EXPERTISE

SAMPLE ASSIGNMENTS

We help clients align their product development programs with marketplace realities. By engaging in this process early in a product’s history, companies can make critical alterations to a product’s development program and thus achieve both optimal returns on their research investments and more rapid and effective commercial launches.

  • Indication Optimization:  Identify and prioritize the potential indications for an early-stage technology

  • Go/No-Go Analyses:  Identify the “make-or-break” development milestones for an early-stage product candidate

  • Line of Therapy Forecasting:  Characterize the future competitive environment and a drug candidate's potential role in the treatment hierarchy

  • Addressable Market:  Segment, prioritize, quantify, and describe the target physician and patient audiences

  • Product Adoption:  Determine the minimum commercially viable target product profile. Predict how physician prescribing, patient usage, and payer access will vary with base case, upside, and downside target product profile scenarios

  • Product Attribute Analysis: Identify the commercial trade-offs of optimizing one product attribute in lieu of another

  • Optimize Internal and External Investment Decisions: Develop the clinical, reimbursement, and commercial arguments to substantiate major internal investment decisions as well as strategic alliances

THERAPEUTIC AREAS

We have completed work in practically every therapeutic category and geography, including North and South America, Europe, and Asia for clients ranging from start-up companies to large multinationals.

Autoimmune

  • Ankylosing spondylitis, idiopathic pulmonary fibrosis, rheumatoid arthritis, Sjogren’s, SLE   

Cardiology

  • ACS, atrial fibrillation, dyslipidemia (TG, HDL, LDL), familial hyperlipoproteinemias, hypertension, Lp(a)

Critical Care

  • Acute pancreatitis, acute lung injury, CAP-sepsis, post-operative surgical complications

Dermatology

  • Acne, alopecia, atopic dermatitis, basal and squamous cell carcinoma, cutaneous lupus, onychomycosis, melanoma, psoriasis, rosacea, seborrheic keratosis, urticaria, aesthetic fillers

Drug-Coated Devices

  • Anti-infection catheters, drug-loaded anti-adhesion devices 

Gastroenterology

  • Crohn’s, GERD, IBS, ulcerative colitis 

Hearing Disorders

  • Idiopathic sudden sensorineural hearing loss (ISSHL), noise-induced hearing loss, Meniere’s disease, ototoxicity, presbycusis, tinnitus

Hepatology

  • Acute liver injury, alcoholic hepatitis, autoimmune hepatitis, drug-induced liver injury, hepatitis B, hepatitis C, liver transplant, primary biliary cirrhosis, NAFLD, NASH

Infectious Disease

  • Candidiasis, C. difficile-associated disease, CMV, HBV, HCV, HPV, HIV, influenza, opportunistic fungal infections norovirus, rhinovirus, ventilator-associated pneumonia

Metabolic Disease

  • Diabetes, metabolic syndrome, obesity, NASH, NAFLD

Nephrology

  • Acute kidney injury, CKD, lupus nephritis, vascular access 

Neurology

  • Event associated cognitive impairment (TBI, chemotherapy, HIV, cardiac surgery, post-infectious encephalitis), epilepsy, migraine, multiple sclerosis, Parkinson’s, schizophrenia, stroke

Oncology

  • Immuno-oncology, majority of major solid tumors and hematological malignancies 

Ophthalmology

  • Acute angle closure glaucoma, chronic glaucoma, myopic CNV, optic neuritis, wet and dry AMD 

Orthopedics

  • Cartilage repair (tissue regeneration), joint replacement, OA, trauma

Pain Management

  • Neuropathic pain, post-operative pain, novel formulations

Rare Disease

  • Alpha-1 antitrypsin deficiency, autoimmune hepatitis, carcinoid syndrome, polycythemia vera, MPS I, MPS II, IPF, HAE, HoFH, MELAS and other mitochondrial diseases, sickle cell disease, gene therapy for GBM and LSDs, post-infectious encephalitis, myelodysplastic syndrome, MGUS

Respiratory Disease

  • Asthma, COPD, idiopathic pulmonary fibrosis, allergic rhinitis, cystic fibrosis

Trauma/Surgical Complications

  • Adhesions, complex fractures, blunt and penetrating abdominal-pelvic surgery

Urology

  • Erectile dysfunction, interstitial cystitis, overactive bladder, stress incontinence, urinary retention, BPH

Vascular Disease

  • Diabetic nephropathy, vascular grafts, AV fistulas, peripheral vascular disease

Women's Health

  • Caesarean sections, female sexual dysfunction, hysterectomy, interstitial cystitis, IVF, stress incontinence, myomectomy, OAB, osteoporosis