pediatric regulatory safety studies update development resources guidelines incorporating children trials project strategies evaluating clinical solutions PROUDLY PRESENTS 4 th Pediatric Clinical Trials Successfully Balancing Regulatory Requirements While Designing and Conducting Effective Pediatric Clinical Studies REGISTER BY SEPTEMBER 24TH FOR REDUCED PRICING SPONSORED BY: To Register Call 866-207-6528 or visit us at www.exlpharma.com/pediatrics November 11-12, 2010, Westin Washingtion, National Harbor, MD FEATURED SESSIONS: Assessing Pediatric Proposals from the EMA Perspective: Determining Key Challenges and Opportunities in Pediatric Studies Gilles Vassal, MD PhD, Director Clinical and Translational Research, Institut Gustave-Roussy, Villejuif, France, EMA PDCO MEMBER Kevin Connolly, FRCPI, Director, Paediatric Clinical Development, Portiuncula Hospital, Galway Ireland, EMA PDCO MEMBER Bolstering Safety Data: Forming Networks Between Sponsors and Investigators Kenneth J. Cohen, MD, MBA, Clinical Director, Pediatric Oncology, SIDNEY KIMMEL COMPREHENSIVE, CANCER CENTER AT JOHNS HOPKINS Strategies for Dealing with Issues of Consent and Assent to Reduce Patient Dropout Rates in Long Term Studies Brahm Goldstein, MD, Senior Medical Director, Translational Science, IKARIA Robert “Skip” Nelson, MD PhD, Pediatric Ethicist, Office of Pediatric Therapeutics, FDA Plus! Examining Three Approved PIP Case Studies CONFERENCE PRESENTERS: Abbott Laboratories AstraZeneca Bristol-Myers Squibb FDA Ikaria Institut Gustave-Roussy John Hopkins Merck Laboratories Pfizer Seaside Therapeutics Vertex Pharmaceuticals
Transcript
pediatricregulatory
safety
studies
update
developmentresources
guidelines
incorporating
childrentrials
project
strategies
evaluatin
g
clinical
solutio
ns
PROUDLY PRESENTS 4th Pediatric Clinical TrialsSuccessfully Balancing Regulatory Requirements While Designing and Conducting Effective Pediatric Clinical Studies
RegisteR by September 24th foR Reduced PRicing
SponSored By:
To Register Call 866-207-6528 or visit us at www.exlpharma.com/pediatrics
November 11-12, 2010, Westin Washingtion, National Harbor, MD
F e A t U r e D S e S S I O N S :
Assessing Pediatric Proposals from the EMA Perspective: Determining Key Challenges and Opportunities in Pediatric StudiesGilles Vassal, MD PhD, Director Clinical and Translational Research, Institut Gustave-Roussy, Villejuif, France, EMA PDCO MEMbER
Kevin Connolly, FRCPI, Director, Paediatric Clinical Development, Portiuncula Hospital, Galway Ireland, EMA PDCO MEMbER
Bolstering Safety Data: Forming Networks Between Sponsors and InvestigatorsKenneth J. Cohen, MD, MBA,Clinical Director, Pediatric Oncology, SIDNEY KIMMEL COMPREHENSIVE, CANCER CENTER AT JOHNS HOPKINS
Strategies for Dealing with Issues of Consent and Assent to Reduce Patient Dropout Rates in Long Term StudiesBrahm Goldstein, MD, Senior Medical Director, Translational Science, IKARIA
Robert “Skip” Nelson, MD PhD, Pediatric Ethicist, Office of Pediatric Therapeutics, FDA
Plus! Examining Three Approved PIP Case Studies
ConferenCe Presenters:
Abbott Laboratories
AstraZeneca
Bristol-Myers Squibb
FDA
Ikaria
Institut Gustave-Roussy
John Hopkins
Merck Laboratories
Pfizer
Seaside Therapeutics
Vertex Pharmaceuticals
Who Should Attend?Professionals from Pharmaceutical, Biotechnology and Medical Device companies with responsibilities in the fol-lowing areas:
• Clinical Operations• Clinical Development• Regulatory Affairs• Translational Medicine• Pediatric/ Paediatric/Perinatal• Drug Development • Clinical Research• Clinical Project• Trial Management• R&D Operations• Drug Safety• Project Management• Clinical Trial Management• Medical Affairs• Clinical Affairs• Pharmacovigilance• Pharmacology
This event is also of interest to:• CROs specializing in pediatric studies• Patient Recruitment Firms• Consultants who can assist in the PIP scripting process and trial design• Regulatory firms working in trial design
Venue Information The Westin Washington National Harbor171 Waterfront StreetNational Harbor, Maryland 20745
For Reservations please call (301) 567-3999Discounts End on October 20, 2010
Rising up on the shores of the scenic Potomac River, The Westin Washington Na-tional Harbor looks out over views of our nation’s capital and its many landmarks. One of the newest hotel additions to Washington, DC, the Westin stands on the banks of the Potomac River, 10 minutes to Washington DC proper and close in prox-imity to Old Town Alexandria, Arlington, and Georgetown.
Please contact the hotel directly at (301) 567-3999 to book your room. Please men-tion ExL Pharma and the 4th Pediatric Clinical Trial conference to take advantage of this discount. You must book your room by October 20, 2010 to be eligible for the discounted rate. Please book your room early as the rooms available at this rate are limited and review your hotel confirmation to ensure that you received the ExL group rate.
pediatricregulatory
safety
studies
update
developmentresources
guidelines
incorporating
children
trials
project
strategies
evaluatin
g
clinical
solutio
ns
development
strategies
Dear Colleague,It is with great pleasure that I invite you to the 4th Pediatric Clinical Trials Confer-ence: Successfully Balancing Regulatory Requirements While Designing and Con-ducting Effective Pediatric Clinical Studies.
The development of new medications for children is a rapidly expanding area of pharmaceutical research. While this growth has occurred partly in response to evolving regulatory requirements by the FDA in 1997 and the EMEA in 2007, the development of more marketed drugs for children is a societal imperative.
The successful conduct of pediatric trials involves an in-depth understanding of current regulatory mandates as well as clinical, operational, ethical, and legal chal-lenges. Furthermore, the incorporation of pediatric clinical research into an overall organizational framework for drug development can be equally as daunting.
In response to the increased pressure to conduct clinical trials in children, this fo-rum will serve to provide a foundation for the successful implementation of pedi-atric trials. Key industry and academic experts will address the unique concerns raised by ethics committees, investigators, and parents surrounding the conduct of clinical trials in children and will provide strategies for incorporating a pediatric clinical program into an existing global clinical trials paradigm.
Please join us for in-depth discussion and a shared learning opportunity.
Sincerely,
Julie A. Rosenberg, MD
Director, Oncology Global Clinical ResearchBRISTOL-MYERS SQUIBBCONFERENCE CHAIR
Preliminary AgendaDAy ONe | Thursday, November 11, 2010
pediatricstudiesdevelopment
resources incorporating
trialspediatric
regulatory
studiesdevelopmentresources
guidelines
incorporating
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project
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evaluatin
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ns7:30 REgiSTRaTion anD ConTinEnTal BREakfaST
8:30 Chairperson’s Opening RemarksJulie A. Rosenberg, MD, Director, Oncology Global Clinical ResearchBRISTOL-MYERS SQUIBB
8:45 R E G U L AT O RY U P DAT EEvaluating Global Regulatory Perspectives in Future Pediatric Drug Development• Regulatory overview and update on 2012 PREA and BPCA sunset provisions• Update on the Best Pharmaceuticals for Children Act (BPCA) priority list• Examining key issues of interpretation and effectiveness of EMA legislation
△ Timing of discussions with coordinator/rapporteur/peer-reviewer and oral explanations to address outstanding issues△ Determining the value of pre-submission discussions with the EMA△ Evaluating the core reasons for the high number of withdrawn PIP sub missions
• Understanding the role of WHO’s Better Medicines for Children initiative and the new Pediatric medicines Regulators Network (PmRN)Thomas Hassall, Senior Director, Global Pharmaceutical Regulatory AffairsABBOTT LABORATORIES Emma Du Four, Director, Regulatory Policy & Intelligence, Global Pharmaceutical Regu-latory and Medical Sciences, ABBOTT LABORATORIES, UK
9:30 E U R E G U L AT O RY P E R S P E C T I V EAssessing Pediatric Proposals from the EMA Perspective: Determining Key Challenges and Opportunities in Pediatric Studies• Examining an historical background of the PIP and it’s progression• Understanding the PDCO perspective on PIP timelines and stages• Assessing the impact of the PIP process to pediatric studies o Approval trends in the EU o Evaluating the causes for incomplete PIP submissions• Discussing the negotiation and facilitating process with PDCOGilles Vassal, MD PhD, Director Clinical and Translational Research, Institut Gustave-Roussy, Villejuif, France, EMA PDCO MemberKevin Connolly, FRCPI, Director, Paediatric Clinical DevelopmentPortiuncula Hospital, Galway Ireland, EMA PDCO Member
10:45 P I P C A S E S T U D I E SExamining Three Approved PIP ApplicationsWe have brought together three different Paediatric Investigational Plans (PIPs) recently approved by the EMA
• Discuss the challenges with and approaches taken • Examine the negotiation process with the EMA• Evaluate lessons learned
Each PIP will be discussed for 30 minutes, followed by a group Q&A and panel discussion.
Liz Morgan, Regulatory Affairs, UK, PFIZERMark De Roche, Senior Director, Regulatory Affairs, VERTEX PHARMACEUTICALSSamuel C Blackman, Associate Director, Experimental Medicine/Oncology,MERCK RESEARCH LABORATORIES
1:30 E T H I C SDefining the Latest Ethical Pediatric Drug Trial Guidelines in Evaluating Design and Implementation Strategies• Forming frameworks to guide and monitor drugs development in children• Examining safety, pharmacokinetics, and initial indications of efficacy• Criteria for IRB approval of research• Ethical issues of particular concern in drug investigations in pediatric populations• Recruitment challenges and proper ethical guidelines in child assentPaul Wang, MD FAAP, Vice President, Clinical Development, SEASIDE THERAPEUTICS
2:15 C O R P O R AT E S T RU C T U R E S D I S C US S I O NAssessing Organizational Structures to Best Incorporate Pediatric Studies into the Product Development Process• Assessing the scientific and biologic rationale in considering pediatrics during the drug development process• Incorporating pediatric plans in each development program from the Leadership level• Involving pediatricians throughout development• Determining how early to evaluate pediatric populations Jeffrey Skolnik, MD, Director of Clinical Development, ASTRAZENECA
3:30 A A P I N I TAT I V EExamining the Developing AAP Initiative on Medical Advances In Pediatrics• Evaluating the gaps between pediatrician abilities and understandings and the increasingly stringent requirements of the pharmaceutical industry• Bolstering the ability to uncover qualified pediatrician investigators do mestically by raising the profile of industry-focused pediatriciansCharles A Thompson, Medical Director, Infectious Diseases, PFIZER (Chair, AAP SoMAP)Brahm Goldstein, MD, Senior Medical Director, Translational Science, IKARIAPaul Wang, MD FAAP, Vice President, Clinical Development, SEASIDE THERAPEUTICS
4:15 RO U N D TA B L E D I S C US S I O NSRoundtable Discussions On Specific Therapeutic Areas Roundtable discussions are an opportunity to break into smaller, concentrat-ed groups and focus on specific issues. Each table is moderated to facilitate deeper discussion.• Oncology• Neonatology/Critical Care• CNS• Infectious Disease
.......................................................................................................................................5:30 CloSE of Day onE
Preliminary Agenda
Post-Conference Workshop
DAy TWO | Friday, November 12, 2010
Evaluating current understanding in pediatric pharmacology• Reviewing the regulatory environment• Drug safety studies• Extrapolating data from adult studies
Modeling and Simulation Examples in PK/PD • Use of M&S in pediatric trial design
• Use of M&S in the evaluating pediatric study results• Physiologically-based pharmacokinetic modeling
Formulation Development Strategies• Strategies to increase drug product palatability• Tase masking, texture, smell in developing dosage forms
Pharmacological Strategies in Pediatric Drug Development: Getting to the Right Dose
POST-CONFereNCe WOrkSHOPDeveloping Formulation and Dose Selection Strategies that ensure High Levels of efficacy and Safety in Pediatric Studies
To Register Call 866-207-6528 or visit us at www.exlpharma.com/pediatrics
7:30 ConTinEnTal BREakfaST
8:30 Chair’s Welcome and Roundtable RecapJulie A. Rosenberg, MD, Director, Oncology Global Clinical ResearchBRISTOL-MYERS SQUIBB
9:00 I N F O R M E D C O NS E N TStrategies for Dealing with Issues of Consent and Assent to Reduce Patient Dropout Rates in Long Term Studies• Writing effective consent form information that covers tangible and con ceptual aspects of the trial• Building effective trial information that can best inform patients and families to changes during trials• Determining when you do and do not need assent formsBrahm Goldstein, MD MCR FAAP FCCM, Senior Medical Director, Translational Science, IKARIARobert “Skip” Nelson, MD PhD, Pediatric Ethicist, Office of Pediatric Therapeutics FOOD AND DRUG ADMINISTRATION
9:45 PA R T N E R S H I P D I S C US S I O NForming Global Patient Recruitment and Retention Strategies to Increase Pediatric Trial Involvement • Best and emerging practices for communicating with patients and family members about participation• Examining age group specific support methodologies• Understanding and overcoming special retention and compliance obstacles• Engaging stakeholders to maximize trial participation Ann Kottcamp, Vice President, CNS & Mental Health, MMG
11:00 I N V E S T I GAT O R P E R S P E C T I V EBolstering Safety Data: Forming Networks Between Sponsors and Investigators• Building regional and global ‘sub-specialty’ networks to further investigation into a wide class of initiatives• Evaluating the investigator initiated approach to pediatric trials• Examining strategies unique to pediatricsKenneth J. Cohen, MD, MBA, Clinical Director, Pediatric Oncology, SIDNEY KIMMEL COMPREHENSIVE, CANCER CENTER AT JOHNS HOPKINSGilles Vassal, MD PhD, Director Clinical and Translational Research, Institut Gustave-Roussy, Villejuif, France, EMA PDCO Member
11:45Building Effective Pediatric Clinical Trials Unit• Evaluating the Cost to Benefit in Determining the Number of Clinical Sites• Establishing pediatric administrative staff• Assessing the number of sites necessary from an administrative viewpointRon Portman, MD, Group Director, Pediatric Drug Development Program, BRISTOL-MYERS SQUIBB
.......................................................................................................................................12:30 CloSE of Main ConfEREnCE
Take advantage of our group discount rates to strengthen your entire team’s pediatric strategies.
pediatricregulatory
safety
studies
update
developmentresources
guidelines
incorporating
childrentrials
project
strategies
evaluatin
g
clinical
solutio
nsFax: 888-221-6750Mail: ExL Events, Inc. 555 8th Ave, Ste 310 New York, NY 10018
registration fees for attenDing exL PharMa’s 4th PeDiatriC CLiniCaL triaLs:
sPonsorshiP anD exhibiting oPPortunitiesDo you want to spread the word about your organization’s solutions and services to potential clients who will be attending this event? Take advantage of the opportunity to exhibit, present an education-al session, host a networking event, or distribute promotional items to attendees. ExL Pharma will work closely with you to customize a package that will suit all of your needs. To learn more about these opportunities, please contact:Steve Decker Business Development Manager212.400.6234, [email protected]
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EARLY BIRD PRICINGRegister by Friday, September 24th, 2010 to Take Advantage of Early-Bird Pricing:Conference + Workshop $1995Conference Only $1695
STANDARD PRICINGRegister After Friday, September 24th, 2010: Conference + Workshop $2195Conference Only $1895
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Government & Academic Rates Available. For more information, please call 212-400-6240 or email [email protected]
Group Discount Program: Discounts cannot be combined; Early Bird Rates do not apply
SAVE 25% PER PERSON wHEN REGISTERING FOuR For every three simultaneous registrations from your company, you will receive a fourth complimentary registration to the program (must register 4 at one time). This is a savings of 25% per person.
SAVE 15% PER PERSON wHEN REGISTERING THREE Can only send three? You can still save 15% off of every registration. To find out more on how you can take advantage of these group discounts, please call 866-207-6528.
pediatricregulatory
safety
studies
update
development
resources
guidelines
incorporating
children
trials
project
strategies
evaluating
clinicalsolutions
PROUDLY PRESENTS4
th Pediatric C
linical Trials
Successfully Balancing Regulatory Requirements W
hile Designing and Conducting Effective Pediatric Clinical Studies
RegisteR
by September 24th
foR
Red
uced
PRicin
g
Spon
Sored
By:
To Register Call 866-207-6528 or visit us at ww
w.exlpharm
a.com/pediatrics
Novem
ber 11-12, 2010, Westin W
ashingtion, National H
arbor, MD
Fe
At
Ur
eD
Se
SS
ION
S:
Assessing Pediatric Proposals from
the EMA
Perspective: D
etermining K
ey Challenges and
Opportunities in Pediatric Studies
Gilles Vassal, MD PhD, Director Clinical and Translational Research,
Institut Gustave-Roussy, Villejuif, France, EMA PDCO M
EMbER
Kevin Connolly, FRCPI, Director, Paediatric Clinical Development, Portiuncula Hospital,
Galway Ireland, EMA PDCO M
EMbER
Bolstering Safety Data: Form
ing N
etworks Betw
een Sponsors and InvestigatorsKenneth J. Cohen, M
D, MBA,Clinical Director, Pediatric Oncology, SIDNEY KIM
MEL
COMPREHENSIVE, CANCER CENTER AT JOHNS HOPKINS
Strategies for Dealing w
ith Issues of C
onsent and Assent to Reduce Patient
Dropout R
ates in Long Term Studies
Brahm Goldstein, M
D, Senior Medical Director, Translational Science, IKARIA
Robert “Skip” Nelson, MD PhD, Pediatric Ethicist, Offi
ce of Pediatric Therapeutics, FDA
Plus! Examining T
hree Approved PIP C
ase Studies
ConferenCe Presenters:Abbott Laboratories
AstraZeneca
Bristol-Myers Squibb
FDA
Ikaria
Institut Gustave-Roussy
John Hopkins
Merck Laboratories
Pfizer
Seaside Therapeutics
Vertex Pharmaceuticals
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