1. Edmund Capparelli - Research Interests
Pediatric Clinical Pharmacology
Pharmacometrics – Population Pharmacokinetic Pharmacodynamic and Disease Modeling
Emphasis Areas–
Pediatric Infectious Diseases
Antivirals
Antibacterials
Neonatal Therapeutics
Anti-convulsants

2. Core Expertise – Pediatric Pharmacology Laboratory
Lab currently located in Hillcrest (CTF-B112)
Quantitative assays using HPLC / LCMS / GCMS methodology
Emphasis on anti-infectives / CNS active agents
Various matrices – Plasma, DBS, CSF, urine, hair, protein binding
CLIA for real time / FDA submissions
NIH Collaborative Programs
Center for Research in Pediatric and Developmental Pharmacology Network (RPDP) - U54 (NICHD)
International Maternal Pediatric and Adolescent AIDS Clinical Trials Network (IMPAACT) – Pediatric Pharmacology Laboratory (NIAID)
Pediatric Trials Network (PTN) – Pharmacometrics Core (NICHD)
UCSD HIV Neurobehavioral Research Center (HNRC – S Letendre, R Ellis)
CFAR – TB genotype-phenotype PK/PD simulations (T Rodwell)
Auranofin Phase I – PK / Safety (S Reed)
SSPPS-Pfizer Clinical Pharmacology-Oncology Fellowship Training

3. UC San Diego - E Capparelli / V Nizet
Center Research in Pediatric and Developmental Pharmacology (NICHD U54)
UC San Diego - E Capparelli / V Nizet
Other Centers
Projects
Colistimethate Dose Optimization in Infants and Children – J Bradley / J Le
Drug-Drug Interactions between Pharmaceutical and Endogenous Antibiotics – G Sakoulas
Developmental Aspects of Aminopenicillin Clearance – S Nigam
Pilots –
Cathelicidin
Ampicillin
Renal Development
Furosemide
National Children’s Hospital: J van den Anker / E Hoffman
Duchene’s Dystrophy – Antisense therapy
New York U (Downstate): J Aranda
Retinopathy of prematurity – Caffeine / NSAIDS /. VEG inhibitors
Indiana: D Flockhart / Jamie Renbarger
Emphasis: Oncology – VCR neurotoxicity, biomarkers

4. Core Expertise – IMPAACT Pediatric Pharmacology Laboratory
Overview
UCSD Lab Focus Areas
NIH supported Peds Pcgy Lab since 1992
Other IMPAACT Pcgy Labs – UAB, Colorado, Cape Town
PPL Investigators
E Capparelli – PI
B. Best – Pcgst
S Rossi – Lab Manager
R Espina – Lab Tech
N Ilog – Lab Tech
HIV Treatment Committee
Lab / CPQA Committees
PK/PD of ARVs in pregnancy
P316, P353, P358, P1039, P1026s, P1077, P1081
PK/PD of ARV in infancy
P239, P331, DACS096, DACS606, DACS609, DACS610, P1030, P1070 (EFV), P1106 (preemies), P1111 (RPV), P1112 (VCR01), P1115 (LPV/NVP)
PK/PD Modeling and Simulation for Pediatric Dosing Guidelines (WHO, DNDi)
3TC , ABC, LPV, NVP, ZDV, EFV
CNS Complications
P1080 (B Best Chair)

5. Pediatric Trials Network (PTN)
Organizational Structure
Projects
Supported by NICHD under BPCA
Leadership Committee – Multi Center
Key Investigators / Cores
PI: Danny Benjamin PI (Duke)
Safety and Ethics: R McKinney / K Wade (CHOP)
Pharmacometrics: (PK/PD/DZ) – E Capparelli (UCSD)
Clinical Pharmacology: G Kearns (KC Mercy)
Devices: A Muelenaer / M O’Shea
Mentorship: J Van Den Anker (DC Nat Childrens’)
POPS (A Tremoulet / J Le)
Ampicillin
Methadone
Metronidazole
Fluconazole PPX in infants
Acyclovir (I and II)
Anti-staph trio
Clindamycin
Antibiotic safety (SCAMP)
Midazolam for SE
Lorazepam for SE
TAPE
Lisinopril PK
Drugs in Obesity

6. UCSD Pediatric Pharmacology Lab – Miscellaneous Collaborative Activities
Praziquantel for Schistosomiasis During Pregnancy (PI J Freidman - Brown University / Tacloban Philippines)
Congenital Transmission of T Cruzi - NFX and BZ in Newborn Infants (P Buekens – Tulane Univ)
Levetiracetam in Cerebral Malaria (G. Birbeck - U Rochester / Blantyre Malawi)
Option B+ for Prevention of Mother to Child HIV Transmission (MG Fowler & P Musoke – J Hopkins U / Kampala Uganda)
IL-6 Blockade in Treated HIV Infection (AIDS 347) (B Rodriguez - Case Western Reserve U)
Early Treatment of HIV in Infants (R. Shapiro - Harvard / Botswana)
VCR01 anti-HIV monoclonal antibodies VRC601, VRC602 (B Graham –VRC/NIAID)
Benigno Rodriguez

7. Edmund Capparelli – Proposed Collaborations with SSPPS Faculty
Current SSPPS Collaborators
V Nizet, B Best, J Le, J Momper
Areas for New SSPPS Collaborators
PK/PD Modeling – Pediatric Drug Development
Oncology (I Saunders, J Ma)
Training SSPPS-Pfizer fellows
PREDICT Study (R Kuzrock)
Phase I Clinic
Development of quantitative assays
Peds Oncology –
dual PI-3K /BET bromodomain inhibitor
Pediatric PI-3K (SF-1126) neuroblastoma study
Seizures associated with neurotoxins – NICHD – pediatric- bioterrorism initiatives, P Taylor, J Momper
Renal Development – Nephrotoxicity (L Awdishu)

8. Brookie Best - Research Interests
Primary interest is pharmacokinetic (PK) and dosing studies in pregnant and breastfeeding women
HIV experience, starting in TB, postpartum contraceptives, Breast Milk Biorepository
Others:
pediatric PK (Kawasaki disease, GI, psych meds, etc.), any HIV PK, HIV CNS PK, pharmacy education, training grants
Brookie Best – Proposed Collaborations
Current/Past SSPPS Collaborators
Capparelli, Atayee, Ma, Morello, Singh, Hirsch, Taylor, Adler, Daniels, Brandl (new), Awdishu, Anderson
New Areas:
Breast Milk Biorepository, Short-term Training Grants, PK of various drugs in pregnant women or in children

9. Jennifer Le - Research Interests
Primary interest in pediatric infectious diseases
Pharmacokinetic/pharmacodynamic (PK-PD) studies
Antibacterial agents
Antifungal agents
Antimicrobial resistance studies
Methicillin-resistant S. aureus
Extended-spectrum beta-lactamase
Patient outcome studies
Safety and effectiveness of antimicrobial agents
Other interests
Patient outcome studies in adults
Community-based medical center partnerships
5 hospitals and many outpatient entities

10. Research Sites MemorialCare Health System
Nonprofit integrated delivery system that includes six top hospitals
Long Beach Memorial, Miller Children's & Women's Hospital Long
Beach, Community Hospital Long Beach, Orange Coast Memorial,
Saddleback Memorial Laguna Hills and San Clemente
Medical groups – MemorialCare Medical & Greater Newport Physicians
Seaside Health Plan
Numerous outpatient health centers, imaging and surgery centers in
through Los Angeles and Orange County
Miller Children’s and Women’s Hospital of Long Beach
383 pediatric beds and 94 women’s beds
Long Beach Memorial
462 beds, level 2 trauma center
Rady Children’s Hospital – J Bradley
449 pediatric beds
Children’s Hospital of Orange County – M Jahng and F Adler-Shohet
279 pediatric beds

11. Proposed Collaborations with SSPPS Faculty
Current
PK-PD modeling studies, especially in pediatrics (E Capparelli, J Bradley, A Tremoulet) – funded by NIAID, NICHD, Foundations
Antimicrobial resistance study (V Nizet, G Sakoulas) – funded by NIAID
Antimicrobial resistance surveillance (national and international SENTRY) – funded by JMI Laboratories
Areas for New SSPPS Collaborations
Antimicrobial resistance studies, including collection of clinical isolates
Patient outcome studies for pediatric and adult infections
Physiologic-based modeling for pneumonia (J Bradley, D Gonzales)
Bridge for studies conducted at community-based medical centers

12. Jeremiah Momper: Research Interests
Pediatric Clinical Pharmacology and Drug Development
Exposure-response relationships in adults and pediatric patients with CINV and PONV (funded by FDA)
Kidney Disease and Transplantation
Hormonal regulation of drug metabolizing enzymes (D McKay, R Tukey, S Chen)
Pharmacodynamics of statins in transplant patients with cyclosporine-mediated OATP1B1 inhibition
Biodefense Research
Preclinical pharmacokinetics of novel reactivators of organphosphate Inhibited cholinesterases (P Taylor, Z Radic)
Analytical support (LC-MS/MS) for faculty interested in pre-clinical and clinical PK/PD studies in various therapeutic areas
Pediatric drug safety
Pediatric oncology
Proposed Collaborations