Big picture - Why invest in Ergomed Plc
Ergomed Plc Snapshot
Founded in 1997, Ergomed plc is a profitable UK-based company, dedicated to the provision of specialised services to the pharmaceutical industry and the development of new drugs. It operates globally in over 40 countries.
Ergomed plc has two complementary businesses:
(1) The Services Business – a well-established, clinical research business providing services to the pharmaceutical and biotechnology industry; and
(2) The Co-Development Business – a growing portfolio of partnerships with pharmaceutical and biotech companies, providing its drug development services in exchange for a carried interest in any revenues attributable to the drug asset, including outlicensing milestones as well as sales of the product
Since its formation, Ergomed plc has been providing expertise in clinical development / trial management from the largest pharmaceutical companies, as well as many small and mid-sized drug development companies. Ergomed plc successfully manages clinical development from Phase I through to late phase programmes.
Ergomed plc has a wide therapeutic focus, but has particular expertise in oncology, neurology and immunology and the development of orphan drugs. Ergomed plc believes its approach to clinical trials is differentiated from that of other providers by its innovative Study Site Management model and the use of Study Physician Teams, resulting in a close relationship between Ergomed plc and the investigational sites involved in clinical trials. As well as providing high quality clinical development services, Ergomed plc is building a portfolio of co-development partnerships with pharma and biotech companies which share the risks and rewards of drug development. Ergomed plc leverages its expertise and services in return for carried interest in the drugs under development.
The company has planned, managed, monitored, and reported clinical trials with a range of technologies that include small molecule drugs, monoclonal antibodies, tri-functional antibodies, soluble receptors and other targeted agents, cancer vaccines and immunotherapy, radioactive agents, and photodynamic therapies.
Clinical Development Services
ERGOMED's approach to Site Management ensures effective patient recruitment reducing time and cost of clinical trials.
Ergomed’s leading position in the successful integration of a functional Site Management Model into full Clinical Development Services is highly regarded by investigators, sponsors and partners. This model enables the most efficient and cost effective study management structure which delivers faster recruitment of quality patients to agreed timelines. Optimal investigator site contributions are ensured by combining good patient recruitment with high quality data collection and assistance to investigators with their many administrative and logistical responsibilities including activities such as the scheduling of patient visits and the shipment of blood and tissue samples.
Ergomed project management teams consist of project directors, project managers, project manager assistants, monitors (or clinical research associates) and clinical trial administrators which together form the core of the Ergomed operational organisation. The team consists of highly qualiﬁed personnel of whom many are either physicians, PhDs or have other medically-related qualiﬁcations. Besides being highly trained, Ergomed study monitoring teams are recruited locally and based close to the sites they visit. They understand the local culture and are fluent in the local language as well as English, thus ensuring an efficient service that can resolve local issues fast.
The Ergomed Corporate Information System (ECIS), a SharePoint based clinical trial management system, is used to aid management of all aspects of the clinical trials process and can be customized to meet client needs for reporting and study management.
ERGOMED's approach in implementing successful site management strategies was established over 15 years ago.
Ergomed’s approach to successful Site Management was established over 15 years ago by the company’s founder who was previously a Principal Investigator himself. Ergomed’s assessment and knowledge of the experience of physicians and nurses, investigator facilities, pharmacy and laboratory services significantly improves the access to and the availability of appropriate patients. Ergomed’s Site Management model is an integrated part of Ergomed’s approach to the management of clinical trials.
With over 300 trained Site Coordinators based at sites across Europe and the MENA region. Ergomed has demonstrated high ‘patient-per-site’ ratios as compared to other CROs. Ergomed’s medically led team provides continuous and ongoing site support thereby achieving enhanced patient recruitment rates whilst maintaining data quality. Early and meticulous site evaluation in the feasibility process is critical in ensuring accelerated recruitment.
SSC support to investigators results in:
- Faster recruitment
- More patients per site
- Enhanced data quality
- More timely data entry
- Fewer data queries
- Better compliance to GCP
Ergomed has successfully rescued complex, under-performing and failing trials across a variety of therapeutic indications. These successes are due to the implementation of our Site Management Model combined with our local knowledge and established relationships with investigators and sites. Ergomed advises on the best country strategies for rapid study set-up and trial execution to deliver a successful turn around of a failing study.
SSCs identified and trained by Ergomed work at the sites in full compliance with ICH GCP and completely independently of our CRAs and PMs; they follow their own SOPs and have separate line management and reporting structure. The Site Management Model has been audited as part of regulatory audits and has been used in clinical studies Ergomed has completed for clients that have resulted in successful product approvals in USA and Europe.
In the example illustrated by the chart above, Ergomed was brought into the study 11 months after it started. It recruited 571 out of a total of 762 patients and facilitated the study finishing five months ahead of schedule.”
Study Physician Support
Ergomed has established a Study Physician Team – a highly specialised group of MD’s that deal with the supervision of complicated or demanding therapeutic or diagnostic trials/procedures. All of the MDs that are part of the Study Physician Team have extensive previous clinical practice experience as well as experience in clinical research and drug development.
The presence of an experienced clinician on a study site representing the sponsor improves the understanding of the local investigator of the protocol requirements and improves overall compliance. This speeds up recruitment and lowers the dropout rate. Our Study Physician Team has proven to be highly effective in trials with demanding protocols or study procedures, or low recruitment rates and maintenance of high motivation of the principal investigator is of key importance.
Tasks of the Study Physician Team are:
- Performing study specific site training
- Representing Sponsor’s clinical interest at the sites
- Maintaining good medic to medic relationships with the on-site physicians
- Supporting investigators in appropriate patient selection
- Encouraging the sites to seek new study subjects – enhances recruitment
- Shares the most recent experiences from other sites
- All potential medical issues are addressed swiftly and resolved
Dr. Miroslav Reljanovic – Founder and Chief Executive Ofﬁcer
Dr. Miroslav Reljanovic is a medical doctor and a board-certiﬁed neurologist. Whilst practicing as a physician in a large WHO Collaborating Centre in Zagreb, he was the clinical investigator in numerous Phase II and III studies in the ﬁeld of neurology and a consultant to various pharmaceutical companies. In 1997 Miro founded Ergomed and he introduced the novel Study Site Coordination model as an intrinsic part of the conduct of clinical studies. This model became a landmark of the Ergomed approach to clinical research, which is paramount to provide high quality.
Miro successfully introduced the ﬁrst European innovative co-development business model and he has completed several transactions with European and North American listed biopharmaceutical companies. Together with co-founder Elliot Brown, MB, MRCGP, FFPM, a well-known international expert in drug safety, Miro started PrimeVigilance in 2008, which soon became a leading specialist vendor of contracted pharmacovigilance services to the pharmaceutical industry.
Stephen Stamp – Chief Finance Officer
Stephen Stamp brings to Ergomed more than 30 years of experience in corporate finance and general management in both public and private companies in the UK and the USA. Stephen joins Ergomed from US-based AssureRx Health, Inc, a personalised medicine and bio-informatics company where he was CFO. Prior to this he was CFO of EZCORP, Inc. (NASDAQ:EZPW), a consumer financial services company and Chief Operating Officer and CFO at Xanodyne Pharmaceuticals, Inc, a specialty pharmaceutical company.
Before leaving for the US, Stephen was Group Finance Director at Shire Pharmaceuticals (LSE:SHP, NASDAQ:SHPG) where he led the IPO on London Stock Exchange as well as a number of major acquisitions and financings. During his time at the Company, Shire’s market capitalisation increased from GBP20 million to GBP3.1 billion. He was also Group Finance Director at Regus Plc (LSE:RGU) where he successfully listed the Company on London Stock Exchange Main Market and NASDAQ. Earlier in his career, Stephen was an investment banker with Lazard in London, advising mainly public companies on cross-border M&A and corporate finance. Prior to Lazard, he worked for KPMG in London where he qualified as a Chartered Accountant.
Neil Clark FCA – Chief Executive Officer PrimeVigilance
Neil Clark joined Ergomed as Chief Finance Ofﬁcer in January 2009 and was CFO on its IPO in July 2014 until his move to be full time CEO of PrimeVigilance in January 2016. He has been closely involved in the management of PrimeVigilance Ergomed’s successful pharmacovigilance business since its formation in 2009.
Prior to joining Ergomed, Neil was Chief Executive Ofﬁcer of CeNeS Pharmaceuticals plc, a UK biotech company listed in London. Neil joined CeNeS in 1997 when it was a venture capital backed private biotech company. He was involved in the ﬂotation of CeNeS in 1999 and as CFO and then CEO he led the company through to its sale in 2008.
Prior to joining CeNeS, Neil worked for PWC in Cambridge, UK for over ten years on a variety of local, national and international assignments in audit, corporate ﬁnance and consultancy.
Neil is a qualified chartered accountant (FCA).
Andrew Mackie – Chief Business Officer
Andrew Mackie joined Ergomed as Chief Business Officer in 2015 having worked with the company as a consultant since 2004. He has been instrumental in developing the co-development business and negotiating the partnerships signed to date. Andrew joins from the Business Development group at Eli Lilly. Previously he was Head of Life Sciences at IP Group and Head of Alliance Management at Antisoma. He brings with him over 25 years’ industry experience in pre-clinical research, clinical development and business development.
After ten years in R&D positions at Novartis, Sanofi and MDS, Andrew joined the UK biotech sector in 1996 at Antisoma as Head of Clinical Development. He establish the clinical development department which ran several oncology phase I to phase III programmes and later managed their strategic alliance with F Hoffman-La Roche. The role also included in-licensing new drug leads. At IP Group, he managed several portfolio companies and worked with the University partners to create new businesses.
Andrew holds a BSc in biochemistry from Queen’s University (Canada), an LLB from the University of London and an MBA from the London Business School.
Nick Davies, MSc
Head of Global Business Development
Wenke Möller-Höhne, PhD
Business Development Consultant
Ines Medved, MBA
Senior Business Development Manager
Senior Business Development Associate
Maya Juras, JD
Business Development Manager
Miriam Kreko, BSc
Business Development Associate
Nominated Adviser and Broker
Stifel Nicolaus Europe Limited
Hume Brophy Limited
One Fetter Lane
Solicitors to the Company
Covington & Burling LLP
Share Registrars Limited
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