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Deliver Performance and Impact

Drug Products Wrapped with Care

to Increase Access, Improve Adherence, and Personalize the Consumer Experience

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In partnership with global leaders in care transformation

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In an era of digital care, our team is a ready resource for clients across the pharmaceutical,
consumer healthcare, and device sectors

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.

In partnership with Amwell, Biograph clients are able to access the digital capabilities of the Amwell Converge™ platform and apply them to support digital care initiatives.

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.

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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 operationalization of the ACNU Pathway for nonprescription access.


The Nicholas Hall Group of Companies is a team of international specialists, offering the full spectrum of support for consumer healthcare companies, including a full range of consulting services, data analysis and insights, recruitment & training, conferences & seminars and competitive intelligence — globally, regionally or locally.


Join us for the Nicholas Hall 2024 North America CHC Conference

Nicholas Hall
ZS Associates


Biograph serves pharmaceutical, consumer healthcare, and medical device companies with strategies and solutions that expand access to treatment and improve health outcomes.

Biograph offers a unique set of capabilities and digital care connectivity to implement portfolio strategies for business growth. Our team helps companies navigate access frameworks, regulatory guidelines, and commercial implications as they consider investments in new products and services.

Strategic Business Planning

Landscape Assessments

Rx-to-OTC Switch

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Investment Rationale

Healthcare Ecosystem Influence

ACNU Factory

Move from idea to implementation with optimal speed and certainty

FDA Rules and Implications

Biograph helps internal, cross-functional teams to understand the intent and intricacies of the ACNU rule from FDA. 


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.

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Biograph Capabilities to Fast-Track Innovation

The Biograph ACNU Factory

The Biograph ACNU Factory provides:

  • A Consumer Experience (CX) based on science and proven in market

  • Interoperability with systems, data, and care services through a proven digital platform

  • Connectivity for seamless operationalization

  • Built-in Quality Assurance to meet reporting requirements

The Biograph ACNU Factory is a single source for access to proven and science-based capabilities necessary for FDA approval and commercial performance. The ACNU Factory is integrated with digital care services and systems to support every program from development through implementation.


The Biograph ACNU Factory assures every program is afforded the capabilities , connectivity, and credentials to deliver Additional Conditions that meet regulatory standards and can deliver commercial goals.

The ACNU Rule
Nonprescription Drug Product With an Additional Condition for Nonprescription Use
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Undertreatment of many common diseases or conditions in the United States is a well-recognized public health problem.

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.

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 ACNU program is unique to the product and tailored to  the Sponsor's business strategy; thereby each is a proprietary asset of the business

The Biograph ACNU Factory leverages gold standard healthcare processes, systems and data to deliver the appropriate care intervention and fulfill reporting requirements.

Biograph brings standards in methods and process to assure efficient ACNU development and successful results. Within the standards, Sponsors can customize key elements to support marketing objectives.

The Biograph ACNU Factory equally weights the Consumer Experience (CX) aspect of an ACNU program. Every program is designed for least friction and maximum value to consumers/patients.

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The Biograph Commitment: Performance and Impact

Our vision is a new generation of care that empowers consumers, increases access to treatment, and reduces burden on the healthcare system.


Our mission is to facilitate the approvals and launch of new nonprescription products and improve adherence to Rx treatment with the application of data, services, and technology in the consumer journey.


Guiding our work is ongoing interaction with FDA, regarding the ACNU rule, and more recently the, PMI rule, both intended to advance digital labeling as a means to reverse undertreatment and noncompliance to drug therapy.

Unique Insight



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.

Let's Connect!

We look forward to working with you to deliver new levels of performance and impact

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