SPECIAL ROUNDTABLE - Leadership Panel: 4 Trends That Will Have the Most Impact on Drug Development in 2024

Next-generation biomanufacturing, partnering for success, formulating the future, innovative therapies, manufacturing 4.0, patient-centric development, and quality management fundamentals were the hot topics of discussion at CPhI Barcelona 2023. These topics are the framework for what we anticipate seeing more of in 2024. Drug Development & Delivery asked some of today’s life science leaders what they expect will have the greatest impact on drug development this year and beyond. So, back by popular demand, below is the third annual exclusive Leadership Panel discussion.

1. DEMAND FOR COMPLEX INGREDIENTS

Dr. Paul Quigley, Principal Research Fellow, Drug Substance, Quotient Sciences – As promising treatments for onco­logical, chronic, and rare disease in­dications, the demand for more complex and potent active pharma­ceutical ingredients is on the rise. This is reflected in the global HPAPI mar­ket, forecast to be worth $81.8 billion by 2028 with a compound annual growth rate of 9.27%, up from $26.9 billion in 2023.¹ These complex potent materials provide enhanced therapeu­tic efficacy at low concentrations. Consequently, when harnessing com­pounds with increasing potency and complexity, only low quantities are re­quired in final formulations. As the chronic and rare disease patient pop­ulations tend to be small, contract development and manufacturing or­ganizations (CDMOs) — traditionally built for large-volume manufacturing — must adapt their capacity to cater to smaller-volume needs. This flexibil­ity is key to maintaining a competitive market advantage and meeting the ever-evolving needs of the industry. As the pharmaceutical industry moves to­ward new molecular entities (NMEs) such as HPAPIs and new modalities, the need for these products to be made at accelerated rates to meet in­dustry demand has been growing. In addition, the current financial con­straints impacting the biotech industry mean production processes need to be particularly cost-efficient.

2. A SAFER & RESILIENT SUPPLY CHAIN FOR GREENER MANUFACTURING

Felix Solamo, Senior Global Director, Field Applications Scientist from Purolite, an Ecolab Company – At CPhI Barcelona 2023, industry demon­strated continued commitment to ad­dressing the myriad of challenges within the biopharmaceutical industry, including the need to ensure security of supply and hurdles in meeting growing market demand for bioprocessing materials. Ensuring un­interrupted access to critical biopro­cessing materials is essential. Innovative technology in this area promises to revolutionize bioprocess­ing purification by widening the win­dow of operation for the elution of antibodies at a higher pH. Market de­mand for bioprocessing materials re­mains strong, driven by the growing pharmaceutical sector’s demand for high-quality resins. A focus on security of supply, strategic partnerships, cut­ting-edge technologies, and a keen understanding of market dynamics will continue making a significant im­pact in the industry.

Dr. Michael Quirmbach, CEO & President of CordenPharma – As we look ahead to 2024, there will be industry commitment to inno­vation, sustainability, and customer-centric solutions. This was evident at CPhI in Barcelona where key take­aways on the agenda included supply chain resilience and diversification, which are critically important topics. Industry’s ability to support a resilient supply chain and drive innovation with greener manufacturing processes will be highly valued, as the whole world continues to face geopolitical chal­lenges and sustainability concerns. To that end, there will be increased par­ticipation in the Science-Based Targets initiative (SBTi), which is committed to reducing global emissions by evaluat­ing and setting science-based reduc­tion targets that reflect an ongoing, proactive approach to environmental responsibility. In addition, utilizing green technologies, such as innovative methods for recycling solvents, Supercritical Fluid Chromatography (SFC), and continuous manufacturing demonstrates a commitment to environmental, social, and gover­nance (ESG) manufacturing processes, which is increasingly essential in the life sciences.

3. ADVANCED TECHNOLOGY

Ramesh Jagadeesan, PhD, Vice President, Analytical Development, Recipharm – The ever-evolving drug develop­ment landscape, which is enhanced by investments, novel technologies, patent expiries, collaborations, and a supportive regulatory environment, presents several key considerations as we move into 2024. As technology continues to advance and analytical capabilities progress, there is a need for more specialized and innovative testing.

Providing insight into specific characteristics, part of harnessing cus­tomized analytical testing is identifying the right techniques to use at the right time to get the most insight. The adop­tion of automated robotic systems in laboratories boosts efficiency, reduces errors, and increases productivity, and barcode-based management systems streamline inventory management and improve drug safety.

Joon Yoon, Senior Data Scientist, Samsung Biologics – Bringing in unprecedented effi­ciency may be to my knowledge one of greatest impacts Artificial Intelli­gence has had on drug development. Any in silico automation, from an ac­ademia perspective, can be consid­ered a work assisted by AI technology. Drug developers had wanted to find a way to reduce the so-called “search­ing space,” a pre-filtered range of drug combination to be considered in a wet-lab, in the pre-AI era in order to minimize and get a practical iteration number of experimental trials to find a compound with drug-like properties. The advent of AI in the early 2000s then enabled developers to reduce the searching space thanks to the ad­vances in computational power, which made the calculations/computations possible for reliable multimodal pre­diction models. The reduced search­ing space from testing a near-infinite number of drug-combinations to tens of thousands not only has empowered drug screening with the cost of rea­sonable time and budget, but also has made it easier to optimize the drug development process. Furthermore, with AI in hand, drug developers have become capable of predicting drug responses, helping them save a signif­icant amount of development time. The biopharmaceutical industry now has enough drug development data incorporated into an AI system that predicts chemical reactions and alerts which genetic modification could alter drug response. The AI-based drugs, or at least the drugs that were screened using AI, will soon become the norm in the near future.

4. SUSTAINABLE PACKAGING & ENVIRONMENTALLY FRIENDLY PRODUCTS

Chris Hirst, President, Advanced Delivery Systems Business Unit, Recipharm – Innovation is essential as the in­dustry considers pressurized metered dose inhalers (pMDIs) and their re­lease of hydrofluorocarbons (HFCs) into the atmosphere upon actuation. Given that existing HFC propellants have carbon footprints that are no longer acceptable to any of us, the transition to propellants with a lower global warming potential (GWP) is a priority for the pharmaceutical indus­try.² As a result of the Kigali Amend­ment to the Montreal Protocol, the introduction of legislation aims to phase down HFC use and promote the move towards low-GWP alterna­tives.³ In fact, the phase down of HFC use is accelerating in certain regions such that the availability of HFC-134a and -227ea in inhalers is likely to be impacted. As a result, pMDI develop­ers must navigate existing regulations and changing legislation, to effectively transition to low-GWP propellants in order to maintain patient access to this familiar and life-saving method of drug delivery.

Marcelo Cruz, Vice President Business Development & Marketing, Tjoapack – The pharmaceutical packaging sector played a significant role in addressing issues experienced by the wider industry, such as supply chain disruptions and regulatory hurdles during CPhI this year. The industry’s resilience and commitment to innovation were evident in the face of these challenges, along with the desire to enhance drug packaging solutions for safety, sustainability, and security. We discussed innovations in packaging materials, labeling, and serialization to combat counterfeit­ing and improve patient adherence. Reflecting on the learnings of CPhI, the outlook for the global pharmaceutical sector remains promising as we move into 2024. Advances in smart packaging technologies such as Radio Frequency Identification (RFID) and QR code integration will enhance traceability and ensure the authenticity of pharmaceutical products. RFID is being used increasingly to streamline the packaging process via a unique chip that processes information, such as the number of units or location. Overcoming challenges to ensure sustainability will con­tinue to be a focus, with eco-friendly packaging materials and reduced waste solutions gaining traction. Personalized medicine and collaboration between pharmaceutical developers and their packaging partners will be key to harnessing these trends to drive growth over the next 12 months.”

REFERENCES

1. High Potency APIs Market Size & Share Analysis – Growth Trends & Forecasts (2023-2028), Mordor Intelligence, https://www.mordorintelligence.com/industry-re­ports/highpotencyapis.
2. Pritchard, JN. “Change is in the air – the new pressurized metered-dose inhaler propellants.” Drug Delivery to the Lungs. Volume 33 (2022). Accessed December 6, 2023. https://ddl-conference.com/ddl2022/conference-papers/change-is-in-the- air-the-new-pressurized-metered-dose-inhaler-propellants/.
3. About Montreal Protocol, UN Environment Programme, https://www.unep.org/ozonaction/who-we-are/about-montreal-protocol.