From patient-centricity to venture capital networks
The biotechnology sector is leading the way in developing innovative therapies that will address the unmet needs of many challenging diseases. Since biotechnology companies often focus on a small portfolio of compounds within a specific therapeutic area, many lack the resources, drug development experience or therapeutic expertise required to bring novel therapies to market. Moreover, biotechnology companies often prefer a light internal infrastructure, creating the need for externalised clinical development with partners that can devise a clinical development plan that is tailored to a company's specific needs.
Seeking a partner in drug development can help small biotechnology companies streamline trial designs across the entire spectrum of drug development. The services offered by a partner such as a CRO can span from the preclinical phase through to commercial positioning. For example, partnership between a biotechnology company and a CRO can provide benefit when it comes to adopting patient-centricity into trial designs and establishing networks with venture capital (VC) firms to attain clinical research funding. Here we discuss these examples to illustrate the value of partnering with a CRO, as well as outline key characteristics to look for in a strong drug development partner.
Adopting patient centric models
According to the FDA, 70 percent of Americans have reported being inclined or even very willing to participate in clinical research.1 Despite this, only about 5 percent of adult cancer patients were enrolled in clinical trials at the time of the report, highlighting an opportunity for more patients to become involved.1 Integrating the patient voice into clinical trials has potential to address this by impacting patient recruitment, enrollment and retention. Although patient-centric approaches to trial design holds great potential, there is a perception amongst small companies that it is too costly and time-consuming to put into practice, preventing them from pursuing these approaches. With experience and expertise, however, there are several opportunities for companies to integrate the patient perspective effectively.
Working with an experienced CRO partner can help incorporate patient-centric approaches into clinical plans in a thoughtful way. These tactics can ensure that patient experiences, needs and priorities are recorded and incorporated in future trials for the sponsor, and can be tailored to the needs of each study. Working with a CRO to develop a step-wise approach to patient-centricity can make it feasible for small biotechnology companies that may not otherwise have the resources or expertise to integrate these tactics on their own. Accessing this expertise can help biotechnology companies to develop clinical trials that better serve patients without sacrificing efficiency.
Establishing networks with VC firms
The ability to work effectively with VC firms and clinical research experts is critical to biotechnology companies when it comes to demonstrating the value of their scientific discoveries. As such, the opportunity to establish networks with VC firms is a strong example of how a CRO partnership can be particularly beneficial to biotechnology companies.
Partnering with a CRO can help facilitate these relationships and accelerate development of novel therapies. For example, ICON’s rich VC network, includes a partnership with ALSA Ventures’ Eclipse model. This programme focuses specifically on assisting biopharmaceutical companies generate first-in-human data as quickly and efficiently as possible.
Characteristics of a strong partnership
Working with a drug development partner that has experience bringing novel therapies to market can benefit small biotechnology companies, as exemplified by the opportunity to elevate patient-centric approaches and network with VC firms. Moreover, when selecting a drug development partner, biotechnology companies should consider a nimble approach. This strategy allows different functions to be moved as needed based on the project requirements, and enables knowledge-sharing and distribution of resources between the CRO and the sponsor. In addition, this type of partnership allows for the development of complementary workflows and governance.
The ICON team has experience establishing key processes and infrastructure internally for biotechnology companies, including due diligence and asset valuation, good manufacturing practices, flexible costing models and regulatory expertise. To learn more about ICON’s services in this sector, visit https://iconplc.com/sectors/biotech/
Sources
- https://www.fda.gov/news-events/speeches-fda-officials/16th-annual-accelerating-anticancer-agent-development-and-validation-workshop-05092019
In this section
-
Digital Disruption
-
Clinical strategies to optimise SaMD for treating mental health
-
Digital Disruption: Surveying the industry's evolving landscape
- AI and clinical trials
-
Clinical trial data anonymisation and data sharing
-
Clinical Trial Tokenisation
-
Closing the evidence gap: The value of digital health technologies in supporting drug reimbursement decisions
-
Digital disruption in biopharma
-
Disruptive Innovation
- Remote Patient Monitoring
-
Personalising Digital Health
- Real World Data
-
The triad of trust: Navigating real-world healthcare data integration
-
Clinical strategies to optimise SaMD for treating mental health
-
Patient Centricity
-
Agile Clinical Monitoring
-
Capturing the voice of the patient in clinical trials
-
Charting the Managed Access Program Landscape
-
Developing Nurse-Centric Medical Communications
- Diversity and inclusion in clinical trials
-
Exploring the patient perspective from different angles
-
Patient safety and pharmacovigilance
-
A guide to safety data migrations
-
Taking safety reporting to the next level with automation
-
Outsourced Pharmacovigilance Affiliate Solution
-
The evolution of the Pharmacovigilance System Master File: Benefits, challenges, and opportunities
-
Sponsor and CRO pharmacovigilance and safety alliances
-
Understanding the Periodic Benefit-Risk Evaluation Report
-
A guide to safety data migrations
-
Patient voice survey
-
Patient Voice Survey - Decentralised and Hybrid Trials
-
Reimagining Patient-Centricity with the Internet of Medical Things (IoMT)
-
Using longitudinal qualitative research to capture the patient voice
-
Agile Clinical Monitoring
-
Regulatory Intelligence
-
An innovative approach to rare disease clinical development
- EU Clinical Trials Regulation
-
Using innovative tools and lean writing processes to accelerate regulatory document writing
-
Current overview of data sharing within clinical trial transparency
-
Global Agency Meetings: A collaborative approach to drug development
-
Keeping the end in mind: key considerations for creating plain language summaries
-
Navigating orphan drug development from early phase to marketing authorisation
-
Procedural and regulatory know-how for China biotechs in the EU
-
RACE for Children Act
-
Early engagement and regulatory considerations for biotech
-
Regulatory Intelligence Newsletter
-
Requirements & strategy considerations within clinical trial transparency
-
Spotlight on regulatory reforms in China
-
Demystifying EU CTR, MDR and IVDR
-
Transfer of marketing authorisation
-
An innovative approach to rare disease clinical development
-
Therapeutics insights
- Endocrine and Metabolic Disorders
- Cardiovascular
- Cell and Gene Therapies
- Central Nervous System
-
Glycomics
- Infectious Diseases
- NASH
- Oncology
- Paediatrics
-
Respiratory
-
Rare and orphan diseases
-
Advanced therapies for rare diseases
-
Cross-border enrollment of rare disease patients
-
Crossing the finish line: Why effective participation support strategy is critical to trial efficiency and success in rare diseases
-
Diversity, equity and inclusion in rare disease clinical trials
-
Identify and mitigate risks to rare disease clinical programmes
-
Leveraging historical data for use in rare disease trials
-
Natural history studies to improve drug development in rare diseases
-
Patient Centricity in Orphan Drug Development
-
The key to remarkable rare disease registries
-
Therapeutic spotlight: Precision medicine considerations in rare diseases
-
Advanced therapies for rare diseases
-
Transforming Trials
-
Accelerating biotech innovation from discovery to commercialisation
-
Ensuring the validity of clinical outcomes assessment (COA) data: The value of rater training
-
Linguistic validation of Clinical Outcomes Assessments
-
Optimising biotech funding
- Adaptive clinical trials
-
Best practices to increase engagement with medical and scientific poster content
-
Decentralised clinical trials
-
Biopharma perspective: the promise of decentralised models and diversity in clinical trials
-
Decentralised and Hybrid clinical trials
-
Practical considerations in transitioning to hybrid or decentralised clinical trials
-
Navigating the regulatory labyrinth of technology in decentralised clinical trials
-
Biopharma perspective: the promise of decentralised models and diversity in clinical trials
-
eCOA implementation
- Blended solutions insights
-
Implications of COVID-19 on statistical design and analyses of clinical studies
-
Improving pharma R&D efficiency
-
Increasing Complexity and Declining ROI in Drug Development
-
Innovation in Clinical Trial Methodologies
- Partnership insights
-
Risk Based Quality Management
-
Transforming the R&D Model to Sustain Growth
-
Accelerating biotech innovation from discovery to commercialisation
-
Value Based Healthcare
-
Strategies for commercialising oncology treatments for young adults
-
US payers and PROs
-
Accelerated early clinical manufacturing
-
Cardiovascular Medical Devices
-
CMS Part D Price Negotiations: Is your drug on the list?
-
COVID-19 navigating global market access
-
Ensuring scientific rigor in external control arms
-
Evidence Synthesis: A solution to sparse evidence, heterogeneous studies, and disconnected networks
-
Global Outcomes Benchmarking
-
Health technology assessment
-
Perspectives from US payers
-
ICER’s impact on payer decision making
-
Making Sense of the Biosimilars Market
-
Medical communications in early phase product development
-
Navigating the Challenges and Opportunities of Value Based Healthcare
-
Payer Reliance on ICER and Perceptions on Value Based Pricing
-
Payers Perspectives on Digital Therapeutics
-
Precision Medicine
-
RWE Generation Cross Sectional Studies and Medical Chart Review
-
Survey results: How to engage healthcare decision-makers
-
The affordability hurdle for gene therapies
-
The Role of ICER as an HTA Organisation
-
Strategies for commercialising oncology treatments for young adults
-
Blog
-
Videos
-
Webinar Channel