discovery & development

Technology Transformation

Now, more than ever, companies are transferring products and processes from one site to another, often facing limitations on time, resources, and regulatory expectations. Transfers can be complicated, and many companies don’t have a technology transfer plan, standard operating procedures (SOPs) or guidelines in place to effectively conduct the transfer.

Our cross-functional team of consultants have proven success in managing product and process transfers for clients around the world.

Manageable Milestones for Successful Technology Transfers

Research Platforms

ProPharma understands that you have an important job in getting your product to the clinic and eventually to patients. Your technology should enable you to do this more quickly and efficiently. Let our team of experts develop and deliver tailored roadmaps to help you hit your milestones.

Key Platforms

There is a range of Research systems that can store your data and provide analytics to help you make data-driven decisions about the outcomes of your study. These systems support the life cycle of your product and are comprised of an array of technologies including:

• Electronic Lab Notebooks (ELNs)
• Research Data/Laboratory Data Management Systems (LIMS)
• Document Management Systems
• Imaging Platforms
• Data Warehouse and Analytics
• Data Visualization and Reporting
• Bioinformatics & Data Science platforms
• Machine Learning/Artificial Intelligence Platforms (ML/AI)

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Target & Lead Selection

Propharma’s team of leading regulatory experts utilize a science-first approach to understanding your product, combined with first-hand insights of regulatory expectations to augment target-to-disease relation. Expert review of the literature, in vitro, ex vivo, in silico, and early non-Good Laboratory Practice (GLP) exploratory in vivo assessments will enable the selection of drug candidates with an acceptable safety profile and provide the opportunity to reduce attrition and increase the success of drug development.

Expert Discovery/Exploratory Toxicology Assistance

ProPharma’s experts understand regulators’ interest in biomarker and mechanistic data and the ability of these data to define organs’ and cells’ sensitivity to therapeutic agents. We can assist with the design, evaluation, and optimization of investigative toxicity and exploratory/discovery studies for candidate therapeutics early in the drug discovery process. In addition to a Sponsor’s own data, we utilize publicly available information to identify potentially supportive data.

ProPharma can help establish the relevance of in vitro and animal data to humans in support of the initiation of clinical testing. Our expertise in typical early discovery assessments includes, but is not limited to:

Scientific Advisory and Regulatory

ProPharma provides high-value advisory services through its worldwide base of top-tier expert consultants, who support the full product development life cycle, from initial concept to marketing authorization. Advisory services include product development and regulatory strategy, development program planning and management, and expert scientific and technical advice.

ProPharma’s team of experts can act as the Regulatory Representative for the FDA and international regulatory bodies on behalf of a client and can take on leadership roles such as membership on Scientific Advisory Boards or working on a part-time basis as an interim executive (e.g., Chief Medical Officer, Head of CMC, and Head of Regulatory Affairs).

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