Drug Development Consulting

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 Laboratory provides 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.