Rules-Based Medicine Rules-Based Medicine (RBM) is a CLIA-certified biomarker testing laboratory specializing in cost-effective, high-quality multiplexing services. Our protein immunoassays benefit drug discovery & development from...
Beckloff Associates Founded in 1976, Beckloff Associates, Inc. assists companies with worldwide development of pharmaceutical, biotechnology, and medical device products through regulatory and product development planning, regulatory...
Drug Development Consulting Support
Since 1976, Beckloff Associates has been a full-service pharmaceutical research and development consulting firm that specializes in helping pharmaceutical,...
Formedix Formedix delivers CDISC software and consultancy services. Our Origin suite features the first study design tools built entirely around the CDISC standards. Formedix consultancy practice offers planning, preparation and...
The Jackson Laboratory We help researchers discover treatments, preventions and cures for human disease through the provision of inbred, mutant and genetically engineered mouse models, research services, and comprehensive technical information...
Brighter Ideas, Inc. Brighter Ideas, Inc. is a biotechnology company offering premium quality proteins & purified antibodies, protein purification kits & unique high throughput screening assays, and hands-on biotech training courses &...
PHARMADIRECTIONS A drug development consulting and management company built on superlative scientific expertise and deep industry experience.
It can manage your drug development project from discovery to commercialization, bridge...
ALZA Corporation ALZA Corporation, headquartered in Mountain View, California, is a leading developer and manufacturer of drug delivery based products for the global healthcare industry. ALZA's has the world's broadest array of drug...
Schizophrenia’s early detection possible if promise of immunoassay fulfilled.
"If you treat [schizophrenics] early on in the disease, you improve the outcome," explained Sabine Bahn, Cambridge University professor and co-founder of Psynova Neurotech Limited. In other words, early treatment can significantly slow the progression of the disorder. A recent discovery has shown that biomarkers in the blood are much better indicators of this debilitating psychiatric disorder, and the race to develop a diagnostic immunoassay is ongoing.
Non-drug early interventions have not been productive, reported drug development consultants Ian R.H. Falloon et al in "Early Detection and Intervention for Initial Episodes of Schizophrenia," from the Schizophrenia Bulletin. The promise of immunoassay holds out hope for better treatments for the disorder, while offering significant opportunities for the pharmaceutical company that develops this technology.
Best-in-Class Drug Development Consulting Providers:
Have record of scientific achievements including awards and honors, publications, patents, or presentations at industry conventions.
Well connected to leading research organizations.
Received positive reviews from customers.
Top Considerations Before Selecting Drug Development Consulting Provider:
Think long term about your needs. If you have narrowed down your search to a specific set of potential biomarkers, firms with experience in that area are appropriate choices, but if you haven’t, go with an organization that has a broader experience base. If you plan on marketing your drug internationally, the consultant you engage should be familiar with regulatory policies around the world.
Key Producers:
1. Rules-Based Medicine, Inc. (RBM)’s CustomMAP service involves the use of a larger more comprehensive MAP to cast a wide net in the search for novel biomarker patterns and then a smaller more focused MAP of just the biomarker assays of interest. Founded in 1998, RBM has corporate headquarters and CLIA-certified biomarker testing laboratory in Austin, TX; multiplex assay development and manufacturing in Lake Placid, NY and a wholly owned subsidiary EDI GmbH in Reutlingen, Germany. Through EDI GmbH, RBM provides Human Organo-Typic (HOT) cell culture systems which serve as a platform for ex vivo drug safety and efficacy studies. By combining EDI’s cell culture systems with its HumanMAP® biomarker testing services, RBM is able to offer customers a preview of the physiological and biochemical impact of a new drug before the initiation of the clinical trial stage.
2. Beckloff Associates is a subsidiary of Cardinal Health Inc., a global healthcare company serving hospitals, pharmacies and suppliers. Founded in 1976, Beckloff is a full-service pharmaceutical research and development consulting firm that offers regulatory strategies for obtaining approval to market new drugs in countries around the world, as well as post-approval regulatory support to pharmaceutical, biotechnology and medical device companies. Its "goal is to help you increase the financial return on your research investment by offering a comprehensive consulting platform." Its parent company, Cardinal Health, and the Cardinal Health Foundation have contributed cash and products worth more than $150 million to non-profit organizations in the United States and abroad since 2001.
3. Brighter Ideas, Inc. (Bii), founded in 2003, is a biotechnology organization whose specialty is expanding existing fluorescent protein technology. This technology can be used to discover where different proteins are produced by connecting a gene that codes fluorescence with various gene switches or with genes from other proteins. Bii offers unique high throughput screening assays, protein purification kits, purified antibodies and hands-on biotech training courses. It is marketing a new assay for proteases and protease inhibitors that has applications in research, drug discovery, diagnosis and clinical testing of Alzheimer’s disease, HIV/AIDS and many forms of cancer. Bii has exclusive licensing to this technology which is tentatively called “GFP-on-a-String(GoaS).”
4. The Jackson Laboratoryprovides genetically engineered mice, research services and comprehensive technical information to organizations around the world working on the development of new drugs and preventative measurements for the treatment of a wide range of diseases. The Jackson Laboratory’s services include testing numerous medicinal entities, including small molecules, antibodies, siRNAs and ES cell-derived therapies, as well as customizable compound evaluation, phenotyping and pathology services . Its extensive experience with experimental genetics enhances the services it offers pre-clinical trial researchers. The Jackson Laboratory also offers academic programs to teachers and students. The state of Florida recently approved funds to build a third Jackson Laboratory research facility. The original laboratory is in Maine and a second one was built in California in 2001.
Drug Development Consulting Definition: Drug development consultants advise researchers during all the processes involved in creating a new drug, including drug discovery and development, and pre-clinical and clinical trials.
Although a three-year
clinical trial called the Diabetes Prevention Program (DPP) comparing current care,
metformin, and lifestyle modification was just being completed, the ADA wanted to compare
the expected effects of the different strategies on long-term health and economic outcomes,
as well as answer several other questions beyond the scope of the DPP trial. The only feasible
way to get ...
The Archimedes Model is a clinically realistic simulation model of human physiology, diseases, behaviors, interventions, and healthcare systems. Because of the Model’s complexity and the importance of the questions it can help answer, we conduct a rigorous suite of re-validations on an ongoing basis. This paper describes how these validations are done.
Analytical Bio-Chemistry Laboratories is a GLP- and CGMP-compliant contract research laboratory that supports pharmaceutical and chemical product develop- ment. Because we are a service provider, ensuring data quality and on-time delivery are critical to customer satisfaction.
This presentation outlines a Quality Improvement Program (QIP) established by the GLP operations and GLP Quality ...
The U.S. Orphan Drug Act was signed into law in 1983 and for the first time, provided incentives for the pharmaceutical industry to develop drugs that otherwise had minimal commercial return on investment, but which are necessary, and often life-saving, for patients with rare diseases. The Orphan Drug Act is codified in 21 CFR Part 316.
There are approximately 6000 rare disorders affecting ...
A crucial element in the development of topical and transdermal drug products is evaluation of the percutaneous absorption of the active pharmaceutical ingredient (API). Generally, the goal for topical products is to maximize cutaneous delivery of the API, whereas for transdermal products the goal is to achieve a specific rate of absorption sufficient to achieve a systemic blood level within the ...
Selection of a pre-clinical drug candidate for advancement to clinical trials is a critical
decision. Large clinical trials often require years of observation and cost millions of dollars.
When a clinical trial runs over schedule, drug developers can lose over $600,000 a day in
sales for smaller niche products and over $8,000,000 a day for blockbuster drugs. Adding to
this problem, the ...
In 2002 some physicians at Kaiser Permanente came up with an idea: What if KP members
with diabetes or CAD were systematically given a bundle of drugs consisting of aspirin,
lovastatin (a cholesterol drug) and lisinopril (a blood pressure drug) – called “A-L-L”? Their
clinical intuition told them that it should have an important effect on complications, but there
was no direct evidence of ...
A large pharmaceutical company was in the process of designing a Phase III clinical trial for
a diabetic agent. In the trial design phase, they needed to develop a strategy to maximize
the probability that the population they enrolled would experience enough MACEs to ensure
that the company had appropriately powered the trial.
The Preventive Health Partnership, a collaboration between the ACS, AHA, and ADA, wanted to identify which individual single or combined health care prevention activities, when implemented throughout adulthood, will lead to improvements in health, quality of life, and medical costs for patients who enter Medicare during the years spanning 2009-2033.
Recent randomized, controlled studies have shown that diabetes can be prevented or delayed in high-risk individuals by intensive lifestyle modification programs, or glucose-lowering drugs. These findings generate obvious questions: What are the long-term effects of trying to prevent diabetes in high-risk people? Does lifestyle modification truly prevent or just postpone diabetes? Is such a ...
Have you ever wanted to run trials for 10 years, 20 years or 60 years? Or run huge trials with hundreds of thousands or even millions of people?
Math is ...
Company descriptions and contact
information are quoted
from the company's website or other promotional information. JAZ'D is not responsible for
the accuracy
of this information. Unless specifically noted, JAZ'D is not sponsored by, affiliated with
or otherwise
connected with any of the listed companies.
