Analytical Chemistry
Todd R. Daviau, Ph.D., Analytical and Preformulation Services
Dr.
Daviau has a Ph.D. in marine natural products chemistry
as well as an M.S. in chemistry. In addition, he
holds a B.S. in marine biology and chemistry from
Roger Williams University. With almost 20 years
experience, Dr. Daviau has held several positions
as an analytical chemist and consultant to the
pharmaceutical industry. Prior to joining CoreRx,
Inc., he was director of analytical and preformulation
for MDS Pharma Services in Tampa, Florida. Dr.
Daviau also was technical specialist for Shimadzu
Scientific Instruments where he specialized in
the LC, LC-MS, GC and GC-MS product lines. He was
formerly manager of analytical chemistry for SunPharm
Corporation and spent over 10 years in the analytical
quality control laboratories of Nova Pharmaceuticals,
Scios-Nova and Guilford Pharmaceuticals in Baltimore,
Maryland. He has extensive experience in the separation,
isolation and analysis of novel pharmaceutical
compounds, impurities, degradants and biotechnology
products as well as fractionation isolation and
discovery of novel natural products from marine
and terrestrial sources.
Jim
Davis, M.S., Analytical Chemistry, Analytical and Preformulation Services
Mr. Davis has a M.S. in analytical chemistry
from Georgia State University in Atlanta as
well as a B.S.A. in biological sciences from the
University of Georgia in Athens. With 10 years
experience, Mr. Davis has held several positions
as an analytical chemist and consultant to the
pharmaceutical industry. Prior to forming CoreRx, Mr. Davis served as both a section head and
as a senior scientist within the analytical laboratory
of MDS Pharma Services in Tampa, FL. Prior to MDS
he was a lead scientist in the R&D Nasal
Division of Bausch and Lomb in Tampa. He formerly served as a scientist in analytical services
for contract research organizations (CROs) Proceutics
and Oread in Atlanta. He has extensive experience
in the separation, isolation and analysis of emerging
and classical pharmaceutical compounds. Mr. Davis
has an in-depth understanding of the drug development
process from molecule to market.
Preformulations/Formulation
Development
Brian McMillan, B.A.
Biochemistry, Formulation Development
Mr.
McMillan is a 1989 graduate of Ohio State University
with a degree in biochemistry where he also majored
in the College of Pharmacy. He has seventeen years
of relevant experience in the pharmaceutical development
arena. He began his professional career at Roxane
Laboratories in Columbus, Ohio as a methods development
chemist and eventually moved into formulation development
and concentrated on solid and semi-solid ANDA and
NDA product development. After eight and a half
years at Roxane, he joined Bausch and Lomb Pharmaceuticals
in Tampa, Florida as a formulation research chemist
and worked on a wide range of ANDA and NDA ophthalmic
and nasal medications. While at Bausch and Lomb
Mr. McMillan played a lead role in the development
of Retisert™, which was approved in April
2005. Retisert™ (fluocinolone acetonide intravitreal
implant 0.59mg), is a sterile implant (micro-tablet),
designed to release fluocinolone acetonide locally
to the posterior segment of the eye. Retisert™ is
the world's first intravitreal drug implant for
the treatment of chronic non-infectious uveitis
affecting the posterior segment of the eye. Prior
to joining CoreRx, Inc., Mr. McMillan was at MDS
Pharma services in Tampa where he worked
as a manager of formulation development. In this
capacity he worked closely with clients to design
and execute formulation and process development
studies and was responsible for the technical transfer
and scale-up of prototype formulations to client
facilities. These prototype formulations included
IND, NDA, and ANDA development of various dosage
forms including but not limited to tablets (IR,
MR, SR, micro-tablets), capsules, creams, suspensions,
ointments, gels, lotions, ophthalmics, and parenterals
(IV and IM).
Manufacturing/Engineering
Mark
J. Licarde, Manufacturing
Mr. Licarde has an A.S. in
business systems technology. He is a very resourceful
individual with more than 25 years in the manufacturing
industry, which includes more than 15 years experience
in cGMP pharmaceutical manufacturing facilities. He
started his pharmaceutical career with Bristol Myers
Squibb as a maintenance mechanic and soon advanced into
technical procurement and inventory management. Later
in his career, he held the position of manufacturing
supervisor at UDL Laboratories (Mylan). Mr. Licarde
has been employed by MDS Pharma Services, Tampa (MDSPS),
for 8 years. As one of the original 12 employees
of this company, he played a key role in the start up
of this CRO facility. Through his tenure with MDSPS,
he has held various positions within the company to include
process/systems validation technician and manufacturing
supervisor. In addition to his technical and management
skills, his expertise incorporates a thorough working
knowledge of manufacturing and packaging processes for
solids, semi solids and liquids, business development,
project quotes, technical writing, equipment maintenance,
and design and implementation of preventative maintenance
and calibration programs.
Saurabh
(Rob) Trivedi, BS Engineering, Manufacturing
Mr.
Trivedi holds a BS in engineering from NJIT (NCE).
He has 13+ years of experience in the pharmaceutical
industry as well
as CRO facilities. He started his career as a building
automation/operations engineer at Schering-Plough
and was involved with all aspects of operations,
facilities, clean rooms, production, utilities,
automated systems, and engineering. Moving over
to the manufacturing world at Schering-Plough,
Mr. Trivedi impacted the tablet coating department,
utilizing his knowledge from his previous position
as an operations engineer. His knowledge of the
manufacturing process combined with the engineering
background led to his being promoted to special
projects supervisor. In this role, Mr. Trivedi
was the manufacturing representative for a new
$80MM manufacturing facility built at the Kenilworth,
NJ site headquarters for Schering-Plough. He was
involved in the designing, specifying, and selection
of coating and HSG manufacturing equipment, CIP
and USP systems, and all other associated systems
and supporting equipment. Mr. Trivedi played a
key role in the validation of the aforementioned
items in order to meet FDA timelines. Documentation
development and execution consisted of IQ/OQ/PQ
protocols, SOPs, implementation plans, SFATs, FATs,
SATs, regression testing, computer system validation
plans, and test summary reports. Mr. Trivedi joined
MDS Pharma Services (CRO), in January 2004 as the
manufacturing manager and is knowledgeable in manufacturing
various dosage forms with a vast working knowledge
of FDA, GMP, and CFR guidelines. He provided guidance
and support for the daily functions of the manufacturing
department.
|