Pediatric Drug Development Center of Excellence

Your trusted partner for customized, comprehensive pediatric product development consulting services


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



  • Diseases in children are often different than those in adults. Medicines that work one way in adults may not work the same way in children, therefore it is important that medicines intended for children are studied in children.
  • Children aren’t small adults. Children respond differently to medicines than adults and typically require unique dosage and formulation considerations.
  • Children have difficulty swallowing capsules and tablets. Unfortunately, when given liquid medications as an alternative, children often reject these due to their bitter taste.
  • 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 (financial incentive) 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. Designing a pediatric program that meets the expectations of both agencies can be challenging.
  • Not paying attention to pediatric (paediatric) regulations can negatively impact the progress of drug development programs for adult indications.


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

Although NGT is neither a laboratory or manufacturing services provider, we can serve as your single point of contact to our network of reputable CRO’s and CDMO’s.


Experience Matters.

NGT BioPharma Consultants’ multi-disciplinary team of Pediatric Drug Development consultants are seasoned pharmaceutical experts whose combined experiences encompass the full range of pediatric (paediatric) drug development technical, regulatory, and quality disciplines. Our shared goal is to leverage our team’s broad and deep global pediatrics and drug development knowledge to help your team increase your probability of success for advancing safe and efficacious therapies designed for children.


Making the Right Decisions at the Right Time is Critical for Success.

Pediatric (paediatric) drug development programs are complex and often difficult to navigate – especially with the US and European regulatory agencies requiring similar, but different things, and the requirements continuing to evolve.  Not fully understanding, or paying attention, to what may be required can be costly to your program in both time and money.  NGT BioPharma Consultants’ multi-disciplinary, experienced, team of Pediatric drug development consultants comprehensively understand, and can help your team navigate, the global drug development and regulatory landscapes so you can confidently make the right decisions at the right time.


Your Needs. Our Focus. 

We don’t believe drug development consulting services should be “1 size fits all”.  Some pediatric (paediatric) drug development programs need flexibility for different strategic approaches.  NGT BioPharma Consultants’ comprehensive consulting services are flexible, customizable based on your needs, and designed to help with strategic & tactical support in seamless collaboration with client project teams. Whether you need an individual subject matter expert, or a cross-functional team, our consultants provide the expertise and resources you need, when you need them.

Daniel Schaufelberger, PhD
Daniel is head of the newly created Pediatric Center of Excellence at NGT BioPharma Consultants. He is a pharmaceutical executive with over 30 years of experience in pharmaceutical development and he has 10+ years expertise in developing pediatric products. Daniel retired from Janssen R&D LLC (Johnson & Johnson) in 2019 as Sr. Scientific Director, CMC Leader, where he co-chaired the J&J internal pediatric formulation network.
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Steven A. Silber, MD
Steven joined NGT Biopharma Consultants after his retirement from Janssen Research and Development (a JNJ company) and he is an expert on our Pediatric Center of Excellence team. From 2007 until his retirement in 2018, Steven led Janssen Research and Development (a JNJ company) as VP and Head of Established Products. In addition to other drug development projects, Steven led the program to obtain Pediatric Exclusivity for AcipHex (a proton pump inhibitor). This 10-year program involved multiple trials, some conducted in NICUs, and was ultimately successful.
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Carsten Timpe, PhD
Carsten joined NGT Biopharma Consultants after his retirement from Roche at the end of 2022 and he is an expert on our Pediatric Center of Excellence team.  His research interests include pediatric and geriatric drug development, drug delivery of poorly soluble drugs and early phase drug development topics. Carsten most recently led the pediatric formulation working group at Roche from 2014 until he retired from Roche.
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Fran Muller, PhD
Fran is a member of the NGT BioPharma Consultants team and is an expert on our Pediatric Center of Excellence team. He has over 30 years of experience in the pharmaceutical industry, including 21 years at GlaxoSmithKline and 5 years at Incyte Corporation where he led pharmaceutical development teams that successfully commercialized four products and progressed a wide variety of early and mid-stage new chemical entities into clinical studies.
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