Michael Bauer, Ph.D. Email & Phone Number

Vienna, At

QUANTRO Therapeutics GmbH is a privately funded research company that strives to discover and develop novel effective therapeutics that interfere with disease-causing transcriptional programs in cancer and other diseases.Based on proprietary transcriptional signatures, QUANTRO will assemble a highly innovative drug-discovery pipeline that employs time-resolved RNA sequencing and comparative transcriptomics to identify drug candidates interfering with transcriptional regulators.By introducing ‘transcriptional fingerprinting’ to drug discovery, QUANTRO intends to revamp the scope of pharmacologic interventions in a variety of cellular, target and disease contexts.A prime focus will be the discovery and development of drug candidates blocking the activity of oncogenic transcription factors, a class of particularly promising therapeutic targets that has so far remained largely unamenable to pharmacological intervention.

I am an experienced Biotech Entrepreneur and Executive with a proven track record as CEO, Member of the Board of Directors, and other senior leadership roles. Overall, I have gained more than 25 years’ leadership, development, research, and regulatory experience in the life sciences industry. I brought several innovative oncology drugs with new modes of action into clinical development, some of them later advancing to Ph 3o or reaching approval. I hold a Ph.D. in Biotechnology and M.Sc. in Chemistry.

Basel, Basel-Town, Ch

As Co-founder, CEO and member of Cellestia Board of Directors I have advanced a single-molecule post-doc research project into a pioneering Oncology R&D Ph2 clinical stage company targeting new modes of action, closely integrating the drug development, diagnostic approaches for patient selection and response tracking, implementing a successful global Ph2 clinical stage program in oncology and auto-immune/inflammatory diseases, and creating a pipeline of innovative discovery programs. Key achievements at Cellestia include building the Team, Board, defining and implementing a successful research and clinical development strategy and successful fundraising.

Allschwil, Ch

Leading Drug Development at Polyphor, a broad portfolio covering several drug development programs in a wide range of different indications, e.g. Oncology, Antibiotics, Hematology, Cardiology, Inflammatory Diseases, reaching a strong proof of concept in Oncology opening the path for Ph 3.

Basel, Baselstadt, Ch

Senior Program Manager and Portfolio Manager for global drug development programs of novel Anti-Cancer Drugs (both small molecule and biologics) in a wide range of solid tumor (e.g. NSCLC, mBC, aGC etc.) and hematological malignancies(e.g. AML, MM, etc). Responsible for global development programs ranging from late pre-clinical development to Translational Medicine (Phase I First in Human & Phase II Proof of Concept, single agent and combination therapy) to full development Projects (Full Phase III development program incl. pediatric development and diagnostic co-development).Key Achievements:- led one project from early phase I to MTD and phase II expansion into multiple indications (NSCLC, mBC, aGC, MM) single agent and combination therapy- Successfully established robust clinical proof of concept in multiple indications (single agent and combination therapy) and molecular pathways- preparation and strategic outline for phase III development program- instrumental in setting up a broad external program of investigator initiated trials complementing multi-indication internal development program - brought one compound from preclinical to clinical development, completing MTD determination and preliminary assessment of multiple indications- successful transition of biologic compound from resarch to development and successful parallel IND submission and simultaneous launch of clinical phase I evaluation for single agent and combination therapy- successful management of a complex multi-trial Ph III program with biomarker guided patient selection and Diagnosti co-development- led multi-project program teams of complex portfolio of multiple indications and compounds, both small molecule as well as biologics- leadership and coaching of junior project / trial managers- key contributions in defining budget review & decision making and portfolio management process

Project Leader in Preclinical and Clinical Drug Development (Pharma/Biotech)- responsible for preclinical development of different novel antibiotics (iv and topical therapy), successful implementation of IND enabling program- responsible for clinical development of oral dose form of iclaprim (Phase I , preparation phase II)- active contribution to NDA & MAA creation (large parts of preclinical and clinical dossier), submission and post-submission response to authorities for Iclaprim

Basel, Basel, Ch

Key responsibilities:- Leading multi project global development programs - Team size ranges from 10-60 people plus associated sub-teams- New compound development and life cycle management programs- Manage annual R&D budget of ca $20-60 million on projects with associated sales of ca. $600 million p.a. - Lead Development Portfolio Strategy Team- Manage communication to senior management - Portfolio review and strategic investments with global marketing. Achievements (Examples):- Fast track evaluation of licensed in new Active Ingredient - Formulation Innovation Project to rejuvenate a blockbuster product- Restructured and established Project Teams - Implementation of cost saving programs > $5m p.a.

Basel, Basel, Ch

Develop and implement regulatory strategy for assigned product portfolio. Product range including blockbusters, divestments, re-registration and new formulation development.Key Achievements:- Development and execution of global regulatory strategies for assigned portfolio, strategic regulatory leadership to business in International Project Teams.- Led product development covering all aspects for product safety and regulatory positioning (toxicological, environmental and other safety relevant information)- Led regulatory evaluation of new development compounds.- Represented regulatory affairs in business development activities (in-licensing and divestments). Post transaction relationship management for divestment portfolio.- Built regulatory development project teams after merger of Zeneca and Novartis - Delivered regulatory maintenance, re-registrations and post-merger fast-track submissions for assigned product portfolio- Active contribution to successful portfolio review and divestment of compounds. Managed post-divestment relationship and registration transfer.

- Lead a team of scientists and technicians as line manager, laboratory head & study director. Monitoring of contracted–out studies. - Represent the company at international industry work-groups and authorities.- Lead interdisciplinary metabolism research projects aiming to streamline the safety assessments for human and environmental safety and optimise metabolism research inputs in early phase compound evaluation and selection.Achievements:- Delivery of important regulatory metabolism studies of high technical complexity for successful registration of one new blockbuster compound- Developed a high throughput screening system for early phase metabolism used in lead optimisation and selection

Screening, isolation and characterisation of thermophilic microorganisms able to degrade xenobiotic organic compounds; Elucidation of degradation pathway; Purification and characterisation of proteins involved in phenol degradation; Assay development for protein detection; PCR, Molecular cloning and bioinformatic analysis of sequence;

Doctorate, Biotechnology

Diploma Chemistry, Analytical Chemistry