THERAPEUTIC EXPERTISE

  


 

Deep therapeutic knowledge combined with clinical development experience drives more effective and efficient pathways to commercialization. Helping you meet regulatory requirements in each jurisdiction for study execution and market entry. Ensuring your data are scientifically meaningful to the clinical, regulatory, payer and patient communities. Targeting your product messaging to each market and stakeholder.

  

Oncology

New oncology therapies must overcome some of the lowest approval rates in biopharma. To realize your product’s potential, work with the most experienced CRO in oncology development. Knowledgeable in virtually every major cancer indication, our oncology specialists combine scientific and medical expertise with commercial strategies to optimize your product’s success. Our fully integrated approach to oncology development extends across the product life cycle, offering you expertise in:

  • Clinical development – Supporting 900+ oncology trials.
  • Regulatory – Global and regional experts with FDA, European, Japanese and other regulatory backgrounds.
  • Commercialization – specific teams to assess your product’s commercial viability and maximize market success.
  • Market Access – Validate the price point of your oncology treatment to gain formulary access.
  • Risk-sharing – Innovative models to ease your up front investment and build portfolio value.

Cardiovascular

The challenges of cardiovascular research are many: global scope with high enrollment, competition for investigators and patients, new regulatory requirements, growing scrutiny from payers. 

Biotec Partners has clinical and operational expertise in cardiology as well as the capital required to drive your product’s success.

Specializing in cardiovascular research to give you competitive advantage

For truly global reach and therapeutic depth, Biotec Partners’ experience spans more than 300 cardiovascular studies involving more than 439,000 patients. We’ve built long-term relationships with academic key opinion leaders and investigators around the globe to bring unmatched expertise to your clinical development.

Count on Biotec Partners to help maximize the potential of your therapy or cardiovascular device and meet your time, quality and cost objectives. From early clinical development to global registrational and late phase studies to commercialization, we offer a comprehensive solution:

  • Protocol feasibility and site identification to ensure on-target patient enrollment 
  • Regulatory strategy and execution and quality systems 
  • Accurate safety reporting to meet stakeholder demands in the US and abroad 
  • Cardiovascular device development – from catheters to combination products such as drug-eluting stents and in-vitro diagnostics

Endocrinology

The clinical development landscape for endocrinology and diabetes drugs is changing as new regulatory guidance continues to evolve. Trial requirements are increasing timelines, development cost and data complexity. Now more than ever, it is critical to have an ally who understands these implications and can take your product through development to market success. Specialized expertise in endocrinology and diabetes therapies to help you:

  • Ensure trial development meets global regulations
  • Track cardiovascular events
  • Increase market access
  • Implement targeted messaging and tools to ensure patient compliance
  • Develop partnerships to manage risks and costs
  • Track record in global diabetes research studies and endocrinology research.

Biotec Partners has provided services for more than 165 diabetes clinical research studies involving more than 148,800 subjects and more than 19,200 investigator sites. We have worked on close to 90 endocrinology research studies involving approximately 29,000 patients. The wide variety of indications in this therapeutic area include obesity, calcium disorders (osteoporosis), growth hormone disorders (including acromegaly) and pituitary hormone disorders (including hyperprolactinemia and hyperthyroidism).

Nervous System

Developing products to treat diseases of the central nervous system poses a number of hurdles. Recruitment difficulties. Subjective outcome measures. Treatment adherence issues.

Biotec Partners’ CNS experts and data-driven approach can help you overcome obstacles to your product’s success:

  • Clinical development – Our team leverages expertise in protocol design, biomarker strategies and diagnostic imaging technologies that are opening doors for CNS research
  • Trial operations – Global medical and operational staff accelerate recruitment and streamline trials
  • Outcomes reporting – Trained investigators understand the nuances of subjective outcomes 
  • Commercial strategies – Sales and marketing specialists with neuroscience experience can speed your market entry

Internal Medicine

From allergy research to arthritis research, developing products in internal medical specialties requires a deep understanding of the intricate requirements of each.

Our integrated capabilities can help you minimize risk, ensure trial feasibility, and drive regulatory and commercial success of your program.

Biotec Partners' internal medicine research expertise spans the breadth of specialties:

  • Musculoskeletal & Rheumatology – Team led by board-certified rheumatologist; conducted 280+ musculoskeletal / rheumatology trials for arthritis research and other studies, and 55 late phase trials 
  • Respiratory & Allergy – Global team of pulmonologists and respiratory medical advisors, as well as senior project directors trained and/or certified on guidelines including GINA, GOLD and ERS/ATS 
  • Gastroenterology – Four board-certified gastroenterologists; extensive GI studies for indications including ulcerative colitis, Crohn’s disease, IBS and GERD 
  • Dermatology & Aesthetics – Conducted over 100 dermatology trials with devices, topical applications and systemic use of monoclonal antibodies and other biologics 
  • Nephrology – Worked on 180 trials at 9,390 sites for chronic kidney disease; work effectively with nephrology investigators and manage hemodialysis studies 
  • Ophthalmology – Indications from dry eye to glaucoma to retinopathies; experience in technologies including optical coherence tomography, scanning laser ophthalmoscopy and corneal topography

Infectious Disease

The threat of infectious disease is real, and it’s growing fast – sometimes faster than biopharma’s ability to respond. Old standards like influenza, malaria and tuberculosis are re-emerging as a danger to public health, while modern foes like H1N1 and HIV-AIDS present new and ongoing challenges. Add to that the increase in drug-resistant microorganisms, the global spread of infectious disease and the threat of bioterrorism, and complexity increases.

How do you get desperately needed new treatments and antimicrobial agents to market in a timely, cost-effective manner? Partner with a leader who has a track record in infectious diseases, from influenza to tuberculosis.