|
|
|
|
|
|
Development of a Clinical Trial Strategy: Health Advances helped a large public medical device company develop a clinical trial development plan for cellular therapies in cardiac indications.
The client needed to address issues related to clinical trial feasibility, timelines, and cost in order to evaluate potential investment opportunities.
The analysis included an extensive investigation of relevant cellular therapy literature, existing trial benchmarks for relevant patient segments, and
interviews with cardiovascular and cell therapy experts. Final output included identification of the most promising cell types and delivery mechanisms to
move into development, attractive patient target populations, inclusion/exclusion criteria, endpoints for Phase I, II, and II trials, and estimates of trial
size based on literature benchmarks.
Formulation of a New Product's Development and Commercialization Plan: Health Advances worked with a large public biotech company to formulate
a business strategy for a new product's development and commercialization. First, the team assembled a comprehensive primer on the disease, its segmentation,
its presentations and its manifestations. Then, the team recommended primary and secondary endpoints for their clinical trials based on clinician feedback as
to which endpoints would capture the largest patient population and what labeling the product could achieve. The work highlighted commercialization activities
targeted at each stage of development of the product. Lastly, Health Advances delved into reimbursement issues in the US and in Europe (France, UK and Germany),
addressing issues such as office infusions for rheumatologists.
Designing Key Clinical Trial Protocol Inputs: Health Advances was asked to assist a small biotech company in the process of designing key inputs to
a clinical trial protocol to understand the appropriate clinical endpoints that should be measured, as well as the importance of capturing pharmacoeconomic and
quality of life information. Health Advances characterized the current patient populations, referral patterns, and gathered information regarding diagnosis,
evaluation and treatment of patients to help develop the clinical trial strategy. Additionally, information regarding current resource utilization and quality
of life issues was summarized into a pharmacoeconomic model.
Evaluation of Clinical Trial Design Options: Health Advances helped a small private biotech company to evaluate various clinical trial design options
for its therapeutic vaccine for pancreatic cancer in the US, Canada, and Australia. Specifically, Health Advances: 1) defined disease progression and current standards
of care in each of the major pancreatic cancer patient segments, 2) assessed the pros and cons of various trial designs (patients and treatment arms), and 3) estimated
the likely accrual rates for the most attractive trial designs.
Regulatory Strategy and Market Assessment in Europe and Japan: Health Advances performed an analysis of the market potential for a pegylated EPO
product in Europe and Japan. The study looked at current products on the market as well as those in development. A review of the various regulatory pathways was
also examined to identify any major hurdles by country or potential faster track pathways to initiate approval.
Assessment of Regulatory and Reimbursement Requirements in the EU: A commercialization strategy was developed in the UK, France, Germany, Italy and
Spain that maximized adoption of an assay predicting patient response to HIV therapy. Health Advances determined regulatory and reimbursement requirements in each
country for a diagnostic assay that would be performed in a CLIA approved lab in the US. In addition, shipping and handling logistics and costs were considered under
numerous possible scenarios. Health Advances then developed a strategy to provide the greatest opportunity for adoption as well as approval while considering costs.
|
|
 |
|
|
|
|
