Michael Herrler, Phd,Mba Email & Phone Number

Lisbon, PT

L'Hospitalet De Llobregat, Barcelona, ES

• Currently report to VP of R&D and BD
• Performed interviews with key stakeholders to evaluate and assess Werfen’s PMO maturity level.
• Presented mission, vision and roadmap to Werfen’s Sr. Management team to setup enterprise-level Strategic Portfolio Management Office (SPMO).
• Hired one senior project manager and two project managers into current PMO.

Currently provide consulting services in the areas of strategic planning, new product development & commercialization, IVD & CDx program management, business development, pharma partnering & alliance management. Act as startup advisor, mentor and coach.

Franklin Lakes, New Jersey, US

• Reported to VP of PMO and General Manager of Clinical Platform. Had three direct reports. As Director and PMO executive team member, supported PMO setup and led multiple, business-critical clinical programs.
• Managed BDB’s clinical reagents portfolio. Directed Leukemia & Lymphoma and Multiple Myeloma MRD programs. Received IVDR approval for multiple flow-cytometry based OneFlowTM L&L assays and launched products.
• As Program Director of BDB’s Companion Diagnostics initiative, led the company’s first flow-cytometry based CDx program in partnership with Ono Pharma in Japan, provided program & resource management, business.
• As Business Integration Lead, managed all BDB-Cytognos business integration related activities in Salamanca, Spain.

Franklin Lakes, New Jersey, US

• Reported to Head of PMO and to Head of Clinical Platform.
• Partnered with global CROs, developed and launched cGMP antibodies for cell therapy applications.

La Jolla, CA, US

Using multiple case studies and real-world examples, the "Foundations of Project Management" course describes the complexity of today’s project management in a global drug development effort. It will be discussed how the underlying risk markets are very challenging to manage drug development and how project management can help mitigate risk. Project.

South San Francisco, California, US

• Reported to Head of Strategic Planning & Portfolio Management. Provided strategic consulting and business management support to local site and Roche network.
• Oversaw, supported and managed a portfolio of activities related to key site programs including Strategy and Goal Setting, Budget Support, Site Resource Management and Project Business Case Development.
• Initiated, developed and implemented process improvement plans to enhance organizational efficiency and continuous improvement.

San Diego, CA, US

• Reported to SVP of Product Development and had 3 direct reports. As one of the Directors of Illumina’s PMO, supported the company’s Oncology Business Unit.
• Led multiple clinical programs to develop next-generation sequencing (NGS) Oncology panels for the research market (RUO) and for investigational use only (IUO).
• Worked effectively with internal and external stakeholders to ensure program goals were in alignment with business objectives. Interacted with business partners, including pharma partners and CROs to ensure that all.
• Implemented Illumina’s product development process (PDP) and FDA design control standards and regulations. Trained core teams on changes to the PDP process and FDA regulations.

Waltham, MA, US

• Reported to Head of PMO. Acted as leader of cross-functional core teams, internal expert in product commercialization process, IVD project management, and communication liaison with Business Unit Management.
• Led the PMA submission process for a companion diagnostics (CDx) program in collaboration with GlaxoSmithKline (GSK) to develop a gene signature assay for lung and melanoma cancer patients.
• Supported multiple global programs to develop next-generation sequencing (NGS)-based tests for the oncology market in Europe.
• Managed two multi-million dollar government contracts funded by the Biomedical Advanced Research and Development Authority (BARDA) and the Department of Defense (DoD) to develop a qPCR-based quantitative biodosimetry.

Switzerland 🇨🇭, CH

• Reported to Head of Biologics in South San Francisco (SSF) and to Head of Small Molecules in Basel/Switzerland. Provided on-site leadership for global programs in the area of business process improvement and GMP.
• Led two cross-functional work streams in SSF and Basel to drive the completion of a detailed plan for implementation and realization of Manufacturing Science & Technology (MSAT) Improvements with the objective to.

Thousand Oaks, CA, US

• Reported to Amgen’s Head of Program Management & Strategy.
• Created workflow and implemented phase gate reviews to improve Amgen's process of preparing drug dossiers in compliance with the Academy of Managed Care Pharmacy (AMCP) format for formulary submissions.

• Served the life sciences, medical devices, in-vitro diagnostics, biotech, and biopharmaceuticals industries. Provided expertise and support in the area of strategic planning, market development, business development.
• Clients included Life Technologies Corporation, Cellpoint Diagnostics, Cellective Dx, Cellecta, SciGene, Stanford University and Swissnex San Francisco (German and Swiss start-up support).

• Developed business model for a crowdfunding platform to seed fund academic biomedical research and early stage biotech projects.
• Presented business plan to EuroMBA Consortium and raised €100,000 in seed capital from private investors in Europe.

• As a member of SciGene’s Senior Management Team, reported directly to the company’s CEO.
• Directed automation of sample preparation workflows for aCGH and next-generation sequencing (NGS).
• Launched automated platform for diagnostic cytogenetic testing services ahead of schedule and installed instruments at key accounts in the U.S.
• Supported effort to raise capital for new projects,

Washington, District Of Columbia, US

• Hired into CTC as first Key Executive Director and member of Applied Imaging’s Executive Team. Played key role in Applied Imaging's turnaround and re-positioning, ultimately enabling successful sale of Applied Imaging.
• Directed Circulating Tumor Cell (CTC) program and launched research-use-only ARIOL CTC assay.
• Supported 510(k) submission process for Her2/Neu FISH assay, resulted in FDA approval.
• Presented CTC’s published & patented data as invited speaker at major International Breast Cancer Symposia (AACR, SABCS).

Männedorf, ZH, CH

• As member of NuGEN’s extended Executive Team, reported directly to the company's CEO. Established the company’s first product development group and had 3 direct reports.
• Directed cross-functional project team to develop NuGEN’s first commercial product.
• Initiated and managed global strategic partnerships and alliances, identified KOLs in the field of genomics and oncology and managed industry collaborations with life science industry leaders to support company's.
• Successfully launched microarray and qPCR compatible mRNA probe amplification kit 3 months ahead of schedule and within budget.
• Evaluated channel partners in U.S., Europe and Asia to distribute NuGEN's first product.
• Prepared technical articles, presentations, white papers and marketing collateral.

Franklin Lakes, New Jersey, US

• Reported directly to Clontech’s VP of Research & Development and had 10 direct reports.
• Managed entire product commercialization process including product development, optimization, validation and product transfer to manufacturing.
• Defined market opportunities for new products, initiated, directed and executed comprehensive product strategies that led to successful launch of more than 35 products.
• Initiated and managed co-development programs with leading life science businesses.
• Established academic partnerships and alliances with key opinion leaders in genomics and next-generation sequencing (NGS).

Bethesda, MD, US

Performed research on transcription factors and chromatin regulation. Data were published in peer reviewed journal (EMBO J.).

Basel, Basel-Stadt, CH

Cloned and sequenced an antibiotic synthetase gene in Bacillus licheniformis.

Ph.D. (Magna Cum Laude), Chemistry/Biochemistry

Technology & Innovation Management

Master Of Business Administration (M.B.A.), Focus: Technology & Innovation Management

M.Sc., Chemistry

B.Sc. (Hons), Chemistry