Elijah Tan Email & Phone Number

SUMMARY: Demonstrated success in defining and implementing global regulatory CMC strategies to advance biological products including orphan products from preclinical studies to global marketing approvals (e.g. US, EU, Japan, Canada, Australia, etc.). Two decades of industry experience across multiple disciplines (immunology, oncology, hematology, ophthalmology) including pharmaceutical development, QA/QC, and more than 15 years in regulatory affairs (both generalist and CMC-focused regulatory roles). Strategic lead on numerous health authority meetings (e.g. with FDA/CDER and CBER, Health Canada, Japan PMDA, etc.) and EU scientific advice briefing packages. ACCOMPLISHMENTS: 1) Supporting initial BLAs/MAAs (Japan, Canada, EU, etc.) for several novel therapeutic proteins (e.g. monoclonal antibodies, fusion proteins, and enzymes) and biosimilars as adviser, author and/or interim regulatory lead. Advised on health authority meetings and authored several briefing packages. Contributed to several initial BLAs with recent approvals (2021-2023).2) Provided Japan regulatory CMC support as an interim lead for two commercial products, and an investigational orphan mAb product. Regulatory strategy lead on a CMC focused PMDA meeting package, and spent several months in Japan to support client's affiliate with PMDA filings.3) Provided strategic CMC guidance and other support on >20 investigational products (gene therapy, oncolytic vaccine, autologous cell therapy, allogeneic cell therapy, monoclonal antibodies, clotting factor fusion protein, bispecifics, allergenic substances, pegylated cytokine, pegylated enzymes, ADC, etc.) across various stages of clinical development and across multiple indications since 2018.4) Presented on behalf of client to client's board of directors on CMC risks and mitigations

Redwood City, Ca, Us

1) Global Regulatory Leader responsible for global licensing of adalimumab biosimilar. Responsible for all aspects (administrative, CMC, nonclinical and clinical) of the BLA/MAAs. 2) Led multiple health authority meetings including a pre-BLA meeting. Led/authored several EUCentralized Scientific Advice meeting packages and a pediatric study plan (iPSP).3) Regulatory leader (starting in 2018) on clinical aspects (Module 2 clinical summaries and CSRs) of Class 2 BLA resubmission for pegfilgrastim biosimilar following CRL, with subsequent approval in U.S. and Europe.

South San Francisco, California, Us

1) Supported 6 development products spanning multiple indications (immunology, dermatology, ophthalmology, and oncology) and a commercial biological product for intraocular administration. Acted as the global technical regulatory leader on 4 early-phase and late-phase development products and as technical regulatory advisor on 2 pre-clinical development candidates. Led the technical team on drafting of investigational product dossiers and on developing strategies for several health authority interactions (US and EU). Provided regulatory advice on global registrational strategies for late-phase development programs.2) Active member of Genentech/Roche IND/IMPD model document team.3) Secretarial role in the Biologics Regulatory Advisory Committee which is tasked with providing review of large molecule products within the entire Roche/Genentech network when issues of significant scope or importance to the portfolio occur.4) Supported Roche Technical Regulatory Policy and Intelligence group in mapping of FDA regulatory guidance documents to Module 3 CTD sections.

Cambridge, Ma, Us

Global RA-CMC strategic lead for a recombinant-derived coagulation factor product which achieved marketing approvals in multiple countries (US, Canada, Australia, etc.). Led BLA/NDS/MAA submission teams and developed strategy for pre-authorization consultation with global health authorities. Led CMC-focused pre-BLA and other meetings with CBER.

Cambridge, Ma, Us

Responsible for development and implementation of global regulatory strategy (clinical, non-clinical and CMC) for a recombinant derived coagulation factor product under the Biogen Idec Hemophilia business unit.Accomplishments/Activities:1) Led preparation of FDA Type B meeting briefing document on clinical study design / Phase 3 clinical protocol2) Primary FDA and Health Canada contact for a Phase 3 investigational product3) US orphan drug and Fast Track application preparation4) Led preparation of Phase 3 IND/CTAs (CMC, clinical and non-clinical) and management of submission teams5) Represented regulatory on various cross-functional project teams (core, clinical, CMC, supply, etc.)

Provided regulatory and quality consulting for pharmaceutical, biotechnology, and medical device companies.*Regulatory consultation and CTA/IND submission management for a recombinant peptide and a synthetic peptide product. *Regulatory/quality consultation for Class II (Class IIb for EU) medical devices including 510(k) strategy, device licencing strategies, review of technical files and quality systems procedures, post-market surveillance activities, and correspondences with health authorities.

New York, New York, Us

1) Compliance assessment of CMC dossiers/information registered with global health authorities for several key Wyeth Biotech products as part of a corporate initiative to streamline regulatory processes.2) High-level CMC content review and regulatory gap assessment for global biologics clinical trial, marketing authorization, and post-approval variation applications, including strategy role for several post-marketing manufacturing change supplements.

Boston, Ma, Us

Regulatory Affairs-Chemistry, Manufacturing & Control (CMC) strategist for small molecule investigational new drug candidates. Duties included consultation on, development of, and implementation of regulatory CMC strategy for product development and commercialization. Overall project lead and ultimately responsible for CMC submission content.

Boston, Ma, Us

Lead quality assurance and regulatory-CMC liaison of Pharmaceutical Development (PharmDev) division:* Led PharmDev Quality Lead Team (QLT) meetings.* Primary author for manufacturing sections of clinical trial applications.* Key functional player in design, implementation and optimization of various corporate-level quality systems including change management, document control, and training.* Functional Quality-by-Design (QbD) expert.* Primary authors of various guidelines and SOPs.

Rahway, New Jersey, Us

Quality Administration (August 2004 to August 2005)Analytical Method Development (Jan 2000 to Aug 2004)

M.S., Pharmaceutical Quality Assurance/Regulatory Affairs

B.S., Chemistry