For more specific therapeutic area expertise, please contact us.
Neuroscience is one of our primary therapeutic areas of expertise, including several combined years of experience in Parkinson’s disease (PD), epilepsy, anxiety, depression, chronic and neuropathic pain, Alzheimer’s disease, multiple sclerosis, and others. Our team has a thorough knowledge of US and EU requirements for these indications as well as the agencies’ preferences for data displays (e.g. exposure, titration, special safety etc.). MMS has not only completed over 200 CNS projects since 2006, but we have worked extensively on special safety topics within these indications.
Our team has supported the creation of clinical development plans, protocols, sample size calculations based on single endpoints or co-primaries, and data collection for several studies in depression and other related anxiety and bipolar disorders. Our team has significant experience working with this regulatory agency division and has worked with studies investigating novel and adjunct therapies.
MMS recent depression trials include the following protocols:
- A Randomized, 6-Week, Double-Blind, Placebo-Controlled, Fixed-Flexible Dose, Parallel-Group Study of <Compound> for the Treatment of Bipolar I Depression
- <Compound> Adjunctive to Lithium or Valproate for the Treatment of Bipolar I Depression: A Randomized, Double Blind, Placebo-Controlled Study
- A Randomized, 7-Week, Double-Blind, Placebo-Controlled, Quetiapine-Referenced, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of Fixed Doses of <Compound> in Adults with Bipolar Depression
Our team is proficient with various design options including, but not limited to, randomized withdrawal and placebo run-in studies. Yet another recent study in pain done here at MMS used an adaptive trial design which had its own nuances.
In addition, our safety board led by Dr. Ethan Weiner provides excellent safety input for go and no go considerations based on the adverse event (AE) profile at various stages of the development program.
CNS is one of our primary therapeutic areas of expertise. We have over 25 years of experience in epilepsy, anxiety, depression, chronic and neuropathic pain, Parkinson’s disease, Alzheimer’s disease, multiple sclerosis and other indications. Our team has a thorough knowledge of US and EU requirements for these indications as well as the agencies’ preferences for data displays (e.g. exposure, titration, special safety etc.). We have worked extensively on special safety topics within these indications, including but not limited to suicidality, weight gain, nerve conduction velocity, QT prolongation etc. Our support for project teams continues beyond regulatory approval. MMS has supported marketing efforts including numerous CNS publications.
In addition, MMS has led regulatory efforts and supported submissions to PMDA including defining indications specific to the Japanese population (e.g. neuropathy and depression deviants)
Scientific advisors and senior staff at MMS have a long and diverse CNS background. Dr. Edmund Harrigan was the former head of Head of CNS therapeutic area and Regulatory affairs at Pfizer and Dr. Ethan Weiner, led the Celebrex defense while at Pfizer.
Dr. Bob Rappaport former FDA Division Director responsible for the analgesic, anesthetic and addiction drug products is also a member of the MMS Scientific Advisory Board. In 2013, Dr. Rappaport received FDA’s Lifetime Achievement Award for his contributions including accelerating the discovery and development of new drugs with improved efficacy and safety.
MMS Chief Scientific Officer, Dr. Uma Sharma was the Global clinical lead for neuropathic pain and fibromyalgia within the CNS therapeutic area. Ms. Linda LaMoreaux, lead statistician at MMS has worked in the CNS area for more than 25 years and has been responsible for numerous regulatory submissions. She offers critical reviews of SAPs and provides input on trial design. MMS has completed hundreds of CNS projects and more than 20 CNS submissions for new drug approval since our inception in 2006.
Highlights of our experience in CNS indications:
Parkinson’s Disease (PD)
MMS has supported the creation of clinical development plans, protocols, sample size calculations based on single endpoints or co-primaries, and data collection for several studies in PD and other related extrapyramidal disorders. Our team has significant experience working with this division at the FDA and with regulators at EMEA including working with studies investigating the Parkinsonism itself and/or looking at motor disorders associated with the disease. Consequently, the design to achieve success varies depending upon the MOA of the compound. More recently, MMS worked to design and is currently implementing yet another aspect of this disease in a protocol for a sponsor. This study evaluates non-motor elements like depression, cognition and dysautonomia among others. We are proficient in all the scales used for PD (UPDRS, UPDRS Motor Part III, ADL ME (II and III)) and other QOL including CGIC and SF-36 from an implementation in the protocol to scoring perspective.
Our team is knowledgeable with various design options including but not limited to randomized withdrawal and placebo run-in studies. Yet another recent study in pain done here at MMS used an adaptive trial design which had its own nuances.
In addition, our DSMB provides excellent safety input for go no go considerations based on AE profile at various stages of the development program.
Alzheimer’s Disease (AD)
MMS has supported a large number of AD trials as well as regulatory filings within and outside the US. In the area of Alzheimer’s disease (AD), MMS has performed review and or preparation of greater than 10 AD clinical study protocols. MMS has familiarity with AD endpoints, regulatory preferences, and guidance for the conduct of CNS trials. We are experienced at data interpretation and CSR preparation for a number of AD trials including preparation of the most recent approval for regulatory submissions (NDA/MAA). MMS support for AD research also extends to marketing teams and products including preparation of summaries related to efficacy, safety and tolerability for external journal publications in this specific indication.
Multiple Sclerosis (MS)
At MMS, we supported a mid-size pharma with end of Phase 2 meeting involving drafting of briefing book and detailed discussions on end-points, DSMB requirements and long term efficacy measures. We designed the Phase 3 protocol for this sponsor in conjunction with literature search of current trials in the area. The MMS team has extensive knowledge of the disease including pathology, etiology, symptoms, available treatment options, as well as products in development.
We currently support one large pharma with REMS and dedicated safety management and life cycle support for an oral MS drug.
Post Herpetic Neuralgia (PHN) and Diabetic Peripheral Neuropathy (DPN)
MMS has supported a large number of PHN and DPN trials as well as regulatory filings within and outside the US. Senior members of the MMS Holdings team have led the clinical, statistical and programming efforts for the Lyrica submissions worldwide and we continue to act as expert consultants in this arena. Most recently, we have supported a rescue trial in PHN where our biostatistics and clinical programming teams stepped in to provide critical inputs, re-work and final stat and programming outputs allowing this leading CNS sponsor to complete the project without impact to the overall development timeline.
Within the last year our team has also supported other sponsor teams with rescue efforts for two DPN POC studies, stepping in to provide expert review of the study SAPs and correction or refinement of the planned data displays. We have successfully supported this sponsor with completion of the program and continue to support Phase 3 development.
In addition to other pain indications, senior staff at MMS defined and developed Fibromyalgia as an indication with a vast network of rheumatologists. We have supported FMS for over 5 clients and have led the approval for Lyrica in FMS both in the US and globally.
As an organization specializing in neuroscience we have experience in evaluating sleep measures, factors influencing sleep disturbance as well as evaluating the sedative side effects of many centrally acting compounds. We have supported protocol development and data out activities through study reporting for a number of sleep aids. In addition, we have also supported sponsors in their investigation of various sleep disorders including Narcolepsy.
MMS offers deep experience in many areas of the oncology drug development process at all levels of our organization. Our oncology team members and medical personnel have critical first-hand experience with the complex issues often associated with oncology studies. This means highly experienced resources will be assigned to support your trial. We have worked on small molecule kinase inhibitor projects as well as biological agents including monoclonal antibodies. We have experience ranging from standard dose-escalation trials to the rescue of more complex phase III trials. We have experience with reporting of efficacy including response and imaging data, the safety requirements for DSMBs and the statistical challenges related to sample sizes and interim analysis. This therapeutic depth and experience translates into faster start-up times, early identification of problems, and rapid resolution. Our teams have experience drafting documents with the following targets: breast, lung, prostate, pancreatic, skin, leukemias, solid tumors, and sarcomas
MMS leverages over two decades of experience summarizing data collected from Phase 1 – Phase 4 global cardiovascular related trials across a diverse spectrum of indications. The MMS leadership and scientific advisory team, while at Pfizer, successfully led the product defense of the cardiovascular challenges related to Celebrex and can provide strategic support including full clinical plan development upon request. Specific to the data elements of a clinical study within the cardiovascular arena, our programmers and statisticians routinely complete CV datasets and safety summary documents within this therapeutic area. The MMS staff also remains current on the latest guidelines and requirements by participating in annual training from industry experts in this area.
Ultimately, our Medical Writers are scientists and researchers and are able to serve as thinking partners for our clients. Our writers support Phase 1 – 4 protocols, Investigator Brochures, (IBs), CSRs, and other clinical documents across a broad range of therapeutic areas. We understand the important role of a single study report to a sponsor’s full data package. From a submission writing perspective, our expertise allows us to build comprehensive documents that are the buildings blocks of a robust submission.
Our writing staff works alongside other key functional areas such as clinical/medical, statistics and programming, and regulatory affairs. This cross-functional team environment brings extensive industry experience to our medical and regulatory writing functional area, further enhancing the delivery of high quality clinical documents with clear messaging and effective data presentations. Based on the vast experience of our Medical Writers across multiple documents written throughout their extensive careers and a thorough knowledge of US and EU requirements for various indications, MMS writers bring value to your team.
MMS has experience across a variety of Therapeutic Areas including Infectious Disease. In the past five years, we have provided support across our core service areas for more than 50 projects. This includes support for data summarization and/or drug approvals in the following areas: Fungal, Viral and Bacterial infections including Meningococcal & Pneumococcal Diseases, HPV, Hepatitis C, Skin Infections, Urinary Tract Infections, Sepsis, Influenza and Vaccines. We understand the complexities of the data handling, management and analysis plans as well as the importance of a focused clinical review and monitoring of those data points used to determine the evaluable population and those endpoints that will be used to determine approvability.
Beyond our therapeutic areas of expertise, all team members take personal responsibility for the success of the project. MMS team members bring value to your organization and your development programs in the following ways:
- We value teamwork, collaboration, and our Kaizen philosophies emphasis process improvement.
- All team members work with what we term a Sense of Urgency and Leadership (SOUL). The result is on time and project deliverables.
- There is a continual Quality focus that includes ad hoc peer input/review of potential areas of ambiguity ensures accuracy. This is made easier because 95% of our staff are collocated (vs. home-based) and this facilitates spontaneous discussion and problem solving
- Each functional line will operate as a ‘thinking partner’, critically assessing requirements, offering valuable insights based on our prior experience and offering solutions should you encounter a problem
Over-the-Counter (OTC/Non-Prescription) NDAs
Several MMS core team members have gained valuable experience over the past years supporting a wide range of non-prescription NDAs. These have been within the fields of Over-the-counter (OTC) consumer medication, Pharmacy-only medications (POM) as well as Animal healthcare. Additionally, a number of programs supported have involved OTC products applied by means of a medical device, thereby encompassing another additional set of relevant legislation and guidance.
As it is commonplace for older, more established compounds, to become transitioned away from Prescription only (Rx) through to a POM or even OTC status once the patent window has expired and a solid safety profile for the molecule has been demonstrated, a number of our team have had direct exposure in creating ‘Switch’ documentation and associated dossiers for submission to the relevant Regulatory bodies.
Within the field of Consumer Healthcare, Risk Management Profiles (RMPs), Common Technical Documents (eCTDs), Clinical Evaluation Reports (CERs) and various ‘safety landscaping’ documents have also been produced by our team members in recent years, in combination with wider matrix Sponsor teams as well as completely outsourced projects.