HUGHES BIOPHARMA ADVISERS
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Clinical development problems delay product marketing approval.
We create custom fixes that get your therapies to market faster.​ 

How Your Peers Hired Us & Earned More Faster.
Our Consulting Services are Custom Fit to Solve Your Problems.

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How We Solve Clinical Trials & Startup Challenges: Getting on the Market and to Your Patients Faster
  • A Phase 3 clinical trial stage Boston biotech needed their first product on the market. They hired HBP on their small team to rapidly get their data into a clear, compelling, compliant submission. Our biotech client got their first product, an oncology therapy, approved 3 months earlier than expected, generating $6.4 million in revenue and shifting a Wall Street analyst rating to Buy because we were a key member on the NDA submission team.
  • An Australian clinical stage biotech needed to start their Phase 1/2 trial. They hired HBP. Our biotech client enrolled and conducted their early-stage clinical trial for an oncology product because we developed their clinical trial monitor training, protocol and other clinical trial initiation documents based on our deep knowledge from >1,000 clinical trial documents developed at global biopharma firms. 
  • A Venture Capital wanted to understand the digital health market before investing. They came to HBP to rapidly understand if this space was investible for them.
  • ​A global pharma firm needed to get a new product on the market. They hired HBP. Our client launched a new metastatic breast cancer therapy, a key part of their 5-year plan in record time, facilitated by us increasing agility by restructuring their R&D processes, helping teams and functions be tightly aligned and making SOPs lean and clear, cutting excess red tape processes in half, so staff could focus effectively on the therapy approval and launch.
How We Streamline BioPharma Firms to Get Innovative Therapies to Market Quicker
  •  A Japan-based global biopharma needed to integrate R&D processes across global cultures and functions. They hired HBP to streamline R&D operations like Pharmacovigilance, Medical Affairs, Regulatory and more. HBP got functions working smoothly across countries & regions. We cut many processes by 50%.
  • A global pharma firm needed to quickly respond to a new FDA regulation that affected nearly every product in their portfolio. They hired HBP. Our client met their company-wide clinical trial transparency requirement with delivery of ~700 regulatory documents, on time and on budget, without taking staff away from development and launch of new therapies.
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Testimonials:
Former Pfizer Senior Executive & Chief Quality Officer:
"[HPB is] able to anticipate problems and plan solutions....creative and open to different ways of doing things while remaining bedded in good business compliance."
Former Pfizer Senior Executive & Current VP Data Sciences Early Development: "interfaced with many customers, some very senior in the organization, and many overseas...routinely delivered on time, high quality and to the expectations set"
Senior Consultant, Quality & Manufacturing: "[HBP] worked with various vendors, challenging audit observations, and stakeholders that had difference in opinions...handled with professionalism, and was able to develop innovative resolutions."


Industries We Work In:
Biopharmaceutical, Biotechnology, Pharmaceutical, Digital Therapy, Medtech, Health Tech, Venture Capital
Business Functions We Work With:
Alliance, Business Development, Clinical Operations, Clinical Development, Compliance, Digital, Innovation, Quality Assurance, Quality Compliance, R&D Development or Operations, Regulatory, Risk Management, Strategy
Therapeutic Areas We've Worked In:
Allergy, anemia, autoimmune, hematology, immunology, immuno-oncology, immunotherapy, infectious diseases, cardiovascular, CNS, diabetes, digital health, neurology, neuroscience, neutropenia, oncology, osteoporosis, rare diseases, vaccines, viral, virology
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  • BioPharma Services
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  • In the News
  • About Us