Doctor comforting his elderly patient

Neuroscience

Neuroscience drugs take, on average, 20% longer to develop and 38% longer to approve as compared to non-CNS drugs, according to the Tufts Center for the Study of Drug Development.1 Our team anticipates the challenges of these studies—from complex protocols to difficulty finding eligible participants to high screen failure rates.

Our neuroscience team bring therapeutic expertise across several indications:

  • Divided into nine specialty areas, we focus on building specific expertise about the pipeline, sites, vendors, advocacy groups and best practices in each indication.
  • We work hard to retain our superior talent. We are proud of our industry-leading turnover rate within our neuroscience team.
ACCELERATE YOUR TIMELINES BY PARTNERING WITH A NEUROSCIENCE TEAM WHO UNDERSTANDS YOUR DISEASE

In the past five years, we have supported:

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Neuroscience trials

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Global patients

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Global sites


John Hamlet, senior director of project management at PPD, brings both extensive expertise in pain and movement disorders and a personal perspective to neuroscience clinical research.

As a person living with MS, John is benefiting from some of the very same medications that PPD helped bring to market.


What excites me the most is the promise of effective disease-modifying therapies for Parkinson’s disease. We are now where MS was 15 to 20 years ago in terms of providing Parkinson’s patients with a lot of hope in an indication that’s growing in prevalence with an aging population.

I have benefited directly from the research PPD has done. Clinical research certainly needs to continue to make progress and lessen the MS disease burden on others, and, I’m hopeful, discover a cure.
John Hamlet
John Hamlet Headshot

Our dedicated neuroscience team has resources, approaches and infrastructure to overcome the specific challenges of neuroscience trials

Our customers can depend on us for the latest trial design innovations, the ability to navigate complex logistics and our keen understanding of customized patient access strategies, even in low-prevalence, widely dispersed patient populations.

Examples of how PPD employs leading strategies to navigate the nuances of neuroscience trials:

  • Leveraging clinical trial simulations to identify potential gaps in the program early on and guide the selection of design parameters, particularly when there are multiple interacting parameters. We’ve used simulations in Alzheimer’s disease studies, for example, to successfully predict study results and reduce the risk of inconclusive studies.
  • Increasing our insights and our pool of potential patients using the Synexus HealthyMinds Registry, one of the largest research initiatives of its kind in the United States. This five-year study, examining the lifestyle and genetic risk factors impacting cognitive function over time. The registry is a collaboration between Accelerated Enrollment Solutions (AES), a PPD business and the University of Exeter in the United Kingdom.
  • Implementing a robust process for placebo response mitigation in pain studies that is proven to produce clearer data outcomes and that distinguishes placebo versus drug response. We have a long track record of delivering studies with significantly lower placebo rates (average 20% versus 35-50% placebo rates).
  • Streamlining integration of multiple systems to minimize data duplication and ease the burden on sites and subjects for data entry. It is not unusual to have upwards of eight to 10 vendors working on a single neuroscience study, traditionally requiring repeated and burdensome data entry across multiple systems. Our rigorous process identifies potential overlap and risk across multiple systems to produce cleaner, more consistent data and allow teams to focus on higher level functions instead of data reconciliation across systems.

The Voice of the Patient

We surveyed Alzheimer’s caregivers to understand the patients motivations for seeking a medical evaluation.  

  • 77% – Desire to stop further memory loss or behavior changes
  • 56% – Family or friends are worried about symptoms
  • 41% – Loved one is worried about symptoms
  • 41% – Desire to help test an Alzheimer’s disease treatment that could help family in the future

One of the resulting ads addressed the fact that Alzheimer’s disease has a strong genetic component, and clinical research is key to advancing the future of dementia treatments for loved ones who may be at risk. As a result, we engaged 132 caregivers, bringing 300 patients to our study for this difficult-to-recruit population.

alzheimer's ad

WENDY BUCKLAND
WENDY BUCKLAND

“Our Neuroscience team is inspired by the prospect of being part of the therapeutic breakthroughs that will occur this decade in debilitating neurological, psychiatric and ophthalmological diseases.”

Our Experiences Spans the Complex and Diverse Landscape of Neuroscience Studies

Neuroinflammatory Disorders

Even though there are now many approved multiple sclerosis (MS) treatments, patients still have significant unmet needs. Within this complex competitive landscape, customers often struggle to position and differentiate their compounds to engage sites and patients. Our MS team members and neurologists not only know how to navigate these trials, but they also understand how to favorably position your compound considering a nuanced understanding of competitive strengths and weaknesses such as side effect profiles and routes of administration.

Within the neuroinflammatory group, we also have experience in a range of rare diseases such as neuromyelitis optica (NMO) and chronic inflammatory demyelinating polyneuropathy (CIDP) where we combine our therapeutic expertise with our rare disease acumen.

Neurodegenerative Disorders

Developing strategies for Alzheimer’s Disease/Dementia studies can be challenging, given their high rates of failure. PPD has supported 28 studies from 14 sponsors across 20 compounds in the past 5 years. We have developed novel approaches including clinical trial simulation to optimize trial design and predict results, accelerated enrollment solutions like the Synexus HealthyMinds Registry to increase the pool of potential study candidates, and digital offerings to reduce patient burden and minimize trial disruption. We offer full development solutions and experienced study teams, including leading industry-leading early phase clinical research units and a global network of quick-start sites all focused on neurodegenerative disorders.

Movement Disorders

Our experts in movement disorders recognize the tremendous advancements and momentum in this therapeutic area, particularly in Parkinsons and related indications. Our global Parkinsons disease experience includes studies conducted in the past five years across various phases in a broad spectrum of populations ranging from early to advanced Parkinsons and including gene mutation populations.

In the past five years, we have conducted 20 full service movement disorder trials, including gene therapy studies.

Pain Disorders

More than half of studies in pain indications fail because the outcomes do not distinguish placebo from active drug responses. We have developed a robust process for placebo response mitigation that helps produce clearer data outcomes by using operational controls, which subsequently help form a better picture of placebo versus drug response.

Our relationships with experienced clinical trial investigators result in quicker study startup. Our use of a variety of clinical technologies – electronic data collection (EDC), electronic case report forms (CRFs) and handheld diaries, interactive voice response (IVR) and interactive Web response (IWR) – allows for rapid retrieval and analysis of data for single country or global studies. We have also developed streamlined processes to allow integration of multiple systems to minimize data duplication and ease the burden on sites and subjects for data entry.

Our experience includes acute pain, chronic pain, neuropathic pain and migraine pain.

Psychiatry & Neurobehavioral Disorders

Psychiatric studies bring a unique set of challenges, including subjective assessments, inter-rater reliability, scale validation and placebo response rates. Over the past five years, we have conducted studies in indications ranging from schizophrenia to anxiety, expertly overseeing global programs of all sizes. We offer our customers access to a strong network of qualified global resources, including our global investigator database of psychiatrists, neurologists, neurological surgeons, and gerontologists.

Ophthalmology

We offer a clinical operations and therapeutic focus on ophthalmology studies with dedicated project teams. Our professionals are experts in facilitating multinational submissions and expeditious agency reviews and have global experience in age-related macular degeneration, conjunctivitis, dry eye, glaucoma, keratitis, lens opacification and intraocular lenses (IOLs), diabetic macular edema, retinal vein occlusion and geographic atrophy.

Rare Diseases

The execution of any rare disease trial requires different skill sets. This is especially true when a rare disease crosses with neuroscience indications. We attack the challenges of these trials head on by embedding specialized and flexible development strategies that includes rigorous assessment of feasibility, robust training and supportive relationships with sites, collaboration with patient advocacy groups, patient concierge services and more.

We have refined our approaches to rare disease research having participated in many that were in neuroscience indications in areas as diverse as Duchenne muscular dystrophy (DMD), Huntington’s disease, retinopathy of prematurity, and more. We assign dedicated therapeutic area leads to oversee rare disease studies so that customers get the best of both worlds – deep therapeutic expertise combined with rare disease experience. We also tap into our Rare Disease and Pediatric Center of Excellence to focus on the design and execution of clinical trials that address the unique strategic, operational, medical and scientific challenges of clinical studies in rare disease and pediatric patient populations.

Neuroscience Expertise

Our neuroscience teams are led by senior scientists and clinicians with extensive drug development experience across nine pillars of research.

CONTACT PPD

Learn more about our Neuroscience capabilities.

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