Surya Prakasarao Kovvasu
Summary
Scientist with 10+ years in oral and parenteral formulation development under 505(b)(1), 505(b)(2), and 505(j) pathways. Expertise in peptides, small molecules, and complex injectables. Skilled in preformulation, stability, analytical methods, scale-up, tech transfer, CMC documentation, and QbD/DoE-driven development, with proven cross-functional leadership in clinical and commercial programs.
Experienced with complex scientific methodologies and advanced data analysis. Utilizes interdisciplinary collaboration to drive research innovation and project success. Strong understanding of regulatory compliance and scientific integrity, ensuring high-quality outcomes in research initiatives.
Overview
14
14
years of professional experience
Work History
Sr. Principal Scientist
Padagis LLC
New Hope, MN
08.2024 - Current
- Leading oral GLP-1 peptide program (tablets with permeation enhancers); clinical study Q1 2026.
- Developing ophthalmic ointments (in-situ sterilization); exhibit batch planned 2025.
- Managing depot IM injection project (GnRH agonist) for oncology.
- Preparing CMC documentation to support ANDA filings.
Principal Scientist
Azurity Pharmaceuticals
Overland Park, KS
01.2023 - 08.2024
- Led formulation development of a controlled-release oral suspension for hypertension using spray-congealing technology; cGMP clinical batch manufactured at CDMO (Jun 2024).
- Directed [505(b)(2)] formulation development of an oral solution with a novel salt form for schizophrenia; prototype identified.
- Advanced [505(b)(2)] formulation development of an oral solution for refractory complex partial seizures and infantile spasm; Pre-IND submitted.
- Authored CMC documentation supporting NDA filings for oral suspensions (ADHD and epilepsy).
- Prepared PDRs and technology transfer documents; successfully transitioned projects to Hyderabad, India facility.
- Served as technical lead for a cross-functional team of four in formulation and analytical sciences, providing due diligence and guidance on [505(b)(2)] strategies.
Senior Formulation Scientist
AmbioPharm Inc.
North Augusta, SC
11.2020 - 01.2023
- Directed formulation, analytical development, and project management of a long-acting peptide gel injectable; Pre-IND submitted with FDA feedback (2021).
- Led development of sterile peptide drug–device injectables: osteoporosis (PV → US approval, Nov 2023) and type 2 diabetes (Exhibit/NCE-1, Dec 2021; PV/CRL responses → US approval, Oct 2024).
- Oversaw formulation and peptide characterization for sterile peptide injectables, serving as technical lead for a cross-functional team of five.
- Advanced lyophilized peptide injectable for short bowel syndrome (optimized formulation, lead prototype identified) and developed controlled-release GLP-1 biodegradable beads.
- Authored CMC sections and regulatory source documents (Pre-INDs, ANDAs, background packages); prepared PDRs, comparability reports, BMRs, and tech-transfer documentation.
- Consolidated physicochemical/biophysical peptide data and drafted readiness packages for Pre-IND (BLA) diabetes programs.
Research Investigator
Apicore LLC
North Brunswick, NJ
10.2019 - 10.2020
- Developed sterile powder injectable (oncology, validation batches) and ophthalmic suspension (glaucoma, tech transfer).
- Advanced lyophilized peptide injectables for prostate cancer and ovarian stimulation; identified stable prototypes.
- Designed [505(b)(2)] strategy for anticancer lyophilized injectable (liposarcoma, lead prototype identified).
- Established dissolution (Type II/IV), PSD, and viscosity methods for suspensions.
- Executed experimental design, data analysis, PDR review, and cross-functional study coordination.
Postdoctoral Researcher
Western University of Health Sciences
Pomona, CA
03.2015 - 09.2019
- Directed program management, formulation, and analytical development of poorly soluble drugs using advanced drug-delivery technologies.
- Developed and validated stability-indicating HPLC methods for anticancer IND (Pre-IND submitted).
- Advanced lyophilized liposomal formulations (anticancer, Ph 1/2A) and proliposomal capsules (male hypogonadism, Ph 1/2).
- Proposed and led a [505(b)(2)] sustained-release ADHD suspension (coating technologies, stable prototype, CDMO scale-up).
- Investigated cardiovascular drugs; identified lead liposomal/proliposomal formulations with improved Cmax in rat models.
- Developed nasal spray for erectile dysfunction (concept → pivotal clinical trial in 12 subjects; Pre-IND submitted).
- Completed formulation of fixed-dose combination tablets (loop diuretic + SGLT-2 inhibitor) for clinical studies.
- Optimized particle size to develop controlled-release corticosteroid injectable suspension; transferred technology.
- Scaled up liposomal and SLN formulations using microfluidic devices.
- Conducted in vitro dissolution (USP II & IV), transport (Caco-2, PAMPA), and in vivo ADME studies in rodents; analyzed with LC-MS/MS and PK modeling tools.
Assistant Manager
Aizant Drug Research Solutions
Hyderabad, India
11.2011 - 02.2015
- Authored CMC sections and tech transfer documents supporting 3 EU ANDA submissions (IR tablets, powder-filled capsules, MR pellets).
- Advanced product development to PDR stage (gastro-resistant tablets, IR capsules, IR tablets for NCE-1).
- Designed non-infringing controlled/sustained-release formulations through patent interpretation.
- Led formulation, scale-up, and tech transfer at internal sites and CMOs/CDMOs for BA/BE supplies.
- Applied QbD, risk analysis, and innovative technologies to process development, optimization, and transfer.
- Conducted preformulation, stability, packaging studies, and supported pilot BE studies per ICH GCP.
- Partnered with cross-functional teams (drug substance, supply chain, quality, regulatory).
Education
Ph.D. - Pharmaceutical Technology
Andhra University
M. Pharm. - Pharmaceutical Technology
Andhra University
Skills
- Solutions, Suspensions, lyophilized, depot, ophthalmics gels, Proliposomes
- Complex Injectables: Peptides, Small Molecules, Lipid-Based, and Long-Acting Systems
- Preformulation, Physicochemical & Biophysical Characterization
- Analytical Method Development (HPLC/UPLC, PSD, Dissolution, Rheology)
- Scale-Up, Process Optimization, and Technology Transfer (CDMO/CMO Management)
- CMC Documentation for IND, NDA, and ANDA Submissions
HIGHLIGHTS
- 40+ peer-reviewed publications & 11 conference presentations
- Contributor to US FDA-approved peptide injectables (2023–24)
- Hands-on experience with global CDMOs & regulatory agencies
- Recipient of UGC-JRF & AICTE Fellowship
Timeline
Sr. Principal Scientist
Padagis LLC
08.2024 - Current
Principal Scientist
Azurity Pharmaceuticals
01.2023 - 08.2024
Senior Formulation Scientist
AmbioPharm Inc.
11.2020 - 01.2023
Research Investigator
Apicore LLC
10.2019 - 10.2020
Postdoctoral Researcher
Western University of Health Sciences
03.2015 - 09.2019
Assistant Manager
Aizant Drug Research Solutions
11.2011 - 02.2015
M. Pharm. - Pharmaceutical Technology
Andhra University
Ph.D. - Pharmaceutical Technology
Andhra University