ABOUT

ABOUT

Mission:

Our mission is to provide outstanding Consulting Services for Pharmaceutical Development including Analytical Chemistry, Quality, and Process Development, thereby meeting the needs of our patients and exceeding the expectations of our clients. 

Mission:

Our mission is to provide outstanding Consulting Services for Pharmaceutical Development including Analytical Chemistry, Quality, and Process Development, thereby meeting the needs of our patients and exceeding the expectations of our clients. 

Values: 

  • Purpose & Responsibility
  • Our purpose is to assist clients with CMC development activities, and it is our responsibility to do so in a GMP-compliant manner. 
  • Passion & Excellence
  • We are passionate about helping patients and clients, and about science. This passion translates into our standard of excellence in our operations. 
  • Integrity & Thoughtfulness
  • Operating with integrity is not only critical to successful pharmaceutical development, but also expected by regulatory agencies, and it is our belief that it’s the best way to do science and conduct business. We are thoughtful about everything we do, and are experience working with not only our clients, but also those supporting them such as additional consultants and contract research and manufacturing organizations. Honesty and respect are the foundations upon which we work to build and maintain positive, enjoyable, and productive relationships with every collaborator. 

Values: 

  • Purpose & Responsibility
  • Our purpose is to assist clients with CMC development activities, and it is our responsibility to do so in a GMP-compliant manner. 
  • Passion & Excellence
  • We are passionate about helping patients and clients, and about science. This passion translates into our standard of excellence in our operations. 
  • Integrity & Thoughtfulness
  • Operating with integrity is not only critical to successful pharmaceutical development, but also expected by regulatory agencies, and it is our belief that it’s the best way to do science and conduct business. We are thoughtful about everything we do, and are experience working with not only our clients, but also those supporting them such as additional consultants and contract research and manufacturing organizations. Honesty and respect are the foundations upon which we work to build and maintain positive, enjoyable, and productive relationships with every collaborator. 

Areas of Expertise & Experience

  • Pharmaceutical CMC Development
  • Regulatory Dossier Submission & Pre-Approval Inspection
  • Small and Large Molecule Analysis

Areas of Expertise & Experience

  • Pharmaceutical CMC Development
  • Regulatory Dossier Submission & Pre-Approval Inspection
  • Small and Large Molecule Analysis

JOHN D. ORR, Ph.D.

President, Associated Analytics LLC.

Bio

Analytical chemistry consulting firm owner with 28 years of pharmaceutical R&D experience, from drug discovery through commercialization of small molecules through antibody-drug conjugates, who is passionate about patients, people, and science. 

Key Highlights:

Industry Service:

  • Board of Directors Member, IQ Consortium
  • Board of Directors Member, Allotrope Foundation
  • Chair, Analytical Leadership Group, IQ Consortium

Drug Development, Analytical Chemistry:

  • Led analytical team through successful Eribulin FDA Pre-Approval Inspection
  • Contributed to numerous global NDA, MAA, IND, IMPD filings
  • Contributed to >30 global CMC regulatory responses 

Academic Affiliations:

Ph.D., Organic Chemistry

    University of Chicago

Jason Pontrello

Bio

Pontrello entered the University of Michigan intending to go on to medical or some other professional school. But after getting the opportunity to teach through an honors chemistry program, he decided that he wanted to pursue a professorial path instead. He also spent a year and a half working at Pfizer during and after college.

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Student Reviews of Professor Pontrello:

"Everyone fears organic chemistry. Pontrello explained everything step by step, making you understand why everything happens, so you are not left to memorize a million mechanisms. His lectures were always compelling. He was extremely organized and clear. He provided practice problems from previous years' exams that SAVED me. Best professor I've had.""Dr. Pontrello is incredible at what he does. His perennial spirit of adventure towards teaching and research is laudable.""I never thought I'd miss orgo, but I will. Pontrello's dedication is pretty amazing, and if you put forth the same amount of effort as a student you'll do well. Love this class"

Research:

Advances in understanding about teaching and learning which have taken place in the education sciences are often not utilized by basic science departments. As one of many interdisciplinary combinations that is possible in a chemistry department in the 21st century, joining together ideas about chemistry and education is a rich frontier for exploration. Read More →

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Publications

Description Title

1.   Orr, J.D. and Reid, G.L. (2020): Analytical Methods in the Clinical Phase of Development. In: Riley, C.M., Rosanske, T.W., and Reid, G.L. (Eds), Specification of Drug Substances and Products: Development and Validation of Analytical Methods, Second Edition, Elsevier, pp. 101-124. 


2.   Orr, J.D. and Reid, G.L. Process Analytical Technology: Meeting FDA’s Aspirational Guidance in Continuous Manufacturing. Pharmaceutical Online, Guest Column, July 9, 2018. https://www.pharmaceuticalonline.com/doc/process-analytical-technology-meeting-fda-s-aspirational-guidance-in-continuous-manufacturing-0001. 

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Description Title

Coppola, B. P.; Pontrello, J. K. “Student-Generated Instructional Materials.” In, Mintzes, J. J.;

Walter, E. (Eds.) “Active Learning in College Science, The Case for Evidence-Based Practice.”

Springer, Cham, 2020; pp. 385-407. ISBN 978-3-030-33599-1, DOI: 10.1007/978-3-030-33600-4

https://link.springer.com/chapter/10.1007/978-3-030-33600-4_24

Book reviewed in: Reiness, C. G. “A Compendium of Rationales and Techniques for Active

Learning.” CBE – Life Sciences Education 2020, 19 (4), 19:fe6, 1-3. DOI: 10.1187/cbe.20-

08-0177

https://www.lifescied.org/doi/10.1187/cbe.20-08-0177

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