T U M C E R S C E P F I IQ C P HALLENGES AND STRATEGIES
THE UNIVERSITY OF MARYLAND CENTER FOR EXCELLENCE IN REGULATORY SCIENCE ANDINNOVATION, IN COLLABORATION WITH THE EUROPEAN PAEDIATRIC FORMULATION INITIATIVE(EUPFI) AND THE IQ CONSORTIUM, PRESENTS:CHALLENGES AND STRATEGIES TO FACILITATEFORMULATION DEVELOPMENT OF PEDIATRICDRUG PRODUCTSFINANCIAL ASSISTANCE PROVIDED BY ABBVIE, BRISTOL-MYERS SQUIBB, LILLY, AND TAKEDACOLLEGE PARK MARRIOTT HOTEL ANDCONFERENCE CENTERJUNE 8-9, 2016HYATTSVILLE, MD
CONFERENCE AGENDAO VERVIEW AGENDADAY 1: JUNE 8, 2016TIMEA CTIVITY8:00-8:05 a.m.WELCOME AND WORKSHOP G OALS8:05-8:20 a.m.PLENARY O PENING8:20-10:30 a.m.SESSION 1: AGE APPROPRIATE FORMULATION – G ENERALCONSIDERATIONSSession Chairs: Anne Zajicek (NIH), Hari Sachs (FDA), Rob Ju(AbbVie), and Brian Aylward (Irish Medicines Board)10:30-11:25 a.m.ACCEPTABILITY ASSESSMENT O PENING11:25-3:00 p.m.SESSION 2: ACCEPTABILITY ASSESSMENT OF PEDIATRICFORMULATIONS – SWALLOWABILITYSession Chairs: Arzu Selen (FDA), Fang Liu (University ofHertforshire), and Siri Wang (Norwegian Medicines Agency)3:00-5:15 p.m.SESSION 3: ACCEPTABILITY ASSESSMENT OF PEDIATRICFORMULATIONS – PALATABILITYSession Chairs: Bob Ternik (Eli Lilly and Company) and Siri Wang(Norwegian Medicines Agency)5:15-5:30 p.m.WRAP-UP FOR DAY 1DAY 2: JUNE 9, 2016TIMEA CTIVITY8:00-12:00 p.m.SESSION 4: FOOD EFFECTS IN PEDIATRIC MEDICINES DEVELOPMENTFOR P RODUCTS CO - ADMINISTERED WITH F OODSession Chairs: Andrew Mulberg (FDA), Hannah Batchelor(University of Birmingham), and Ann Marie Kaukonen (FinnishMedicines Agency)SESSION 5: SAFETY Q UALIFICATION OF EXCIPIENTSSession Chairs: Darren Fegley (FDA), Lorrene Buckley (Eli Lillyand Company), Jacqueline Carleer (Belgian Federal Agency forMedicines), and Gerri R. Baer (FDA)
1:00-4:00 p.m.SESSION 6: BIOPHARMACEUTICS AND CLINICAL PHARMACOLOGYSession Chairs: James Polli (University of Maryland School ofPharmacy), Jian Wang (FDA), Brian Aylward (Irish MedicinesBoard), and Tycho Heimback (Novartis)4:00-4:30 p.m.WRAP-UP FOR DAY 2DETAILED AGENDADAY 1: JUNE 8, 2016TIMEA CTIVITY8:00-8:05 a.m.WELCOME AND WORKSHOP G OALS8:05-8:20 a.m.PEDIATRIC G LOBAL REGULATORY O VERVIEW: STATUS,CHALLENGES, AND O PPORTUNITIES WITH FOCUS ON PEDIATRICFORMULATION DEVELOPMENTLynne Yao, MDDirector, Division of Pediatric and Maternal HealthOffice of Drug Evaluation IVFood and Drug AdministrationSESSIONS 1-3: AGE APPROPRIATE FORMULATION ANDACCEPTABILITY ASSESSMENTRegulations in both the EU and US require that pediatric drugproducts be appropriate for use in the target population. Therehas been significant discussion on demonstrating acceptability ofdosage forms for pediatric patients. Formulations can beoptimized based on pharmacokinetics, taste and overallacceptability measures. Given the high heterogeneity of the globalpediatric population and the wide variety of existing and emergingformulation options, attributes of product acceptability arecomplex. The session purpose is to discuss patient acceptabilityand clinical performance from a global perspective, and will focuson palatability and swallowability of oral dose forms. Theseattributes will serve as examples around which a rational riskbased approach for determining acceptability can be proposed,including: sources of data to demonstrate acceptability ofpalatability and swallowability; example methodology for use inassessing palatability and swallowability; and approaches toestablishing criteria for acceptability.SESSION 1: AGE APPROPRIATE FORMULATION -- G ENERALCONSIDERATIONSSession Chairs: Anne Zajicek (NIH), Hari Sachs (FDA), Rob Ju(Abbvie), and Brian Aylward (Irish Medicines Board)
8:20-8:30 a.m.G ASTROINTESTINAL PHYSIOLOGY IN PEDIATRICS: IMPLICATIONS FORPEDIATRIC FORMULATION DEVELOPMENTAndrew Mulberg, MD, FAAPDeputy DirectorDivision of Gastroenterology and Inborn Errors ProductsFood and Drug Administration8:30-8:40 a.m.PEDIATRIC FORMULATION DEVELOPMENT: O PPORTUNITIES FROM ANINDUSTRY PERSPECTIVERobert Ternik, PhDSenior Research Advisor and Design Team LeaderEli Lilly and Company8:40-8:50 a.m.EMA/PDCO PEDIATRIC FORMULATION WORKING G ROUPEXPERIENCEBrian Aylward, MDClinical AssessorHealth Products Regulatory AuthorityIrish Medicines Board8:50-9:00 a.m.FDA CLINICAL PERSPECTIVESErica Radden, MDPediatric Team MemberDivision of Pediatric and Maternal HealthOffice of Drug Evaluation IVFood and Drug Administration9:00-9:10 a.m.EUPFI AND PEDIATRIC FORMULATION DEVELOPMENTCatherine Tuleu, PhDReader in PharmaceuticsUniversity College London School of Pharmacy9:10-9:20 a.m.PEDIATRIC FORMULATIONS RESEARCH: NIH PERSPECTIVESAnne Zajicek, MD, PharmDChief, Obstetric and Pediatric Pharmacology andTherapeutics BranchEunice Kennedy Shriver National Institute of Child Health andHuman Development (NICHD)9:20-10:05 a.m.PANEL DISCUSSIONPanelists: Drs. Yao, Mulberg, Ternik, Aylward, Radden, Tuleu,and Zajicek10:05-10:30 a.m.BREAKACCEPTABILITY ASSESSMENT OF PAEDIATRIC FORMULATIONS:O PENING FOR SESSIONS 2 AND 310:30-10:55 a.m.EMA REGULATORY PERSPECTIVESAnn Marie Kaukonen, PhD
Senior Researcher/Pharmaceutical AssessorFinnish Medicines Agency10:55-11:20 a.m.FDA PRODUCT PERFORMANCE/CHEMISTRY PERSPECTIVEArzu Selen, PhDAssociate Director, Scientific DevelopmentOffice of Testing and ResearchOffice of Pharmaceutical QualityCenter for Drug Evaluation and ResearchFood and Drug Administration11:20-11:25 a.m.SESSIONS 2 AND 3: BREAKOUT LOGISTICS AND G OALSSESSION 2: ACCEPTABILITY ASSESSMENT OF PEDIATRICFORMULATIONS -- SWALLOWABILITYSession Chairs: Arzu Selen (FDA), Fang Liu (U of Hertfordshire),and Siri Wang (Norwegian Medicines Agency)11:25-11:40 a.m.LITERATURE REVIEWFang Liu, PhD, MSc, BScSenior Lecturer in Pharmaceutics and Drug DeliveryUniversity of Hertfordshire11:40-12:00 p.m.INDUSTRY PERSPECTIVEDavid Tan Cheng ThiamAssociate ScientistAbbVie12:00-1:00 p.m.LUNCH1:00-2:20 p.m.BREAKOUT DISCUSSIONSCase studies of swallowability questions will be provided.Participants will be broken up into smaller groups to discusspotential solutions.2:20-2:35 p.m.BREAK2:35-3:00 p.m.SUMMARY REPORTS FROM BREAKOUT DISCUSSIONSSESSION 3: ACCEPTABILITY ASSESSMENT OF PEDIATRICFORMULATIONS -- PALATABILITYSession Chairs: Bob Ternik (Lilly) and Siri Wang (NorwegianMedicines Agency)3:00-3:15 p.m.LITERATURE REVIEWYuet Mei Khong, PhDSenior Scientist/Group LeaderAbbVie3:15-3:30 p.m.PEDIATRIC FORMULATION DEVELOPMENT: INDUSTRY PERSPECTIVEON P ALATABILITY CHALLENGES AND O PPORTUNITIESJeremy Bartlett, PhD
Associate Research FellowPharmaceutical Sciences Drug Product DesignPfizer, Inc.3:30-4:50 p.m.BREAKOUT DISCUSSIONSCase studies of palatability questions will be provided. Participantswill be broken up into smaller groups to discuss potentialsolutions.4:50-5:15 p.m.SUMMARY REPORTS FROM BREAKOUT DISCUSSIONS5:15-5:30 p.m.WRAP-UP FOR DAY 1DAY 2: JUNE 9, 2016TIMEA CTIVITYNOTE: SESSIONS 4 AND 5 WILL BE HELD IN PARALLEL.SESSION 4: FOOD EFFECTS IN PEDIATRIC MEDICINES DEVELOPMENTFOR P RODUCTS CO - ADMINISTERED WITH F OODSession Chairs: Andrew Mulberg (FDA), Hannah Batchelor(University of Birmingham), and Ann Marie Kaukonen (FinnishMedicines Agency)The objectives of this session include: identify bestpractices/process flow (based on current information) that couldbe used to de-risk the formulation development strategy; and planappropriate clinical studies and subsequent label claims forpediatric products that are co-administered with food. Gapswhere more research or data is required will also be identified.8:00-8:05 a.m.INTRODUCTIONSession Chairs: Andrew Mulberg (FDA), Hannah Batchelor(University of Birmingham), and Ann Marie Kaukonen (FinnishMedicines Agency)8:05-8:25 a.m.IN VITRO TOOLS TO RISK ASSESS THE LIKELIHOOD OF AFOOD/VEHICLE EFFECT IN PEDIATRIC POPULATIONSSandra Klein, PhDProfessor of Pharmaceutical TechnologyUniversity of Greifswald8:25-8:50 a.m.PRECLINICAL IN VIVO, CLINICAL PK AND PKPD TOOLS TO RISKASSESS FOOD/VEHICLE EFFECTSBarbara Davit, PhDExecutive DirectorMerck8:50-11:30 a.m.BREAKOUT DISCUSSIONS
Case studies of food/vehicle effect questions will be provided.Participants will be broken up into smaller groups to discusspotential solutions.10:00-10:15 a.m.BREAK11:30-12:00 p.m.SUMMARY REPORTS FROM BREAKOUT DISCUSSIONSSESSION 5: SAFETY Q UALIFICATION OF EXCIPIENTS USED INPEDIATRIC FORMULATIONSSession Chairs: Darren Fegley (FDA), Lorrene Buckley (Eli Lillyand Company), Jacqueline Carleer (Belgian Federal Agency forMedicines), and Gerri R. Baer (FDA)The objective of this session is to identify how current regulatoryguidance is interpreted by various stakeholders and tocharacterize approaches to qualify pediatric excipients.Experiences from both the nonclinical and clinical perspectives willbe highlighted for possible paths forward towards moreconsistent, risk-based approaches.8:00-8:15 a.m.O VERVIEW OF ISSUESDarren Fegley, PhDPharmacologist/ToxicologistFood and Drug AdministrationLorrene Buckley, PhD, DABTToxicologistEli Lilly and CompanyJacqueline Carleer, DVMNon-clinical AssessorBelgian Federal Agency for MedicinesGerri R. Baer, MDMedical OfficerOffice of Pediatric TherapeuticsFood and Drug Administration8:15-8:35 a.m.CURRENT CLINICAL PERSPECTIVE ON RISK ASSESSMENTMark Turner, PhDSenior Lecturer in NeonatologyUniversity of Liverpool8:35-9:15 a.m.PANEL DISCUSSIONFacilitators: Lorrene Buckley (Lilly) and Mark Turner (University ofLiverpool)Panalists: Darren Fegley (FDA), Brian Aylward (Irish MedicinesAgency), Gerri Baer (FDA), Karen Thompson (Merck), SmitaSalunke (UCL School of Pharmacy), and Jacqueline Carleer(Belgian Federal Agency for Medicines)
9:15-11:30 a.m.BREAKOUT DISCUSSIONSCase studies of safety qualification of excipients questions will beprovided. Participants will be broken up into smaller groups todiscuss potential solutions.10:00-10:15 a.m.BREAK11:30-12:00 p.m.SUMMARY REPORTS FROM BREAKOUT DISCUSSIONS12:00-1:00 p.m.LUNCHSESSION 6: BIOPHARMACEUTICS AND CLINICAL PHARMACOLOGYCONSIDERATIONSSession Chairs: Jian Wang (FDA), James Polli (University ofMaryland School of Pharmacy), and Brian Aylward (Irish MedicinesBoard)The objectives of this session include: discuss considerations froma perspective of clinical pharmacology and biopharmaceutics; andidentify the role of physiologically-based pharmacokinetic (PBPK)modeling and a pediatric BCS in drug development, classboundaries, and necessary research for a pediatric BCS. Topicsinclude age range, BCS class boundaries, and frameworks forpredicting drug absorption in paediatric patients.1:00-1:15 p.m.FORMULATION-DEPENDENT PEDIATRIC PHYSIOLOGICALLY-BASEDPHARMACOKINETIC (PPBPK) MODELING TO AID DRUGDEVELOPMENTWen Lin, PhDSenior InvestigatorNovartis1:15-1:30 p.m.BIOPHARMACEUTICAL CONSIDERATIONS IN PEDIATRICFORMULATION DEVELOPMENTJack Cook, PhDClinical Pharmacology LeaderPfizer, Inc.1:30-1:45 p.m.PROPOSED BCS FOR PEDIATRICS AND IMPLICATION ONBIOEQUIVALENCE ASSESSMENTJames Polli, PhDShangraw/Noxell Endowed Chair in Industrial Pharmacy andPharmaceuticsDepartment of Pharmaceutical SciencesUniversity of Maryland School of Pharmacy1:45-2:00 p.m.CLINICAL PHARMACOLOGY CONSIDERATIONS OF PEDIATRICFORMULATION: CASE STUDIES ON ANTIVIRAL AND ANTI-INFECTIVEPRODUCTSShirley Seo, PhDClinical Pharmacology Team Leader, Antiviral ProductsFood and Drug Administration
2:00-3:00 p.m.BREAKOUT DISCUSSIONSCase studies of biopharmaceutics and clinical pharmacologyquestions will be provided. Participants will be broken up intosmaller groups to discuss potential solutions.3:00-3:10 p.m.BREAK3:10-4:00 p.m.PANEL DISCUSSION OF BREAKOUT DISCUSSIONSPanelists: Drs. Seo, Fang, Polli, Heimbach, Kim, Abernethy, Suarez,Cook, Green, Liu, Aylward, and Burckart4:00-4:30 p.m.WRAP-UP FOR WORKSHOPTRANSPORTATION INFORMATION:If you are staying at the Greenbelt Marriott Hotel, a shuttle service has been arranged totake you to and from the meeting on June 8 and 9. Morning Shuttle Pick-Up Time: Begin boarding at 7:00 a.m. at the GreenbeltConference Center entrance in the REAR of the hotel. The shuttle departs promptlyat 7:15 a.m.Evening Shuttle Pick-Up Time: Begin boarding at 5:45 p.m. outside of theConference Center entrance alongside the UMUC garage entrance. The shuttledeparts promptly at 6:00 p.m.
Sandra Klein, PhD Professor of Pharmaceutical Technology University of Greifswald 8:25 -8:50 a.m. P RECLINICAL IN V IVO, C LINICAL PK AND PKPD T OOLS TO R ISK A SSESS F OOD /V EHICLE E FFECTS Barbara Davit, PhD Executive Director Merck 8:50 -11:30 a.m. B REAKOUT D ISCUSSIONS
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PERFORM SOME BALLET THEMES: Choose from the three themes on the Tchaikovsky Ballet Music sheet and perform on an instrument of your choice. Add in the left hand chords if you are playing on keyboard or piano. You could play either: Theme from the Dance of the Sugar Plum Fairies The Waltz from Sleeping Beauty The March from the .
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5 II. TINJAUAN PUSTAKA 2.1 Jambu Mete Menurut Baker (2009), jambu mete (Anacardium occidentale L) termasuk tumbuhan yang berkeping biji dua atau juga disebut tumbuhan berbiji belah.
to examine how young EFL learners (11-12-year olds with 5 years of English instruction) process text and pictures in RO and RWL conditions and the impact that the potential differences in the allocation of attention to both text and pictures has on comprehension.
