Advanced Therapeutics

We have been in your shoes, worked in small company teams. We have a track record of developing cutting edge therapies with limited resources and tight, ever changing timelines. Our team has extensive biotech and pharma
background in Sponsor roles for multiple technologies. We have directly experienced the benefits and the pain of partnering with CROs unaccustomed to Advanced Therapeutics.

We are strategists and tacticians. We partner to deliver a holistic, customized approach, tailored to the needs of your unique product. As nimble and flexible extensions of your team, we provide efficient development options from early feasibility to high value exit strategies or through pivotal trials and commercialization. Our offerings define and sharpen clinical development plans. This includes phase appropriate manufacturing control, product characterization, regulatory, reimbursement/market access, safety signal
detection, and clinical study design/execution.

Our expertise includes unique antimicrobial/ microbiome, cell and gene, and combination products. It builds upon the successful BBA history of developing complex device platforms.

How Will You Experience BBA?

  • Seamless engagement of senior experts as integral members of your team—more than a consult
  • Triage of key risks and opportunities to align across functions
  • Granular options for concurrent execution of program design including regulatory, clinical, and reimbursement elements
  • Agile, adaptive program management; we are accustomed and adapt to changes in regulations, reimbursement and internal/external business drivers
  • Unwavering focus on patient safety, data quality and credible evidence to catalyze partnering, license application, approval and market access
  • Effective, transparent review and decision-making

Advanced Therapeutics Team

advanced therapeutics chart

BBA’s Advanced Therapeutic Team offers expertise across several disease domains including:

• Neurologic
• Peripheral Vascular
• Infectious Disease and Microbiome
• Gastrointestinal
• Diabetes
• Rare or Orphan
• Rare Pediatric

Let Us Help You Navigate the Course

We are delighted to have worked with a company like BBA that offered us the full spectrum of clinical and data management services, with an integrated approach to study design, data management, statistical analysis and report generation. BBA’s team of industry leading experts was committed to servicing our needs and delivered high-quality results.
— Barbara S. Lindsay, Vice President at Benvenue Medical, Inc.

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