Medical Professionals

	Pharmaceutical Products		Biopharmaceutical Products and Services

The mission of this division is to manage the development of Accentia portfolio products by leveraging internal companies and personnel as well as external resources. This group will specialize in taking products from the laboratory to the clinic. Capabilities of our Services group span from Technology Assessment thru Phase IV Surveillance, and are organized as follows:

Biologics Manufacturing

We produce custom biologic products for a wide variety of customers, including biopharmaceutical and biotechnology companies, medical schools, universities, hospitals, and research institutions. These capabilities enable us to more effectively identify, screen, and attract new product opportunities and to efficiently develop, clinically test, and market our products.

Technology Assessment

he Technology Assessment group is responsible for the design, planning and matching product licensing opportunities with unmet medical needs and company attributes.

Clinical Research Unit

The Clinical Research Unit is responsible for the design, planning, execution, and analysis of clinical trials, ensuring that proper procedures are followed during the conduct of the trial and the collection of clinical data.

Project Management

Our project management team oversees the process of development of a drug from the earliest stages of research through the conduct of clinical development and regulatory filings.

Medical Affairs

As our products advance in clinical testing, our medical affairs group interfaces with our Clinical Research Unit and investigative sites, and collects and analyzes information on drug experience and safety, and distributes accurate medical information.

Biostatistics and Data Management

The Biostatistics Group will provide state-of-the-art biostatistical support to clinical and basic research projects. Clinical Data Management will use its professional expertise to lead and influence the development of optimal data capture and data management technologies and processes to enable efficient reporting and analysis.

Regulatory Affairs and Quality Assurance

The Regulatory Affairs group manages communications with and submissions to regulatory authorities, while the quality assurance group oversees the testing, manufacturing, and the facilities that support manufacturing and ensures compliance with all regulatory requirements for the manufacturing and development of new products.

Market Services

Capabilities include analytical and consulting services relating to the biopharmaceuticals industry, including pricing and market assessment, reimbursement strategies, clinical trial services, and outcomes research.

We view our two potential blockbuster opportunities as just a beginning in the creation and growth of an enduring company with a novel approach to Biopharmaceutical development and commercialization. This new Division is designed to facilitate that growth.

Our Biopharmaceuticals Products and Services segment develops late-stage innovative biopharmaceutical products with an emphasis on the respiratory and oncology therapeutic areas. The products currently being developed in this segment consist of SinuNase and Biovaxid. This segment also includes our analytical and consulting business, which provides a broad range of services relating to biopharmaceutical product development, and our biologics products business, which is engaged in the production of custom biologic products and cell culture instruments and systems for biopharmaceutical and biotechnology companies, medical schools, universities, hospitals, and research institutions.

Please visit our specific product families for additional information on our portfolio:

• BIOVAXID Immunotherapy for Non-Hodgkin's Lymphoma
• Pre-Market Services
• Drug Commercialization
• Medical Communications

Accentia offers a number of cell line development and cell optimizations contract services. Accentia has been distinguished by the National Institute of Health as the National Cell Culture Center.

Biologic Manufacturing Services

Accentia offers the following biologic manufacturing services:

• Cell-line Development
• Media Assessment
• Cell-line Optimization
• Cell Bank Creation
• Process Development
• Production: GMP and non-GMP
• Purification: GMP and non-GMP
• Aseptic Fill
• Viral Validation
• Stability Studies

Biologic Manufacturing Instruments

Accentia also manufactures a number of cell production instruments that are used in 24 countries worldwide. These instruments provide the technology and flexibility to support optimization studies and pilot-cale prod uction of cell-secreted proteins. Accentia also has the Xcellerator® instrument, which has been designe d for large-scale production of mammalian cell-secreted proteins.

Our cell production instruments include:

• ResCu-Primer HF® - hollow-fiber cell culture system capable of producing small quantities of monoclonal antibody
• miniMAX® - optimization studies and research-scale production of mammalian cell-secreted prot eins.
• MAXIMIZER® - optimization studies and pilot-scale production of mammalian cell-secreted prote ins
• Xcellerator® - large-scale production of mammalian cell-secreted proteins