Historically, predicting the future sales of compounds in clinical development is difficult to do.
Dr. Moscicki currently serves as senior vice president (SVP), Head of Clinical Development at Genzyme Corporation.
Biopharmaceutical companies have been building such comparative effectiveness studies in their clinical development programs for the past decade.
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Pfizer had hired Juan Walterspiel, a pediatric infectious disease specialist at Yale Medical School, in 1994 for Trovan's pediatric clinical development.
For example, you periodically put out press releases about PhRMA member pipelines and the impressive number of compounds in clinical development.
The drug, developed through Cancer Research UK's Clinical Development Partnerships (CDP), starves cancer cells of the sugars they need to grow and develop.
Ann Baker of Accenture, a consultancy, says that most firms are nowhere near their goal of tripling the output of molecules for clinical development.
"It's basically a microexplosion, " says Ioana Rizoiu, the head of research and clinical development at Biolase Technology, the San Clemente, Calif. company that created the Waterlase.
If outside investigators want additional information, "we would have to discuss it internally, " says Howard Mayer, head of global clinical development and regulatory affairs at Shire.
"This kind of label is pretty unique for drugs in type II diabetes, " says John Amatruda, the head of clinical development for diabetes and obesity at Merck.
The first application, currently in clinical development, is to treat interstitial cystitis (IC), a painful bladder disease in women that forces them to urinate every 10 minutes.
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It is these attributes that allow the company to function as a small market cap company but still do the clinical development traditionally limited to the domain of big pharma.
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Given the intrinsically high likelihood of failure, long-term survival requires the ability to advance a portfolio of products through clinical development, something that typically only fairly large companies can afford to do.
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Apart from its anti-cancer drugs Fusilev and Zevalin, Spectrum has 10 other oncology drug candidates that are now in clinical development, two of them in phase 3 clinical trials and several undergoing phase 1 and 2 clinical studies.
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"Key strategies for clinical trials should be outlined in formal clinical-development plans, publicly vetted, and submitted to regulatory agencies, " they said.
His point was that the NIH and the Food and Drug Administration are increasingly able to handle preclinical and early clinical drug development, and that with these first steps taken medicines are more likely to be brought to market by large pharmaceutical companies.
This includes investigational clinical products whose development programs are discontinued.
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Bresee said he is not equating this new H3N2 flu with the 2009 flu, but a new H3N2 vaccine is in the early stages of development and clinical trials are expected later this year.
Nonetheless, Berry says that most companies are "making solid progress" in development and clinical trials and that Big Pharma, with pipelines running dry and blockbuster drugs coming off-patent, needs biotech partners more than ever.
"Additional improvements include the development of an enhanced clinical service over the telephone to avoid taking patients unnecessarily to hospital and the development of a range of alternative care pathways to support patients receiving care at home or within the community, " the spokesperson said.
But then the drug increased the death rate in clinical trials, and its development was ended.
These are facilities that can potentially do the clinical trials and some of the development at a much lower cost.
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This meant building a team of anywhere from ten to fifty people to deal with all the complexities of the process: chemistry, biology, regulatory affairs, clinical medicine, finance, business development, patent strategy, etc.
But Paul Herrling, head of corporate research at Novartis, says such investments could go far, as the firm does not expect to do the costly bits of drug development, such as clinical trials, itself.
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Cell Therapeutics said it intends to use net proceeds from the offering for general corporate purposes, including paying interest on or retiring outstanding debt and funding research and development, preclinical and clinical trials, and the preparation and filing of new drug applications.
Medicines that will soon go off patent or didn't finish clinical trials could also be options for development.
The other third is your development costs which are essentially clinical trial costs.
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In 2002 the Institute of Medicine (which is not part of the NIH, but is the health arm of the National Academy of Sciences) called for the creation of a National Vaccine Authority that would have sweeping responsibilities, including market research, the establishment of priorities, control of intellectual-property rights, the conduct of in-house research and development and the financing of clinical trials of candidate vaccines.
When BMS was getting ready to start late stage clinical trials, they decided to seek a development and co-marketing partner.
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