discovery & development

Drug discovery specialists for all phases of your product lifecycle.

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Accelerate Drug Development

Delivering new drugs and therapies to market is a complex process which includes both discovery (target identification and validation, hit identification, lead generation & optimization, identification of a viable candidate for future & further development) and development (optimization of chemical synthesis and formulation, toxicological studies, clinical trials, and regulatory approval) stages. ProPharma’s expertise spans across the following Discovery and Development competencies:

  • Technology Transformation
  • Research Platforms
  • Target Identification
  • Lead Validation
  • Scientific Advisory and Regulatory
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Discovery & Development Services

ProPharma’s Discovery and Development experienced consulting services help you avoid potential obstacles, navigate the drug development process and expedite your efforts to ensure the best possible outcome for your assets.

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

Milestones for Technology Transfer

 

ProPharma’s proprietary Gated Technology Transfer disciplines are customizable to meet your specific production and technology demands.

Our approach provides a robust process framework to consistently transfer technologies from development to production, or from site to site in a compliant and efficient manner.

We collaborate with you to finalize the milestones (or gates) so that your organization understands the approach and can effectively make decisions throughout the process. We have successfully completed more than 175 product transfers using our Gated Technology Transfer approach. Clients credit this successful methodology in helping them navigate the complexities of the technology transfer process while realizing efficiencies along the way. 

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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:

  • In vitro and in vivo models for the mechanism of action and efficacy assessments
  • CEREP/Kinase panels to flag off-target activities of compounds
  • Cell culture, tissue slice, 3D tissues models, and Organs on a Chip
  • In vitro human ether-a-go-go-related gene (hERG) and cardiovascular studies
  • In vivo cardiovascular, pulmonary, central nervous system (CNS), gastrointestinal, and renal assessments
  • In vitro metabolism and drug interaction studies
  • In vivo pharmacokinetic (PK) studies (various species and routes of administration)
  • Quantitative structure-activity relationship (QSAR) assessments for genotoxic potential
  • In vitro and in vivo genotoxicity tests

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Toxicology

 

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.

 

Expert Advisory Services

 

Expert Advisory Services

ProPharma’s worldwide team is comprised of highly knowledgeable experts with extensive experience preparing and submitting applications, including:

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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Complex Needs Require Custom Solutions

ProPharma builds solutions at the intersection of innovation and flexibility. We’re here to offer a custom alternative that fits your unique needs. Standout solutions scaled to your size.

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The Inc. 5000 list recognizes ProPharma as one of the fastest-growing companies in America, achieving the highest ranking in ProPharma's 20+ year history.

Previous Award Arrow Next Award Arrow
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Decentralization of cell and gene therapeutics improve patient outcomes by reducing time to treatment, increase viability and reduce overall costs.

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Meet Kirsty Bryant! She is a MI Program Manager at ProPharma within the Medical Information team.

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Discover what to expect during the NDA review process, from acceptance for filing to information requests and label negotiation.

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Project Management isn’t for the faint of heart. There is a shockingly high rate of project failure… but on the other hand, great project management can be a key differentiator that leads a company...

Infographic Successfully Passing MHRA Inspections for Overseas Manufacturing Sites - ProPharma

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Successfully Passing MHRA Inspections for Overseas Manufacturing Sites

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