Register for this webinar here

A clear understanding of your competitive advantages and the needs of your end users is essential for turning a promising idea into a compelling market offering. Insight into customer priorities and unmet needs not only strengthens your strategic positioning but also enhances your credibility when engaging potential partners and investors.

This seminar will address key questions central to early-stage commercial development:

• How can you systematically identify and interpret customer needs with precision?

• How should you approach market analysis to inform strategic decisions?

• How can you articulate your value proposition in a clear, credible, and compelling manner to external stakeholders?

Register here to join the call or to gain access to the recording.

Dr. Nastaran Hiedari, a product and strategy leader in genomics, precision medicine, and AI-driven healthcare innovation, will share about the role of AI in Drug Development.

Prior to entering industry, Dr. Hiedari was a postdoctoral scholar in genetics at Stanford, an Instructor in Radiation Oncology, and an Associate Faculty member at Stanford HAI. Dr. Hiedari has held product leadership roles at Thermo Fisher Scientific, Illumina, and Pfizer across molecular diagnostics, clinical genomics, product strategy, and digital transformation. Most recently, she led strategic enterprise data and AI initiatives supporting Pfizer Oncology Research & Development. She is currently the founder of BioArchai, an advisory board member at Tfive, and a strategic advisor to life sciences organizations through Guidepoint, AlphaSights, and Cepton Strategies.

To register for this webinar, please click here.

Turning research into real-world impact often depends on how intellectual property is identified, protected and positioned. This webinar explores how IP strategy can support commercialisation, spin-outs, and investment - bridging the gap between academic innovation and investor expectations. We'll discuss how IP choices influence value, risk and long-term opportunity, with practical insights relevant to researchers, post-graduates, and start-up founders alike. 

UK and Europe patent attorney Peter Mumford specialises in chemical inventions, particularly small molecule therapeutics, pharmaceutical formulations, and new medical uses. He works with a broad range of clients with considerable experience of helping spin-off and start-up life science companies to prepare for fundraising as well as due diligence for investors. Peter will lead this webinar. 

This webinar is sponsored through Aston University's active involvement in the West Midlands Health Tech Innovation Accelerator (WMHTIA). The WMHTIA is funded by the Department for Science, Innovation and Technology, in partnership with the West Midlands Combined Authority and Innovate UK.  

SPARK The Midlands has been expanded to 16 universities across the entire Midlands as part of the Forging Ahead project. Forging Ahead was established to supercharge the innovation ecosystem in the region and is funded by Research England. 

Please register here if you would like to attend this event!

We're bringing together the Midlands innovation ecosystem — and you're invited to be part of it.

This isn't just another networking event. We're gathering the people who matter:
→ Innovators turning research into reality
→ Spin-outs and startups scaling breakthrough ideas
→ Investors backing the next generation of health tech
→ World-class OEMs and industry leaders

Our mission? Bridge the gap between world-class research and real-world clinical impact.

Supported by Forging Ahead, SPARK The Midlands is creating a platform for meaningful collaboration — connecting brilliant science with the resources, expertise, and networks needed to transform healthcare.

Whether you're developing or supporting cutting-edge research, funding innovation, or delivering clinical solutions, this is your chance to engage with a community committed to translating science into impact.

Join the upcoming SPARK GLOBAL Webinar on Tuesday, February 10th, at 5:00 PM Pacific Time, by registering here.  

Dr. Jin Billy Li, a professor of Genetics at Stanford University, will share his experiences participating in the SPARK at Stanford program and the role it played in founding two companies. 

Dr. Jin Billy Li's research has focused on RNA editing mediated by ADAR enzymes from two distinct perspectives. First, he has co-developed methods to harness ADAR enzymes for RNA base editing, work that led him to co-found AIRNA, which has successfully raised $245 million in funding. Second, his laboratory has investigated the biological function of RNA editing in preventing RNA-mediated autoimmunity, forming the scientific basis for Mangrove Therapeutics. Both projects were initially supported by the SPARK Program at Stanford. Before establishing his laboratory at Stanford in 2010, Dr. Li completed his postdoctoral training at Harvard Medical School. He received his bachelor’s degree from Tsinghua University in Beijing, China, and his Ph.D. from Washington University in St. Louis. 

Please register for this webinar here.

SPARK The Midlands are very fortunate to have DLRC deliver back-to-back webinars for us. This second one is an introduction to the EU Clinical Trials Regulation (EU-CTR), designed to support sponsors in navigating the new regulatory landscape. This session will provide an overview of the key changes introduced by EU-CTR, guidance on using Clinical Trials Information System (CTIS) and insights into preparing compliant submissions across member states. Whether you're new to clinical trials or looking to refresh your understanding, this training offers a concise, hands-on look at what you need to know to submit successful applications under the new framework.

Hosted by Christie Watson, a Regulatory Affairs professional with seven years of experience with both local and global regulatory submission management, specialising in clinical drug development. She began her career at a CRO, gaining broad exposure to a wide range of therapeutic areas, working with both small molecules and biologics. ​Since joining DLRC in 2021, Christie has played a key role in supporting clients through the preparation and submission of Clinical Trial Applications (CTAs) across the UK, EU and RoW markets.

Join us in learning more about the regulatory landscape for therapeutics in the EU.

Please register for this webinar here.

Join Sharon, Associate Director and Senior Regulatory Consultant for DLRC (a group of award-winning, regulatory affairs consultants strategically located across two continents), for this SPARK Studio session. 

Sharon joined DLRC in January 2022, bringing over 20 years of experience in nonclinical development and an additional 6 years in regulatory affairs. With a strong focus on nonclinical regulatory strategy, she supports clients across all stages of the product life cycle—from early-phase development, Scientific Advice, and PIPs, to INDs, MAA/NDA/BLA submissions, and post-approval procedures. Her work spans various research and therapeutic areas and includes both small molecules and biologics.

Sharon has extensive experience in developing and implementing nonclinical regulatory strategies tailored to product-specific and regional requirements, ensuring alignment with both EU and US regulatory expectations. She has held positions in contract research organizations, large pharmaceutical companies, and small biotech firms, and has successfully led nonclinical regulatory activities for multiple small molecule and biologics filings in both the EU and US.

Common Non-Clinical Deficiencies & Issues in Regulatory Submissions

Non-clinical studies form the backbone of early drug development, providing critical safety and pharmacological data that support the initiation and continuation of clinical trials. Despite their importance, regulatory submissions such as INDs, CTAs, MAAs, and NDAs frequently encounter delays or setbacks due to avoidable non-clinical deficiencies. These issues often stem from gaps in study design, documentation, regulatory misalignment, or failure to meet region-specific expectations. This presentation aims to highlight the most common non-clinical pitfalls observed by regulatory agencies and offer practical strategies to enhance submission quality, minimise regulatory risk, and ensure a smoother path to clinical development and marketing approval.

This webinar is sponsored through Aston University’s active involvement with the West Midlands Health Tech Innovation Accelerator (WMTHIA). The WMHTIA is funded by the Department for Science, Innovation and Technology, in partnership with the West Midlands Combined Authority and Innovate UK.

Join us in kicking off our 2025-2026 academic year's SPARK Studio sessions, with Jack Armstrong the Business Development Manager for ERBC in the UK and Ireland. To join this online session, please register here.

Are you developing a novel therapeutic and wondering what preclinical studies you need, when to start them, and which guidelines to follow? Join us for an in-depth webinar that unpacks the fundamentals of preclinical development, helping you navigate the complexities of regulatory requirements and timelines with confidence.

This session will cover:

• When preclinical studies are required in the drug development lifecycle

• Types of studies needed, including pharmacology, toxicology, safety pharmacology, and ADME#

• Typical study durations and planning considerations

• Key regulatory guidelines and authorities (EMA, MHRA, FDA, ICH) that inform study design and approval

• How to ensure compliance with GLP and international standards

• Common pitfalls and how to avoid delays during preclinical planning and execution

We’ll also be showcasing how ERBC, a leading preclinical CRO, supports biotech and pharma companies through this critical phase. ERBC is a full-service preclinical Contract Research Organisation (CRO) with over 50 years of experience. ERBC guides innovative life science companies through the complexities of preclinical development from early discovery to IND-enabling regulatory studies. By bridging emerging biotech and large pharma with highly specialized preclinical services, ERBC helps de-risk drug development programs and accelerate time-to-clinic. With a broad scientific offering and expert teams across diverse therapeutic areas, ERBC is committed to helping the right drugs reach the patients who need them most.

This webinar is sponsored through Aston University’s active involvement with the West Midlands Health Tech Innovation Accelerator (WMTHIA). The WMHTIA is funded by the Department for Science, Innovation and Technology, in partnership with the West Midlands Combined Authority and Innovate UK.

Curious about how we accelerate preclinical innovation in the Midlands? Join us for a special open-door edition of our monthly SPARK Cohort Meeting during West Midlands Life Sciences Week. SPARK is a preclinical accelerator programme supporting academic and early-stage therapeutic development. Come meet our innovators, see how we support translational research, and explore opportunities to get involved.

To join us, please email spark-uk@aston.ac.uk

Join us for an exclusive evening with the Technology Supply Chain celebrating innovation within the sector as part of Life Sciences Week. This engaging innovation social is your opportunity to mix with key players, disruptors, and forward-thinking professionals driving innovation across life sciences. Enjoy a relaxed yet vibrant setting in Hotel du Vin, complete with complimentary drinks and canapés, while expanding your network and gaining fresh insights into the exciting future for Life Sciences in the region.

The evening includes a short briefing highlighting the latest trends and innovation breakthroughs impacting the life sciences with a focus on AI.

Whether you’re a business innovator, investor, or curious collaborator, this event offers valuable connections and perspectives to spark new possibilities.

Get a ticket for this event here.

To join this webinar, please register here.

In today's challenging biopharma world, treating your Target Product Profile (TPP) as a simple checklist is a recipe for disaster. It's time to create a TPP that not only secures regulatory approval but also drives long-term differentiation, market access, and commercial success.

Join us to discover how early, cross-functional alignment around a future-proofed TPP can help your biopharma team proactively navigate evolving clinical, competitive, and payer dynamics. We'll provide practical guidance and real-world insights to strengthen your decision-making, develop robust TPPs, and maximize asset value.

Leveraging Lumanity's extensive experience, we'll show you how a robust Early 360° TPP acts as a dynamic blueprint, guiding decisions from preclinical stages through commercialization. Our integrated, cross-functional approach helps teams shape strategies early for maximum commercial success by:

• Driving internal alignment across development and commercialization teams.

• Incorporating deep insights from evolving clinical, access, and competitive landscapes.

• Functioning as a living decision playbook adaptable at key milestones.

The Made in the UK, Sold to the World Roadshow events will bring together our overseas network of sector and market experts, international buyers, and UK businesses looking to seize the opportunity to grow their businesses internationally.

The Roadshows will provide multiple opportunities for direct contact with UK businesses across the Industrial Strategy sectors and places, engaging and collaborating with regional stakeholders and partners.

Come visit our stand at the Life Sciences focused Roadshow in Oxford. Learn more here.

Curious if your clinical research has real-world business potential? Join our panel discussion in unpacking how to navigate risk assessment and make confident, informed decisions about turning academic science into a viable commercial venture.

Join our panelists; Barbara Diehl (SPRIND), Peter Mumford (Potter Clarkson LLP) and Julia Wagner (Positron Ventures), by clicking here.

Barbara is a proven expert in entrepreneurship, innovation and education. In Oxford, she led early-stage investment programs and an executive education program for fast-growing small businesses. Following her return to Germany, she served as Director of Transfer and Innovation at the Helmholtz Association of German Research Centres, and now works at SPRIN-D, the German Federal Agency for Breakthrough Innovation.

Peter is a UK and European patent attorney specialising in chemical inventions, particularly small molecule therapeutics, pharmaceutical formulations, and new medical uses.  He works with a broad range of clients, with considerable experience of helping spin-off and start-up life science companies to prepare for fundraising as well as due diligence for investors.

Julia is an investor at Positron Ventures, focusing on early-stage deep tech start-ups across Europe. She is passionate about turning breakthrough science into scalable companies, holds a PhD from ETH Zurich, and previously built a student-led venture fund investing in university spin-offs.

Questions will be encouraged during this talk.

This showcase is sponsored through Aston University’s active involvement with the West Midlands Health Tech Innovation Accelerator (WMTHIA). The WMHTIA is funded by the Department for Science, Innovation and Technology, in partnership with the West Midlands Combined Authority and Innovate UK. 

🎉 Get ready for Astonbury 2025 – where music, magic, and memories collide! 🌟 Join us for an unforgettable weekend packed with epic performances, local legends, street food, and family fun. Don't miss the Midlands' biggest celebration of summer vibes! 🎶🍔☀️

Get tickets here.

Please note this workshop is an exclusive in-person training. If you are interested in joining, please email us at spark-uk@aston.ac.uk.

Poorly planned and executed clinical evaluations of medical devices is the number 1 reason for medical devices failing to achieve UKCA and CE marking. Notified bodies require a robust and scientific approach to clinical evaluations based on the current state of the art with sufficient evidence for the device under evaluation. 

The following workshop will provide participants with the following skills and education to help them prepare for the notified body assessment: 

• How to adequately conduct a state-of-the-art assessment and develop objectives and endpoints for the clinical evaluation. 

• Understanding the sufficient evidence requirements for the device under evaluation. 

• Claiming equivalence and the common pitfalls of the approach. 

• Expectations on clinical investigation design for conformity assessment process

• Post Market Clinical Follow Up – Its scientific purpose and the requirements to conduct these activities. 

This showcase is sponsored through Aston University’s active involvement with the West Midlands Health Tech Innovation Accelerator (WMTHIA). The WMHTIA is funded by the Department for Science, Innovation and Technology, in partnership with the West Midlands Combined Authority and Innovate UK. 

For the full event page, please click here

To join this FDA hosted webinar use this meeting link and the password: %KeTf9

On May 6, 2024, the U.S. Food and Drug Administration (FDA) issued a final rule amending the FDA's regulations to make explicit that in vitro diagnostic products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act) including when the manufacturer of the IVD is a laboratory. Along with that amendment, the FDA outlined a policy to phase out, over the course of four years, its general enforcement discretion approach to laboratory developed tests (LDTs). FDA expects compliance with establishment registration and device listing requirements for most IVDs offered as LDTs by May 6, 2025 (Stage 2 of the phaseout policy).

To register for this event, please click here.

With over 35 years of leadership in the MedTech industry, Mark Webster is a seasoned expert in the commercialisation of cutting-edge technologies, international sales strategy and market development. A former International Vice President, he has been responsible for driving significant increases in both market share and new technology uptake across EMEA and Latin America, in so doing achieving high revenue and EBITDA growth in a variety of market segments. 

Recognised for this deep expertise in new technology commercialisation, Mark has a proven track record of transforming market strategies into sustained, high-revenue outcomes. He has a large network of key thought-out leaders, physicians and guideline bodies, which are pivotal in introducing and scaling life-saving innovations globally. 

Following recent retirement from his executive roles, he continues to serve on numerous boards, including as a trustee of Resuscitation Council UK, contributing to the advancement of life-saving interventions in resuscitation. 

A Fellow of the Royal Society of Arts, Mark is also an experienced speaker and mentor. He will share insights on technology commercialisation, sales strategy and scaling operations, hopefully inspiring the next generation of entrepreneurs and leaders in the health-tech space. 

This SPARK The Midlands event is part of Aston University's active involvement in the delivery of the West Midlands Health Tech Innovation Accelerator (WMTHIA). The WMHTIA is funded by the Department for Science, Innovation and Technology, in partnership with the West Midlands Combined Authority and Innovate UK. 

To access this meeting on Teams, please use Meeting ID: 324 096 054 458 Passcode: xHVSCh

This SPARK Studio session will provide a high-level overview of the U.S. FDA regulatory framework for medical devices, focusing on key requirements for manufacturers. Topics will cover FDA classification system (Class I, II and III), product code selection and premarket pathways (i.e. 510(k), PMA, De Novo). Attendees will gain insights into the submission process, predicate device selection, and ongoing compliance obligations under FDA guidelines. 

Alexandra (Alex) Schardt, Manager, Regulatory Affairs for MCRA will be hosting this talk. Alex has over 7 years  of experience in the biotechnology industry and medical device regulatory affairs. Alex is RAC-certified in medical device regulatory affairs. 

As Manager, Regulatory Affairs, she specialises in both US FDA and international regulatory strategy, writing regulatory submissions, development and maintenance of technical and regulatory documentation, conducting systemic literature reviews, and performing gap analyses. She leads and supports regulatory projects from regulatory strategy assessments through final submission writing and communications with the FDA and Notified Bodies. Alex has supported projects including Clinical Evaluation Reports (CERs), Technical Documentations, 510(k)s, Pre-Submissions, De Novo 510(k)s, Investigational Device Exemptions (IDE), and Premarket Approval (PMAs). She has supported regulatory projects in the orthopaedic, spine, neurology, and cardiovascular spaces. 

Before joining MCRA in 2021, Alexandra worked in viral vector product development at a privately hed biotech company. Alexdra received her Bachelor of Science for Gettysburg College in Biochemistry and Molecular Biology. Alexandra also received a Master of Science in Biotechnology from Johns Hopkins University, concentrated in Regulatory Affairs. 

This SPARK The Midlands event is being delivered as part of Aston University's active involvement in the delivery of the West Midlands Health Tech Innovation Accelerator (WMHTIA). The WMHTIA is funded by the Department for Science, Innovation and Technology, in partnership with Innovate UK and the West Midlands Combined Authority.

To register, click here.

From 4-6 November 2024 leading biotech and biopharma companies and development teams will gather in Stockholm, Sweden to realise BIO-Europe 2024.

BIO-Europe is Europe's largest life sciences partnering conference, designed to foster collaboration, investment, and innovation in the biotechnology, pharmaceutical, and healthcare sectors. It typically gathers thousands of industry leaders, investors, innovators, and business development executives from around the world. The event is known for its one-to-one meetings, networking opportunities, and panel discussions, offering participants the chance to explore new partnerships, funding opportunities, and emerging trends in the life sciences.

BIO-Europe features:

• One-on-One Partnering: Facilitated through a partnering platform, allowing participants to schedule meetings with potential collaborators, investors, and other stakeholders.

• Presentations and Panels: Covering key topics like drug development, emerging biotech innovations, healthcare technologies, regulatory challenges, and market trends.

• Company Showcases: Startups and established companies present their innovations, research, and solutions to attract investment and collaboration.

• Workshops and Networking: Opportunities to connect with industry leaders and experts, share knowledge, and explore synergies.

SPARK The Midlands is joining forces with the Science Entrepreneur Club and their BioEntrepreneur group to host an evening for the SPARK teams to engage with C suite professionals in the health and biotech sector.

For more information on this event, please get in touch with us via the Contact page or email us directly on spark-uk@aston.ac.uk

Drug Safety Forum 2024: A Patient First Approach to Translational Safety. From Nonclinical to Clinical.

Presented by Apconix and held in the Wellcome Collection.

For more information on this event, please click here.

To register for this event, please click here

For this SPARK Studio, Mark Grumbridge, the MHRA Head of Clinical Investigations, will be talking us the through what to expect when applying for authorisation to conduct a clinical investigation of a medical device in the UK. 

Mark is an NMC registered nurse, first qualifying for this position in 1991. Since March 2022 he has been the Head of Clinical Investigations at MHRA having previously held the role of Senior Clinical Advisor and has worked at the MHRA since January 2012. 

He is also a committee member for ISO 14155 (Clinical Investigation of Medical Devices) representing MHRA and the UK. 

His role at the MHRA involves managing all aspects of clinical investigations including: 

• Provision of advice and support for applicants 

• Sourcing expertise 

• Reviewing applications for clinical investigations 

• Managing a team of regulatory handlers 

• Implementing regulation 

Mark has an NHS career spanning over 35 years and has worked in many clinical areas including Haematology, Acute Medicine, Senior Management and Project Management. 

This SPARK The Midlands is being delivered as part of Aston University's active involvement in the delivery of the West Midlands Health Tech Innovation Accelerator (WMHTIA). The WMHTIA is funded by the Department for Science, Innovation and Technology, in partnership with Innovate UK and the West Midlands Combined Authority. 

To register for this event, please follow this link

Join SPARK The Midlands for an insightful discussion on 'Life Science Pitch Strategies and VC Due Diligence.' Dr Glenn Crocker MBE will explore the critical elements of early stage pitches and the rigorous due diligence process. Attendees will gain valuable insights into how to effectively present preclinical research to potential investors, highlighting key factors that VCs consider when evaluating early-stage medtech, biotech and pharmaceutical ventures. 

Topics will include:

• What an early-stage investor is looking for;

• Crafting compelling pitches that capture investor interest; 

• Understanding the due diligence process from a venture capital perspective; 

• Strategies for showcasing the scientific, commercial and financial viability of preclinical projects; 

• Real-world case studies and lessons learned from successful funding rounds. 

This discussion is essential for entrepeneurs, researchers and startup teams looking to secure venture capital funding for their preclinical innovations. 

This talk will be led by Dr Glenn Crocker, who is Executive Director of Pioneer Group, a company that creates human and planetary health ecosystems through venture building and real estate. 

At Pioneer, Glenn is responsible for the venture building and venture investment business. Over 30 years in the industry, he has co-founded and invested in many life science companies, especially in the discovery and development services sector. 

As founding CEO of BioCity Group, he built a successful business that was acquired by Trinity Investment Management in 2021, providing an excellent exit for shareholders and leading to the formation of Pioneer Group.

He has a D Phil in Immunology from Oxford University and qualified as a chartered accountant with EY, where he ran the UK Biotech practice. In 2014 he awarded an MBE for services to the biotechnology industry. 

This SPARK The Midlands event is being delivered as part of Aston University's active involvement in the delivery of the West Midlands Health Tech Innovation Accelerator (WMHTIA). The WMHTIA is funded by the Department of Science, Innovation and Technology, in partnership with Innovate UK and the West Midlands Combined Authority. 

To register for this event, please click here.

Do you want to propel your start-up or innovative project to new heights? A collaboration or partnership with a large medtech or pharma company might be a valuable opportunity to explore. Depending on your needs, it could provide access to funding, resources, expertise, and networks which are otherwise might otherwise remain out of reach. In turn this could help to speed up development and enhance the overall probability of regulatory approval and market success for a new healthcare intervention, thus de-risking the overall development.

To a start-up company , the process of building a collaboration with a large healthcare company might seem daunting and the criteria used for assessing potential deals unclear. During this Johnson & Johnson Innovation – JLABS program we will demystify what due diligence entails, what the pitfalls are and how you might set yourself up for success.