Pediatric Center Of Excellence
Your trusted partner for customized, comprehensive pediatric product development consulting services
Business development strategies
Program development strategies
Due diligence technical assessments
Due diligence project management
Corporate transactions
Alliance Management
A Shared Vision
Developing safe and efficacious drugs with age-appropriate formulations is not only a mandate by European and US Regulatory Authorities, but also the right thing to do for our youngest patients. The NGT BioPharma Consultants team is passionate about leveraging our combined expertise to help companies, research institutes, and global organizations achieve success with their Pediatric (Paediatric) focused drug development programs.
“New knowledge and new medicines can offer hope that children today will recover from illnesses and grow into healthy adults.” PhARMA Fact Sheet
- Medicines that work one way in adults may not work the same way in children.
- Children aren’t small adults and typically require unique dosage and formulation considerations.
- In the US, the Pediatric Research Equity Act (PREA) requires companies to assess safety and efficacy of new products in pediatric patients.
- The pediatric exclusivity provision of the BPCA (Best Pharmaceuticals for Children Act) allows companies to qualify for an additional six months of marketing exclusivity if they do the studies in children as requested by the FDA.
- The European Medicines Agency (EMA) mandated requirements and resulting incentives are similar but can result in different pediatric studies with respect to scope and timing.
- Not paying attention to pediatric (paediatric) regulations can negatively impact the progress of drug development programs for adult indications.
Business development strategies
Program development strategies
Due diligence technical assessments
Due diligence project management
Corporate transactions
Alliance Management
Services
NGT BioPharma Consultants’ Pediatric Center of Excellence was developed to provide global clients access to a wide range of cross-functional expertise and the opportunity to work with seasoned pharmaceutical experts who have successfully developed and brought multiple pediatric products to market. Our service offerings span all the essential, interdependent pediatric drug development functions, including but not limited to:
- Pediatric compound strategy (e.g., pediatric target product profile)
- Preclinical gap assessment (e.g., need for additional juvenile tox studies)
- Regulatory strategy, including Pediatric Study Plans (US) and Paediatric Investigational Plans (EU)
- CMC strategy (e.g., selection of age-appropriate dosage forms and formulation development; administration and dosing devices; taste masking and acceptability)
- Clinical strategy (e.g., indications, type and order of studies, defining age-groups)
- Clinical Pharmacology strategy (e.g., for dose selection, modeling and extrapolations)
- Business solutions (e.g., organizational design for pediatric programs, outsourcing strategies, partnering with global CROs and CDMOs)
DIGITAL SERVICES EXPERTISE
Cloud based systems, highly connected labs (IOT), standardized and unified data models, product and process digital twins, and the use of artificial intelligence and machine learning offer significant opportunities to transform and accelerate R&D and manufacturing workflows. However, many functions are struggling to navigate these opportunities and move beyond lab digitization and automation.
The Digital Services is a key service area within NGT BioPharma Consultants that focuses on helping clients increase their digital capability.
OUR SERVICES INCLUDE:
- STAFF AUGMENTATION
- Enhancing internal digital intervention team capabilities through contracted subject matter experts who provide specific skill sets such as computer systems validation experts, business analysts, product managers, and Agile Scrum masters.
- SOFTWARE DEVELOPMENT AND MARKETING CONSULTANCY
- Bespoke advisory services to interpret industry challenges and translate into requirements and IT products or platform functionality.
- Marketing support to position digital products with the right decision-makers.
- DIGITAL STRATEGY CONSULTANCY
- Benchmarking current digital capabilities against industry best in-class and highlighting gaps and opportunities.
- Reviewing and critiquing existing digital strategies.
- Facilitating the creation of a digital strategy.
- Work-flow reinvention and disruption to exploit digital capabilities.
Talk to NGT BioPharma Consultants to learn how we can deliver a customized solution to address your project needs.
DIGITAL SERVICES EXPERTISE
Cloud based systems, highly connected labs (IOT), standardized and unified data models, product and process digital twins, and the use of artificial intelligence and machine learning offer significant opportunities to transform and accelerate R&D and manufacturing workflows. However, many functions are struggling to navigate these opportunities and move beyond lab digitization and automation.
The Digital Services is a key service area within NGT BioPharma Consultants that focuses on helping clients increase their digital capability.
OUR SERVICES INCLUDE:
- STAFF AUGMENTATION
- Enhancing internal digital intervention team capabilities through contracted subject matter experts who provide specific skill sets such as computer systems validation experts, business analysts, product managers, and Agile Scrum masters.
- SOFTWARE DEVELOPMENT AND MARKETING CONSULTANCY
- Bespoke advisory services to interpret industry challenges and translate into requirements and IT products or platform functionality.
- Marketing support to position digital products with the right decision-makers.
- DIGITAL STRATEGY CONSULTANCY
- Benchmarking current digital capabilities against industry best in-class and highlighting gaps and opportunities.
- Reviewing and critiquing existing digital strategies.
- Facilitating the creation of a digital strategy.
- Work-flow reinvention and disruption to exploit digital capabilities.
Talk to NGT BioPharma Consultants to learn how we can deliver a customized solution to address your project needs.
Working with Big Pharma Globally
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Get in touch
For additional information pertaining to our Pediatric Drug Development Center of Excellence, please contact Daniel Schaufelberger or our CEO, Michael O’Brien via the contact information provided below.
MEET A FEW OF OUR EXPERTS
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