The 10th GCC Closed Forum: rejected data, GCP in bioanalysis, extract stability, BAV, processed batch acceptance, matrix stability, critical reagents, ELN and data integrity and counteracting fraud.
The 10th Global CRO Council (GCC) Closed Forum was held in Orlando, FL, USA on 18 April 2016. In attendance were decision makers from international CRO member companies offering bioanalytical services. The objective of this meeting was for GCC members to meet and discuss scientific and regulatory issues specific to bioanalysis. The issues discussed at this closed forum included reporting data from failed method validation runs, GCP for clinical sample bioanalysis, extracted sample stability, biomarker assay validation, processed batch acceptance criteria, electronic laboratory notebooks and data integrity, Health Canada's Notice regarding replicates in matrix stability evaluations, critical reagents and regulatory approaches to counteract fraud. In order to obtain the pharma perspectives on some of these topics, the first joint CRO-Pharma Scientific Interchange Meeting was held on 12 November 2016, in Denver, Colorado, USA. The five topics discussed at this Interchange meeting were reporting data from failed method validation runs, GCP for clinical sample bioanalysis, extracted sample stability, processed batch acceptance criteria and electronic laboratory notebooks and data integrity. The conclusions from the discussions of these topics at both meetings are included in this report.
Covance, Madison, WI, USA.
Stephanie
S
Cape
Celerion, Lincoln, NE, USA.
Rafiq
R
Islam
PPD Laboratories, Madison, WI, USA.
Corey
C
Nehls
LGC, Fordham, UK.
John
J
Allinson
BioAgilytix, Durham, NC, USA.
Afshin
A
Safavi
PPD Laboratories, Madison, WI, USA.
Patrick
P
Bennett
Eurofins Pharma Bioanalytics Services, Saint Charles, MO, USA.
James
J
Hulse
inVentiv Health, Princeton, NJ, USA.
Chris
C
Beaver
Alliance Pharma, Malvern, PA, USA.
Masood
M
Khan
Pyxant Labs, Colorado Springs, CO, USA.
Shane
S
Karnik
Anapharm Europe, Barcelona, Spain.
Maria Cruz
MC
Caturla
Q2 Solutions, Ithaca, NY, USA.
Steve
S
Lowes
3S - Pharmacological Consultation, Bucharest, Romania.
Adriana
A
Iordachescu
3S - Pharmacological Consultation, Bucharest, Romania.
Luigi
L
Silvestro
ACDIMA Center for Bioequivalence & Pharmaceutical Studies, Amman, Jordan.
Rabab
R
Tayyem
AIT Bioscience, Indianapolis, IN, USA.
Ron
R
Shoup
Previously with AIT Bioscience, Indianapolis, IN, USA.
Stephanie
S
Mowery
Algorithme Pharma, Laval, Quebec, Canada.
Anahita
A
Keyhani
Previously with Algorithme Pharma, Laval, Quebec, Canada.
Andrea
A
Wakefield
Alliance Pharma, Malvern, PA, USA.
Yinghe
Y
Li
Alturas Analytics, Moscow, ID, USA.
Jennifer
J
Zimmer
Anapharm Europe, Barcelona, Spain.
Javier
J
Torres
Atlanbio, Saint-Nazaire, France.
Philippe
P
Couerbe
Axis Clinicals, Dilworth, MN, USA.
Ardeshir
A
Khadang
BASi, West Lafayette, IN, USA.
James
J
Bourdage
Bioanalytical Laboratory Services, Toronto, Ontario, Canada (currently BioPharma Services).
Nicola
N
Hughes
Kayode
K
Awaiye
Brent
B
Matthews
Biotrial Bioanalytical Services Inc., Laval, Quebec, Canada.
Saadya
S
Fatmi
Celerion, Lincoln, NE, USA.
Rhonda
R
Johnson
Charles River Laboratories, Reno, NV, USA.
Christina
C
Satterwhite
CIRION Biopharma Research, Laval, Quebec, Canada.
Mathilde
M
Yu
CMIC, Hoffman Estates, IL, USA.
Jenny
J
Lin
Covance, West Trenton, NJ, USA.
Laura
L
Cojocaru
Covance, Chantilly, VA, USA.
Michele
M
Fiscella
Covance, Indianapolis, IN, USA.
Eric
E
Thomas
Envigo, Somerset, NJ, USA.
Kai
K
Kurylak
Eurofins Pharma Bioanalytics Services, Saint Charles, MO, USA.
John
J
Kamerud
Frontage Lab, Exton, PA, USA.
Zhongping John
ZJ
Lin
GCC, Toronto, Ontario, Canada.
Wei
W
Garofolo
GCC, Toronto, Ontario, Canada.
Natasha
N
Savoie
Intertek, San Diego, CA, USA.
Mike
M
Buonarati
inVentiv Health, Quebec City, Quebec, Canada.
Nadine
N
Boudreau
inVentiv Health, Princeton, NJ, USA.
Clark
C
Williard
KCAS Bioanalytical & Biomarker Services, Shawnee Mission, KS, USA.
Yansheng
Y
Liu
KCAS Bioanalytical & Biomarker Services, Shawnee Mission, KS, USA.
Dominic
D
Warrino
Lambda Therapeutic Research, Ahmedabad, India.
Prashant
P
Kale
LGC, Fordham, UK.
Neil
N
Adcock
Lotus Labs Pvt. Ltd., Bangalore, India.
Radha
R
Shekar
Loveless Respiratory Research Institute, Albuquerque, NM, USA.
Edward
E
O'Connor
Mercodia AB, Uppsala, Sweden.
Hanna
H
Ritzen
MicroConstants, San Diego, CA, USA.
Christina
C
Sanchez
MPI Research, Mattawan, MI, USA.
Roger
R
Hayes
Pharma Medica Research, Inc., Mississauga, Ontario, Canada.
Mohammed
M
Bouhajib
Pharma Serv International, Bucharest, Romania.
Simona Rizea
SR
Savu
PPD Laboratories, Richmond, VA, USA.
Bruce
B
Stouffer
PPD Laboratories, Richmond, VA, USA.
Edward
E
Tabler
PPD Laboratories, Richmond, VA, USA.
Jing
J
Tu
PRA Health Sciences, Lenexa, KS, USA.
Chad
C
Briscoe
PRA Health Sciences, Assen, The Netherlands.
Barry van
BV
der Strate
Q2 Solutions, Marietta, GA, USA.
Paul
P
Rhyne
Smithers Avanza, Gaithersburg, MD, USA.
Phyllis
P
Conliffe
Smithers Avanza, Gaithersburg, MD, USA.
Ira
I
DuBey
SNBL USA, Everett, WA, USA.
Jim
J
Yamashita
UP-Pharmatech, Beijing, China.
Daniel
D
Tang
WIL Research, Ashland, OH, USA (currently Charles River).
Elizabeth
E
Groeber
WIL Research, Skokie, IL, USA (currently Charles River).
Jenifer
J
Vija
Worldwide Clinical Trials, Cedar Park, TX, USA.
Michele
M
Malone
WuXi Apptec, Plainsboro, NJ, USA.
Mohamed
M
Osman
D015415:Biomarkers / Q000032:analysis*; D002623:Chemistry Techniques, Analytical / Q000592:standards*; D003625:Data Collection / Q000592:standards*; D004355:Drug Stability; D033161:Government Regulation; D017408:Guidelines as Topic; D006801:Humans; D004364:Pharmaceutical Preparations / Q000032:analysis*; D058028:Research Report
D015415:Biomarkers; D004364:Pharmaceutical Preparations
GCC; bioanalysis; method validation