According to The STM Report (2015), more than 2.5 million peer-reviewed articles are published in scholarly journals each year. PubMed alone contains more than 25 million citations for biomedical journal articles from MEDLINE. The amount and availability of content for clinical researchers has never been greater – but finding the right articles to use is becoming more difficult.
Repurposing marketed drugs or rescuing compounds that failed in clinical trials offers entrepreneurs the potential to replenish pipelines with reduced risk and time.
The cost of new drug discovery has skyrocketed in recent years, and is something that should have everyone in the drug discovery industry concerned. Sergei Varshavsky, M.D., Ph.D., and senior VP of global strategy for contract research firm Synergy Research Group (SynRG), notes it was not always this way. Some of the greatest medicinal discoveries in the history of mankind were inexpensive to develop and test. “There was the discovery of the smallpox vaccine in 1796, ether anesthesia in 1846, and insulin and penicillin in the early 20th century,” he says. “None of them cost much. In fact, the patent for insulin was sold to the University of Toronto for a half-dollar. Despite the low cost, these drugs have saved billions of lives.” Unfortunately today’s medical community is no longer able to accomplish similar feats for such a low cost.
The commercial success of mAb products such as Rituxan, Erbitux, and Herceptin has catapulted mAbs to the forefront of molecular medicine.
While choosing the wrong product is never a good idea, when it comes to clinical trials software, the wrong product could be disastrous for your company.
Sponsors and CROs want to ensure that the processes and workflows they use in their electronic Trial Master Files (eTMF) comply with all regulatory requirements, resulting in a robust system that will produce complete documentation able to withstand an agency audit. To provide a solid basis for decision-making, we’ve researched both the regulatory basis for signatures and the technology implications around how to collect signatures. Since the goal of any eTMF system is to streamline processes and increase compliance, implementing valid signature processes in the least cumbersome manner is always of concern.
Assume a generic drug company, let’s call them AB Generics, Inc., always targets the introduction of its generic drugs when the reference product comes off patent. AB’s executive team has looked ahead and seen the generic cliff — few products coming off patent after 2016 — and is looking for alternative revenue sources.
Electronic patient-reported outcome (ePRO) solutions are transforming the quality of self-reported data collected from subjects in clinical trials worldwide.
StudyWorks is an online portal which provides real-time access to data collected using the LogPad System, SitePad or NetPRO. With standard and custom data summaries and reports, it enables site personnel to manage compliance and enrollment, while helping sponsors stay on top of their global trial at all times.
Taking new products successfully through clinical development, submission and approval can be a difficult, expensive and lengthy process. SynteractHCR’s medical regulatory affairs group offers a wide range of services that spans the full range of product development, including training, performed by senior regulatory professionals with experience in pharmaceutical, diagnostic, device and biotechnology industries. Our medical regulatory affairs team is here to deliver on aggressive timelines and control costs, while ensuring compliance and patient safety.
As an international, full-service clinical contract research organization, SynteractHCR strives to deliver actionable results for your clinical trial needs. Our medical writing group consists of qualified Ph.D., M.D., and other experts, and our European medical writers are all members of the European Medical Writers Association. Our translation team consists of native speakers with many years of experience in translating all documents necessary for the performance of clinical studies. Our medical writers are committed to delivering a well-designed clinical program that will meet your study’s ultimate goals.
At Sentrx, we run the gamut, covering every aspect of pharmacovigilance for all stages of development and all sizes of clients. Whether your circumstances are more heavily influenced by clinical needs or post-marketing surveillance requirements or you are examining drug safety as part of your New Drug Application planning or preparing to implement risk mitigation strategies, Sentrx has the expertise to make your drug safety operations more flexible, cost-effective, and efficient.
Omeros Corporation (NASDAQ: OMER) today announced that its Investigational New Drug Application (IND) to evaluate OMS824 in Huntington's disease has been cleared by the U.S.
Takeda Pharmaceutical Company Limited (Takeda) and H. Lundbeck A/S (Lundbeck) today announced that the companies will be presenting new data from four studies that evaluated effectiveness in treating the overall symptoms of depression in patients taking vortioxetine, an investigational agent under review with the U.S. Food and Drug Administration (FDA) for the treatment of major depressive disorder (MDD). These data will be presented at the 2013 American Psychiatric Association Annual Meeting (APA) in San Francisco.
BioClinica, Inc. a global provider of clinical trial management solutions, recently announced that members of its team will attend, participate in, and speak at several upcoming industry conferences in April, May, and June.
Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced the appointment of Lee F. Allen, M.D., Ph.D., as Chief Medical Officer. Dr. Allen will be responsible for leading the clinical development of Spectrum’s product pipeline, including belinostat, for which the Company anticipates an NDA filing mid-year, apaziquone, and glycol-free formulation of melphalan for both of which the NDA filings are expected in 2014. Dr. Allen brings over 15 years of biotech and pharma experience, as well as over 10 years of extensive research experience with over 40 papers published. He will report to Ken Keller, Executive Vice President and Chief Operating Officer. Spectrum also announced today that Dr. Steve Fruchtman, previously Chief Medical Officer at Spectrum, will take on the new role of Senior Vice President, Hematology and Oncology R&D, as of March 18, 2013. In this newly created position, he will report directly to Dr. Allen.
Anacor Pharmaceuticals today announced positive preliminary results from the second of two Phase 3 trials of tavaborole (known as Study 302). Tavaborole is a topical anti-fungal for the treatment of onychomycosis, a fungal infection of the nail and nail bed that affects approximately 35 million people in the United States.
The Michael J. Fox Foundation (MJFF) is today announcing the launch of four new funding programs focused on driving forward research toward transformative treatments and a cure for Parkinson's disease (PD).
Savant HWP, Inc. today announced the receipt of a three-year grant to support the development of 18-MC (18-methoxycoronaridine) as a potential orally active treatment for drug addiction, obesity and other forms of compulsive behavior.
Peregrine Pharmaceuticals (
Agile Therapeutics presented findings from a phase III pivotal trial of AG200-15, Agile's investigational once-weekly combination contraceptive patch containing ethinyl estradiol (EE) in combination with levonorgestrel (LNG).
Janssen Research & Development, LLC (Janssen) today announced that use of the investigational medicine canagliflozin substantially lowered blood glucose levels when used as add-on therapy in patients on insulin therapy for type 2 diabetes and who are considered to be at greater risk for cardiovascular disease.
ADVENTRX Pharmaceuticals, Inc. (NYSE MKT: ANX) today announced that it has engaged Theradex® Systems, Inc., a contract research organization with 30 years of experience, to manage the Company's upcoming phase 3 study of ANX-188 (purified poloxamer 188) in sickle cell disease.
Researchers have launched a clinical trial to evaluate the drug candidate DEX-M74 as a treatment for a rare degenerative muscle disease, hereditary inclusion body myopathy (HIBM). National Institutes of Health scientists from the National Center for Advancing Translational Sciences (NCATS) and the National Human Genome Research Institute (NHGRI) will conduct the clinical trial at the NIH Clinical Center.
Agile Therapeutics announced today that Dr. Marie Foegh, Chief Medical Officer and Vice President of Clinical Research and Development, will be presenting at CBI's Forum on Phase II-III Clinical Study Optimization. The event takes place September 20-21, 2012 in Chicago.
Merck, known as MSD outside the United States and Canada, recently announced new data for suvorexant, the investigational medicine Merck is developing for the treatment of insomnia. The new data are from one of the longest, continuously-dosed, placebo-controlled trials of a sleep medication ever conducted.
