Naga Durgarao Koduri

13+ years of experience in working pharmaceutical and medical device industries for FDA and EU MDR Compliance. Expertise in Analytical, polymer, toxicology, and Organic chemistry. Expertise in ISO series/ technical standards/guidance documents (e.g., 10993, ICH M7(R1), ICH Q3C, ICH Q3D etc.).

Extensive experience in design and execution of Biocompiatability and extractables/leachable (E&L) studies for qualifying various medical devices such as IV therapy systems and Implanting devices.

Experienced scientific writer for compiling Biological Evaluation Reports for FDA and EU MDR submissions. Providing responses to FDA inquiries and participating in advanced FDA review processes in a fast-paced highly regulated environment.

Experience with writing toxicological safety evaluations for various E&L compounds several end points. Specialized in compound identification, chemical structure elucidation, quantification, and small molecule trace-level analysis. Mentored and leaded biocompatibility specialists in hazard identification/biocompatibility testing and risk assessment principles.

Experienced working with cross-functional development teams, external development organizations, and focused on the implementation of advanced analytical measurement and data analysis techniques in support of analytical method development and validation, drug degradation and stability E&L testing and structural elucidation of unknown compounds.

Experienced leading a group of highly focused scientists to evaluate the product needs and its interactions with components throughout the development lifecycle.

Principal Scientist/Team Lead, R&D, Sep 2022- Current

ICU Medical, Chicago, IL

• As a biocompatibility Subject Matter Expert, supporting the delivery of Biological Evaluation Report (BER) for FDA and EU MDR compliances.
• Review technical documents including Gap Assessment to determine the gaps. Writing technical plan and Biological Evaluation Report in compliance with ISO 10993 for FDA and the EU Medical Device Regulation MDR (2017/745).
• Coordinates chemical characterization and biological testing with CROs and internal laboratory to complete the testing requirements for FDA and EU MDR submission.
• Communicating with laboratory Scientists, Toxicologist, Engineers, Quality, Regulatory, Medical Affairs, Supplier Chain, and marketing representatives to ensure necessary inputs are available on time for FDA and EU MDR submissions.
• Review and respond to notified body inquiries. Participate in multiple team meetings for updates and to develop strategy for FDA and EU MDR remediation.

Principal Scientist/Team Lead (E&L), R&D, Jan 2020- Aug 2022

Hikma Pharmaceuticals, Bedford, OH

• Working as a Subject Matter Expert, primary role is to provide knowledge and insight on appropriate regulatory compliance strategies for parenteral and ophthalmic drug products (PODP) and orally inhaled and nasal drug products (OINDP).
• Designing and implementing strategies for risk assessment, characterization of extractables and leachables, elemental impurities, and characterization of mutagenic impurities.
• Performed several initial laboratory studies and manage the development and validation of analytical methodologies for long term leachable studies with CRO's.
• Initiates, designs, accurately interprets, troubleshoots, and completes non-routine extractable studies.
• Authored several EL risk assessment reports and other documents in support of regulatory submissions.
• Responsible for training and mentoring of junior staff in areas of the incumbents' subject matter expertise.
• Proposes, evaluates and implements new technologies based on scientific principles and regulatory knowledge; performs literature searches, attends scientific meetings, and keeps abreast of literature relevant to analytical science in product development.

Senior Scientist (E&L), Dec2018-Dec2019

Senior Analytical Chemist (E&L), Mar - Dec 2018

American Preclinical Services, Minneapolis, MN

• Provide subject matter expertise for biocompatibility/chemical characterization evaluations, validations for new products, existing product improvement, and new market introductions. Develop strategies for new product introductions for US FDA 510(k) submissions.
• Provides study design development and pre-study consultation with clients and scientific staff for biocompatibility/chemical characterization related projects.
• Assures adherence to protocol, protocol amendments, and SOPs throughout the conduct of studies. Assists in the coordination and execution of study conduct tasks from study initiation to study completion.
• Designed, implemented and managed various extractables and leachables projects for medical devices and product contact materials.
• Developed and validates analytical methods and protocols adhering to GLP guidelines, and develops stability indicating assays
• Operated a variety of chromatographic and spectroscopic systems such as LC, LC/MS/MS, ICP/MS, and GCMS to analyze biological and chemical elements as directed by assays or study protocols.
• Researches additional technologies, instruments, and assays for potential opportunities for growth in department business offerings.
• Leads projects in the laboratory, and acts as a resource for department team members for project guidance and trouble-shooting.
• Excellent knowledge and understanding of GLP, FDA, ISO 10993 standards, ISO 18562, biocompatibility principles and regulatory submission.
• Oversaw daily laboratory operations, set weekly targets and long-term goals. Supervised and trained other chemists and technicians to perform their duties and other assignments as needed.

Scientist III, Contractor, Apr 2016-Dec 2017

Sanofi Pasteur, Swiftwater, PA

• Designed and generated Extractables and Leachables (E&L) study methods according to cGMP guidelines.
• Authored protocols, and reports for quantification of product contact materials and single use components for extractables and leachables
• Developed analytical methods for trace level identification and quantification of E&L compounds using different chromatographic and mass spectrometry techniques such as GC/MS (Head-space, Direct injection), LC/MS/UV, and ICP-MS.
• Collaborated with a multidisciplinary team of subject matter experts to develop E&L strategies that align to regulatory requirements for different single use systems.
• Interfaces with internal partners and CRO's to interpret complex analytical data; including quantification, structural elucidation and toxicological assessment.

Analytical Research Chemist III, Feb 2015-Mar 2016

Spectrum Tracer Services (STS), Tulsa, OK

• Designed and conducted experiments leading to the development and, or optimization of various analytical methods (LC-MS, GC-MS, ICP-MS, UV-Vis, FTIR and NMR) for chemical tracers.
• Software experience with Empower, Xcalibur, Trace Finder, Mass Hunter, Chemstation, and ChemDraw

• Published several peer-reviewed scientific articles and gave conference presentations including American Chemical Society (ACS) national meetings and several E&L conferences
• Obtained research experience in a variety of reaction methods including Metal catalysis, Organo-catalysis, Sonochemistry. Synthesized a wide range of Enaminones and Chiral amines
• Training and lead the group of chemists. Proved team leader with excellent interpersonal and communication skills
• Conversant in the regulatory requirements and design experiments and draw meaningful conclusions from lab data for extractables and leachables

• Naga D Koduri ,Halee Scott, Bethany Hileman, Justin D. Cox, Michael Coffin, Lindsay Glicksberg and Syed R. Hussaini. "Ruthenium Catalyzed Synthesis of Enaminones". Org. Lett., Vol. 14, No. 2, 2012 ,440- 443.
• Naga D Koduri , Bethany Hileman, Justin D. Cox, Halee Scott, Phuong Hoang, Alexa Robbins, Kyle Bowers, Lemma Tsebaot, Kun Miao, Maria Castaneda, Michael Coffin, Guan Wei, Tim D. W. Claridge, Kenneth P. Roberts and Syed Raziullah Hussaini. "Acceleration of the Eschenmoser coupling reaction by sonication: efficient synthesis of enaminones". RSC Adv., 2013 ,3, 181–1883.
• Naga D. Koduri , Zhiguo Wang, Garrett Cannell, Michael Nguyen, Dragos Albinescu and Syed R. Hussaini. "Enaminones via ruthenium catalyzed coupling of thioamides and -diazocarbonyl compounds".J. Org. Chem, 2014 4.
• Megan L. Elliot, Kevin Thomas, Steven Kennedy, Naga D. Koduri, Syed R. Hussaini, Robert J. Sheaff. "Identification of Novel Proteasome Inhibitorsfrom an Enaminone Library", Chemical Biology & Drug Design, 2015 , 86(3), 322–3325.
• Arpal Pal, Naga D. Koduri , and Syed R. Hussaini. "Copper-catalyzed chemoselective cross-coupling reactionof thioamides and α-diazocarbonyl compounds: Synthesis of enaminones", Tetrahedron Letters, volume 58 (6), 2017 , 586–589
• Jim Secka, Mohamed K. Fakhr, David R. Wallace, Naga Koduri, Deacon Herndon, Kenneth P. Roberts, Zhiguo Wang,a Bethany Hileman, Nisha Rajagopal, and Syed R. Hussaini; Coupling of acceptor-substituted diazo compounds and tertiary thioamides: synthesis of enamino carbonyl compounds and their pharmacological evaluation. RSC Adv., 2022 ,12, 19431–19444.

* Bellwether Fellowship Award (UTulsa) 2014

Student Travel Award (Department of Research, UTulsa) 2013

* Travel grant (Graduate Student Association, UTulsa) 2013

* Chapman Student Travel Award (Graduate School, UTulsa) 2011

* Student Research Award (The office of Research and graduate studies, UTulsa) 2010-2012

* Summer Research Fellowship Highly competitive research fellowship, (sponsored by UTulsa) 2010