NAME: Kamala Kalyani Maddali DVM , Ph.D.

Immigration status: Greencard holder

Address: *** *********** *****, ************, **, 18960

Phone: 215-***-**** (Home)/980-***-**** (Cell)

Email: fiog0h@r.postjobfree.com

EDUCATION:

2002-2005: Doctorate of Philosophy Ph.D. (Cardiovascular Pharmacology/Physiology), Biomedical Sciences, University of Missouri, Columbia, MO

1995-2001: Doctorate in Veterinary Medicine DVM, Andhra Pradesh Agricultural University, India

PROFESSIONAL EXPERIENCE:

2008-2010: Translational Scientist, Huntingdon Life Sciences, Princeton Research Center, East Millstone, NJ 08875

2005-2008: Research Associate- Pre clinical Development, Merck Research Laboratories, West Point, PA 19486

2002-2005: Graduate Research Assistant, Dept of Biomedical Sciences, University of Missouri-Columbia, MO 65211

2001: Intern Veterinarian, Veterinary Poly Clinic, Kurnool, AP, India-518001

DETAILED RESPONSIBILITIES:

Fields of experience:

Oncology/Cardiovascular/Diabetes/Neurology/Endocrine/Immunology

2008-2010: Translational Scientist, Huntingdon Life Sciences: This customer focused position acted as a “Scientific Liaison” for biomarker selection and analysis by providing strong scientific link between clients and analytical departments at Huntingdon Life Sciences’ UK and US facilities. Preclinical and clinical biomarker analyses were undertaken by genomics, MRI-PET tracers, Veridex (circulating tumour cells) CTCs, immunoassay, LC-MS, histopathology, mass spectrometry, and cell based assays.

Job Responsibilities:

Biomarker advisory services:

• Play a pivotal role as a Preclinical and Clinical R&D advisor (GLP/GCP) in recommending biomarker/personalized medicine (diagnostics) strategies and applications based on sponsor's small molecule/biologics drug development programs.

• Translating scientific or clinical data into high quality medical information to help clinical investigators best design their drug development programs.

• Responsible for the creation and ownership of a biomarker work plan (for clinical protocols) for clinical and preclinical phases by interacting with healthcare professionals/pharmaceutical investigators/physicians etc.

• Project management with Pharma/biotech clients to best understand client project objectives and goals

• Implement pricing/new technology strategies globally with in the company

• Scientifically translate client needs into effective research plan

• Execute research plan as part of a team including survey design, data analysis, and structuring of presentations and also responsible for professional review of the published literature as well as other sources of information to provide team members with timely summaries and critical evaluations of advances in basic and clinical programs.

Business Development activities: Act as a “consultant” in the following activities:

• Establish and maintains effective communication/coordination with sponsors, field sales, and managed market account representatives. Traveling to client sites and interacting with sponsors on a regular basis through communications, publication planning, slide decks, manuscript publications and marketing case studies

• Works closely with the global director of marketing/sales in regard to biomarkers/personalized medicine on the management of diverse R and D programs.

• Stays abreast with literature in the field and contributes to case studies, pricing strategies, forecasting markets, proposal writing, and other strategic development efforts.

• Identifies, interacts and maintains relationships with consultants, vendors and KOLs in the arena of biomarkers/personalized medicine field involving pharmaceutical/biopharmaceutical clients.

• Represented HLS at several national scientific meetings (ASCO, DIA, SOT etc.). Business development through customized presentations and creating distinctive marketing materials for HLS Biomarker services.

• Matrix involvement with four “Analytical groups” with 6 PhD’s involving Flow cytometry/Immunoassay/Clinical Pathology/Mass Spec/Histopathology/Immunohistochemistry.

Process Improvements:

• Create a Business Biomarker Proposal Process for initial communication with the clients and a hand-off of the project to Operations group.

• Create a formal feedback mechanism for client communication and measurement of client satisfaction by initiating monthly "Process Improvement" meetings between Operations and Business Development.

2005-2008: Research Associate, Merck Research Laboratories

1. Development of in vivo pharmacology and toxicity models that can be used to screen drug development candidates; leading to go/no-go decisions. Work with researchers on study designs during lead optimization of the drug development process. Experience working in the area of cancer (knock-out mice models), metabolic disorders (diabetes, obesity, atherosclerosis), cardiovascular, inflammatory diseases.

2. Formulate and execute novel strategies to decrease attrition of drug development candidates due to toxicity.

3. Plan experimental approaches (GLP/Non-GLP) to gain mechanistic understanding around safety signals observed in preclinical toxicity studies and place in context of human risk.

4. Develop translatable biomarkers to effectively monitor and manage safety in humans.

5. Identify the key routes to translate in vitro observations into whole animal studies to provide in vivo Proof of Concept/ Proof of Mechanism for novel therapeutic candidates.

6. Identify efficacy markers (“biomarkers”) in animal models (oncology/endocrine/cardiovascular) which may be translatable into human studies and ensure that these are appropriately examined in translational approaches.

7. Dotted line supervision of a laboratory (with 4-5 scientific staff) for biomarkers (Molecular Diagnostics Lab) and training technical staff in newly introduced techniques (through IHC/RT-PCR/Luminex/Meso-scale/Veridex (CTCs); etc). Interactions with local lab leads & scientists from Discovery and Safety Assessment groups.

8. Key role in the oncology, inflammatory and myotox biomarker committees tasked with the identification and validation of safety biomarkers.

9. Translational animal model experience working in the area of oncology, neuroscience, metabolic disorders (diabetes, obesity, atherosclerosis), cardiovascular, endocrine disorders, inflammation, hypertension.

a. Oncology models

b. Neuroscience models-Alzhimers/Parkinsons/Sleep Apnea

c. Cardiovascular models- Atherosclerosis/Restenosis models

d. Obesity models – Primates- Rhesus, Cynologous Monkeys; Rats, Mice, Marmosets

e. Respiratory models-Cough model

f. Inflammatory models.

10. Development, validation, and implementation of technologies that include:

a. Veridex/CTC

b. MRI/PET Imaging

c. FLIPR

d. MSD/Luminex

e. Flow Cytometry

f. LC-MS

g. Confocal microscopy

h. Electron microscopy

i. RT-PCR

j. Immunoprecipitation

k. Immunohistochemistry

l. Laser Capture Micro dissection

m. Western Blots

¬¬¬

2002-2005: Graduate Research Assistant, University of Missouri-Columbia, MO 65211

Thesis Title: A Mandatory requirement of PKC-delta in testosterone regulated smooth muscle cell differentiation, proliferation, and apoptosis

• Training in porcine and rat models of atherosclerosis and restenosis

• Investigated the role of inflammation and protein trafficking in coronary heart disease utilizing in vivo and ex-vivo porcine models and cell based assays

• Delineating the role of various cell cycle proteins (positive and negative cell cycle regulators), apoptotic proteins, signalling pathways like PKC, MAP kinase, and lipid and lipoprotein metabolism in the regression of coronary plaques in porcine disease models.

• 4 year extensive training in various in vivo and in vitro techniques such as primary cell cultures, western blots, flow cytometry, confocal microscopy, siRNA based gene knockouts, immunohistochemistry etc.

2001: Intern Research Veterinarian, Veterinary Poly Clinic, Kurnool, AP, India-518001

GRANTS AND AWARDS: 2005: American Heart Association Heartland Affiliate: $ 50,000

Grant Title: “Testosterone Regulation of Coronary Smooth Muscle Cell Differentiation and Proliferation”

PUBLICATIONS AND PRESENTATIONS:

K.K. Maddali- “Invited speaker for Association of Inhalation Toxicology, Germany-Biomarkers in COPD”, October 2010.

K.K. Maddali- “Invited speaker for AECCP, Verona, Italy-Translational strategies for cardiac biomarkers”, Sep 2010.

K.K.Maddali, Sample processing and Biomarker analysis”. Webinar for ACRP, 2009.

K.K. Maddali- “It is time to implement an early renal toxicity biomarker strategy”, Developments in Life Sciences (HLS internal journal), Vol. 9, No. 1.

K. K. Maddali, C. I. Starks, C. McDonough, J. Dharmadhikari, B. A. Litzenberger Bone biomarkers significantly enhances the predictability of preclinical study outcomes and translation to first in man studies targeted towards osteoporosis. AACC National Meeting, 2009.

KK Maddali, IT Rogers, SL Motzel D Connor H Klein Development of Cough model in Guinea Pigs National AALAS, Charlotte, NC 2007.

KK Maddali, IT Rogers, SL Motzel D Connor, H Klein Development and validation of Biomarkers in Rhesus monkey model of Diet induced obesity, ENDO, Canada, 2007.

D. K. Bowles, K. K. Maddali, V. C. Dhulipala, and D. H. Korzick PKC-delta mediates anti-proliferative, pro-apoptic effects of testosterone on coronary smooth muscle. Am J Physiol Cell Physiol, August 2007; 293(2): C805 - C813.

KK Maddali, IT Rogers, SL Motzel D Connor, H Klein Metabalonomic markers in obesity monkey models, ENDO, San Diego, 2006.

KK Maddali, DH Korzick, JR Turk and DK Bowles. Isoform-specific modulation of coronary PKC by glucocorticoids. Vascular Pharmacology. 2005 42:153-162.

KK Maddali, DH Korzick, Tharp DL and DK Bowles. PKC-delta mediates testosterone-induced increases in coronary smooth muscle Cav1.2. J Biol Chem. 2005 Dec 30;280(52):43024-9. Epub 2005 Oct 21.

KK Maddali, Donna Korzick and Douglas K. Bowles. Testosterone alters coronary proliferation through PKC-delta mediated mechanism. Experimental Biology, 2005. FASEB J.

KK Maddali, Donna Korzick and Douglas K. Bowles. Testosterone alters coronary apoptosis through PKC- , delta mediated mechanism. Experimental Biology, 2005. FASEB J.

Vamsidhara C. Dhulipala, KK Maddali, Wade V. Welshons and Chada S. Reddy. Effects of Secalonic acid-D toxin, on murine palatal mesenchymal cell cycle. Developmental and Reproductive Toxicology, Birth defects Journal, 2005, June ;74(3):233-42.

Bowles DK, Cl Heaps, JR Turk, KK Maddali, EM Price. Hypercholesterolemia inhibits L-type calcium channel current in coronary macro-, not micro circulation. Journal of Applied Physiology, 2004 June; 96(6):2240-8.

Bowles DK, KK Maddali, VK Ganjam, LJ Rubin, DL Tharp and CL Heaps. Endogenous testosterone increases L-type Ca2+ channel expression in porcine coronary smooth muscle. American Journal of Physiology – Heart and Circulatory Physiology, 2004 Nov; 287(5):H2091-8.

KK Maddali, Donna Korzick and Douglas K. Bowles. Testosterone alters coronary PKC- delta expression and PKC-mediated Voltage gated calcium channel expression, 6587, Experimental Biology, 2004.

KK Maddali, Donna Korzick and Douglas K. Bowles. Effect of glucocorticoids on PKC isoform expression in porcine coronary arteries, 6330, Experimental Biology, 2003.

REFERENCES: Provided upon request

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