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DLRC wins the Business Growth award in the Hertfordshire Business Awards 2018
What is being done to meet the need for new antibiotics?
Stability testing – finding ways forward to avoid common deficiencies
DLRC supports Academy of Pharmaceutical Sciences (GB) Regulatory Essentials II seminar
BREXIT: the clock is ticking...
Transparency of Clinical Data
New Stars Shining at DLRC
DLRC Directors Kevin Judges and Dianne Lee meet The Queen
DLRC wins Queen's Award for Enterprise: International Trade
DLRC wins Employer of the Year in the 2016 Hertfordshire Business Awards
Dianne Lee wins the TOPRA Inspiration Award 2016
Michelle- 5 years at DLRC
The New Clinical Trial Regulation: What Should We Expect?
Starting at DLRC - Katherine's story - UPDATE June 2016

Transparency of Clinical Data

DLRC wins the Business Growth award in the Hertfordshire Business Awards 2018

At a spectacular evening at Knebworth House last night, DLRC were thrilled to win the Business Growth category in the prestigious Hertfordshire Business Awards.


The award was sponsored by Datum and presented by comedian Dominic Holland to DLRC directors Kevin Judges and Dianne Lee.


This is the third major award won by the company in the last three years, having collected the Herts Business Employer of the Year award in 2016 and a Queen’s Award for Enterprise in 2017. DLRC was well represented at the gala event with twenty of their forty or so staff in attendance.


Managing Director Dianne Lee said, “It has been a fantastic year and this is great recognition for the hard work of our employees and I want to thank them for their dedication to doing an excellent job for all our clients.”


IT & Marketing Manager Chris Absalom expressed his gratitude to the team who had contributed to, and compiled, the award applications and had taken part in the judging meetings. “It’s a pretty robust judging process and we were given quite a grilling. The team did a fantastic job in highlighting the company’s achievements and ethos, and we are ecstatic that it paid off with a win!”


This award comes only a month after one of DLRC’s Principle Consultants won an award in the TOPRA (the regulatory industry’s professional body) awards. Mike McConnell was presented with the Contribution award for his long career in Regulatory Affairs and his tireless enthusiasm and mentoring in the field.


DLRC was also a finalist in the Employer of the Year category of the 2018 Hertfordshire Business Awards for the third year running, having won the award in 2016.

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What is being done to meet the need for new antibiotics?

The development of resistance to antibiotics has been recorded for almost as long as we have known about antibiotics – Amedeo Bondi and Catherine Dietz were writing about penicillinase and its relationship to bacterial resistance as early as 1944. By 1949, the WHO were beginning to worry about the potential emergence of antibiotic resistance in the treatment of venereal diseases. This was further highlighted by a report from the Director General leading to a resolution in 1998 and culminating in the establishment of a Global Plan in 2015.


In Europe, the European Commission first proposed a Community strategy in 2001, which established and encouraged activities under four key areas; Surveillance, Prevention, Research and Product Development and International Cooperation. This was followed by an updated plan in 2011 and a European One Health Action plan in 2017. In each of these, and specifically in the latter, there is a focus on empowering research and the development of new products. In the Action Plan, the Commission undertook to analyse regulatory tools and incentives in the hope of developing new economic models to incentivise new product development.


Since September 2016, the FDA, EMA and PMDA have also been holding regular tripartite meetings on antibiotic product development intended to harmonise requirements and facilitate development. Much of the focus has been on appropriate clinical trial designs and the notes of the second meetingstated that the group would work on updating the guidance documents and reflect the changes in scientific advice.


Since the last tripartite meeting about 2 years ago, the FDA has updated the guidance for complicated and uncomplicated urinary tract infections and for complicated intra-abdominal infections and has published guidance on Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases and issued procedural guidance on Limited Population Pathway for Antibacterial and Antifungal Drugs and on Qualified Infectious Disease Product Designation.The latter is of particular significance, as it offers incentives in terms of five years exclusivity for products designated as qualified products (QIDP). Relevant products are those developed for the treatment of serious or life-threatening infections by resistant organisms or those listed in the regulations as posing a risk to public health. This offers developers an incentive to target limited populations where the need may be greatest. Many of these developmentsare as a result of the 21st Century Cures Act which became US law at the end of 2016 and provides funds to help accelerate medical product development and bring new innovations and advances to patients who need them faster and more efficiently.


Recently, FDA announced the approval of Arikaycea new antimicrobial product for Mycobacterium avium complex lung infections that are unresponsive to conventional therapy. This was the first approval using the limited population pathway which was also designated as QIDP and an orphan product.


In Europe the pace has been slower with the concept paper for a revision of the guidance on the evaluation of medicinal products indicated for the treatment of bacterial infections being published this year which makes reference to the tripartite discussions and the resulting need to update European guidance which dates from 2012. The comment period finished in September and the draft of the new guidance is expected before the end of 2018.


There have been recent academic studies looking at incentives to new antibiotic development on both sides of the Atlantic; in Europe, the London School of Economics has published an international review while in the USA, the Duke-Margolis Center for Health Policyhas looked at specific US policy initiatives. Both these studies outline the case for decoupling funding for antibiotic development from consumption. As expected discussions about providing additional European incentives, which would likely require legislation are lagging behind the USA. The latest progress report on the European Action Plan anticipates that a study on the impact of the Supplementary Protection Certificate (extended as part of PIP rewards) will complete this year and be followed by studies on orphan and paediatric legislation in 2019 with a presentation to the Pharmaceutical Committee. Any new incentives may need to await changes to European Law that result.


DLRC is actively involved in providing support to companies in this important area of research and we’d be happy to enter into a discussion with you about your anti-microbial development program, regulatory strategy and available incentives. Contact us for details.

Stability testing – finding ways forward to avoid common deficiencies

Stability is a critical part of pharmaceutical development, whether this is using a traditional approach or Quality-by-Design. Stability testing ensures that any pharmaceutical remains efficacious, safe and of an acceptable quality throughout its shelf-life. In short, that the product is fit for use by patients and healthcare professionals.


Harmonised international guidance, in the form of the ICH Q1 series, has been published for over 25 years now, and the stability dossier is a critical part of any regulatory submission, whether this is for an initial marketing authorisation, post-approval variation or clinical trial application.


In Methods for Stability Testing of Pharmaceuticals (published by Springer Protocols), our senior consultant, Dr Paul Marshall, explores the common deficiencies that regulators consistently find with sections 3.2.S.7 and 3.2.P.8 of the common technical document, and looks at ways that companies can improve their stability package to facilitate review, reduce the risk of questions and expedite approval.


DLRC Ltd supports Academy of Pharmaceutical Sciences (GB) Regulatory Essentials II seminar

At the APSGB Regulatory Essentials II seminar in Loughborough in May 2018, Dr Paul Marshall, a Senior Consultant at DLRC, presented on API Manufacture and Control, as well as Designing Stability Studies on APIs and Finished Products.


Regulatory starting materials for APIs continues to be a frequent deficiency in dossiers, and can lead to significant delays in approval. Paul discussed the rationale behind selecting and justifying acceptable starting materials, the Q11 guidance, ICH Q11 Q&A, and European guidance on the chemistry of active substances. He also spoke about the impact of starting material selection on GMP, as well as addressing the increasing use of APIX materials (API-excipient mixes).


Stability testing of APIs and finished products is a critical quality aspect of medicinal products, and is a significant part in the development of APIs and medicinal products. Paul talked about stability testing in the various stages of a product’s lifecycle, from initial product development on understanding the inherent stability to the market product, shelf-life and storage conditions, as well as stability data required to support clinical studies in small molecules and biologicals. He also addressed how stability studies should be designed to get to market faster and the differing global regulatory expectations, and looked at ways to improve the acceptability of the stability dossier.


The seminar was popular and attended by representatives from small and large pharma, CROs and regulatory agencies.

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Transparency of Clinical Data

What could come next in Clinical Data Transparency?

Speculations from Mike McConnell, Principal Consultant

Anybody who has had any exposure to medicines approved in the last two years via the European Centralised procedure will know about the European Medicines Agency’s policy regarding the Transparency of Clinical Trial data. The policy (Policy 70), was adopted in October 2014 and data from Marketing Authorisation Applications (submitted in 2015 onwards) started to be published in October 2016. As the Policy makes plain, the publication of the clinical study reports, summaries and the overviews is not the limit of the Agency’s transparency ambitions for clinical data; they anticipate making the individual patient data from studies available, even though these are not routinely submitted in European MAAs.


Given this background, how can they expect to realise their ambition?

One clue, I think, is the expected timeline for the introduction of the Clinical Trial Regulation, which awaits the delivery of a working Portal and Database, expected to be operational later this year. Article 37 of the regulation requires sponsors to submit a summary of the trial results (with a lay summary) within a year of the trial completion and, where the study forms part of a MAA, the full CSR within 30 days of approval. Unlike the provisions of Policy 70, this article applies to any EU marketing authorisation, not just those using the Centralised Procedure. Moreover, the same Article specifies that the Commission will provide guidance on the voluntary sharing of the individual patient data.


Why would sponsors agree to voluntarily share the patient data?

Part of the answer lies, I think, with the policies of the International Committee of Medical Journal Editors (ICMJE). This body adopts recommendations to review best practice and ethical standards in the conduct and reporting of research and other material published in medical journals. They, and others, have been concerned for some time about publication bias; the selective publication of positive trials while trials that did not meet their endpoints are unpublished. Since 2004, they have been requiring that Medical Journals that are members, only accept trials that have been registered prior to patient recruitment in a database that is freely publicly accessible, (while not specifying any database in particular). Their current policy accepts registration in EudraCT (or ClinicalTrials.gov), or indeed in the WHO registry or any of its primary participating registries.


In a December 2017 update to their policy, ICMJE extended the requirement for registration, to insist that manuscripts submitted to member Journals include a statement about the sharing of the data on which the publication is based, including the individual patient data. The same update states that from January 2019, the ICMJE will require that the plan for sharing data be included in the trial registration.


Could this indicate the way forward?

The ClinicalTrials.gov registration database already requires a data-sharing statement in the registration form. In Europe, a similar field could be added to EudraCT or, more likely, the database foreseen by the Clinical Trials Regulation. There are already independent repositories available where the individual patient data can be stored and retrieved including Clinical Study Data request, the NHLBI Biorepository, Project Data Sphere, and YODA. Efforts to harmonise access requirements to these, including the need for an Ethics approval are ongoing. It looks therefore that all the pieces needed to achieve the Agency’s data sharing ambitions are already in place. Those interested will await further developments!

Transparency of Clinical Data

What could come next in Clinical Data Transparency?

Speculations from Mike McConnell, Principal Consultant

Anybody who has had any exposure to medicines approved in the last two years via the European Centralised procedure will know about the European Medicines Agency’s policy regarding the Transparency of Clinical Trial data. The policy (Policy 70), was adopted in October 2014 and data from Marketing Authorisation Applications (submitted in 2015 onwards) started to be published in October 2016. As the Policy makes plain, the publication of the clinical study reports, summaries and the overviews is not the limit of the Agency’s transparency ambitions for clinical data; they anticipate making the individual patient data from studies available, even though these are not routinely submitted in European MAAs.


Given this background, how can they expect to realise their ambition?

One clue, I think, is the expected timeline for the introduction of the Clinical Trial Regulation, which awaits the delivery of a working Portal and Database, expected to be operational later this year. Article 37 of the regulation requires sponsors to submit a summary of the trial results (with a lay summary) within a year of the trial completion and, where the study forms part of a MAA, the full CSR within 30 days of approval. Unlike the provisions of Policy 70, this article applies to any EU marketing authorisation, not just those using the Centralised Procedure. Moreover, the same Article specifies that the Commission will provide guidance on the voluntary sharing of the individual patient data.


Why would sponsors agree to voluntarily share the patient data?

Part of the answer lies, I think, with the policies of the International Committee of Medical Journal Editors (ICMJE). This body adopts recommendations to review best practice and ethical standards in the conduct and reporting of research and other material published in medical journals. They, and others, have been concerned for some time about publication bias; the selective publication of positive trials while trials that did not meet their endpoints are unpublished. Since 2004, they have been requiring that Medical Journals that are members, only accept trials that have been registered prior to patient recruitment in a database that is freely publicly accessible, (while not specifying any database in particular). Their current policy accepts registration in EudraCT (or ClinicalTrials.gov), or indeed in the WHO registry or any of its primary participating registries.


In a December 2017 update to their policy, ICMJE extended the requirement for registration, to insist that manuscripts submitted to member Journals include a statement about the sharing of the data on which the publication is based, including the individual patient data. The same update states that from January 2019, the ICMJE will require that the plan for sharing data be included in the trial registration.


Could this indicate the way forward?

The ClinicalTrials.gov registration database already requires a data-sharing statement in the registration form. In Europe, a similar field could be added to EudraCT or, more likely, the database foreseen by the Clinical Trials Regulation. There are already independent repositories available where the individual patient data can be stored and retrieved including Clinical Study Data request, the NHLBI Biorepository, Project Data Sphere, and YODA. Efforts to harmonise access requirements to these, including the need for an Ethics approval are ongoing. It looks therefore that all the pieces needed to achieve the Agency’s data sharing ambitions are already in place. Those interested will await further developments!

New Stars Shining at DLRC

At DLRC we are very fortunate to have a wealth of talented individuals with a broad range of expertise and now over 450 years of collective regulatory experience working for pharma companies and consultancies. In 2017 we were joined by two ex-assessors from the MHRA who have brought additional expertise to our team having seen things from the regulators perspective.


Michelle Beharry joined us in August last year straight from the Agency where she was a senior nonclinical assessor for 10 years. Michelle has a wide variety of experience including being an expert adviser to the CHMP, providing input into ICH and OECD guideline changes globally and presenting papers to the CHM, CHMP and EAG for first in man studies, centralised and decentralised novel compounds. Michelle has expertise in assessing nonclinical aspects of CTAs and MAAs and providing nonclinical strategic expertise for Sponsors seeking scientific advice. She also provided regulatory advice on new technologies and assays such as biomarker development, and on environmental risk assessment.


In October Paul Marshall joined us after a 2-year spell outside the Agency in consulting. He was a senior quality assessor at MHRA for 11 years during which time he assessed quality and bioequivalence aspects of MAAs and variations submitted via centralised, DCP/MRP and national procedures covering all dosage forms and submission routes. He provided regulatory and strategic advice on product development plans for MHRA advice and SAWP meetings, presented papers to CHMP, CHM and CPSEAG. He also participated in GMP inspections and represented licensing division on the Inspection Action Group (IAG), was the chair of the joint CHMP/CVMP/CMDh/CMDv working group on ASMF procedures, a member of the technical advisory board and UK nominated expert for the EDQM (CEP) certification scheme and the UK nominated expert to the EMA for CNS therapy area. Paul is also an expert on electronic cigarettes and nicotine containing products, as well as drug-device combinations.


We are all benefitting from Paul and Michelle’s expertise as they support our clients and bring a new dimension to our offering as a specialist regulatory consultancy group.

DLRC Directors Kevin Judges and Dianne Lee meet The Queen

Following on from winning a Queen’s Award for Enterprise, Dianne and Kevin were invited to a reception at Buckingham Palace. There they had the opportunity to meet with Her Majesty The Queen, and enjoyed a brief conversation.


Dianne said that she was very impressed by The Queen. “She’s an amazing person. Having already attended two engagements during the day, she then met a couple of hundred business leaders and was able to engage on many levels, and seemed interested in everything we do.”


The evening reception was hosted by Her Majesty and was attended by other members of the Royal Family: The Duke of Edinburgh, The Duke and Countess of Wessex, The Princess Royal, and The Duke of Kent. It was held in the opulent state rooms of the palace with views over the beautiful gardens. Kevin and Dianne were greeted with champagne and canapés, and mingled with other Queen's Awards winners before meeting members of the Royal Family.


Later in the year the Lord Lieutenant of Hertfordshire is due to present the Queen’s Award crystal bowl to the company, and representatives of DLRC will be attending a celebratory dinner hosted by the Institute of Export and Overseas Trade at the Royal Horseguards Hotel in London.

DLRC wins Queen's Award for Enterprise: International Trade

DLRC is proud to announce that it has been named the winner of a 2017 Queen’s Award for Enterprise, in recognition of its exceptional international business.


A Queen’s Award for Enterprise is the highest honour that can be bestowed on a UK company. The winning organisations are recommended for the awards by the Prime Minister and are then approved by Her Majesty The Queen. Each year, the announcement of the winners is made on 21st April, the Queen’s birthday. DLRC was chosen for an award in International Trade in recognition of its substantial year-on-year growth in overseas sales over a six-year period. In addition, the company demonstrated the vision and strategies which it has employed in order to achieve this success.


“Winning the Queen’s Award is a tremendous accolade for DLRC and we are extremely proud to receive it,” said Kevin Judges, Director and joint business owner. “Over the six-year period that formed the basis for this award, our turnover increased four-fold and our overseas sales by a factor of six. Everyone in the organisation has worked so hard to achieve this level of business expansion and it’s great that their efforts are now being recognised with this prestigious honour.”


The 2017 Queen’s Awards for Enterprise are being given for the highest levels of excellence demonstrated in each of four categories; International Trade, Innovation, Sustainable Development and Promoting Opportunity (through social mobility). DLRC’s award for International Trade reflects the continuous expansion of its work with companies overseas and with government regulatory bodies here and abroad.


As a Queen’s Award winner, DLRC will receive an invitation to attend a reception at Buckingham Palace with H.M. The Queen later in the year. It will also be presented with a commemorative crystal bowl by the Queen’s representative, the Lord Lieutenant of Hertfordshire, in a separate ceremony, and will be permitted to use the Queen’s Award Emblem for five years as a symbol of the company’s success.


Dianne Lee, DLRC Founder and Director, is thoroughly delighted with the announcement. She said, “We are immensely proud that we play a part in the development of important medicines for patients. This award acknowledges the dedication and performance of our highly skilled team, and reinforces my belief that employing great people is step-one on the way to business success.”


Last year DLRC was awarded the Employer of the Year by the Hertfordshire Business Awards, and Dianne Lee also received the 2016 Inspiration Award from TOPRA, the regulatory affairs professional body.


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DLRC wins Queen's Award for Enterprise: International Trade

DLRC is proud to announce that it has been named the winner of a 2017 Queen’s Award for Enterprise, in recognition of its exceptional international business.


A Queen’s Award for Enterprise is the highest honour that can be bestowed on a UK company. The winning organisations are recommended for the awards by the Prime Minister and are then approved by Her Majesty The Queen. Each year, the announcement of the winners is made on 21st April, the Queen’s birthday. DLRC was chosen for an award in International Trade in recognition of its substantial year-on-year growth in overseas sales over a six-year period. In addition, the company demonstrated the vision and strategies which it has employed in order to achieve this success.


“Winning the Queen’s Award is a tremendous accolade for DLRC and we are extremely proud to receive it,” said Kevin Judges, Director and joint business owner. “Over the six-year period that formed the basis for this award, our turnover increased four-fold and our overseas sales by a factor of six. Everyone in the organisation has worked so hard to achieve this level of business expansion and it’s great that their efforts are now being recognised with this prestigious honour.”


The 2017 Queen’s Awards for Enterprise are being given for the highest levels of excellence demonstrated in each of four categories; International Trade, Innovation, Sustainable Development and Promoting Opportunity (through social mobility). DLRC’s award for International Trade reflects the continuous expansion of its work with companies overseas and with government regulatory bodies here and abroad.


As a Queen’s Award winner, DLRC will receive an invitation to attend a reception at Buckingham Palace with H.M. The Queen later in the year. It will also be presented with a commemorative crystal bowl by the Queen’s representative, the Lord Lieutenant of Hertfordshire, in a separate ceremony, and will be permitted to use the Queen’s Award Emblem for five years as a symbol of the company’s success.


Dianne Lee, DLRC Founder and Director, is thoroughly delighted with the announcement. She said, “We are immensely proud that we play a part in the development of important medicines for patients. This award acknowledges the dedication and performance of our highly skilled team, and reinforces my belief that employing great people is step-one on the way to business success.”


Last year DLRC was awarded the Employer of the Year by the Hertfordshire Business Awards, and Dianne Lee also received the 2016 Inspiration Award from TOPRA, the regulatory affairs professional body.


website_QA_banner_copy.gif

DLRC wins Queen's Award for Enterprise: International Trade

DLRC is proud to announce that it has been named the winner of a 2017 Queen’s Award for Enterprise, in recognition of its exceptional international business.


A Queen’s Award for Enterprise is the highest honour that can be bestowed on a UK company. The winning organisations are recommended for the awards by the Prime Minister and are then approved by Her Majesty The Queen. Each year, the announcement of the winners is made on 21st April, the Queen’s birthday. DLRC was chosen for an award in International Trade in recognition of its substantial year-on-year growth in overseas sales over a six-year period. In addition, the company demonstrated the vision and strategies which it has employed in order to achieve this success.


“Winning the Queen’s Award is a tremendous accolade for DLRC and we are extremely proud to receive it,” said Kevin Judges, Director and joint business owner. “Over the six-year period that formed the basis for this award, our turnover increased four-fold and our overseas sales by a factor of six. Everyone in the organisation has worked so hard to achieve this level of business expansion and it’s great that their efforts are now being recognised with this prestigious honour.”


The 2017 Queen’s Awards for Enterprise are being given for the highest levels of excellence demonstrated in each of four categories; International Trade, Innovation, Sustainable Development and Promoting Opportunity (through social mobility). DLRC’s award for International Trade reflects the continuous expansion of its work with companies overseas and with government regulatory bodies here and abroad.


As a Queen’s Award winner, DLRC will receive an invitation to attend a reception at Buckingham Palace with H.M. The Queen later in the year. It will also be presented with a commemorative crystal bowl by the Queen’s representative, the Lord Lieutenant of Hertfordshire, in a separate ceremony, and will be permitted to use the Queen’s Award Emblem for five years as a symbol of the company’s success.


Dianne Lee, DLRC Founder and Director, is thoroughly delighted with the announcement. She said, “We are immensely proud that we play a part in the development of important medicines for patients. This award acknowledges the dedication and performance of our highly skilled team, and reinforces my belief that employing great people is step-one on the way to business success.”


Last year DLRC was awarded the Employer of the Year by the Hertfordshire Business Awards, and Dianne Lee also received the 2016 Inspiration Award from TOPRA, the regulatory affairs professional body.


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DLRC wins Employer of the Year in the 2016 Hertfordshire Business Awards

DLRC is extremely proud to have been crowned the 2016 Hertfordshire Business Awards Employer of the Year.


The award was announced and presented at a prestigious ceremony at Knebworth House in Hertfordshire on Thursday 24th November, attended by a contingent from the DLRC team and over 400 local business people.


The judges were impressed with the flexible working arrangements offered to staff, the commitment to supporting professional development and the social aspects of the work environment. They also praised the way the company works to ensure clients get the best service by matching the right people to projects in terms of experience.


DLRC founder Dianne Lee was particularly pleased to receive the award. It was, she said, a great endorsement of the aims and achievements of the company in providing the best possible employment for regulatory professionals.


She was also keen to point out that the awards success was down to DLRC staff. “We're delighted to win this award because our approach to running DLRC is only made possible by the dedication and hard work of our employees. Many of them have family commitments and their valuable input into the development of new medicines would be lost if they couldn't have flexible working arrangements.”


Dianne went on to explain that in a complex and ever-evolving industry, it was crucial that the team kept up-to-date with changes in legislation and best practice. The company’s commitment to training and knowledge sharing was essential to provide the quality of support that clients expected, and this had been recognised by the judging panel, she said.


DLRC Director Kevin Judges was also thrilled to receive the award, and commented, “It’s fantastic to get this recognition as an employer and it’s also a great reflection on the commitment and hard work of the entire DLRC team”.


This is the second award that DLRC has won recently – Dianne also achieved individual recognition when she was presented with TOPRA’s 2016 Inspiration Award. However, she is delighted that the latest accolade reflects the efforts of the whole company. As Dianne notes, the company is working hard to create a good working environment and fantastic career opportunities, but ultimately it is DLRC’s employees who make it such a great place to work.


If you are a regulatory professional who’s interested in a great place to work, contact us here.


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Photographs courtesy Archant Limited - photographer Casey Gutteridge

Dianne Lee wins the TOPRA Inspiration Award 2016

We are extremely proud to announce that our founder and director, Dianne Lee, has won the Inspiration award in TOPRA’s Awards for Regulatory Excellence 2016.


The Inspiration Award is aimed at a person who inspires the intellect, or prompts action or innovative outcomes. It recognises exceptional contributions by an individual in inspiring fellow regulatory professionals in the development of their regulatory career, or as an inspirational team leader in a regulatory activity or project.


Dianne was nominated for the award in secret by a group comprising her work colleagues, regulatory professionals from other companies and other people who have been inspired by Dianne or who have witnessed her effect on those around her.


The nominating group was unanimous in their praise for Dianne’s approach to regulatory affairs. Their nomination stated: “An inspirational and motivational leader, Dianne has a business philosophy that encourages achievement, embraces flexible working and apportions care and attention to colleagues and business in equal measure. Dianne has created a highly successful organisation which has allowed and encouraged regulatory professionals to work in an individualised way, adapting the traditional working week to suit people with family and other external commitments.”


The prestigious annual TOPRA Awards attract a lot of nominations, and the judging committee first decides on a shortlist before eventually selecting a winner from each category. In September, Dianne was extremely surprised to be told she had been shortlisted when she had no idea she had been nominated in the first place. She then had to wait until the awards ceremony in November for the final result.


Making the award, the TOPRA judges said: “Dianne is an inspiration as a Regulatory Professional with her extensive knowledge and decades of experience across the whole product lifecycle. During the last 10 years, she has set up and continues to lead a successful and growing business; one which nurtures new graduates and veterans alike. Under Dianne’s direction the company has offered paid internships, employed students for work experience and has recruited, trained and provided ongoing mentoring for several new graduates.”


Dianne received the award at TOPRA’s gala awards evening on 2nd November 2016 at the Grand Connaught Rooms in London. Details about the awards can be found here.


If you are interested in the services that DLRC can provide, or would like to find out about the careers that we can offer, please get in touch.

Dianne Lee wins the TOPRA Inspiration Award 2016

Michelle- 5 years at DLRC

I joined DLRC in 2011 as a recent graduate with a BSc (Hons) in Biomedical Sciences. I love science but didn’t like working in the laboratory environment. So when I saw the position at DLRC advertised, even though I had no idea what regulatory affairs was, I applied. After a successful telephone interview, I had to attend for face to face interview and give a presentation on why I wanted to work within regulatory affairs. It was only once I properly started looking into regulatory affairs during the interview process that I realised what a perfect job it would be for me. I would get to work in a collaborative office environment and apply my scientific knowledge as well as project skills. I then realised how hard it was to get a job within the profession and wanted the role even more! Luckily my interview was successful and I was offered the position of Regulatory Executive.


In my 5 years of working at DLRC, I have seen the company grow a huge amount. There were only 5 regulatory employees when I started, including me. Since then we’ve moved offices twice and now employ around 20 regulatory staff. It’s been great to see the company expand with the appointment of both experienced staff and also newer graduates who are starting out in their careers. Everyone gets on well and we are all willing to help each other out with our different areas of expertise. We also have regular sharing information sessions and we have recently appointed 4 team leaders which all helps with personal development. To aid both current and new clients, we have also implemented a, “Strategic Expertise and Operational Excellence” initiative. This allows us to ensure that we continue to develop our expertise regarding regulatory strategy and operational excellence as well as ensuring that our practises and knowledge evolve and reflect current requirements and guidance.


On a personal level, my personal development has grown a huge amount with the knowledge that I’ve learnt so far. Since joining DLRC, I have worked on a large compliance project and various post marketing projects. More recently I have been working mainly within clinical development including the submission and approval of a Paediatric Investigational Plan (PIP) and multiple early and late phase clinical trial applications (CTAs). All of this experience has allowed me to see the great many aspects that Regulatory Affairs covers. I like that working for a consultancy allows me to work on very different projects for a wide range of clients while still being able to specialise in areas that I find interesting. I have been promoted twice and am now a Regulatory Project Manager. This means that I have progressed from supporting other people in a primarily operational role, to having more strategic input and managing my own projects.


As well as enjoying my current role, I have always had an interest in progressing myself academically. After working at DLRC for just over 2 years, I was given the opportunity by the company to start an MSc in Regulatory Affairs which is run by The Organisation for Professionals in Regulatory Affairs (TOPRA) and validated by the University of Hertfordshire. I was very appreciative of this sponsorship as the course is costly and requires 3 days out of the office in order to attend each module; 8 modules in total. I have now finished all 8 modules with a distinction and am planning on starting my dissertation on the Clinical Trial Regulation shortly. I have already gained a huge amount of knowledge from the MSc and have been able to apply this knowledge directly into my work. Equally, I have also been able to apply my day job into my coursework, and so the MSc has been very complimentary for my career. DLRC has really helped me achieve a lot so far within my MSc and I am excited to continue applying what I have learnt on a daily basis. I am looking forward to what the next 5 years at DLRC will bring!


If you too are interested in a career that offers varied opportunities and flexible working options, call 01462 372 472 or go to Join Us and send in a CV.

Michelle- 5 years at DLRC

I joined DLRC in 2011 as a recent graduate with a BSc (Hons) in Biomedical Sciences. I love science but didn’t like working in the laboratory environment. So when I saw the position at DLRC advertised, even though I had no idea what regulatory affairs was, I applied. After a successful telephone interview, I had to attend for face to face interview and give a presentation on why I wanted to work within regulatory affairs. It was only once I properly started looking into regulatory affairs during the interview process that I realised what a perfect job it would be for me. I would get to work in a collaborative office environment and apply my scientific knowledge as well as project skills. I then realised how hard it was to get a job within the profession and wanted the role even more! Luckily my interview was successful and I was offered the position of Regulatory Executive.


In my 5 years of working at DLRC, I have seen the company grow a huge amount. There were only 5 regulatory employees when I started, including me. Since then we’ve moved offices twice and now employ around 20 regulatory staff. It’s been great to see the company expand with the appointment of both experienced staff and also newer graduates who are starting out in their careers. Everyone gets on well and we are all willing to help each other out with our different areas of expertise. We also have regular sharing information sessions and we have recently appointed 4 team leaders which all helps with personal development. To aid both current and new clients, we have also implemented a, “Strategic Expertise and Operational Excellence” initiative. This allows us to ensure that we continue to develop our expertise regarding regulatory strategy and operational excellence as well as ensuring that our practises and knowledge evolve and reflect current requirements and guidance.


On a personal level, my personal development has grown a huge amount with the knowledge that I’ve learnt so far. Since joining DLRC, I have worked on a large compliance project and various post marketing projects. More recently I have been working mainly within clinical development including the submission and approval of a Paediatric Investigational Plan (PIP) and multiple early and late phase clinical trial applications (CTAs). All of this experience has allowed me to see the great many aspects that Regulatory Affairs covers. I like that working for a consultancy allows me to work on very different projects for a wide range of clients while still being able to specialise in areas that I find interesting. I have been promoted twice and am now a Regulatory Project Manager. This means that I have progressed from supporting other people in a primarily operational role, to having more strategic input and managing my own projects.


As well as enjoying my current role, I have always had an interest in progressing myself academically. After working at DLRC for just over 2 years, I was given the opportunity by the company to start an MSc in Regulatory Affairs which is run by The Organisation for Professionals in Regulatory Affairs (TOPRA) and validated by the University of Hertfordshire. I was very appreciative of this sponsorship as the course is costly and requires 3 days out of the office in order to attend each module; 8 modules in total. I have now finished all 8 modules with a distinction and am planning on starting my dissertation on the Clinical Trial Regulation shortly. I have already gained a huge amount of knowledge from the MSc and have been able to apply this knowledge directly into my work. Equally, I have also been able to apply my day job into my coursework, and so the MSc has been very complimentary for my career. DLRC has really helped me achieve a lot so far within my MSc and I am excited to continue applying what I have learnt on a daily basis. I am looking forward to what the next 5 years at DLRC will bring!


If you too are interested in a career that offers varied opportunities and flexible working options, call 01462 372 472 or go to Join Us and send in a CV.

BREXIT – How will this affect registration procedures and the approval of new medicines in the UK and in the EU?

The clock is ticking. . . .

The story so far

On 29th March 2017 the UK government triggered the process of leaving the EU under Article 50 of the Lisbon Treaty.


On 19th March 2018, the UK and EU agreed draft terms (1) for a Brexit transition period from 30th March 2019 to 31st December 2020 that could help with the orderly withdrawal of the UK. However, currently, this transition agreement has not been legally ratified by either the UK or the EU and therefore is subject to change or might not be agreed at all. Furthermore, the transition period does not cover significant parts of the medicines legislation and therefore the advice from the European Medicines Agency/Heads of Medicines Agency and Pharmaceutical Industry associations is for manufactures and developers of medicinal products with a UK presence to ensure that they are ‘Brexit ready’ by 11pm GMT on 29 March 2019 when the UK will cease its EU membership and will become a so-called ‘3rd country’.


Currently, the UK has two mechanisms for the study and authorisation of medicines. The first is standalone, whereby the UK Regulatory Agency (MHRA) can approve the use of medicines within the UK both in a clinical trial setting and as an authorised product. This independent review and approval mechanism is unlikely to change as a result of Brexit. However, more commonly, and possibly more advantageously, many medicines are assessed and regulated in collaboration with other EU Member States. In some instances, this results in a medicine granted approval which is valid throughout the EU (a Centrally Approved Product/CAP). Other products take advantage of either a co-ordinated review phase (Decentralised Procedure/DCP) or one which relies on the prior review of another Member State (Mutual Recognition Procedure/MRP), both of which ultimately ends with a national approval.


To be part of the EU network, the UK and all other Member States rely on their status as part of the EEA.Furthermore, it is enshrined in EU pharmaceutical legislation that the same standards of medicines control apply across the EU network and that there should be no barrier to free movement of goods: goods accepted for one EU country are accepted for all.


For the UK, a 3rd country as of 30 March 2019, it will no longer be possible to take advantage of any pan-EU approval system or the ease of access across the EU. Likewise, companies based in the UK will no longer be able to be the MAH, sponsor EU clinical trials or fulfil functions such as import, QC testing and release, and pharmacovigilance activities. In addition, the assessments of the UKs regulatory bodies will no longer be recognised across the EU pharmaceutical network.

Transition Agreement?

While still draft, the transition agreement is clear that the UKs involvement with EU Institutions and EU bodies (i.e. EMA, HMA), will cease as of 29th March 2019, as will the UKs participation in Member State meetings (with exceptions) and there will be no UK role as a leading authority (1). This has extensive implications for manufacturers and developers of medicinal products where the UK is involved as MAH, RMS or site of the Qualified Person for Pharmacovigilance (QPPV) and the Pharmacovigilance System Master File (PSMF).


With regards to the manufacture/importer testing and/or QP release of (investigational) medicinal products, the transition agreement seems less clear and remains the topic of legal debate. One current legal interpretation is that for the duration of the transition agreement, medicinal products can continue to be manufactured, released and supplied in line with the existing regulatory framework. However, there is no confirmation that this view is held by Competent Authorities throughout Europe and we await final ratification of the transition period and legal interpretation of this clause.

Preparation for Brexit

A number of documents have been released by the EMA and HMA on the topic of Brexit. The most recent guidance published in January 2018 covers practical guidance for procedures related to Brexit including guidance regarding classification of variations, requirements for supporting documentation and grouping variations as well as many other items (2). An updated Q&A document giving organisations further guidance related to Brexit submissions, specifically covering situations where the UK is part of the MA registration in various aspects such as API, batch release, QPPV, MAH and so on was also released early this year (3). It is foreseen that both documents will be regularly reviewed and updated.


Other considerations covered in the documents are around generic/hybrid applications where the MA will be granted after 29 March 2019 and orphan designation applications submitted after 29 March 2019 where patients in the UK should no longer be considered in the calculation of the prevalence of the disease in order to meet the requirements for orphan drug designation as set out in Regulation (EC) No 141/2000 (3).

MHRA Brexit implications

The MHRA recently published a statement (4) confirming that they are in support of regulatory alignment with the EU following the withdrawal of the UK from the EU in March 2019. Furthermore, they have confirmed that, despite the lack of any transitional arrangement, all current EU legislation pertaining to medicinal products will convert from the existing EU legislative framework into UK law meaning there would be no sudden changes to the UK regulatory framework. Existing Marketing Authorisations granted via MRP/DCP will remain valid in the UK and those authorised at EMA level, via CAP, will be recognised in the UK, although the mechanism (including data requirements and timelines) is unclear. However, over and above these reassuring statements it is unclear what changes might take place within the Agency post Brexit.


Most pressing is the role of the MHRA as (co)-rapporteur, PRAC rapporteur (for products registered as CAPs) and as RMS (for products registered via DCP/MRP) where changes from the MHRA to an alternative member state for these various positions must be made prior to the 29 March 2019. Under current guidance these changes can only be made once all ongoing procedures are completed which means that as companies get Brexit ready the number of procedures and renewals submitted to the MHRA is likely to increase significantly. Furthermore, for products where the UK is the RMS they will be required to prepare an assessment report prior to migration. The MHRA will be hard-pressed to do this for every MRP/DCP it leads, so an interim process is required, although currently not foreseen in the transition arrangement.


It is also clear that where activities which are currently required to be performed by an EU MS (such as MA Holder, QP testing and release) are currently performed by a UK registered organisation, post Brexit (where product is for use in the EU) companies will be required to transfer activities from the UK to the EU to supply the EU markets and transfer from the EU into the UK to supply the UK market, meaning yet more work for MAHs and the MHRA.

Clinical trials

In a similar requirement to that of MAAs, clinical trials including European sites with UK involvement, either as a UK sponsor or where the manufacture and supply of clinical trial material is from the UK, will need to be amended to ensure continuity after 30 March 2019. There are currently 1,500 registered clinical trials including multiple EU member states with a UK sponsor (lead), of which fifty per cent will be ongoing as of March 2019 (5). Clinical trial sponsors will need to act to ensure these trials can continue after 30 March 2019.


In addition, as the EU plan to move from conducting clinical trials under the requirements of the current Clinical Trials Directive No, 2000/20 to Clinical Trials Regulation No. 536/2014, it has become clear that there will be a requirement to transpose this text into UK law when it is implemented in the second half of 2019. While the UK Government has committed to bringing the EU CT Regulation into UK law, it is obvious that there are certain parts of the procedure from which the UK will be excluded, i.e. Portal and Database and the single assessment model.

Summary

According to current arrangements, the UK will become a 3rd country and no longer part of the EU as of 11pm GMT on 29th March 2019. The full impact of Brexit will not be understood until a detailed exit strategy is agreed at the highest political level and even then, the full ramifications may not be realised until after Brexit takes place. The message that is being sent from the EU Institutions and bodies is that manufacturers and clinical trial sponsors must start to plan for all Brexit related activities now to allow for as smooth a transition as possible. The clock is ticking!!

Help from DLRC Ltd

As there is no precedent for a Member State leaving the EU, it is not possible to predict with accuracy what the outcome of Brexit will be. DLRC Ltd is actively monitoring the developments and encourages you to consider the possible consequences for your products now. DLRC’s highly experienced team is available to answer any questions you may have and to help you with your Brexit related regulatory projects and plans to ensure that the UKs move away from the EU is as seamless as possible for you.


DLRC has established a company in Ireland to ensure we will be able to continue to offer full EU regulatory services post-Brexit.


Please contact us if you would like to find out more about DLRC's services.

clock_-_ticking.jpg

Further reading:

1. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/691366/20180319_DRAFT_WITHDRAWAL_AGREEMENT.pdf


2.

(http://www.ema.europa.eu/docs/en_GB/document_library/Other/2017/05/WC500228739.pdf) and

http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/BREXIT/CMDh_373_2018_Rev0_2018_04.pdf


3.

http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2017/11/WC500239369.pdf and

http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/BREXIT/CMDh_361_2017_clean.pdf


4. https://www.gov.uk/government/news/medicines-and-healthcare-products-regulatory-agency-statement-on-the-outcome-of-the-eu-referendum


5.

BRIEFING PAPER Number 8148, 20 November 2017 Brexit and medicines regulation


Starting at DLRC - Katherine's story


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A few weeks ago, Katherine, a new starter at DLRC, wrote about her experiences since joining the company. Now MD Dianne Lee reports on Katherine’s technical progress in her role and the kind of training and project work she has experienced in the last few months.

"In the short time that Katherine has been at DLRC she has become proficient in publishing, one of the first tasks in which she was involved, getting some excellent hands-on training from our eCTD publishing guru, Tim. She completed the TOPRA basics course online in her second week and has recently attended the TOPRA Cred course in variations. As part of her training, we’ve assigned Katherine to a range of projects, including assisting Michelle (Reg Proj Mngr) with clinical trials activities and supporting Laura (Snr Reg Exec), Carl (Reg Proj Mngr) and Kevin (Director) with transfer of ownership and variations submissions. Katherine was also part of a DLRC team that pitched for a significant project with an existing client as she came to us with already excellent presentation skills and featured in the proposal. We look forward to watching her develop in the same way we have seen excellent progress of our other colleagues that joined as new graduates." Dianne Lee, MD.



Katherine_Edwards.JPG


As the newest member of DLRC I wanted to share my experiences of joining the company.

I started at DLRC in February 2016 with no previous experience in regulatory affairs and little idea of what to expect. I have a degree from Nottingham University in Animal Science and for the last 6 years I had worked as a zoo keeper, so this was a huge career change for me in many respects.

Starting in February I was immediately grateful for being inside in the warm and dry. For me this job was very much a coming home in both the sense of returning to my biological roots from university and a return to the county I grew up in.


I am fortunate that DLRC don’t just look at experience, but also select their graduates on the type of people they want to have in the office. Luckily my brand of cheerful optimism fell into the right category and after a series of interviews I was offered a position.


On my first day I was familiarised with the computer system, taught how to create hyperlinks and set off on my first task. I started at a busy time for DLRC and was able to aid with projects and feel productive very quickly. There is a wealth of knowledge within the office, so if I am ever unsure there is always someone who is willing and able to help me. As DLRC has previously taken on new graduates, I am surrounded by people who understand my situation, and they have all been very patient and understanding with me as I learn the ropes. Within my first week I had completed the TOPRA ‘Online Basics of European Regulatory Affairs’ course and was beginning to get involved in a wide variety projects.


Flexible hours were a new concept to me, having worked to a strict timetable previously. It allows employees to start and finish at times that suit them, as long as they are still completing their required weekly hours. There is also an option to work from home, provided your current projects are of a nature that allows for it. This amount of flexibility in the work hours means I can fit my job around my lifestyle, even when my routine changes.


DLRC is a small to medium sized company which provides for a varied workload and opportunities to obtain experience in many different areas of regulatory affairs. There is also the opportunity to be involved in the development of business processes and procedures. I am currently participating in the development of the on-boarding procedures for new members of staff, since I have the most recent experience.

With the aid of multiple abbreviation guides, a lot of support and frequent checking of the EMA website, I am slowly getting to grips with the role of a Regulatory Executive. It is early days but I am thoroughly enjoying working at DLRC. The wide range of work makes DLRC a good place to discover the many areas of Regulatory Affairs within the pharmaceutical industry.


If you too are interested in a career that offers varied opportunities and flexible working options then call 01462 372 472 or go to Join Us and send in a CV.

Launch of PRIME and EMA review

UPDATE 2nd June 2016: We are very pleased to announce that a PRIME eligibility application, submitted on behalf of one of our clients as part of the first batch of applications, is one of only 4 which have been successful. All other 14 applications submitted were unsuccessful. We are excited to see how the scheme will impact the accelerated assessment of the Marketing Authorisation Application and we keenly await the proactive support of the EMA.


We have also recently submitted a second PRIME eligibility application for a different client, to meet the third submission date of the PRIME scheme and look forward to hearing the outcome of this submission in July 2016.



From News - April 2016

On the 7th March 2016, EMA formally launched their much anticipated PRIME scheme. DLRC have already submitted an application on behalf of a client for the eligibility to the PRIME scheme - our application was completed in time for the first submission deadline of this exciting new scheme.


To ensure we were up to the minute on the PRIME scheme and other EMA activities, a number of DLRC staff attended a Review of 2015 at the EMA offices in London. Below we provide a summary of the sessions that focused on PRIME and other ways of optimising regulatory strategy by using accelerated regulatory pathways:


Jordi Llinares from EMA gave a presentation which provided a summary of the PRIME initiative. This initiative aims to enable accelerated assessment for products with a high unmet medical need in the EU. PRIME will use the existing EU regulatory framework and will encourage prospective planning, earlier interactions with stakeholders and the generation of robust data.


Eligibility for the PRIME scheme must be based on data that demonstrate a potential major public health interest. Entry to the scheme for SMEs could be as early in development as proof of principle during the non-clinical stage. For larger companies, entry to the scheme is envisaged at proof of concept or prior to phase III studies. The rationale for the different entry points is that one key aim of PRIME is to help SMEs in the very early stages of product development, where products may be lost due to lack of funding or lack of understanding of the development process and requirements.


Key benefits of the PRIME scheme were explained and included: early identification of eligibility and stakeholder involvement, rapporteur appointment at proof of concept stage, kick-off meeting with the rapporteur and relevant committees, scientific advice at key development milestones, collaboration with national incentive schemes and fee incentives for SMEs on Scientific Advice requests.


The PRIME scheme was greeted with much enthusiasm from the delegates with numerous questions for example around the stage of entry, the restriction to NMEs and the eligibility criteria.


Olga Solomon from the European Commission gave a presentation which provided information about the commission group of experts known as STAMP (Safe and Timely Access to Medicines for Patients). In March 2014, the Adaptive Pathways initiative landed and questions were raised around whether the existing legislation would be fit for purpose. STAMP was created to address these questions and to further improve safe and timely access to medicines for patients. In 2015, STAMP had discussed experiences from national early patient access schemes and the optimisation of three existing tools: conditional marketing authorisations, accelerated assessment including PRIME and the Adaptive Pathways pilot project.


Overall, a holistic approach utilising all of the currently available regulatory tools to support and facilitate early access for patients was advocated and was well received by the delegates.


If you would like more information about any of the areas covered above or would like assistance with a PRIME eligibility application, please contact our trusted and resourceful team: Email DLRC or call 01462 372 472

Launch of PRIME and EMA review 2015

UPDATE 2nd June 2016: We are very pleased to announce that a PRIME eligibility application, submitted on behalf of one of our clients as part of the first batch of applications, is one of only 4 which have been successful. All other 14 applications submitted were unsuccessful. We are excited to see how the scheme will impact the accelerated assessment of the Marketing Authorisation Application and we keenly await the proactive support of the EMA.


We have also recently submitted a second PRIME eligibility application for a different client, to meet the third submission date of the PRIME scheme and look forward to hearing the outcome of this submission in July 2016.



From News - April 2016

On the 7th March 2016, EMA formally launched their much anticipated PRIME scheme. DLRC have already submitted an application on behalf of a client for the eligibility to the PRIME scheme - our application was completed in time for the first submission deadline of this exciting new scheme.


To ensure we were up to the minute on the PRIME scheme and other EMA activities, a number of DLRC staff attended a Review of 2015 at the EMA offices in London. Below we provide a summary of the sessions that focused on PRIME and other ways of optimising regulatory strategy by using accelerated regulatory pathways:


Jordi Llinares from EMA gave a presentation which provided a summary of the PRIME initiative. This initiative aims to enable accelerated assessment for products with a high unmet medical need in the EU. PRIME will use the existing EU regulatory framework and will encourage prospective planning, earlier interactions with stakeholders and the generation of robust data.


Eligibility for the PRIME scheme must be based on data that demonstrate a potential major public health interest. Entry to the scheme for SMEs could be as early in development as proof of principle during the non-clinical stage. For larger companies, entry to the scheme is envisaged at proof of concept or prior to phase III studies. The rationale for the different entry points is that one key aim of PRIME is to help SMEs in the very early stages of product development, where products may be lost due to lack of funding or lack of understanding of the development process and requirements.


Key benefits of the PRIME scheme were explained and included: early identification of eligibility and stakeholder involvement, rapporteur appointment at proof of concept stage, kick-off meeting with the rapporteur and relevant committees, scientific advice at key development milestones, collaboration with national incentive schemes and fee incentives for SMEs on Scientific Advice requests.


The PRIME scheme was greeted with much enthusiasm from the delegates with numerous questions for example around the stage of entry, the restriction to NMEs and the eligibility criteria.


Olga Solomon from the European Commission gave a presentation which provided information about the commission group of experts known as STAMP (Safe and Timely Access to Medicines for Patients). In March 2014, the Adaptive Pathways initiative landed and questions were raised around whether the existing legislation would be fit for purpose. STAMP was created to address these questions and to further improve safe and timely access to medicines for patients. In 2015, STAMP had discussed experiences from national early patient access schemes and the optimisation of three existing tools: conditional marketing authorisations, accelerated assessment including PRIME and the Adaptive Pathways pilot project.


Overall, a holistic approach utilising all of the currently available regulatory tools to support and facilitate early access for patients was advocated and was well received by the delegates.


If you would like more information about any of the areas covered above or would like assistance with a PRIME eligibility application, please contact our trusted and resourceful team: Email DLRC or call 01462 372 472

Launch of PRIME and EMA review 2015

UPDATE 2nd June 2016: We are very pleased to announce that a PRIME eligibility application, submitted on behalf of one of our clients as part of the first batch of applications, is one of only 4 which have been successful. All other 14 applications submitted were unsuccessful. We are excited to see how the scheme will impact the accelerated assessment of the Marketing Authorisation Application and we keenly await the proactive support of the EMA.


We have also recently submitted a second PRIME eligibility application for a different client, to meet the third submission date of the PRIME scheme and look forward to hearing the outcome of this submission in July 2016.



From News - April 2016

On the 7th March 2016, EMA formally launched their much anticipated PRIME scheme. DLRC have already submitted an application on behalf of a client for the eligibility to the PRIME scheme - our application was completed in time for the first submission deadline of this exciting new scheme.


To ensure we were up to the minute on the PRIME scheme and other EMA activities, a number of DLRC staff attended a Review of 2015 at the EMA offices in London. Below we provide a summary of the sessions that focused on PRIME and other ways of optimising regulatory strategy by using accelerated regulatory pathways:


Jordi Llinares from EMA gave a presentation which provided a summary of the PRIME initiative. This initiative aims to enable accelerated assessment for products with a high unmet medical need in the EU. PRIME will use the existing EU regulatory framework and will encourage prospective planning, earlier interactions with stakeholders and the generation of robust data.


Eligibility for the PRIME scheme must be based on data that demonstrate a potential major public health interest. Entry to the scheme for SMEs could be as early in development as proof of principle during the non-clinical stage. For larger companies, entry to the scheme is envisaged at proof of concept or prior to phase III studies. The rationale for the different entry points is that one key aim of PRIME is to help SMEs in the very early stages of product development, where products may be lost due to lack of funding or lack of understanding of the development process and requirements.


Key benefits of the PRIME scheme were explained and included: early identification of eligibility and stakeholder involvement, rapporteur appointment at proof of concept stage, kick-off meeting with the rapporteur and relevant committees, scientific advice at key development milestones, collaboration with national incentive schemes and fee incentives for SMEs on Scientific Advice requests.


The PRIME scheme was greeted with much enthusiasm from the delegates with numerous questions for example around the stage of entry, the restriction to NMEs and the eligibility criteria.


Olga Solomon from the European Commission gave a presentation which provided information about the commission group of experts known as STAMP (Safe and Timely Access to Medicines for Patients). In March 2014, the Adaptive Pathways initiative landed and questions were raised around whether the existing legislation would be fit for purpose. STAMP was created to address these questions and to further improve safe and timely access to medicines for patients. In 2015, STAMP had discussed experiences from national early patient access schemes and the optimisation of three existing tools: conditional marketing authorisations, accelerated assessment including PRIME and the Adaptive Pathways pilot project.


Overall, a holistic approach utilising all of the currently available regulatory tools to support and facilitate early access for patients was advocated and was well received by the delegates.


If you would like more information about any of the areas covered above or would like assistance with a PRIME eligibility application, please contact our trusted and resourceful team: Email DLRC or call 01462 372 472

Annual European Medicines Agency Review of the Year and Outlook for 2016

The Annual European Medicines Agency Review of the Year and Outlook for 2016 took place at the EMA on 26th and 27th November. This was the 10th annual review of the activities of the EMA and the respective EU national agencies. There were eight Sessions in total across the 2 days; the full meeting report is available in the March edition of Regulatory Rapporteur. DLRC were well represented at this key conference and contributed to the writing up of 4 of the 8 sessions.


Topics covered all aspects of the regulatory spectrum from accelerated regulatory pathways (including the recently launched PRIME initiative), the forthcoming Clinical Trial Regulation to a review of EMA’s evaluations during 2015 and post-approval activities. Aspects covered are listed out below. If you would like more information on the meeting itself or specific regulatory advice for your project, please contact our trusted and resourceful team on info@dlrc.co.uk or 01462 372 472.


Session 1: Developing new medicines: What is the regulatory role in fostering and supporting pharmaceutical innovation? [written-up by Kevin Judges]


Session 2: Optimising your regulatory strategy by using accelerated regulatory pathways [written-up by Roz Sutton]


Session 3: Data sharing and disclosure – Operational aspects of EMA policies


Session 4: Regulator roundtable


Session 5: Involvement of HCPs and patients in the work of the EMA and its committees


Session 6: Reflections on 2015 – Review of evaluation highlights, surveys and progress in the area of telematics


Session 7: Post-approval activities [written-up by Fiona Bright]


Session 8: The new EU Clinical Trial Regulation [written-up by Dianne Lee]

The New Clinical Trial Regulation: What Should We Expect?

The new Clinical Trial Regulation (EU No 536/2014) aims to streamline, simplify and harmonise clinical trials in the EU, and will replace the existing Directive 2001/20/ EC. The regulation is now anticipated to come into force in the second half of 2019, following full functionality validation of a new EU Database infrastructure and single online EU Portal.


The regulation will introduce a number of key provisions, including:

  • A Single Application Process: streamlined and submitted via a single entry point (the EU portal) and inclusion of the ethics committees in the assessment procedure
  • Strictly defined deadlines for the assessment of the clinical trial application
  • Reporting by the Sponsor on to the EU Portal of key trial milestones, within specific timelines
  • Increased efficiency in extending the clinical trial to another EU Country
  • A Risk-Adapted Approach, with the introduction of a category of "low-intervention trials"
  • Changes to protection of subjects in clinical trials, intended to harmonize requirements and also allow for national rules in some cases
  • Increased transparency concerning clinical trials and their outcomes
  • Data privacy changes
  • Simplified Safety Reporting requirements
  • Clearer duration of Trial Master File archiving (25 years)

While in principle the new Regulation should make it easier for pharma companies to conduct multinational clinical trials and prevent potentially numerous rounds of questions during assessment from different countries, questions remain on how the processes of the Regulation will work in practice.


Our team here at DLRC have significant experience in all aspects of clinical trial applications. If you would like more information on the new Clinical Trial Regulation, advice regarding your clinical development or assistance with Clinical Trial Applications, please contact our trusted and resourceful team at enquiries@dlrc.co.uk or 01462 372 472.

EMA Regulatory Tools for Early Access to Medicines

Priority Medicines (PRIME)

The EMA expects to launch a new Priority Medicines scheme called PRIME in the first quarter of 2016 which aims to:

  • enable accelerated assessment for products with a high unmet medical need through earlier interactions with stakeholders and the generation of robust data
  • optimise the use of the existing regulatory framework and to encourage more prospective planning and early interaction with EMA for these important medicines

Currently, confirmation that an application will be reviewed according to an accelerated timetable is only possible just prior to filing. Under the PRIME initiative, NMEs fulfilling the accelerated review criteria can be identified much earlier in development and once identified, enhanced regulatory support will be on offer.

Key benefits of the PRIME scheme include:

  • early identification of eligibility and stakeholder involvement
  • rapporteur appointment at proof of concept stage
  • kick off meeting with the rapporteur and experts from relevant committees
  • scientific advice at key development milestones
  • fee incentives for SMEs on Scientific Advice requests

In addition to the PRIME scheme, the EMA issued two draft revised guidelines for consultation:

Accelerated Assessment

Accelerated assessment offers the opportunity for a more rapid assessment of marketing authorisation applications for medicines of major interest from the point of view of public health. The time to CHMP decision is reduced from 210 days to 150 days for standard assessments. The revised guideline aims to encourage earlier dialogue between all stakeholders so that the compressed timelines can be met.

Conditional Approval

Conditional approval allows the approval of a medicine based upon less complete data for products that target unmet medical need and target a seriously debilitating and life threatening disease. The EMA particularly noted in discussions that there is a lack of stakeholder confidence in this tool and that it is seen as a rescue solution during review of the marketing authorisation application. The revised guideline aims to increase stakeholder confidence, in particular by encouraging early dialogue and planning of conditional authorisations.

The end of the consultation period for the draft revised guidelines was 30th September 2015.

If you would like more information or advice around maximising the benefits of these early access to medicines tools in your development programme, please contact our trusted and resourceful team on info@dlrc.co.uk or 01462 372 472.