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Product Development and Consulting

guidance across preclinical, clinical and post-approval development pathway

Our product development and regulatory experts offer consulting services that span a product’s life cycle, from pre-IND to a clinical development plan and into real-world settings. Our strategic services provide the path to make an asset viable in the marketplace.

Preclinical

Creating a detailed preclinical plan with an eye toward later stages of development for your asset is vital. Our non-clinical regulatory experts specialize in developing plans that satisfy the needs of regulators to move a product to the clinic and beyond. These services include:

  • Evaluating technical data including chemistry/manufacturing, preclinical and clinical
  • Determining the appropriate regulatory procedure and legal status for products
  • Proposing optimal filing and submission strategies
  • Establishing frequent contact with regulatory authorities to facilitate compliance
  • Identifying and managing external resources/experts

To ensure the best possibility for an asset’s success and avoid potential setbacks, each step of the drug development process, from discovery through loss of exclusivity, must be strategically planned. Evidera, PPD’s dedicated peri- and post-approval business, offers a team of experts who provide end-to-end regulatory, clinical development, and value and access consulting services that span all phases of development. With over 30 years of experience, our team of clinicians, scientists, analysts and consultants provides a wealth of diverse knowledge that can provide insights as stand-alone engagements or serve as an ongoing extension of your team.

clinical

Our clinical development consultants are experts in the design and execution of full product development programs. With access to a range of internal experts including physicians, biostatisticians and clinical scientists, our team can help design a development plan that reduces risk and maximizes clinical success. Our clinical development services include:

  • Cross-functional integrated product development plans
  • Minimum and target product profiles and associated clinical development plans
  • Clinical trial design
  • Biomarker and companion diagnostic strategies
  • Global and regional regulatory strategies
  • Pharmaceutical and medical device product development
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Areas of expertise

Cell & gene therapy
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Biosimilars
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Adaptive trial design
Medical devices
Diagnostics
Translational medicine

Optimizing Studies in an Increasingly Complex Development Landscape

As clinical trials become more complicated and involve patient populations that are increasingly difficult to enroll, developing an optimized protocol is essential to drive study success. Our study optimization experts can craft new study protocols or review existing protocols through a variety of lenses to find ways in which they can be improved. Providing input into the protocol optimization process is a cross-functional team of experts from across the organization, including:

  • Physicians with therapeutic-specific expertise
  • Clinical scientists
  • Operations experts
  • Feasibility specialists
  • Statisticians
  • Regulatory experts

This team, which mimics a study team, leverages a variety of data sources in addition to their expertise to recommend improvements to a protocol, including internal historical data, real-world evidence, patient-centered research and research on similar protocols.

Optimizing Market Access

With rigorous, evolving and heterogeneous payer evaluation criteria, challenging price negotiations, and a dynamic competitive environment, drug developers need to prepare their market access strategy early in the product life cycle to ensure optimal access. Our expert team of industry leaders, former payers, policy experts, and experienced strategists can help you navigate complex evidence requirements and anticipate and overcome payer barriers to help you achieve optimal price and access. Our offerings include:

  • Global pricing and market access strategy
  • Value and evidence strategy
  • Value story development and testing
  • Payer engagement plans
  • In-licensing assessments
  • Integrated scientific advice
  • Integrated launch support

Thinking Outside the Box – Precision and Transformative Medicines

Value demonstration and commercial success for precision medicines and emerging technologies are substantially different from conventional products, and strategies for successful commercialization extend beyond conventional approaches. We leverage more than 25 years of experience and internal centers of excellence to provide solutions tailored to the specific needs of these types of products with offerings including:

  • New product planning
  • All stages of evidence development
  • Market access and commercial strategy specific to innovative technologies worldwide

Focus areas

  • Diagnostics, companion diagnostics and next generation testing
  • Cell, gene and regenerative medicine therapies
  • Orphan indications, rare diseases and specialty treatments
  • Immunotherapies, novel biologics and therapeutic vaccines
  • Medical devices and combination products
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