T&T Scientific Add's a New Operation Chief for Improved Efficiency, Effectiveness, and Quality of Its Execution of Partnerships, GMP Manufacturing, as well as Novel New Formulation and Manufacturing Technologies

We are thrilled to introduce T&T Scientific’s new operation lead, Dr. Venkata M. Yenugonda, part of one of the earliest research groups worldwide working on Gene Therapies with targeted delivery during his Ph.D. and post-doctoral in pharmaceutical science. Dr. Yenugonda is an accomplished LNP drug discovery and delivery leader with broad experience across the science, technologies, business, and management sectors. Dr. Yenugonda has exhibited his strong judgment and decision-making skills in the context of critical go/no-go decisions within R&D programs during his career as a Scientist and Professor at the Saint John’s Cancer Institute. Highly motivated and hypothesis-driven application of state-of-the-art LNP platform technologies and automation to deliver innovative solutions to complex scientific problems across multiple drug project phases, including lead discovery, lead optimization, and IND enabling studies. He is also experienced and skilled in business development activities, including academic/pharma/CRO collaborations and evaluation of in-licensing and partnering opportunities. I have a thorough working knowledge and certification in the drug development process, including nonclinical pharmacology, CMC, drug substance (API), as well as drug product, and IND application frameworks. Listed in 3 Issued US patents, 2 PCT, 1 provisional patent, and 30 accepted manuscripts.

SELECTED ACCOMPLISHMENTS

Contributions to Science

  • Lead high-impact research across LNP delivery research programs, including lipid discovery (chemistry, SAR, largescale production to GMP standards (reproducibility, .etc.), DOE optimization of lipid formulations and quality control assays for characterization (size and PDI, charge and morphology), preclinical evaluation (specialized Pharmacology and toxicology studies, stability studies), and STED parameters to optimize the payload pharmacodynamics (cellular uptake, subcellular trafficking, and distribution), IND enabling studies (GLP toxicology and CMC).Ph.D.D in Lipid Medicinal Chemistry with excellent scientific contributions towards novel LNP discovery and formulation optimization, process development, and delivery a of variety of payloads (plasmid DNA, ,siRNA and small molecule) with a track record of peer review publications (PMID: 30936695, 30223393, 20050668, 19157538, 18347143, 15509171, 15267233, 11708919), Patents and Presentations.
  • Recipient of multiple awards in contribution to small molecule drug discovery and LNP drug delivery research, including the Best Research award during doctoral training, ACS SciMix poster presentation, SNO/EANO invited poster presentation, and the Gordon research conference travel award, and the Fellow of the national academy of
  • Led team to develop a first-in-class non-glycerol-based cationic lipids with improved gene delivery efficacy compared to commercially available
  • Completed industry collaborated project aimed at deveto developsostere (shikimic acid) based cationic lipoplex for targeted dendritic cell-based DNA vaccination. I am the co-inventor of a joint US granted the patent
  • First time demonstrated that single glycosylated cationic lipowas were sufficient to deliver payloads (Genes)the to liver compFDA-approvedapproved complex multivalent glycosylated (tri-GalNAC) liver targeted delivery
  • Develop anti-HER2 siRNA immunoliposomes for targeted HER2 expressed breast cancer
  • I am experienced in GLP and GMP standards toward llarge-scalepreparation of clinically active llipid-basednanocomplex (SGT-53, NCT02340156) formulations in collaboration with SynerGene Therapeutics, Inc.
  • Experienced in CMC component for IND package with injectable oil -based oil-basednanoemulsion formulation (SFCR001).
  • Strong biology and translation research background with cross-functional lipid medicinal chemistry and pharmacology experience enable me to design innovative patient-centric and science driven liposome drug product development screening

Contributions to Management and Leadership

  • Independently built the drug discovery and nanomedicine research program at Saint John’s Cancer Institute with a science-driven state of the art LNP synthesis and characterization
  • Track record of successfulcoachingg, mentorship ,and development of individuals and teams to build long-term organizational capability. Successfully trained more than a dozen students at various levels, from college interns, graduate students, technicians, and postdocs.
  • Excellent critical thinking and scientific acumen, with a demonstrated ability to analyze, interpret, and communicate (orally and in writing) complex data and their impact on the program and regulatory strategy.
  • Principal Investigator on several innovative CNS/Oncology drug delivery (LNP) grant proposals, ranging from inception through lead optimization and raised close to 2-million-dollar funds.
  • Project leader for LNP drug delivery projects at SJCI’s that deliver qudrugsy drug like IND liposomal drugs and nucleic acid products across the two therapeutic areas,s including Oncology and
    • Led team and directly discovered first-generation ALK Inhibitor liposomal nanoformulation.
    • Led team and directly discovered tumor-targeted liposomal drug/siRNA formulations for liver, prostate, and
    • Led team and directly discovered nano liposomal drug formulation for brain
  • Extensive experience interfacing with, providing scientific guidance to, and managing US domestic and international CRO partners for chemistry and pharmacology
  • Oversaw nonclinical pharmacology assessments, including ADME, DMPK, Biology-specific PD, PK/PD,and Biodistribution R&D programs across multiple drug project phases, including lead discovery, lead optimization, and IND enabling
  • Recipient of startup package award from Saint John’s Health foundation to build the drug discovery and nanomedicine research program at 

Certifications

  • Biopharmaceutical Development Certified Professional (BDCP) and Pharmaceutical Development Certified Professional (PDCP) from The Center for Professional Innovation & Education Inc (CfPIE), Malvern , PA,athesuccessful successfullylly creation of the below courses
    • Comprehensive Overview of FDA Regulatory Compliance for Drug and Biotech Products
    • ADME, PK/TK, and Drug Metabolism in Drug Discovery and Development
    • The Drug Development Process from Concept to Market
    • Preparing the CMC Section for NDAs/INDs/CTDs
  • Certification for Principles of Clinical Pharmacology from NIH Office of Clinical Research
  • Certification for Introduction to the Principles and Practice of Clinical Research from NIH Office of Clinical Research
  • Certification for CRISPR: Gene-editing Applications from HARVARD
  • PMP Certification Training training from Simplilearn

High Impact LNP Delivery Research:

More than 14+ years in academia with other industry collaboration experience supporting multidisciplinary LNP drug discovery and delivery projects, with a track record of delivering best-in-class liposome drug products. Extensive experience in discovering novel cationic and ionizable lipids for nucleic acid delivery. I am experienced in formulation optimization aspects, transfection, and dosing re and experienced in rigorous QC process and ADME/PK characterization of final liposome drug products, including drug substance (payload), lipids, nonlipid components of the liposomes (Cholesterol, PEG), Nanoliposome inactive ingredients (e.g., buffer components are experienced in applying STED (Spreading through and reaching appropriate cells in the target tissue, transduction efficiency) parameters to optimize payload pharmacodynamics.

High Impact Nonclinical Pharmacology Research: Comprehensive understanding and capability of the interplay between nonclinical pharmacology (ADME, DMPK, PK/PD, DDI risks) and toxicology methodologies to support early and late-stage lipid-based drug developmental programs. Extensive experiencin providingng scientific guidance o, and managing and manage both US domestic and international CRO partners for non-GLP and GLP pharmacology and safety studies. Proficient in designing and executing biodistribution and bioanalytical assay methods for biology-specific PD and target occupancy studies.

High Impact Clinical Drug Development Research: As a Center for Professional Innovation & Education (CfPIE) Pharmaceutical and biopharmaceutical Certified Professional, I have familiar with regulations, best practices, and regulatory guidelines in general (ICH, FDA, EMA) and expert knowledge of those related to nonclinical pharmaceutical product development. In addition, I have completed a certification course for Principles of Clinical Pharmacology from the NIH Office of Clinical Research. As a member of Saint John’s Cancer Institute’s translational and clinical advisory board, I have reviewed investigator-initiated and IRB clinical protocols related to the investigator’s Brochure document, involving strategic planning, and initiated corrective actions as needed.

PROFESSIONAL EXPERIENCE

Saint John’s Cancer Institute, Santa Monica, CA                                                                                                  2016-2022

A research institute dedicated to the understanding, diagnosis, and innovative treatment of cancer.

Director, Translational Experimental Therapeutics (TET) Research Program, 2018-Present Associate Professor, 2016-Present

Notable Team Achievements: 3 Patents | 10 Publications (Corresponding and Co-author) | Close to 2-million-dollar funds raised | Posters and Invited talks # 10| Poster Awards (2) and Cover Art (1) |Strategic Industry and Academic Collaborations # 7

 

  • I have built the TET (formerly Drug Discovery and Nanomedicine) research program at SJCI and aim to collaborate with internal and external clinicans, ath scientists on challenging drug discovery and delivery projects to maximize therapeutic effect and minimize adverse effects of therapeutic agents for rare or hard-to-treat
  • I have built a strong collaborative team within various scientific disciplines (medicinal chemistry, nano-pharmaceuticals, biology, and pharmacology) to achieve the project goals on time. Effectively manage and mentor >15 scientists, including direct reports,and academic and CRO collaboration engaged in discovery and development
  • Established strategic collaborationsdrovedrive innovative drug discovery FTE and FFS programs withCROCRO’s lead,ers incluing: Syngene International, Anthem Biosciencend Eurofins Advinus and DDNSlabs (for synthetic organic chemistry services) E,namine Bienta (for ADME and PK services) Reaction Biology, TD2, Altogen labs, Crownbio (for discovery biology services).
  • Actively collaborate with various academic labs at UCI and UAE (Dr David Mobley and Jerome Baudry, Computational Drug Discovery), James Graham Brown Cancer Center ( Dr. Yoannis Imbert-Fernadez, Breast Cancer), UT Health San Antonio( Dr. Sandeep Burma, Glioblastoma), Northwestern Lurie Children’s Hospital (Dr. Rintaro Hashizume, Pediatric high-grade glioma), Georgetown University Medical Center (Dr. Chris Albanese, Prostate and Medulloblastoma) and The Picower Institute (Dr. Li-Huei Tsai, Alzheimer’s Disease) to implement drug discovery biology
  • Member of SJCI’s translational and clinical advisory board and providing research direction,reviewingw IRB protocol, involving strategic plan,ning and initiating corrective actions as
  • Plan, execute and interpret translational drug discovery projects for a hit to lead optimization campaign

.They are protecting patent IP rights for innovative drug discovery ideas and due diligence review of licensing opportunities.

  • Ensure compliance with standard operating procedures (SOP) and project operations
  • Increase funding by submitting grant requests to private companies, nonprofits, and government

Georgetown Lombardi Comprehensive Cancer Center, Washington, DC                                                                       2005-2016

One of 40 comprehensive cancer centers in the U.S. and part of the prestigious Georgetown University Medical Center.

Adjunct Assistant Professor, Department of Oncology, 2016-Present

  • Advanced multidisciplinary cancer research, including cures for central nervous system (CNS) cancers and neurodegenerative diseases, by designing innovative novel small molecule therapeutics.
  • Instruct students enrolled in cancer and neuroscience drug discovery and development D. programs.

Research Instructor (Junior faculty), Center for Drug Discovery, 2011-2016

  • Mentoring unsolved synthetic chemistry problems for graduate and master students in various medicinal chemistry projects.

Documents achievement: Mentored KUSCO (Korea-US Science Cooperation) masters students on various drug discovery projects and a few trained students who were now pursuing their careers in the pharma/biotech industry and Ph.D. programs in Korea the, and mentored two graduate students

  • Engaged in GUMC’s collaborative drug discovery projects via planning and coordinating project goals and priorities, providing strategic direction, and designing key experiments to drive the projects forward. Documents achievement: I have been involved in two novel medicinal chemistry SAR projects towards leading the identification of small molecule inhibitors for DNA repair proteins such as MPG and TDP2 (Collaborators: Dr. Rabindra Roy, Dr. Sanjay Adhikhari), Working towards the development of novel compounds that selectively distrain nicotinic-brain nicotinic acetylcholine receptors (Collaborators: Kenneth Kellar and Dr. Milton Brown), gram-scale for the gram-scale synthesis of selected lead compounds developed by me (VMY-1-10.3, VMY-2-95…etc.) for preclinical development (Collaborators: Dr. Ed Levin, Dr. Chris Albanese).
  • They drafted papers and abstracts for peer-reviewed journals, grant applications, and patent

Documents achievement: I have submitted several PI and Co-PI grant applications (>20) on lead optimization and medicinal chemistry SAR studies. Some of them have decent scores from the NIH study section.

  • Delivered an experimental cancer drug VMY-1-103, targeting a novel cyclin-dependent (CDK)
  • We developed a neuronal nicotinic acetylcholine receptor (nAChRs) desensitizer for treating nicotine and alcohol
  • Achieved certification from the National Institutes of Health (NIH) in preclinical and clinical drug

Post-Doctoral Research Fellow, Drug Discovery Program, 2007-2011

Advisor: Milton L. Brown, MD, PhD

  • Completed extensive research in computational drug design, multi-step organic synthesis, and medium
  • We have developed novel therapeutic small molecules for cancer and CNS-related drug discovery
  • She stabilized p75 neurotrophic receptor upregulation by creating a potent lead small molecule via ligand-based
  • Synthesized compounds for various cancer and CNS protein and receptor targets, including Cadherin-11, cyclin-dependent kinase (CDK), and histone deacetylase’s (HDAC) nicotinic acetylcholine receptors.
  • I discovered preclinical therapeutics for treating medulloblastoma, triple-negative breast cancers, and CNS

Post-Doctoral Research Fellow, Cancer Nanotechnology, Department of Oncology, 2005-2007

Advisor: Esther H. Chang, PhD

  • Improved drug efficacy and reduced toxicity by optimizing delivery methods for cancer
  • Prepared liposomes, executed in vitro cancer assays, and developed in vivo cancer

Doctoral Research, 2000-2005

Indian Institute of Chemical Technology (IICT), Hyderabad, India.

Advisor: Arabinda Chaudhuri, Ph.D., FASc, FRSC

The dissertation title is “Design, synthesis and in vitro gene-delivery efficacies of novel glycofectins, glycomimicking cytofectins, and simple cationic amphiphiles.”

The first time they designed and synthesized non-glycerol-based cationic lipids (glycolipids) and demonstrated their high transfection efficiency compared with commercial

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