Pharmaceutical companies and their suppliers are faced with an ever-increasing complex and global supply chain. As companies are tasked with ensuring product integrity and supply-chain security, they also are confronting evolving expectations in customer–supplier relationships and changing regulatory requirements. To gain a perspective on these issues, Xavier University will be hosting the Global Outsourcing Conference in partnership with FDA in Cincinnati, Ohio, Oct. 2–5, 2011. The conference was developed through a collaborative effort of pharmaceutical companies, contract organizations, and FDA regulators as a means of engendering critical thinking, understanding, and continuous improvement in drug development, manufacturing, and the related supply chain.
The upcoming Global Outsourcing Conference in October is the second time that Xavier University and FDA will be holding the conference, which was first held in 2010. “We saw a need to have a meaningful dialogue among pharmaceutical companies, contract manufacturers, suppliers, and regulators to address the challenges that the industry faces in the global supply chain,” says Marla Phillips, director at Xavier University and formerly head of quality operations of the Wilson, North Carolina, facility of Merck & Co. To that end, the conference features panelists from FDA, pharmaceutical companies, suppliers, contract manufacturers, and other industry experts.
On the regulatory front, Deborah Autor, FDA deputy commissioner for global regulatory operations and policy, will provide the keynote address by examining the newly released report: “Pathway to Global Product Safety and Quality,” and collaborative approaches between regulators and industry. Richard Andrews, operations manager within the GMP/GDP Inspectorate at the Medicines and Healthcare Regulatory Products Agency (MHRA), Michael Levy, director of the Office of Drug Security, Integrity and Recalls at the Office of Compliance at the Center for Drug Evaluation and Research (CDER) at FDA, and Jair Calixto, manager of good practices and audits with the Association of the Pharmaceutical Industry in Sao Paulo State (SINDUSFARMA) will offer perspectives on global regulatory expectations and the initiatives and challenges in global outsourcing and supply-chain security. In another session, Levy also will provide an update on FDA’s Drug Integrity and Security Program. Kathleen Culver, field investigator and drug pre-approval manager in the Cincinnati District at FDA, and MHRA’s Andews will offer insight into trends in inspection findings and enforcement action. Rick Friedman, director of drug manufacturing and product quality with FDA’s CDER, has been invited to join Steve Niedelman, lead quality system and compliance consultant with King & Spalding and formerly FDA’s deputy associate commissioner for regulatory affairs and formerly FDA’s chief operating officer of the Office of Regulatory Affairs, to discuss supplier-qualification programs and related approaches in risk management.
The conference also will feature panels examining quality by design and audits. Several speakers will offer insight into how to operationalize quality by design (QbD). The panelists offering QbD perspectives include: Eric Ahuja, director of analytical chemistry development and supply at Merck & Co.; John Lepore, senior director of chemical process development and commercialization of global pharmaceutical commercialization at Merck; Stephen Closs, director of global technical affairs at Patheon; and Chris Watts, partner of consulting at NNE Pharmaplan. Another panel will discuss best practices in audits. Participating in the panel are: Janeen Skutnik, director at Pfizer responsible for developing the company’s position on quality and CMC; Vicky Stoakes, president of the consultancy IntegRx; Christopher Smith, vice-president of quality assurance and regulatory affairs at AAIPharma; and Bob Coleman, senior compliance expert of pharmaceuticals at IHL Consulting.
Integrating best practices in supply-chain management in early-stage drug development is an effective way to ensure that quality, cost, and delivery of product is achieved throughout product development and commercialization. Offering insight into this area are: Edward Kobeliski, formerly vice-president of global API manufacturing for Pfizer Global Research and Development; Patrick Crowley, formerly vice-president of GlaxoSmithKline; and Hedley Rees, managing partner at Biotech PharmaFlow. And John Curran, distinguished scientist at Merck & Co., will provide case-study analysis of end–to–end planning for successful product launch.
Other industry experts will offer insight into global supply-chain practices. Brian Johnson, senior director of supply-chain security at Pfizer, will provide case-study analysis of effective processes to manage global and complex supply chains. Mary Foster, vice-president of quality at Catalent Pharma Solutions and US Pharmacopeia guideline author, will discuss good storage and distribution practices, including USP guidelines in this area.
Effective supply-chain management relies on successfully working with contract manufacturers and other suppliers, and several speakers will offer insight into the outsourced relationship. Andrew Cox, chairman of the advisory board for the International Institute for Advanced Purchasing and Supply, will offer insight into strategic sourcing from a pharmaceutical supply perspective. Javaid M. Cheema, president of the consultancy Lean-O-Pex, will provide case-study analysis and best practices in determining the total cost of ownership in product development and manufacturing. James Ryan, associate in the technology transactions group of the London office of Morrison and Foerster, will offer insight into the development of commercial contracts. Alan Minsk, partner and practice leader of the food and drug practice team at the law firm Arnall Golden Gregory will discuss how best to develop and monitor functional quality agreements. And Andrew McNicoll, senior director of global quality compliance at Patheon, will provide insight into performance metrics.
In addition to the conference, which will be held Oct. 3 to Oct. 5, two supplemental workshops will be held Oct. 5 to Oct. 7. International Pharmaceutical Excipient Auditing (IPEA) will hold workshops on excipient GMP auditing on Oct. 5, 6, and 7. Another workshop relating to documentation practices and legal ramifications will be held on Oct. 5.
The Global Outsourcing Conference is one of two pharmaceutical-related conferences held by Xavier University and FDA. MedCon, which was held in May 2011, focuses on the strategic and regulatory issues affecting the medical-device industry. A third conference, focusing on best practices in supply-chain management across various sectors, food, drug, medical device, aerospace, and automotive is under consideration.
Details of the Global Outsourcing Conference may be found here.