Life Sciences & Healthcare

Further advantages emerge operationally with a targeted diagnostic approach to inclusion of the appropriately identified patients in a clinical trial of an experimental therapy, due to reduction in the number of patients required to show benefit and shorter timelines for recruitment resulting in significant cost savings.

Regulatory Authorities are a unique component of the drug development industry to ensure an acceptable benefit:risk ratio for new therapies. As opposed to being considered a challenge, Regulatory Authorities are open to collaboration on improving end-points for approval of novel therapeutics for challenging diseases where the ability to demonstrate a meaningful clinical difference in an area of unmet medical need is hampered by inferior measurement tools that are predominantly subjective and exposed to significant variability. This collaboration will be data-driven and can be further supported by the technological advances in mining large datasets with the use of bioinformatics, machine learning and artificial intelligence (AI). This effort will require committed investment and collaboration involving the drug development industry (Pharma and Biotech), academia and clinical care specialists to improve the success rate of bringing meaningful treatments to patients. Although the task may appear daunting initially, it makes economic sense for the industry in the long term. With reimbursement strategies by payers setting high standards across the globe including the pricing adjustments and reimbursement trends taking place in the US, demonstrating value for investment in the healthcare industry is an essential for patients now and in the future.

The additional advances in medical technology (MedTech) including digital wearables, consumer driven medical devices for home care and self-directed diagnosis, discovery platforms for new therapies, efficiency of manufacturing for both large and small molecules, diagnostic tool capability at the molecular and cellular level is driving the industry to new heights and fast. The leadership talent pool across the industry needs to stay abreast of the dynamic interplays and collaborations that are fostering significant innovation in the field.

Additionally, the Healthcare industry needs to remain mindful of its carbon footprint. In building strategies and fleshing out ideas for the future it will be important to take account of environmental, social and corporate governance goals.

The scientifically driven task of developing disease modifying therapy In the areas of neurodegeneration such as Alzheimer´s disease, Parkinson’s disease, Amyotrophic Lateral Sclerosis (ALS), the Leukodystrophies and Huntington’s disease, remains extremely challenging. Although the scientific effort is producing some important breakthroughs in discovery; the pathobiology of these diseases is complex and defining a clinical trial design for testing new drug therapies that can clearly demonstrate clinically meaningful improvement using validated clinical trial endpoints is a significant challenge. This effort requires collaboration with Regulatory Authorities in carving out approval paths that meet the unmet need. Pre-emptive data collection in support of surrogate biomarkers that can predict clinical benefit, if available in time, may alleviate some of the strain on timelines and cost for testing of therapies in, sometimes large, pivotal Phase III trials. For disease areas where there is no established regulatory path, conducting groundwork in validating reliable tools for measurement of meaningful clinical benefit in and gaining an understanding of the heterogeneity of disease course across patient populations, is fundamental to moving the field forward in getting novel therapeutics to patients of high unmet need.

Moderate to severe inflammatory chronic diseases brought about by autoimmune or immune mediated disorders including the arthritides (e.g. rheumatoid, ankylosing spondylitis, psoriatic arthropathy), systemic lupus erythematosus (SLE), psoriasis, multiple sclerosis (MS), inflammatory bowel disease (Crohn’s disease, ulcerative colitis) all require manipulation of the immune system to control the inflammation and modify the disease with the aim of preventing irreversible end-organ damage. There is a fine balance in avoiding intercurrent serious infection while modulating the underlying inflammatory process. A high benefit:risk ratio is the objective for novel therapies that are more targeted in controlling inflammation accompanied by a lower risk for serious infection. Improvements in patient immune profiling at both the cellular and molecular level through further understanding of the disease pathobiology will enable a more personalized approach to therapy. in addition, continued development of clinical trial endpoints in the diseases that require more objective quantifiable clinically relevant measurement tools will support the development of safer and effective therapies in these challenging disease areas where heterogeneity in patient populations is a factor.

The cardiovascular outcome trials (CVOT) conducted in the past decade have been dominated by safety studies for new therapies in the treatment of patients with Type 2 diabetes mellitus (T2DM) and cardiovascular disease (CVD). Encouragingly, the sodium-glucose cotransporter-2 (SGLT2) inhibitors and the long-acting glucagon like peptide-1 receptor agonists (GLP-1 RA) showed cardioprotective benefits in addition to improvements in glucose control. Despite, major advances in the management of risk factors for CVD over the past 3-4 decades with a selection of effective lipid-lowering agents, antihypertensives, glucose lowering drugs in addition to healthy lifestyle modifications, CVD remains the leading cause of death worldwide. There are several confounding factors influencing this observation ranging from non-compliance with, to lack of access to, long term medication and healthy adjustments in lifestyle. The traditional CVOT of previous years are necessarily very large to demonstrate a clinically meaningful benefit over standard of care and therefore, time consuming and expensive to operationalize. Of note, the state of affairs as we currently know it may be tipped with emerging data from the COVID-19 pandemic indicating a concerning increased risk of CV events in the aftermath of infection.

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For the Pharmaceutical and Contract Research Organisation industries, Wirz & Partners know that success in the future relies on present day innovative ideas and strategies.  In order to achieve this, companies need to hire the best people with the talent and skill set to lead on the cutting edge.   Wirz & Partners use innovative and best-practice-management in recruitment in the support of companies meeting their business goals. For any company leaders in this field it is important that they have the networking, influence and negotiation skills required to manage all stakeholder and business interests successfully, even when these interests don’t seem immediately compatible.  A key advantage of Wirz & Partners is our ability to stay ahead of the growth momentum and dynamic change that characterizes this challenging, fast-evolving and competitive field and to understand that potential leaders who have the motivation, talent and skill to achieve great results with the support of their team are in short supply.