Pharmaceutical Outsourcing Q2 2024 - 31

ROUNDTABLE
How do regulatory requirements,
such as those outlined in the Pediatric
Research Equity Act (PREA) and
Pediatric Investigational Plans (PIPs),
impact the development timeline
and commercialization strategy for
pediatric formulations?
Shanmugam: Regulatory requirements stipulated by mandates
like PREA and PIPs are important components of drug safety, but
they also introduce complexities and considerations that can
impact the development timeline and commercialization strategy
for pediatric formulations.
Due to the complexity of designing age-appropriate formulations,
these mandates can impact a product's development timeline and
commercialization strategy significantly in several ways. Extended
timelines are required for these more complex regulatory processes.
Careful planning and execution are needed to overcome the
unique challenges of comprehensive pediatric studies, resulting in
additional time needed to complete these studies.
These regulatory requirements are essential for ensuring pediatric
drug safety and their impact underscores the importance of
strategic considerations in pediatric formulation development and
commercialization. Regulations aim to ensure the safety and efficacy
of drugs in pediatric populations, and sponsors must navigate these
challenges strategically to successfully bring pediatric formulations
to market.
Kanji: In the United States, the US FDA's Pediatric Research Equity
Act (PREA) requires mandatory studies of new drugs in pediatric
populations unless a waiver is granted. A Pediatric Study Plan must
be submitted within 60 days of the " End of Phase II " meeting for the
adult product under development.
Similarly, in Europe, the EU Pediatric Regulation also mandates
companies to perform pediatric studies and requires that a PIP
should be submitted no later than upon completion of the Phase I
PK studies in adults. The PIP is a binding document which includes
information about the timings and studies proposed to demonstrate
quality, safety, and efficacy. Following review by the Pediatric
Committee (PDCO), amendments could be requested, which could
impact the timeline for the development of a pediatric dosage form.
LaBella: Regulatory requirements such as PREA and PIPs significantly
impact the development timelines and commercialization strategy
for pediatric formulations within the pharmaceutical industry.
Compliance with PREA mandates the conduct of pediatric studies
for certain drugs, necessitating additional time and resources for
study design, execution, and regulatory submission. Moreover,
adherence to PIPs entails meticulous planning and execution
of pediatric clinical trials according to predefined timelines and
study objectives. Pharmaceutical companies must strategically
incorporate these regulatory requirements into their development
plans from inception to streamline processes and optimize timelines
for pediatric formulation commercialization.
This is just proper science. Children and infants have very different
physiologies than adults. Drugs may not be tolerated as well by
pediatric patients, metabolism and elimination in children is very
different from adults as well.
Looking ahead, what are your
predictions for the future of the pediatric
dosage form market, considering
advancements in technology, evolving
regulatory landscape, and changing
healthcare priorities?
Shanmugam: The future of the pediatric dosage form market is
likely to encompass technological innovation, patient-centricity,
regulatory refinement, and global collaboration. These are the
trends that address current challenges, help optimize therapeutic
outcomes, and are in line with evolving healthcare priorities focused
on improving pediatric healthcare.
I anticipate a shift in the pediatric dosage form market towards
more patient-centric formulations and personalized medication.
Most importantly, child-friendly formulation design will be driven
by children and caregivers.
Regarding technology advancements, I am confident that
innovations such as 3D printing and nanotechnology will
revolutionize pediatric formulations and enable personalized and
precise drug delivery. Integration of digital health and dosing
solutions like smart devices will help enhance medication adherence
and monitoring in pediatric populations.
The regulatory environment for pediatric drug development is likely to
evolve with a focus on refining guidelines and incentivizing research.
I anticipate streamlined approval pathways, especially for rare
pediatric diseases. Also, I predict that strategies will emerge that will
expedite regulatory processes, including international collaboration
and global harmonization of regulations and guidelines.
In terms of healthcare, the future will involve growth in telemedicine
and remote monitoring technologies offering innovative ways to
monitor pediatric patients.
LaBella: This area will continue to grow. Innovations will also continue
in order to make more palatable platforms for children. Mikart has
invested in the area of suspension manufacture in order to continue
to grow with the trend. A new manufacturing suite was constructed
at our facility in Atlanta, Georgia. The suite offers mix tanks from 50 L
to 4000 L and various homogenizers and other capabilities.
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Pharmaceutical Outsourcing Q2 2024

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