David Tan work email
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David Tan personal email
As an Associate Director of CMC Strategy and Portfolio Leadership at AbbVie, I leverage my Ph.D. in Pharmacy and many years of experience in pharmaceutical development to lead the global and matrix CMC teams on multiple assets across various stages of development. I am accountable for delivering integrated CMC strategies for large and small molecules, including monoclonal antibodies, antibody drug conjugates, parenterals, and aesthetics products.I have authored several regulatory submission documents (e.g. IND, IMPD, NDA, and MAA) and have extensive experience in developing age-appropriate formulations, modified release formulations, technology transfer, enabling technologies, in vitro in vivo correlation, process analytical technology, and clinical in-use stability. My mission is to bring innovative and high-quality drug products to patients in need.
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Senior DirectorVertex PharmaceuticalsBoston, Ma, Us -
Associate Director Cmc Strategy And Portfolio LeadershipAbbvie May 2023 - PresentNorth 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 commercial formulation and manufacturing processes with appropriate control strategies and specifications.• Represent the CMC teams and collaborate cross functionally with stakeholders such as Clinical, Commercial, Regulatory, Clinical Pharmacology, Toxicology, and many others. -
Principal Research ScientistAbbvie Oct 2020 - May 2023North 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.
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Senior Scientist IiAbbvie May 2018 - Sep 2020North 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 Applications (MAA). • 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.
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Senior Scientist IAbbvie Dec 2016 - Apr 2018North 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. • 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
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ScientistAbbvie Jul 2014 - Nov 2016North 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) and co-leading the Pediatric Taskforce to streamline pediatric drug development, align geostrategy and ensure compliance with regulatory policies and best practices.
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Chair Of Iq Consortium Drug Product Leadership GroupIq Consortium Jan 2023 - Dec 2023 -
Vice Chair Of Iq Consortium Drug Product Leadership GroupIq Consortium Jan 2022 - Dec 2022
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Co-Chair Of Iq Consortium Accelerated Drug Development Working GroupIq Consortium Aug 2020 - Feb 2022
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Co-Chair Of Iq Consortium Drug Product Pediatric Working GroupIq Consortium Apr 2017 - Jul 2020• 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.
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Associate Scientist IiiAbbott Dec 2012 - Jun 2014Abbott 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. -
Associate Scientist IiAbbott Nov 2010 - Nov 2012Abbott 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.
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Associate Scientist IiAbbott Apr 2009 - Oct 2010Abbott 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.
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PharmacistNational University Health System Jun 2007 - Feb 2009Singapore, Singapore, SgResponsible for reviewing, monitoring and optimizing drug therapies for patients to ensure appropriate and safe use of drugs.
David Tan Skills
David Tan Education Details
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National University Of SingaporePharmacy -
National University Of SingaporePharmacy
Frequently Asked Questions about David Tan
What company does David Tan work for?
David Tan works for Vertex Pharmaceuticals
What is David Tan's role at the current company?
David Tan's current role is Senior Director.
What is David Tan's email address?
David Tan's email address is da****@****ott.com
What schools did David Tan attend?
David Tan attended National University Of Singapore, National University Of Singapore.
What skills is David Tan known for?
David Tan has skills like Formulation, Gmp, Drug Delivery, In Vivo, Technology Transfer, Clinical Trials, Characterization, Pharmaceutics, Life Sciences, Drug Development, Pharmaceutical Industry.
Who are David Tan's colleagues?
David Tan's colleagues are Eric Gillberg, Muhammad Arslan Muhammad Riaz, Jinjin Zhu, Dave Bean, Sage Zeolie, Ching-Yuan (Peggy) Chang, Alam Lakhani.
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