Your International Specialty Pharma & Orphan Drug Distributor

International Specialty Pharma Distributor

“Ethically connecting the world of medicine to patients with no treatment alternatives” is the defining objective of OWI. There are many patients around the world who do not have access to US FDA approved products. No matter what lifecycle stage a product is in, OWI can ethically connect patients in desperate need to innovative new medicines that would otherwise be unavailable to them because of where they live in the world. We accomplish this through temporary regulatory authorization established by countries for experimental and newly approved FDA drugs. OWI can ensure compliant early access for desperate patients around the world while protecting manufacturers’ interest and providing strategic support throughout the product lifecycle.

Product Lifecycle Optimization

Product Life Cycle Optimization

OWI can supply experimental drugs for eligible patients who are not part of a clinical trial and have exhausted all remaining and approved treatment options. OWI’s role is critical because the time required for the new drug to achieve market approval is significantly longer than the patients’ life expectancy.

OWI is licensed to purchase and distribute FDA approved products awaiting market authorization and commercialization outside the U.S. through temporary regulatory pathways. These pathways only exist until a product receives MA in a given country. Upon MA, OWI transitions patients to commercial supply and is no longer involved.

OWI supports authorized access to discontinued products still in demand outside the U.S. and where product shortages prompt requests from local governments.

Authorized Pre-License Sales

One-World specializes in ethical Authorized Pre-License Sales (APLS) programs allowing providers outside the US access to FDA approved treatments for their patients.

APLS programs are often referred to by many different names, including:

Expanded Access Diagram

Benefits include:

APLS can help companies create early awareness and clinician acceptance while confirming targeted physician specialties and reimbursement strategies. APLS also allows for the early identification of prescribing and adherence issues that may affect product perception and uptake.

OWI can report regulatory compliant information back to the manufacturer concerning real-world experiences (RWE) and safety information in a real-world setting outside the United States. This information can guide future promotional activities and help identify physician/prescriber characteristics, preferences, and early clinical practices and perceptions that can reveal actual prescribing behavior.

In addition, RWE can:

  • be useful in economic and budgetary evaluations
  • establish evidence for a novel agent use in a specific indication
  • support development of physician educational and patient support materials
  • identify compliance issues in specific patient groups

OWI supports ethical and compliant APLS by acquiring and ethically distributing newly approved treatments that can address unmet medical needs outside the U.S. OWI purchases these needed medicines at wholesaler pharmacy pricing.  Many physicians around the world who treat patients with serious and life-threatening diseases are often fully aware of an innovative new, and potentially beneficial product, well before it is approved in the U.S. Even more physicians are aware of these potentially life-saving and live-changing products after they receive FDA approval. This is particularly true for physicians that returned to their home countries after training in the U.S. and are now faced with caring for patients who have run out of approved treatments available in their home country. APLS is often the last chance for many of these patients.

OWI supports corporate social responsibility (CSR) through implementation of authorized ethical early access to unavailable life-saving medications. Pharmaceutical manufacturers are viewed as special cases when addressing CSR, because their business decisions directly impact human health, making CSR efforts particularly important. Pharmaceutical companies have been criticized for specific behaviors such as setting prohibitively high prices and sluggishness in responding to demands to provide access to life-saving drugs for poor populations and now the same criticisms apply to APLS for desperate providers and patients for no sound or viable reason. Recent focus and industry awareness of existing legitimate, ethical and regulatory compliant pathways for early access to life-saving treatments (e.g., APLS) have magnified pressures on manufacturers to actively work to promote societal well-being through authorized responsible distribution and management of these unique pathways.
By working with OWI, manufacturers can offer patients who have run out of treatment options in their home country a chance at a longer life. OWI can provide compliant, secure, and ethical product access in over 125 countries worldwide establishing temporary regulatory pathways for early access to needed life-saving medications.

Orphan Drug Distribution

One-World has been providing orphan drugs to physicians of patients with rare diseases for over 15 years.

Orphan drugs are defined as “Drugs and biologics intended for the safe and effective treatment, diagnosis or prevention of rare diseases and disorders that affect fewer than 200,000 people in the U.S. or less than 5 per 10,000 individuals in the European Union.”

We support successful orphan drug distribution outside the U.S. by:

  • Aligning with rare disease advocacy organizations and physicians’ groups to identify unmet patient needs
  • Navigating government importation regulations to make sure treatments are received in a timely manner
  • Using ethical authorized supply channels while maintaining the highest level of supply chain security
  • Mitigating manufacturer currency fluctuation risks
  • Reporting and managing sales and strategic market data in compliance with local early access requirements

At One–World we believe that all patients with rare diseases deserve access to life-saving or life-enhancing treatments.

Clinical Trial Procurement

Clinical Trial Procurement has been a driving force of One-World’s business since the company was founded in 2001. We offer efficiency, dependability and confidentiality to sponsors, CRO’s and institutions procuring pharmaceuticals for clinical trials.

Because of our extensive international experience, we have developed strong supplier and manufacturer relationships worldwide. We can:

  • Secure the product
  • Obtain support documentation
  • Consolidate and ship to the desired location around the world

We attend to all the details, such as:

  • Specific lot numbers
  • Specific shelf life
  • Chain of custody documentation
  • Special delivery dates
  • Special shipping requirements