Keynote Address By Prof. Mojisola Christiana Adeyeye At The 12th Institute Of Chartered Chemists Of Nigeria On Synergistic Relationship Between Chemistry And Pharmacy And It’s Impact On Drug Development In Nigeria

Keynote Speech By Prof. Adeyeye C. M

Director General NAFDAC

On Synergistic Relationship Between Chemistry And Pharmacy And It’s Impact On Drug Development In Nigeria

Abuja.

24^th July, 2019.

Protocol

It gives me great pleasure to be here today to deliver this keynote address to these distinguished professionals on the occasion of your 12^th Mandatory Continuing Professional Development (MCPD) workshop. I must commend the ICCON for making efforts to continually update its members with the changes and advancement in your profession. The same should be said of you the participants, who have shown the enthusiasm to continue learning and keep abreast with current trends in the Chemistry profession.

Today’s topic, “Synergistic Relationship between Chemistry and Pharmacy and its Impact on Drug development in Nigeria”, is very dear to my heart as it entails lots of research which is one of my key areas. I became enthused with chemistry as early as the second or third year in my high school – Yejide Girls Grammar School in Ibadan in the early to mid 1960s. This was because chemistry added anticipation and satisfaction to my inquisitive mind as chemicals come together with observable outcomes.

Chemistry has long been an integral part of pharmacy and its importance has not diminished especially as it pertains to drug discovery and development. The emphasis of chemistry is more today than what it has ever been due to the new frontiers in pharmaceutical sciences such as molecular pharmacology, medicine, epigenetic protein families, microneedles, functional material science, etc. Though changes and advancement in technology have continuously influenced the role of both professions in drug development, both the pharmacist and chemist have been and will continue to be key players in the drug discovery and development process.

Chemistry as we know is a scientific discipline involved with elements and compounds composed of atoms, molecules, and ions; their composition, structure, properties, behaviour and the changes they undergo during a reaction with other substances.

Chemistry is the science of the composition, structure, properties and reactions of matter, especially of atomic and molecular systems. Life itself is full of chemistry i.e., life is the reflection of a series of continuous biochemical processes. Our identities, heredities and continuation of generations are all governed by chemistry.

Pharmacy is the study of the formulation of an active chemical entity, in the form of tablets, capsules, powders, aerosols, injections etc. It is the science and technique of Preparing, Dispensing and Review of drugs, providing additional clinical services. Pharmacy is a health profession that links health sciences with pharmaceutical sciences and aims to ensure the safe, effective and affordable use of drugs.

Chemistry and Pharmacy in Drug Discovery and Development

Pharmacy is a health profession that links health sciences with pharmaceutical sciences and aims to ensure the safe, effective and affordable use of drugs. . Pharmaceutical Sciences is the bedrock of drug discovery and development is one of the most complex and expensive activities within the framework of the pharmaceutical industry. It encompasses a wide array of end-to-end activities with a plethora of supply chain and support services. It is estimated that the average cost to research and develop each successful drug is between $800m to $1bn, spanning a period of over 10 years. Drug discovery and development can be classified into discovery phase, preclinical phase and early stage development, mid stage development and late stage development. Drug discovery has undergone many changes over the years but the goal has remained same: to uncover safer medicines for all diseases. Drug discovery and development is driven by the knowledge of chemistry of the molecules and their association with life process. It is conducted by a project team of multidisciplinary professionals which includes the pharmacist, chemist, bioscientist, toxicologist, pharmacokineticist and others.  Some branches of chemistry include that form the backbone of pharmaceutical sciences include:

• Organic chemistry
• Analytical chemistry
• Biochemistry
• Inorganic chemistry
• Medicinal Chemistry
• Physical Chemistry

My interest in chemistry in general and organic/analytical chemistry in particular contributed to my relative success as a pharmaceutical scientist, academician and regulator. It gives an opportunity to be outcome-driven knowing that there is an action and a reaction that ends up with an intermediate or the product.

Organic chemistry has been a driving force for drug discovery since its very beginning. After the isolation and characterization of the pure chemical ingredients of natural medicines (e.g., morphine, 1804), the first synthetic drugs were developed (e.g., nitroglycerine, 1844), and soon thereafter the first systematic drug‐finding efforts led to significantly enhanced treatment options (e.g., Aspirin, 1897; Salvarsan, 1909; plasmoquine, 1926). Since then, organic chemistry, through medicinal chemistry as its specialization for the discovery of small‐molecule drugs, has had a growing impact on an ever‐increasing number of disease areas.

This branch of Chemistry has been tied to combinatorial chemistry that involves design and simulation of drug molecules to underscore structure-activity relationships. This aspect of chemistry is often handled by the medicinal chemist or biochemist. The medicinal chemist is indispensable in the pharma industry and he/she often interfaces with the biologist, medical doctors and pharmaceutical scientists.  They evaluate the structure-activity relationships (SARs) of analogous compounds with regard to their in vitro and in vivo efficacy and safety. The goal is to arrive at a hit or lead compound that could be synthesized or resynthesized with the goal of obtaining a new chemical entity (NCE) or active pharmaceutical ingredient (API).

Another branch of Chemistry in the pharmacy or food technology curriculum especially at the post-graduate graduate level is Analytical Separations. It is one of the most important aspect of drug development without which the product will fail if enough consideration is not given to the robustness of the repeatability, reproducibility, ruggedness, precision, etc. As a regulator, it is applied to check the quality of foods, drugs and other chemicals used in daily life. It underpins pharmaceutical drug development by providing assurance of the quality, safety and efficacy of new medicines. The overall drug development process requires robust, accurate analytical methods throughout the product lifecycle: from preformulation, preclinical studies to drug formulation, purity assessment, clinical studies, pharmacovigilance and epidemiological studies.

There are various Analytical techniques involved in the drug development process. These include High-Performance liquid Chromatography (HPLC), liquid Chromatography/Mass Spectrometry (LC/MS or LC/MS/MS) and Nuclear Magnetic Resonance (NMR). Drug developers also leverage on the analytical chemical testing and process development for meeting the regulatory requirements of Good Manufacturing Practices (GMP) standards needed for drug production.

An area of Analytical Chemistry is solid-state characterization of a composite in Material Science. The composite can be the API or non-active ingredient or excipient in a drug or food is conducted. Some of the observable variables include thermal events such as melting and crystallization that could show any drug-drug or drug-excipient interactions and the implications on the performance of final product in vitro or in vivo.

Biochemistry is another branch of chemistry that is used in molecular medicine, precision medicine, gene-based drug development, biopharmaceutical technology or biosimilar products, etc. Another importance of biochemistry is its use in drug metabolism. Biochemistry gives an idea of how drug molecules are metabolised by many biochemical reactions in the presence of enzymes. At the clinical trial stage, biochemical analysis helps to identify toxic metabolites when clinical adverse side events are simultaneously considered. Detection of metabolites also helps to avoid drugs which have poor metabolism. The clinical outcomes are very important in pharmacovigilance before a drug product is released into the market or post-marketing surveillance. Biochemical techniques are also utilized in determining the half-life of drugs in terms of stability under varying conditions.

A branch of chemistry – Inorganic Chemistry – deals with the chemistry of all non-organic compounds, and mainly involves the chemistry of metals especially transition metals. It is not widely used in drug development, however it used in bulk materials synthesis where elements play a catalytic in reaction mechanism .

Pharmaceutical Development

Pharmacy on the other hand provides an invaluable interface in the drug development process. It is a multi-disciplinary profession that neatly weaves together biology, chemistry, physics, mathematics in order to make the clinical use of drugs relevant to man and animal.

However, chemistry has a noticeable resonance on pharmacy at all levels of drug development and health care delivery.  At the early phase of drug development, chemistry is invoked when the new chemical entity evolved into an active pharmaceutical ingredient (API). Here, medicinal chemistry, natural products chemistry, analytical chemistry or pharmaceutical chemistry are used in the creation and identification of the new molecules. At this point also, once the API is identified, a characterization process begins to ensure that the physical and chemical attributes such as morphology, size and shape of the drug particle will not compromise the stability, manufacturability and general handling of the drug product.  Alongside this evaluation is pre-clinical studies in animal models in order to ascertain safety, efficacy and effectiveness.

This includes investigating of the molecule relative to its permeability across the biological membrane which will be very important in determining the route of administration and the type of dosage form. Depending on the molecule, the investigation could involve molecular biology and biochemistry, use of cell lines and tissues. This aspect of drug development is all wrapped up in chemistry.

A relatively newer emphasis that has to be taken into consideration is the disposition of the drug, beginning with the receptor binding characteristics in the cell line, tissue culture or animal model This aspect is pharmacodynamics which essentially refers to what a drug does to the body and the mechanism of drug action. It involves receptor binding (including receptor sensitivity), post-receptor effects, and biochemical interactions . The pharmacologic response depends on the drug binding to its target. The concentration of the drug at the receptor site influences the drug’s effect. A drug’s pharmacodynamics can be affected by physiologic changes due to disorders, aging, or other drugs but the process is driven by chemical nature of the drug and the biochemical/physiological functions of the receptor site.

An extension of pharmacodynamics is pharmacokinetics that serves as a useful tool in the drug development process both in terms of therapeutics and in defining the drug’s disposition characteristics.  Pharmacokinetics has emerged as an integral part of drug development and a critical part of early drug development, especially when identifying a drug’s biological properties. Pharmacokinetics (PK) is the study of how a drug is absorbed, distributed, metabolized, and excreted over time. Pharmacokinetics provides a mathematical and biochemical basis to assess the time course of drugs and their effects in the body. It enables the following processes to be quantified: Absorption, Distribution, Metabolism, and Excretion (ADME). These pharmacokinetic processes determine the drug concentration in the body when medicines are taken. A fundamental understanding of these parameters is required to design an appropriate drug regimen for a patient .

In general, pharmacodynamics and pharmacokinetics help explain the relationship between the dose and response, i.e., the drug effects that are often tied to the functional groups on the drug molecule having established the drug backbone.

Human pharmacokinetic information is vital for new drug development in order to ensure the appropriate use of medicines.  Pre-clinical pharmacokinetic studies are performed to examine the ADME of an investigational drug or approved drug in animal models. At this point, the chemistry of the molecule may be changed if for example, there is a solubility or permeability issue. Once these attributes became optimized and the toxicity, safety and efficacy become non-issues, the drug is then tested in healthy volunteers. Data obtained from such studies are useful for the design and conduct of subsequent clinical trials. The data are also necessary for appropriate analysis and evaluation of the efficacy and safety data obtained in clinical trials for new drug development and in post-marketing clinical trials. The results of clinical pharmacokinetic studies are useful for determining the appropriate use of medicines according to patient characteristics, such as disease and genotype of drug-metabolizing enzymes, and for predicting the influence of pharmacokinetic drug interactions.  It also provides information for therapeutic drug monitoring (TDM).

Disorders that affect pharmacodynamic responses include genetic mutations, polymorphisms, malnutrition, and some forms of insulin-resistant diabetes mellitus. These disorders can change receptor binding, alter the level of binding proteins, or decrease receptor sensitivity.

Modelling and simulation of pharmacodynamics and pharmacokinetics are often conducted and are crucial components of a mechanistic approach to optimal drug development in both early and late drug development efforts. The approach is useful for prediction of the drug disposition where human volunteers may not be available such as in neonates, infants and some paediatrics or where dose response is needed before moving on to the next phase of development.

As a result of the evolutionary changes in professional training, the drug marketplace, and the advances in research in the pharmaceutical sciences, the role played by pharmacy has markedly increased throughout the entire spectrum of drug development. Pharmacy is now important in the molecular design of new drugs; in the clinical evaluation of drugs; and most importantly, in the design of drug delivery systems.

During the discovery research phase of drug development of a medicine, trained pharmacists, biochemists, biologists at an advanced level or pharmaceutical scientist to develop and select drug compounds that may be valuable as medicines.  The trained pharmacist could provide in-depth knowledge and understanding of the biopharmaceutical properties of the compound, the drug delivery system and dosage form and how the route of administration might affect the rate and extent of absorption. An area of pharmaceutical development where the pharmacist can play a great role is in Clinical Trials.

Formulation and Development

A fundamental aspect of formulation and development of a dosage form is what I referred to as preformulation which occurs very early on in development. This is the stage where the API and the non-active ingredient or excipient are studied in order to understand the critical variables that could affect the formulation attributes such as stability, quality, and efficacy of the drug. Chemistry (organic and analytical) is heavily weighed in at this stage because, whether it is drug or excipient, the chemistry and the reactivity of the two can determine the attributes. A lot of experimental design is also infused to the formulation design at this point in order to avoid developing many formulations. The optimized formula so derived via experimental design can then be moved forward in the pipeline to get a prototype formulation that can be scaled up to pilot scale and then plant scale or clinical batch size.  A large number of pharmacists in the industry work in the areas of formulation development.  After a successful formulation of the pilot scale, the product can be tested in humans. Sometimes, the first-in-human testing may be done earlier without excipients as a solution to understand the permeability and absorption characteristics and to determine the best possible route of administration.

Highly specialized formulations such as targeted release and skin patches can enhance the effectiveness of the drug and sophisticated packaging can aid administration and acceptability of the product and also deter fraud. For exports, and of course for veterinary pharmaceuticals, different markets demand different formulations and packaging.  The pharmacy training, including the knowledge of pharmaceutics, equips the pharmacist with many skills relevant to these activities.

Clinical Research /Trials

Clinical Trials of an Investigational or generic drug are studies designated and authorized by the National Medicines Regulatory Authority (NMRA) on a new medicine or an existing medicine for a known or different condition.  The study can assess what doses should be given, how well the drug works in a population (its efficacy), how it works within the body and any unwanted side effects using animal and human subjects. This enables a better understanding of trial drugs and wider access for patients to drugs for a given condition.

The clinical research team includes the pharmacist/pharmacologist from inception; planning the trial, developing the prototype formulations for administration first in animals and later for trials in humans.  He/she often is heavily involved in the production, packaging, labelling and supply of the medicine to clinical researchers, through to the monitoring and reporting of complex studies in pharmacovigilance.  At this stage, the knowledge of drug composition and associated indications, dosage, administration, contraindications, adverse effects and drug interactions in vivo guide the pharmacist in monitoring of adverse events and signals

An approval to conduct the clinical research at the institutional level is sought prior to the clinical trial through the local Institutional Review Board (IRB) to ensure that the safety of human subjects and their rights are protected. For any of these functions, the pharmacist is trained to be familiar with the research protocol, understand informed consent, investigator’s brochure, and standard operational procedures of the clinical research that include regulatory, ethical, and legal requirements.

The type of control of an investigational drug receives may lead to the success or failure of a clinical study depending on versatility of the clinical research team.  This includes the pharmacist role, which is to ensure that the drug dispensing and receipt are recorded in the study documents or in the interactive voice response system .

Evidently, pharmacy and chemistry are ancient lovers who have been inseparable till date and it is impossible to discuss one without the other in the drug development process. We can therefore assert that chemistry and pharmacy remain truly invaluable professions that play critical roles in the drug development process in the pharmaceutical industry. They are the scaffold on which all key components of the drug discovery and development paradigm are assembled and so, provide a synergistic effect, which drives the other components of the process.

However, the continuous changing and advancing scope of modern drug discovery and development including current shift from chemical entities to biological entities as novel drug leads, evolution of modern drug discovery screening assay methods and technologies such as combinatorial chemistry (combichem), microwave assisted organic synthesis (MAOS) and high-throughput (HTS) biological screening methods. This era of molecular targets, protein receptors, new drug delivery systems and aspects of genomics, proteomics and metabolomics, will require trained chemists and pharmacists to continuously update themselves if they are to remain relevant in the industry. This is why today’s workshop is so relevant and mandatory for you. Again I say kudos to ICCON.

In Nigeria, it is rather unfortunate that this love affair between chemistry and pharmacy as a synergy for drug discovery and development is not adequately harnessed.

Available performance indices for the Nigerian pharmaceutical sector suggest poor performance with capacity utilization of under 40%. The sector is only able to satisfy 25% of the local demand for drugs while imports, mainly from Asian countries, account for the remaining 75 per cent. This portends a bleak prospect for drug discovery and development for the sector also noting that mostly cheaper generics make up large chunk of the imports. The problem of poor infrastructure, brain drain and inadequate funding also pose serious challenges to the sector.   However, the new NAFDAC’s regulatory policies being put in place will revert the current high imports and ensure drug security.

Another issue is Research and Development (R & D) that is lacking in the industry. There is however a glimmer of hope with recent reports of increased R & D efforts in natural products at the National Institute for Pharmaceutical Research and Development (NIPRD) that could lead to new formulations, therapeutic agents, nutraceuticals and phytomedicines. This is a low hanging fruit considering our abundant indigenous biodiversity and traditional medicine. In the last decade, NIPRD has successfully researched and developed six traditional herbal products for the treatment of Ebola, malaria and other diseases. The institute has also developed ‘NIPRISAN’ for the management of sickle cell anaemia..  Research, being one of NAFDAC’s functions is being put back in our activities with ongoing talks with NIPRD, universities and researchers in general.

More efforts must be put into research in the herbal medicine sector in Nigeria to harness the enormous potentials inherent in developing new drug moieties. NIPRD and other academic institutions should collaborate to promote research in the sector. Medicinal chemists and research pharmacists especially in academia in Nigeria should get involved in drug discovery and development process. Pharma companies must realize the huge potentiality from academia in Research and Development (R&D) for possible collaboration. In medical research, the industry-academia cooperation often pair university (medicinal chemistry research) with pharma industry (resources). Such collaborations, if instituted in Nigeria, have and will continue to improve human health by facilitating novel and innovative drug molecules particularly from our vast array of herbal medicines. As a researcher myself, I fully appreciate the role and potential of R&D.

The potential cures of the future could be in our backyards and in our forests. The herbal remedies passed down by our forefathers have a role to play and we have a responsibility to encourage the research & development of such remedies.

As a regulator, the National Agency for Food and Drug Administration and Control (NAFDAC) will continue to encourage drug development by ensuring adequate regulations are in place to promote quality, safety and efficacy of our drugs.  In doing so, the Agency regulates and controls the conduct of clinical trials which is part of the drug development process. Clinical trial regulations and guidelines have been put in place to guide our stakeholders appropriately. The conduct of clinical trial is mandatory for the following category of products:

• New or relatively new drug products, herbal formulations or cosmetics for which safety/efficacy profile has not been determined especially in our population.
• Drugs for new indications.
• Drugs for new patient population group (e.g. paediatrics, geriatrics, race etc)
• New combination drug products.
• New dosage schedule/regimen.
• New drug delivery system.
• New medical devices.
• New medical procedures
• Academic clinical trials on any of the above and
• Bioequivalence Study

It is necessary to emphasize that:

• No person shall import, procure or manufacture a drug product, cosmetic or medical device in Nigeria for the purpose of a clinical test unless he is a holder of a valid clinical trial approval issued by NAFDAC.
• Clinical trial should be conducted in accordance with the approved Protocol, Good Clinical Practice (GCP) and Agency’s requirements.

For parties interested in carrying out clinical trial in Nigeria, the two responsible regulatory authorities are:

1. National Agency for Food and Drug Administration and Control (NAFDAC) and National Health Research Ethics Committee (NHREC): The two bodies are  responsible for protocol review and authorization of clinical trial before it is conducted in Nigeria. They are also responsible for carrying out inspection of trial sites to monitor the conduct of authorized studies to ensure that well-being and safety of the participants is protected and credible data is obtained from the study. Fine tuning of the two regulatory bodies are underway in order to create an enabling environment for ease of doing clinical trials.

Most of the Chemists employed in NAFDAC are domiciled in the Chemical Evaluation and Research Directorate. This directorate has the mandate to safeguard public health by ensuring that only the right quality chemicals are manufactured, imported, exported, distributed, sold and used in Nigeria. The Directorate is structured into 4 Divisions: Chemical Import Control Division, Agro-Chemicals and Controlled Chemicals Division, Chemical Monitoring & Risk Assessment Division and Chemical Research and Review Division.

The directorate ensures availability of chemicals to eligible companies through prompt issuance of permits to import and clear Industrial and Restricted Chemicals. The process of obtaining import permits is electronic and this can be done on the Nigeria Single Window Portal website. (www.trade.gov.ng/nafdac)

The directorate has put in place effective regulations and guidelines for sound chemical management in Nigeria. This is achieved by ensuring proper utilization of chemicals in a manner that reduces risk to health and environment and advocating for use of chemicals that are less harmful and hazardous.  The directorate collaborates with other Ministries, Departments and Agencies (MDAs) like Office of the National Security Adviser, Ministry of Environment, Office of the Secretary to Federal Government and others on life cycle management of chemicals.

Furthermore, the directorate ensures conformity to international conventions and protocols like the Chemical Weapons Convention, Montreal Protocol, Stockholm Convention, and Basel Convention for Chemicals and development of   policies   and   science-based advice and information on chemical risk assessment.  The directorate also investigate and inspect production and storage premises thereby promoting standards and regulations on the handling of chemicals.

Chemists are also employed in our Laboratory Services (LS) Directorate. This directorate is the arm of the Agency that investigates and pronounces on the quality, safety, efficacy and wholesomeness of regulated products both imported and locally manufactured. Operations here depend largely on analytical chemistry skills and knowledge of our chemists in our Seven (7) functional laboratories (3 food labs and 4 drug labs) across the country. Our laboratories;

• Conducts appropriate tests and ensure compliance with standard specifications designated and approved by the NAFDAC Council for the effective control of the quality of food, drugs and other regulated products and their production processes as well as their production processes in factories and other establishments;
• Makes pronouncement on the quality and safety of food, drugs and other regulated products after appropriate analysis.
• Develops analytical methods for analyzing food, drugs and other regulated products and
• Serves as reference Laboratory for other Governmental Agencies like Nigeria Customs Service by analyzing samples for tariff classifications, NDLEA to identify narcotic drugs and Psychotropic substances, Nigeria Police Force for analysis of forensic samples.

The origins and advancements of pharmacy, chemistry and drug development are interwoven in nature. Drug development is a complex, lengthy and expensive process. Pharmaceutical companies have recognised that the drug development process needs optimisation for efficiency in view of the return on investments. The industry has surely found dependable allies in Chemistry and Pharmacy as both professions have proved invaluable to the drug development process with a synergistic partnership that promotes the growth of the pharma industry.

As stakeholders, we must continue to push for increased research in drug development in Nigeria especially in the herbal medicine sector. Pharma industry and academia collaboration must be encouraged to promote technology transfer to bring new medicines from bench to bedside.

In NAFDAC, the role played by Chemists cannot be undermined as your skills are paramount to the success of our operations. Just last month, we attained the ISO 9001: 2015 certification for management system implemented across the Agency including chemical inspection. This is a huge achievement not just for NAFDAC but also for Nigeria, and our Chemists adequately played their role.

As you undertake your MCPD course, I wish you a successful workshop.

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Prof Mojisola Christianah Adeyeye

Director General