Letter from the Editor

Contributed by:

Taren Grom, Editor

NOTE: The content below contains the first few paragraphs of the printed article and the titles of the sidebars and boxes, if applicable.

Generics coming home to roost… By now, everyone in the pharmaceutical industry realizes that billions and billions of sales of branded products are going away, and the impact of this is going to be huge. According to IMS Health, the 5% to 8% compound annual growth rate during the next five years is going to reflect the impact of leading products losing patent protection in developed markets. Market growth is projected at almost $300 billion over the next five years,which would bring sales to about $1.1 trillion in 2014 — numbers that are staggering, yet still below what may be necessary to continue to drive higher growth in those therapy areas where there is a need for innovative science. The loss of patent protection for so many blockbusters has many companies re-­evaluating their business models and strategies. And as a result, this has many prominent thought leaders also looking to the future. This year’s annual DIA meeting in Washington, D.C., is a great opportunity to learn what industry luminaries have to say about the industry’s possibilities in the near and far term. The conference will feature sessions that aim to address what is needed for innovation, as well as health outcomes. A multitrack plenary session will look at the implications on innovation from comparative effectiveness research and the needs of payers. More than 25 special topics are available this year, including sessions devoted to oncology, biosimilars, pediatrics, and social media. The DIA also will feature John Crowley and the innovative work of Amicus Therapeutics. His amazing story was showcased in the January 2009 issue of PharmaVOICE. ­Pharma­VOICE also conducted a podcast with Mr. Crowley, whose story led to the making of the movie Extraordinary Measures. In our podcast, Mr. Crowley shares his personal journey to find viable treatments for Pompe disease, a neuromuscular condition that affects two of his children. The perennial challenge of speeding the development process for drugs to reach the market faster remains a main topic at DIA. Patient recruitment, CRO/sponsor relationships, data capture, and regulatory issues are just some of the many issues to be addressed. In this issue, the Forum takes a look at one idea for speeding development: the use of adaptive trial designs. The flexibility of an adaptive design allows sponsors to make course corrections during a trial based on interim data, but ensuring integrity of the study and controlling against bias are two issues that need to be addressed in up-front planning. The FDA’s new draft guidance on the subject should help to provide more clarity. Our experts also address the use of cloud computing in research, which can provide sponsors with the speed, agility, and deeper analysis of data to improve efficiency. Pharma and biotech companies are just starting to put their toes in the water in this arena, but experts say there will be rapid adoption when the industry realizes the opportunities for R&D. See you in Washington, D.C. And don’t forget to stop by the PharmaVOICE booth — No. 400 — and say hello. New revenue streams Publisher Lisa Banket Editor Taren Grom Creative Director Marah Walsh Managing EDitor Denise Myshko Senior EDitor Robin Robinson features EDitor Kim Ribbink Contributing Editor Carolyn Gretton design associate Ariel Medel national account manager Cathy Tracy CIRCULATION Assistant Kathy Deiuliis Copyright 2010 by PharmaLinx LLC, Titusville, NJ Printed in the U.S.A. Volume Ten, Number Six PharmaVoice (ISSN: 1932961X) is published monthly except joint issues in July/Aug. and Nov./Dec., by ­Pharma­­Linx LLC, P.O.?Box 327, Titusville, NJ 08560. ­Periodicals postage paid at Titusville, NJ 08560 and additional mailing offices. Postmaster: Send address changes to PharmaVoice, P.O. Box 292345, Kettering, OH 45429-0345. PharmaVoice Coverage and Distribution: Domestic subscriptions are available at $190 for one year (10 issues). Foreign subscriptions: 10 issues US$360. Contact PharmaVoice at P.O.?Box 327, Titusville, NJ 08560. Call us at 609.730.0196 or FAX your order to 609.730.0197. Contributions: PharmaVoice is not responsible for unsolicited contributions of any type. Unless otherwise agreed in writing, PharmaVoice retains all rights on material published in PharmaVoice for a period of six months after publication and reprint rights after that period expires. E-mail: tgrom@pharmavoice.com. Change of address: Please allow six weeks for a change of address. Send your new address along with your subscription label to PharmaVoice, P.O. Box 292345, Kettering, OH 45429-0345. Call us at 800.607.4410 or FAX your change to 937.890.0221. E-mail: mwalsh@pharmavoice.com. Important notice: The post office will not forward copies of this magazine. PharmaVoice is not responsible for replacing undelivered copies due to lack of or late notification of address change. Advertising in PharmaVoice: To advertise in Pharma­­Voice please contact our Advertising ­Department at P.O.?Box 327, Titusville, NJ 08560, or ­telephone us at 609.730.0196. E-mail: lbanket@pharmavoice.com. Volume 10 • Number 6

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