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 unique combination across the value chain of target & drug discovery as well as Translational Medicine, Clinical Development & Regulatory to effectively support my clients in Clinical Biomarker, Personalized Medicine & strategic clinical study efforts & to help establish/evaluate a portfolio, enable expedient drug development, assess licensing opportunities or the opportunity to position a drug in a competitive environment.• 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 more heavily where & when needed.• 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• Bayer Healthcare, a global pharmaceutical company developing innovative therapies for cancer and orphan diseases• Anacor Pharmaceuticals, a commercial-stage biopharmaceutical company with a novel chemistry platform• Zenith Epigenetics, a small Biotech company focusing on small molecules with a novel mechanism-of-action• Mitobridge, a startup company developing novel therapeutics that improve mitochondrial functions for a variety of different diseases• PrognosDx Health, a small diagnostic startup companyTranslationalMedicineConsulting[at]Yahoo.com

• 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.

• 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 selections. - Reshaped, prioritized & focused the programs’ Biomarker efforts into a cohesive & result-driven Biomarker strategy to support decision making.• 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 tree to determine a recommended Phase 2 Dose in ongoing clinical studies.• 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), Clinical Biomarker/CDx & Bioanalytical, Non-Clinical Safety & Toxicology, and Clinical Data Management & Biostatistics• 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 readouts & companion diagnostics• 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 assay development & clinical sample analyses• 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 to support patient selection/stratification strategies• Designed & implemented biomarker studies to monitor Aduro-sponsored clinical trials including implementation of pharmacodynamic biomarkers indicating target engagement, biological/clinical response biomarkers and building hypotheses for patient enrichment for proof-of-concept studies• Provided Translational & Predictive Medicine input to clinical protocols, informed consents, sample collection manuals, as well as regulatory documents, including Investigator Brochures and dossiers for Agency interactions• Built relationships with scientific advisors and KOLs• Interfaced with academic/corporate preclinical and/or clinical collaborators/partners

• 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

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 studies to demonstrate pan-tumor potential.• 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• Partnered with Clinical Development, Regulatory & Biostatistics to stratify/select patient population in order to maximize therapeutic benefit & identify best responders; implemented Ph 1 proof-of-mechanism/pharmacodynamic & Ph2 proof-of-concept strategies. Co-developed clinical strategies & clinical protocols for IND/Ph1 to Ph3 clinical studies.• Defined & implemented translational medicine & biomarker strategies for late stage asset PEGPH20 & for pipeline bio-therapeutics in preclinical and/or clinical development (from IND/Ph1 to Ph3 clinical trials). Implemented all aspects of clinical sample collection; evaluated risks for biomarker programs & developed contingency plans.• Partnered with preclinical research to develop clinically relevant model systems.• Represented Translational Medicine on the life cycle team, commercial launch team, project teams with internal stakeholders as well as on teams with corporate partners to support efforts with Halozyme’s clinical stage and approved products.•Responsible for an annual budget of up to $10M.

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

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 mutational status thus providing a strategic competitive advantage compared to EGFR inhibitors.• 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 approval and secure sustainable resources for implementation.• 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 making.• 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 development in order to select patients and/or predict response to therapy.• Collaborate with senior internal, academic and external industry-based experts, key opinion leaders on Translational Medicine aspects and approaches.• Supported Global and US Medical Affairs efforts to evaluate, establish and conduct collaborations, and Genentech-sponsored as well as IST studies with biomarker components.• Provide leadership and expertise in evaluating companies & novel technologies as tools for the development & execution of biomarker assays for use in clinical trials.

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 approval path; identified, implemented and executed translational medicine and biomarker strategies in a fast-paced environment with aggressive, tight time lines.• 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 clinical strategies & protocols• 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 with regulatory compliance & high quality sample collection.• 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 biomarker programs and developed contingency plans.• Analyzed biomarkers identifying prognostic and/or predictive biomarkers to guide clinical decision making and to understand mechanism-of-action of response/benefit or resistance.• Evaluated need for companion diagnostic development & implementation; worked with corporate partner on co-development of a diagnostic assay intended for prospective patient enrollment into a Ph3 study.• Initiated interactions with KOLs. Evaluated n partnering & technology opportunities.• Point-of-contact in Pharma-selected collaboration programs for Translational Medicine-related activities.

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 management. Selected to represent Roche Palo Alto in research, technology and academia.• 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.

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 clinical trials.• 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. Validated 6 Oncology targets to progress them to drug discovery stage.• 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 platform (RNAi, Antisense).• 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.