OUR STORY

Human Health Research Services, (HHRS) organized by Florence R. Parker Chailla, JD., M.Sc,. At HHRS, Medical Research Publication Services, (MRPS) is her way of communicating important healthcare information to the public. Professionally she was formally employed with the U. S. Federal Government in the U.S. Government Accountability Office,  an arm of the U. S. Congress, and subsequently in the multinational pharmaceutical industry for approximately 20 years.  She held multiple Directorships of Regulatory Affairs, Quality Assurance, Pharmacoviligence, Strategic Planning and Governance. She is  the Chief Executive Officer of HHRS, LLC. At senior executive levels in Research and Development, (R&D) in life science firms, her career dealings were had with national and international regulatory health authorities such as the FDA, European Medicines Agency (EMEA), Canadian Health Protection Bureau (HPB), United Kingdom’s Medicines Healthcare Regulatory Agency (MHRA), Japanese Ministry of Health and China State FDA Administration. She directed corporate sponsored R&D projects involving investigational New Drug – brand and generic, Vaccine, Biologic, Medical Device and Combination products using genetic monoclonal antibody vaccines used to mitigate, treat or cure infectious disease, childhood immunization, traveler immunization, oncology, cardiac, genetics and Class I/II medical device PMA, 510K regulated under the Food Drug and Cosmetic Act of 1938, Safe Devices Act and Generic Drug Act and ICH harmonization of standards et. al., via global human clinical trials and for market approvals.
In 2000, she wrote a White Paper recommendation to her prior vaccine biologic sponsor employer — whom was without candidates in its R&D pipeline, its branded products neared six-month Patent expiry. She recommended a generic-like vaccine product;  as a result she advocated and designed the beginnings of Biosimilars. Her intent was to gain a new market while also making necessary lifesaving vaccines available to patient populations at reduced cost. In reliance on her knowledge of the FD&C Act and Generic Drug Act i.e., branded products vs generics, therefrom industry developed the name Biosimilars. Nearly a decade later, her recommended concept is called Biosimilars. Today, Biosimilars are marketed globally- saving lives.

Dr. Parker Chailla has lectured at Regulatory Affairs Professional Society (RAPS) and other organizations. She is the author of FDA Administrative Enforcement Manual, published by Taylor & Francis.
Academically, she holds a Bachelor of Science degree in multiple majors of Biology, Integrated Information Systems and Business; additionally, she has a earned a Master of Science in Pharmacy with specialization in Drug Regulatory Affairs and a Juris Doctorate with specializations in Intellectual Property, Health and Environmental Laws. She was a partner in a Regulatory Compliance Partnership consulting firm Drug Regulatory Affairs Institute; a joint venture. She lectures, teaches regulatory concepts and issues to both professional and novice audiences.
Recent interests of Dr. Parker Chailla are Precision,  Regenerative Medicine (Stem Cell) Genomics and Functional Medicine. As an advocate for health, opting for the least invasive more precise and personalized therapies to obtain and maintain health are best in her opinion.