Dr. Peter G. Milner Scholarship for Biomedical Innovation 2024

Foundation Doctors and Core medical trainees – this is an exciting and unique opportunity to work in the US health system, gaining exposure to cutting edge research and development in medical devices, medical informatics and biopharmaceutical healthcare companies

Introduction

As medicine and healthcare change globally, there is an even greater need for doctors to become more innovative and entrepreneurial. This scholarship is an exciting opportunity to crystallize innovative thinking by working with biomedical and tech companies to create products and processes that ultimately enhance patient care.

In order to facilitate this process in Liverpool, we are offering, through the generosity of Dr. Peter Milner, a distinguished physician and alumnus of the University of Liverpool (BSc Biochemistry 1978, MBChB Medicine 1980), the opportunity to spend 3 months at one, or a combination of 3 biomedical companies in the USA, learning about innovation in the biomedical industry.

It will involve working with management and founders at a start-up medical device, medical informatics or bio-pharmaceutical company or a combination of the above. The recipient of the scholarship will gain valuable exposure to, and introductory experience in the rapidly evolving US biomedical industry. Useful contacts can be established with individuals in these companies and the respective industries that will be of value to a recipient, should they choose to pursue a career in the global biomedical industry.

Eligibility and the application process

1) All doctors who are on Foundation, Core or Specialty training rotations within the Health Education Northwest region [previously known as the Mersey Deanery] will be eligible to apply. Applications are particularly encouraged from F1 and F2 doctors, and those who have completed a year of intercalation.

2) Liverpool Medical School students in their final year are eligible to apply, and particularly encouraged from those who have completed a year of intercalation.

The application process involves submitting a short, focused Curriculum Vitae and a covering letter to explain why you should be selected. This should be emailed to Lorraine Evans (levans@liverpool.ac.uk) in the Office of Professor Tom Walley, Associate Pro Vice Chancellor for Clinical Research, University of Liverpool. The closing date for applications is 5pm on Monday 13 November 2023.

Shortlisted candidates will be asked to attend an interview at the University of Liverpool on 14 or 15 December 2023, TBC.

Previous Fellow

Dr Christian Flynn: “The Peter Milner Fellowship has been an invaluable experience which has offered exposure and experience within international biotech and pharmaceutical companies based in California, USA. I have been involved in drug development, clinical trials, FDA approval and funding for cutting-edge medicines which have applications in the field of neurodegenerative medicine and autoimmunity.”

The Fellowships

The two Fellowships will cover airfare, accommodation, subsistence, local transportation allowance and a discretionary allowance.

The successful applicants must be in a position to obtain the necessary permissions to travel from their training position from the appropriate authorities and in possession of valid travel documents allowing them to travel to the USA.

The Fellow will be expected to submit a written report of the Fellowship, which we hope to present at an appropriate forum upon their return.

The Fellowship placements [3 months in one, or a combination] are available in the following locations:

Renexxion Ireland Ltd (RIL)

A private profitable US holding company with wholly owned Irish operating subsidiary developing its unique topically active intestinal prokinetic agent (naronapride) globally in collaboration with pharmaceutical and private equity partners. The drug is in Phase 2b in US for PPI non-responsive symptomatic gastroesophageal reflux disease (GERD) and in EU for gastroparesis in partnership with Dr Falk of Germany. Naronapride addresses the large unmet medical need that exists for a prokinetic agent for the treatment of a variety of common GI conditions like gastroesophageal reflux and Irritable bowel syndrome. Naronapride is a novel gastro-prokinetic agent that has been shown to accelerate gastric emptying and speed up intestinal transit in man by the only clinically and commercially validated mechanism of action, namely 5HT4 receptor stimulation and D2 receptor inhibition. Naronapride, a small molecule NCE administered orally, acts topically on receptors in the stomach and intestinal wall to increase motility throughout the gut. By design, only a very small fraction of the ingested drug is absorbed into the body making it, safer than most drugs that cause side effects when absorbed. It was found to be safe and effective in multiple randomized clinical trials in almost 1000 patients with commonly occurring gastrointestinal motility disorders including, 4 positive Phase 2 trials. The topical mechanism of action on the gut motility receptors combined with its very low absorption, has the advantage that in all the trials the side effect profile of naronapride was indistinguishable from placebo. Hence, it appears to be safe, effective and well tolerated. In particular, naronapride, unlike other drugs in this class, has no stimulatory effect on the heart. Thus, in September 2016 the FDA Safety Outcomes Trials (SOT) Committee granted it the first and only waiver on the need for a 10,000 patient $200M cardiovascular (CV) outcomes trial. This is important because two prior top selling (>$1B) drugs in this class, Propulsid (cisapride) and Zelnorm, (tegasrode) were commercially successful when they had to be withdrawn because of CV safety issues. These issues have been successfully overcome in the design of naronapride. In 2020 RIL received a new composition of matter patent on the trihydrate crystal isoform of the drug which will grant patent protection till at least 2028. In May 2021 RIL entered in a licensing and joint development deal with Dr Falk of Germany a leading GI focused company. It is also seeking a new partner in China In all of these deals Renexxion retains control of the global late-stage clinical development, manufacturing and commercialization. RIL has been funded over the last 5 years with tens of $10M in non-dilutive funding and private investment and is now seeking to access public markets for capital to complete development of its drug.

IL-2Rx

IL-2Rx is a private company spun out of Stanford University and located in San Jose CA and Florida based upon a novel unpublished observation that a defect in pJAK1 signaling off the IL-2 receptor in regulatory T cells (Tregs) is responsible for a broad range of autoimmune diseases. The company has raised $3M in seed funding and $500,000 in non-dilutive funding from a regional partnership. With these proceeds in their labs, they have successfully created a protein drug conjugate (PDC) of an IL-2 fusion protein and several molecules of a neddylation activating enzyme inhibitor (NAEi) and demonstrated that the PDC is much more effective in therapy of animal models of autoimmunity and asthma than are the combination therapy or, IL-2 alone. These PDCs have the potential to treat a range of autoimmune diseases where we have identified the defect in IL-2 receptor pJAK1 signaling as causative such as SLE, T1D, MS and RA; inflammatory diseases such as asthma and allergy as well as the autoimmune problems associated with CPI use in cancer. There is also the potential for a companion diagnostic to identify the target population and to judge response to therapy. These PDCs are potent and have a long duration of action since they reprogram or normalize defective Treg function in these diseases. The company is conducting further feasibility studies with top 10 Pharma company with the intent of negotiating a global exclusive license on its technology and products.

XYRA, LLC

There are 7 million people in the US suffering from atrial fibrillation (AF) and apart from a catheter ablation, an expensive, invasive and risky surgical procedure that often doesn't work, there are no truly safe and effective drugs to treat AF. XYRA is a privately funded US LLC which owns 2 important assets in AF management that the FDA would like to see complete testing and get approved to improve management of AF within the next 2-3 years.

Biography: Dr Peter Milner (BSc Hons Biochemistry 1978; MBChB 1980)

California-based Dr Milner is a cardiologist and successful entrepreneur with extensive experience in drug development and clinical trial design in cardiovascular indications, with an emphasis on imaging. Currently Executive Vice President of Optivia Biotechnology Inc., which he co-founded in 2007, he had previously co-founded ARYx Therapeutics in 1997, where he served as CEO until 2005, and then President from 2005 to 2010, with overall responsibility for R&D. In 1990 Dr Milner co-founded CV Therapeutics, where as a member of senior management from 1992 to 1996 he licensed and co-invented several successful pharmaceuticals. CV Therapeutics was acquired by Gilead for $1.5 billion in 2009.

Earlier in his career, Dr Milner was an Assistant Professor of Medicine at Washington University in St Louis. His research led to the discovery of pleiotrophin (PTN), a novel growth factor that regulates stem cell differentiation, organ development, and the epithelial mesenchymal transition (EMT). After completing his undergraduate studies at the University of Liverpool, Dr Milner completed his postgraduate training at Johns Hopkins Hospital, University of Virginia, and Washington University in St Louis.

He is co-inventor on 60 issued patents, an author of 40 original scientific articles and a Fellow of the American College of Cardiology (FACC). In addition, he has served as adjunct clinical faculty at Stanford University School of Medicine and as a board member of the California Healthcare Institute (CHI). In 2012 Dr Milner was recognised as EY Entrepreneur of the Year.

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