Apricus Biosciences, Inc.

Fountain Medical Development is a clinical contract research organization (CRO) offering a full range of ICH GCP compliant clinical research services in China, US, Japan, and Europe. FMD has extensive global experience in multiple therapeutic areas. The company has completed dozens of registrations trials which supported marketing authorization applications in US and Europe.

Our people is the basis of our success. The 1,700+ professionals are dedicated and diverse. At any given moment, at least 3 languages are spoken in our 20 offices in Asia, US, and Europe.

FMD is on the forefront of the paradigm shift in global clinical development. The regulatory reform in China has the potential to fundamentally change how an innovative therapy is developed. FMD is on the frontline building and shaping the future.

FMD is large enough to serve 7 out the 10 largest Pharma companies, and nimble enough to customize to the needs of startup firms.

In the US and Europe, FMD is doing business as FMD K&L. In China, we operate under the name FMD. Whatever the names are, the company is managed globally by a seasoned senior management team comprised of industry veterans.

Together we build a bright future.

Athena Diagnostics is a clinical diagnostics service testing laboratory focused on neurology, endocrinology and nephrology. As a leader in genetic testing and personalized medicine, Athena's mission is to improve the lives of patients by providing the best possible diagnostic services to their physicians. Started as Genica Pharmaceuticals in 1988, Athena Diagnostics has undergone several changes of control: acquired by Athena Neuroscience in 1995, acquired by Elan Pharmaceuticals in 1996, acquired by Behrman Capital in 2002, acquired in 2006 by Fisher Scientific, which became Thermo Fisher, and acquired by Quest Diagnostics in 2011. Athena has over 300 diagnostic tests, 300 employees and 2010 revenues of $110 million.

Quanterix is a company that is digitizing biomarker analysis with the goal of advancing the science of precision health. The company’s ultra-sensitive detection solution, Simoa, has the potential to change the way in which healthcare is provided today by giving researchers the ability to closely examine the role of biomarkers in the continuum of health to disease. Quanterix’ technology is designed to enable much earlier disease detection, better prognosis and precise treatment methods to improve the quality of life and longevity of the population for generations to come. The technology is currently being used for research applications in several therapeutic areas, including oncology, neurology, cardiology, inflammation and infectious disease. The company was established in 2007 and is located in Billerica, Massachusetts.

Founded in 2002, CELPROGEN is a biotechnology company, with over 5000 products in the market, focused on developing stem cell research and therapeutics products for regenerative medicine in cardiology, oncology, diabetes & neurology. All of Celprogen’s biological products, including stem cells, cancer stem cells, iPC’s & media with specific ECM’s, are manufactured and produced in the United States of America.

CELPROGEN provides novel molecular diagnostics and therapeutic product development solutions for Biotechnology, Pharmaceutical, In-vitro diagnostics and academic partnership for drug discovery.

It has 3 divisions:

• Therapeutic Division: Focused on Drug Discovery efforts to develop Pharmaceutical agents and Drugs in the following categories: Cardiovascular, Diabetes, Neurological, Oncology,Renal and Metabolic disorders.
• Life Science Division: Provides research tools & solutions for assays, enzymes, antibodies, antigens, stem cells, Tissue culture expansion and differentiation media, primary and established cell cultures, tumor markers, cardiac markers, proteomic and genomic reagents and assay systems for life science academic and pharmaceutical communities.
• Device Division: Provides novel ELISA based assay, protein array, DNA array and cellular based assay systems that are cost effective for Research and In-vitro diagnostics Industries.

Drug Discovery Alliances is a provider of chemistry and formulation services bringing together scientific expertise and support during all stages of the R&D continuum for emerging biotechs, existing multinationals and the United States government. We provide a global service where our partners – located in N. America, China, Japan, Czech Republic, England, Germany and Italy – cover four key services:

Consulting
• CMC Project Management
• GMP Auditing
• Licensing
• Sourcing & Procurement

Drug Discovery
• Medicinal Chemistry

R&D/Pre-Clinical
• Analytical Method Development
• Catalysis Screening
• Crystallization
• Metabolites, Impurities ID & Synthesis
• Process Research
• Reference Standards
• Solid Form Capabilities

Manufacturing (Phase I-III)
• Advanced Intermediate Manufacturing
• API & Commercial Manufacturing
• cGMP Manufacturing
• Final Drug Product Manufacturing
• Formulation Development
• Quality and Regulatory Support
• Raw Material Manufacturing

Chemistry Technology Platforms
Aseptic Fill & Finish
• Chlorination
• Chromatography
• Cryogenic
• Distillation
• Fermentation
• Heck Reactions
• HPAPI / High Potency
• High Pressure
• High Temperature
• High Throughput / High Resolution X-ray Diffraction
• Hydrogenation
• Lyophilization
• Nitration
• Pastillation
• Phosgenation
• Polymorph Screening
• Powder Filling
• X-ray Crystallography

Project Examples
• 4 year program for development of Regulatory Starting Material supporting NDA filing for a neurology product
• Urgent API consulting for Clinical Phase III with supplier change and identified savings of $10M
• CMC project consulting on pre-IND candidates ($760M) for a CNS product licensed by Astellas
• Generic new formulation consulting supporting Clinical Phase III for 505(b)(2) for hypertension product
• Commercial API manufacture for ophthalmology product sourcing key suppliers leading to successful FDA approval
• Phase III API for antibody conjugate for oncology identifying key supplier