Thomas Mueller Email & Phone Number

San Francisco, CA, US

• R&D consultant providing tailored solutions across the value chain from target and drug discovery, Translational Medicine, Biomarker/CDx and Clinical Development to therapeutic and diagnostic companiesMy expertise is a.
• Partner at Phraktion, a consultancy that provides fractional teams of experts that help biopharma companies achieve their goals by seamlessly participating in the running of their business & always ready to lean in.
• Expert at MDisrupt & Veritux/Umbrex, consultancies providing healthcare experts with expertise across the entire product lifecycle.
• Member of the Guidepoint Global Advisors Network, BioPoint, Inc. Life Science Consulting Services, AlphaSights Knowledge Partners and VisasQ/Coleman Research.Current and past clients:
• Treadwell Therapeutics, a clinical stage, multi-modality oncology company
• Goldfinch Bio, an innovative biotech company focused on discovering and developing precision therapies for patients with kidney disease

South San Francisco, California, US

• Lead molecule, pathway & disease area strategies in partnership with clinical development.
• Lead science-based design of translational efforts including CDx activities across all clinical studies.
• Serve as effective team leader on product teams & ensure strategy alignment with products’ life cycle & development plans as well as portfolio strategies.
• Lead the development of strategic plans for all pipeline assets and implementation.
• Represent Translational Sciences at advisory boards, regulatory agency interactions & scientific conferences.
• Serve as Trishula Therapeutics Translational Science lead in collaboration with Pharma partners.

Singapore, SG

• Built and le a Translational Medicine department across entire pipeline of assets across US and Singapore sites.
• Developed and implemented Translational Medicine strategy for all clinical stage assets, including indication selection, endpoints, study design, patient selection/stratification, safety evaluations and dose.
• Led Clinical Pharmacology & Modeling activities - Laid out path based on modelling of preclinical & toxicology data as well as clinical Biomarker and PK data to determine an efficacious dose & co-develop a decision.
• Led companion diagnostic assay development activities from preclinical, clinical development, regulatory approval.
• Responsible for Translational Medicine focused cross-functional teams identifying predictive & prognostic biomarkers and developing diagnostic assays.

R&D consultant providing tailored solutions across the value chain from target and drug discovery, Translational Medicine, Biomarker/CDx and Clinical Development to therapeutic and diagnostic companies

• Built newly formed Translational & Predictive Medicine department (up to ~40 FTE; annual budget of $12M) across an US & an European site with the following functional groups: Translational Biology (in vitro & in vivo).
• Member of the Company Leadership Team, Development Leadership Team, Development & Research Committee, Program Review Board
• Led & mentored senior level scientific team (including Director/Sr. Director level)
• Advanced development of investigational anticancer & autoimmune drugs by implementing strategies to bridge preclinical research with clinical development and support clinical trials with pharmacodynamic biomarker.
• Identified & built sample inventory- & biomarker data analysis platforms to enable integration of preclinical disease models, pharmacology, toxicology, biomarker discovery & development as well as clinical biomarker.
• Worked with Translational & Predictive Medicine Team, cross-functional project teams (such as life cycle team & clinical development team) Clinical Development, Project Team and with Management to create an agreed plan.

LYON, Rhône-Alpes, FR

• Develop and implement Translational Medicine strategy
• Contribute to Phase 2 & 3 global clinical study designs & protocols, informed consents, sample collection manuals, as well as regulatory documents, including Investigator Brochures and dossiers for Agency interactions
• Implement clinical biomarker and potential co-diagnostic development efforts
• Partner with Research to advance internal research and early development projects and to establish a seamless transition of biomarker programs from Research into Clinic Development
• Establish preclinical and clinical collaborations, build relationship with scientific advisory board and KOLs

San Diego, California, US

• Responsible for companion diagnostics and the development and implementation of Translational Medicine approaches and clinical biomarker strategies for targeted therapy including immune-oncology.
• Led & mentored scientific team (incl. MD/PhD, Pathologists & PhDs at Director/Sr. Director level) & Histology team.
• Established & developed companion diagnostics for PEGPH20 as Halozyme’s companion diagnostic lead in collaboration with diagnostic partner Ventana to support patient selection for Phase 3 pancreatic cancer and Ph1 & 2.
• Team developed novel CDx assay & algorithm from start to IDE approval within record 8 months
• Responsible for identification of plasma-based biomarker & CDx development/strategy
• Responsible for CDx interaction with regulatory authorities & ethic committees and several cross-functional teams identifying biomarkers and developing diagnostic assays

R&D consultant providing tailored solutions across the value chain from target and drug discovery, Translational Medicine, Biomarker/CDx and Clinical Development to therapeutic and diagnostic companies

South San Francisco, California, US

• Responsible for the development and implementation of Translational Medicine approaches and clinical biomarker strategies for late stage clinical programs in oncology focusing on the Angiogenesis franchise.
• Global Personalized Healthcare Leader in Oncology late stage Clinical Development (Phase 3 & 4) study-, project and regulatory filing/submission teams.
• Global filing of ML18147, the first clinical study demonstrating clinical benefit of bevacizumab treatment beyond progression on a bevacizumab-containing regimen. Demonstrated bevacizumab benefit independent of KRAS.
• Provide expert advice to clinical teams for the optimal strategy, design and conduct of clinical trials with (companion) diagnostics and/or biomarker endpoints. Build internal alignment on biomarker strategies, obtain.
• Provide ongoing monitoring of biomarker and diagnostic activities, ensuring effective wet lab support, coordination of data collection and interpretation as well as preparation of the results for informed decision.
• Responsible for multi-disciplinary diagnostic development teams to discover novel biomarkers, characterize patient (sub-) populations; implement, verify and validate diagnostics and integrate them into clinical.

Alameda, California, US

• Led experimental medicine efforts in the development of investigational anticancer drugs supporting clinical study strategy, design and decision making under consideration of clinical feasibility, medical need and.
• Overall responsibility for translational medicine strategies for anti-cancer drug programs (from IND/Ph1 to Ph3 clinical trials).
• Partnered with ClinDev Regulatory & Biostats to stratify/select patient population to maximize therapeutic benefit & identify best responders; implemented Ph2 proof-of-concept & proof-of-mechanism strategies; IND/Ph1-3.
• Engaged in preparation & execution of global Ph3 clinical trial (130 sites in 26 countries)
• Contributed as Translational Medicine lead to US and global site activation; guided CRO & Clinical Operations in Translational Medicine-related regulations enabling effective and timely country- and site activation.
• Prioritized and coordinated the development of pharmacodynamic biomarker & pharmacogenomic/-genetic assays for use in clinical trials; implemented all aspects of clinical sample collection; evaluated risks for.

Switzerland 🇨🇭, CH

• Led and mentored senior level scientific team (8) providing portfolio support for drug programs in preclinical development; served as member of the strategy team and as liaison between project teams and senior.
• Collaborated with therapeutic areas using RNAi- and overexpression tools enabling mechanism of action-, drug profiling & optimization-studies. Established RNAi in vivo system to shorten time lines of in vivo studies.
• Defined and actively managed critical path activities, milestones, time lines and Functional Biology department budget.
• Managed academic collaborations and evaluated technologies and programs of biotech companies interested in partnering.

US

• Developed strategy and led operations for the HSP90-inhibitor (Geldanamycin) anti-cancer program with preclinical and clinical components.
• Managed and coordinated the drug program in a matrix organization of up to 25 scientists from Process Sciences, Molecular Biology, Chemistry, Pharmacology and Medical Affairs.
• Defined primary/secondary drug screens and criteria for progression of lead compounds into PK and in vivo efficacy models resulting in selection of several potent analogs for preclinical development.
• Contributed to the planning of the clinical development of geldanamycin analogs together with the National Cancer Institute; established multiplex assays for pharmacodynamic biomarkers to support development and.
• Initiated and managed collaboration with corporate partner to develop multiplex biomarker assay.
• Initiated and managed academic collaborations to further elucidate mechanism of action of drug candidates as well as to expand indications for HSP90-inhibitors beyond oncology.

• Led a highly integrated target validation group, established a variety of pathway- and disease relevant in vitro- and in vivo functional genomics tools to validate and progress genomic targets towards drug screening..
• Contributed to design, implementation and analysis of gene discovery projects (gene expression profiling, genetic screens) and selection/prioritization of targets; established and implemented knock-down technologies.
• Established molecular pathology tools to prioritize potential disease-relevance of targets.
• Designed and coordinated validation projects with disease groups (e.g. Oncology, Immunology, Respiratory) and functional genomics groups within Aventis.
• Managed collaboration with corporate partners in target discovery and tool development. Evaluated technologies and programs of biotech companies interested in partnering.

Postdoc

Phd

Diploma (Ma Equivalent), Biology