Nagendra Chemuturi Ph.D., MBA

Senior Director @ Eli Lilly and Company

About

A dynamic DMPK and Clinical Pharmacology Scientist with vast experience and a proven track record. Over 18 years of experience working with Gene therapies (viral and non-viral), non-oncology cell therapies, biotherapeutics (monoclonal antibodies, ADCs, antibody fragments) and small molecules. Expertise in multi-disciplinary project teams representation in drug discovery and development in hematology, CNS, pain, ophthalmic and oncology therapeutic areas. Proven leadership skills leading intra-company and external pan-industry working groups on topics like first in human (FIH) dosing strategies, novel modalities and ophthalmics. Mentored junior staff to achieve their potential Extensive experience in preparing regulatory documents (IND sections 2.6.4, 2.7.2, 2.7.1 & 2.6.5, IB, BD and support NDA and BLA filings) and interacting with regulatory agencies worldwide (FDA, Health Canada, TGA, PMDA, etc.) for gene therapies, biologics and small molecules. Additional experience with PK/PD analysis, defining therapeutic window, and prediction of human pharmacokinetics. Designing and implementing strategy for assessing ADME issues and addressing those using conventional and novel technologies. Adept at mentoring and developing junior staff, managing contractors and CROs. Lead efforts to innovate and developed partnerships with multiple disciplines to hunt for leads and explain mechanisms behind unexpected scientific findings. Adept at conducting due diligence on external assets.

Country

United States

City

Cambridge

Industry

Pharmaceuticals

Skill

Pharmacokinetics, Drug Metabolism, In Vitro, In Vivo, PK/PD Modeling and Simulation, Drug Discovery, IND Filing, Bioanalysis, Drug Development, Xenobiotic Transporters, Ophthalmology, Nasal Drug Delivery, CNS Drug Delivery, Pharmacology, LC-MS, IND, Biomarker Discovery, Pharmaceutical Research, ADME, Assay Development

Experience

Senior Director

Eli Lilly and Company

2023-8 - Present · 3 yrs 2 mos

Cambridge, Massachusetts, United States

Senior Director, Head of DMPK, Clinical Pharmacology and Pharmacometrics

Moderna

2022-10 - 2023-6 · 9 mos

Cambridge, Massachusetts, United States

Scientific Director Research

Takeda

2020-8 - 2022-11 · 2 yrs 4 mos

Cambridge, Massachusetts, United States

Viral and non-viral gene therapies Cell therapies

Senior Investigator-I

Novartis

2017-9 - 2022-11 · 5 yrs 3 mos

Cambridge, MA

Principal Pharmacokineticist

Seagen

2014-3 - 2017-8 · 3 yrs 6 mos

Bothell, WA

Represent DMPK on multi-disciplinary oncology teams all the way from discovery to development. Provide and execute DMPK strategy to help early research efforts in lead identification, optimization all the way to IND and beyond. Responsible for design and conduct of in vitro and in vivo DMPK studies including PKPD studies on antibodies, antibody drug conjugates (ADCs) and small molecules. Investigating the effect of physicochemical properties in ADC ADME. Extensive experience writing INDs (Sections 2.6.4, 2.6.5 and other documents). Mentored direct report and manage contractors and CROs.

Senior DMPK Study Director

Alcon

2011-2 - 2014-2 · 3 yrs 1 mo

Fort Worth, TX

Conducting in vitro and in vivo PKDM studies, including PKPD analysis, while representing PKDM on multi-disciplinary ophthalmology and nasal projects to move molecules into Development. Conduct pre-clincial PKPD studies and predict human PKPD. Developing and setting up in vitro PKDM studies focused on and targeted towards ocular drug delivery in a semi-high throughput mode.

Senior Scientist II

Alcon Research Ltd

2008-7 - 2011-4 · 2 yrs 10 mos

Conducting in vitro and in vivo PKDM studies, including PKPD analysis, while representing PKDM on multi-disciplinary Discovery projects to move molecules into Development. Developing and setting up in vitro PKDM studies focused on and targeted towards ocular drug delivery in a semi-high throughput mode. Mentoring direct reports to conduct PKDM studies.

Research Scientist-II and Research Scientist-I

Vertex Pharmaceuticals

2005-5 - 2008-7 · 3 yrs 3 mos

Was in Discovery DMPK doing drug metabolism studies as well as permeability studies. Set up multiple transporter assays based on permeability studies, ATPase and Calcein- AM to be conducted in a high throughput mode. Designed in vivo IV and PO PK screening studies as well as mechanistic studies to address issues arising out of needs of the projects. PKPD modeling to support discovery projects. Represented DMPK on discovery projects. Interacted with multiple disciplines to move projects to IND filing.

Senior Business Officer

Zydus-cadila

1998-1 - 1999-6 · 1 yr 6 mos

Hyderabad, Telangana, India

Provided clinical pharmacokinetic and drug metabolism data to specialists such as cardiologists, neurologists, nephrologists, and gynecologists on drugs including erythropoietin, interferon α-2a and human chorionic gonadotrophin.