Deliver Brand Performance and Business Impact
Empower Consumers for Everyday Care
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Partnerships & Affiliations
Biograph works in partnership with Amwell
Since 2021, Biograph and Amwell have collaborated to bring digital care capabilities to Life Sciences applications, with a focus on regulated programs like ACNU. Working together, the Biograph and Amwell teams connect strategy with the data and digital care systems necessary for successful implementation and sustainable program performance at scale.
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In partnership with Amwell, Biograph clients are able to access the digital capabilities of the Amwell Convergeâ„¢ platform and apply them to support digital care initiatives.
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Amwell is transforming hybrid care delivery, connecting and empowering providers, payers and innovators to improve outcomes and make care more accessible to all. Its cloud-based Converge enablement platform was designed to digitally enable a single, unified, scalable healthcare experience for in-person, virtual and automated care. The Converge platform provides the flexibility for clients to build their optimal hybrid care model and stakeholder experience – leveraging just one component or a combination of many components, all working together seamlessly across the platform.
Biograph is a Network Partner of Nicholas Hall
Biograph is a strategic partner and shares a mission with the Nicholas Hall Group of Companies to advance consumer healthcare in North America and around the globe. Together, we publish thought leadership, host industry learning events, and advise industry leaders on strategic initiatives. We have collaborated on the Rx to OTC Switch of high performing brands, working with companies across the industry.
Nicholas has been integral to the evolution of Biograph from its early, strategic approach to next generation Rx to OTC Switch, and he continues to be a trusted advisor to the development and innovation for nonprescription access.
Biograph is an event partner for the annual Nicholas Hall North America CHC Conference.
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Check out past conference highlights.​
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The Biograph Commitment
Brand Performance and Business Impact
Our vision is the transformation of healthcare consumerism to an experience that empowers each individual, facilitates access to treatment, and builds loyalty and satisfaction.
Our mission is to accelerate brand and business growth by helping clients to connect data,
services, and technology to transform the consumer experience of healthcare.
Guiding our work is ongoing interaction with FDA and an understanding of the intention to
empower consumers to manage their everyday health, as articulated in the forthcoming ACNU
and PMI rules.
Unique Insight
Policy
Access
Digital Care
From direct dealings with FDA, Biograph offers first-hand insights about how digital care can improve treatment outcomes and product performance.
The Biograph team is a leading authority on access strategies, including Rx to OTC switch and nonprescription product approval under FDA’s new rule for Nonprescription Drug Product with and Additional Condition for Nonprescription Use (ACNU).
Biograph is a first-mover to frame a digital care solution that addresses FDA’s pending rule for Prescription Medication Information (PMI). The PMI rule is intended to improve public health by providing patients with clear, concise, accessible, and useful information about a prescription drug product.
Capabilities
Biograph serves pharmaceutical, consumer healthcare, and medical device companies with strategies and solutions that expand access to treatment. Biograph offers innovative approaches to personalize treatment journeys and extend product lifecycles.
Biograph applies a unique set of capabilities and digital care connectivity to activate portfolio strategies for business growth. Our team helps companies navigate access frameworks, regulatory guidelines, and commercial implications as they consider investments in consumer engagement, novel distribution models, and portfolio expansion.
Strategic Business Planning
Landscape Assessments
Rx-to-OTC Switch / NPD
Investment Rationale
Access Planning
Care Interventions
Move from idea to implementation with optimal speed and certainty
Embrace FDA Policy Evolution
Biograph helps internal, cross-functional teams to understand the intent and intricacies of new regulations, including the ACNU and PMI rules.
Together, we facilitate a team exercise to break down complexities in the rule, highlight key requirements, explore eligibility criteria, and summarize potential benefits and drawbacks for the company's specific products, categories, and future investment decisions.
Assess Investment Options to Inform Business Decisions
Biograph works with client teams to assesses the suitability of product candidates for company investment. In this exercise, called the Biograph BD Thesis, candidates may include products that likely will need an ACNU and may include some that can be pursued via conventional regulatory pathways. The BD Thesis renders a fully auditable business conclusion informed by both qualitative and quantitative inputs.
Engineer New Products and CX for Enduring Value
Once a drug product is identified, Biograph works with the sponsor company to develop a Pre-IND that reflects the chosen regulatory pathway. In the case of ACNU programs, Biograph works with sponsors to design and specify an engaging Consumer Experience (CX) of Additional Labeling and Additional Conditions for safe nonprescription use of the product.
Biograph Capabilities to Fast-Track Innovation
Maximize Brand Performance with Empowered Care
Biograph provides high value care solutions:
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Consumer Experience (CX) based on science and proven in market
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Interoperability with systems, data, and care services through a proven digital platform
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Connectivity for seamless operationalization
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Built-in Quality Assurance to meet reporting requirements
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The Biograph Empowered Care Center is a single source for access to proven and science-based capabilities to drive increased commercial performance. The Empowered Care Center brings together services and systems to support every program from development through implementation.
Every program is unique to the brand and is afforded the capabilities, connectivity, and credentials to deliver commercial goals.
The ACNU Rule
Nonprescription Drug Product With an Additional Condition for Nonprescription Use
Undertreatment of many common diseases or conditions in the United States is a well-recognized public health problem.
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Increasing the number of people who are able to obtain for the first time and those who continue on necessary drug therapy could provide improved health outcomes.
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FDA believes that ACNU will contribute to improved health outcomes for consumers staying on their medications and will reduce the burdens on the already overburdened health care system, and reduce health care costs.
Every Program is Exclusive to the Sponsor
Although the capabilities and systems are common, every Empowered Care program is unique to the brand and tailored to the Sponsor's business strategy; thereby each is a proprietary asset of the business.
Biograph leverages gold standard healthcare processes, systems and data to deliver the appropriate care intervention and fulfill reporting requirements.
Biograph brings standards in methods and processes to assure efficient development and successful results with Empowered Care interventions. Within the standards, Sponsors can customize key elements to support marketing objectives.
The Biograph team equally weights the Consumer Experience (CX) aspect of an intervention program. Every program is designed for least friction and maximum value to consumers/patients.
Let's Connect!
We look forward to working with you to deliver new levels of performance and impact
