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We needed an auditor to conduct two types of audits, a document audit at an archives audit, as well as a Good Laboratory Practice audit at another company. I came across Cecilia’s Linkedin’s profile and was impressed with her background and experience; after speaking with her, there was no doubt about her suitability for both audits. Cecilia conducted both audits seamlessly and with expertise. The audit was completed, and the audit report was written in a record period of time, much to the delight of the customer who also commented on the high quality of the report. I was pleased with the quality of her audit, as well as the speed of delivery of the audit report without sacrificing quality. In summary, our experience was quite pleasant and professional. Without a doubt, I would recommend Dr. Huaman’s services to any company needing Clinical project management, GCP/GLP audits. The affordability and quality are the two areas that I found to be unique with Biomed Consultants LLC. PRESIDENT, QUALITY RESOURCE SOLUTIONS LLC.
Our company is developing a gene therapy, and the FDA requested that we implement an immune response monitoring plan in our next clinical trial. We did not have any expertise in immunology within the company to develop an appropriate plan, and our timeline was extremely reduced (less than 6 weeks). Biomed Consultants was recommended by our IND agent from their previous work experience; within one week, Dr. Huaman was on board to provide the necessary guidance. She rapidly reviewed our product and its pre-clinical and clinical data, as well as existing literature on immune response testing methodologies used to support recent gene therapy regulatory approvals.
This area is rapidly evolving, and Dr. Huaman explained newer techniques, their validity, and acceptance by FDA reviewers. Dr. Huaman balanced our product’s risk profile to the FDA’s expectations for immunogenicity monitoring for similar products; she was attentive to work already done within the company, and the company’s scope and limitations. She was knowledgeable not only in the area of immunology, but in the existing expertise at FDA, methodologies acceptable to the agency, and the language of FDA communications. In the end, Dr. Huaman delivered an immune response monitoring plan that met the company’s goals and timelines completely. I cannot speak more highly of her professionalism, excellent communication, and delivery on the contracted work. CLINICAL DIRECTOR, VM BIOPHARMA.
Dr. Huaman worked at Intrexon under a contract for 3 months. Dr. Huaman quickly came on-board within a few days and provided support with assay development for immuno-oncology projects. Her expertise in flow cytometry, cell culture, purification, and multi-plex cytokine analysis was instrumental in evaluating immune responses elicited by CAR T cells and characterization of functional aspects of these cells. Dr. Huaman is an experienced immunologist with extensive and comprehensive experience in assay development and cellular immunology techniques. Dr. Huaman would be a great asset to any company evaluating immune responses, using both cellular and molecular approaches. DIRECTOR OF ASSAY DEVELOPMENT AT INTREXON, NOW PRECIGEN.
I had a client who needed help with a plan to assess the immunogenicity of a gene therapy product - Cecilia was very responsive and knowledgeable and helped us draft a document for FDA submission on a very short timeline. The client was very satisfied and she made me look good too - thanks, Cecilia! Looking forward to working with you again. SENIOR CLINICAL CONSULTANT AT BIOLOGICS CONSULTING.
I worked with Cecilia to create proposals for our clients surrounding flow cytometry services in almost every therapeutic area. Cecilia works very hard and is diligent to ensure that you are happy with the work she provides. She is eager to succeed and always willing to go above and beyond. VP OF GLOBAL SALES AND MARKETING, FLOWMETRIC INC.