Kathi Breen, MBA
Senior Director, Program Management at Kymera Therapeutics- Claim this Profile
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Bio
Credentials
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PMP
Project Management InstituteApr, 2006- Nov, 2024
Experience
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Kymera Therapeutics
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United States
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Biotechnology Research
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100 - 200 Employee
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Senior Director, Program Management
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Aug 2020 - Sep 2022
Co-led preclinical and early clinical programs to develop novel targeted protein degradation (TPD) therapies to treat cancer and immune-related disorders. Achieved 2 DC's + 1 IND. ➢ STAT3 Oncology: Co-led cross-functional team over 2 years of early development of KT-333, a novel first-in-class degrader of STAT3, intended to treat certain lymphomas and solid tumors. -- During my tenure, team progressed from Lead Optimization phase => declared DC (development candidate)… Show more Co-led preclinical and early clinical programs to develop novel targeted protein degradation (TPD) therapies to treat cancer and immune-related disorders. Achieved 2 DC's + 1 IND. ➢ STAT3 Oncology: Co-led cross-functional team over 2 years of early development of KT-333, a novel first-in-class degrader of STAT3, intended to treat certain lymphomas and solid tumors. -- During my tenure, team progressed from Lead Optimization phase => declared DC (development candidate) => filed IND => initiated first-in-human Phase 1 trial => evaluated initial clinical data -- Led planning for long-term clinical strategy; identified data readouts, milestones and timing for path to launch. ➢ STAT3 I&I: Co-led preclinical team to explore feasibility of developing a second STAT3 degrader for inflammatory/fibrotic diseases. Program eventually cancelled. ➢ MDM2 Oncology: Managed preclinical program from Lead Optimization phase to successful declaration of DC compound KT-253. Planned the pathway to IND filing before transferring to another program. ➢ Developed and maintained integrated development plans spanning preclinical safety/tox, in vivo pharmacology, proteomics, clinical, translational, regulatory, manufacturing and quality activities. ➢ Proactively identified risks and implemented strategies to mitigate them. ➢ Created visual tools to facilitate team decision-making for complex issues. ➢ Wrote/polished numerous presentations to senior leadership and the Board. ➢ Re-organized Core Team and sub-team structure to improve efficiency. ➢ Developed program Sharepoint site for collaboration and information sharing. Show less Co-led preclinical and early clinical programs to develop novel targeted protein degradation (TPD) therapies to treat cancer and immune-related disorders. Achieved 2 DC's + 1 IND. ➢ STAT3 Oncology: Co-led cross-functional team over 2 years of early development of KT-333, a novel first-in-class degrader of STAT3, intended to treat certain lymphomas and solid tumors. -- During my tenure, team progressed from Lead Optimization phase => declared DC (development candidate)… Show more Co-led preclinical and early clinical programs to develop novel targeted protein degradation (TPD) therapies to treat cancer and immune-related disorders. Achieved 2 DC's + 1 IND. ➢ STAT3 Oncology: Co-led cross-functional team over 2 years of early development of KT-333, a novel first-in-class degrader of STAT3, intended to treat certain lymphomas and solid tumors. -- During my tenure, team progressed from Lead Optimization phase => declared DC (development candidate) => filed IND => initiated first-in-human Phase 1 trial => evaluated initial clinical data -- Led planning for long-term clinical strategy; identified data readouts, milestones and timing for path to launch. ➢ STAT3 I&I: Co-led preclinical team to explore feasibility of developing a second STAT3 degrader for inflammatory/fibrotic diseases. Program eventually cancelled. ➢ MDM2 Oncology: Managed preclinical program from Lead Optimization phase to successful declaration of DC compound KT-253. Planned the pathway to IND filing before transferring to another program. ➢ Developed and maintained integrated development plans spanning preclinical safety/tox, in vivo pharmacology, proteomics, clinical, translational, regulatory, manufacturing and quality activities. ➢ Proactively identified risks and implemented strategies to mitigate them. ➢ Created visual tools to facilitate team decision-making for complex issues. ➢ Wrote/polished numerous presentations to senior leadership and the Board. ➢ Re-organized Core Team and sub-team structure to improve efficiency. ➢ Developed program Sharepoint site for collaboration and information sharing. Show less
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Syros Pharmaceuticals
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United States
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Director, Program Management
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Oct 2017 - Aug 2020
Managed 2 clinical development programs (Phase 1 & 2) to develop novel small molecule drugs intended to treat biomarker-selected patients with hematological or solid tumors. ➢ Tamibarotene (RARA agonist): Managed program across 3 years of Phase 2 clinical development, through multiple clinical trials, to reach alignment with FDA on pathway to registration in AML (leukemia) and MDS (its precursor). o Co-led Companion Diagnostic (CDx) sub-team to develop a novel RNA… Show more Managed 2 clinical development programs (Phase 1 & 2) to develop novel small molecule drugs intended to treat biomarker-selected patients with hematological or solid tumors. ➢ Tamibarotene (RARA agonist): Managed program across 3 years of Phase 2 clinical development, through multiple clinical trials, to reach alignment with FDA on pathway to registration in AML (leukemia) and MDS (its precursor). o Co-led Companion Diagnostic (CDx) sub-team to develop a novel RNA expression assay (qRT-PCR) to select patients who would benefit from this drug. Actively participated in scientific discussions and managed integration of CDx activities into the overall development program. ➢ SY-1365 (novel CDK7 inhibitor): Managed program for 2 years during Phase 1a (dose escalation) and Phase 1b (expansion) in ovarian and breast cancers. Program was discontinued after completing Phase 1b. ➢ Collaborated with clinical operations, clinical development, translational medicine, regulatory, manufacturing, quality and commercial functions to develop integrated development plans. ➢ Drove execution of plans and timeline. Managed team meetings and Sharepoint site. ➢ Organized logistics to support external academic research collaborations. Show less Managed 2 clinical development programs (Phase 1 & 2) to develop novel small molecule drugs intended to treat biomarker-selected patients with hematological or solid tumors. ➢ Tamibarotene (RARA agonist): Managed program across 3 years of Phase 2 clinical development, through multiple clinical trials, to reach alignment with FDA on pathway to registration in AML (leukemia) and MDS (its precursor). o Co-led Companion Diagnostic (CDx) sub-team to develop a novel RNA… Show more Managed 2 clinical development programs (Phase 1 & 2) to develop novel small molecule drugs intended to treat biomarker-selected patients with hematological or solid tumors. ➢ Tamibarotene (RARA agonist): Managed program across 3 years of Phase 2 clinical development, through multiple clinical trials, to reach alignment with FDA on pathway to registration in AML (leukemia) and MDS (its precursor). o Co-led Companion Diagnostic (CDx) sub-team to develop a novel RNA expression assay (qRT-PCR) to select patients who would benefit from this drug. Actively participated in scientific discussions and managed integration of CDx activities into the overall development program. ➢ SY-1365 (novel CDK7 inhibitor): Managed program for 2 years during Phase 1a (dose escalation) and Phase 1b (expansion) in ovarian and breast cancers. Program was discontinued after completing Phase 1b. ➢ Collaborated with clinical operations, clinical development, translational medicine, regulatory, manufacturing, quality and commercial functions to develop integrated development plans. ➢ Drove execution of plans and timeline. Managed team meetings and Sharepoint site. ➢ Organized logistics to support external academic research collaborations. Show less
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Radius Health, Inc.
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United States
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Pharmaceutical Manufacturing
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100 - 200 Employee
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Director, Project Management
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Oct 2016 - Sep 2017
➢ IND FILING: Managed cross-functional activities to write/edit/review IND for first-in-human Phase 1 trial for small molecule therapy in breast cancer indication. IND filed on time, program later cancelled. ➢ COMBINATION DRUG/DEVICE: Managed project to develop transdermal patch for the company's lead drug in osteoporosis. Planned and coordinated Phase 1 clinical, CMC and design control activities. ➢ Developed cross-functional program timelines, helped create first… Show more ➢ IND FILING: Managed cross-functional activities to write/edit/review IND for first-in-human Phase 1 trial for small molecule therapy in breast cancer indication. IND filed on time, program later cancelled. ➢ COMBINATION DRUG/DEVICE: Managed project to develop transdermal patch for the company's lead drug in osteoporosis. Planned and coordinated Phase 1 clinical, CMC and design control activities. ➢ Developed cross-functional program timelines, helped create first Integrated Development Plans, coordinated program budget process, managed financial and contract issues, established program sharepoint site. Show less ➢ IND FILING: Managed cross-functional activities to write/edit/review IND for first-in-human Phase 1 trial for small molecule therapy in breast cancer indication. IND filed on time, program later cancelled. ➢ COMBINATION DRUG/DEVICE: Managed project to develop transdermal patch for the company's lead drug in osteoporosis. Planned and coordinated Phase 1 clinical, CMC and design control activities. ➢ Developed cross-functional program timelines, helped create first… Show more ➢ IND FILING: Managed cross-functional activities to write/edit/review IND for first-in-human Phase 1 trial for small molecule therapy in breast cancer indication. IND filed on time, program later cancelled. ➢ COMBINATION DRUG/DEVICE: Managed project to develop transdermal patch for the company's lead drug in osteoporosis. Planned and coordinated Phase 1 clinical, CMC and design control activities. ➢ Developed cross-functional program timelines, helped create first Integrated Development Plans, coordinated program budget process, managed financial and contract issues, established program sharepoint site. Show less
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MedImmune
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United States
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Biotechnology Research
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700 & Above Employee
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Sr. Project Manager
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Jun 2014 - Jul 2015
➢ CMC - BIOLOGIC DRUG: Working within Global Biologics Operations, played key role establishing a new cross-functional Ops/R&D team tasked with generating CMC deliverables for BLA filing and launch planning for Imfinzi / durvalumab (anti-PD-L1 immuno-oncology drug). -- Led timeline development for critical path Operations activities including Drug Product validation, analytical/QC testing, stability, packaging/label development, supply chain planning -- Led/facilitated… Show more ➢ CMC - BIOLOGIC DRUG: Working within Global Biologics Operations, played key role establishing a new cross-functional Ops/R&D team tasked with generating CMC deliverables for BLA filing and launch planning for Imfinzi / durvalumab (anti-PD-L1 immuno-oncology drug). -- Led timeline development for critical path Operations activities including Drug Product validation, analytical/QC testing, stability, packaging/label development, supply chain planning -- Led/facilitated steering team meetings, managed 2 key sub-teams (Drug Product, Packaging) ➢ TECH TRANSFER: Managed multi-site global project team to plan and execute successful transfer of 13 analytical methods + stability program from site in California to 2 sites in U.K. CBE30 filed on time to FDA. Show less ➢ CMC - BIOLOGIC DRUG: Working within Global Biologics Operations, played key role establishing a new cross-functional Ops/R&D team tasked with generating CMC deliverables for BLA filing and launch planning for Imfinzi / durvalumab (anti-PD-L1 immuno-oncology drug). -- Led timeline development for critical path Operations activities including Drug Product validation, analytical/QC testing, stability, packaging/label development, supply chain planning -- Led/facilitated… Show more ➢ CMC - BIOLOGIC DRUG: Working within Global Biologics Operations, played key role establishing a new cross-functional Ops/R&D team tasked with generating CMC deliverables for BLA filing and launch planning for Imfinzi / durvalumab (anti-PD-L1 immuno-oncology drug). -- Led timeline development for critical path Operations activities including Drug Product validation, analytical/QC testing, stability, packaging/label development, supply chain planning -- Led/facilitated steering team meetings, managed 2 key sub-teams (Drug Product, Packaging) ➢ TECH TRANSFER: Managed multi-site global project team to plan and execute successful transfer of 13 analytical methods + stability program from site in California to 2 sites in U.K. CBE30 filed on time to FDA. Show less
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Baxter Healthcare (BioScience division)
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Westlake Village, CA
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Sr. Global Project Manager R&D, BioTherapeutics
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Apr 2011 - May 2014
➢ PH 2/3 CLINICAL - BIOLOGIC DRUG: Led/managed high-visibility “Baxter Top Project” in late stage development of subcutaneous injectable therapy indicated for Primary Immunodeficiency Diseases, enabling self-administration by patients at home. -- Created detailed project timeline, managed project cost center and annual financial model -- Integrated parallel tracks of project work: Phase 2/3 clinical trials in U.S. and EU + development of commercial scale manufacturing… Show more ➢ PH 2/3 CLINICAL - BIOLOGIC DRUG: Led/managed high-visibility “Baxter Top Project” in late stage development of subcutaneous injectable therapy indicated for Primary Immunodeficiency Diseases, enabling self-administration by patients at home. -- Created detailed project timeline, managed project cost center and annual financial model -- Integrated parallel tracks of project work: Phase 2/3 clinical trials in U.S. and EU + development of commercial scale manufacturing process + CMC activities + regulatory planning -- Led cross-functional discussions (up to VP level) and drove consensus re: U.S. clinical strategy -- Secured approval/budget for U.S. clinical trial, participated in study start-up planning -- Led device sub-Team to select and qualify infusion equipment for patients to use during trial ➢ COMBINATION DRUG/DEVICE: Led/defined early stage project to integrate biologic drug with delivery device, to significantly improve patient self-administration. -- Defined project and assembled project team, helped develop product Concept -- Created big picture timeline, presented Stage Gate Entry to Development, secured initial funding -- Led team to cross-functional consensus on high-level Product Requirements -- Participated in physician advisory board to gather input about product concept and clinical design -- Drove development of clinical strategy for U.S. and EU Show less ➢ PH 2/3 CLINICAL - BIOLOGIC DRUG: Led/managed high-visibility “Baxter Top Project” in late stage development of subcutaneous injectable therapy indicated for Primary Immunodeficiency Diseases, enabling self-administration by patients at home. -- Created detailed project timeline, managed project cost center and annual financial model -- Integrated parallel tracks of project work: Phase 2/3 clinical trials in U.S. and EU + development of commercial scale manufacturing… Show more ➢ PH 2/3 CLINICAL - BIOLOGIC DRUG: Led/managed high-visibility “Baxter Top Project” in late stage development of subcutaneous injectable therapy indicated for Primary Immunodeficiency Diseases, enabling self-administration by patients at home. -- Created detailed project timeline, managed project cost center and annual financial model -- Integrated parallel tracks of project work: Phase 2/3 clinical trials in U.S. and EU + development of commercial scale manufacturing process + CMC activities + regulatory planning -- Led cross-functional discussions (up to VP level) and drove consensus re: U.S. clinical strategy -- Secured approval/budget for U.S. clinical trial, participated in study start-up planning -- Led device sub-Team to select and qualify infusion equipment for patients to use during trial ➢ COMBINATION DRUG/DEVICE: Led/defined early stage project to integrate biologic drug with delivery device, to significantly improve patient self-administration. -- Defined project and assembled project team, helped develop product Concept -- Created big picture timeline, presented Stage Gate Entry to Development, secured initial funding -- Led team to cross-functional consensus on high-level Product Requirements -- Participated in physician advisory board to gather input about product concept and clinical design -- Drove development of clinical strategy for U.S. and EU Show less
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Baxter Healthcare (BioScience division)
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Westlake Village, CA
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Sr. Global Project Manager R&D, BioSurgery
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Jun 2006 - Mar 2011
NEW CLASS III MED DEVICE: Assembled and led global team during first 2 years development of a new biomaterial indicated for control of bleeding during surgery. -- BioScience R&D award for "Outstanding Innovation" 2010 (with project team); -- Guided concept development and coordinated in vivo labs to obtain feedback from surgeons; -- Led Design Control and Risk Management activities; -- Coordinated creation of functional strategies: preclinical, clinical… Show more NEW CLASS III MED DEVICE: Assembled and led global team during first 2 years development of a new biomaterial indicated for control of bleeding during surgery. -- BioScience R&D award for "Outstanding Innovation" 2010 (with project team); -- Guided concept development and coordinated in vivo labs to obtain feedback from surgeons; -- Led Design Control and Risk Management activities; -- Coordinated creation of functional strategies: preclinical, clinical, intellectual property, regulatory; -- Created launch timeline; developed and managed project budget and cost center; -- Organized relationship with vendor of key component; initiated planning of pilot GMP production. MAJOR REGULATORY FILING (COMBINATION DEVICE/BIOLOGIC): Led/managed global team over 2½ year project which obtained EU and U.S. approval for a manufacturing change to the Biologic component in Floseal®, the strongest selling BioSurgery product. Cost savings $7MM/year. -- Assembled and led global team including R&D, Quality, Regulatory (global and regional, device and biologic), Clinical, Medical Affairs, Marketing, Manufacturing, Supply Chain. -- Collaborated closely with Regulatory to define required submission documents, prepare the filing, answer authority questions after the submission, and obtain regulatory approval. -- Filed in EU as new product: Device filing with Notified Body + Biologic filing to EMA. First EU device/biologic filing in company history, 5th such medical device Consultation in EMA history. -- Nominated by my supervisor for company-wide “Project Team of the Year -- Execution” award. Nominated separately by a team member for company-wide “Project Manager Leadership” award. COUNTRY LAUNCH: Planned and managed launch of Floseal® into Canada. Coordinated regulatory filings, labeling changes, supply chain set-up, manufacture/shipment of launch quantities to the country. Show less NEW CLASS III MED DEVICE: Assembled and led global team during first 2 years development of a new biomaterial indicated for control of bleeding during surgery. -- BioScience R&D award for "Outstanding Innovation" 2010 (with project team); -- Guided concept development and coordinated in vivo labs to obtain feedback from surgeons; -- Led Design Control and Risk Management activities; -- Coordinated creation of functional strategies: preclinical, clinical… Show more NEW CLASS III MED DEVICE: Assembled and led global team during first 2 years development of a new biomaterial indicated for control of bleeding during surgery. -- BioScience R&D award for "Outstanding Innovation" 2010 (with project team); -- Guided concept development and coordinated in vivo labs to obtain feedback from surgeons; -- Led Design Control and Risk Management activities; -- Coordinated creation of functional strategies: preclinical, clinical, intellectual property, regulatory; -- Created launch timeline; developed and managed project budget and cost center; -- Organized relationship with vendor of key component; initiated planning of pilot GMP production. MAJOR REGULATORY FILING (COMBINATION DEVICE/BIOLOGIC): Led/managed global team over 2½ year project which obtained EU and U.S. approval for a manufacturing change to the Biologic component in Floseal®, the strongest selling BioSurgery product. Cost savings $7MM/year. -- Assembled and led global team including R&D, Quality, Regulatory (global and regional, device and biologic), Clinical, Medical Affairs, Marketing, Manufacturing, Supply Chain. -- Collaborated closely with Regulatory to define required submission documents, prepare the filing, answer authority questions after the submission, and obtain regulatory approval. -- Filed in EU as new product: Device filing with Notified Body + Biologic filing to EMA. First EU device/biologic filing in company history, 5th such medical device Consultation in EMA history. -- Nominated by my supervisor for company-wide “Project Team of the Year -- Execution” award. Nominated separately by a team member for company-wide “Project Manager Leadership” award. COUNTRY LAUNCH: Planned and managed launch of Floseal® into Canada. Coordinated regulatory filings, labeling changes, supply chain set-up, manufacture/shipment of launch quantities to the country. Show less
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Leiner Health Products
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Director, Corporate Product Development OTC
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Apr 2003 - May 2006
Managed portfolio of OTC (over the counter) drug development projects, internally and at external subcontractors. Hired/trained project manager. NEW PRODUCT DEVELOPMENT: Planned/managed fastest new OTC drug development ever at company, new “rapid release” technology, filed patent application, first-to-market by 3 months, $10 million product.
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Sr. Manager, Project Management, OTC Group
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Jan 2000 - Mar 2003
CHAMPION PM: Created project management function within OTC (over the counter) unit, assembled cross-functional teams where none existed before. Led projects to develop/reformulate 20% of OTC products. NEW PRODUCT DEVELOPMENT: Planned and managed most complex new product development program in company history: 8 formulas, > 50 finished products, $20 million annual sales, launched on-time. -- Directly coordinated 15 internal functions, 5 factories, 2 vendors, 1 strategic… Show more CHAMPION PM: Created project management function within OTC (over the counter) unit, assembled cross-functional teams where none existed before. Led projects to develop/reformulate 20% of OTC products. NEW PRODUCT DEVELOPMENT: Planned and managed most complex new product development program in company history: 8 formulas, > 50 finished products, $20 million annual sales, launched on-time. -- Directly coordinated 15 internal functions, 5 factories, 2 vendors, 1 strategic partner. -- Project scope included R&D formulation; analytical method validation; stability; process & cleaning validations; supply chain planning; making launch quantities; marketing prep.
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Education
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University of Virginia - Darden Graduate School of Business Administration
M.B.A., General Management -
2018 - 2018
Harvard Extension School
Undergraduate course credits, 2 semester-long courses: Immunology; Intro to Cellular and Molecular Biology -
University of Virginia
B.S. Commerce, Finance major -
2021 - 2021
Harvard Medical School - HMXPro Online Learning
Certificates of Achievement, 3 online courses: Pharmacology; Cancer Genomics; Novel Therapies for Chronic Inflammatory Disease
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