Haffner Associates, LLC, was founded in 2009 as a company dedicated to facilitating the development of therapies for the diagnosis, treatment and prevention of rare and devastating diseases. As a company Haffner Associates specializes in working with - Biotechnology and pharmaceutical companies of all sizes and stages to: • create individualized orphan product strategies that include guidance on regulatory strategy and feasibility of drug development, evaluation of clinical study design, and trouble-shooting regulatory and development issues, • author and review applications for orphan drug designations, pediatric rare disease designation vouchers, breakthrough therapy designations, • develop materials for meetings with the FDA and EMA and assist with meeting preparations, • facilitate connections with patient advocacy groups and key opinion leaders, and • interpret policies and communications from regulatory agencies around the world. Patients and patient advocacy groups to: • develop and implement policy initiatives, • identify the right pharmaceutical company to “adopt” a product, and • navigate the biotech and regulatory communities. Visit www.MHaffner.com for more information on our company and our team.