… bye 2024, welcome 2025!

As groupH steps into its 20th Anniversary year, we’re thrilled to continue evolving and embracing innovative technologies and ideas to advance early-asset evaluation.

A heartfelt thank you to our clients, partners, and the team for being part of this incredible journey.

Wishing you a Merry Christmas, Happy Holidays, and a peaceful, well-deserved break. Here’s to continued growth and innovation in the year ahead!

The groupH Team

Citeline Elevate Commercial Event London, 4th December 2024: 5 Key Takeaways

I was delighted to attend the half-day Citeline Elevate Commercial event, focused on the pharma and bioindustry commercial landscape. It combined fireside chats, data insights and case studies in an intimate Whitehall setting in central London.

Here are my 5 key-take aways:

  1. Industry topline revenues are predicted to increase by 7.5% CAGR up to 2030 while internal R&D spend will decrease from 29% to 21% with the result of more externalisation of R&D activities. The market access landscape will become more hostile to new product launches [Daniel Chancellor, Norstella]
  • Fewer assets [on average] are predicted to come from inhouse development due to declining success rates and R&D productivity. This in return will drive deal-making and externalisation of R&D spend.
  • Increasing coverage burdens with US payers will put pressure on Pharma’s bottom line. Payers have learned how to control costs, i.e. tightening criteria for PAs (Prior Authorisations) and shifting burden to other players in the value chain. PBMs are anticipated to exercise more exclusions and providers will rely more on GPOs (Group Purchase Organisations) to counter 340B exposure and pressure on their GtN (Gross to Net)
  1. More assets – higher attrition: Phase 1 asset likelihood of approval has dropped from 9.6% to 6.7% on average
  • In 2023 the number of pipeline assets was 23k which was an all-time high and more than 1k Phase III trials were ongoing. While the future looks promising, however, with more assets comes higher attrition and the need to more effectively evaluate assets commercially at all stages of development and in particular those at earlier stages.
  1. ‘We course correct every 90 days’ – How Dynamic Shared Ownership [DSO] gives a glimpse of Bayer’s new mantra on keeping [organisationally] fit and think long term ahead of a patent cliff
  • Germany’s large pharma company is prescribing itself a new way of avoiding organisational silos and staying agile. Peter Cichon, VP, Business Development & Licensing shared its new vision of DSO, which will shape every function and level in the organisation.
  • For 1 + 1 = 5, the focus moves to the Early Space where the company sees more opportunity to add value and leverage its experience in key franchises such as women’s health and ophthalmology. Arms-Length models shape its collaboration philosophy and acquisition activities.
  1. ‘How can we AI this?’ – Tom Halliday and Vincent Spurr from Norstella illustrated their vision of future data analytics: Contextualising AI curated data for first-in-class and best-in-class treatments.
  2. AI: Good for drug discovery but not so good for drug development?!? – Scrip’s Kevin Grogan, Simon Turner from Sofinnova and Rob Grundy from Intelligent Omics explored this question and they are not so sure this is true. Better, faster, cheaper patient recruitment and retention through AI is already being worked on.
  • The discussion also highlighted that the desire to instil confidence in AI faces an interesting inherent paradox – the desire to protect AI’s IP is diametrically opposed to AI’s explainability. With this in mind, is the ‘black box’ argument resolvable?

For commercial analysis, get in touch
Erik Holzinger. Founder, groupH
erik.holzinger@grouph.com

New Product Planning Summit Boston 2024: 5 Key Takeaways

In October 2024, I attended and moderated a panel session at the New Product Planning (NPP) Summit in Boston. The NPP Summit is a gathering of biopharma and pharma professionals focusing on commercial and other NPP topics with lots of insightful presentations, networking, small group discussions, case studies and learning from others.

Here are my 5 key takeaways from the event:

1. You can’t afford to make any mistakes but if so, fail early

There is always a statement from a speaker that seems to stick in the mind even long after the event. Against the backdrop of another year of lacklustre investment in the biopharma industry and IRA forcing many companies to rethink their pipelines and programmes, for me this year, the statement was: ‘Failure is not an option’ from Steven Bloom, VinceRx. While not new, it sums up the current general mood and highlights an urgent call for action: To get even better at every aspect of what we are doing. Allowing to ‘Fail a programme early’ for commercial reasons is still not practiced enough for lack of commercial insight in the early stages of asset development.

2. The fallout from IRA so far, -13% for Part D drugs net but ‘on average’

IRA: While most presentations and panels covered this topic, there is still uncertainty about how this will play out in detail. The challenge IRA poses can seem somewhat overstated, while for individual products it can be substantial. ~80 Part B and Part D drugs will be subject to mandatory maximum fair price rebate negotiations by 2030. However, analysis of the first 10 drugs subject to rebate negotiations shows that the net impact, on average, is approx. -13% after IRA vs. rebates, and this is applicable only to the Part D portion of the payer mix. So, whether IRA will affect you or not will be on a case-by-case analysis.

3. AI: Too fast too soon – is it the end of the honeymoon period?

AI: Comments such as ‘too fast too soon’ echoed through some of the icebreaker exercises. Others referenced AI as the silver bullet that will help the industry to get better at what it is doing. The truth lies probably somewhere in the middle and, notably, as is often the case with AI, it is not always clear if we talk about AI in drug discovery and disease diagnosis or AI and machine learning in analytics and market research or even genAI and LLMs.

4. The traditional LCM model is dead

Another thread that weaved itself through many panels covering TPP development, commercial strategy, pricing and HEOR was the call for more commercial insight and identification of critical value elements earlier in the drug development process together with the courage, if needed, to fail early. The (early) NPP voice is critical for this job and, making sure that it comes across loud enough. And, leveraging multi-indication potential in post-IRA times requires close and early collaboration between NPP and R&D teams. In this sense the traditional LCM model is changing.

5. Forecasting: Building consensus around assumptions is the hardest part

As the LCM model is changing in line with shorter ROI times and potential price pressure from IRA, forecasting processes need to adapt. It was concluded that consensus building around assumptions is the hardest part. The forecasting process is not static and finding the right update frequency, the right tools or platforms is very much driven by individual market characteristics, the stage of the programme and the size of the organisation. While the future of long-term strategic forecasting may one day be algorithm/AI based with much less PMR input, the present reality is that this future is not yet there and that forecast structure and transparency and human factors of how it is being delivered to senior management play a far greater role in the success of a programme than any forecasting tool.

Get in touch
Erik Holzinger. CEO, groupH
erik.holzinger@grouph.com

Insights from the New Product Planning Summit Boston 2024

Collective learning has been the main focus of this NPP Summit and how to best navigate IRA and leveraging AI during challenging times for biotech. On the topic of advanced forecasting this fantastic cross-industry panel shared their experiences on what panel and audience agreed was the main challenge: Managing the forecasting process and building team consensus around forecasting assumptions. Few were surprised that processes alignment with lifecycle and business needs play an important role but that, beyond this, unfortunately, there is no one-size-fits-all solution, only continuous evolution or well planned, customised step-change. Thanks to a very engaged and super-prepared panel, Ashley Robinson/BioMarin, Deepak Wadhwa/AZ, Aaron Furtado/Bayer and Mayank Misra/Soleno with Erik Holzinger/groupH moderating.

groupH London Away-Day: Celebrating Teamwork and Milestones

On Friday, 13th September 2024, the groupH core team and associates gathered in London for a special event at the Enrica Rocca Cooking School in Notting Hill, marking not only a memorable team experience but also the 10-year anniversaries of our dear colleagues, Sara Uttley and Anju Patel. Both were honored throughout the evening for their incredible contributions over the past decade.
This event was a testament to the strong bonds we’ve built as a team, and we’re excited for many more milestones to come!

 

Join groupH’s panel discussion on Advanced Forecasting – Organizing the Forecasting Process, Future Impact of IRA and AI at the NPP Summit Boston

 

groupH’s CEO Erik Holzinger will lead a panel discussion addressing the complex landscape of forecasting in different types of organizations. Discussions will focus on:

  • Which strategies do different types of organisations pursue to make the forecasting process more efficient?
  • Where do experts see AI’s potential to enhance forecast accuracy, support demand planning, offer more insightful analytics and optimize value?

Don’t miss this opportunity to hear from experienced professionals and gain valuable insights into the future of forecasting.

About Erik Holzinger, groupH:

Erik Holzinger MBA is the founder of groupH a Consulting company dedicated to commercial decision making and analysis. In recent years Erik has been particularly interested in exploring the topics such as forecasting efficiency and driving value at the more delicate, early stages of an asset when commercial and scientific uncertainty is still quite high. Erik is also active as a member of the ephmra Annual Conference Organizing Committee and co-founder of the ephmra Forecasting Forum. Prior to 2005, he was a Principal Consultant in the Pharmaceuticals and Biotechnology team at Wood Mackenzie and a Consultant at The Wilkerson Group. His native language is German, and he is fluent in English and Spanish. Erik enjoys living in South-West London with his family.

Find out more about the NPP Summit Boston, September 30, 2024:

Register for the event: https://www.newproductplanning.com/newproductplanningcom/register

See full list of speakers: https://www.newproductplanning.com/newproductplanningcom/speakers

View full programme: https://www.newproductplanning.com/newproductplanningcom/schedule

Any questions just get in touch – erik.holzinger@grouph.com

The groupH Team

ISPOR Conference “HEOR: A Transformative Force for Whole Health” Atlanta, 2024

The ISPOR 2024 conference in Atlanta is themed “HEOR: A Transformative Force for Whole Health”. Will this advocated, holistic approach to HEOR, which is conceptually not new, be reflected in future drug pricing?

In strategic forecasting, pricing and market access are key parameters. The Inflation Reduction Act has dominated the headlines on this topic since its introduction to the US in 2022. However, without much detail on its impact on net price being known yet, what can be learned from the initial negotiations?

No conference is without AI nowadays. What is the role of generative AI in Health HEOR and RWE? And, of course, Real World Data (RWD) and data analysis remain evergreen topics at ISPOR.

Key Takeaways

  • The benefits of a holistic approach to health are well accepted but value beyond the patient has yet to significantly and directly impact pricing and reimbursement decisions
  • The complexity emerging in IRA’s price-setting process was highlighted as CMS prepares for another round of negotiations
  • As generative AI continues to evolve, hurdles still have to be overcome before its transformative benefits can be realised
  • Integrating diverse RWD sources to create dependable and ethical evidence demands the overcoming of challenges in data accuracy, reliability and stakeholder communication

What we won’t forget from the conference

  • The IRA negotiation process and its likely outcome for manufacturers remains uncertain for now on many levels. However, for long term forecasting, a high-level, rule-of-thumb discount is needed for your forecast. groupH proposes to use an average rate of ~30% for the Medicare insured share of target patients from the year the IRA rebate might kick in onwards
  • RWD and HEOR remain evergreen topics. Important but only indirectly supporting key forecast assumptions
  • AI has also made its way to ISPOR. Its multitude of possible uses promise long term opportunity and transformation, but high validation and educational hurdles prevent any short term impact in market access or pricing & reimbursement
  • We note the continued, holistic approach to health that ISPOR has been advocating this year was expressed by numerous sessions focused on patient-centredness in research and decision making. But we also continue to watch how this approach will exactly
    translate to pricing negotiations in the long term

Please follow the link to a more detailed summary: EVENT SUMMARY

Summary is for long term forecasting specialists and strategic market access.

By Erik Holzinger, groupH, London and Keshalini Sabaratnam, London

 

Event Summary “German Chapter Meeting” Berlin, April 2024

We are almost one year on from ephmra’s 2023 annual conference when we were told that in the future, on average, AI will free up 37% of our time. For many this was a wake-up call at the time but one year later in Berlin, there is still a sentiment that it cannot yet be foreseen how exactly AI is going to change future market research and insight work. There are still relatively few pharma case studies around and overall AI literacy is only just emerging, similar to AI being as novel as a new molecule in Phase 1.

The ephmra German Chapter meeting was looking to provide not only more food-for-thought but also hands-on AI experience and perhaps a reminder that innovation is not all about AI.

Here is groupH’s pick of the key messages.

AI is not perfect but engage rather than wait

Paul Simmering from Team Q gave some background on the history of AI, its progress in recent years, its key principles and illustrated ways of how to customize AI for more relevant responses. In his view, the promise of AI lies in its ability to offer a bigger scale of analysis while also allowing more time for big-picture strategy, communication and action. QC measures, however, remain to be optimised to address potential issues with LLMs. These challenges include potentially imprecise, incomplete, obsolete, not-reproduceable or hallucinating responses, which may undermine trust in the technology.

Acquiring AI literacy includes refining prompt engineering skills

Guided hands-on AI training sessions helped to create synthetic respondents and AI images. We also used AI for the coding of open-ended questions and learned how to use the right prompts to find, extract and condense publicly available information with ChatGPT for a case study. In this example case study extracting and comparing existing or planned use of AI and other new technologies between the 2023 annual reports of Pfizer and AstraZeneca was possible in less than 2 minutes even for a less experienced AI user.

Traditional research formats such as ATUs are evolving

While popular and seen as indispensable, traditional message recall projects may suffer from shortcomings such as lack of actionability of outputs or potential inflation of ‘true’ impact while they are resource intensive and time consuming. Samy Issaoui from Instar suggests that more value can be generated with a more holistic approach involving customisable master KPI modules, expanded recall timeframes, use of chatbots and real-time dashboards.

What we won’t forget from the conference

  • Demystifying AI is much less daunting when organised as a series of informal workshops
  • There is another angle when looking at AI, not as a rising tide of new AI enabled tools but as a range of possibilities that may enhance or complement a given use-case
  • It is still early days for AI. Similar to a Phase 1, FIH drug trial, the milestone generates excitement but still carries a lot of uncertainty. Generative AI LLMs mimic human responses but unlike humans they do not [yet] have an internal view of the world and hence may lack the important attribute of reproducibility
  • Loft workspaces are nice but do come at the cost of climbing at least 5 flights of stairs in the typical Berlin early 20th century houses

By Erik Holzinger, groupH, London

 

Seasons Greetings 2023

Unlike 2022, luckily our Christmas lunch gathering has not been affected by any train or air travel strike action this year.  So some of the people who make up groupH in Europe came together at the Zetter Townhouse for a couple of hours. Special thanks to our cello player Garwin Lynnell for not only a rendition of Bach but also of Kraftwerk – very special indeed.

We will be off to a short break and look forward to serve you again in 2024.

The groupH team

Happy Holidays from the groupH team

Dear clients and colleagues,

As another year draws to a close, it is not only friends, colleagues and family who have been sitting at work and dinner tables this year, but also a new visitor called AI. We hope you like the illustration on our Christmas card and that meeting AI is the ‘beginning of a beautiful friendship’ as in ‘Casablanca’, rather than the fate of HAL9000 in 2001: A Space Odyssey, who faced deactivation in the end.

I leave you with a quote from the physicist Richard P. Feynman “I can live with doubt and uncertainty and not knowing. I think it is much more interesting to live not knowing than to have answers that might be wrong.”

Thank you to all our clients, collaborators, associates and friends and to all their families who supported us whilst we delivered on our work commitments throughout the year. Thanks to Yasmin El-Saie, our resident artist for the drawing (www.yasminelsaie.com)

The groupH Team