PHARMACY & PHARMACEUTICS

B.Pharm., M.Sc.
University of Ife (Now Obafemi Awolowo University), Nigeria
1980 & 1983

PHARMACEUTICS

Ph..D.
University of Manchester, Egland
1986

Biopharmaceutics and Pharmaceutical Technology

DAAD RESEARCH FELLOW
Institute of Biopharmaceutics and Pharmaceutical Technology, University of Munster, Germany
1983

PHARMACEUTICS AND BIOENGINEERING

NIH Postdoctoral Fellow in Pharmaceutics and Bioengineering
University of Utah, USA.
1994-1997

Professor of Pharmaceutics, Chair, Howard University Institutional Animal Care and Use Committee (IACUC) and Director, Laboratory for Nanomedicine, Drug Delivery, and Pharmaceutical & Biopharmaceutical Drug Products Design. USP EXPERT COMMITTEE

Emmanuel O. Akala, R. Ph., Ph.D. is a Professor of Pharmaceutics, Chair, Howard University Institutional Animal Care and Use Committee (IACUC) and Director, Laboratory for Nanomedicine, Drug Delivery, and Pharmaceutical & Biopharmaceutical Drug Products Design.  His training is cosmopolitan and his curriculum vitae (CV) provides details of his professional training as a pharmacist and an immunization pharmacist (registered in Utah, Maryland, Washington DC and  in  Nigeria),  a  pharmacy professor, and  a research scientist with bias for conventional and novel drug delivery systems. Professor Akala received B. Pharm.  (Hons)  degree and M.Sc.  (Pharmaceutics)  degree at The  University  of  Ife  (Now  Obafemi Awolowo University), Ile-Ife, Nigeria and Ph.D. degree in Pharmaceutics at The University of Manchester,  England  (as  a  Commonwealth  Scholar).  He was a DAAD Fellow at the  Institute of Biopharmaceutics and Pharmaceutical Technology, University of Munster, Germany, and an NIH Postdoctoral Fellow  in  Pharmaceutics and  Bioengineering at The University  of  Utah,  USA. He has worked as a pharmacist in Nigeria and USA, and as a Lecturer and Senior Lecturer in Pharmaceutics in Nigeria, as a Teaching Assistant in England, as a Laboratory Instructor and  Research Associate in  USA  and  Germany and  as  an  Assistant Professor, Associate Professor and Professor of Pharmaceutics in USA. Professor Akala has established a very active research group with capability for the design and development of conventional and novel drug products/drug delivery systems. His research focus, at the moment, is on nanotechnology platform for the treatment of cancer and HIV/AIDS with the applications of quality by design (QbD), statistical experimental design, computer optimization, and process analytical technology in his research efforts. At Howard University, he has obtained more than ten million dollars in research grants. His current research grant funding is as follows:   (1) NIH/NCI (Akala (PI): Novel Nanotechnology Platform for Breast Cancer Treatment ($1,132,500:00: 2015 -2018). (2) NIH/NIAID (Akala (PI):The District of Columbia Center for AIDS Research: Targeting Drug (ARV) Loaded Multifunctional Nanoparticles to M Cells Overlaying GALT (HIV-1 Reservoir) ($600,000:00: 2011 -2016). (3). U.S. ‐ Russian University Research Competition (CRDF Global - Peace and Prosperity Through Science Collaboration PI: ($110,000) (June 1, 2015 – May 31, 2017). Professor Akala holds three patents. He has numerous research publications in peer reviewed journals and several conference proceedings and abstracts.  Over the years, Professor Akala has taught several Pharm. D. courses and has developed and taught several Ph.D. courses and mentored several Doctor of Pharmacy students. He has directed the research work of eight M.S. students, four Ph.D. students, eight postdoctoral fellows, several Pharm. D., B.S., and high school students and four pharmacy students from different Universities in Brazil (Brazil Scientific Mobility Program). His research endeavors have been characterized by wide interactions and associations (interdisciplinary approach to research) at Howard University, within USA and in Germany, UK and Demark. Professor Akala received the 2013 Distinguished Howard University College of Pharmacy Alumni Award, the 2013 Top Reviewer Award in the Journal of Pharmaceutical Sciences, the 2013 Top Reviewer Award in the Journal of Nanomedicine, the 2014 AACR Minority-Serving Institution Faculty Scholar in Cancer Research Award, and the 2016 Washington DC Pharmacy Association NASPA Excellence in Innovation Award. Professor Akala has been serving as a member of the Advisory Group of the Center for Pharmaceutical Advancement and Training of the United States Pharmacopeia since 2013. He was appointed, in 2015, a member of the USP (the General Chapters-Dosage Forms USP’s Expert Committee). USP Expert Committees are responsible for developing and revising USP standards that comprise its compendia: the USP and the NF, USP Compounding Compendium, Herbal Medicines Compendium, Dietary Supplements Compendium, and Food Chemicals Codex.

PHARMACEUTICS (SCIENCE OF PHARMACEUTICAL DOSAGE FORMS DESIGN) Pharm.D. Course (13636-307-01)

The design of this course is based on the integration of the study of physicochemical principles of pharmacy with the study of formulation and preparation of pharmaceutical dosage forms. The integration is done within each main class of pharmaceutical dosage forms. The study of the physicochemical principles of pharmacy serves as a prelude to the materials on dosage form design covered in each section. Thus the applications of the knowledge of the physicochemical principles of pharmacy to the rational formulation, preparation/compounding, quality control, stability, packaging and storage of pharmaceutical dosage forms follow directly after the study of the physicochemical principles for each module (i.e. each major class of dosage forms).

ADVANCES IN DRUG DELIVERY SYSTEMS (87125-512-01) Ph.D. Course

A drug is rarely given to man as a pure chemical compound; what is given for administration is a drug product containing the drug. When a drug is prepared in a form suitable for administration, it is called a dosage form or a drug product or, in a more recent terminology, a drug delivery system. Almost anything done to the dosage form may alter the availability (the rate and amount) of the drug delivered to the desired place in the body.Following the administration of a drug, it should arrive ideally at the biophase (the site of action) in an optimum concentration which is maintained for the desired duration of treatment. However, delivering the desired amount of a drug to a specific site in the body to produce a beneficial therapeutic response is rarely achieved satisfactorily using conventional dosage forms (oral ingestion of tablets, capsules, emulsions, or suspensions; topical administration of ointments and creams; rectal administration of suppositories; injection of sterile suspensions and solutions, etc). Attention is now focused on new approaches to providing improved delivery of drugs or bioactive agents based on the philosophy that optimum biological response occurs when the level and time of availability of drugs are optimized. In fact new drug delivery technologies have made it possible for pharmaceutical and biopharmaceutical companies to develop drug candidates previously considered too toxic for man into dosage forms suitable for administration.The course assumes previous background in principles of drug formulation and basic pharmacokinetics. As the name (Advances in Drug Delivery Systems) implies, the course presents developments in pharmaceutical dosage form design: from the first generation (conventional dosage forms) to the fifth generation (gene delivery) drug delivery systems to enable students to follow the progress made in the efforts to improve  the delivery of bioactive agents (drugs).The materials of formulation (mainly polymers) in every generation of drug delivery systems are considered vis-à-vis their roles in the proper design of the drug delivery systems.  The major technique in the design of the new drug delivery devices is based on physical and chemical combination of drugs with polymers. Given the complexities of natural polymers, efforts have been concentrated on synthetic polymers because they can be synthesized reproducibly and predictably, thereby permitting the drug formulation scientists to have uniform and controlled polymer composition. It is known that drug delivery in the past was mainly the application of polymer  matrices to regulate the release of drugs and it is still a very important field of study. However, drug delivery today, in an era of nanotechnology and molecular biology (genomics, proteomics and metabolomics), has its root in biological rationale as shown by the rise in polymer therapeutics which involves disciplines such as chemistry, physics, biology, bioengineering, biochemistry, pharmacy and medicine.Part of the objective of the course is to help expand your awareness of the developments in the fascinating science of drug product design. The secondary objective is to help you anticipate new and novel developments and applications, to urge you to think creatively towards the future, rather than to simply accept and apply the past. We will make reference to original research and review articles in key pharmaceutical, science, medical, and engineering journals.

Drug Stability and Packaging (17811-714-01) Ph.D.

The importance of the knowledge of the stability and packaging of pharmaceutical dosage forms vis-à-vis drug product development cannot be over emphasized. Many drugs are susceptible to some form of chemical decomposition when formulated as dosage forms. In the rational design and evaluation of pharmaceutical dosage forms, the stability of the active components must be a major criterion in determining their suitability. Several forms of instability (loss of potency, formation of toxic products, decrease in bioavailability and changes in the physical appearance of the dosage forms as exemplified by discoloration following the photochemical decomposition of the drug) can lead to the rejection of a drug product. It is now recognized that the chemical and physical stability of the active pharmaceutical ingredient alone, and when combined with excipients in drug product formulation, is critical in developing a successful pharmaceutical product.In the past, pharmaceutical packaging was considered as the effective containment of pharmaceutical dosage forms such that, at any time point before expiration date of the drug product, a safe and efficacious dosage form was available. However things have changed and the contemporary definition of pharmaceutical packaging is as follows: the combination of components necessary to contain, preserve, protect, and deliver a safe and efficacious drug product. I want you to pay a particular attention to the operative word “deliver” in that definition. Thus the packaging system may deliver the drug product to the final consumer (the patient). Consequently the package is an integral part of the dosage forms because the package may control or affect the quantity of drug delivered. One of the objectives of this course is to help you as pharmaceutical scientists (the future belongs more to you than your professors and you must not fail humanity) to be aware of the issues involved in the stability and packaging of pharmaceutical dosage forms. The secondary objective, which is characteristic of all the graduate courses I teach, is to help you anticipate new and novel developments and applications and to urge you to think creatively towards the future, rather than to simply accept and apply the past. We will make reference to original research and review articles in the field of the science of drug stability and packaging. Finally I urge you to take all the graduate courses very seriously: read beyond what is required to get an “A” grade. Experience has shown me that what many people do in their jobs post-graduation is not what they did for their thesis work.

NANOTHERAPEUITCS (17932-747-01 ) Ph.D.

Nanotechnology describes many diverse technologies and tools, which do not always appear to have much in common! Therefore it is better to talk about nanotechnologies, in the plural. One thing that all nanotechnologies share is the tiny dimension that they operate on Nanotechnologies are the design, characterization, production, and application of structures, devices and systems by controlling shape and size at the nanometer scale.Nanotechnologies are not new to Pharmacy: Professor Peter Paul Speiser’s strategy for controlled drug release was the development of miniaturized delivery systems and in the late 1960s he developed the first nanoparticles for drug delivery purposes and vaccines. The advent of new and sophisticated tools, such as atomic microspcope, has allowed scientists to gain an in depth understanding  of nanostructured substances. Recent advances in the field of nanotechnologies have made nanoparticles to be very promising in the delivery and targeting of bioactive agents, drug discovery and diagnostics. Nanoparticles are submicron (< 1 mm) colloidal systems.  Nanoparticles are colloidal systems and can be fabricated from varied and diverse materials in a variety of compositions, including quantum dots (QDs), polymers,  gold, paramagnetic iron, etc. Our interest in this course is biomedical applications of nanoparticles. According to the National Cancer Institute (NCI), nanotechnology has tremendous potential to make an important contribution in cancer prevention, diagnosis, imaging, and treatment as well as HIV/AIDS. The evolution of nanoparticles for biomedical applications has moved from the first generation nanoparticles (mainly suitable for liver targeting) through the second generation (stealth) nanoparticles for long blood circulation and passive targeting to the third generation nanoparticles with molecular recognition (active targeting).  The fourth generation is dubbed theranostics. These multifunctional nanoparticles can target a tumor, sense pathophysiological defects in tumors, deliver therapeutic drugs, genes, or imaging agents, respond to external triggers to release the agent, and monitor the therapeutic response. One of the objectives of this course is to help you as pharmaceutical scientists (the future belongs more to you than your professors and you must not fail humanity) to be aware of the issues involved in the design of nanoparticles and biomedical applications of nanoparticles. The secondary objective, which is characteristic of all the graduate courses I teach, is to help you anticipate new and novel developments and applications and to urge you to think creatively towards the future, rather than to simply accept and apply the past. We will make reference to original research and review articles in the field of the pharmaceutical nanoscience. Finally I urge you to take all the graduate courses very seriously: read beyond what is required to get an “A” grade. Experience has shown me that what many people do in their jobs post-graduation is not what they did for their thesis work.

Grant Proposal Writing (85721-703-01) Ph.D.

COURSE OUTLINES I     IntroductionI. a. Why is it necessary to seek grants? I. b. Funding Agencies II    Grant Application Basics (Based on NIH Funding Reports) III  How to Plan a Grant Application (Based on NIH Funding Reports) IV   How to Write a Grant Application (Based on NIH FunV    Completion and Submission of a Prepared Grant Application in NIH Format by Each Studentding Reports)

Priciples of Drug Formulation (Introductory Ph.D. Course for Non-Pharmacist) 13979702 01

The design of this course is based on the integration of the study of physicochemical principles of pharmacy with the study of formulation and preparation of pharmaceutical dosage forms. The integration is done within each main class of pharmaceutical dosage forms. The study of the physicochemical principles of pharmacy serves as a prelude to the materials on dosage form design covered in each section. Thus the applications of the knowledge of the physicochemical principles of pharmacy to the rational formulation, preparation/compounding, quality control, stability, packaging and storage of pharmaceutical dosage forms follow directly after the study of the physicochemical principles for each module (i.e. each major class of dosage forms).

1983-1986 Commonwealth Scholar, University of Manchester, England

1994-1996 NIH (Fogarty International Center) Post Doctoral Fellow, University of Utah

2003-Present: NIH, NSF and DoD and other Agencies Grant Review Consultancy

2013 – Present Appointed Member of USP Center for Pharmaceutical Advancement and Training Advisory Group

2013 Howard University School of Pharmacy Alumni Distinguished Faculty Award.

2013 Top Reviewer in the Journal of Pharmaceutical Sciences.

2013 Top Reviewer in the Journal of Nanomedicine

2014 American Association for Cancer Research (AACR) Minority-Serving Institution Faculty Scholar in Cancer Research Award

2015-Present Appointed Chair of IACUC at Howard University

2015-Present Appointed a Member of United States Pharmacopeia (USP) General Chapters Dosage Forms Expert Committee (USP Expert Committees are responsible for developing and revising USP standards that comprise its compendia: the USP and the NF, USP Compou

2016 Washington DC Pharmacy Association NASPA Excellence in Innovation Award