biomedicalinsights

info@bio-insights.com

(415) 392-0710

Therapeutic Expertise

BMI has substantial experience in every major disease category, therapeutic class, and modality: small molecules, siRNA and ASOs, antibodies, enzyme replacement therapies, radiotherapeutics, cell and gene therapies, new molecular diagnostic platforms, and more.

While we tailor our projects to each client’s unique needs, you can be assured that when we start your project, BMI is not starting at square one. We will bring a depth and breadth of knowledge built from solving numerous challenging problems, like yours.

While our expertise is wide-ranging, BMI has a particularly in-depth understanding of the development challenges and opportunities for new oncology and rare disease therapeutics, informed by the successful completion of hundreds of engagements, from evaluating the market for novel gene therapies for rare genetic diseases to helping our clients overcome market access challenges for novel cell therapies with no existing reimbursement pathways.

  • Alopecia areata
  • Axial spondyloarthropathy (ankylosing spondylitis and non-radiographic SpA)
  • Behcet’s disease
  • Bullous pemphigoid
  • Cryopyrin-associated periodic syndromes (CAPS)
  • Gout
  • Grave’s disease
  • IgA nephropathy
  • Inflammatory bowel diseases (Crohn’s disease, Ulcerative colitis)
  • Juvenile psoriatic arthritis
  • Multiple sclerosis (RRMS, SPMS, PPMS)
  • Osteoarthritis
  • Primary membranous nephropathy
  • Psoriasis (all types)
  • Psoriatic arthritis
  • Rheumatoid arthritis
  • Sjogren’s syndrome
  • Systemic lupus erythematosus & Lupus nephritis
  • Systemic sclerosis (scleroderma)
  • Vasculitis (multiple types)
  • Vitiligo
    • Anticoagulants
    • Arrhythmias
    • Atherosclerosis
    • Congestive heart failure (HFpEF, HFrEF)
    • Dyslipidemias (hypercholesterolemia, hypertriglyceridemia, mixed dyslipidemias)
    • Myocardial infarction
    • Peripheral vascular disease (PVD)
    • Stroke
    • Thrombolytics
    • Alzheimer’s
    • Amyotrophic lateral sclerosis (ALS)
    • Frontotemporal dementia (FTD)
    • Huntington’s disease
    • Lewy Body Dementia
    • Migraine
    • Multiple sclerosis (RRMS, SPMS, PPMS)
    • Multiple System Atrophy (MSA)
    • Neuropathy (various)
    • Parkinson’s
    • Progressive supranuclear palsy (PSP)
    • Rare CNS disorders (ataxias, epilepsies, LSDs, NDDs)
    • Alopecia areata
    • Atopic dermatitis
    • Bullous pemphigoid
    • Chronic dermal ulcers (all types)
    • Chronic itch (various conditions)
    • Hidradenitis suppurativa
    • Lichen planus
    • Psoriasis (all types)
    • Pyoderma gangrenosum
    • Vitiligo
    • Acromegaly
    • Alstrom syndrome
    • Bardet-Biedl syndrome (BBS)
    • Congenital hyperinsulinism
    • Cushing’s disease
    • Diabetes (T1D, T2D)
    • Gout
    • Growth hormone deficiency (GHD)
    • Hyperprolactinemia
    • IGF-1 deficiency
    • Lipodystrophy syndromes
    • NASH (MASH)
    • NAFLD (MAFLD)
    • Obesity (including genetic causes)
    • Osteoporosis
    • Primary and secondary
    • hyperparathyroidism (PHPT, SHPT)
    • Rare bone disorders (e.g., achondroplasia, X-linked hypophosphatemia (XLH), hypophosphatasia, tumor-induced osteomalacia, osteogenesis imperfecta)
    • Constipation
    • Gastroparesis
    • Hereditary hemochromatosis
    • Hepatitis (B & C)
    • Irritable bowel syndrome (IBS)
    • Inflammatory bowel diseases (Crohn’s disease and Ulcerative colitis)
    • NASH (MASH)
    • NAFLD (MAFLD)
    • Short bowel syndrome (SBS)
    • Pancreatitis (Acute and Chronic)
    • Post-operative ileus
    • Primary sclerosing cholangitis (PSC)
    • Erectile dysfunction (ED)
    • Fertility
    • Incontinence
    • Peyronie’s disease
    • Prostate cancer (PC)
    • UTIs
    • Anemia (multiple forms)
    • Atypical hemolytic uremic syndrome (aHUS)
    • Beta thalassemia
    • Cytopenias and immunodeficiencies (wide range)
    • Hemophilia (A & B)
    • Hereditary hemochromatosis
    • Myelodysplastic syndromes
    • Paroxysmal nocturnal hemoglobinuria (PNH)
    • Polycythemia vera
    • Red cell substitutes
    • Sickle cell disease (SCD)
    • HIV/AIDS
    • Bacterial (wide range)
    • Fungal (wide range)
    • Hepatitis B and C viruses
    • Site specific and complex infections
    • Viral (wide range)
    • Diabetic retinitis
    • Glaucoma
    • Leber congenital amaurosis (LCA)
    • Macular degeneration (wet and dry)
    • Joint replacement
    • Dupuytren’s contracture
    • Spinal surgery technologies
    • Synovial fluid therapies
    • Pain
    • ADHD
    • Depression
    • Schizophrenia
    • Substance abuse / addiction
    • Anemia
    • Atypical hemolytic uremic syndrome (aHUS)
    • Chronic renal insufficiency (CRI)—various causes
    • End stage renal disease (ESRD)
    • Secondary hyperparathyroidism (SHPT)
    • Orphan / rare renal diseases (IgAN, FSGS, pMN, Lupus nephritis, Alport’s syndrome
    • Asthma
    • Chronic rhinosinusitis
    • Chronic obstructive pulmonary disease (COPD)
    • Cystic fibrosis
    • Idiopathic pulmonary fibrosis (IPF)
    • Interstitial lung disease
    • Pulmonary arterial hypertension (PAH)
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    Elizabeth K. Brooks, Partner, San Francisco 

    Ms. Brooks has worked in market research and health care policy for 30 years. During this time, she has helped biotechnology, pharmaceutical, and medical device companies develop marketing, reimbursement, distribution, and overall launch strategies for their products.  Ms. Brooks has analyzed markets for, and provided due diligence support on, hundreds of therapeutics.  She is also expert at reimbursement issues, offering analysis, education, and tactical support to pharmaceutical and biotechnology concerns, as well as medical device companies. In addition, Ms. Brooks has developed a model for helping companies evaluate the need for pharmacoeconomic studies and has trained hundreds of staff on the appropriate use of outcomes research tools.  Ms. Brooks holds a Masters of Business Administration and an Honors Bachelor of Arts degree in English, both from the University of Chicago. She also earned a Certificate from the University of Chicago Graduate Program on Health Administration and Policy.

    Elizabeth K. Brooks, Partner, San Francisco 

    Ms. Brooks has worked in market research and health care policy for 30 years. During this time, she has helped biotechnology, pharmaceutical, and medical device companies develop marketing, reimbursement, distribution, and overall launch strategies for their products.  Ms. Brooks has analyzed markets for, and provided due diligence support on, hundreds of therapeutics.  She is also expert at reimbursement issues, offering analysis, education, and tactical support to pharmaceutical and biotechnology concerns, as well as medical device companies. In addition, Ms. Brooks has developed a model for helping companies evaluate the need for pharmacoeconomic studies and has trained hundreds of staff on the appropriate use of outcomes research tools.  Ms. Brooks holds a Masters of Business Administration and an Honors Bachelor of Arts degree in English, both from the University of Chicago. She also earned a Certificate from the University of Chicago Graduate Program on Health Administration and Policy.

    Paul C. Nagle, Partner, San Francisco

    Mr. Nagle has advised medical product manufacturers on a wide range of strategic issues for over 30 years. He specializes in market assessments, payer and reimbursement strategy, and pricing and contracting strategy. With his thorough knowledge of payer policies, he has helped dozens of product manufacturers understand and penetrate managed care, Medicare, and Medicaid segments, as well as provider segments when they are de facto payers. He also frequently conducts due diligence for M&A and licensing opportunities for manufacturers and the investment community. Mr. Nagle performs pricing analyses and develops contracting strategies (including multiple product contracting) using a variety of methodologies. Mr. Nagle also has significant expertise in international market assessments.  Mr. Nagle is frequently called upon by his clients to research, analyze and strategize about particularly unique and challenging manufacturer dilemmas and novel areas of interest.  Mr. Nagle holds a Bachelor of Science in Business Administration from the Olin School at Washington University in St. Louis.

    Paul C. Nagle, Partner, San Francisco

    Paul C. Nagle for over 30 years, Mr. Nagle has advised medical product manufacturers on a wide range of strategic issues. He specializes in pricing strategy, payer and reimbursement strategy, and assessing markets and products for licensing and M&A due diligence. Mr. Nagle’s focus is most frequently on the US and Europe, but also includes Japan and Brazil. He frequently consults to the investment community for opportunities under consideration. Mr. Nagle performs pricing analyses and develops pricing and contracting strategies using a variety of methodologies. Mr. Nagle also has significant expertise in third-world market assessments. Mr. Nagle is frequently called upon by his clients to research, analyze and strategize about particularly unique and challenging manufacturer dilemmas and novel areas of interest. Additionally, Mr. Nagle has helped state Medicaid programs and private payers understand the impact of specialty products, and his analyses have impacted Medicare legislation. Mr. Nagle holds a Bachelor of Science in Business Administration from the Olin School at Washington University in St. Louis. Before co-founding BioMedical Insights, Mr. Nagle was at Health Technology Associates, which became part of Covance.

    Christopher A. Nicita, Partner, San Francisco

    Mr. Nicita specializes in market and technology assessment, new product planning, and pricing and reimbursement strategy. He has over 30 years of experience in health care market analysis and medical research. Mr. Nicita has helped identify and evaluate opportunities afforded by dozens of new products, technologies, and markets and has helped the firm’s clients develop and launch a number of innovative new therapies. He has worked with a range of companies, from industry leaders to start-ups, to make sound portfolio investment decisions and to optimize clinical development strategy. Mr. Nicita frequently consults to companies on prospective in-licensing and merger and acquisition candidates, and has provided due diligence services to a variety of health care investors. He has broad expertise in most therapeutic classes and disease areas including oncology, infectious diseases, immune-mediated and inflammatory diseases, endocrinologic diseases, ultra rare genetic diseases, and cardiovascular diseases, among others. Mr. Nicita holds a Masters of Business Administration and an Honors Bachelor of Science in Molecular Biology, both from the University of Michigan.

    Christopher A. Nicita, Partner, San Francisco

    Mr. Nicita specializes in market and technology assessment, new product planning, and pricing and reimbursement strategy. He has over 30 years of experience in health care market analysis and medical research. Mr. Nicita has helped identify and evaluate opportunities afforded by dozens of new products, technologies, and markets and has helped the firm’s clients develop and launch a number of innovative new therapies. He has worked with a range of companies, from industry leaders to start-ups, to make sound portfolio investment decisions and to optimize clinical development strategy. Mr. Nicita frequently consults to companies on prospective in-licensing and merger and acquisition candidates, and has provided due diligence services to a variety of health care investors. He has broad expertise in most therapeutic classes and disease areas including oncology, infectious diseases, immune-mediated and inflammatory diseases, endocrinologic diseases, ultra rare genetic diseases, and cardiovascular diseases, among others. Mr. Nicita holds a Masters of Business Administration and an Honors Bachelor of Science in Molecular Biology, both from the University of Michigan.

    Andrew P. Kloek, Ph.D., Principal, Nashville

    Dr. Kloek has worked in market research, reimbursement and technology assessment with BioMedical Insights since 2007. He holds a Bachelor’s degree in Genetics and Chemistry from Western Kentucky University and a Ph.D. in Genetics from Washington University in St. Louis. Prior to joining BioMedical Insights, he spent eight years with biotechnology start-up companies including three years working with Affymetrix-based micro-array technologies at Perlegen Sciences, a Mountain View, California-based company focused on pharmacogenomics and personalized medicine. He has co-authored 20 peer-reviewed scientific publications and 10 issued patents in the fields of genetics and biotechnology.

    Andrew Kloek, Ph.D., Principal, Nashville

    Dr. Kloek has worked in market research, reimbursement and technology assessment with BioMedical Insights since 2007. He holds a Bachelor’s degree in Genetics and Chemistry from Western Kentucky University and a Ph.D. in Genetics from Washington University in St. Louis. Prior to joining BioMedical Insights, he spent eight years with biotechnology start-up companies including three years working with Affymetrix-based micro-array technologies at Perlegen Sciences, a Mountain View, California-based company focused on pharmacogenomics and personalized medicine. He has co-authored 20 peer-reviewed scientific publications and 10 issued patents in the fields of genetics and biotechnology.

    Jacqueline D. Koenig, Principal, Houston

    Ms. Koenig has been with BioMedical Insights since 2004. She helps life sciences and medical device companies conduct due diligence, analyze market nuances, assess licensing and investment opportunities, prioritize clinical indications, and create market access strategies across numerous therapeutic categories. Prior to joining BioMedical Insights, Jacqui worked at the Kaiser Family Foundation developing national public education campaigns and conducting public opinion and provider surveys. She started her career at what is now Covance (formerly Health Technology Associates). Ms. Koenig holds a Bachelor of Arts degree in Economics from Vassar College and a Master of Science in Business degree from Johns Hopkins University.

    Jacqueline Koenig, Principal, Houston

    Ms. Koenig has been with BioMedical Insights since 2004. She helps life sciences and medical device companies conduct due diligence, analyze market nuances, assess licensing and investment opportunities, prioritize clinical indications, and create market access strategies across numerous therapeutic categories. Prior to joining BioMedical Insights, Jacqui worked at the Kaiser Family Foundation developing national public education campaigns and conducting public opinion and provider surveys. She started her career at what is now Covance (formerly Health Technology Associates). Ms. Koenig holds a Bachelor of Arts degree in Economics from Vassar College and a Master of Science in Business degree from Johns Hopkins University.