Pharmaceutical Drug Development

New partnerships in drug development spur trust as well as cost efficiency.

With the rise of biotech firms, the establishment of new compounds in the early drug development pipeline, and outsourcing to Pharmaceutical Drug Development services have become commonplace. Yet, these firms are emerging as trusted partners in regulatory matters internationally, experts in specific diagnostic trials, and proficient in streamlining early phase trials. And, with typical drug development from discovery to market ringing at just short of $1 billion USD and 12 years, drug development services become an attractive option to offset the costs of time and resources.

Best in Class Pharmaceutical Drug Development feature:

• Full-scale simulations for physiological and economical modeling
• The ability to take over development projects mid-phase and integrate data and results
• Regulatory expertise to ensure compliance at all levels of bureaucratic and governmental oversight

Top Considerations Before Outsourcing Pharmaceutical Drug Development:

Many vendors espouse the virtues of outsourcing drug development to free up cash and resources to allocate to more core competencies for drug company clients, such as manufacturing. If this is your reason for buying, it is crucial to ensure a financial plan that sees the redeployment of internal resources to those critical areas. A modeling of the outsourced plan and budget should include a boost in productivity in a corresponding business unit due to the resources reallocation. 

Key Vendors to Consider

1. Based in Miami, Cetero’s Central Laboratory anchors their Clinical Pharmacology unit. The Clinical Laboratory is licensed in areas including Hematology, Chemistry, Coagulation, Urinalysis, Special Chemistry, Serology, and Viral Markers. Focusing heavily in allergy and asthma research, Cetero is the only professional CRO that has developed and fully validated models in the Environmental Exposure Chambers (EEC) for cGCP compliant studies. The EEC Model is a validated, rapid and FDA-accepted clinical solution for the development of small molecule drugs, immunotherapies and therapeutic devices.

2. With their Clinical Trial Simulation, Archimedes, Inc. aims to save clients valuable cash assets by modeling outcomes prior to full phase execution. Archimedes enables clients to conduct realistic clinical trial simulations to distinguish their drug’s clinical and economic benefits from standard treatments and competitor drugs. Additionally, the firm focuses on comparative effectiveness of one drug to an emerging solution, and helps clients more accurately answer questions regarding costs and target markets through healthcare modeling.

3. Specializing in antibodies, Covance prides itself on delivering solutions to client’s clinical challenges with unique solution sets, including biopharmaceutical services, clinical and nonclinical services, strategic partnering and other strategies for development. The company asserts that it generates more drug development data for the regulatory evaluation of efficacy than any other firm in the world. As so, Convance maintains a long history of successful collaborative relationships to drive down R&D costs. 

4. Symyx Isentris for SharePoint is a collection of Microsoft SharePoint Web parts that improves project team data collaboration in analysis and gives scientists access to real-time project information. Additionally, Symyx provides a host of software solutions that aid in database access, decision support, lab execution and analysis, cheminformatics and others. Symyx is dedicated to supporting their product offerings through a variety of portals for quick problem resolution. The firm will also consult on software implementation and correct solution choosing.

5. Therapure Biopharma’s Drug Development focuses on the development of therapeutic proteins – representing one-third of all new drug developments. The firm provides end-to-end trial services, process and test development, as well as final release testing, filling, packaging and shipping services. Therapure has compiled an extensive listing of proprietary products based on hemoglobin—most designed to treat infectious disease, anemia, and cancer. Protein modifica-tion technology allows clients to boost efficacy and half-life.

Pharmaceutical Drug Development
Definition: Pharmaceutical Drug Development offers "outsourced" research support to the pharmaceutical and biotechnology industries. These “outsourced” firms provide clients with research services to aid in the drug and medical device research and development process, including product development, formulation and manufacturing; clinical trial management (preclinical through phase IV); clinical, medical and safety monitoring; preclinical, toxicology, and clinical laboratory services for processing trial samples; data management, biostatistics and biomedical writing services, especially in preparation for an FDA New Drug Application or NDA. See also Clinical Research Organizations or CROs.