Eight Themes That Will Shape Biopharma In Transformational 2021
Source : IN VIVO
“2021 will be a transformative year for biopharma and the life sciences. It will be the year where the credibility and power of science applied to human health will shine.” These words from Usman “Oz” Azam, president and CEO of Tmunity Therapeutics Inc., encapsulate the feelings of many of those working in a sector that has delivered vaccines and therapeutics at unprecedented speed in response to a terrifying new infectious disease that swept around the world in a few short weeks.
“It’s the year that we will hopefully recognize the personal investment by countless women and men in the life sciences around the world that tirelessly helped to stem a modern pandemic by developing innovation at breakneck speed. It’s the year where we will dare to say we can see a path to ‘cure’ certain diseases. It’s the year we will realize hope after the dark,” said Azam.
Again, his words reflect a general feeling that the technology, ingenuity, collaborative spirit and sheer effectiveness demonstrated by the life sciences community in 2020 will continue to be deployed in many different areas to the benefit of global health beyond the immediate crisis of COVID-19.
Meanwhile, actions and adaptations necessitated by the pandemic are widely expected to lead to lasting changes in the way the industry operates. “If I had to give you one word, I would say transformational. That would be my headline, because COVID, in my mind, has not created any new trend but it has accelerated trends that were already emerging,” said Victor Bulto, president of Novartis AG US, when asked for his outlook for 2021. And those trends are not going away. “We are off to a big transformation, embracing hybrid models of interaction both with patients, with physicians. Whoever goes faster and the smartest with that transformation will have a big advantage in the marketplace next year.”
1. Efficiency and Speed – Lessons From Fighting COVID-19
2. Decentralized Trials Come Of Age
3. Diversity Matters
4. Data And Digital Will Gather Pace
5. Manufacturing And Supply Shifts
6. Oncology Firing On All Cylinders
7. There’s Mileage In mRNA
8. Deals And Investment Will Continue Apace
It is well known that it typically takes a decade or more to develop a new pharmaceutical product for market. Will that change after the industry produced and rolled out safe and effective vaccines within a year of COVID-19 being identified as a novel virus?Many industry leaders believe so.
"2021 will actually see a positive and long-lasting impact from COVID-19 in that inefficiencies in the system, particularly when it comes to lack of scale and cost, have been highlighted in a massive way and as a result, structural changes will be implemented," said Ken Chahine, CEO of AI-based cancer detection test developer Helio Health.
David Lucchino,co-founder, president and CEO of biotech company Frequency Therapeutics Inc., expected that "in the years ahead [the industry's] 'pandemic problem solving' mindset will continue to pay off as we more quickly look to adopt novel platforms and approaches to attack the most complex challenges in medicine."
Executives expect change across the board, from product discovery to clinical trials to regulatory review and beyond. Collaboration between companies, institutions and government agencies is expected to flourish.
“Cross-company and cross-industry collaboration fueled the biopharma and medical device industry’s pandemic response. A similar effort will be harnessed more broadly in 2021 and beyond to find breakthrough medicines for difficult-to-treat diseases where innovation may have previously been stalled,” predicted Karin Rosén, chief scientific officer of rheumatic and rare disease drug specialist Horizon Therapeutics plc. “If anything, the race to a safe and effective vaccine has reinvigorated the life sciences industry, and paved the way for faster medicine development.”
“The huge upheaval of processes and leveraging e-technology have brought dramatic improvements in efficiency, and I expect this to help streamline efforts across the industry. I also expect to see streamlining of our clinical trial efforts given the dramatic shift to virtual care and remote monitoring," said Phil Jones, vice president, therapeutics discovery, atthe University of Texas MD Anderson Cancer Center.
Dermavant Sciences Ltd. CEOTodd Zavodnickshared that view. "I often say that in order for Dermavant to succeed as a startup biotech, we need to be nimble, execution-focused and thoughtful in how we spend our money. Biopharma as a whole has shifted and demonstrated this in the face of the COVID-19 pandemic, and I believe this has enhanced the industry's efficiency and public perception as a whole," he said.
"This year has highlighted the ever-growing need for innovation in drug discovery and shone a light on how the pharmaceutical sector can quickly adapt and make a meaningful impact on humankind when it's facing one of its greatest challenges. The speed at which vaccines have been developed is immense and there is potential for this to continue across all clinical trial work in the future, so I'm hoping to see a more efficient and faster regulatory and development process for new life changing therapies after the pandemic," saidClive Dix, CEO of
C4X Discovery Holdings plc and interim chair of the UK's Vaccine Taskforce.
Daniel Chancellor, director of thought leadership at Informa Pharma Intelligence’s Datamonitor Healthcare, cautioned that this may take time, however: “It may be too soon to see regulatory flexibility necessitated by COVID-19 bleed through into general R&D, but expect the conversations to continue as to how best to capture the benefits of speed such as real-time, rolling reviews outside of oncology,” he said.
Still, optimism is in the air. “In 2021 we can build on the fruitful dynamics developed during the pandemic that significantly improved the relationships between companies, clinicians, regulators and state institutions. Greater speed and better collaborative spirit without compromising rigor and safety! We hope these new dynamics will continue to prevail to accelerate the development of novel therapies in different areas of high medical need,” said Philippe Pouletty, chair of Abivax and CEO of Truffle Capital.
“2021 will be the year of the global decentralized clinical trial,” declared John Reites, president technology and service provider THREAD, which specializes in enabling decentralized clinical research. “2021 is shaping up to be a transformative year for sponsors and CROs. Decentralized clinical trial (DCT) approaches, which have proven to be more sustainable in times of uncertainty, will take priority over traditional designs in 2021. Rather than adopting midway through the trial, as many did throughout the pandemic, studies will embrace DCT as their design of choice at the start of the planning process. As the industry aims to improve recruitment, retention, and data collection, there will be an increasingly heightened focus on trial flexibility and participant inclusivity. This focus will catalyze the industry’s inevitable shift to more global studies, powered by hybrid DCTs. 2021 will be a pivotal year for the expansion of global studies as the viability of traditional trials continues to dissipate.”
Reites was one of several executives who told us they expect a seismic shift in the conduct of clinical trials.
“2020 will be known as the year the biopharmaceutical industry (re)designed health care – and it will have enduring implications on the way we do business in 2021 and beyond,” said Rick Winningham, chair and CEO of Theravance Biopharma Inc., a member of the COVID R&D Alliance (which brings together more than 20 companies including most of the biggest global pharmaceutical companies). “Future innovations resulting from today’s vaccine and therapeutics, and also the application of digital solutions to advance non-coronavirus-related programs, will have impact across all stages of business from research and development to commercial products."
Winningham continued: “For example, we worked collaboratively with regulators to decentralize one of our clinical trials, balancing in-person and remote health care to improve safety for patients and health care professionals. This allowed participation from patients at home while ensuring data integrity in a clinical trial program we are conducting in a fragile patient population. This change was embraced by the community and will hopefully have a lasting imprint on how clinical trials are conducted far into the future.”
Peyton Howell is executive vice president and chief commercial and strategy officer of contract research organization Parexel. “Looking ahead to 2021, Parexel and other CROs will apply the lessons learned with a #NoGoingBack mentality,” she said. “We expect to see an increased adoption of decentralized clinical trials, also known as virtual clinical trials, a heightened focus on diversity and access to clinical trials, along with a continued focus on the heart of everything we do – patients.”
Stuart Peltz, CEO of PTC Therapeutics, Inc., agreed. “The pandemic stimulated a plethora of new ideas on how to do clinical trials. These changes have specifically impacted clinical trials and patient care, as we all began working remotely. This included remote patient assessments, telehealth evaluations, and remote monitoring devices. This trend will continue, and despite the new virtual format, we have not jeopardized the quality of care for the patients. In fact, my view is this new format can actually accelerate trial enrollment in 2021 – particularly for patients living with rare diseases who are often geographically far from the appropriate study center(s) or can’t travel."
Peltz added: “With the evolution of virtual and remote trials, patients no longer need to be put at increased risk by traveling into hospitals or trial sites, and with telehealth we’ll be better suited to provide faster and more frequent therapy interventions – all of which can help evolve our standard model of care. So, while the pandemic has made us find new ways to work, we’ve actually uncovered many improvements. From challenges comes opportunities to evolve and become more efficient, and I believe 2021 will allow for continued changes to the way trials are conducted, for the better of patients and their families.”
If 2020 was the year of the coronavirus pandemic, it was also the year when Black Live Matters went global, forcing society to acknowledge uncomfortable truths and about systemic inequality. Health care was no exception.
“Recognition of health inequities is not new, but the COVID-19 pandemic has helped bring this issue to the surface in a clear way, and we need to address it and find solutions to make sure everyone, despite their location, ethnicity, income, insurance, or socio-economic status, is able to access health care in a more equitable way,” said Gwen Nichols, chief medical officer of the Leukemia & Lymphoma Society. “As a hematologist/oncologist I am pained when I hear that people have to choose between the food on the table and their medical care, having to delay or avoid their medical screenings and life-saving treatments because they cannot pay for them. All the innovative treatments that we are funding and developing are only beneficial if people can actually access them. As we head into 2021, there is an urgency to address the issue of health inequities and a strong commitment from all members of the health care industry to find solutions that will allow equitable access. Together, we have the ability to tackle this, but our passion cannot wane and our mission cannot be diverted until it is solved.”
“For too long, clinical trial participants have not been representative of the broader patient population. With COVID-19 bringing the challenges diverse patients face into sharper focus, the industry must take more action to address health equity,” said Alexander Hardy, CEO of Genentech, Inc. . He pointed out that Genentech had rapidly designed a launched a clinical study in COVID-19 pneumonia in which around 85% of patients were people of color, “proving that including underrepresented groups in clinical trials is not only possible, but that it can be done quickly, even during a pandemic.!
“In 2021, we must be ambassadors of the industry standards set for inclusive clinical research and come together to make bold changes that advance health equity for all people," Hardy said. "We will build trust with patient communities to better understand their experiences, their needs and the obstacles that have prevented participation in clinical trials. In response, we will take action – ranging from taking trials into the community to making significant philanthropic investments – to address these obstacles, provide support and enable access for communities of color.”
“In 2021, I believe we will see more innovation around access to health care, including an increased focus on implementation science and addressing health disparities among people of color and other marginalized communities. These more creative approaches to health care will ensure we are better prepared for future pandemics while continuing to find creative solutions for other public health crises, like HIV,” said Lynn Baxter, head of North America at ViiV Healthcare.
“In 2021, society will challenge our companies to collaborate more as innovators and corporate citizens when addressing what matters to them,” said Doug Langa, executive vice president, North America Operations and president of Novo Nordisk A/S. He believes this goes beyond just developing more medicines, faster. “The pandemic should propel us to really make fighting chronic diseases like obesity and diabetes national priorities because we saw how people with these conditions, especially within communities of color, were hit hard. That includes doing better at calling out and reducing the disparities that may prevent people from getting the care they need and working across the public and private sectors to create meaningful change.”
“COVID-19 has accelerated the application of data and digital in drug development. I expect 2021 will see increased utilization and acceptance of both real-world data and digital tools in 'normal' circumstances given our reliance on them during the pandemic." These sentiments of Anne Heatherington, head of the Data Sciences Institute, Research & Development, at Takeda Pharmaceutical Co. Ltd., were broadly shared.
“The future of biopharma will be significantly impacted by greater and more sophisticated use of data and technology. Advanced analysis of historical clinical trial data allows for real time optimization of industrial processes and personalized treatments. Combining data like these with those from the complex multi-omics that represent the total physiology of a human will lead to increasingly more precise tools, enabling greater discovery of new therapeutic targets and more possibilities of precision intervention. One such tool is simulation, which will increasingly give us a greater reflection of reality,” said Mimi Keshani, vice president of operations at deep tech startup Hadean.
“It is inevitable that someday all drugs and medical devices will undergo a series of in silico (virtual) trials before animal or human ones can begin, and it’s possible it could be the only trial necessary," she said. “In 2021 we expect to see regulation beginning to catch up to this idea, with the FDA already signaling a mandate may be coming soon. These innovative solutions are also contributing towards the wider influence of preventative methods. With more vaccines and curative therapies available, drugs used in the treatment of these diseases will in turn be less in demand in the future and forward looking firms will already be looking to adapt their business models. On top of all of this, COVID has caused an unexpected increased need for remote services, adding a further weight to technology. Digital therapeutics, telemedicine and remote monitoring through wearables will continue to boom as people look to access health care away from the clinic.”
Noticeably, the pandemic has helped move digital possibilities into actualities.
“For years, biopharma companies have had chief digital officers or digital strategists presenting the vision of what the future may bring for biopharma with the application of digital health technologies – but until 2020, this has been mostly hypothetical, with most companies finding it difficult to define a practical commercial strategy for value creation with digital health tools," said Michael Seggev, chief commercial officer of artificial intelligence-based health technology company Vocalis Health. "But as a result of COVID, the reality on the ground today has rapidly changed, and the barriers have fallen; we now have physician acceptance, customer demand, technological readiness and reimbursement approval for digital health technologies, and smart biopharma players will move quickly to implement and experiment with these technologies.”
Raj Kannan, CEO of Chiasma, Inc., which took its first medicine to market in 2020, also foresaw change – specifically around product launches. "While it is too soon to evaluate the full impact of the pandemic on drug launches, the traditional 'launch model' of a 'one-size-fits-all' may evolve to a hybrid model. Digital and quality remote engagement will continue to become increasingly important while simultaneously encouraging a local, digital and personal engagement launch strategy," he said.
Lisa Anson, CEO, Redx Pharma Plc, on the other hand, focused on the possibilities for R&D: “Sophisticated medical approaches and AI technologies, such as the protein structure at DeepMind, will continue to impact research in a meaningful way,” she said. UK-based DeepMind, an AI subsidiary of Google’s Alphabet Inc., has developed a tool to predict the 3-D shape of a protein based on its amino acid sequence, something that could enhance our understanding of disease and improve and speed up drug discovery.
The disruptions to workforce activity and travel occasioned by COVID-19 threw a spotlight onto risks in global supply chains in 2020. Industry leaders forecast changes such as a trend towards local manufacturing as a result. With the advent of vaccines and therapeutics for the coronavirus, urgently needed by the world’s population, the need for a huge manufacturing ramp-up also heaped pressure on industrial capacity. Meanwhile, the rapid maturation of various advanced therapies, such as CAR-T cell therapy and gene therapy, is creating additional demand for new types of manufacturing and distribution capability and capacity.
Ronald Piervincenzi, CEO of USP (US Pharmacopeia), the non-profit organization that develops standards to strengthen the global supply chain for medicines and supplements, thought that "the focus, as well as practical effort and supplies, on COVID-19 vaccines and therapies will overshadow and exacerbate the production and delivery of other key vaccines and therapeutics from infectious to rare diseases."
He warned, "The competition for raw materials, reagents, other disposables and facilities for manufacturing and testing of biologics could threaten the supply of quality biologics broadly. I believe this challenge is both temporary and necessary – but one that requires awareness and agility."
Mahesh Veerina, CEO of Cloudleaf, which provides digital tracking services for pharma supply chains, shared these concerns. “The operation to deliver a COVID-19 vaccine will put enormous pressure on the supply chain to share resources with other products that demand cold chain transit, including flu vaccines, cancer treatments, and genomics and precision medicine. The industry will make an unparalleled collaborative effort to communicate and share resources. New capabilities for tracking their assets such as palettes and temperature-controlled transport and storage devices will be the underpinning for this success.”
Tackling this challenge will have wider benefits, in Veerina’s view. “The work done in the cold chain for COVID-19 has put the industry 16-18 months ahead of schedule on digital transformation. In the long term, the supply chain practices adopted in response to the pandemic will position companies to avoid costs associated with lost or damaged products – a critical capability as the future of medicine points toward smaller batches of more personalized, higher value medicines, many of which will require cold chain transit.”
Meanwhile, Rajiv Khosla, CEO of contract development and manufacturing organization Enteris BioPharma Inc., noted, "The COVID-19 pandemic magnified how vulnerable the pharmaceutical industry is to global supply chain issues, specifically the heavy reliance on ex-US markets for key starting materials, intermediates and APIs needed to produce drugs, as well as the actual manufacturing of medications prescribed to millions of Americans. These are not new concerns, but the disruption brought on by COVID-19 has highlighted the need to return more of the manufacturing and supply chain to the US. Given these dynamics, we expect to see a sharp growth in demand for US-based CDMOs with the ability to handle complex manufacturing needs for specialty pharmaceutical and biotechnology companies."
Veerina also expected more localization of manufacturing. “Increased regionalized production of active pharmaceutical ingredients will catalyze a long-term policy shift throughout the global supply chain,” he said. “As a result of the drug shortages and stockpiling witnessed at the start of the COVID-19 pandemic, combined with global political tensions, pharmaceutical manufacturers will look to partner with local, near-shore active pharmaceutical ingredient (API) suppliers. This in turn will ensure that pharmaceutical products can be produced in the event of another global crisis -- eliminating the possibility of drug shortages. In 2021, the near-shore regionalization of APIs will cause a long-term policy shift throughout the global supply chain, fueling changes in supply chain behavior such as the creation of a larger, connected ecosystem within the supply chain. This ecosystem will result in the building of new partnerships between not only drug manufacturers and API suppliers, but also logistics providers, vendors and other organizations throughout the supply chain. As supply chain entities work to quickly form these new partnerships, the element of ’blind trust’ between long-time business partners will no longer be a factor and organizations will look to adopt new solutions that provide real-time visibility into a product’s location -- reassuring both parties that each other is on track.”
Dave Lennon, president, Novartis AG Gene Therapies, drew attention to the production of advanced therapies. “We will start to see the investments in manufacturing buildouts come to fruition with next generation engineering advances improving the industry’s capacity to reach patients and deliver on the promise of gene therapy,” he predicted.
Jennifer Buell, president and chief operating officer of immuno-oncology developer Agenus Inc., noted that “Manufacturing and supply chain independence will be critical. Production space is at a premium and independence here will be coveted.” Her company, which manufactures both antibodies and autologous and personalized cancer vaccines, has been expanding its own production capacity.
With oncology still representing a large minority of all biopharma R&D, and attracting high levels of public and private financing, the focus on COVID-19 has not dampened expectations for progress in treating cancer.
“I believe that 2021 will be the year when biopharma renews the commitment to get to cures in oncology,” was the prediction of Peter Lebowitz, global oncology therapeutic area head at Janssen Pharmaceutica Inc.. “With novel technologies and highly actionable science, the time is ripe to develop anticancer regimens with curative intent. With data science, the time is now to approach cancer biology with better focus. With cancer interception, the world is ready for us to change the paradigm in order to eliminate disease.”
Others homed in on specific advances expected this year. For example, Genenta’s chief medical officer, Carlo Russo, thought 2021 would “see a new phase for gene therapy: the first clinical evidence of its utility in the treatment of solid cancers.”
He wasn’t the only one to anticipate progress in the treatment of solid tumors. Christi Shaw, CEO of Gilead Sciences, Inc. subsidiary Kite, said: “In CAR T-cell therapy, the industry is poised to deliver treatments for more types of cancer, including advances for solid tumor research, as well as in earlier lines of therapy – potentially bringing this promising therapy to more patients.”
Others highlighted expectations for advances in diverse and intersecting areas of cancer therapeutic development, including harnessing a growing understanding of the mechanics of the tumor micro-environment, applications of precision medicine, combination approaches and the promise of new immuno-oncology targets including TIGIT, CD155 and A2A.
“Despite the huge innovation in cancer immunotherapy over the past decade, currently only a minority of patients realize durable benefit from existing checkpoint therapies so there remains a huge need to develop more effective options,” said Markku Jalkanen, CEO of immunotherapy-focused Faron Pharmaceuticals Oy. “Our growing understanding of how the tumor microenvironment (TME) shields a cancer from the immune system and fuels its growth – including so called ‘don’t eat me’ signaling – makes it a clear target for the next generation of immunotherapies and we are likely to see further clinical data from a number of companies in 2021.”
Chris Boshoff outlined a couple of areas of focus for Pfizer Inc. Oncology, where he is chief development officer: “More and more, we will see the use of liquid biopsies to select patients for cancer studies, to inform decisions regarding new therapies and to intercept disease at an early stage. Expansion of the use of liquid biopsies, that detect either circulating tumor DNA (ctDNA) or methylated DNA fragments from blood plasma, has the potential to transform cancer medicine. With increased sensitivity, ctDNA detection could allow us to identify cancer earlier and potentially also dictate randomization to new treatments for M0 disease, which is disease that has spread as detected by molecular blood analyses, but not by conventional imaging. We plan to integrate liquid biopsies in studies initiating in 2021 for M0 breast cancer. These studies could inform the development of our portfolio of next-generation CDK inhibitors for HR+ breast cancer."
He went on, “2021 will also reveal the true potential of novel immunotherapies to transform the outcome of patients with certain hematological malignancies ... The appropriate sequencing and rational combinations of bispecific antibodies and CAR-T therapies that target B-cell maturation antigen (BCMA) and other antigens in multiple myeloma have the potential to transform outcomes for patients. The continued development of breakthrough treatments, specifically with bispecific antibodies targeting BCMA, is an exciting and fast-moving area where we will see great advancements in 2021. Pfizer is looking forward to launching new registration-enabling studies for our subcutaneously administered BCMA-CD3 bispecific antibody in 2021, including those as monotherapy and combination studies.”
“2021 will be the year of new vaccine technologies," declared Emmanuel Hanon, senior vice president of vaccines R&D at GlaxoSmithKline plc. "We will see the advancement and validation of disruptive platform technologies, as well as learn about their potential impact on humanity and our societies.”
One of the most exciting platform technologies is mRNA, and its potential application is broader than infectious disease.
Franz-Werner Haas is CEO of CureVac NV, which is hoping to launch an mRNA-based vaccine for COVID-19 in 2021. "The pioneering work in the mRNA technology that our founder Ingmar Hoerr started more than 20 years ago has now reached a high level of maturity especially in the vaccine field. However, the mRNA-based technologies open up several opportunities in various medical applications that go beyond prophylactic vaccines - such as against COVID-19," he noted. "This includes cancer immunotherapies and protein-based therapies. We are confident that this approach is an important contribution not only to the current situation, but also to global medical challenges of the future.”
“2021 is poised to be a breakthrough year, especially in the area of delivery of a range of genetic medicines including mRNA, small RNAs, protein and even mixed payloads for gene editing applications,” declared David Lockhart, CEO of ReCode Therapeutics. But he highlighted the challenges ahead.
“The most pressing need is to deliver these complex molecules to cells in organs and tissues beyond just the liver. Messenger RNA (mRNA) therapies in particular are poised to make a big impact in 2021. mRNA can now be designed for many purposes, made at scale and packaged in lipid nanoparticles (LNPs) for delivery to the body. Once inside cells, the delivered mRNA can instruct cells to make the encoded proteins, and this approach has become much more widely known thanks to the groundbreaking work of companies leveraging mRNA as a foundational element of COVID-19 vaccines. However, mRNA medicines, gene editing approaches and other genetic therapies continue to face the important challenge of how to deliver them to the right cells in the right tissues in the right amounts. And this has been particularly difficult in the case of delivery outside the liver, especially with systemic administration. Given the clear importance and the increased attention on these challenges, we expect to see great progress around delivery technologies that enable genetic medicines to be directed to organs and tissues in a predictable fashion.” ReCode has developed technology to tune the delivery of mRNA and other cargos encapsulated in LNPs to previously unreachable organs, tissues, and cells types.
Companies in the sector found funds flowing strongly through 2020. The amount raised by biotech companies through initial public offerings increase nearly three-fold to $17bn in the US alone, while US venture capital financing totaled a record-breaking $27.4bn. The mood among industry leaders is bullish on the investment front.
"In 2020, biopharma was the industry that responded to the global call for a solution to a once in a century pandemic that has crippled world economies and caused so much death and despair. I expect and hope that in 2021 we will see full realization and appreciation of the global social impact of this industry, translating to greater investment into biotech and bigger bets on technologies to address unsolved diseases and historically undrugged targets,” said Nello Mainolfi, CEO of Kymera Therapeutics, Inc., which develops protein degrader therapeutics.
Ken Krisko, a US-based partner in the life sciences corporate partnering and licensing group at law firm Cooley LLP, was optimistic investment will increase. “The seemingly insatiable appetite of US investors continues to support growth in the sector, particularly in Europe. The flow of the public market cash firehouse hasn’t ebbed. Companies with platform potential and high differentiation continue to attract investors. SPACs [Special Purpose Acquisition Companies] are the life science industry’s ‘bellbottoms’ attracting new money and companies – a unique opportunity for UK and European companies that opt not to pursue the crossover route to US public market financing.”
He continued: “Market indicators also point to a brisk pace for acquisition and collaboration deal making. The drive toward public market financing and acquisition means that many companies with cash will look less to asset dilutive transactions and more toward a later value inflection. Companies will continue to search for value earlier with discovery collaboration deals back in vogue. Novel technologies accelerate these trends and sustain value for acquisition opportunities. Larger companies continue to hunt for partners to solve nagging problems and present new modalities, such as gene therapy vectors, protein folding, precision oncology and mRNA.”
For Paul Garofolo, CEO of phage therapy developer Locus Biosciences, Inc., "2020 and the COVID-19 pandemic has shone a light on an area of medicine where investment has been waning for years: infectious diseases.” He believes this could open the way for much needed investment in the antimicrobial space. “As a society, we had to relearn the significant impact infectious diseases can have on our health system and day-to-day lives, with COVID likely to be the number-one cause of death in the United States from April 2020 to mid-2021. Additionally, we are facing down a rising tsunami of multidrug-resistant infections that will hit our health care system because of the historical misuse and overuse of antibiotics in this pandemic layered on top of the already increasing prevalence of antibiotic resistance. We have seen the lengths governments will go to fight deadly infectious diseases and novel payment/reimbursement models are likely to ride on these coattails. Given the improving commercial attractiveness of antimicrobials, in 2021 we expect to see additional investments and strategic transactions in the antimicrobial space as large pharma make their bets on new technologies and therapeutics."
Looking beyond the US and Europe, Christian Hogg, CEO of Hutchison China MediTech, expected increasing investment in Chinese R&D to yield good things. “We are seeing Chinese biopharma coming of age with companies maturing into engines for global research, innovation, and eventually commercialization. This is being accelerated by greater access to capital and a resurgence of sector investment due to regulatory reforms in China and to a lesser extent the global impact of covid-19. In 2021, I think we will see leading China-based biotechs kicking into gear and delivering a stream of new medicines, particularly in the oncology space, across the globe.”
On the deals front, Annalisa Jenkins, board member of Milken Institute’s FasterCures center and chair of the Court of London School of Hygiene and Tropical Medicine, predicted a “continuation of the marked increase in M&A activity that we saw in the fourth quarter. Pharma is back out on the hunt for innovation to fill their pipelines and they have the cash along with very low cost of capital for a shopping spree.”
AndGil Van Bokkelen, CEO of Athersys, Inc., predicted both “consolidation as larger companies make strategic acquisitions” and “high value partnerships in select areas.”
Robert Armstrong, CEO and co-founder of Boston Pharmaceuticals Inc., expected to see new trends in the ongoing activity. “In 2021, we expect to see new transaction structures and business models that shift the interplay between biotech and pharma,” he said. “While we will continue to see pharma interest in later stage programs or companies, we are already seeing the shift to earlier stage or preclinical companies as they seek value inflection points, such as Bayer AG's multiple deals with emerging gene and cell therapy companies, AbbVie Inc.’s partnership with Frontier Medicines Corp., and Eli Lilly and Company’s recent foray into gene therapy via Prevail Therapeutics Inc. We expect to see new transaction types, such as program specific investments and de-SPACing transactions.”
To conclude, in the words of Cooley’s Krisko: “A fluid year is an understatement.”
By Eleanor Malone