BERG LLC

Evotec is a life science company with a unique business model that delivers on its mission to discover and develop highly effective therapeutics and make them available to the patients. The Company’s multimodality platform comprises a unique combination of innovative technologies, data and science for the discovery, development, and production of first-in-class and best-in-class pharmaceutical products. Evotec leverages this “Data-driven R&D Autobahn to Cures” for proprietary projects and within a network of partners including all Top 20 Pharma and over 800 biotechnology companies, academic institutions, as well as other healthcare stakeholders. Evotec has strategic activities in a broad range of currently underserved therapeutic areas, including e.g. neurology, oncology, as well as metabolic and infectious diseases. Within these areas of expertise, Evotec aims to create the world-leading co-owned pipeline for innovative therapeutics and has to-date established a portfolio of more than 200 proprietary and co-owned R&D projects from early discovery to clinical development. Evotec operates globally with more than 3,700 highly qualified people. The Company’s 14 sites offer highly synergistic technologies and services and operate as complementary clusters of excellence.

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

Biorasi is a customer-focused, full-service, contract research organization (CRO) that leverages speed and agility in the execution of clinical trials to maximize speed-to-market for its sponsors – all powered by our proprietary TALOS™ project management system.

Biorasi is a leader in neurology, nephrology, dermatology, oncology, and the emerging digital therapeutics market. It is our mission to be a catalyst for growth, innovation, and evolution in the field of clinical research – moving the industry forward while improving results for our partners and outcomes for their patients. Our culture is based on our strong commitment to building true partnerships with our sponsors. We approach all of our trials with urgency, commitment, and resolve.

Established in 2002, Biorasi is headquartered in Aventura, FL, with office-based teams around the globe. From its regional presences, Biorasi is able to directly support studies in the Americas, Europe, and APAC. We have received multiple accolades including placement in the INC 500 and 5000 list of fastest-growing companies in America, Frost and Sullivan’s Entrepreneurial Company of the Year for the CRO Industry, and the CRO Leadership Award from Life Science Leader magazine.

Camargo Pharmaceutical Services is a leading global strategy, regulatory, and development partner for emerging to mid-size biopharma. We specialize in complex drug development programs where no playbook exists, with integrated solutions spanning from product concept to commercial stages that enable sponsors to reach milestones with speed and capital efficiency.

We have experience in rare and accelerated approval pathways, specialty populations, and innovative science including orphan drugs, the 505(b)(2) pathway, oncology, neurology, pediatrics, combination products, and digital therapeutics. We are proud to support clients in more than 35 countries around the world.

DP Clinical, Inc. is a privately held Contract Research Organization (CRO) specializing in neurology/CNS (including spinal cord injury), oncology, ophthalmology, infectious disease/vaccines, and rare disease Phase I-IV clinical programs. DP Clinical provides a full complement of clinical trial services to pharmaceutical, biotech, and medical device companies including trial management, monitoring, data management, biostatistics, regulatory, safety monitoring and reporting, and medical writing. Since 1994, we have worked for clients of all sizes — small to large pharmaceutical and biotech companies, academic research institutions, and government sponsors.

DP Clinical provides integrated trial solutions as well as specific service components based on sponsor need. Our comprehensive services include:
• Project management
• Clinical trial monitoring
• Data management
• Biostatistics
• Pharmacovigilance and safety
• Regulatory affairs
• Quality assurance
• Medical writing