Armstrong Clinical has now completed its first 2 years of operations. Although these two year have been during challenging time, our first years providing strategic advice to companies looking to develop new therapies has been very positive and I am happy to share some metrics describing our first two years. During this time, 21 clients, from Biotech, MedTech, Venture Capital and Medical Research Institutes have engaged AC for support. Therapies involved have ranged from biologics (antibody and cell-based therapies), small molecules, medical device, and combination device therapies, some targeting orphan indications and others focusing on diseases more prevalent in the population. Disease areas have included infectious disease, neurology, oncology, respiratory and cardiovascular disorders. Below are just some of our key activities performed over the last 2 years:
- 11 Early Phase Clinical Studies (First in Human, 2a and 2b studies) designed and protocols written: Working with the clients to design early phase clinical studies, from concept to design optimisation, with multiple stakeholder input through to drafting and protocol finalisation.
- 7 Clinical Developments Plan/Commercialisation reports: 50-60 pages of indication and therapeutic class specific, path to market reports that include detailed phase I-III clinical study designs, CMC requirements, pricing, global regulatory strategies and requirements, post market commitment, critical decision points, real word data utilisation, time and cost to market. Reports have been used for, internal communication, development planning, capital raising/financing rounds, grant applications.
- 5 Preclinical Gap Analysis Reports: 30-40-page report including indication and therapeutic class specific regulatory requirements for entering first in human clinical studies, global differences for evidence generation prior to first in human clinical studies, review of pre-clinical data generated to date and company development goals, suggestions for further pre-clinical studies required to enter first in human studies.
- 4 Real Time Clinical Development Support Services; Review of current pre-clinical experiments to advise on translational implications, optimize study designs, review of submission packages to ensure regulatory compliance. Act as sponsor representative both internally and externally (CRO’s, Sites) during the implementation of the clinical studies.
- 3 Pharmacometrics advisory services to aid in identifying potential responders and personalized medicine optimisation.
- 3 Health Economic and Pricing Reports added to reimbursement submissions. Reports have also been made to provide an expected market price of therapies still in early phase of development phase.
- 2 Data Safety Monitoring Board member appointments.
Although 21 clients is a modest number, for a small, flexible group (myself and contract based subject matter experts) we are happy to have added significant value to our clients’ therapeutic discoveries and brought their improved therapies closer to reaching patients. I would like to personally thank all thE clients that have chosen AC and I look forward to finding innovative, effective and efficient means to help more clients bring their improved therapies to market and to patients.