Amedio CMC Consulting - Testimonials

Amedio CMC Consulting LLC

Testimonials

“I have worked with John at several companies. He is outstanding at taking an NCE from discovery through development, always supplying the 'white powder' on time and on budget. In this era of virtual, project-based companies, John excels at working with contractors and dispersed teams. He has my highest recommendation.”

– Michael D. Webb, President and CEO, Allegro Diagnostics

"I highly recommend Dr. John Amedio as an expert consultant in all aspects of drug manufacture, CMC and FDA-regulatory advice and assistance. Dr. Amedio was a key member of our CMC team and helped produce and shepherd a peptide-based drug through several phases of drug substance and product development. He is highly knowledgable and efficient in accomplishing the complex CMC tasks set before him."

– Athan Kuliopulos, MD, PhD, Professor of Medicine and Biochemistry,

Director, Hemostasis and Thrombosis Laboratory, Tufts Medical Center

“John made major contributions that saved considerable time, money and at the same time increased confidence in the purity, quality and consistency of our drug products. John has broad expertise in process R&D, analytic method development, formulation development, cGMP manufacture of drug substance and drug product, primary and secondary packaging, labeling and supply chain and distribution. John has broad expertise, is incredibly competent and a consummate professional. Drug development is never a linear process and I am incredibly fortunate, when the unexpected event leads to crunch time, to have had John Amedio on my team.”

– Randall Carpenter, MD, Co-founder, President and CEO, Seaside Therapeutics

“I have had the pleasure of working with John as he led all of the manufacturing activities involved in taking a drug from development candidate through all phases of clinical trials. The range and breadth of his manufacturing experiences were very evident as the company dealt with all of the challenges of bringing a new product to market. While very hands on in assuring that all functions ran smoothly, he also had a grasp of the big picture. His contributions as a senior leader extended well beyond his CMC expertise and improved the overall effectiveness of the team. His style projected both competence and confidence such that he had the respect of the entire organization.”

– Kenneth Bate, Biotechnology Consultant

“In the capacity as Chief Technology Officer, Senior Vice President for Technology at ZIOPHARM Oncology I have worked closely with John's group on preclinical research, process development and manufacture of all of ZIOPHARM's product candidates. John's extensive chemical expertise, his ingenuity and in many cases creativity made a rapid advance from preclinical to clinical research possible. I strongly recommend John to any company that needs solid and creative chemistry expertise.”

– Barbara Wallner, former CTO, ZIOPHARM Oncology

Providing Excellence in Chemistry, Manufacturing and Controls (CMC) Consultation