Thomas Haws Email & Phone Number

West Chester, Pennsylvania, United States

- Responsible for Company’s clinical programs, strategy, development, and life-cycle management in dermatological disease indications.- Develops the Clinical Development Plan in line with the Target Product Profile.- Leads and supports the clinical components of key documents (e.g., Clinical Trial Protocols, Investigator’s Brochures, Clinical Study Reports (CSRs), regulatory documents including IND/CTA and regulatory responses) with high quality and consistency with the CDP. - Collaborates with Scientific Communication of clinical data, including external messaging, publication planning and congress management. -Develops and leads KOL speaker programs on company-relevant disease states, current therapeutics, and patient care gaps.

Cambridge, Massachusetts, United States And West Chester, Pa

- Strategic lead for PKU program team and early-stage development programs in metabolic disorders- Member on the strategic leadership team and Science and Technology Committee- Provides strategic guidance to support Clinical (Clinical Development, Clinical Operations, Biomarker), CMC, Regulatory, and Commercial teams- Responsible for leading, prioritizing and managing the multi-disciplinary team to deliver the development of the product development plan- Coordinate development of global clinical and regulatory strategy in alignment with CMC. - Highly involved in all aspects of development, from contributing to regulatory interactions and IND/CTA submissions, engagement with KOLs and patient advocacy organizations, and in market research activities.

Philadelphia, Pennsylvania, United States

- Therapeutic Development Team Leader for GM1 Gangliosidosis and Krabbe Disease. - Single point of accountability for the GM1 Gangliosidosis and Krabbe Disease compound development to the Passage Executive Team and Joint Steering Committee for the Passage/Penn collaboration.- Developed and lead both the compound strategy and corresponding integrated compound development plan for GM1 Gangliosidosis and Krabbe Disease.- Was responsible for leading, prioritizing and managing the multi-disciplinary teams to deliver all aspects of the GM1 Gangliosidosis and Krabbe Disease programs. - Acted as spokesperson for the GM1 Gangliosidosis and Krabbe Disease programs both internally and externally.- Provided strategic guidance to support Clinical (Clinical Development, Clinical Operations, Biomarker), CMC, Regulatory, and Commercial sub-teams.- Member of the Diversity, Equity, and Inclusion (DEI) Committee.

Collegeville, Pennsylvania, United States

- Discovery Medicine Leader for four assets (pre-clinical to clinical phase), targeting COVID-19, allergy, heart failure and a rare pediatric disease. - Single point of accountability for the Clinical Development Plans from Commit-to-Target to Commit-to-Phase 2.- Provided clinical development and strategic leadership to the Clinical Matrix Team (CMT) and translational and clinical input to the project beyond Commit-to-Phase-2.- Was responsible for clinical indication prioritization and sequencing on targets in the early research pipeline. - Conducted and planned First Time in Human, clinical pharmacology, and = PoC trials in adult and pediatric patients.- Was accountable for clinical input into clinical protocols, study documentation, clinical components of regulatory submissions and responses to regulatory authority questions, or questions arising from Ethic’s review.- Participated in data review ongoing through studies including dose-escalation meetings, interim analyses, in-stream data review, etc.- Prepared and presented data externally in the form of abstracts, posters, presentations for conferences.- Ability to matrix lead with the broader GSK organization, including Translational Biologists, Safety Assessment, Biomarker Group, CMC, DMPK, Late-Stage Development, VEO, and Commercial.- Experienced with interactions with regulatory agencies, key opinion leaders, patient advocacy groups, CROs, etc. to build strong clinical development plans. - Standing Member of Clinical Pharmacology and Experimental Medicine Protocol Review Forum.- Functional lead for the Integrated Resource Management Program.

King Of Prussia, Pa

- Provided clinical development leadership, disease area expertise, regulatory and prescriber insight to the Discovery Performance Unit (DPU).- Created and implemented high quality clinical development plans (CDPs) and data analysis strategies that applied appropriate models and surrogate markers by delivering compelling information to inform decision making within the DPU.- Early Development Leader for Daprodustat program for rotator cuff injury. Responsible for development of the pre-clinical safety packages, CDPs, clinical study designs, clinical operations, regulatory strategies, manufacturing, and senior leader engagement.- Helped execute and shape the overall R&D strategy by working with matrix partners both internal and external to GSK.- Interfaced on behalf of GSK with key external experts and members of program-level external committees (e.g., Executive Steering Committee, and Independent Data Monitoring Committee).

Collegeville, Pennsylvania, United States

- Built, led, and motivated global project and clinical teams to deliver their designated portfolios. - Supported the workload, resource requirements, operational interactions, and commitment to timelines and budget for the early stage portfolio within the Heart Failure DPU. - Authored and reviewed clinical pharmacology protocols, amendments, informed consents, clinical study reports, clinical pharmacology sections of IBs, annual IND updates, new INDs, case report form development, and designed other study related materials. - Coordinated multiple Phase I and IIa clinical studies: reviewed CRO contracts and budgets; reviewed and tracked all study related invoices; CRA training, conducted study initiation meetings, investigator meetings and KOL meetings; study center evaluation, initiation, and operational oversight on clinical conduct of studies; coordinated shipment of study drug and analysis of clinical specimens; reviewed case report forms and electronic databases; monitored clinical study data; closed out study sites; reviewed final safety listings; worked with data management to achieve final database lock.- Accountable for the execution and delivery of Clinical Pharmacology, Proof of Concept and Proof of Mechanism studies.- Ability to understand and analyze complex cross-discipline technical details with drug development- Proficient in outsourcing of clinical trials in a global environment- Proficient budget management and negotiations across various countries and vendors - Conduct studies with strict adherence to ethical and regulatory standards governing clinical research, including ICH, GCP and international regulatory guidelines, as well as company operating procedures. - Led and participated in Global teams focusing on re-engineering and simplification- Line management responsibilities including recruitment, setting objectives, driving performance, building, development plans, and coaching.

King Of Prussia, Pennsylvania, United States

- Author and review clinical pharmacology protocols, amendments, informed consents, clinical study reports, clinical pharmacology sections of CIB and annual IND updates.- Coordinate multiple Phase I and IIa cardiovascular clinical studies: review CRO contracts and budgets; review and track all study related invoices; conduct study initiation meetings; coordinate shipment of study drug to sites; coordinate shipment, receipt and analysis of clinical specimens; review case report forms and electronic databases; monitor clinical study data; close out study sites; review final safety listings; work with data management to achieve final database lock.- Communicate with Project Team and Clinical Matrix Team members on a regular basis to give Phase I and IIa updates and offer input on clinical development plans from a Phase I/IIa perspective.

King Of Prussia, Pennsylvania, United States

- Author and review clinical pharmacology protocols, amendments, informed consents, clinical study reports, clinical pharmacology sections of CIB and annual IND updates.- Coordinate multiple Phase I cardiovascular clinical studies: review CRO contracts and budgets; review and track all study related invoices; conduct study initiation meetings; coordinate shipment of study drug to sites; coordinate shipment, receipt and analysis of clinical specimens; review case report forms and electronic databases; monitor clinical study data; close out study sites; review final safety listings; work with data management to achieve final database lock.- Communicate with Project Team and Clinical Matrix Team members on a regular basis to give Phase I updates and offer input on clinical development plans from a Phase I perspective.

King Of Prussia, Pennsylvania, United States

- Assumed responsibility for all aspects of assigned clinical studies (review of study protocols, design of pharmacodynamic plans, interaction with KOLs, laboratory, and scientific staff to ensure project completion. - Co-Chaired the Biomarker Sub-Team to identify the appropriate biomarkers for upcoming clinical studies. - Designed, validated and conducted assays for the pharmacodynamic assessment of clinical assets by authoring SOPs and validation reports and maintained laboratory under GLP regulations.- Assumed responsibility for supervising summer interns and new hires within the US biomarker lab.

Westtown Township, Chester County, Pa

Positions Held - 2017- Police Commissioner, 2016- Chairman of the Board of Supervisors, 2015- Police Commissioner, 2014- Police Commissioner, 2013- Chairman of the Board of Supervisors, 2012- Vice-Chairman of the Board of Supervisors - Charged with the general governance of the township and the execution of legislative, executive and administrative powers in order to ensure sound fiscal management and to secure the health, safety and welfare of the citizens of the township.

Wilmington, Delaware, United States

- •Responsible for the PCR cloning of selected novel and known genes in the fields on Cardiovascular, Cancer, CNS, and Inflammatory Diseases.- •Responsible of the construction of new expression vectors that employs the Cre/Lox technology.- •Responsible for the PCR-Purification and Cloning of HIV Amplicons, which support NNRTI Clinical Trials. All work is performed using GLP and GMP protocols.

Collegeville, Pennsylvania, United States

Positions Held:Associate Scientist, Cardiovascular Biology 1999-2000Research Assistant, Cardiovascular Biology 1998-1999Ursinus College RPR Fellowship awardee in Cardiovascular Biology. 1997-1998Ursinus College RPR Fellowship awardee in Gene Medicine 1997- •Independent contributions in molecular analysis of cathepsin S helped demonstrate its role in atherosclerosis. This resulted in it being accepted as a candidate target for high-throughput screening.- Adapted a low throughput secondary screening assay for cathepsin S to 96 and 384 well formats.- •Isolated RNA from coronary and arterial tree material from animal models of atherosclerosis and analyzed gene expression using Northern blot analysis.- •Responsible for the PCR cloning and expression of selected novel gene targets involved in atherosclerosis.- Responsible for the construction of generic expression vectors containing signal peptide and HA-, MYC-, or HIS-tag sequences for use in high throughput screnning procedures. - Responsible for the PCR cloning and expression of several chemokine receptors implicated in atherosclerosis. - Assumed responsible for the identification of novel genes in the SMAD Gene family. - Employed RT-PCR and SSCP to identify novel SMAD sequences important in Transforming Growth Factor Beta (TGF-b) signal transduction pathways.

Master Of Science - Ms, Qa/Ra

Bs, Biology

Activities and Societies: - Associate member in Sigma XI, The National Honor Society in Scientific Research - Rhône-Poulenc Rorer.

Education record