Sheng Song

 As a Global Regulatory lead, drove regulatory strategies and conducted scenario-based risk benefit analyses to advise the global program team/senior stakeholders on how to optimally position and approach to critical issues as well as leveraging advantages and interactions with global health authorities as part of the product lifecycle management.  Hands-on experiences to lead and make regulatory fillings (e.g., IND/CTA and amendments, NDA, MAA, DMF), as well as health authority interactions (FDA, EMA, PMDA), ensuring adherence to regulatory project timelines.  Converted TPP and CDP into actionable regulatory deliverables, including drafting and reviewing Pre-IND briefing document, IND package, clinical amendment, fast track designations etc to meet programs’ milestone goals.  Led a consorted group of cross-functional teams to evaluate current submission management system and identify gap to build a fit-for-purpose RIM system with updated SOPs, eCTD templates, and coached team members. This increases the agility and durability when company expands to uncharted territories dealing with external partners and service providers.  Acted as a SME to proactively advise on PK, PD, Tox and CMC related issues in the science advisory committee review meetings for senior stakeholders as well as gave critical feedback and suggestions in collaborative review meetings at project level to improve the overall quality of briefing documents, IB, GIP, and protocols, etc, are sound and strong to substantiate durable company positions and live up to the authorities' standards.

 Developed the regulatory strategies of four INDs (OQL011, -036, -051, -025) in US and other ICH countries to safeguard preclinical, CMC, clinical development adequacy for the regulatory fillings;  Provided proactive portfolio management with risk-benefit assessment against current TPL/TPP concept and advised investment decisions on BD and license-in/out for the stakeholders;  Led cross-functional teams as a program lead to execute detail-oriented plans with extensive collaborations and ensure GXP compliant for the clinical trial development;  Initiated and engaged with US FDA and other authorities in PreIND meetings (Type B/C/INTERACT) and correspondences to seek scientific advice and address feedback (RFIs) for the product development;  Built regulatory information system and scaled up the internal capability and durability across the functional teams to achieve project milestones and team maturity.

 Developed and reviewed key regulatory documents (IB, PSP/PIP, ODD, and EOP2/SA briefing document to FDA/EMA) with collaborations of global cross-functional teams to support marketing approval applications (MAA) for two first-in-class biologic drugs: anifrolumab (Saphnelo, type 1 interferon inhibitor for SLE) and tezepelumab (Tezspire, TSLP inhibitor for asthma );  Managed the development and implementation of existing data to support subsequent indications after the initial approvals, at both regional and global level to maximize regulatory success;  Supported Health Authority interactions with many different Agencies, e.g., US FDA, EMA, China NMPA, Japan PMDA, wherever assigned;  Performed risk-benefit assessment and planned the global submissions under scope of target product profile (TPP) to leverage advantageous labeling in keeping with the properties of the products and the needs identified by the business, market and patients;  Conducted due diligence advising and researching on all other assigned projects, such as regulatory defense strategy for post-approval commitments, FDA advisory committee meetings, early access program, investigator-initiated research, as well as portfolio reviews in respiratory and inflammatory therapeutic areas.

- Built regulatory affairs infrastructure and team to expand long-term internal RA capacities/capabilities in US; - As a Global Regulatory Lead -GRL, directed and drafted varieties of regulatory filings (CMC, preclinical, and clinical amendment, IB, DSUR, etc) for INDs and amendments to the FDA with absolute oversight and leadership in aggressive timelines; - Provided direct insights and strategies for cross-functional groups including CMC, preclinical, clinical offices, CROs, as well as other key stakeholders to ensure planned deliverables; - Led and prepared PIND meeting materials as well as a main point of contact for FDA communications whenever needed ; - Proactively advised and fast-reacted to various submission deliverables even in most stressing and demanding environments and global crisis; - Leveraged evidence-based outcomes and evaluating science-driven clinical design to navigate potential expedited pathways (orphan drug designations, breakthrough designations, priority review) intended for accelerated drug approval.

Regulatory Strategy Role: -Actively contributed to the development of regulatory strategies for new products and biosimilars in Investigational New Drug (IND) through drafting, reviewing, and revising sections in but not limited to Chemistry, Manufacturing and Control (CMC) and nonclinical studies; -Prepared and reviewed key regulatory modules in INDs, BLA, and pre-IND (BIA/BPD) meeting packages to ICH member Health Agencies, and engaged discussions with FDA when needed; -Advised proactively with in-depth breadth of RA understanding, both domestically and internationally, in support of CMC related development activities and submissions, without losing focuses on global competitive landscape, regulatory environment, and development strategies; Project Lead Role: -Participated in and/or led cross-functional teams, including but not limited to, contract research organizations (CROs), subject matter experts, global RAs, R&D, product development, to ensure timely submission with regulatory compliance; -Initiated, planned, and oversighted product development for projects at various stages from early preclinical studies to late P3 clinical trials, setting reasonable resource allocations and executable milestoned timelines. Regulatory CMC Role: -Performed risk assessment for any CMC change from regulatory perspectives on pre-and post-approval products, with mitigation strategies and impact analysis to make informed decisions.

 Authored and filed regulatory submissions for INDs, CTAs, BLA and NDA, including information amendments (CMC and preclinical/clinical), Structured Product Labeling, Annual Reports, and IB to global health agencies;  Evaluated preclinical data and provided consultations allowing fast and reliable entry of investigational products (IP) in clinical trial, which efficiently lowered and redistributed the valuable front cost to other functional areas during early stage of development;  Provided regulatory intelligence and technical advice in all CMC-related functional areas and drug development activities to ensure quality safety of IPs, such as specifications, analytical methods/validations, excipients selections, in-process controls, and stability programs;  Prepared pre-IND meetings package, drafted point-to-point responses to address FDA comments during the meeting discussions, and provided meeting minutes to stakeholders after meetings;  In-depth evaluated overall development status of investigative products with fact-checked analysis to navigate regulatory options, optimize operation plans, and mitigate potential risks;  Maximally leveraged available resources to address internal and external stakeholders’ demands, by resolving conflicts and overcoming obstacles.

Bioanalyical method development with state of art instruments for advanced biosystems and biomaterial engineering.

Legal, Regulatory and scientific due diligence for patent filing and competitive landscape evaluation within the university biomedical center and graduate schools.

Perform environmental chemistry detection and measurements for trace chemical substances collected from natural water sources surrounding great Boston area.

Extend and push the scientific understanding of serum protein adsorptions on size-tuned nanostructures, by applying real-time single-molecule spectroscopy and methodology derived from biophysics, nanotechnology and surface chemistry.