Takeda eBook - 2

Expert Roundtable Biographies
Mike Baratta currently serves as a

Takeda) for more than nine years, her role was develop-

Scientific Director/Chief of Staff for

ing challenge bioanalytical methods, outsourcing the

the Clinical Biomarker Innovation

methods to CROs and managing the methods to support

and Development group at Takeda

non-clinical and clinical studies. Dr. Cao received her

Pharmaceuticals in Cambridge, MA.

Ph.D. in Medicinal Chemistry from the LC-MS laboratory

He received his B.A. from Loyola

of Dr. Richard B. van Breemen at the University of Illinois

University of Chicago and a Master's Certificate in

at Chicago, and her B.S. in Chemistry from Xiangtan

Applied Healthcare Project Management from Villanova

University in China.  She is one of the members of the

University. Mike began his career as a member of the

Scientific Committee of Boston Pharmaceutical &

Global Drug Metabolism group at Pharmacia/G.D. Searle

BioScience Society, and a member of American

and transitioned to a Principal Scientist role with Pfizer

Association of Pharmaceutical Scientists for many years.

after closure of the merger. Prior to joining Takeda in

Dr. Cao has involved and supported many INDs and one

2013, he served as a Director on Nonclinical Develop-

MAA/NDA filing. Dr. Cao has published over 17 peer-

ment, Pharmacokinetics and Biometrics with Duck Flats

reviewed scientific papers, as well as many posters.

Pharma. Mike is a member of several FNIH biomarker
consortia, industry committees and is a NIH/NINDS translational research funding application reviewer.  Mike's
research focus is mass spectrometry based analytical
assay development and clinical validation of post translation biomarkers supporting patient characterization/
stratification strategies.  

Since 2008, Shashi Ramaiah has
been employed by Pfizer, overseeing
translational biomarker strategies for
developing innovative medicines.
Currently, Shashi is the Executive
Director and Global Head of Safety
Biomarkers and Translational Sciences within Drug Safety

Dr. Karen Cao is currently a

R&D at Pfizer Inc. In his current role, he is responsible

Principal Scientist at Alnylam

for Safety Biomarker activities across all DSRD sites and

Pharmaceuticals, she is responsi-

for establishing and maintaining scientific strategy and

ble for Bioanalytical Outsourcing

operations group across global biomarker groups. Shashi

which include method development

is leading several precompetitive consortia (IMI, PSTC)

and validation, sample analysis of

involving biomarkers and safety biomarker initiatives.

chromatography (mass spectrometry and HPLC) and
ligand binding assays (LBA) to support PK (pharmaco-

During his 20 years of combined academic and pharma-

kinetic), anti-drug antibody and biomarkers. Her role

ceutical industry experience, Shashi has delivered over 50

is teamwork with cross functional teams and CROs for

invited seminars and written more than 45 peer-

bioanalytical method development, method transfer,

reviewed publications and over 15 book chapters

method validation, sample analysis management,

including serving on editorial board of peer reviewed

and report review for nonclinical and clinical studies.

journals and leadership within scientific societies.

Prior to joining Alnylam, Dr. Cao worked for Shire (now

2	

A Clinical OMICs Sponsored Publication



Takeda eBook

Table of Contents for the Digital Edition of Takeda eBook

Takeda eBook - 1
Takeda eBook - 2
Takeda eBook - 3
Takeda eBook - 4
Takeda eBook - 5
Takeda eBook - 6
Takeda eBook - 7
Takeda eBook - 8
Takeda eBook - 9
Takeda eBook - 10
Takeda eBook - 11
Takeda eBook - 12
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