CAPITAL MARKETS & INVESTMENT

11:10 Panel: Leading the Way in Today’s Global Investment Landscape – New Innovations, Strategies and Future Outlook

It’s no secret that the funding environment took a major shock and reset in 2022. However, no matter what the current geopolitical climate or state of the capital markets, innovation continues at ever-increasing speed and this innovation needs funding. Investors continue to raise record breaking levels of capital from LPs through new and recharged funds, so will 2023 see an upturn? Unexpected events create unexpected challenges, and unexpected challenges breed new opportunities. Leading investors discuss the global investment landscape and shifts in public and private finance, as well as what they expect 2023 and onwards to hold.

• Where are the safe havens, if any, during uncertain times?
• Perspectives on the public markets and the trickle-down effect on private funding
• Is the investment community now prioritising early-stage investments?
• Is competition for deals higher than ever? What can biotech companies, whatever stage they are at, do to ensure they are most attractive for investment?

11:50 Cureline’s journey from the US to Europe, setting up R&D in Lithuania

Hear firsthand from Cureline, a leading human biospecimen CRO, that recently decided to invest in Lithuania. Get an exclusive insight into:

• Cureline’s clinical R&D strategy and the factors that made them choose Lithuania as its base for R&D.
• Discover why Lithuania has become an attractive destination for R&D-based operations.
• Hear about financial incentives available for R&D and manufacturing projects directly from Invest Lithuania representative.

12:10 Panel: Investing in the New Landscape – Future Directions in Neurodegenerative Disease

Recognition that aging populations will give rise to new healthcare needs, and heightened awareness of mental health issue, is bringing renewed focus to neurological health. Dementia is the most common degenerative neurological condition in the United States, with most cases coming from Alzheimer’s disease. In 2021, 653 clinical development programs for medicines to treat neurological diseases, 43% of which are for neurodegenerative medicines. An expert panel discusses the investment needed to overcome these obstacles and explore the future of NDD research financing and commercialisation.

• Current neurodegenerative drug development bottlenecks and progressing beyond them
• Exploring transformative new platforms on the horizon for Alzheimer’s, ALS, Parkinson’s, Huntington’s and more
• How to effectively incorporate novel research into drug development approach to maximize success commercially and in the clinic
• How new mechanisms and modalities have opened doors for early-stage investment
• Public market reception for neuro focused companies and the effect on M&A

PARTNERSHIPS & DEAL MAKING

11:10 Panel: The Next Era of Vaccinology: How Partnerships are Shaping the Future of Infectious Diseases

It has been a landmark year for vaccines with continued development of next-generation platforms and vaccines for unmet needs. What comes next? Opportunities to develop global partnerships and collaboration is clearer than ever. A panel of trail-blazing experts share experience and insights and on the future of this technology and wider therapeutic area of infectious diseases.

• How can new partnerships be leveraged to boost success?
• How do we sustain R&D innovation?
• The need for new human trial regulations to test vaccine efficacy – alternative routes to licensure?
• What are the next most exciting opportunities in infectious diseases?

11.50 New Approaches to Partnering with Novo Nordisk

Together with our partners, Novo Nordisk is committed to driving change in how the world sees, prevents, and treats diabetes, obesity and other serious chronic diseases. Taking the company in a new strategic direction requires an enhanced and renewed focus on partnering

• What is the new direction for the company?
• How to improve its pipeline?
• How best to communicate this strategy to both internal and external stakeholders?

John McDonald, Corporate Vice President, Global R&D Business Development, Novo Nordisk

12:10 Panel: Future Horizons in Oncology Therapeutics and Global Deal-Making

• Assessing the growing market for oncology drugs
• The types of products are oncology drug marketers are looking for and typical deal terms
• Current roadblocks, activities, and opportunities in oncology partnering in 2023
• Significant trends in oncology deal-making and identifying remaining areas of unmet medical need

CAPITAL DEPLOYMENT & COMMERCIALISATION STRATEGY

11:10 Go-It-Alone or Partner? A Review of First Launch and Partnering Trends

In Europe or the US, more than a 100 emerging biotech and pharmaceutical companies have commercialized themselves for the first time since 2011.  Should we launch ourselves, co-promote, our out-license in key regions?  This is one of the most strategic set of choices facing development-stage biotechs. What has been the experience of first-launch companies in rare disease, oncology and other therapeutic areas?  How are companies adapting to a more challenging funding environment? We will share an insight and benchmark-packed short presentation to set the stage for an expert panel discussion.  This is a must attend session for companies considering commercializing themselves. We will discuss: 

• A look at more than a decade of data for the US and EU markets (solo first launch, co-promote, out-license and key benchmarks)
• A spotlight on lean commercialization models and launches <$500M in peak sales
• Partnering across the R&D value chain
• Expert panel discussion and Q&A

Ben Hohn, Principal - Pharmaceuticals & Biotech, Emerging Pharma Lead, ZS Associates

11:30 Panel: First Launch and Partnering Trends

• Can we “go it alone”, and what have existing companies done?
• Partnering across the R&D value chain
• Should we partner in Europe, the US, or Japan/Asia?
• Preparing to launch – what and when? “Table stakes” vs differentiating?
• What best practices and innovations should we aspire for?

12:00 Panel: Biotech Valuation Tips, Tricks & Best Practices – Increasing the Value of your Company

Biotech companies with little to no revenue can still be worth billions. Despite facing some stiff headwinds, the biotech sector remains a strong engine for innovation, and small and emerging companies account for more than 50% of the current research and development pipeline. In uncertain times, with a market downturn and difficult geopolitical situations, how can a biotech company look to increase its value?

• Why we need to understand biotech valuation, and why biotech pipeline valuation is different
• Drug roulette? Switching business models to circumvent difficulties
• Alternative strategies to increase value of the company

Moderator: Matthew Cardinal, VP, Strategy & Program Leadership, Halloran Consulting
Sven Kili, CEO, Antion Biosciences
Duncan Young, Head of Business Development, Redx Pharma
Mike Booth, CFO, Crescendo Biologics
Bev Carr, CBO, Amphista Therapeutics
Giulia Vestri, Head of Business Development, Azafaros

14:40 Fast-Tracking Drug Development Through Understanding Key Decision Factors When Outsourcing to CRO

CRO have operated on a business model which predominantly focused on serving as external service providers for manufacturing mature pharmaceuticals, however in recent years a dramatic shift in business models have occurred. CRO have increasingly become leaders of innovation and are covering more areas of the Drug Development pipeline from discovery and pre-clinical through the clinical phases to post commercialisation – but what does this mean for biotech and pharma?

• Changing customer requirements leads to a change in business models
• The role of CROs in the production of medicines today.
• How these changes can be valuable to biotech and pharma

14:00 Panel: Early-stage Investment: What’s the New Normal for Biotech Funding?

Venture-capital funding and valuations for biotechnology start-ups remain high despite economic turmoil. For emerging biotech start-up companies, funding is one of the first challenges they will face and can influence the long-term success of a company. Spurred by the Covid-19 pandemic, new approaches to treating cancer, inflammatory diseases and other conditions have arrived, but how are they being sourced and funded?
A panel of expert early-stage investors with a keen eye for innovation discuss the latest innovations that excite them, their advice for biotech execs, and best practice in raising funds and positioning yourself as a leading, young company.

• What are the top priority areas for investment and how are the latest discoveries and technological advances being sourced?
• What are some of the factors which a company should possess to indicate they can be an attractive investment?
• How will biotech early-stage funding change in the coming year?
• How can founders and biotech execs prepare for the future?
  

14:50 Panel: What I Wish I Had Known When Taking Assets to the US Market

Entering new markets comes with many challenges; intellectual property (IP) licensing, transactions, agreements – the list goes on. Entering the US market is becoming a strategic consideration ever-earlier in the growth process for many biotech companies, and experience, knowledge, and effective due diligence in navigating the whole process can save time, money, and headaches down the line. A multi-stakeholder panel will discuss how companies and their investors can optimize their IP portfolios for entry to the US, ensure long-term success in securing capital from investors, prepare for licensing and transactions, and minimize litigation risk.

• How to put yourself in the best possible position for investment and deals
• What assets investors and partners will want to see in your IP portfolio
• How to protect privileged and confidential information during the due diligence process
• Experience and lessons learned about ‘what I wish I had known’ and ‘what I think I could have done better’

14:00 Panel: Accelerating Gene Therapies for Rare Disease Patients – Where Are the Bottlenecks & How Can We Overcome Them

New partnerships continue to emerge within the gene therapy field, but the past year has also flagged distinct development challenges that need to be overcome. Experts from pioneering companies and leading pharma the way to pinpoint these obstacles and explore how we can address them to bring gene therapies to patients more quickly, safely, and effectively:

• Adapting to the novelty of gene therapies with respect to regulatory, pricing, market access, and patient needs
• Accelerating gene therapy programs while maintaining safety and quality standards
• How new partnerships are being leveraged to advance the field
• Building out internal manufacturing capacity for commercial products
• Exploring the concept of centres of excellence versus multi-centre gene therapy
  

14:40 Debiopharm’s unique partnering approach to maximise patient access across the globe

With an emphasis on both in- and out-licensing, Debiopharm’s unique approach to forming partnerships bridges the gap between disruptive discovery products and real-world patient reach. With strong experience in clinical development manufacturing, attend this presentation to hear:

• Debiopharm’s licensing strategy, including both in- and out-licensing 
• The different types of partnerships which are possible
• Real-world examples of regional to global deals

Sandra von Meier, Head BD & Licensing, Debiopharm International 

15:00 Panel: Immuno-Inflammation: A Doorway to New Partners and Therapeutic Areas

Various dysfunctions in the immune system are the underlying cause for many health conditions, thus researching the mechanisms that drive these diseases can provide new insights across multiple therapeutic areas, ranging from neurodegenerative to cardiovascular diseases. Immuno-inflammation can also serve as a starting point leading to non-traditional partnerships between pharma, biotech, and research organisations. This panel gathers companies active in immunology & inflammation, discussing how they use this cross-indication response to identify R&D opportunities and inform their BD strategies.

• How can we gain a better understanding of our patients’ journeys to achieve enhanced outcomes?
• How can identifying new R&D opportunities inform BD strategies?
• What partnerships can we form with patient groups, research institutions, public health authorities, and others in the industry across diseases?
• What new innovations are coming down the pipeline, and how is the field as a whole developing? What are the future directions?

14:00 Ensuring A Swift And Successful Launch - Early Commercial Innovation & Planning

It may have previously been the norm to focus on clinical development and to leave commercial thinking to a bigger partner. However, as more and more companies choose to go it alone, or to do later stage deals, there is a need for asset owners to have a more granular understanding of their target market, the needs of their stakeholders, and the evidence required to ensure successful uptake and long-term differentiation

• Forming your target product profiles and development strategy
• Generating key data and information at every part of the development path
• Having a commercial strategy to work towards and selling this to stakeholders, investors and
  partners

14:40 Fast-Tracking Drug Development Through Understanding Key Decision Factors When Outsourcing to CDMOs

CDMOs have operated on a business model which predominantly focused on serving as external service providers for manufacturing mature pharmaceuticals, however in recent years a dramatic shift in business models have occurred. CDMOs have increasingly become leaders of innovation and are covering more areas of the Drug Development pipeline from discovery and pre-clinical through the clinical phases to post commercialisation – but what does this mean for biotech and pharma?

• Changing customer requirements leads to a change in business models
• The role of CDMOs in the production of medicines today.
• How these changes can be valuable to biotech and pharma

Jette Cowan, Head of Commercial – Pharmaceuticals, RSSL

15:00 Panel: Optimising the Value of your Asset For Entry Into the US and EU/UK Markets

Achieving a commercial transatlantic presence as a biotech company requires gaining regulatory approvals, and a successful launch of the product on the markets.  The development of a clear roadmap with the right strategy to overcome challenges will increase the value of your assets and can dramatically reduce the time taken to reach market.

• How to translate what we hear from regulatory bodies and payers/HTA bodies to inform our own internal decision-making?
• Major differences between US and EU/UK that you need to consider during development
• Lessons learned and tangible takeaways anyone can apply to their programs, today.

CAPITAL MARKETS & INVESTMENT

11:10 Panel: Mitigating Risks and Attracting Rewards – How To Capitalise and Spot Innovation

The past three years saw venture capitalists invest $52 billion into therapeutic-based biotech companies globally, with $35 billion of this going into startups with transformative platform technologies. This session explores how investors evaluate “the next big thing” and what biotech founders with novel or innovative technologies can do to put their best feet forwards.

•  How investors evaluate risk, particularly when looking at new fields or technologies
• Appetite for investing in novel biotechnologies vs platforms
• How investors keep on top of new ideas and what grabs their interest (and what turns them off)
• How to identify “must have” science early on
• Building an effective founding team including crucial roles and qualities
• Where to deploy capital at the outset and why
  

12:10 Panel: Navigating the Public Markets – Adapting to Shift in Dynamics

US biotech stock prices declined toward the end of 2021, following a bull run that started in 2020. Investors who had recently rejoiced in positive clinical news from public companies now fled from risk. Small-cap exchange-traded funds (ETFs) struggled against ETFs skewed toward mid- to large-cap biotechs. Although the recent downturn has been less severe for businesses with commercial-stage assets, most have been negatively affected.

• Perspectives on the public markets and impacts its having on private funding
• What are later-stage investors advising their portfolio and growing later stage biotechs
• Strategies to navigate the current volatile market
• How to develop a long-term value mindset
  

PARTNERSHIPS & DEAL MAKING

11:10 Panel: Emerging Pharma Deal-Making Take Centre stage – Shifts in Focus and New Opportunities

An increasing number of new and emerging deal makers at small pharma continue to make their mark, and with a shift towards commercialising products to serve orphan populations and specialist-treated conditions in recent years. While industry giants dominate the news, how are the Heads of BD and M&A at growing and emerging pharma viewing the landscape? A panel of top emerging pharma dealmakers discuss focus, strategy, and vision for becoming a lead player in the industry.

• Product acquisition vs in-licensing – what factors affect the decision-making process?
• How do emerging Pharma differentiate themselves and source aligned innovation
• New focus areas for 2023
• Are emerging pharma deal-making strategies evolving?
  

11:50 Panel: Research Beyond Borders - Developing Emerging Science For Unserved Patients

12:00 Panel : Early-Stage Pharma Partnering – Building a Strategy For Success

Partnerships with early-stage companies often spark some of the most innovative research and development collaborations in the healthcare industry. As breakthrough science continues to come from emerging biotech, the dynamics of innovation continue to evolve. The size, scale, expertise and connections of big pharma is still critical to the ecosystem, but are strategies changing? Pharma execs discuss how they are supporting innovation, sourcing and forming networks, and continuing to work to form win-win deals to partner with next wave biotechs.

• How are the industry biggest players looking to source innovation sooner and support the youngest startups?
• With a relative scarcity of capital are pharma seeing an increase in approaches for partnering?
• What are the key considerations for companies in their partnering strategy approaching pharma? What is most commonly overlooked?
• Which type of partnering at which stage?
  

CAPITAL DEPLOYMENT & COMMERCIALISATION STRATEGY

11:10 Planning for CGT Commercialisation: It Starts Sooner Thank You Think

Every decision throughout cell and gene therapy preclinical development is an opportunity to ensure future commercial success. From anticipating supply needs to planning ahead for commercial scale-up, what are the major factors that influence commercial readiness for these therapies at every stage?

• Which practical strategies enable a seamless, adaptive manufacturing plan from preclinical development to commercialization
• How integrated scale-down platforms can inform future scale-up decisions
• Where the industry is headed next with data analytics, automation and technology
  

12:00 Panel: Attract, Retain, Develop – Building a Leading Executive Team & Board

Recruiting and attracting talent remains a key priority and increasing challenge as companies grow and the industry matures. Competition for roles with the right experience or training is higher than ever and with an increasing demand for hybrid or virtual workforce, how can biopharma organisations ensure the right people for their organisations. Executives discuss and tackle the biggest challenges in attracting, retaining talent and building out boards.

• Small versus large company strategies and challenges
• Should companies be building management teams and boards bigger and sooner as seen in the US??
• How can companies work to maintain and retain top talent within their organisation?