Haffner Associates, LLC

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.

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