GO-TO-MARKET / PRODUCT LIFECYCLE

Shorten FDA Approval Times by Minimizing the Impact of Product Changes

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Along with FDA approval for a drug or device comes a myriad of post-approval commitments the company must keep.

Most notable among these commitments is to inform the FDA of post-approval changes. Set into action, this means that all post-approval changes that might impact the CMC section or product label must be evaluated to determine what the change means in terms of regulatory action the company may need to take.

The FDA must be informed of every change. The question is whether you will inform them by filing a Prior Approval Supplement (PAS), changes being effective (CBE30 or CBE0) or by including the updated information in the annual report. We help our clients understand the magnitude of impact that a change can have and help them strategize on how to manage any regulatory implications that result.

SERVICE OVERVIEW

Go-to-Market

Commercial Market Assessment or Go-to-Market (GTM) Strategy are essential elements in a successful product launch. They come into play for new product launches and relaunches either during the product lifecycle or after a merger/acquisition.

To create an effective GTM strategy, organizations must possess an understanding of the work environment and the target market. New and existing workflows should be clearly defined and a system should be established to manage the GTM strategy.

Organizations can use a GTM strategy for a range of events, including launching new products or services, introducing a current product to a new market, and even relaunching the company or brand. The GTM strategy will help a business clarify why it’s launching the product, understand who the product is for, and create a plan to engage with the customer and convince them to buy the product or service.

Here are some examples of what we do:

  • Assess a company’s current state and outline a plan to get them where they need to be both operationally and from a compliance perspective
  • Convert findings into a detailed GTM strategy that aligns stakeholders and establishes a timeline to ensure each stakeholder meets the defined milestones and outcomes, creating an attainable path to market success

 

SERVICE OVERVIEW

Product Lifecycle Management

Generally speaking, the period of time before authorization or approval of a new drug is referred to as the Development Phase. Product Lifecycle Management (PLM) occurs after authorization and is the process of managing the entire post-approval lifecycle of a drug product after manufacture and launch. PLM has four stages: introduction, growth, maturity and decline. Almost from the moment of commercial approval, change is inevitable. The sponsor has a duty to keep the FDA informed of all changes to the original basis of approval. While all changes are important, those that impact the CMC section or product labeling may have the most consequences. Being aware of when and how to inform the FDA of such changes relative to implementing them is of utmost importance.

Depending on the scope of change and its impact to human health and safety, it may be necessary for the drug sponsor to receive FDA approval before making the change. Anticipating regulatory implications for CMC-related PLM changes ahead of time can result in shorter FDA approval times. Whether it’s a change needed to comply with new regulations, replace or add a new vendor, maintain, improve or expand manufacturing capacity, or even to add a new indication to the product label, the FDA will need to be notified.

 

Here are some examples of what we do:

  • Assess PLM plans using a scientific and risk-based approach to identify regulatory roadblocks and implications before moving ahead
  • Evaluate impact of the change to regulatory status (i.e., SUPAC)
  • Fashion the best regulatory strategy to “bundle” multiple changes when they are planned to be implemented simultaneously
  • Outline alternative phased-in implementation plans whereby a client can obtain FDA approval, if required, in a shorter time period
  • Ensure the PLM program complies with FDA and ICH standards

CASE STUDY

Pills and Growth Chart

Commercial Readiness

How Priorities Must Shift to Launch Your First Commercial Product

RESOURCES

US FDA Presentation: “Lifecycle Management of Drug Products: FDA’s Perspective” DOWNLOAD

US FDA Guidance Document: “Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management” DOWNLOAD

US FDA Office of Pharmaceutical Quality Overview: “Pharmaceutical Quality Oversight” DOWNLOAD

Sample Engagements

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Provided regulatory strategy support to an Eastern European biosimilar company interested in obtaining USFDA approval of an EMA-approved biosimilar. All clinical studies were conducted ex-US. Assembled a cross-functional team, including clinical development and compliance experts, and successfully recreated informed consent for all clinical trials. Had a successful type B, face-to-face FDA meeting whose guidance was to do a bridging study in the US. The bridging study is now complete and being analyzed.

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Provided product life cycle, management regulatory and clinical development support to a US specialty pharma company seeking to revitalize its orphan designated oncology drug portfolio. Proposed a label expansion strategy whereby client could conduct new studies using special protocol assessment “SPA” option and potentially obtain FDA approval of two additional orphan indications. Support has involved FDA meetings, sourcing CROs and clinical development plans for clinical studies.

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Conducted a commercial readiness assessment and Go-to-Market strategy for a new product launch for a diagnostics company. Client already had commercially approved imaging agents in their portfolio. During product lifecycle management, a marketing decision was made to repurpose the product so that a new configuration be marketed as a therapeutic treatment. The purchasers and users for the two different indications of the same molecule are different which required a very different go-to-market strategy. An assessment was completed and client was provided with a detailed report on suggested changes for launch of a therapeutic vs. a diagnostic. Project has moved forward and is now in the implementation stage.

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A not-for-profit (NFP) Women’s Health Pharmaceutical company’s leading branded product’s patents were to expire within the next few years. The company’s Board tasked the leadership team to come up with a defensive lifecycle management strategy. Ayd Group was retained to develop a justification for them in the event they decided to expand operations to include a generic drug business unit. After a lengthy and complex process that factored in the company’s mission-statement, it was determined that generic market entry was feasible. The company would continue to focus on developing additional branded products, but would now have a business unit focused on complementary generic drugs focused on women’s health. Ayd group delivered a detailed evaluation report. We provided specific recommendations on what types of generic products their portfolio should include and what channels are best suited for marketing, sales and distribution. We also were able to determine who their competition is likely to be and described how they would need to transform from an internal perspective to be competitive.

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A physician conceived to use an FDA-regulated food component as an experimental Sars-Covid-2 treatment due to its demonstrated anti-viral properties. The treatment is indicated in mild-to-moderate cases where the patient is deemed unlikely to get worse. In an IND meeting facilitated by Ayd Group, the FDA gave Fast-Track status and the client went directly into Phase 2 clinical study. There is potential for the FDA to grant Emergency Use Authorization (EUA) within the year. The physician wants to create a virtual pharma company that can outsource critical functions to third parties. This will put him in a position to manufacture and distribute the therapeutic treatment if EUA is granted. Ayd Group was retained in the first phase of work to develop a strategic plan to enable the new pharma company to operate in a regulation-compliant fashion on Day 1. Day 1, defined as the earliest conceivable date when the FDA would issue the EUA, was arrived at by making “best case” assumptions and reverse-engineering goals the company needed to complete. Phase 2 of the project is in progress. Ayd Group has been retained as the company’s Acting EVP, Regulatory Affairs, as well as role of “Integration Specialist” to help build the infrastructure needed to operate.

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A leading provider of modeling and simulation software and services that accelerate the regulatory submissions of medical innovations worldwide was lagging behind their competition who provide support to Healthcare companies impacted by recent implementation of the new European Union Medical Device Regulations (EU MRD). The EU MDR raised the bar for medical device safety and efficacy and brought it more in line with the bar which has long been in place for drugs.

A MedTech/device market analysis was conducted using client-provided data and used to frame a high-level picture of the competitor landscape. This enabled identification of new value-adding market segments and geographies the client could pursue. Since new and more-restrictive regulations similar to those for drugs are now in place for medical devices, it was recommended that the client offer new bundled services (e.g., Product Registration & Clinical Trial Application, Regulatory & Medical Writing and Regulatory Submissions) to Medical Device companies, too.

As the project progressed, we learned of the client’s pending acquisition of a data acquisition and market access company. The competitor landscape was reassessed and it was recommended that the client also market these new service offerings and capabilities (e.g., HEOR Analytics, Market Access & Value and RWD/Evidence Services) to Medical Device companies.

Identify the Regulatory Implications for CMC-related PLM Changes before they Cause Delays.

If your PLM strategy involves changes needed to comply with new regulations, replace or add a new vendor, maintain, improve or expand manufacturing capacity, or expanding an existing indication, we can help support your plans.

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