Medilink and the University of Central Lancashire (UCLan) are hosting a FREE event on 3rd March, which can be attended in person or remotely via Zoom, on how to navigate the regulatory landscape and internationalise successfully. The event is aimed at pre-revenue and early stage start-up life science companies, as well as clinicians and academics who are looking to commercialise their ideas and staff looking to update their knowledge in these important areas.

 

During the first part of the programme, speakers will talk about how to navigate the regulatory landscape and understand regulation and compliance.

 

In the next part, attendees will hear about insights into international trade and international regulatory challenges, while learning from a company with a first-hand experience in this area.

Agenda

Speakers

Peter Leather, Head of IP and Commercialisation for Innovation and Enterprise at UCLan

For more than 25 years, Peter has been providing leadership in key roles in the Innovation, Research & Technology sectors at policy, strategy and operational levels. He is presently leading the delivery of UCLan`s investment readiness, innovation, IP and research commercialisation strategies to ensure a professional and sustainable programme delivery.

Peter has an enviable network and a track record of providing professional market and client-led services to organisations vital for them to assess technology and investment readiness. He is also skilled at applying technology and technical and commercial insight that help turn research ideas into successful products and services. His expertise is used by industry, academia, business and government.

 

Kevin Kiely, Executive Chair, Medilink North of England

Kevin has developed a dedicated team of international specialists that service both Medilink UK members, private clients, the Department for International Trade (DIT) and other foreign and domestic organisations. He also leads a team of health technology innovation specialists with a strong track record in international markets. Much of Kevin’s work internationally has related to technology transfer and he is passionate in promoting alternative market entry strategies for key international growth markets based on early-stage partnership.

 

Michael Kipping, Director, Medical Technologies for Europe, Middle East & Africa, Element Materials Testing

Michael has experience in supporting companies to access funding, navigation of regulatory pathways and different approaches to commercialisation. 

He has a keen interest in regulation having worked at MHRA in the Devices Division and is currently on the advisory board of The Organisation for Professionals in Regulatory Affairs (TOPRA). After completing his Ph.D. in Biomedical Engineering (orthopaedic implants) he spent 10 years in industry in a range of commercial roles with Guidant, Boston Scientific and BIOTRONIK where he was responsible for commercial operations in UK & Eire.

 

Richard Hall, Director, QMS Consultancy Ltd

Richard is an experienced QA professional who has worked within the Medical Device industry since 1993. He has experience of developing and manufacturing medical devices & IVD’s in a range of companies, from start-up to blue chip international healthcare businesses. He spent 5 years as QA and Design Manager at Bio-Rad Laboratories before starting QMS Consultancy in 2014. Richard now specialises in supporting medical device start-ups to certify to ISO 13485, to gain Regulatory approval and accelerate their route to market.

 

Dr Patrick Trotter, Head of Innovation & Commercialisation, Medilink North of England

Patrick assists companies in the medical device, diagnostics and digital health spheres with innovation strategy, market and competitor analysis and developing business cases for adoption of new health technologies. He has regularly run courses and workshops focused on innovation strategy and product development for the healthcare sector. These courses provide senior executives and managers the skills to launch differentiated successful products.

 

Fiona Costello, Vice President of National Accreditations, ORCHA 

Fiona is responsible for supporting governments and policy makers to consider their approach to digital health accreditation, supporting the design, development and delivery of new assessment schemes. Fiona has an extensive healthcare career in strategy, business development and transformation. Prior to joining ORCHA as Vice President of National Accreditations, she was involved in accelerating growth strategies for a number of organisations, including NHS, private sector and non-profit organisations. Her experience of working within traditional healthcare settings as well as for start ups has led to a passion for ensuring digital health is always framed within clinical and operational priorities to yield the maximum benefits for patients.

 

Clare Unsworth, Quality and Regulatory Affairs Director for NGPOD Global Limited

Clare is the Quality and Regulatory Affairs Director for NGPOD Global Limited. She has several years’ experience working in Quality and Regulatory senior roles within the Medical Device industry, and has also worked as a consultant, supporting companies with ISO 13485, ISO 9001 and Technical file compilation/maintenance, 1st and 2nd party audits and general regulatory compliance.

 

Tom Elliott, Managing Director, Medilink North of England

Tom is an advocate for the UK’s Life Sciences and Healthcare industry, often asked to present his knowledge and insight at international congresses and to foreign trade delegations. As well as his role within Medilink UK, Tom supports the work in Yorkshire and Humber of the Department for International Trade Life Sciences Regional Sector Specialist.  He is also engaged in a strategic role as the Healthcare, Life Sciences and Bio-tech lead for International Trade across the Northern Powerhouse region.

 

Alastair Clarke, Managing Director, Weaver Technical Solutions

Alastair has Bachelor and Master Engineering Degrees, is a Chartered Engineer and a Fellow of the Institute of Mechanical Engineers.

Alastair Clarke has worked in the pharmaceutical industry for over 30 years with experience in respiratory, semi-solid and sterile liquid technology, becoming a strong protagonist for robustness in all aspects of technology and product development from strategy, through innovation to industrialisation and scale-up.

He has worked for a number of large pharmaceutical companies and during his time in industry he contributed significantly to his employers’ patent inventories, facilitated and implemented franchise strategy and delivered both sustainable organisations and a number of drug delivery platforms, which have made their mark in the industry.  This work has equipped Alastair with a good understanding of the product approval processes for both medicinal products and medical devices in the major markets.

Alastair’s last role in pharma involved setting up and running a large parenteral design, development, and test facility, which included establishing a quality management system that conformed to ISO13485:2016.

Latterly, Alastair setup his own consulting business to assist companies develop and implement product strategies, solve technology development problems, enhance development creativity and optimise processes. 

 

Richard Paxman – CEO, Paxman Scalp Cooling

Richard studied management science at Manchester’s UMIST and joined Paxman in 2008.  Since then the business has had international success and Richard is passionate about improving scalp cooling efficacy, ensuring that everyone undergoing chemotherapy treatment keeps their hair and empowering cancer patients with a choice.   It is Richard’s vision to ensure that every applicable cancer patient, no matter where in the World, has the opportunity to maintain their privacy and sense of normality by keeping their hair.  Richard supports investment in people, biological research, clinical trials for both regulatory and marketing reasons, plus developing innovative scalp cooling-related treatments .  

Following FDA clearance of the product in 2017, the Paxman scalp cooling is now available at all of the five highest-ranked cancer centres in the USA.  Successful business infrastructure including logistics, warehousing, call center, technical services and pharmacy is in place to facilitate the growth of the business across all states in the US.  Richard has contributed as a keynote speaker at innumerable business events around the world, ensuring the latest scalp cooling news, best practice and protocols are shared across the PAXMAN network and beyond. 

Following FDA clearance of the product in 2017, the Paxman scalp cooling is now available at all of the five highest-ranked cancer centres in the USA. 

 

Simon Bradbury, Partner, Appleyard Lees

Simon is a partner in the Life Sciences team and is based in our Manchester office.

Simon’s practice encompasses a wide range of technologies within life sciences and biotechnology, with clients ranging from large multi-nationals to universities and small spin-out companies.

Simon is particularly involved in formulating intellectual property strategies for start-ups, spin-outs and SMEs, where he assesses their business plan, budget, exit strategy, current IP position and then clearly setting out patent filing programmes to maximise and extend patent protection, ensuring trouble free product launch or licensing by undertaking freedom to operate analysis.

He works on a number of technologies including medical devices, pharmaceuticals, biologics, nanoparticles; drug delivery, diagnostic assays; pro- and pre-biotics, gene chips and bioinformatics.

Simon has a BSc in Genetics and MSc in Oncology and is both a member of the Licensing Executives Society and a Chartered Biologist.

He is a highly regarded attorney and is a Ranked Lawyer in Band 1 in Chambers under Intellectual Property: Patent Attorneys UK, a Recommended Patent Attorney in the Legal 500, Ranked as an IP Star in Managing Intellectual Property Handbook, Listed as a Leader in the World Intellectual Property Review and listed as Recommended in the IAM Patents 1000 Rankings.

 

Dr Chris Benson, Partner and Head of Electronics, HGF

Chris is an experienced UK and European patent attorney.  Chris helps to protect client’s inventions in the fields of electronics, computing, software, MedTech and automotive fields amongst others.

Chris seeks to understand a client’s business and needs, such that he is able to offer advice enabling clients to achieve their commercial goals. Chris has an academic research background which enables him to work with world-leading inventors in industry and academia.

Chris has represented a full spectrum of clients from multinational companies to start-ups and academic institutions. From this, he is able to work effectively with all types of clients. Chris has experience in working with inventors from academics to industrial R&D technologists. Chris has experience in not only the nuts-and-bolts of taking inventions through to granted patents in a wide variety of different countries including Europe, the US and China, but also in advising on patent strategy, patent enforcement and patent infringement defence.

 

Richard Parker, Legal Director, Hill Dickinson

Richard works with a wide variety of public and private organisations operating in the health, care and life sciences sector, with a particular emphasis on information governance, public law, regulatory compliance, commissioning and dispute resolution.

 

 

Mark Philmore, Director, MFL Insurance

Mark has 35 years experience in the insurance industry having worked for both insurers and brokers providing an excellent insight in to the assessment of risk and its mitigation.

Heading up MFL’s Science and Technology offering he works with Life Science businesses from their format stages through the entirety of their lifecycle providing advice across all specialist general insurance products.

He is ACII qualified and a Chartered Insurance Broker.

 

When registering for the event, you will have two options – registration for those wishing to attend in person and those wishing to join remotely via Zoom. If you’re attending remotely, you will receive an email with a link to join prior to the event.

We’re looking forward to seeing you!