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@mhaffner.com
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3 phones found area 301
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Marlene Haffner is listed as Principal and founder at Orphan solutions and Haffner Associates, LLC at Haffner Associates, LLC, a company with 9 employees, based in Rockville, Maryland, United States. AeroLeads shows a work email signal at mhaffner.com, phone signal with area code 301, and a matched LinkedIn profile for Marlene Haffner.
Marlene Haffner previously worked as Principal and founder at Haffner Associates, Llc and President and CEO at Haffnerassociates, Llc. Marlene Haffner holds Master Of Public Health (Mph), Health Policy And Management from Johns Hopkins Bloomberg School Of Public Health.
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Specialist in orphan product development both in the US and globally. 20 years experience as Director of the FDA Office of Orphan Product Development.Specialties: Internal Medicine, Hematology, Health Policy, strategic planing, orphan products developmnet, global pharma, life sciences, pharmaceutical regulatory affairs, FDA,
Listed skills include Regulatory Affairs, Clinical Development, Clinical Trials, Fda, and 46 others.
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Rockville, Maryland
Orphan Solutions was founded in April, 2013 with Lisa Beth Ferstenberg, MD an experienced pharmaceutical executive. Her skills coupled with the skills of Haffner Associates now broaden the capabilities of Haffner Associates, LLC to include preclinical work including tox testing; design and conduct of clinical trials; and design and development of trials.
Work with companies large and small as well as with advocacy groups in the development of products for the treatment of rare/orphan diseases. As an accomplished public speaker am frequently invited to speak in major venues concerning orphan drugs and rare diseases. Have extensive experience in writing orphan designation requests, Fast Track, pediatric.
Rockville, MD
As Director of the Orphan Products Office, I was responsible for the administration of the US Orphan Drug Act - the first in the world. Because of my expertise and knowledge, I advised the EU, Japan and Australia re their orphan drug programs. I developed strategy, policy and approaches to the development of products for the treatment of rare diseases in.
For 5 years was the Director of the Office of Health Affairs at the Center for Devices and Radiological Health (CDRH) and for 20 years directed the Office of Orphan Products Development. In addition to FDA direct responsibilities assisted the EU and Japan in the development of their orphan products regulation.
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Marlene Haffner works for Haffner Associates, LLC.
Marlene Haffner is listed as Principal and founder at Orphan solutions and Haffner Associates, LLC at Haffner Associates, LLC.
AeroLeads has found 1 work email signal at @mhaffner.com for Marlene Haffner at Haffner Associates, LLC.
AeroLeads has found 3 phone signal(s) with area code 301 for Marlene Haffner at Haffner Associates, LLC.
Marlene Haffner is based in Rockville, Maryland, United States while working with Haffner Associates, LLC.
Marlene Haffner has worked for Haffner Associates, Llc, Haffnerassociates, Llc, Vp File Bank, Inc, Kakkis Everylife Foundation, and Amgen Inc.
Marlene Haffner's colleagues at Haffner Associates, LLC include Patrick Le and Patrick Phuong Le.
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Marlene Haffner holds Master Of Public Health (Mph), Health Policy And Management from Johns Hopkins Bloomberg School Of Public Health.
Marlene Haffner is listed with skills including Regulatory Affairs, Clinical Development, Clinical Trials, Fda, Pharmaceutical Industry, Drug Development, Biotechnology, and Medical Devices.
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