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The need to reduce the time it takes to get biological medicines to patients for unmet medical needs, rare diseases, The CMC Strategy Forum series provides a venue for biotechnology and biological product discussion.

These meetings focus on relevant chemistry, manufacturing, and controls (CMC) issues throughout the lifecycle of such products and thereby foster collaborative technical and regulatory interaction.

This pathway shortens the review timeline from 10 months to six. Product demonstrates potential to address an unmet medical need.

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So companies are seeking ways to accelerate the approval of these therapies and rapidly bring them to market.

Many such products take the form of well-characterized proteins (e.g., Ig G1 or Ig G2 monoclonal antibodies, MAbs) for which both industry and regulators can leverage extensive CMC and clinical experience.

726/2004 (3) Pathway makes a product available to a group of patients with a chronically or seriously debilitating disease — or those whose disease is considered to be life threatening — and who cannot be treated satisfactorily by an authorized medicinal product.

The product must either be the subject of a market- approval application (MAA) or ongoing clinical trials.

This panel discussion included Brendan Hughes (Bristol-Myers Squibb and Company), Emanuela Lacana (CDER), Helena Madden (Biogen Idec), Ilona Reischl, Anthony Ridgway (Health Canada), and Emily Shacter. Regulatory Mechanisms for Expedited Approval: The “US Pathways” box lists regulatory mechanisms for accelerated approval, priority review, fast-track, and breakthrough drug pathways.

The “Canadian Pathways” box lists regulatory mechanisms for accelerated approval in Canada.

The Forum strives to share information with regulatory agencies to assist them in merging good scientific and regulatory practices.

Outcomes of the Forum meetings are published in this peer- reviewed journal to help assure that biopharmaceutical products manufactured in a regulated environment will continue to be safe and efficacious.

Product must meet the same statutory standard for safety and effectiveness.

Sponsor must agree to conduct postmarketing confirmatory trials.

Accelerated Approval Surrogate endpoint reasonably likely to predict clinical benefit can be measured earlier than an effect on mortality or irreversible morbidity.

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