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About

New Treatments for Patients Who Need Them

Processa Pharmaceuticals develops products that improve survival and quality of life for patients with unmet medical needs. Using our years of regulatory experience, we identify de-risked, underappreciated drugs and develop assets with an unmet medical need and leverage prior research toward high value clinical milestones and a lower risk of development failure. Our management and development teams have a track record of obtaining FDA approvals and creating significant shareholder value by successfully delivering much needed therapies to patients and caregivers.

Our portfolio of candidates is disease agnostic and all programs must meet strict evaluation criteria for further development including (but not limited to): representing an unmet medical need; have demonstrated (preferably in humans) clinical evidence of efficacy; that our Regulatory Science approach can make a difference in the time, cost and risk to obtaining marketing authorization and thus are highly capital efficient and contributes to substantial returns on equity. This includes studies of the drug itself, an analog of the drug, or a drug with similar pharmacological targets. We then work with the FDA to define a complete development program and out-license the drug after 2 to 5 years, either just before or after the pivotal study. We have a history and are known for working collaboratively with Regulators to identify an efficient path to commercialization and our intention is to out-license programs either just before or after pivotal studies.

Regulatory Science is What Sets Us Apart

We focus on acquiring de-risked, preclinical- and clinical-stage assets and applying our years of regulatory experience to navigate those drugs efficiently through FDA approval.

High Unmet Medical Need

High Unmet Medical Need

  • Clear and obvious patient need
  • Favorable competitive dynamics
Efficacy Evidence

Efficacy Evidence

  • Direct proof of concept or other proof of principal
  • De-risking development, higher probability of successful development
Regulatory Science

Regulatory Science

  • Optimize trial design (Trifecta: ↓risk, ↓cost, ↓time to approval)
  • Anticipate what FDA requires to assist in discussions on IND enabling studies, clinical trials, and approval
Capital Efficiency

Capital Efficiency

  • Leverage considerable investments prior to licensing (tox, CMC, etc.)
  • Efficient clinical trials and development program
Potentially High ROI

Potentially High ROI

  • Intelligently monetize and partner assets
A Portfolio that Focuses on Patient Needs

A Portfolio that Focuses on Patient Needs

Because our focus is patient-centric with significant needs and limited or poor solutions we carefully design studies to provide clear and convincing data to support to a positive risk/benefit ratio that is compelling for Regulators.

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Partnerships Are Our Business

Partnerships Are Our Business

Contact us if you are interested in licensing, developing, or commercializing a new drug with Processa.

Change Lives With Us

A Healthy Patient Population is Our Driving Force

Our team has successful track record of developing drugs tackling high unmet medical needs. Our aims align with patients suffering from life-threatening and life-compromising chronic diseases. We can accomplish this by developing drug products from Investigational New Drug-enabling studies to New Drug Applications.

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30+

FDA Drugs Approved

100+

FDA Meetings