David Tan Email & Phone Number

Boston, MA, US

North Chicago, Illinois, US

• Lead the global and matrix CMC teams on developing and executing asset specific integrated CMC strategies across drug substance, drug product, analytical, quality, regulatory, and clinical supplies.
• Accountable for managing multiple assets from large and small molecules across various stages of pharmaceutical development ranging from candidate selection, First-In-Human, and pivotal clinical studies, to intended.
• Represent the CMC teams and collaborate cross functionally with stakeholders such as Clinical, Commercial, Regulatory, Clinical Pharmacology, Toxicology, and many others.

North Chicago, Illinois, US

• CMC drug product development lead for monoclonal antibody (mAb), antibody drug conjugate (ADC), small molecule parenteral, and aesthetics product.
• Development Team Lead (DTL) for two small molecule oral drug products and lead the global and matrix CMC teams to ensure effective execution of CMC strategies.
• Coordinates the review of control strategy, specifications, and regulatory story board.

North Chicago, Illinois, US

• CMC Formulation development project lead. Led the technology transfer of clinical formulations to commercial manufacturing sites and enabled timely readiness for New Drug Application (NDA) and Market Authorisation.
• Addressed CMC Formulation related regulatory responses from multiple agencies (e.g. FDA, EMA, PMDA, etc.) to enable timely approval of an extended release drug product.
• Recognized with "Development Sciences Astound Award” by Senior Director and “R&D President's Award” for project leadership and outstanding contributions.
• Represents AbbVie in pediatric related consortia.

North Chicago, Illinois, US

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• CMC Formulation development project lead. Led the development of clinical formulations and Investigational New Drug Application (IND) and Investigational Medicinal Product Dossier (IMPD) to enable clinical studies.
• Supported activities to enable New Drug Application (NDA) and Market Authorisation Applications (MAA) submissions.
• Led the interaction and project coordination with contract development and manufacturing organization (CDMO)
• Representative for AbbVie's Pediatric Taskforce

North Chicago, Illinois, US

• CMC Formulation development project lead.
• Led the development of clinical formulations and Investigational New Drug Application (IND) and Investigational Medicinal Product Dossier (IMPD) to enable clinical studies.
• Recognized with "Development Sciences Astound Award” and “Special Projects Discretionary Incentive Award” by Vice Presidents for establishing the Pediatric Expert Council (a cross-functional pediatric strategy team).

• Led the Working Group consisting of representatives from multiple pharmaceutical companies to collaboratively advance pediatric formulation development through regulatory harmonization and sharing of best practices.
• Recognized with “IQ Consortium Recognition Award” for three consecutive years for strong leadership of the Working Group and outstanding contributions.
• Co-chaired a two-day workshop in collaboration with U.S. Food and Drug Administration (FDA) and University of Maryland Center of Excellence in Regulatory Science and Innovations (M-CERSI) attended by 123 participants.
• Co-chaired the pediatric webinar series that serve as an online platform for a pre-competitive interaction and collaboration among industry-peers focusing on pediatric drug formulation and development.

Abbott Park, Illinois, US

• CMC Formulation development project lead. Led the development of clinical formulations and Investigational New Drug Application (IND) and Investigational Medicinal Product Dossier (IMPD) to enable clinical studies.
• Led multiple research initiatives with external (academia) and internal stakeholders.

Abbott Park, Illinois, US

• Established the capabilities of the Formulation lab from ground zero to enable the development of water soluble and poorly water soluble drugs.
• Supported the formulation development for IND/IMPD for Phase 1 clinical trials.

Abbott Park, Illinois, US

• Conducted bio-relevant dissolutions with artificial stomach duodenum, biphasic model and pH dilution model to support clinical formulations screening and development of poorly soluble drugs.
• Supported formulation development of water soluble and poorly water-soluble compounds using enabling technologies such as solid dispersion and lipids.

Singapore, Singapore, SG

Responsible for reviewing, monitoring and optimizing drug therapies for patients to ensure appropriate and safe use of drugs.

Doctor Of Philosophy (Ph.D.), Pharmacy

Bachelor Of Science (Hons.), Pharmacy