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
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.
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
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.
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)
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
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
ProPharma’s worldwide team is comprised of highly knowledgeable experts with extensive experience preparing and submitting applications, including:
- Investigational New Drug (IND) applications
- Abbreviated New Drug Applications (ANDAs)
- New Drug Applications (NDAs)
- Biologics License Applications (BLAs)
- Premarket Approval (PMAs)
- 510(k) (Premarket Notification) and de novo submissions
- Special designations
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).
News & Insights
November 27, 2023
Key Steps to Creating a Successful Market Access Strategy
Understanding Health Technology Assessment (HTA) authorities’ requirements throughout the product development phase is crucial for a successful market access strategy and planning. This will increase...
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The Hidden Costs of Project Communication Gaps
Ineffective communication may be a key factor contributing to the challenges in your projects. Communication is a vital aspect of our daily lives, and the success of a project is closely linked to...
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Meet the Expert: Brian Wellins
Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and...
News & Insights
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EY Announces Michael Stomberg as an Entrepreneur Of the Year® 2023 National Finalist
Entrepreneur Of The Year® celebrates ambitious entrepreneurs who are building a better world. RALEIGH, NC, November 27, 2023 – Ernst & Young LLP (EY US) today announced that Chief Executive Officer,...
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ProPharma Launches an Integrated MedTech Organization Providing End-to-End Solutions for Innovators
Raleigh, NC, November 16, 2023: ProPharma Group, the world’s largest Research Consulting Organization (RCO) and the leading global provider of regulatory, clinical and quality compliance services for...
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ProPharma Group Recognized by Everest Group as a Major Contender in Life Sciences Operations PEAK Matrix® Assessment 2023
Raleigh, NC, October 11, 2023: ProPharma Group (ProPharma), the leading global provider of regulatory, clinical and compliance services for the life sciences industry, and a portfolio company of...
