COVER LETTER

A total of 8+ years’ experience in the Drug Metabolism, Pharmacokinetics and preclinical formulation research

Establish DMPK lab and Design protocols, coordinate studies, interpret data/reporting, solve DMPK issues, and Optimize ADME properties of compounds in Lead to Candidate Selection.

Successfully led due diligence programs that resulted in out-licensing of several new chemical entities in the areas of Oncology, Obesity, pain and immune disorders.

Successfully generated several hits to leads, with saving significant costs and precious time and generated significant revenues to the companies as milestone payments.

Expertise in designing and interpreting in vitro and in vivo pharmacokinetic studies for small molecules

Sufficient knowledge and experience in pharmacokinetic-pharmacodynamics (PK-PD) modeling (Simple Emax, Bio phase distribution, Indirect response etc……) and simulations for early drug discovery

Expertise in design, conduct and interpret toxicology studies for preclinical compounds

Expertise in designing and development of preclinical formulations for New chemical entities

Expertise in projecting human pharmacokinetics and efficacious dose using PK-PD modeling, compartmental based pharmacokinetic approaches

SRINIVSASA RAO MADDI#207 Royal gardens, Near reliance mall, P.O. Nacharam, Secunderabad -500094

Contact: +919701166299 Email: daadmaddi@gmail.com; Linked In Profile: http://in.linkedin.com/pub/srinivas-maddi/15/756/aab

DRUG METABOLISM & PHARMACOKINETICS / DRUG HUNTER

Experienced and passionate drug discovery researcher, pursuing and having pursued diversified projects

CAREER OBJECTIVE

Be instrumental in improving the quality of life, to make a difference….

PROFILE Passionate, analytical, technically astute, diligent R&D professional with proven leadership skills in

drug discovery, with an experience of 6+ years post-PhD, currently spearheading discovery research with GVK Biosciences Pvt. Ltd.

Supporting Multiple Discovery Programmes, guiding a team of 5 DMPK scientists across all programmes. Responsible for three Oncology and one metabolic programmes in collaboration with US Pharma and mid size Biotech.

Experienced in setting up a DMPK Lab from scratch, from ordering consumables to instruments & subsequently validating all standard experiments

Scientific hands-on Skill set : In vivo PK studies (Rat, Mouse), In vitro ADME studies ( solubility, permeability, metabolic stability, CYP inhibition & induction), bioanalysis with API4000 triple quad, API 5500QTRP, PK/PD modeling

Drug Discovery experience: Integrated understanding of preclinical drug discovery research from medicinal chemistry to DMPK, HTS/Hit-to-lead, LO, pre clinical models to IND directed studies.

Character Traits: Deal confidently with difficult situations; highly motivated and transparent individual, passionate and single-minded in my pursuit of excellence. Zeal to learn and to keep abreast of new literature in the relevant field.

Belief: Believe that honest and intelligent approach with the right rationale will achieve success.

CAREER HIGHLIGHTS

GVK BIOSCIENCES PVT. LTD INDIAPrincipal Scientist since MAY 2013

Lead DMPK department with a Group of 7 scientists (including Ph.D.,M.Pharm) involved in evaluating in-vitro ADMET, in-vivo pharmacokinetics, pre-formulation and bio-analysis of small molecule drug candidates to support various therapeutic areas of drug discovery projects.

DMPK coordinator (completed 2; ongoing 6) for discovery collaborative and internal programs in the multiple therapeutic areas 

Directly responsible for designing, executing, and presenting scientific experiments within a program and contribute to manuscripts.

Work closely with chemistry, lead discovery evaluation, in-vivo pharmacology to advance compounds from lead optimization to preclinical development.

Prediction of human pharmacokinetic (Allometric) properties from in vivo data (preclinical species).

Serves as a DMPK representative for outsourced dog PK studies as a part of preclinical development for small molecule drug candidates.

Serves as a DMPK representative for service based DMPK studies Design and oversee in-vivo mouse, rat and dog pharmacokinetic and tissue distribution studies

(rodents) including dose range finding studies to support toxic kinetic studies Evaluate metabolic pathways and prediction of possible metabolites and proposing the structures

of metabolites that are observed in microsomes / hepatocytes Evaluate metabolite similarities/dissimilarities in different species to guide species selection for

the developmental toxicology studies Review and finalize the toxic kinetic component of the regulatory toxicity study protocols and

reports (including toxic kinetic data analysis and interpretation) Prepare Nonclinical Pharmacokinetics and Bio pharmaceutics sections of IND for regulatory

submissions. Review and finalize in-house PK study reports BRISTOL- MYERS SQUIBB & BIOCON R&D CENTRE (BBRC), INDIA FEB 2009 – MAY 2013 Senior Research Investigator

Support discovery teams as a drug metabolism and pharmacokinetic lead (nominated two small molecules into clinical development) in the area of immunology and neuroscience

Responsible to take strategic decisions and progression of NCEs for further advancement

Responsible for analyzing, interpreting and reporting pharmacokinetic data from pre-clinical studies 

Designing and interpreting in vitro and in vivo metabolic and pharmacokinetic studies for small molecules

Providing quantitative pharmacokinetic and pharmacodynamics modeling and simulation expertise to pre-clinical project

Expertise in projecting human pharmacokinetics and efficacious dose using PK-PD modeling, compartmental based pharmacokinetic approaches

Interacting cross-functionally with other departments including Medicinal chemistry, Pharmacology, Toxicology, Applied biotechnology, Formulation and clinical pharmacology for optimizing the drug able candidates

Explored new methodologies and techniques to address unmet problems and reduce the cost of drug discovery

Responsible for presenting the project update to discovery working group scientists in US

EURO DRUG LABORATORIES INDIA AUG 2002 – DEC 2004Research Scientist

Responsible for analytical method development and pharmacokinetic evaluation of formulations

EDUCATIONAL CREDENTIALS

Ph.D : Pharmaceutical sciences, DEC 2004 – SEP 2008 DAAD Sandwich Doctoral Program (Ph.D)School of Pharmacy,

Friedrich Schiller University, Jena, GERMANY. Supervisor: Prof. Gerhard Scriba &University college of Pharmaceutical Sciences, Kakatiya University, Warangal, INDIA.Major: Pharmaceutical Sciences Supervisor: Prof. Prof.Madhusudan Rao Yamsani Ph.D Thesis: Pharmacokinetics and Pharmacodynamics of Chiral drugs

Master of Pharmacy JUN 2000 – AUG 2002Department of Pharmaceutics (75% with distinction)University college of Pharmaceutical Sciences, Kakatiya University, Warangal, INDIA.Major: Pharmaceutical Sciences Thesis: Development & Evaluation of Buccal drug delivery systemsSupervisor: Prof.Madhusudan Rao Yamsani

Bachelor of Pharmacy, (78%) MAY 1995 – DEC 1999 University College of Pharmaceutical Sciences, Kakatiya University, Warangal, INDIA.

GATE examination-2000 – 99.89 % ile. (All India 4th rank)

PUBLICATIONS

Srinivas Maddi. Development of preclinical formulation for the Pharmacokinetic, Pharmacodynamics and toxicity studies of a highly selective plk2 inhibitor for the treatment of triple negative breast cancer (Manuscript under preparation)

Srinivas Maddi. Pharmacokinetics and pharmacodynamics of first-in-Class PLK2 Inhibitor, GBO-006 in animal models to predict clinical exposure (Manuscript under preparation)

Srinivas Maddi. Development of lipid based nanosuspensions for the Pharmacokinetics and pharmacodynamics of first-in-Class PLK2 inhibitor,GBO-006 (Manuscript under preparation)

Srinivas Maddi, Krishna Pocha, Sandya Mandlekar. Liquid chromatography–tandem mass spectroscopy for the separation of nateglinide enantiomers using chirobiotic-R column: Application for pharmacokinetics (Manuscript submitted)

Srinivas Maddi, Shravan Kumar Y, Edukondalu, Madhusudan Rao Yamsani, Scriba KE Gerhard. Stereoselective and regioselective transport of nateglinide enantiomers in the rat intestine: possible role of P- glycoprotein. Medicinal Chemistry Research, May 2013, Volume 22, Issue 5, pp 2403-2410

Srinivas Maddi, Madhusudan Rao Yamsani, Scriba K.E.Gerhard. Stereoselective binding of chiral anti-diabetic drug nateglinide to plasma proteins. Drug Metabol Drug Interact., PMID: 21732706

Chandramohan Ega, Srinivas Maddi, Madhusudan Rao Yamsani. A new validated chiral HPLC method for the separation of atenolol enantiomers in the pharmaceutical formulations. Int J Pharm Sci Rev& Res, 2010, Vol 4, 22-26.

Srinivas Maddi, Andreas Seeling, Madhusudan Rao Yamsani, Scriba K.E. Gerhard. Stereo Selective protein binding of amlodipine. Chirality, PMID: 19496159

Srinivas Maddi, Srisailam Keshetty, Chandramohan Ega, Madhusudan Rao Yamsani, Gerhard K.E.Scriba. Development and validation of Stereoselective HPLC method for the determination of in vitro transport of nateglinide enantiomers in rat intestine. J Sep Sci, PMID: 17638349

Rao BN, Srinivas Maddi, Kumar YS, Rao YM. Effect of silymarin on the oral bioavailability of ranitidine in healthy human volunteers. Drug Metabolism & Drug Interact., PMID: 17708067

PRESENTATIONS o Tirumaleshwar G, Srinivas M, Devanna N. Pharmacokinetic drug Interactions between

repaglinide and ritonavir innormal, diabetic and hepatic impairment rats. 2014 AAPS Annual Meeting & exposition (Poster)

o Srinivas Rao Maddi, Seetaraju Gembali, Jeyaraj Duraiswamy Athisayamani, Arnab Roy Chowdhury,

Nanosuspension-based Formulation development for the first-in-Class PLK2 inhibitor, GBO-006 toward IND-

enabling studies. 2014 ASCO Annual Meeting (Poster)o Srinivasa Rao Maddi, Arnab Roy Chowdhury, Athisayamani Jeyaraj,,Chandra Deb, Sayan Mitra,

M.V. Ramana Reddy, Shashidhar Jatiani, Manoj Maniar, Stephen C. Cosenza, Amol Padgaonkar,

Prem Kumar Reddy, Pharmacokinetics of PLK2 inhibitor GBO-006-1, developed as a novel first-in-class molecule to treat triple negative breast cancer. 2014 AACR Annual Meeting (Poster)

o Srinivas Maddi. Utility of minipumps in rodents to establish the PK-PD of NCEs in early drug discovery. 2012 DMPK symposium, NIPER, Chandigarh, India (oral)

o Srinivas Maddi, Rajbharan Yadav, Thanga Mariappann, SandhyaMandlekar. Blood Brain Barrier influx

measurement by in situ single pass brain Perfusion technique in rats. 2011 DMPK symposium, NIPER,

Chandigarh, India (oral)o Srinivas Maddi, Shailesh Dughaonkar, Satheesh Nair. Kinase Inhibitors for the treatment of

Inflammatory Disorders. 2010 Bristol Meyers Squibb Symposium , Bangalore, India (poster)

o Chandramohan.Ega, Srinivas.Maddi, Madhusudan .Yamsani. Formulation and in vitro evaluation of S-Atenolol sustained release floating drug delivery systems using natural gums. 2008 68th international congress of FIP , Basel, Switzerland (poster)

o Srinivas Maddi, Gerhard K.E. Scriba, Aparna Peerla, Chandramohan Ega, Madhusudan Rao Yamsani. Stereoselective and regioselective efflux of P-glycoprotein on the transport of nateglinide enantiomers across the rat intestine". 2007 Pharmaceutical world Congress, Amsterdam, Netherlands (poster)