With nearly 20 years of experience in clinical development, Tom Hoggan brings a wealth of knowledge and a proven track record to biotech companies of all sizes. Having overseen over 100 projects across various therapeutic areas, Tom understands the complexities of each phase of clinical development, which has led him to establish Hoggan Biotech Consulting.
His global experience and unique insights into FDA, EMA, and MHRA processes make him an invaluable partner for your clinical development needs. His expertise, alongside established relationships, ensures your team can continue to focus on their core skills, without having to invest in significant hires or to manage several consultants or advisors
Tom's bespoke asset development processes, coupled with his broad network of key opinion leaders (KOLs) and subject matter experts (SMEs), ensure that your project will receive the strategic guidance and support it needs to succeed. Whether you're a start-up or a large pharmaceutical company, Tom's hands-on approach and extensive industry relationships will drive your project from inception to market approval.
"Tom deals with and understands all the elements of a clinical development program from regulatory to commercialisation and is able to confidently guide clients, small and large, through the complexities of navigating their path to market."
Through Hoggan Biotech Consulting, Tom offers expertise that can be tailored for your specific needs. You may have existing expertise in house, you may not. You may require simple guidance or a clear roadmap. It may be that you need a full clinical and commercial strategy with a valued partner throughout the development process. Tom can tailor his services to suit your specific needs.
Working with Tom and his network means you don’t have to necessarily make expensive strategic internal hires until your clinical development plan is in progress.
The flexibility that Tom’s executive consultancy offers means you can utilise his expertise to de-risk as much as possible the path of clinical development for your asset.
Create a strategy that will lead to increasing engagement and excitement from all potential stakeholders, boosting product value and future revenues.
Utilise Tom’s extensive network and experience to Leverage expertise to obtain the best data and insights for development planning and strategy.
Tom will lead risk-based evaluations of pre-clinical assets, assessing needs, competitive landscape, market trends, and revenue potential.
Tom can ensure the right expertise is brought in at the right time to drive development plans and execution, avoiding costly hires at the wrong time.
Utilise Tom’s extensive industry networks and relationships with major CROs to pull in the right partners.
"Tom has a depth of experience in the industry and an unrivalled ability to truly understand unique and often complex client challenges and goals. His ability to develop robust and innovative customised solutions, whilst ensuring patient empathy is at the heart of the strategy, makes him a true rare talent."
Situation
A small US biotech company acquired their first asset – a biologic treatment for a rare pulmonary disease – and had no clinical trial experience in-house.
Approach
Tom worked with clinical, regulatory, statistical, and logistics experts to prepare a clinical development strategy, including a phase I study and an adaptive-design pivotal trial. He also identified a CRO partner to execute the clinical trials.
Result
The plan for the clinical development of this rare disease asset received regulatory acceptance, and the client signed a significant deal with a commercial partner for rights to market the product in North America.
Situation
A mid-size US biotech company considered purchasing a new asset under development to serve an unmet gastrointestinal need but lacked in-house asset evaluation expertise.
Approach
Tom performed a full asset evaluation to assess the clinical need, market landscape and trends, development strategy, costs, revenue potential, and risks. He acquired data and interviewed several payers and prescribers as part of the project.
Result
The client made an offer to acquire the asset at a price that balanced risk and potential reward.
Situation
A small UK biotech company needed a clinical development plan for their lead asset under development for a rare neurological disorder with no current treatment options.
Approach
Tom identified and worked with key opinion leaders worldwide to guide the clinical development strategy and ensure that the clinical trials would explore the most relevant endpoints in the most appropriate population.
Result
The development of a clear, evidence-based plan to discuss with global regulatory agencies.
Situation
A small US start-up needed support with indication selection for their lead asset – an RNA product.
Approach
Tom completed a landscape analysis, balancing scientific data with clinical need. He designed a basket trial to explore leading indications at the earliest opportunity before narrowing the patient population for registrational studies.
Result
A basket trial design that efficiently explored the leading indications.
Situation
A small US biotech company acquired their first asset – a biologic treatment for a rare pulmonary disease – and had no clinical trial experience in-house.
Approach
Tom worked with clinical, regulatory, statistical, and logistics experts to prepare a clinical development strategy, including a phase I study and an adaptive-design pivotal trial. He also identified a CRO partner to execute the clinical trials.
Result
The plan for the clinical development of this rare disease asset received regulatory acceptance, and the client signed a significant deal with a commercial partner for rights to market the product in North America.
Situation
A mid-size US biotech company considered purchasing a new asset under development to serve an unmet gastrointestinal need but lacked in-house asset evaluation expertise.
Approach
Tom performed a full asset evaluation to assess the clinical need, market landscape and trends, development strategy, costs, revenue potential, and risks. He acquired data and interviewed several payers and prescribers as part of the project.
Result
The client made an offer to acquire the asset at a price that balanced risk and potential reward.
Situation
A small UK biotech company needed a clinical development plan for their lead asset under development for a rare neurological disorder with no current treatment options.
Approach
Tom identified and worked with key opinion leaders worldwide to guide the clinical development strategy and ensure that the clinical trials would explore the most relevant endpoints in the most appropriate population.
Result
The development of a clear, evidence-based plan to discuss with global regulatory agencies.
Situation
A small US start-up needed support with indication selection for their lead asset – an RNA product.
Approach
Tom completed a landscape analysis, balancing scientific data with clinical need.
He designed a basket trial to explore leading indications at the earliest opportunity before narrowing the patient population for registrational studies.
Result
A basket trial design that efficiently explored the leading indications.
“Tom is an incredible team player who is key to the success of this organization and I am honored to work with him”
Ready to take your biotech project to the next level? Contact Tom today to discuss how his expertise can help you on the road to achieving your clinical development goals.
Telephone: +44 (0)7745 524246 Email: tom@hogganbiotechconsulting.com
Telephone: +44 07745 524246 Email: tom@hogganconsulting.com
