Research & Development: Page 71
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PharmaVoice Team/PharmaVoice
Table of Contents
10 Molecule to Market The drug development process from lead generation to patent expiration is complex, fraught with risk, and extremely time and cost intensive. 16 Drug Discovery Pharmaceutical companies are using state-of-the-art technologies to understand the basis of disease as a way to brin...
By PharmaVoice Team • April 5, 2010 -
PharmaVoice Team/PharmaVoice
Contents
4 Ap r i l 201 0 Pharm aVOICE 34 James Sapirstein: Steering a Winning Course Managing a biotech company through the myriad obstacles companies face is difficult at the best of times; today it is much more taxing. James Sapirstein is proving that he has what it takes to put Tobira Therapeutics on ...
By PharmaVoice Team • March 23, 2010 -
Explore the Trendline➔
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TrendlineArtificial intelligence & machine learning
After years of excited buzz around the potential of artificial intelligence and machine learning, pharma has begun to realize the true implications and potential value of these technologies.
By PharmaVoice staff -
PharmaVoice Team/PharmaVoice
SHOWCASE FEATURE: IRBs
In accordance with federal regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. This review serves an important role in the protection of the rights and welfare of human research subjects. According to the Consortium of Independe...
By PharmaVoice Team • March 23, 2010 -
PharmaVoice Team/PharmaVoice
Brand Management: Using Market Research To Master Multichannel Challenges
It’s a noisy, cluttered, and competitive market out there, with consumers receiving more messages from more channels — so how can a brand stand out? Everyone knows the right-right–right rule (right message at the right time to the right target), but in today’s environment, every moment represents...
By PharmaVoice Team • March 23, 2010 -
PharmaVoice Team/PharmaVoice
Specialty CROs: Market Opportunities
The need for efficient drug development, as well as advances in technology and medical research, have spurred the growth of the smaller, more focused contract research organizations. These smaller CROs may offer preclinical and early-stage clinical research services such as toxicology, process de...
By PharmaVoice Team • March 23, 2010 -
PharmaVoice Team/PharmaVoice
Last Word
The Acquisition by Medco What does DNA Direct bring to Medco? PHELAN. Medco’s healthcare clients, whether they are large self-insured employers or health plans, are all looking for better patient outcomes and quality of service, as well as reduced costs. DNA Direct helps with the interpretation o...
By PharmaVoice Team • March 23, 2010 -
PharmaVoice Team/PharmaVoice
Talent Pool
Pharmaceutical POOL Dr. Jay FEINGOLD DSI Strengthens Expertise in Oncology Daiichi Sankyo Inc. (DSI) has appointed Jay Feingold, M.D., Ph.D., to manage the strategic direction of its medical affairs department as VP of medical affairs. DSI is the U.S. subsidiary of Tokyo-based Daiichi Sankyo Co.,...
By PharmaVoice Team • March 22, 2010 -
PharmaVoice Team/PharmaVoice
What's New
New Healthcare-related Products, Services, and Companies Featured Briefs: CMR Institute Broadens Curriculum to Offer Targeted Educational Solutions MedTera Specializes in Integrated Healthcare Marketing Mayo Clinic Collaborates with Centerphase to Provide Clinical-Trial Services Velocity Offers ...
By PharmaVoice Team • March 22, 2010 -
PharmaVoice Team/PharmaVoice
E-Media
New Electronic and Web-based Applications, Sites, and Technologies Featured Briefs: Intrasphere Solution Keeps Pace with Clinical Trial Disclosure Requirements New Tool Measures Sales Team’s Grasp of Managed Markets Concepts PPD Unveils Centralized Biostatistics Technology Infrastructure Model...
By PharmaVoice Team • March 22, 2010 -
PharmaVoice Team/PharmaVoice
PharmaTrax
More Consumers Going Online for Pharma Info The number of people using the Internet to obtain information on prescription drugs has tripled over the past five years, and more than 100 million consumers, or 44% of U.S. adults, are now what Manhattan Research terms “ePharma Consumers." According t...
By PharmaVoice Team • March 22, 2010 -
PharmaVoice Team/PharmaVoice
UpFront
Honors and Awards Kendle, Quintiles Named to Training Top 125 Kendle and Quintiles have been named to Training magazine’s Training Top 125, an annual list of the 125 companies that are unsurpassed in harnessing human capital. The Training Top 125 rankings are based on a wide array of benchmarkin...
By PharmaVoice Team • March 22, 2010 -
PharmaVoice Team/PharmaVoice
Letter from the Editor
Ahhh sweet spring… There are a few among us who are no doubt wishing for one more super snow storm (a couple I know very well), but for most of us in the Northeast who have been buried under feet of snow for most of the winter, we couldn’t be more excited to see the first signs of spring, well…sp...
By PharmaVoice Team • March 22, 2010 -
PharmaVoice Team/PharmaVoice
Molecule to Market: A Drug-Development Timeline
According to the most recent report from the Tufts Center for the Study of Drug Development, it takes about 10 years on average for an experimental drug to travel from the lab to U.S. patients. Only five in 5,000 compounds that enter preclinical testing make it to human testing, and of these five...
By Taren Grom • March 5, 2010 -
PharmaVoice Team/PharmaVoice
Experts
John C. Andrews, Ph.D. Director of Regulatory Affairs, Americas, Chiltern, a global CRO. For more information, visit chiltern.com. Jerome Bailey. VP, Early Phase Business Center, Omnicare Clinical Research, a full-service CRO with diverse therapeutic expertise and comprehensive clinical service o...
By PharmaVoice Team • March 4, 2010 -
PharmaVoice Team/PharmaVoice
Phase IV: Technology Solutions
According to John Hall, global medical affairs, epidemiology and outcomes research, at Quintiles, electronic health record providers are at the leading edge of new solutions, and are providing more effective ways to collect data while protecting physician relationships. The industry faces several...
By Robin Robinson • March 4, 2010 -
PharmaVoice Team/PharmaVoice
Phase III: Market Preparation
How the brand begins to be positioned across the spectrum of medical communications — specifically how the science behind the brand and trial results begin to be discussed at global and local congresses, from interactive and traditional exhibit stands to symposia, from posters to special social e...
By Robin Robinson • March 4, 2010 -
PharmaVoice Team/PharmaVoice
Phase III Trials: Patient Recruitment and Data Collection
Two of the biggest bottlenecks in the drug development process, particularly at the Phase III juncture, are patient recruitment and data management. Experts say technology, partnering, and strategic planning can improve Phase III clinical trial efficiency. Phase III: Recruitment Technologies Acc...
By Robin Robinson • March 4, 2010 -
PharmaVoice Team/PharmaVoice
Phase II: Testing Efficacy, Planning for Marketing
Pharmaceutical companies and their partners are working to address productivity and create efficiency in Phase II development. New types of trial designs, such as adaptive trials, are being considered as solutions to these perennial issues. “There are innovative ways in which biopharmaceutical co...
By Denise Myshko • March 4, 2010 -
PharmaVoice Team/PharmaVoice
Phase I: Patient Recruitment
According to Peter Smith, Ph.D., senior VP, nonclinical development sciences at Millennium Pharmaceuticals: The Takeda Oncology Company, shortages in funding, manpower, and patient availability have created the proverbial perfect storm in the current clinical trial system. “The fact that traditio...
By Denise Myshko • March 4, 2010 -
PharmaVoice Team/PharmaVoice
Phase I: From Animals to First-in-Human Studies
The simple study designs of the past have been replaced with more complex designs with the addition of more screening and study procedures, biomarkers, and pharmacokinetic samples requirements, as well as longer study exposure periods. The trend today is conducting more rigorous, early-phase clin...
By Denise Myshko • March 4, 2010 -
PharmaVoice Team/PharmaVoice
CROs and Preclinical Development
To create efficiency and offload the need to maintain staff, instruments, and consumables for irregularly scheduled projects and projects that extend beyond their scope, more labs are engaging CROs as outsourcing partners, according to a recent report by BioInformatics LLC. Thomas Jones, Ph.D., s...
By Denise Myshko • March 4, 2010 -
PharmaVoice Team/PharmaVoice
Preclinical Development: Linking the Lab to Human Trials
The challenge of pharmaceutical discovery and development as a whole is that a large number of conditions need to be met in order for a single molecular entity to successfully reach the market, says Thomas Jones, Ph.D., senior director, toxicology and pathology, Eli Lilly and Company. “The molecu...
By Denise Myshko • March 4, 2010 -
PharmaVoice Team/PharmaVoice
Drug Discovery: From Compound to Product Candidate
The first step in finding a drug to bring to the clinic is screening chemical compound databases against a protein target. There are several phases that comprise early development, including target identification and validation, hit finding, and lead optimization. Activities during these steps, w...
By Denise Myshko • March 4, 2010 -
PharmaVoice Team/PharmaVoice
A Long and Winding Road
In today’s biopharma economy, declining R&D productivity combined with increased development costs have made investment portfolio managers skittish, says Chip Gillooly, VP, capital, at Quintiles. “The risks associated with investments are high, and the lack of output is making everyone nervou...
By Taren Grom • March 4, 2010 -
PharmaVoice Team/PharmaVoice
Last Word
Pfizer’s Mark Swindell discusses the integration of Wyeth’s vaccine business after the acquisition by Pfizer. As President of Vaccines, Mr. Swindell is helping to create a seamless process for melding the former Wyeth specialty business with Pfizer. One of the stated goals for the combined Pfize...
By PharmaVoice Team • March 4, 2010
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