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Want to know more about our PRIME & EAMS / PIM experience? Meet us at the 2017 DIA EuroMeeting in Glasgow, 29 – 31 March 2017

Kinesys DIA

With the increasing acknowledgement of the need to develop an overarching scheme to enhance support for sponsors developing medicines, tackling unmet medical needs to ensure timely access to beneficial therapies, the EMA launched the PRIME scheme in March 2016.

This scheme was designed to build upon the existing regulatory framework supporting faster access to new medicines where they are urgently required. PRIME is a voluntary scheme for medicines not authorised in the EU and can aid in the optimisation of the clinical development programme to support an expedited review process. This enables earlier patient access across the EU (early appointment of a Rapporteur, continuous support ahead of an MAA, accelerated MAA assessment, parallel EMA/HTA advice etc.).

In April 2014, two years prior to the introduction of PRIME, the Early Access to Medicines Scheme (EAMS) was launched in the UK. EAMS is a mechanism enabling early patient access in the UK to important medicines targeted for the treatment, diagnosis or prevention of seriously debilitating or life threatening conditions, prior to submitting a full marketing authorisation.

The PIM designation, which represents step I of the EAMS, provides sponsors with an opportunity to interact with regulators and receive validation of a product earlier in clinical development. Importantly, a PIM designation indicates that the UK Regulatory Agency, the MHRA, considers the product to be a promising candidate for entry into stage II of EAMS, where the sponsor has the opportunity to receive advice related to the clinical development programme from the MHRA and NICE / SMC, and the possibility to make the product available to patients in UK.

To discuss this further and learn more about Kinesys Consulting’s considerable experience with PRIME & EAMS / PIM applications, meet us at EuroMeeting 2017.

To schedule a meeting, please contact us at sziouani@kinesysconsulting.com or call our Glasgow office at +44 141 582 1211.

 To Access the DIA EuroMeeting 2017 Program, click: here

Meet us at the DIA 29th Annual EuroMeeting 2017 in Glasgow, 29 – 31 March 2017

Meet Kinesys at the DIA 2017 Euromeeting

 

Join top regulators, clinical, safety, and research professionals in health care and drug development. Discuss the biggest challenges, gain new, invaluable insights, and leave inspired to take action.

The DIA EuroMeeting goal is to bring together key healthcare stakeholder groups, such as industry, regulators, pharmacovigilance, and patient advocates to discuss and share insights. Collaborative sessions and debates focus on practical solutions, as well as, longer term impacts of issues affecting drug development throughout Europe.

In its 29th year, EuroMeeting 2017 will hold more than 50 sessions across 10 themes and host more than 2,000 global health care professionals in the pharmaceutical, biotechnology, and medical device communities.

The annual programme constantly evolves to address the most pressing issues of today and looking into the future. This year’s theme “Translational Health Care: From Bench to Bedside and Back” specifically highlights the critical role patient input plays throughout the life cycle of drug development. Additionally, the clinical content and “HTA, Value & Access” themes are more robust this year in recognising the growing importance in the market.

Take the opportunity to meet our experts at EuroMeeting 2017.

Learn more about Kinesys Consulting’s broad expertise, and about how Kinesys Consulting can help you find answers to both the large and small, but always frustrating and important questions that arise in your regulatory and development strategies.

To schedule a meeting, please contact us at sziouani@kinesysconsulting.com or call our Glasgow office at +44 141 582 1211.

 To Access the DIA EuroMeeting 2017 Program, click: here

Kinesys secures another Promising Innovative Medicine (PIM) Designation from the UK MHRA

Granted PIM Stamp

Kinesys Consulting last month secured another PIM designation, this time for a new oncology product, on behalf of a US partner. The product, successfully designated as a Promising Innovative Medicine (PIM) by the Medicines and Healthcare Products Regulatory Agency (MHRA), is being developed for the treatment of cutaneous T-cell lymphoma (CTCL).

This disease is a severely debilitating and potentially life-threatening condition that represents an unmet medical need. Even at the earliest stages of the disease patients suffer from symptoms that have a major, negative impact on quality of life. Existing therapies are often not used early on due to the inherent toxicities. And this new and Promising Innovative Medicine could offer a major advantage over the current treatment options, especially for early stage CTCL patients.

The product has also been designed as an orphan drug at both EMA (European Medicines Agency) and FDA (Food and Drug Administration). And Kinesys Consulting is now helping its US partner with the 2nd stage of the Early Access to Medicines Scheme (EAMS) that will enable patients in the UK to more quickly obtain access to this treatment that could substantially improve their quality of life and potentially their survival expectation.

In addition, this EAMS process enables manufacturers to receive early feedback and advice regarding the promising product’s benefit-risk profile, as well as collect valuable Real-World Evidence (RWE) to better understand the efficacy and safety and to support the Marketing Authorisation Approval.

For more updates, follow us on Twitter at @KinesysConsult

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