Strategic Global Drug Development Services

Our team of experts collectively has more than 200 years of experience and special expertise in global drug and biologic development, from discovery and proof-of-concept to worldwide approval and life cycle management. This puts us in a unique position to efficiently assist with global drug development strategies and execution. We have global expertise in small and large molecule development as well as biologics development (antibodies, recombinant proteins, therapeutic cancer vaccines, immunotherapy, gene therapies and combination products) in solid tumors and hematologic malignancies, anti-infectives, retinal diseases and asthma in multiple countries and with regulatory agencies worldwide. We are ready and able to assist small and large pharmaceutical and/or biologics companies with all, or a portion, of your global drug development needs.

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Full Suite of Preclinical Services

Strategia Pharmaceuticals has developed a full suite of discovery and GLP preclinical capabilities that reduce the need for large infrastructure. We tailor our approach to the unique needs of a particular program, and recruit partners with expertise specific to a particular therapy. By streamlining the R&D process, we deliver products in a timely, efficient and cost-effective manner. Our pharmacology, pharmacokinetic and pharmacodynamics experts have more than 200 years’ experience in developing new therapeutics for small and large molecules, immunotherapeutics and diagnostic agents. All are well-versed in medicinal chemistry, bioanalytics, data analysis, interpretation, and regulated study report preparation.

Strategia Pharmaceuticals capabilities include:

Pharmacology

• Small and macro molecule identification and quantification
• Analysis in buffers or complex biomatrices
• In vitro and in vivo drug metabolite identification and quantification
• Drug-protein interaction assessment
• Drug concentration analysis in cell culture material, cells and tissues
• Drug biodistribution in tumor and tissues
• Pharmacokinetic/pharmacodynamic analyses and data modeling
• Stability studies in biomatrices

Pharmaceutics

• Solubility screening
• Dosage form development
• Purity/stability testing
• Labeling/product specifications
• Small scale-up
• CMC

In Vivo Preclinical Testing

• Proof-of-concept studies
• Dose-finding
• Small and large animal toxicology
• Pharmacokinetic/pharmacodynamic studies

Regulatory Services

• Consultation
• Target product profile creation
• Regulatory Agency meetings (worldwide)
• Special Protocol Assessment (SPA)
• Fast-track designation
• Orphan Drug Designation (ODD)
• IND preparation, review, and submission (worldwide)
• NDA/BLA/MAA preparation and submission

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Manufacturing Services

Strategia Pharmaceuticals reviews and selects optimal manufacturing capabilities for each therapy under consideration, choosing among small molecule, large molecule, biologic (antibody, recombinant protein, gene therapy), or combination product cGMP manufacturers.

Capabilities include:

• Medicinal chemistry and custom synthesis
• Process chemistry
• Salt screening and polymorph
• Physico-chemical analysis
• Analytical and bioanalytical chemistry
• Drug product development – oral and aseptic
• cGMP and non-GMP manufacture for small and large molecules and biologics

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Quality Assurance/Quality Control

At Strategia Pharmaceuticals, quality is a core component of our development strategy. We coordinate all quality assurance (QA) activities and assess each specific project to ensure the required resources and expertise are efficiently applied.  Our procedures are unique in that they require cross-functional communication and management attention to our quality responsibilities.  For each project, we prepare a comprehensive quality plan that coordinates a suite of quality services including auditing, document reviews, training, and corrective action (CAPA) plans.

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Clinical Development Strategy and Execution Services

Strategia Pharmaceuticals facilitates drug development by integrating preclinical, translational and clinical expertise and resources. By working with our global partners under collaborative agreements, we bridge the gap between industry and academia, lower development costs, and shorten the timeframe needed to create effective drugs for patients. Our specific alliance with the prestigious M.D. Anderson Cancer Center gives us unique capabilities to optimize and mobilize oncology translational studies through clinical development, conduct efficient and high quality clinical trials, and obtain robust proof of concept data that helps establish rapid global approval. We also work with other academic and community practice institutions to serve your drug development needs.

Capabilities include:

• Design and execution of translational studies needed to fully optimize clinical development plans (e.g., resistant tumors, targeted tumors, genetic and/or other testing designed to optimize patient enrollment into clinical trials)
• Design and execution of Phase 1, Phase 2 and Phase 3 clinical studies for registration, and clinical studies for life cycle management (Phase 3b, Phase 4)
• Design of pivotal, registrational development plans, studies and management of time lines for accelerated and/or full global regulatory approval
• Clinical site and KOL identification, selection and management
• Full suite of clinical services through in-house capabilities and selected GCP partners

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Global Business Development Services

Strategia Pharmaceuticals has a full suite of consulting services for global business development, including:

• Competitive Intelligence
• Benchmarking and Pipeline/Indication prioritization
• Licensing opportunities from identification to alliance management support

Strategia Pharmaceuticals can execute on your Global BD needs by building on these elements:

• Senior level access to business development and R&D contacts in global pharma and biotech developed by our in-house expertise
• A ‘go-getter’, hands-on approach to search and evaluation
• A network of experts to judge opportunities and frame them in present and future clinical/commercial paradigms
• Experience-based framework for deal valuation
• Experience in alliance management

Strategia Pharmaceuticals also is available for risk-sharing opportunities based on flexible terms, including a buy-back option once a therapy reaches proof-of-concept or other development milestones.

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Program Management

Strategia Pharmaceuticals has experience developing, managing and optimizing global drug development programs from late discovery to translational research to first-in-man proof-of-concept studies  through market approval and life cycle management. Our deep expertise in developing drugs and biologics to markets worldwide puts Strategia in a unique position to serve your needs.

Our global network of resources and deep experience in drug/biologic development ensures your goals are met efficiently, with an optimal budget and timeline. Our program management can serve as the strategic lead for your project during all stages of development; or we can play a supporting role to your internal project management team, providing consultation, guidance, and execution on time and within budget. In this management role, Strategia Pharmaceuticals can act as single point of contact to determine your research and development strategy, execute the strategy,  contract with CROs and CMOs, coordinate both operational and reporting activities, and keep your team dynamically updated on the progress of the project.

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