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Michael Luther

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Position - Company  
Chief Business Officer - David H Murdock Research Institute

Member of the Board of Directors for the David H Murdock Research Institute (DHMRI), lead and direct all activities of the institute. DHMRI is a 501(c)3 foundation created to drive innovation at the public private interface on the North Carolina Research Campus. Focus is to drive proof of principle and concept R&D that lead to creating novel products that improve human health. Areas of focus include trans-disciplinary biomarker pipeline platforms to support efforts from discovery to product launch including companion diagnostics. Work is accomplished through strategic partnerships with academia, non-profits, start-ups and established companies.

Productivity Results

• Established and gained IRS approval for DHMRI as a 501(c)(3) foundation.
• Developed and implementing 3 year strategic business plan. This includes establishment of strategic vision and tactical goals as well as setting revenue and budget targets for years one to three. Secured funding to support early organizational growth.
• Staffed, established and implemented 5 core business units. All areas generating revenue (>$4 million in year 2; projected income of ~$6 million year 3).
• Identified, negotiated and closed 8 strategic alliances to increase revenues by greater than $5 million per year on year in first 20 months (LabCorp, Johnson and Johnson, Crown Bio, Merck, International Institute of Biomedical Research, Kellogg, NIEHS, Monsanto).
• Led and successfully built a joint venture and eventual acquisition of Immune Tolerance Institute to establish clinical immune profiling laboratory to support Ph II to post-launch studies.

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Mar 2009 - 2012
Vice President and Site Head - Merck-Frosst

As Site Head, directed the work of 240 employees ($57 million annual budget) focused on delivery of Phase I candidates from target to clinic for novel therapeutics in respiratory and metabolic disorders. In addition, chaired global licensing team responsible for the business development activities and management of investment fund focused on new platform technologies. Executive serving on the Global Research Operating Committee overseeing Merck’s drug discovery operations as well as a member of the Merck Frosst Operating Committee focused on Canadian commercial and R&D operations.

Productivity Results

• Developed and implementing five year strategy for site. This included changes in the organization and therapeutic portfolio including development of an inhaled product line. Delivered six clinical candidates into Phase I in first 20 months and created sustainable pipeline to deliver 4 clinical candidates per year.
• Reorganized and established new charter for new technologies licensing group including portfolio management and business processes to align technology approaches with therapeutic strategies to deliver value. Investments showing impact in first year and a half.
• Working with Canadian operating company, built strategic relationships with key government and academic institutions. Founding member of the Quebec Drug Discovery Consortium
• Achieved $30mm in savings through Six Sigma initiatives (Green Belt/Executive Black Belt)

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Jan 2007 - Feb 2009
Vice President, Discovery Research-HTB - GSK Consumer - New Jersey GSK Consumer Healthcare

As Vice President, built and implemented successful global (250 employees in US, UK, & Japan; $40 million annual budget) division established on changing current paradigms for drug discovery and translational pharmacology. This included implementation of trans-disciplinary approaches for drug discovery, translational pharmacology, and drug repositioning businesses to create new pipeline opportunities for GSK from leads to Ph IIa programs.

Productivity Results

• Developed and implemented high content translational profiling approaches for early and late stage drug discovery including use of primary human cells and adult stem cells for screening. Contributed average of 5 leads per year using this approach
• Established and implemented drug repositioning strategy and department that led to the initiation of 6 FTIH to Phase IIa clinical studies, and 15 new lead to candidate programs from work.
• Built and developed translational medicine unit that led to deeper understanding of diabetes pathology and development of new biomarkers, assays, models and readouts for both pre-clinical and clinical studies.
• Biomarkers from these studies used to accelerate clinical development, and expand indications for existing GSK assets.

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Jan 2002 - Dec 2006
Director Predictive Medicine - GSK Consumer - New Jersey GSK Consumer Healthcare

As Director, one of the first 2 initial members, created and built organization from inception including strategy and operations as well as built out R&D, and business development and finance departments for this new business venture to integrate biomarkers and diagnostics with therapeutics to accelerate and increase success for GSK’s pipeline from discovery to post-launch including differentiation and expansion of market opportunities for both development and marketed assets.

Productivity Results

• Coordinated multiple diagnostic project teams to integrate tests and therapeutics. This involved Phase II to marketed assets including Ziagen, Valtrex, Lamivudine, Tykerb (Ph II and III), Zofran, and LpPLA2 (Ph II).
• Identified and executed deal transactions with strategic alliance partners (Quidel, Quest, Viromed, GE Healthcare, Surromed, Cepheid, and OGS Proteomics).

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Jul 1999 - Feb 2002
Department Head Molecular Sciences - GSK Consumer - New Jersey GSK Consumer Healthcare

As Section and Department Head, Built successful drug discovery organization that made major contributions to early product development for US R&D organization (oncology, metabolic disease, and virology). Led gene to screen and gene to structure efforts for US based drug discovery programs.

Productivity Results

• Successfully built organization from 4 to 75 employees in 5 years. This included development of platforms in genomics, biologics process development, structure based drug design, and assay analytics to drive US drug discovery efforts.
• Contributor to the development of three marketed products, as well as current GSK assets in Phase II and III.
• Initiated and led CCR5 and CXCR4 HIV project team. Compounds progressed from target to clinic (Phase III).
• Co-led Glaxo-ICOS joint alliance focused on phosphodiesterases. Compounds progressed to market and Ph III).

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Oct 1991 - Jul 1999
Principal Scientist - Procept, Inc.

As Principal Scientist, established biochemistry operations & directed research on CD2 and T-cell receptor proteins and antibodies for use as protein therapeutics. Assets progressed to Phase IIa. Fourth employee in this start up.

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Oct 1988 - Oct 1991
MDA Fellow - The Salk Institute for Biological Studies Jan 1986 - Jul 1988
Biologist - National Institute of Environmental Health Sciences (NIEHS) Dec 1978 - Dec 1979
Degree - University  
PhD, Biochemistry - Saint Louis University School of Medicine 1980 - 1985
BS, Biochemistry - North Carolina State University 1974 - 1978
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