Our Expertise and Services
R&D Strategy
Our Synergy Partners team will work with you to determine the optimal path to clinical proof of concept for your molecule, then provide scientific and strategic guidance to design and execute the appropriate experiments to reach critical decision points along the way. We will work with your scientists to design studies to optimize compound selection with a focus on selecting the right molecule to invest in for development, including potency, specificity and activity in well-designed preclinical efficacy and safety studies to inform a robust clinical proof of concept strategy. Our experience will also help guide the development of optimal partnering strategies for your program.
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Therapeutic Expertise
Our network of partners has experience and extensive connections in all major therapeutic areas to complement the scientific expertise of your team. We have an expanded network of preclinical and clinical experts available to provide both strategic and technical expertise on the discovery and development work needed to support an optimal development path in a particular disease area. We will apply our therapeutic expertise and drug discovery and development experience to help your team design experiments to discover the right compound and design the optimal preclinical and clinical development path for your drug.
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Biology and Pharmacology
Our Biology team has expertise in biochemical, cell-based and in vitro and in vivo pharmacological approaches to probe and define the mechanism of action and to characterize any potential off-target effects of your molecule. Working with the latest technologies and connecting you with collaborators across the globe, our scientists will help focus the work on critical-path molecular characterization and pharmacology studies to integrate your preclinical discoveries into a robust and successful development program.
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Chemistry
Our Medicinal Chemistry team has world-class expertise in the design and optimization of small molecule drugs, including structure-based drug design and all aspects of medicinal and synthetic organic chemistry. Our chemists will collaborate with your team as you optimize your molecule for efficacy, safety and bioavailability while protecting and expanding your IP. We are experienced in working with external CROs to support both the discovery and development phases of compound synthesis and optimization.
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Drug Safety
Our experts in Drug Safety will work with your team to test the safety of your molecule using a streamlined approach with studies that are appropriate for each stage of development. Starting in Discovery, we will design and oversee the execution of the appropriate toxicology and safety pharmacology studies to characterize the safety profile of your compound both in vitro and in small and large animals, in a way that is both efficient and cost-effective We are experienced in interacting with regulatory agencies and in designing and executing drug safety studies for both small molecules and biologics.
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Pharmacokinetics and Drug Metabolism
We have strong expertise in pharmacokinetics for both small molecules and biologics as well as in all aspects of drug metabolism, from discovery stage through FIH-enabling studies and beyond. We understand that the collaboration between DMPK and the biology and chemistry teams is a critical success factor for your discovery program. We will work with your team to design and execute appropriate studies to optimize the metabolic and pharmacokinetic-pharmacodynamic profile of your compound in vitro and in vivo in both rodents and large animals. Our clinical DMPK team will integrate that knowledge to ensure optimal translation of the preclinical characterization into a successful early clinical development program.
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Chemistry, Manufacturing & Controls
We have strong CMC expertise for both small molecules and biologics. Starting in late discovery, our network of experts will work with your team to optimize and characterize your molecule and position your program for a seamless transition to development. Working with a network of trusted CRO partners, we provide process development, formulation and bioanalytical support, developing processes and assays appropriate to each stage of development. For later stage projects, our expertise in quality, compliance and regulatory CMC is brought to bear to support successful regulatory filings.
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Clinical Research & Development
We have broad clinical therapeutic expertise to support the design and execution of your clinical development program, both within our Synergy team and through our expanded network of external collaborators. Our clinical development experts will work with your preclinical and clinical scientists to design the optimal clinical development plan for your program, with a focus on moving quickly and efficiently to Proof of Concept. Then our clinical operations professionals will work with your team and your CRO to optimize protocol design and to support the program through to final data review.
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Regulatory Affairs
Our Regulatory network has both strategic and technical expertise to support your overall development program. We have a long history of successful collaborations with international regulatory agencies and will work with your team to develop the strategy and define the appropriate regulatory path to move your molecule forward. Our regulatory experts will support your team through FDA meetings and other regulatory interactions while also providing technical support to assist in the preparation and filing of IND and NDA documents.
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Project Management
We provide robust Project Management support for programs at all stages, from discovery through development. Our project management group will provide support for the development and tracking of a streamlined and cost-effective preclinical research operating plan to select the optimal drug candidate, for preparation and delivery of a successful IND and clinical development program, as well as providing strategic analysis and technical support for fundraising and partnership activities.
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Synergy Partners also has long-standing collaborations with selected, trusted Partner Organizations to provide additional expertise in areas of drug development that are outside of our core expertise.
There are multiple ways to bring Synergy Partners expertise to your team. We look forward to finding the approach that best meets your program needs and budget. Click on the box below to learn more: