Sambasivarao Tadepalli
Principal Scientist, Global Safety
Kalamazoo,USA
Summary
Skilled pharmaceutical professional with nearly 20 years of experience in the pharmaceutical organizations’ regulatory toxicology and R&D divisions and proven track record of successful project management. Superb multitasker able to handle multiple projects efficiently and accurately. Extensive capability of managing nonclinical studies at CROs, authoring regulatory documents, excellent communication skills as well as organization and time management skills.
Overview
19
19
years of professional experience
Work History
Principal Scientist, Global Safety
Dechra
01.2025 - Current
- Serves as the Safety Technical Lead in Project Teams to define and implement safety strategy.
- Has knowledge of regulatory requirements for safety and toxicology testing for new product development and serves as a resource for this information, ensuring that appropriate elements of safety and toxicity are addressed in data collected to support regulatory submissions.
- Directs and delivers the design, execution, interpretation, and reporting of safety studies.
- Responsible for the preparation of health risk assessments using where appropriate established requirements and the generation of toxicological data required to establish MOE, ADI, POD, and MRL values.
- Manages both internal and external resources (CROs) for the execution of safety strategies.
- Acts as Sponsor Representative and directs the design and scope of protocols to evaluate product safety in target and non-target species and interprets safety study data to ensure appropriate reflection of findings in study reports.
- Responsible for presentations or discussions with VMD, EMA, FDA and other relevant regulatory agencies on issues related to safety; prepares data reviews or position papers to resolve regulatory issues pertaining to drug safety.
- May aid in assessment of out of specification batches, safety assessments, E&L QRA evaluation, OELs, SDS preparation.
- Publishes research in peer reviewed publications, and presents research at internal and external scientific venues, as appropriate.
Regulatory Toxicologist/ Principal Research Scientist
CHARLES RIVER LABORATORIES
08.2021 - 01.2025
- As Principal Research Scientist, I was responsible for the overall planning and conduct of non-clinical investigations, in accordance with applicable regulatory guidelines (FDA GLP) and contemporary scientific practice.
- Study Management: Performed as a Study Director in the conduct of animal studies (small molecules, Biologics, Gene Therapy, Oligonucleotides, DNA and RNA) as described under GLP standards.
- Scientific Expertise and Regulatory Compliance: Interpreted, evaluated, and reported studies, and provided peer reviews; developed protocols, knowledgeable of advances in field of expertise, and ensured conduct of preclinical investigations, in accordance with applicable regulatory guidelines and contemporary scientific practice.
- Communications: Communicated both internally and externally in writing and verbally; consulted and negotiated with customers.
- Business Development: Consults and advises Sponsors on design, pricing, and scheduling of studies; maintains market and business development with potential and future clients with a focus on customer service; establishes on-going repeat business with an ever-increasing number of clients.
- Mentoring: Shared experiences with other Study Directors and company staff members to enhance their knowledge and skills.
- Process Improvement: Served on appropriate company process improvement teams.
- Supervisory role: manage junior scientific staff and conduct annual performance reviews.
- Regulatory: provide guidance on FDA and EPA guidelines and assist in FDA audits. Assisted in regulatory writing (INDs) and meetings with FDA.
Regulatory Toxicologist/ Senior Research Scientist
CHARLES RIVER LABORATORIES
01.2016 - 07.2021
- As Senior Research Scientist, I am responsible for the overall planning and conduct of non-clinical investigations, in accordance with applicable regulatory guidelines (FDA GLP) and contemporary scientific practice.
- Study Management: Performs as a Study Director in the conduct of study performance as described under GLP standards.
- Scientific Expertise and Regulatory Compliance: Interprets, evaluates, and reports studies, and provides peer reviews; develops protocols, remains knowledgeable of advances in field of expertise, and ensures conduct of preclinical investigations, in accordance with applicable regulatory guidelines and contemporary scientific practice.
- Communications: Communicates both internally and externally in writing and verbally; consult and negotiate with customers.
Biologicals Manager, US Biologicals VMRD GD&O
ZOETIS Inc.
01.2012 - 01.2015
- Designed and conducted - safety and efficacy studies for Swine Biologicals (PCV, M. hyo, PRRS, Rotavirus, Brachyspira etc.)
- Negotiated successfully with vendors to run the studies under budget.
- Provide Clinical support to global swine bios – US, EU and Asia Pacific.
- Member of project team(s) to develop and license swine Biologicals.
- Evaluation of new adjuvants and immunomodulators / technologies.
- Working Knowledge of regulatory requirements for licensing products in China, India and US.
- Ability to work in a highly matrix environment.
Principal Scientist
Novartis Animal health us, inc.
01.2011 - 12.2011
- Design Study protocols for conducting host and laboratory animal studies (efficacy, safety and post marketing), analyze the data and write technical reports for submission to Regulatory authorities (Ex. USDA- CVB).
- Identify and engage contract research organizations(CROs) and KOLs to support the research and development portfolio.
- Develop and successful implementation of project plans for on time delivery of products.
- Experience in recruiting and supervising scientists and lab interns.
- Drive innovation and quality at all stages for successful completion and on time delivery of projects.
- Technical Project Leader for all recombinant vaccines in Aqua, Cattle, Equine and Swine categories and biopharmaceutical products in cattle, swine.
- Evaluating novel delivery & vaccine technologies (Vectored vaccines, RNA platform).
- Successfully lead scientific and clinical study teams in discovery and development stages of new products.
- Determining the Developability of recombinant proteins including monoclonal antibodies for transition to development phase.
- Development of assays for product registration.
- Review product promotion material for use by sales force.
- Drive collaboration between Novartis Animal Health and other business units (Novartis Vaccines & Diagnostics (NV&D), Novartis Vaccines Institute for Global Health (NVHG) for sharing technical expertise and resources through Cross Functional teams.
Senior Research Scientist
Novartis Animal health us, inc.
08.2007 - 01.2011
- Lead development of recombinant bacterial protein expression platform by using off-patent genes aimed at reducing the COGs.
- Support molecular biology related tasks including but not limited to -Polymerase chain reaction (PCR), primer design, Real Time PCR, Quantitative PCR(Q-PCR), cloning, transformation, screening of clones, sequence confirmation of insert genes and optimize the recombinant protein expression, making glycerol stocks of clones.
- Provide diagnostic support for isolation and identification of field isolates (Vitek 2) as needed.
- Developed strategy for identification of potential virulence factors for Contagious (S. aureus) and Environmental Mastitis (E. coli, S. dysgalactiae, S. uberis) pathogens for further evaluation.
- Successfully completed the genome sequencing (80%) of environmental mastitis strains of S. dysgalactiae, S. uberis, and Clostridium perfringens Type A by employing novel shot gun sequencing method (454 Sequencing).
- Provided technical support to sequence the BAC clones of Parvovirus affecting swine.
- Provided molecular and technical guidance to Lead Finding in identification of potential antigen candidates in Porcine ETEC (Entero toxigenic E. coli) strains by Reverse Vaccinology Method.
- Trained in GLP /GCP /GMP quality system modules. Currently working under GLP /GCP like environment.
- Oversight of major scientific purchases (Nanodrop Spectrophotometer) to improve lab systems, compliant with quality systems, and reduce project lead times and COGs.
- Provide scientific input and update as R&D delegate to the International Project Team for novel vaccine development.
- Collaborate with the Lead Finding Team in identifying and evaluating potential antigen candidates.
- Member of Research / Marketing team to identify innovative drug delivery methods, identifying novel combination products, identify experts in specific disease(s) for engaging them early on for new product development or to generate data to support marketing of licensed products.
Education
Marketing Strategy for Business Leaders -
ECornell University
01-2011
Doctor of Philosophy (Ph.D.) - Veterinary Microbiology
Kansas State University
Manhattan, KS05-2007
Bachelor of Veterinary Science & Animal Husbandry (Equivalent to DVM) -
College of Veterinary Science, Acharya N.G. Ranga Agricultural University
Hyderabad, India01-1999
Skills
- Matrix environment expertise
- Cross-functional team coordination
- Collaborative mindset
- Innovative problem solving
- Quality assurance protocols
- Product development experience
- Team collaboration
- Attention to detail
- Multitasking abilities
- Biotechnology knowledge (gene nanobodies and monoclonal antibodies)
- Interpersonal communication skills
- FDA guidelines compliance
- Project safety representation
Affiliations
- American College of Toxicology
- Society of Toxicology
References
Available upon request
Publications
- Evaluation of Submental Blood Collection in Mice (Mus musculus), J Am Assoc Lab Anim Sci, 01/01/23, 62, 1, 92-98, 10.30802/AALAS-JAALAS-21-000136
- Complete Protection in Macaques Conferred by Purified Inactivated Zika Vaccine: Defining a Correlate of Protection, Scientific Reports, 01/01/20, 10, 3488, Ginger Young, Kelly J. Bohning, Melissa Zahralban-Steele, Greg Hather, Sambasivarao Tadepalli, Kristen Mickey, C. Steven Godin, Srisowmya Sanisetty, Stephanie Sonnberg, Hetal K. Patel, Hansi J. Dean
- Fusobacterium equinum possesses a leukotoxin gene and exhibits leukotoxin activity, Vet Microbiol, 02/24/08, 127, 1-2, 89-96, Sambasivarao Tadepalli, George C. Stewart, T.G. Nagaraja, Spencer S. Jang, Sanjeev K. Narayanan
- Leukotoxin operon and differential expressions of the leukotoxin gene in bovine Fusobacterium necrophorum subspecies, Anaerobe, 02/04/08, 14, 1, 13-8, Sambasivarao Tadepalli, George C Stewart, T G Nagaraja, Sanjeev K Narayanan
- Human Fusobacterium necrophorum strains have a leukotoxin gene and exhibit leukotoxic activity, J Med Microbiol, 02/01/08, 57, Pt 2, 225-31, Sambasivarao Tadepalli, George C Stewart, T G Nagaraja, Sanjeev K Narayanan
- Fusobacterium necrophorum: a ruminal bacterium that invades liver to cause abscesses in cattle, Anaerobe, 01/01/09, 15, 36–43, 10.1016/j.anaerobe.2008.05.005, Tadepalli S, Narayanan SK, Stewart GC, Chengappa MM, Nagaraja TG
Credentials
DVM PhD DABT
Timeline
Principal Scientist, Global Safety
Dechra
01.2025 - Current
Regulatory Toxicologist/ Principal Research Scientist
CHARLES RIVER LABORATORIES
08.2021 - 01.2025
Regulatory Toxicologist/ Senior Research Scientist
CHARLES RIVER LABORATORIES
01.2016 - 07.2021
Biologicals Manager, US Biologicals VMRD GD&O
ZOETIS Inc.
01.2012 - 01.2015
Principal Scientist
Novartis Animal health us, inc.
01.2011 - 12.2011
Senior Research Scientist
Novartis Animal health us, inc.
08.2007 - 01.2011
Marketing Strategy for Business Leaders -
ECornell University
Doctor of Philosophy (Ph.D.) - Veterinary Microbiology
Kansas State University
Bachelor of Veterinary Science & Animal Husbandry (Equivalent to DVM) -
College of Veterinary Science, Acharya N.G. Ranga Agricultural University