Catalyst for Innovation and Leadership
The Center for Translational Medicine is a catalyst for innovation and leadership in the pharmaceutical sciences. We empower future leaders through our dynamic educational initiatives, preparing them to solve real-world drug development issues and navigate complex regulatory landscapes with scientific excellence. Our focus on personalized medicine ensures that we are at the cutting edge of delivering tailored therapies to patients. Additionally, we are committed to fostering entrepreneurial ventures, providing the support and resources needed to transform innovative ideas into successful businesses. Through these efforts, we drive significant advancements in healthcare and contribute to the growth of a robust biotech industry.
Impactful Science
Can We Extrapolate Efficacy of POS Drugs from Adults to Pediatric Patients?
Decisions: We evaluated whether the efficacy of drugs for partial onset seizures (POS) in adults can be extrapolated to pediatric patients aged 1 month and older, potentially eliminating the need for separate pediatric trials.
Information: We analyzed clinical data from trials involving eight drugs, comparing exposure-response relationships and clinical outcomes between adults and pediatric patients.
Analysis: The study found that the pathophysiology and treatment response of POS are similar in adults and pediatric patients. This supported the FDA's conclusion that efficacy data from adults can be extrapolated to pediatric patients, reducing the need for additional pediatric efficacy trials.
Can We Assess Similarity in Antipsychotic Exposure-Response Relationships Between Adults and Adolescents?
Decisions: We explored whether the exposure-response relationships for second-generation antipsychotics in adults with schizophrenia can be applied to adolescents with acute exacerbation of schizophrenia.
Information: We analyzed clinical efficacy data from 16 adult and 4 adolescent trials, focusing on the longitudinal changes in Positive and Negative Syndrome Scale (PANSS) scores. Our analysis aimed to determine the comparability of pharmacokinetic and pharmacodynamic responses.
Analysis: The developed disease-drug trial models predicted similar exposure-response relationships between adults and adolescents for all four antipsychotics studied. This supports the potential for extrapolating adult efficacy data to adolescent patients, facilitating more efficient drug development and approval processes for treating schizophrenia in younger populations.
Should Vancomycin Dosing Regimens for Non-Pregnant Patients Be Applied to Pregnant Women?
Decisions: We assessed whether the pharmacokinetics (PK) of vancomycin in pregnant women justify using the same dosing regimens as those for non-pregnant patients.
Information: We analyzed plasma drug concentration data from 34 pregnant women receiving intravenous vancomycin. A population pharmacokinetic (PPK) model was developed to characterize the PK of vancomycin in this population.
Analysis: The study found that vancomycin PK in pregnant women, described by a two-compartment model, is consistent with non-pregnant adults. The geometric mean AUC0-24 values were similar between pregnant and non-pregnant populations suggesting that existing dosing regimens for non-pregnant patients may be applicable to pregnant women.
Corporations
PumasAI
PumasAI was founded by Dr. Joga Gobburu and Dr. Vijay Ivaturi, along with a team of scientists at the University of Maryland in partnership with scientific computing experts. We help pharmaceutical scientists, healthcare providers, biotechnology and pharmaceutical companies as well as regulatory agencies Deliver Better Treatments to Patients Faster.
Vivpro
Vivpro Corporation was founded by Dr Joga Gobburu and Dr Pravin Jadhav. VivproAI offers a revolutionary biointelligence software platform and innovative services to make evidence-based clinical, regulatory, and business decisions at lightning speed for pharmaceutical, biotech, device developers, CROs, and investors.