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Edmund Capparelli - Research Interests

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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

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