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FDA Veteran Paz Vellanki, MD, joins Precision to become one of 3 ex-FDA oncology leaders supporting clients

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Clinical Development Planning

Custom clinical development planning for global success, with Precision
Precision partners with you to meet them head-on through our extensive footprint across the globe. We succeed by pairing personalized clinical services with translational medicine excellence, making us the first fully integrated clinical research organization created expressly to help advance the promises of precision medicine.

Robust planning and comprehensive capabilities

Clinical trials approaches are increasingly sophisticated. Whether you are developing an advanced cell or gene therapy, leveraging biomarker data, or looking to achieve an ambitious milestone, success depends on the right approach to match your goals.

Physician evaluating data

Precision’s capabilities in clinical development planning

Clinical development plan (CDP) design

The CDP is the blueprint of a drug’s entire clinical research strategy. It outlines the clinical program design, including development, assessment, decision points, personnel, and budgetary estimates.

Leveraging Precision’s comprehensive expertise in biomarker-driven studies allows you to confidently meet the needs of your project, bringing you closer to your desired endpoints.

  • Innovative trial designs
  • Review of preclinical and/or clinical data
  • Assessment of mechanisms of action
  • Proposed patient population(s)
  • Proposed dosing
  • Safety and efficacy data
  • Competitive landscape
  • Proposed synopsis(es)
  • Associated timelines and budget

Creating your Target Product Profile (TPP)

A TPP outlines the desired characteristics of a product. This includes intended use, target populations, and safety and efficacy characteristics, among other criteria. Alongside Precision’s experts, you can analyze your unique criteria, prepare for best- and worst-case events, and catch the attention of the right funders and developers.

Global development

Submission strategy and regulatory support

Pass through regulatory processes the first time with robust submission support for IND, NDA, MAA, and BLA to establish the regulatory pathway. Regulatory strategic and operational support for major filings includes writing and review of CTD modules, as well as viability assessments for expedited or pediatric programs.

For example, recent pre-IND oncology filings and IND package support based on FDA feedback included:

  • Targeted nanoparticle with payload
  • Targeted fusion protein T-cell receptor/cytokine
  • Targeted antibody-drug conjugate
  • Vaccine with mutation-specific peptide and oncolytic virus
  • Antibody designed to alter targeting of cytokine to specific cell types
  • Small molecule oncolytics

Precision's regulatory strategy

 

Regulatory Authority Meetings

  • Question development
  • Briefing document development
  • Meeting preparation support
  • Representative services

Regulatory Submission

  • Regulatory strategic and operational support for major filings
  • Writing and review of CTD modules (IND/CTA/BLA/NDA/MAA)

Orphan Designation

  • Rare experience
  • US and EU Orphan drug application

Expedited Programs

  • Fast-track designation
  • Breakthrough designation
  • Priority review
  • Priority medicine (PRIME)
  • Accelerated approval

Program Management

  • Regulatory program management IND/CTA development
  • Gap analysis
  • Regulatory project plans

Pediatric Planning

  • Extensive population experience
  • Study and investigation plans
  • Pediatric rare disease designation

  • Case study showcase: Clinical development planning and study optimization

    Recent CDP case studies (click arrows to view):

    1. Supporting a rare disease basket trial

    2. BLA submission strategy and planning

    3. Support for pre-IND meetings and IND filings

  • Case study: Supporting a rare disease basket trial

    Contracted services

    Precision supported a sponsor in planning conversations with their board to support the funding of a rare disease basket trial.

    Deliverables

    A white paper supporting a basket study combined medical, regulatory, and statistical considerations. From that white paper, a slide deck summarizing the recommendations and alternative scenarios was developed.

    Outcomes

    The sponsor had a successful board meeting and is moving forward with IND submission.

  • Case study: BLA submission strategy and planning

    Contracted services

    Precision’s regulatory and statistical teams supported a recent oncology study, which is planned to move to BLA submission upon unblinding of the pivotal trial.

    Deliverables

    Type C meeting request, preparation of the briefing document, and development of the strategy for integrated safety submission (ISS), including CDISC conversion.

    Outcomes

    The FDA provided written responses that were clear and supportive of the integration approach. This pre-work helped to set the foundation for the ISS strategy, inclusive of statistical, regulatory, and medical writing support for modules 2.5, 2.7.3, and 2.7.4 and all supporting documentation.

  • Case study: Support for pre-IND meetings and IND filings

    Contracted services

    Assistance for novel targeted therapies, including antibody-drug conjugates, gene therapy, nanoparticles, and engineered proteins.

    Deliverables

    Generation and support for meeting requests and meeting packages; assistance with IND.

    Outcomes

    Introduction of programs to the FDA; input received for IND content expectations; safe-to-proceed assessments for IND submissions.

  • CDP_Case studies
  • Case study_Biomarkers
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  • iStock-1500823492 (1)
People crossing road

Improving market access

Payer evaluation criteria continuously evolve, making strategies for early market access essential to your program’s success. Precision strategists and policy professionals guide you through development and along the regulatory pathway:

  • Early health economic modeling to inform randomized control trial (RCT) data collection to support economic value demonstration to payers and health technology assessments (HTAs)
  • Payer evidence planning to inform RCT data collection and that meets payers’ needs, reducing coverage restrictions
  • KOL mapping to identify sites and shape engagement strategy
  • Patient engagement programs
  • Scientific platform development

Explore Commercialization

Read our latest Precision insights

 Stay ahead with the latest insights in clinical  development planning for global product launches, from our experts. 

 

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Specialized capabilities in every stage of clinical development

Leverage an integrated infrastructure that reduces the inefficiencies inherent in complex development. Integrate lab and trial execution to accelerate speed to market. Precision can customize and converge our capabilities to meet your program's unique needs—driving efficiency, agility, and success from start to finish.

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