on the investigational material supply chain. He has been in the Pharmaceuticals R&D business for 25 years and has extensive experience ranging from formulation development, investigational medicinal product manufacture & supply and design & delivery of Interactive Response Technologies Steve has been leading global organisations for over 15 years and his current role is focussed on the delivery of the GSK R&D patient pack supply chain. | |  | | |
| | |  Dr Sean Smith
Dr Sean Smith has 18 years experience in the Pharmaceutical Industry. After completing his PhD in Medical Chemistry, Sean worked two years as a Post Doctoral Tutor at the University of Manchester. He began his Pharma career as a Formulation Chemist with a Japanese pharmaceutical company based in the UK moving on to become the UK based Product Development Manager in 5 years. Recruited to join Quintiles in 1997 as Director of Pharmaceutical Development, he oversaw the provision of outsourced Pharmaceutical Development and Analysis for a host of major pharma companies. A further move in Quintiles to become Director of Clinical Supplies occurred in 2000 heading up the facility in Bathgate Scotland. The position of Chief Operating Officer Clinical Supplies in Quintiles became available in 2002 and Sean was appointed this role overseeing 3 major sites and leading the establishment of a global depot network in partnership with Quintiles country Clinical Offices. He left Quintiles in 2004 to join Fisher Clinical Services where he took up the post of General Manager UK. In August 2008 Sean was promoted to the new position of Vice President Clinical Supply Chain taking responsibility of the global logistics element of Fisher Clinical Services. | | | |  Kenneth A. Getz
Kenneth A. Getz is the chairman of CISCRP – a nonprofit organization that he founded to educate and raise public awareness of the clinical research enterprise — and a Senior Research Fellow, Research Assistant Professor at the Tufts Center for the Study of Drug Development where he studies R&D management practices; pharmaceutical and biotechnology company operating models; and global investigative site, outsourcing, and study volunteer practices, trends and policies. Ken is also the founder and owner of CenterWatch, a leading publisher in the clinical trials industry.A well-known speaker at conferences, symposia, universities and corporations, Ken has published extensively in peer-reviewjournals, books and in the trade press and holdsa number of board appointments in the private and public sectors including serving on the Institute of Medicine's Clinical Research Roundtable, the DIA Foundation, the Consortium to Examine Clinical Research Ethics, and the Clinical Trials Transformation Initiative. He is on the editorial boards of Pharmaceutical Medicine, and the Drug Information Journal and writes a bi-monthly column nominated for a Neal Award in 2010 for Applied Clinical Trials. Ken holds an MBA from the J.L. Kellogg Graduate School of Management at Northwestern University and a bachelor’s degree, Phi Beta Kappa, from Brandeis University. Prior to founding CenterWatch in 1994, Ken worked for over seven years in management consulting where he assisted biopharmaceutical companies develop and implement business strategies to improve clinical development performance. | | | | | |
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| Previous Roundtables |  |  |  | Capital Efficiency
December 2011
At first glance, 2011 looks like it has been a bumper year for biotech financing. The industry has raised $40 billion plus from the capital markets and yet the amount of money being put to work in innovative pre-commercial biotechs is stagnating at around $5 billion. At the beginning of December, Scrip Intelligence hosted a roundtable discussion, chaired by editor-in-chief Mike Ward, involving Dr Kevin Johnson, partner at Index Ventures, Dr Robert Burns, CEO at 4-Antibody, Dr Johanna Holldack, CEO at Telormedix, and Dr Jason Slingsby, CEO at ProtAffin, to discuss the pressures facing the biotech industry. | Adopting Orphans
October 2011
Scrip's fith roundtable event, 'Adopting', was held at Prospero House, London on 7 June 2011.
Once eschewed by big pharma, increasing numbers of companies are entering the rare diseases arena, both through acquisitions and partnerships with smaller players. The panel discuss the opportunities and challenges for the pharmaceutical industry as it seeks to create value and deliver novel medicines to patients in the orphan drugs space. | Cancer vaccines
June 2011
Scrip's fourth roundtable event, 'Cancer vaccines', was held at Prospero House, London on 7 June 2011.
Five industry experts, representing market analysts, venture capital, biotech, private healthcare and pharma, debated the role of cancer vaccines in the war on cancer, what is holding back their development, what has been achieved thus far, and scientific, clinical and commercial challenges they still face. |  |  | | New challenges for the pharma industry in working with payers
November 2010
Scrip's third roundtable event, 'New challenges for the pharma industry in working with payers', was held at The RSA House, London on 4 November 2010. The panel debated different payer strategies, how best to assess the cost-effectiveness of drugs, value-based pricing, risk-sharing and patient access schemes, and the potential for harmonised approaches across European markets. | Alliances & Partnerships
18 December 2009
Scrip's first roundtable, hosted on the day of the 2009 Scrip Awards at Grosvenor House Hotel, London discussed a range of themes facing the global pharma and biotech industries, including US health reform, the growth of personalised medicine, the return of the mega-merger and other business strategies. | |
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