Martin D. Leach, Ph.D.

Email: martinleach@sbcglobal.net

Martin_leach@merck.com

To Whom It May Concern:

I have spent my career providing IT, informatics and data-mining support in life sciences organizations that include Biotechs, Pharmaceutical companies and not-for-profit research institutions. Through my interactions with numerous leading scientists, IT professionals and executives I have made major contributions across the entire R&D value chain from basic research through clinical and regulatory operations. Public acknowledgement of my contributions to research informatics include winning the 2009 Bio-IT World Best Practices Award for Pharma Knowledge Management, the 2008 Bio-IT World Best Practices Award for Translational and Personalized Medicine, Genome Technology 2002 award for Most Innovative in Bioinformatics and the 2002 Frost & Sullivan Technology of the Year Market Engineering award for informatics platform development.

I attribute my continued success to having a strong background in biology (Ph.D. molecular neuropharmacology, B.Sc. in cellular and molecular sciences) and over 18 years of research informatics & IT experience. With my current role at Merck, I lead IT for Discovery & Pre-Clinical Sciences. In this role I lead a diverse global team of ~100 across 9 North America research sites with responsibilities including High Performance & Scientific Computing, support of research IT for small molecules up to clinical trials.  In early discovery I support multiple molecular profiling technologies, next-gen sequencing, informatics platforms to support chemistry and biology from target ID through lead optimization, integration of basic research and clinical data to support translational research, research imaging and some bioinformatics support.  At the farthest extreme, I provide the IT to support global clinical supplies for clinical trials.

Prior to Merck, I have led IT and informatics groups directly while working in biotech as well as providing strategic direction to IT, informatics and research organizations during my consulting career. In industry and consulting, my interactions range across the C-suite, executive, middle management, direct staff mentoring and I have strong communication skills that allow me to communicate to management at a strategic level as well as at a technical level to the teams that I have led delivering solutions to the customer or business partner.

At Booz Allen I was a senior member of the Global Healthcare Team and during my tenure there I successfully integrated myself into this highly matrixed environment and grown the business in PharmaIT (informatics) through leveraging resources across different sectors. Collaboration with colleagues and teams managing significant projects at the NIH, CDC, FDA, Military Health, Veterans Administration, Defense, Energy/Utilities, Payor/Provider, and Financial Services have allowed me to truly see the common problems and solutions for working collaboratively and innovatively. 

I have always played a leading role setting the vision in informatics, IT and data mining to support business ranging from basic research through clinical and drug safety. I feel just as comfortable in a laboratory, scientific, or clinical setting and can seamlessly transcend these spaces because of my own diverse background. While working with scientists in these different environments I have made a number of calculated decisions around the choice, use and delivery of technology to support informatics solutions for the business. Through the acquisition of 454 Life Sciences by Roche Diagnostics, part of the deal included acquisition of the informatics and data mining platform (GeneScape) that I developed with my team at CuraGen (former parent company of 454).

Recent 'research'/'innovation' interests lie in the use of reward-feedback mechanisms for software/business process adoption, modifying human:computer interactions in research labs, and application of virtual environments for collaboration.

I look forward to the opportunity of discussing my experience and interests further.

OVERVIEW

I have a strong background in biology and 18+ years of research informatics & IT experience. I am interested in providing scientists greater access to all forms of information with the end goal of expediting their research and creating a collaborative, innovative environment to perform research in the life sciences.

PROFESSIONAL EXPERIENCE

11/09-Present: Merck & Co. - Rahway, NJ, Boston, MA

Executive Director MRL IT for Discovery & Pre-Clinical Sciences

·         Following official merger on 11/02/09, my responsibility was tripled to include providing research IT (as below) for the combined company of Schering-Plough and Merck as well as research IT to support DMPK, Safety Assessment, Global Clinical Supply Operations and Process Research.

·         Chair Merck:Microsoft Joint Steering Committee

·         My annual budget is now >50MM and my org size is ~100FTEs plus numerous contractors

7/07-11/09 Merck & Co. - Rahway, <NJ/Boston, MA

Executive Director MRL IT for Basic Research & Biomarker IT

·         Hired to lead IT support for Biomarker (Basic Research through Clinical Research) and Basic Research (Target ID through Lead Optimization).

·         Key responsibilities include:

o        Working with WW Head of Basic Research (Kathleen Metters) to develop IT plans and strategy to support Basic Research

o        Member (extended member from core teams) of the Basic Research Coordinating Committee (BRCC) and Biomarker Alliance Committee (BMAC)

o        Member of the Global Leadership Team (GLT) that is part of the Basic Research Global Operating Strategy (BRGOS)

o        Former chairperson of New Technology Review and Licensing Committee (NTRLC) Informatics Workgroup (had to step down as I could not be GLT and chair of an NTRLC workgroup)

o        Management of budget of ~ $25MM

o        Management of global team of ~80 individuals across 10 basic research sites

o        Redefining Rosetta Biosoftware strategy

o        Creation of Merck Research IT Council governance body

·         Goals (too soon to really call out accomplishments):

o        Responsible for transition of IT for 3 site closures in 2009 (Rosetta Inpharmatics, IRBM – Italy, TRI – Japan)

o        Create overarching informatics vision to integrate data capture, integration and analysis across basic research. Accomplish this working with key thought leaders from Medicinal Chemistry & Molsys, Rosetta Inpharmatics, Applied Computer Science & Mathematics (ACSM), and franchise biology

o        Build out the IT and informatics infrastructure to enable External Basic Research (EBR) – working closely with VP EBR

o        Develop informatics infrastructure and tools to support translational research through an integrated –omics, genetics, assay, and clinical platform

o        Develop flexible IT and analytical 'sandbox' so that chemists and biologists have the ability to build analytical applications and integrate data feeds in novel ways.

12/05-6/07: Booz Allen Hamilton Inc. - New York, NY

Principal

·         Hired as a senior member of Booz Allen’s Global HealthCare team focusing on the Pharmaceutical, Biotechnology, and Life Sciences fields. Expert in R&D Effectiveness and integration of information technology/informatics in life sciences and drug development.

·         Key responsibilities include:

o        Development of the Life Sciences, Clinical and Regulatory Offerings that intersect with IT/informatics.

o        Building and development of PharmaIT team

o        Combining pharmaceutical strategy with deep technical (IT/informatics) expertise from Booz Allen’s government and non-pharma industry practices.

·         Recent client engagements:

o        Bayer/Schering AG Pharmaceutical Merger (Germany) – developed and refined R&D IT strategy and consolidation plans with specific focus on Pharmacovigilance, Drug Safety, CMC, Regulatory Affairs and Global Project Management groups. Development of key IT strategy that is required for a world class R&D IT organization supporting biologics and chemical drugs and alignment with emerging trends. Worked with R&D business and R&D IT teams in Germany and US.

o        J. Craig Venter Institute (Not for profit – MD) – Worked with Dr. Venter on post-merger integration and design of a research organization that supports innovative and creative science. Alignment of IT with business needs and business drivers.

o        Exelixis Inc. (Biotech – CA) – Assessment and alignment of the IT department, staff, capabilities, and development of a roadmap for creation of a world-class IT/informatics department. Developed informatics governance model to enable project portfolio management and to ensure ongoing alignment of IT with business functions.

o        Bristol Myers Squibb – Developed a global operating model and informatics requirements to improve regulatory dossier development for drug filing submissions and communications to 150+ countries.

8/97- 10/05: CuraGen Corporation - New Haven, CT

Vice President of Informatics

·         Built and led a team of approximately 100 individuals and annual operating budget just less than $20M.

·         Developed the informatics vision and supporting informatics platform and architecture to support collaborative science from basic science through clinical and regulatory operations.

·         Developed the supporting infrastructure to ensure collaboration between IT, informatics, and the research organization. This also included the support infrastructure between informatics and collaborators/partners in other biotechs/pharmas.

·         Led software development teams for the purpose of producing software applications for laboratory automation (LIMS), mining of genomic data, sequence analysis, genotyping, gene expression visualization and analysis, proteomics technologies, pathway biology, and drug target pipeline consolidation and tracking.

·         Experienced with management of complex projects spanning multiple groups internally, externally, and of a global nature.

·         In last 2 years at CuraGen I also led the management of corporate IT, aligning IT and informatics as well as supporting IT and informatics in a subsidiary (454 Life Sciences).

·         Successfully navigated IT and informatics through regulatory compliance ranging from Sarbanes-Oxley through 21CFRpt11 and GCP.

1995-1997 Independent Consultant:

                CuraGen Corporation - New Haven, CT - Bioinformatics Strategy

                Amersham International - Little Chalfont, UK - Internet Strategy                    

                Boehringer Mannheim Biochemicals – Web/Portal Consultant                                                                       Edge Biosystems - Gaithersburg, MD – Internet marketing strategy

                Whatman Polyfiltronics - Rockland, MA - Internet & Molecular Biology Consulting

                Bioinformatics LLC - Arlington, VA - Internet & Marketing Consulting

                Biological Data Transport – Emoryville, CA - Internet & Marketing Strategy 

                Biotron Inc. - Chicago, IL - Marketing Consultant    

                The Nest Group - Southboro, MA - Internet Consultant                                                                       

1989-1990: Medical Research Council -Harrow, UK

                Scientific Research Officer – Clinical Research Centre         

·          Linkage analysis of schizophrenia and association of schizophrenia with the pseudo-autosomal region of the sex chromosomes. Identification of new mutations in prion genes associated with Creudtzfeldt-Jakob Disease.

TEACHING EXPERIENCE

                Nov 98-Nov 02: Yale University - New Haven, CT

                Guest Lecturer – Bioinformatics in Industry              

A one-semester class covering many aspects of Bioinformatics.  Lectured on the practical uses of Bioinformatics in industry with an emphasis on data integration. Course Administrator:  Mark Gerstein

Sep 1999: Cold Spring Harbor Laboratory - Long Island, NY

Invited Lecturer – Genome Informatics

A two-week lecture course covering many aspects of Bioinformatics.  Lectured on CGI-scripting and web programming, including:  Introduction to CGI’s, basic CGI scripting, the CGI.pm package, advance CGI scripting, controlling external programs through Pipes and System calls, and building web agents for data collection. Course Administrator:  Lincoln Stein

                Apr 98-Apr 99: University of New Haven - New Haven, CT

                Invited Lecturer – Bioinformatics               

A one-semester class covering many aspects of Bioinformatics.  Lectured on using web resources for sequence analysis and analysis strategies. Course Administrator:  Joel Bader

EDUCATION

                2004: Drug Information Association:

Advanced Auditing of Clinical Research Systems for Validation: What is Enough and What is Now Required

Guidance-compliant eCTDs

2001-2002: CuraGen Corporation - New Haven, CT

                                Behavioral Interviewing Training

                                Personal Interview Control Techniques

                                Management Training

Mar 1999: American Management Association - Boston, MA

                                Technical Writing

Dec 1998: MIT Sloan School of Management - Cambridge, MA

                Developing and Managing a Successful Product Strategy

1990-1997: Boston University School of Medicine - Boston, MA

Ph.D. Pharmacology       

·         Cloning of the human alpha-1 subunit gene of the gamma-aminobutyric acid type A receptor, characterization of the gene promoter, and gene expression analysis following acute and chronic treatment with benzodiazepines, alcohol, barbiturates and neurosteroids.

1986-1989: Anglia Polytechnic University - Cambridge, UK

B.Sc (Hons) Class I (1^st class Honors) Cell and Molecular Sciences   

·         Biochemistry degree with a heavy emphasis on data analysis. 

·         Thesis project:  Characterization of tandem repeats in the soybean 16s rRNA gene.

ADDITIONAL PROFESSIONAL ACTIVITIES

                2005-2007: Ribotic Systems, Inc. – Cambridge, MA

Scientific Advisory Board Member – Ribotic Systems is a synthetic biology company founded to develop a cell-free method of recombinant protein production using a full-defined system based on a synthetic ribosome. Contact: Nader Yaghoubi, CEO & President

2003: Southern Connecticut State University - New Haven, CT

Technical Advisor: Computer Science curriculum for graduates and undergraduates.

2003: Yale University - New Haven, CT

Scientific Advisor – CEGS center of excellence in Genomics Studies. Contact: Michael

Snyder

2001-2003 Yale University - New Haven, CT

                Search Committee - Search committee member for the Albert Williams Chair for Bioinformatics.

                2001-2005: The Rothberg Institute for Childhood Diseases - Guilford, CT

                Scientific Advisory Board Member - The Rothberg Institute is a non-profit organization searching for a drug treatment for the childhood dehabilitating disease Tuberosclerosis.  As a board member, I have hired chemoinformatics software developers and advised on the strategy for data integration, analysis, and publishing.

2001-2002: 454 Life Sciences Incorporated - Branford, CT

                Scientific Advisor - 454 is a company developing technologies for rapidly analyzing genomic data.  As a board member, I have been instrumental in hiring of core key informatics employees and mentoring them.

1999-2000: ApoCom, Incorporated - Knoxville, TN

                Technical Advisory Board Member - ApoCom has commercialized and refined the GRAIL package for gene identification.  ApoCom holds the worldwide rights for a new Bioinformatics tool known as GeneHoundδ.  As a board member, I advise on developing technologies at ApoCom.

1995-1997: Biotech Rumor Mill - Newton, MA

Creator & Sole Proprietor - The first Internet portal for discussion of news in the biotechnology, clinical diagnostics and pharmaceutical industries.  Sold to Biofind Ltd., a subsidiary of KMP Internet in 1997. (http://www.biofind.com/rumor)

1994-1995: Biotech Company Registry - Brighton, MA

Creator & Sole Proprietor - The first Internet portal listing contact information for biotechnology; pharmaceutical, clinical diagnostics and life science companies.  Sold to Biological Data-Transport in 1995.

AWARDS RECEIVED

·          Nominee – CIO Magazine – 'CIO – Ones to Watch' 2011 – Nominated by HCL Technologies (October 2010)

·          MRL Shining Star Award for 'CASI' Clinical Analysis and Specimen Initiative 2010 – Executive Sponsor.

·          Microsoft Life Sciences Innovation Awards 2010 for MRL Virtual World Technology Symposium , June 2010

·          BioIT 'Editors Choice' Best Practices Award for MRL Virtual World Technology Symposium – BioIT World, April 2010

·           (Inaugural) Merck Global Services Award for Innovation – Q4 2009 – Use of virtual-world technology for research symposia.

·          BioIT Best Practices Award for Knowledge Management in Pharma – BioIT World, April 2009

·          Merck Sigma Executive Belt – 2008

·          2008 Overall Merck Sigma Award for Best Innovation for a Major Initiative – iSCORE Clinical Image Management for Late Stage Clinical Trials

·          2008 Merck Global Services Award for Best Sigma Project – iSCORE Clinical Image Management for Late Stage Clinical Trials

·          BioIT Best Practices Award for Translational and Personalized Medicine – BioIT World, April 2008

·          Most Innovative in Bioinformatics – Genome Technology Magazine, October 2002

·         Technology of the Year Market Engineering Award – Frost & Sullivan, July 2002

·         Special Achievement Award for Outstanding Team-work – CuraGen Corporation, Dec. 1998

·         Henry J. Russek Award for Academic Achievement – Boston University School of Medicine, 1995

·         Valedictorian (1^st Class Honors Science Degree) – Anglia Ruskin University, 1989

SOCIETIES AND ORGANIZATIONS

2005-2007 : American Association of Pharmaceutical Scientists (AAPS)

2003-2007 : Drug Information Association (DIA)

1994- : Phi Beta Delta (Alpha Theta Chapter) – Honor Society for International

Scholars

1993-97: New England Pharmacologists

1991-97: Society for Neuroscience (SFN)

PATENTS AND PUBLICATIONS

US 6,670,464 B1 Richard A. Shimkets & Martin Leach - Nucleic Acids Containing Single Nucleotide Polymorphisms and Methods of Use Thereof (2003)

US 6,875,570 B2 Valerie L. Gerlach, Martin D. Leach, et al. – Proteins and Nucleic Acids Encoding Same (2005)

C. J. Welch, S. Ray, J. Melendez, T. Fare & M. D. Leach (2010 – In press) Virtual conferences becoming a reality – Nature Chemistry – vol 2 – p2-6

M. D. Leach & Michael Tedeschi (2007) Web2.0: If THEY Build it They Will Come – Article on web2.0 applied to PharmaR&D – Bio-IT World April 2007:30-32

M. D. Leach (2005) The Oncogenomics Handbook: Understanding and Treating Cancer in the 21^st Century; Chapter 42 – Informatics Strategies and Initiatives used in Cancer Research (eds. R Shimkets, W LaRochelle). Humana Press (Totowa, NJ)

M. D. Leach (2004) Informatics Deconstructed: Where Are We Using It and Where Do We Need to Focus. Global Outsourcing Review 6(1):43-45

M. D. Leach (2004) Gene Expression Profiling: Methods and Protocols; Chapter 10 - Gene Expression Informatics (ed. R Shimkets). Methods in Molecular Biology vol. 258. Humana Press (Clifton, NJ)

L. Giot, J. S. Bader, C. Brouwer, A. Chaudhuri, B. Kuang, Y. Li, Y. L. Hao, C. E. Ooi, B. Godwin, E. Vitols, G. Vijayadamodar, P. Pochart, H. Machineni, M. Welsh, Y. Kong, B. Zerhusen, R. Malcolm, Z. Varrone, A. Collis, M. Minto, S. Burgess, L. McDaniel, E. Stimpson, F. Spriggs, J. Williams, K. Neurath, N. Ioime, M. Agee, E. Voss, K. Furtak, R. Renzulli, N. Aanensen, S. Carrolla, E. Bickelhaupt, Y. Lazovatsky, A. DaSilva, J. Zhong, C. A. Stanyon, R. L. Finley Jr., K. P. White, M. Braverman, T. Jarvie, S. Gold, M. Leach, J. Knight, R. A. Shimkets, M. P. McKenna, J. Chant, J. M. Rothberg (2003) A Protein Interaction Map of Drosophila melanogaster (cover article). Science 302:1727-1736

M. D. Leach (2000) Bioinformatics: DNA in Bits and Bytes. Science Next Wave

(http://nextwave.sciencemag.org/cgi/content/full/2000/08/30/5?)

M. D. Leach & M. Braverman (1999) CuraToolsδ - An Object-Oriented Platform for Developing Sequence Analysis Tools.  (Internal Publication)

H. Guo, M. Welsh and M. D. Leach (1999) OGIδ - A Laboratory Information Management System for Genomic Data.  (Internal Publication)

M. Leach and D. H. Farb (1999) Isolation and Characterization of the Human GABAA/Benzodiazepine Receptor Alpha-1 Subunit Gene. (Thesis)

M. Leach (1997) Marvellous microplates. Drug Discovery Today (DDT) 2(5):174-175

M. Leach (1997) Virtual molecules. Drug Discovery Today (DDT) 2(2):39-40

M. Leach and D. H. Farb (1995) Genomic Regulations of a Promoter for the Human GABAA Receptor Alpha-1 Subunit Gene.  Soc Neurosci. Abst. 21:1589

M. Leach & D. H. Farb (1992) Isolation and Characterization of the Human GABAA/Benzodiazepine Receptor Alpha-1 Subunit Gene.  Soc. Neurosci. Abst. 18:261

M. Poulter, H. F. Baker, C.D. Frith, M. Leach et. al. (1992).  Inherited Prion Disease With 144 Base Pair Gene Insertion I.  Genealogical and Molecular Studies.  Brain 115: 675-685

F. Owen, M. Poulter, J. Collinge, M. Leach et. al. (1991).  Insertions in Prion Protein Gene in Atypical Dementias.  Experimental Neurology 112: 240-242

J. Collinge, L. E. Delisi, A. Boccio, E. C. Johnstone, A. Lane, C. Larkin, M. Leach et. al. (1991).  Evidence for a Pseudo-autosomal Locus for Schizophrenia Using the Method of Affected Sibling Pairs.  British Journal of Psychiatry 158: 624-629

J. Collinge, F. Owen, M. Poulter, M. Leach et. al. (1990).  Prion Dementia Without Characteristic Pathology.  Lancet 336: 7-9

J. Collinge, F. Owen, M. Poulter, A. E. Harding, M. Rossor, M. Mullen, M. Leach, T. J. Crow (1990).  Prion Protein Gene Analysis in Pre-senile Dementing and Ataxic Illnesses.  Second International Conference on Alzheimer’s Disease and Related Disorders.

INTERVIEWS AND ARTICLES

M. May (2009) Connections and Computations. Scientific American Worldview: A Global Biotechnology Perspective 66-69 – Interview with Martin Leach and other experts on High Performance Computing in Research. Quoted

K. Davies (2008) Making IT Work for Merck: Merck's Informatics Mission. Bio-IT World 7(4): 22-26 – Interview with Ingrid Akerblom and me about Merck's Informatics Initiatives. Quoted

R. Mullin (2007) The Big Picture – Drug firms forge an information management architecture to taken on the research data glut . Chemical and Engineering News. 85(40): 13-17,37 – Interview on information management for research in Pharma and quoted for Merck

N. Weil (2006) The Evolving Boon of Bioinformatics. Bio-IT World (http://www.bio-itworld.com/issues/2006/feb/bus-bioinformatics/). February 2006, pg 1. Article on bioinformatics consulting. Quoted.

N. Weil (2006) Bioinformatics Brain Drain Helps Consultancies. ITWorld.com (http://www.itworld.com/Career/1826/060221braindrain/). Article on bioinformatics consulting. Quoted.

Author Unknown (1999) The Hot New Job in agriculture is bioinformatics. Wall Street Journal. August 17, A1 (cover) – Article on bioinformatics and quoted as an expert.

E. Sandlund (1997) Biotech nobbar uppkφpsplaner. Svenska Dagbladet April 1 p24 –

Article on Pharmacia & Upjohn with mention of breaking news on Biotech Rumor

Mill

D. Hughes (1997) Grist to the ‘Mill’. Drug Discovery Today (DDT) 2(1):2 – Article on

Martin Leach’s biotech and life science portal the Biotech Rumor Mill.

K. Brown (1996) Changing Disciplines Can Offer Personal And Professional Satisfaction.

The Scientist 10(20):15  -Article including a mention on how I switched from science to IT

R. Finn (1996) Scientists Benefit As Life Sciences Companies Stream To The Web.

The Scientist 10(1):17  -Article including a mention on my first web portal the Biotech

Company Registry

C. Anderson (1994) Cyberspace Offers Chance To Do 'Virtually' Real Science. Science

264:900-901 – Article including my contribution on scientific collaboration in cyberspace.

D. Bennahum (1994) Fly Me To The MOO, Adventures in Textual Reality. Lingua Franca

June:p22-36 (cover article) – Article on BioMOO including mention of online

bioinformatics tools I had developed.

REFERENCES

                Available upon request