QUALITY RELIABILITY PRODUCTIVITY REGULATORY INNOVATION
K E Y W W W.C R O L E A D E R S H I PA W A R D S .C O M
2015
CRO
LEADERSHIP
AWARDS
WINNERS
Company
Profiles
LIFESCIENCELEADER.COM
THE CRO LEADERSHIP AWARDS 2015
47
SCYNEXIS, Inc.
Durham, NC
www.scynexis.com/services
+1 919 544 8600
Kerrie Powell
business.development@scynexis.com
Key locations: Durham, NC
DRUG LIFE CYCLE STAGES:
Research & Development: Clinical (Phase 1,
Phase 2, Phase 3)
Formulated Drug Production: Logistics
DRUG LIFE CYCLE STAGES:
Research & Development: Discovery, Preclinical
Drug Substance Production: Primary Process
Development, Drug Substance Production
DRUG LIFE CYCLE STAGES:
Research & Development: Discovery, Preclinical,
Clinical
MAIN SERVICE AREAS:
Full Service Clinical
MAIN SERVICE AREAS:
Preclinical
MAIN SERVICE AREAS:
Lab, Preclinical
"The award reflects the Sanaclis actual status. Our
aim is to work according to the highest industry
standards, and to be flexible and reliable so
that our clients can benefit from our competitive
advantages. Our reliability is based on our
business model to provide all services including
the logistics by our own staff in our own facilities
and under one roof."
"At SCYNEXIS we deliver integrated, efficient,
and innovative drug discovery and development
services that complement our customers'
capabilities. Our expert team links great
science with regulatory compliance expertise to
consistently deliver high-quality GMP material.
Our GMP facility has been FDA-inspected with
no 483 issues. I'm proud our high standards for
safety, quality, and compliance continue to be
recognized as drivers of our clients' success as
we rapidly solve the toughest drug development
problems."
"It is an honor to b e recognized with a CRO
Leadership Award for Innovation. We put the
needs of our clients first and share in their
passion and sense of urgency to reach their goals.
We understand time is money and we remain
responsive and flexible, allowing the sponsor
to customize each project to meet their needs.
We are dedicated to being available to act as an
extension of our clients' teams at all times."
SERVICES & CAPABILITIES: Regulatory, import/
export licenses, clinical monitoring, project
management, IMP/CTS local depots, logistics,
customs clearance and brokerage, metrology/
certification, data management, biostatistics,
medical writing, and comparator/rescue
medication, and equipment sourcing
THERAPEUTIC AREAS: Cardiology,
gastroenterology, gynecology, hematology,
metabolic, neurology, oncology, pain, psychiatry,
respiratory, rheumatology, and urology
SERVICES & CAPABILITIES: Process
Development: novel chemistries, small
and non-small molecules, bioactive lipids,
glycolipids; cGMP Manufacture; analytical
control of processes; impurity identification and
characterization, method development, phase-
appropriate validation, ICH stability, and final
product release
THERAPEUTIC AREAS: We have provided
our expertise and support across multiple
therapeutics areas. A few examples include but
are not limited to: CNS, anti-infectives, etc.
SERVICES & CAPABILITIES: Preclinical PK/
PD/TK studies and analysis, pharmacology
and disease models, toxicology studies, in
vitro ADME, histology, immunohistochemistry/
immunofluorescence, pathology, image
analysis, stereology, clinical PK/PD analysis, and
preclinical consulting
ALEXANDER FETKOVSKY
managing partner
YVES RIBEILL
CEO
JOHN SAGARTZ
president & CEO
CATEGORIES WON CATEGORIES WON CATEGORIES WON
Seventh Wave Laboratories
Chesterfield, MO
www.7thwavelabs.com
+1 636 519 4885
Joe Flynn
jflynn@7thwavelabs.com
Key locations: Chesterfield, MO; St. Louis, MO
SanaClis s.r.o.
Bratislava, Slovakia
www.sanaclis.eu
+ 421917820310
Svitlana Udubkova
info@sanaclis.eu
Key locations: Czech Republic, Estonia, Hungary,
Latvia, Lithuania, Russia, Slovakia, Ukraine