The Discovery Phase begins when a disease or condition has an unmet need. It includes several steps, such as identifying which compound or therapy has the greatest chance of success, assessing its safety, and building a solid scientific foundation for its development.

The completion of these steps leads to target identification—a broad term that applies to a range of biological entities and their efficacy, safety, clinical and commercial viability.

Once identified, the target needs to be fully validated using in-vitro and in-vivo testing techniques. The results of these tests determine the best candidate for further evaluation.

Before pre-clinical safety testing can begin, a regulatory and development strategy is defined by key product goals such as net value estimation and market access.

Notoriously complex and regulatory-driven the Discovery to Pre-Clinical Phase often seems overwhelming. And while regulatory approval is critical to getting a drug to market, it does not guarantee market access.

Other non-medical tasks such as defining intellectual property rights and generating enough medicinal product for clinical trials must also be dealt with.

Our 360° Approach

At PharmaLex, we take a unique, integrated approach to this vital part of development.

Our 1000+ specialists use their multidisciplinary experience to inform the Discovery and pre-clinical phases with tailormade expertise from a multitude of perspectives.

With such a comprehensive level of service—expect fewer headaches, lower development cost and a higher probability of commercial excellence.

Clarify, Streamline, Repeat

From development CMC to due diligence, project management to program design, regulatory reporting to medical writing, market access to pricing and reimbursement – our wide range of services deliver competitive advantages.

We’re ready to help you:

  • Identify which therapies have the most potential—medically and commercially
  • Strategize the best global pathway for your product to ensure market access and commercial success
  • Understand your market and the pricing it will bear
  • Build a scientific case for efficacy and safety—with critical prep work for clinical trials
  • Protect your intellectual property locally and around the world
  • Gather commercial data for future licensing and partnership deals
  • Navigate the necessary regulations, their complexities and unknowns
  • Establish close working relationships with health authorities from Day 1
  • Manage your development program from start to finish

Success Stories

PharmaLex has been pivotal in the development of many drugs for unmet medical needs including orphan medicinal products and advanced therapy medicinal products (ATMPs). Here are some examples:

Helped a small biotech devise a development plan

for its allogenic tissue-engineered product (TEP) in order to achieve a MAA.

Provided in-house management for a small US biotech

of a pre-clinical and analytical program of 23 studies to support the registration of an existing rheumatoid arthritis product in the EU.

Provided due diligence for a small US-based pharma company

that had developed a gene-therapy product initially studied in phase 1 trials for ovarian cancer but showed activity in non-clinical glioblastoma models.

Established pharmacology / pharmacokinetic and regulatory services

for a top pharma company to ensure approval of 50+ generic (mono and fixed combination) products onto EU and non-EU markets.

Let’s tailor a service plan that works for you

PharmaLex. Confidence beyond compliance.