“One cool judgment is worth a thousand hasty councils.”  W.Wilson

About Tracy BioConsulting, LLC

NutDepotTracy BioConsulting, LLC is led by Mark A. Tracy, Ph.D. With over 20 years of experience in biopharmaceutical product development, he has an internationally recognized record of accomplishment in developing novel pharmaceuticals spanning research and preclinical phases through regulatory filings, clinical development, and commercialization. He has diverse experience in overcoming technical, alliance, development, and business challenges to advance biomedical platforms and programs into and through the clinic. Tracy BioConsulting, LLC was established to empower clients to plan, build, and navigate a successful path from the research stages and through the clinic for new platforms and drug programs. Tracy BioConsulting, LLC can assist you at any step along the way including planning, providing specialized knowledge, experience and resources, ensuring integration of multidisciplinary activities and collaboration partners to accomplish goals effectively and on time, and identifying new business initiatives and growth opportunities for your technology or organization.

Tracy BioConsulting, LLC clients include:

  • Large biopharmaceutical companies, emerging biotechnology companies, and start-ups
  • CMOs and CROs
  • Venture capital and investment management firms
  • Research institutes and universities

Tracy BioConsulting, LLC works with clients on a wide variety of projects both strategic and operational in nature. Here are just a few examples:

  • Planning and building development capabilities (internally and with CMO/CROs) to advance a new drug platform or program to the clinic
  • Providing product development know-how for nucleic acid (RNA/DNA), protein, peptide and small molecule-based products to support scale-up, GMP manufacturing, and successful regulatory filings
  • Offering scientific expertise in the development of novel products including those utilizing nucleic acids, proteins/peptides, novel delivery systems, nanotechnology and targeting.
  • Identifying new business opportunities for biopharma and drug delivery companies
  • Establishing new business partners and collaborators and managing these relationships to achieve the program goals
  • Performing technology assessments

About Mark A. Tracy, Ph.D.

MATCRS2cropped2Dr. Tracy has played a key role in the advancement of nine programs into the clinic, including several that were commercialized. He is well-known around the world for successfully bringing new protein, peptide, nucleic acid, and small molecule based medicines to the clinic, combining product development know-how with the latest advances in drug delivery, nanotechnology, and targeting. He has played important roles in the development of technology platforms and product pipelines for Alkermes, Inc. and Alnylam, Inc., two leading biotechnology companies, where he worked for over 20 years in various leadership roles of increasing responsibility. At Alkermes, he played a key role in building the company’s parenteral product development capabilities and was a member of the team that developed the first sustained delivery system for proteins approved by the FDA. While at Alnylam, Dr. Tracy successfully brought to the clinic new nanotechnology-based products that enabled human clinical proof of concept for RNAi and a growing pipeline of clinical programs. Recognized by peers internationally for accomplishments and leadership in the pharmaceutical product development, bioengineering, and delivery fields, he is a Past-President of the Controlled Release Society (CRS) and a Fellow of the American Institute for Medical and Biological Engineering (AIMBE). He is an Adjunct Associate Professor of Pharmaceutical Sciences at Northeastern University and a lecturer at Brown University. He is a member of CRS, AAAS, PDA, ACS, AIChE, and AAPS.

Associations and Affiliations

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BioConsulting Briefs
Mark Tracy Receives CRS Distinguished Service Award
Mark A. Tracy was awarded the prestigious Distinguished Service Award of the Controlled Release Soci ( Read More )
Interview with Mark Tracy
Insights into the Biopharmaceutical Industry ( Read More )
Interspecies information website
This website is an excellent resource for physiological, anatomical and biochemical parameters for a ( Read More )
Good review practices for INDs
A helpful new FDA document was recently issued describing the FDA’s good review practices for ( Read More )
Approval of Kynamro
The January 2013 approval of Kynamro (mipomirsen) marks the first systemically administered antisens ( Read More )