Shyam Rele, Ph.D. Email and Phone Number
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Shyam is an experienced scientific professional with 19+ years of demonstrated history in Innovation and Core Technology Development of Enabling platforms, Product and Pipeline development for advancing investigational biologics and therapeutics. Shyam has led, managed and overseen technical ops. and product dev. activities for investigational HIV vaccines drug products including recombinant proteins, cell based self-assembling and synthetic polymer nanoparticle (NP) vaccines, plasmid DNA and mRNA-LNP vaccines, adjuvant acquisition and manufacturing processing activities. Shyam also led scientific and team execution of partner-funded & internal pipeline development of novel NP polysaccharide-protein conjugate vaccines targeting Strep. Pneumoniae, Typhoid Vi, and Hib-conjugate vaccine, viral Replicon delivery targets and systemic delivery of antisense oligonucleotides/siRNA therapeutics. Shyam has led Technical execution & Operations Management, Project management and Outsourcing activities with CDMOs and CROs; Prototype development for Drug Delivery Systems, Nano-/Micro-particle Technologies; Translating Early R&D to Preclinical IND-enabling development; CMC and Product development Lifecycle management including Cell line dev., Upstream/Downstream Process dev., Analytical methods and Formulation dev. for BDS and DP, Scale-up and Phase appropriate GMP Manufacturing, Fill Finish (aseptic, terminal sterilization) and BDS and DP Stability studies.Spearheaded feasibility studies of new technologies. Phase appropriate Technology Transfer and Methods packages for development.Supporting Quality Assurance activities for process compliance, monitoring CQAs, OOS, BDS and DP release; Participated in on-site Audits of CMOs/CROs and internal Quality Mapping sessions. Regulatory Science support and member of CMC subteams in preparation of CMC, Investigators Brochures (IB), Investigational New Drug (IND) filings for investigational biologics. Supporting Supply chain functions and technical oversight for BDS and DP storage, Stability studies, aligning Inventory management, stakeholder coordination and shipment.Working knowledge of Federal Contracts, Broad agency announcements (BAA), RFP solicitations. Managed multi-million-dollar Government Contracts, Development Projects, Grants, SBIRs. Reviewed CDAs and MTA agreements.Shyam also spearheaded technology scouting, emerging technology assessments, strategic initiative & planning development, capacity building, program management, partnership development, stakeholder & alliance management efforts.
Biomedical Advanced Research And Development Authority (Barda)
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Biomedical Advanced Research And Development Authority (Barda)Gaithersburg, Md, Us
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Hhs Senior Advisor (Aspr/Barda)U.S. Department Of Health And Human Services (Hhs) Jun 2022 - PresentWashington, District Of Columbia, Us- Serving as a senior expert and strategic advisor to support BARDA and newly reorganized ASPR (Administration of Strategic Preparedness and Response) mission and initiatives on 21st century health security threats. - SME on targeted interagency efforts for advancing Vaccine development and strategy for Project NextGen COVID vaccines and Pandemic Influenza and emerging infectious diseases (IEID) - Supporting enabling new and alternative delivery technologies & innovative routes of administration development efforts.- Developing strategy for rapid response capabilities for decentralized manufacturing/Vaccines on Demand with the vision to build end to end manufacturing- Product development, CMC/manufacturing SME on PCT teams to advance pandemic vaccines (RNA-based products), antiviral therapeutics/biologics (FASTx) and AI-driven diagnostics programs - Partnering and supporting the DRIVe/Launch Accelerator networks to identify and prioritize host targeted therapeutics and diagnostics, promising enabling technologies and countermeasures to tackle health security threats and sepsis.- Supporting agencies mission on future novel virus families/pandemic pathogen threats and broader federal capacity/sustainment working group/task force efforts.- Working Group thought leader/KOL, providing due diligence and competitive landscape analysis on new and emerging platforms, technologies and manufacturing processes to inform USG decision-making on mission specific initiatives/programs.(*Principal Associate / Senior TPM and SME | Shabas Solutions Inc.) -
Network AdvisorTedco Feb 2020 - PresentColumbia, Maryland, UsServing as an Advisor and resource to Maryland State’s technology-based entrepreneurs, start-ups and early stage technology and life sciences companies. Supporting entrepreneurial development and guidance to translational and technology-based research and strategy in Maryland’s innovation ecosystem. -
Editorial Board: Precision NanomedicineAndover House Inc Jan 2020 - Presenthttps://precisionnanomedicine.com/ -
Editorial Board: Nanomedicine: Nanotechnology, Biology & MedicineElsevier Jan 2020 - PresentAmsterdam, North Holland, Nlhttps://www.journals.elsevier.com/nanomedicine-nanotechnology-biology-and-medicine -
Principal Advisor, Biomedical Innovation, Emerging Technologies And Medical CountermeasuresMitre Jul 2020 - May 2022Mclean, Va, Us- Provide strategic, tactical, technical and operational guidance on large scale federal initiatives and programs.- Core team expert in developing strategy, analysis and models, conducting threat and courses of action for USG bio-industrial and biodefense base to sustain, preserve USG capabilities and global health security.- Resident technical and regulatory expert on Sponsor programs related to integrated biopharmaceutical product development life cycle and commercialization of multitude of biomedical product classes including small molecules and biologics, cell and gene therapies, medical countermeasures, and emerging technologies.- Provide guidance and educate federally funded biomedical innovators and SBIR/STTR innovators to optimize product development operations, provide real world industrial intelligence on viability of translational technologies and help facilitate navigation from laboratory-to-clinic. - Execute on mission critical workstreams, data analysis, modeling and development tools for modernization and digitization to meet various government sponsors and committees project specific requirements.- Current activities encompasses biopharma industry and biomedical research and development ecosystem at the interface of industry, government, and academia, supply chains and public-private partnerships; working across diverse organizational functions leveraging multi-stakeholder networks, effective engagement with KOL, partners and executive steering committee members through different MITRE-based health and security initiatives.- Core clinical science team lead on an initiative working directly with ASPR and Federal Response to COVID-19 initiative to address emerging and evolving needs in the area of mAb therapeutic utilization, safety and efficacy; assess real world evidence of therapeutic effectiveness vis-a-vis regional, national & global epidemiology of variants and provide critical intel on FDA regulations guidance for decision making. -
Senior Scientific Advisor, Product Development, Manufacturing, Strategy; Nih/Niaid, DaidsNational Institute Of Allergy And Infectious Diseases (Niaid) Jun 2016 - Jun 2020Rockville, Maryland, Us• Senior scientific & strategic advisor to Chief, Vaccine Translational Research Branch• Scientific, operational and portfolio management of multiple vaccine products, special projects.• Global Program/Project Leadership on innovation and emerging technologies (process dev., nanoparticle, LNPs & synthetic delivery systems, and adjuvant(s) codelivery and acquisition (TLR4, TLR7/8, Alum etc.).• Technical expert leading Outsourcing activities and projects through GMP manufacturing and product development, including oversight, review, and support phase appropriate QA input on various activities during clinical manufacturing of bulk drug substance and Drug product at CDMOs. Manage and support multi-million dollar outsourced NIH contracts, Task orders, activities.• Portfolio management of programmatic assets.• Capabilities development identifying and harnessing NIH resources and infrastructure • Strategic initiative development for prioritization, small business innovation research (SBIRs) and portfolio expansion.• Technology scouting, forecasting and competitive intelligence. • Creation of strategies for federal investments and value creation.• Stakeholder management and alliances – Partnered with PIs, CDMOs, CROs, non-profits, Clinical Trial networks (HVTN), various academic institutions and consortia. Collaborated across various vertical, lateral and matrixed functions within DAIDS.• Business development with potential partnering prospects.• Pre-audit discussions, SME for on-site GMP audits of CMOs/CROs for compliance.• Member of multiple CMC-related sub-teams. Review, editorialize and provide regulatory input on regulatory submission documents (IB, CMC IND sections, concept sheets etc.).• Participated in SAB and Scientific Review Committees of vaccine developers.• Authored multiple Task Orders, RTOPS, SOWS, technical documents and presentations.• Organized/Chaired 4 workshops and seminars. -
Sr. Translational Staff Scientist, Sme/Technical Lead, Vaccines & Biotherapeutics Master ContractsAbl Inc. May 2015 - Jun 2016Rockville, Md, UsInstitute of Merieux subsidiaryProvided scientific expertise and strategic guidance in translational and Integrated product development of vaccines and bio-therapeutics for infectious diseases.Collaborated with NIAID/DMID on Prime Integration Master Contracts to accelerate Vaccine Product Dev activities.Led oversight, assessment of candidate product dev. activities carried out either at ABL or at select CRO/CMO/vendors. Focussed on activities related to raw materials, Upstream/Downstream PD., analytical methods and formulation dev., GMP CTM manufacturing, tech transfer and outsourcing at/with external vendor/CMO/CRO. Liaised with Mfg., PD, QA, QC in monitoring internal/external technical operations. Worked closely with Scientific Director, Director of Translational Sciences, PMs, Contract Management to plan, direct, and manage internal/external projects deliverables & timelines. Prepared Product development plans (PDPs) to derisk potential technology platforms and products for NIAID decision making/funding. Partnered with BD/Marketing team to define strategy in preparation of Govt. funding and proposal opportunities.Principal Investigator, authored/reviewed SOWs, TO’s and multi-million dollar Master Contracts in Microbicides and Biomedical Prevention (CRMP, PI) and DAIDS Preclinical Master Contract (co-PI) – Contracts awarded to ABL in 2017. -
Director And Program Leader, Polysaccharide Protein Vaccines, Infectious Disease TargetsLiquidia Technologies Jun 2013 - Apr 2015Morrisville, Nc, UsReinvented and led Liquidia’s Vaccine R&D strategy, portfolio and product pipeline involving bio/polymeric nanoparticles codelivering polysaccharide/serotypes, protein antigens/carrier proteins and Replicon RNAs. Led development of multivalent PRINT nanoparticle vaccine carrying bacterial polysaccharide and protein antigens to induce broadly enhanced antibody and cellular responses. Expanded delivery/product strategy to other infectious and enteric disease/vaccine targets. Led R&D efforts involving discovery initiatives, technology assessments and analytics for development of novel nanoparticulate delivery formulations/platforms. Achieved and executed cost effective pilot scale and prototype processes suitable for manufacturing, scale-up and downstream development including formulation development, filtration and lyophilization. Accomplished fundamental nanofabrication and process learnings related to shape and size of nanoparticles, encapsulation versus surface strategies, molding of biopolymers/polymers, lipids and biologics, studied compositional flexibility, transition temperatures, pH and plasticity of materials and its effect on loading of actives, analytics, formulation, biodistribution and biological response. Responsible for driving scientific strategy, product ideation, platform technology and core knowledge development. Led matrix and discovery teams and served as expert on high-value collaborations/partnerships with PATH/BMGF, GSK, Abbott, Hilleman Lab. & academia. Proven ability to establish and expand partnerships that have tangible results that met milestones and deliverables. Led programmatic management, product strategy, development and planning and collaborated with functional leaders, Executive Leadership (CSO, VP’s, Founder) to identify, prioritize new product opportunities and partnerships for asset creation. -
Swat Team Lead - Gsk CollaborationLiquidia Technologies Mar 2014 - Sep 2014Morrisville, Nc, Us• Led team of coworkers to develop a rapid and effective solution for a complex and high value project (GSK vaccines).• Defined critical manufacturing, fabrication and processing conditions impacting hydrogel formulation, dissolution and end product properties.
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Principal Scientist And Program Leader; Nanoparticulate Vaccines, Infectious DiseaseLiquidia Technologies Apr 2011 - May 2013Morrisville, Nc, UsLeading Liquidia's external/internal virtual conjugate vaccine program for preclinical development of vaccines and targeted immunotherapies. Ideated and developed IP-enabling modular/flexible platform strategies, expanded target selection and cost-effective process rationalization and application of PRINT technology, advancing early POCs and late phase preclinical product and process development activities.Led collaboration with PATH/Gates Foundation for development of a prototype virtual-conjugate nanoparticulate vaccine.
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Senior Scientist & Technical Project Lead - Nanoparticulate Vaccines, Infectious DiseaseLiquidia Technologies Dec 2009 - Mar 2011Morrisville, Nc, UsEngineering new generation of nanoparticulate Conjugate Vaccines for providing effective protection against several bacterial diseases
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Senior Scientist/Sme Sirna Delivery, Nanoparticle Formulations, Optimization, Biophysical AssaysLiquidia Technologies Mar 2009 - Mar 2011Morrisville, Nc, UsRNAi Medicinal Chemistry, Drug Delivery using proprietery PRINT technology, and Nanomedicine
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Senior Scientist: Sirna Drug Delivery, Bioconjugation, Process Dev., Analytical Dev., Tech TransferCalando Pharmaceuticals (Now Arrowhead Pharmaceuticals, Inc.) Apr 2006 - Mar 2009- Phase I clinical stage nanobiotechnology company at the forefront of RNAi therapeutics and targeted nanoparticle drug delivery. Key member of a team of seven that advanced Calando Pharmaceuticals proprietary RONDEL(TM) delivery system and lead candidate CALAA01 – a transferrin targeted polymeric nanoparticle containing siRNA that was a first-in-class experimental therapeutic for cancer in a Phase I clinical trial - from bench to clinic in < 2 years. - Executed product development activities to drive early/preclinical development phases. - Led execution, optimization and production and conjugated Transferrin-PEG targeting ligand, and cyclodextrin-based polycationic polymer. - Led overall R&D efforts including chemistry and analytical development efforts for 2nd generation polymeric compositions for delivery of target siRNA for physicochemical, in vitro and in vivo evaluations.- Rationalized lab scale and scale-up process development for generation of IND-enabling TOX study materials - Established qualified Analytical methods (API, excipients) for characterization and testing. - Facilitated Tech Transfer and CMO interactions, oversaw and monitored CGMP Phase I clinical Trial material product manufacturing and scale-up campaigns (lab, pilot scale) at CMO sites including column purifications, process optimization, method development & characterization, quality and release testing and final fill-finish related activities.- Developed API and excipient analytical assay methods (HPLC-based, Gel Permeation chromatography) on monomers, polymers and for monitoring the kinetics of reaction for technology transfer to CMOs/CROs. - Executed stability, forced degradation studies using qualified assays and formulation development activities.
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Assistant ProfessorEmory University School Of Medicine Oct 2004 - Apr 2006Atlanta, Ga, UsFocus Areas: • Design of Synthetic Collagen Analogs and bio-inspired self–assembling peptides for Biomedical and Nanotechnological Applications. Investigated the potential of Collagen-mimetic peptides to recreate higher order assembly and biological function of natural collagens for biomedical/tissue engineering applications.• Role of multivalent sugars in endothelial leukocyte adhesion, inflammation, atherosclerosis and aneurysm formation.Evaluated molecular principles of multivalency for biorecognition by generating artificial multivalent sugar ligands to understand and manipulate carbohydrate-protein interactions. Focused on novel strategies to design glycoligands as synthetic decoys for developing therapeutic anti-inflammatory/anti-thrombotic agents to treat acute and chronic vascular diseases -
Nih-Funded Post-Doctoral Fellow And InstructorEmory University May 2001 - Jul 2004Atlanta, Ga, Us• Synthetic glycosaminoglycan and proteoglycan analogues (targeted Heparin and Hyaluronan GAG-mimetics). Developed methods to access chemically well-defined GAG-mimetics, multivalent structures and glycopolymers.• Synthesized Glycodendrimeric heparinoids as potent L-selectin specific antagonist and bioactive glycoclusters for chemical glycobiology.• Constructed hetero-bifunctional PEG linkers for selective conjugation to biological scaffolds/materials/surfaces.• Developed functionalized oligosaccharides with chemical handles/tethers (alkenes, alkynes, azides, amines, carboxylic acid, thiols) for glycoconjugation and glycobiological applications.• Examined extensively the reactivities of saccharide acceptor-donor partners in glycosylation reactions.• Regio- and chemo-selective protection/deprotection strategies to generate activated monosaccharide derivatives for multi-step oligosaccharide synthesis.
Shyam Rele, Ph.D. Skills
Shyam Rele, Ph.D. Education Details
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Emory University School Of MedicineBioengineering And Biomedical Engineering -
University Of MumbaiOrganic And Natural Product Chemistry
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Wilson College, University Of MumbaiChemistry
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Bs (90-93), Wilson College, University Of MumbaiChemistry
Frequently Asked Questions about Shyam Rele, Ph.D.
What company does Shyam Rele, Ph.D. work for?
Shyam Rele, Ph.D. works for Biomedical Advanced Research And Development Authority (Barda)
What is Shyam Rele, Ph.D.'s role at the current company?
Shyam Rele, Ph.D.'s current role is Global health security, pandemic preparedness | Drug delivery & Nanoparticles | Integrated Product & Innovation Dev. | Scientific Strategy | CMC & GMP Manufacturing | Product lifecycle | Technology Scouting, Partnerships.
What is Shyam Rele, Ph.D.'s email address?
Shyam Rele, Ph.D.'s email address is sh****@****hoo.com
What is Shyam Rele, Ph.D.'s direct phone number?
Shyam Rele, Ph.D.'s direct phone number is +191932*****
What schools did Shyam Rele, Ph.D. attend?
Shyam Rele, Ph.D. attended Emory University School Of Medicine, University Of Mumbai, Wilson College, University Of Mumbai, Bs (90-93), Wilson College, University Of Mumbai.
What are some of Shyam Rele, Ph.D.'s interests?
Shyam Rele, Ph.D. has interest in Writing, Table Tennis, Cooking, Badminton, Googling, Reading Fictioncollecting Books, Reading Fiction Collecting Books, Cricket, Painting, Racquet Ball.
What skills is Shyam Rele, Ph.D. known for?
Shyam Rele, Ph.D. has skills like R&d, Organic Synthesis, Life Sciences, Biotechnology, Formulation, Nanoparticles, Technology Transfer, Protein Chemistry, Drug Development, Pharmaceutical Industry, Clinical Development, Immunology.
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