A Targeted Approach to Medicine and Dosing—A Necessity for Sustainable Healthcare

Maria Saluta

President Obama, during his 2015 State of the Union Address, launched the Precision Medicine Initiative “to enable a new era of medicine through research, technology, and policies that empower patients, researchers, and providers to work together toward development of individualized care.” The message given to the American people reinforced the critical need to implement precision medicine into […]

Read More
Topics: PBPK Modeling & Simulation

Pharmacology to Payer

Focus on Patient Centricity In traditional drug development, limited engagement—or engagement too late in the development program—between sponsors, regulators, and payers can result in unacceptable delays of patient access to life-saving medicines. While alternative approaches such as Adaptive Licensing, which includes staggered approval, managed entry, and progressive authorization have expedited the process, it addresses only […]

Read More
Topics:

Drug Development and Clinical Pharmacology Strategy

Changing the Game in Drug Development through a Strategic and Programmatic Approach Far too many cases treat drug development like a relay race, with the baton handed from one participant to the next. But, this approach risks missing opportunities to develop medicines faster and better. And lacking a holistic and strategic roadmap to achieve milestones […]

Read More
Topics:

Quantitative Systems Pharmacology

Quantitative Systems Pharmacology (QSP): Integrating Quantitative Drug Data with Knowledge of Its Mechanism of Action One of the biggest challenges—and, hence, the biggest opportunity for QSP—is drug attrition in Phase 2 clinical trials. Investigational medicines are usually tested for the first time in patients in Phase 2 clinical trials. This is the point when many […]

Read More
Topics:

Orphan Drug Development

Orphan Drugs: Unique Challenges Require Unique Development Approaches Developing drugs for rare diseases poses a range of clinical, regulatory and commercial challenges. The small number of patient populations are difficult to identify and recruit for clinical trials. Many orphan diseases are genetic. Often these patients have complex phenotypes that react very differently to proposed treatment […]

Read More
Topics:

Pediatric Drug Development

Understanding Drug Effects in Children Pediatric drug development continues to be a vexing challenge, yet pediatric research is increasingly being mandated by regulators and patients alike. Traditional development methods can be problematic for ethical and logistical reasons. Children are a heterogeneous population, especially neonates and infants, as organ maturation affects drug exposure and response. Leveraging […]

Read More
Topics:

Benefits of Modeling and Simulation

The Benefits of Modeling and Simulation in Drug Development Biosimulation, also known as ‘modeling and simulation,’ or ‘model-based drug development,’ has already had a profound impact on drug development, yet its full impact is just now coming to light.  Modeling and simulation (M&S) has the proven ability to influence every phase of the drug development […]

Read More
Topics:

About Our Solutions

Cutting Edge Modeling and Simulation Solutions for Drug Development Drug development has become more complex and multi-layered.  New combination therapies require more precise and individualized analyses, new approaches such as “basket studies” evaluate potential disease targets through a new lens, safety issues are more challenging, and comparative effectiveness plays an increasingly important role in “go/no […]

Read More
Topics:

The Ultimate Guide to the Biosimulation Revolution

Ellen Leinfuss

In my work with biopharmaceutical companies, universities, and regulatory agencies, I fly a lot. Looking out the airplane window, the revolutionary impact of biosimulation on drug development struck me. Unfamiliar with the concept of biosimulation, or modeling and simulation (M&S)? You can think of it as the vast improvements in air travel that have been […]

Read More
Topics: PBPK Modeling & Simulation, PK/PD Modeling & Simulation

The Future is Now: How 3D Printing Could Deliver Personalized Medicine

Adam Calderon

“It will take a few minutes to upload the instructions for your prescription to the 3D printer. We will call you once your medication is ready to be picked up.”  While it seems like science fiction, your pharmacist may describe filling your prescription using this emerging technology sooner than you might think. In this blog […]

Read More
Topics: PK/PD Modeling & Simulation
Learn More LinkedIn Twitter Facebook Email Subscribe to the Blog