Signature Series

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Introducing The Signature Series at INTERPHEX – a compelling selection of presentations on critical subjects affecting the pharmaceutical industry. Join your colleagues for continental breakfast and then attend the Signature Series presentation of greatest interest and application to you.

April 21, 2010

NEW! Signature Series

8:30AM – Continental Breakfast

9:00 AM - 10:00 AM | Room: 1E14
Deficiencies in New Drug Applications
Aloka Srinivasan, Office of Generic Drugs, CDER, FDA; Robert Iser, Office of Generic Drugs, CDER, FDA & Richard Lostritto, Director of Division-III, Office of New Drug Quality Assessment (ONDQA), FDA

Aloka Srinivasan

Robert Iser

Richard Lostritto

FDA Addresses Common Deficiencies in New Drug Applications As part of FDA's recent mandate to be more transparent in their processes and procedures, three FDA administrators discuss deficiencies they commonly see in the CMC portion of New Drug Applications and Abbreviated New Drug Applications. Richard Lostritto, Director of Division-III in FDA's Office of New Drug Quality Assessment is joined on this panel by Aloka Srinivasan, and Robert Iser, both Team Leaders in FDA's Office of Generic Drug, to offer an unprecedented glimpse into FDA's considerations of new drug applications. The panelists will offer brief presentations and then open up the floor to questions from the audience.

9:00 AM - 10:00 AM | Room: 1E16
Supply-Chain Security: What to Expect in the Next Decade
Guy Villax, Chief Executive Officer, Hovione

Supply-Chain Security: What to Expect in the Next Decade Guy Villax, CEO of Hovione (Portugal) and a board member of the European Fine Chemicals Group, discusses current challenges in global supply-chain security, including manufacturing quality control and regulatory perspectives. Mr. Villax will also address proposed solutions to supply-chain security including shared audits and how industry and regulators can work together on this issue.

9:00 AM - 10:00 AM | Room: 1E15
The State of the Outsourcing Industry
Jim Miller, President, PharmSource

2009 was a difficult year for many service providers, and we have entered 2010 with a lot of uncertainty. Global bio/pharma companies are still sorting out their new business models and digesting their acquisitions from last year. Small bio/pharma are hoping that funding resumes. The pipeline of new late stage compounds looks promising, but regulators have made new approvals difficult.

This presentation will look at the demand environment facing contract service providers, and assess their outlook for the next two years.