- CARDIOVASCULAR DISEASE has historically been one of Defined Health’s largest areas of business.
- The CV franchise is led by Michael Rice, MS/MBA, and Ed Saltzman, President.
- Defined Health has provided independent assessments and strategic advice for hundreds of development-stage cardioprevention, acute care and regenerative therapies, as well as interventional devices, for clients across the industry.
- Specific CV diseases in which Defined Health has amassed a substantial knowledge base include:
- Defined Health is the selected advisor to Informa Healthcare, the publishers and The Pink Sheet and In Vivo, to nominate the Top Cardiometabolics Projects to Watch presented annually at the Therapeutic Area Partnerships conference.
Cardiovascular Disease: Select Recent Case Studies
- Franchise Strategy: Cardiovascular landscape assessment and strategy for Big Pharmacos considering re-entering the CV space.
- Evaluation, market positioning and valuation of a novel HDL raising therapy in high risk patient segments.
- Landscape and therapeutic approaches for genetically defined CV disorders such as: HoFH/HeFH, ABCA1/Tangiers, LCAT, ACAT and ApoA1 deficiency, Cardiomyopathy.
- Strategic advice for potential expansion of a pharmaceutical grade omega-3 fatty acid to other indications and therapeutic areas.
- In-licensing opportunity assessment of an oral anti-arrhythmic for the maintenance of normal sinus rhythm in patients with chronic atrial fibrillation. Epidemiology, segmentation, treatment algorithm among primary care and cardiology specialists and competitive assessment.
- Therapeutic overview of acute cardioversion and antiarrhythmic use in atrial fibrillation for a client evaluating opportunities in this non-core business space.
- EU clinical plan and commercial launch strategy for an acute antihypertensive used in perioperative and emergent hypertensive crisis.
- In-licensing opportunity assessment of an IV thrombolytic agent in stroke, PAOD and early use in acute STEMI pts.
- AMI overview and out-licensing opportunity assessment of novel biodegradable polymer delivered via intracoronary injection. Aided client in commercial positioning and exploring partnering options.
- Strategically prioritization of potential indications for a dual acting receptor antagonist in PAH, diabetic nephropathy, CHF and resistant hypertension.
- Evaluation of several products for atrial fibrillation. Products are unique but share similar MOA.
- Developed a vision for a unique emergent / urgent care franchise to drive an acute care franchise strategy.
- Ex-US specialty company evaluating US market entry for an extended release agent in direct competition by a large pharma in the process of market development.