We walk side-by-side with pharma and, especially, biotech companies in a fast-paced research environment pursuing treating cancer. Cancer research is moving at full-speed and tirelessly exploring new approaches. Accompanying this research leading to broadening current therapeutic arsenal, demands a permanent medical update to understand and handle other innovative treatments apart from the “classical” chemo- and radio-therapies, tumor surgeries or hormonal therapies. We have invested enormously in understanding state-of-the-art oncology remedies, and in how to work with these novel therapies, that include those MoAb-based, gene therapies or T-cell-based treatments.
We do have full confidence in our expertise and knowledge to walk hand-in-hand with researchers from the very first moment in which their new medicines are to be tested on real patients, and proud to warrant outstanding reliable, scientifically-sound results.
Rare diseases are uncommon for all, especially for those suffering the disease, and research in these conditions provides hope to patients and their families. Contributing to the development of potential cures for these rare diseases is an attractive challenge from a medical perspective and an unavoidable responsibility from an ethical viewpoint. Finding patients and experienced sites and investigators, and even activating and conducting clinical trials, might be defying but highly rewarding as it helps to bring remedies to affected subjects.
At Pivotal, we have always opted for investigating rare diseases despite all concerns and issues related to the trials that they may bring along. More than half a hundred projects later, in quite diverse conditions and phases, we remain hungry for more of this, aware of what the results of these investigations will bring to the society in general and the affected subjects in particular.
It is estimated that neurological and psychiatric disorders and their sequelae affect as many as a billion people worldwide and impact thereof seems to spread transversally, affecting all age groups and all geographical regions – and even prevalence thereof appears to be growing. Many things can go wrong with the brain and the nervous system, and because of this, a vast number of pathologies have been described. Therefore, therapies to treat these disorders and help patients are also vast and expand from lifestyle changes, to physiotherapy, pain relief, and a broad range of medications. Most of these therapies are oriented to the alleviation of symptoms. Still, there is a clear need for novel therapies that can revert underlying neurological deficits or promote neural regeneration or provide the needed repair. Helping to unravel the causes behind these diseases and to bring new medicines to affected subjects is exciting and challenging but also, and above all, a priceless and rewarding challenge. Over the years, there has been much advance in understanding all these conditions, and in the generation of new treatments.
At Pivotal, we are proud of having been part of this area, and we look forward to remaining hands-on helping researchers, to develop new therapeutics.
No doubt, cardiovascular disorders are the number 1 cause of death globally, with near 18 million people dying every year. And this happens despite the many advances made over the last years in the treatment and prevention thereof. Lifestyle changes do significantly reduce and control the onset and progression of these pathologies and other non-surgical procedures and surgery itself. But also drugs play a crucial role to prevent and mitigate them.
For a long time, the drug pipeline for these diseases – especially cardiovascular diseases- has not been fed up with new medicines as expected, compared to advances made in other therapeutic areas. And this has happened even though clinical research on vascular diseases has never stopped.
Pivotal has been there all along the way, providing support to all developers of potential cures and treatments – and it is our objective to be there for long. We are excited with the idea of still having the opportunity of sharing our expertise and knowledge, based on field-experience, with those teams committed to finding remedies for all these conditions.
Advanced Therapy Medicinal Products (ATMPs) represent a fast-growing field of interest and constitute, themselves, a new category of medicines with a vast therapeutic potential for treating different types of diseases that include cancer, neurodegenerative or cardiovascular diseases.
However, and despite their enormous therapeutic potential, the time frame between “design” and the conduction of the corresponding trials first – and MA later- is notoriously much longer than expected. And this has to do not only with scientific and technical challenges intrinsic to the nature of ATMPs but also with regulatory ones. Trials with ATMPs have challenging designs, and even the definition itself of a new product as ATMP – and hence the legal frame to stick at development- is a theme of debate, and different regions – US and EU- have adopted diverse legal frameworks that may be contributing to creating confusion among researchers which drive to, eventually, delays in the access to these new remedies.
At Pivotal, we are sure of the potential of these products, and are willing to share our technical and regulatory knowledge with all those committed with the development of ATMPs to, eventually, contribute to a much faster release to the market of these therapies and, in the end, bring an additional piece of hope to millions of patients that can benefit from these medicines “of the future”.
Infectious diseases are caused by different pathogenic microorganisms, ranging from bacteria to viruses, protozoan’s, parasites or fungi – that can spread from one person to another, or even from one another species to human, causing the so-called zoonotic diseases. And it is assumed that infectious diseases are one of the major causes of death in the world. In fact, and according to the World Health Organization (WHO), globally, 16% of fatalities result from infectious diseases, making these diseases one of the most significant global challenges in medicine in our time. Infectious diseases are present transversally worldwide, and much emphasis needs to be placed in controlling and treating these diseases in areas of significant poverty, specifically.
New infectious agents appear, and known organisms develop increased virulence or resistance mechanisms to current treatments. The world was recently hit by an international health crisis of unprecedented dimensions and costs caused by the uncontrolled spread of the SARS-CoV-2 virus responsible for the COVID19 outbreak.
All in all, research on infectious diseases shall keep moving forward to provide new therapies to patients and deal with the development of new strategies for prevention. At Pivotal, we have been committed with this purpose, and still are – both, to help in the fight against infectious diseases in general and in that against COVID19 in particular. There is yet a long way to go, so that’s why we want to walk hand by hand with our clients.
Diabetes and Endocrinology
All elements of our body are in permanent contact and communication, gauging at every moment all functions. Hormones – the core of “endocrinology”- are the principal soluble mediator of this communication within the body. Hormones affect many physiological activities, including growth, metabolism, appetite, puberty and fertility, and any disbalance affecting the endocrine system may, hence, provoke the impairment of many different physiological processes. Diagnosis of endocrine disorders is not a straight-forward process, and signs and symptoms may span the entire clinical spectrum; neither it is the treatment. Treatments may include the use of medication, surgery or radiation-based approaches and are in general aimed to re-establish the normal hormone balance – e.g. administration of a synthetic hormone-. However, a change in one hormone level can throw off another
Understanding the endocrine system, from a basic science perspective – and with a “3D” vision- together with the conduction of robust clinical trials are needed to eventually warrant patients the access to better treatments as well as alleviate their symptoms or even ensure the re-establishment of a normal hormone balance and subsequent return to the normality.
Endocrinology is not a foreign discipline for Pivotal, and we will be delighted to explore how your new tools and medicines may bring comfort to patients.
There is not a universally accepted definition of the so-called “medical devices” although, in a very general way, any device intended to be used for medical purposes which exert its function by means that its not direct chemical, pharmacological, immunological or metabolic action, can classify within this category of products. Be as it may, it is generally accepted that medical devices help patients/users by providing new tools for diagnosis and providing solutions for the diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease.
Therefore, although different regulations exist across different regions – EU, US, Japan, other areas- it is generally agreed that an evaluation of risks derived from the use thereof shall be considered first. In response to this need, medical devices tend to be classified as a function of the potential risk derived from their use. Thus, for some devices, less or no clinical research at all is needed; for others, setup and conduction of those trials – with its proper particularities- is, on the contrary, required.
Knowing both the regulatory and other more technical specificities of the clinical research of devices – e.g. trial designs themselves- helps researchers efficiently bring their products to final users and patients. At Pivotal, we have already struggled with the regulatory bodies and designs of these trials. We are anxious to share our knowledge and experience with all companies pursuing to bring a device to the market.
Disorders of the Immune System
The immune system is the body’s defence against infections and other harmful invaders. It is indeed, an elaborate “network” encompassing different types of cells, tissues and organs all working together co-ordinately. And it happens that the immune system does not always function properly, generating a range of pathological conditions. Such malfunctioning of the immune system may be related to genetic errors in any of the genes building up the defences – primary immunodeficiencies- but also to other conditions that weaken our immune system – secondary deficiencies- or that induce a hyperactive response thereof against non-pathogenic agents – allergies- or that drive a non-desired response against the wrong threats – autoimmune diseases-.
All these scenarios lead to pathological conditions – more or less severe- whose potential treatments require a profound understanding of the immune system itself. Depending on the cause behind such malfunctioning, solutions might be quite different – from the prevention and treatment of occurring infections to “chemical” therapies to stem-cell transplantation, the use of gene therapies aimed to re-establish the correct functioning of what is damaged.
Exploring the immune system’s physiopathology is a vast, challenging territory and having a trustful and experienced partner – like Pivotal- to walk with, when looking for remedies might be the difference that leads to success.
Skin is not only our most external wrapper that keeps confined all that is underneath but also the largest organ of the body, with transcendental functions relying on it. Skin acts as the first mechanical barrier that protects us from infections, but also regulates body temperature and fluid balance while allowing us to feel – heat, cold, touch, pain-. Being skin an organ, it can get sick and, in fact, skin diseases – infectious and non-infectious-are wide-spread. However, even though skin diseases are among the most common human illnesses, these conditions continue to receive relatively little attention, even when skin diseases’ detrimental effects on health range from physical incapacity to death.
Non-healthy dermatological conditions are multiple, and so are the corresponding treatments – all of which need to be assessed, as any other cure, in the context of typical clinical trials. At Pivotal, we count with experience, and investigators committed to providing advances in the treatment of skin diseases, and are prompt to guide you in your clinical development.
It is clear that children are not size-reduced adults, with both groups differing in their physiology and PK/PD profiles. Yet it is estimated that 50-90% of medicines for children are prescribed off-label – meaning that these medicines have not been tested (efficacy/safety) in the pediatric population. In this context, it becomes evident that pediatric clinical research is essential for the development of new and effective treatments to manage diseases affecting children, specifically. But this is not an easy task. The regulatory landscape is especially protective and conservative with this type of trials – which demands a profound knowledge thereof to setup any trial- but also because the design of pediatric clinical trials itself comes with specific associated challenges – that may include the preparation of the ICF itself, or the frequent restrictions in the use of placebo arms intrinsic to these trials, or even the questionable use of healthy volunteers as a control. Besides, when setting up a pediatric trial, enrollment difficulties have to be through and evaluated well in advance.
Therefore, all in all, pediatric trials constitute themselves an independent category of clinical trials with its proper regulation and challenges that may enormously benefit from partnering with companies – like Pivotal- well experienced in the activation and conduction of this type of studies.
Other Therapeutic Areas
Most of the therapeutic areas (TA) in which Pivotal has experience have been briefly reviewed in other sections of our webpage. Yet, other TA not explicitly mentioned in which Pivotal may well help you with your clinical research projects’ activation and conduction. These include, but are not limited to, transplantation, respiratory diseases or women health.
If your project does not fit in any of the categories reviewed on this page, do not refrain from contacting Pivotal since we will do our best to help you directly or guide your needs to the best partner.
Non-interventional clinical studies (NIS) are studies in which the medicinal product under investigation is prescribed in the usual manner; that is, in accordance with the terms of the corresponding marketing authorisation. These studies are defined by the methodology used rather than by their scientific objectives. They comprise a number of approaches that include exploring databases, reviewing existing records or the prospective collection of primary data derived from routine clinical practice. Thus, and although medicinal products are used, the study protocol does not dictate the investigators what should be given to their patients. This is left to their clinical judgement and experience.
But these projects are not only particular because of their design but also because of the legal frame regulating approval and conduction thereof. Today, there is no unique common regulation of these trials but somewhat different by country regulations.
When aiming to perform a NIS, selecting a partner who has already faced and walked through all the legal hurdles, these studies bring associated saving time and money. They warrant a successful activation and conduction of the project. With a long-proven experience in NIS, Pivotal may well be a preferred partner for your research when a NIS is being considered.