Pre-approval Access

Today’s demand for access to experimental agents requires sponsors to address complex challenges that shape the approval, use, and price of their best products. Often confusing realities include uncertain costs for program infrastructure, especially in early stage companies; a lack of systems for access; no knowledge of common pitfalls or an understanding of industry best practices as well as ethical concerns about allocation of limited drug supply. Regulatory frameworks vary by country, if they exist at all, and other drug distribution initiatives, e.g., patient assistance programs and philanthropic efforts, may be misaligned. Potential damage to corporate reputation is significant and media interest is great.

Why MK&A?

Our customized services will help ensure you offer a responsible early access program if and when appropriate

What you can expect

  • Thoughtful company policy on early access
  • Understanding of relevant laws and regulations
  • Examination of complex, relevant ethical dilemmas
  • Assessment of key stakeholders’ points of view
  • Industry best practice and current regulatory perspectives
  • Trusting relationships with potential program partners

Insights

Suite of services


To help a company maximize the benefit of a pre-approval access strategy, MK&A also offers:

Needs and landscape assessment

Unbiased examination of the need for compassionate use, expanded access or other compliant mechanisms

Program scoping

Determination of appropriate goals and best approaches to meeting patients’ legitimate medical needs

Internal alignment workshops

Opportunities to ensure the company tackles early access in a unified, consistent fashion

Ethical roundtables

Consultation with the nation’s most respected ethicists about difficult issues

Thoughtful policies

Statements that ensure internal and, if needed, external understanding of the company’s unique approach to early access

Tactical action plans

Detailed blueprints for program execution, including vetting of program partners, costs, and timelines

Help with implementation

Practical guidance and assistance that helps patients in need

Crisis management

Identification and training in the appropriate response to potential crises

Ready to Get Started with MK&A?

We’re ready to help you find common interests with patient, consumer and professional groups.

Get in Touch with Us