The FDA Group's Consultant Finder

041

Written by The FDA Group | Jul 12, 2022 7:13:59 AM

PROFESSIONAL EXPERIENCE

 

Consultant, Nashville, Tennessee                                                                                                       2009-present

Focused on development and commercialization of technologies used to enhance and improve existing therapeutics

Business and Outreach Accomplishments

  • Led the creation of strategic business models to develop and commercialize biotechnology and pharmaceutical products
  • Identified and negotiated on behalf of companies for key value-added technologies from university systems
  • Assisted companies in establishing pre-clinical development plans and navigating the stringent regulatory environment
  • Wrote business plan for advanced technology incubator partnership between Middle Tennessee and Vanderbilt University
  • Launched annual Investor Forum as part of the Life Science TN annual meeting
  • Led effort to model, fund, and launch Life Science TN mentor network

 

  • Nanoferix, Inc., Nashville, Tennessee                                                                                       2012-present

Drug delivery company developing a novel, customizable biodegradable polymer platform that can be tailored for the loading and release of specific therapeutics. Internal efforts focus on intra-articular delivery of steroids for use in orthopedic indications, while strategic partnerships allow for additional development in multiple indications.

 

Vice President of Research and Development

Responsibilities included building teams and participating in efforts to pitch technology, raise capital, form partnerships, and outline development strategies, as well as to manage product development.

Business and Outreach Accomplishments

  • Managed multiple R&D projects, including key partnerships and pre-clinical development/manufacturing
  • Identified and established key members of the founding team
  • Outlined developmental pathways for internal and external programs
  • Pitched to multiple strategic partners to engage in partnered research programs
  • Identified contract research organizations, vendors, and suppliers to support the efforts of Nanoferix technology development
  • Maintained internal knowledge of competition and relevant novel technologies worldwide

 

Cool Springs Life Sciences Center, Franklin, Tennessee 2011-2014 

Ten-acre, 160,000 square-foot life science-focused research and development campus, designed to provide dedicated space for laboratory research, product development and manufacturing facilities for medical device, biotechnology, pharmaceutical and other life science-oriented companies and their support services.

 

Life Science Business Development Director

Served as project manager overseeing enhancement and development of programs to attract and nurture life science companies at all stages of growth. Conceptualized and developed partnerships and support for a life science incubator. Worked with trade organizations such as Life Science TN in efforts to develop the growing industry in Tennessee.

 

Affiliate Broker, The Stanton Group, Brentwood, Tennessee                                                   2011-present Assisted and brokering deal and lease negotiations for life science tenants under the leadership of The Stanton Group, Inc.

 

Business and Outreach Accomplishments

  • Recruited cutting-edge life science companies to the Cool Springs Life Sciences Center, bringing jobs, experience, and new technologies to the campus
  • Managed lease proposals and contracts for new tenants on the campus, including site design and build out
  • Strengthened relationships with university technology transfer offices to launch new companies
  • Worked with local and state industry organizations to strengthen and enhance their economic development efforts
  • Assisted in centralization of the development of private biotech in Middle Tennessee
  • Designed facility components necessary to early stage companies including shared utilities, equipment, and space

BioMimetic Therapeutics, Franklin, Tennessee                                                                                             2007 – 2011

Medical device company focused on the development and commercialization of biotherapeutics or biomaterials combined with protein therapeutics for regenerative medicine

 

Associate Scientist – Research and Development

Aided in product development of Augment™ Bone Graft and its progress through the FDA process. Projects included analytical assay design and implementation

Business and Outreach Accomplishments

  • Established collaborations with multiple university systems to develop new and/or improved assays, including mass spectrometry (MS, LC/MS/MS, MALDI), proteomic analysis, and circular dichroism (CD)
  • Provided key analytical data used in support of the regulatory process for FDA and EMA product approval
  • Assisted in the training and supervision of student interns in a laboratory setting

Technical Accomplishments

  • Analyzed degradation, stability, and safety of a key active ingredient, rhPDGF-BB, for the development of new products within the company’s pipeline in a GLP-like setting
  • Performed  multiple  assays  in  protein  chemistry,  including  HPLC,  SDS-PAGE,  ELISA,  UV  spectroscopy,  affinity purification, and mass spectrometry (proteomics)
  • Worked within the regulatory constraints of Quality Control, Quality Assurance, GLP and GMP guidelines, in preparation for pre-clinical assays and clinical trials
  • Developed, implemented, and validated company methods, procedures, protocols, and their respective reports
  • Aided in the preparation of scientific articles for publication

 

Massachusetts Institute of Technology, Cambridge, Massachusetts                                                           2005 – 2007

Post-Doctoral Fellow Department of Biological Engineering

Identification and Quantification of Biomarkers of Disease Progression in Chronic Inflammation-related Cancer

  • Designed, optimized, and completed a variety of experiments in applied biological chemistry and bioanalytical chemistry. Maintained a strong sense of experimental design with attention to proper controls and rigorous preparation required for ultra-sensitive analytical methods, with a focus on the biological chemistry of inflammation and cancer
  • Established and led collaborations with immunologists and biological chemists around the world in the quantification of DNA and nucleic acid damage in various settings
  • Prepared grant applications and submitted for funding through the NIH
  • Executed research and communicated leading results through co-authorship of peer-reviewed journal articles and presentations at professional society meetings
  • Mentored undergraduate and graduate students through project and research milestones
Vanderbilt University, Nashville, Tennessee                                                                                                     2000 – 2005

Doctoral Candidate – Department of Chemistry

Site-Specific Synthesis and Analysis of Oligonucleotides Containing the C8-Deoxyguanosine Adducts of the Dietary Mutagen 2- Amino-3-methylimidazo[4,5-f]quinoline

  • Designed  and  improved  upon  new  chemical  syntheses  of  carcinogenic  DNA  adducts  for  use  in  nucleosides, oligonucleotides, and nucleic acids
  • Helped establish and grow collaborations with organic, structural, and biochemists in the characterization of structure and physical properties of modified oligonucleotides and nucleic acids
  • Presented leading results through principal authorship of peer-reviewed journal articles and presentations at professional society meetings
  • Mentored undergraduate and graduate students through project and research milestones, as well as classroom and laboratory activities

 

LEADERSHIP ACTIVITIES

 

Co-Chair, Regional Outreach Committee, Southeastern Medical Device Association (SEMDA)           2015

 

Mentor, Vanderbilt University TechVenture Challenge                                                                          2015

 

Committee Member, Life Science Tennessee Programming Committee                                      2013-present

Advise on annual programming and Annual Meeting agenda

 

Committee Member, Life Science Tennessee Economic Development & Entrepreneurship Committee    2012-present

 

Council Member, MIT Postdoctoral Scholars Advisory Council                                                             2006-2007

Advocated postdoctoral interests through meetings with administrators, organization of career seminars, and planning of networking events.

 

EDUCATION

 

Post-Doctoral Fellowship, Biological Chemistry, Department of Biological Engineering, MIT, Cambridge, Massachusetts

2007

Ph.D., Bio-Organic Chemistry, Department of Chemistry, Vanderbilt University, Nashville, Tennessee

2005

B.S., Chemistry, University of South Florida, Tampa, Florida

2000

 

CERTIFICATES, AWARDS, AND HONORS

 

Graduate, Kauffman Foundation FastTrac® TechVenture™    2009

 

Fellowship, NIEHS Training Grant in Toxicology                2005-2007