With COVID-19 continuing to ravage the United States and vaccinations still in the early stages of rolling out, the pandemic seems likely to remain the dominant headline in 2021. But other potential occurrences could have big impacts. AIS Health spoke with a variety of industry experts about what they’re keeping their eyes on in 2021.
What do you expect to see with the pandemic in 2021?
Dan Danielson, R.Ph., senior director of the access experience team at PRECISIONvalue: “Well, that’s where the story of the vaccine will pick up, with a different spin, however. In 2021, the effort will have to be to distribute the vaccines and inoculate as many people as quickly as possible so that we can get the pandemic under control and return to a normal life. That effort will likely be tough. First, there’s a ton of misinformation, disinformation and outright lies in social media that will have to be countered — effectively and vigorously. No, neither mRNA [i.e., messenger RNA] vaccine will alter your DNA. No, the vaccines are not delivery systems for microchips so that the deep state/global government or Illuminati can track you — your cell phone is already able to do that and is likely more reliable.
“Additionally, since both of these vaccines will have to be given twice at 21 or 28 days, that means that there will have to be a high priority on getting folks back for their second shot.
“Based on what I am seeing from CDC and others, we’ll not see widespread vaccinations for low-risk people happening until spring and into summer. So, I’d expect that schools will open for fall 2021, [and] universities will begin in-person instruction (with proof of vaccination) around the same time.
“Unfortunately, I expect the U.S. will have around 1 million deaths due to COVID-19 by the time this is all over. I checked the CDC COVID data tracker at the time of this interview [in mid-December 2020]; the U.S. was cresting 303,000 deaths and adding over 200,000 new cases daily. [By press time on Jan. 11, there were more than 375,000 deaths and more than 22.5 million cases in the U.S., according to the CDC.]
“This looks [like] we are in what appears to be an exponential growth phase of virus transmission, tracking along pretty closely to my own projections based on CDC data. Several states have returned to lockdowns, or at least more restricted activity, but we’ll have to see what happens.
“Economic activity should start picking up more steam once we vaccinate 70% to 80% of the population and more normal life begins. But I think it will be a longer process to re-open than most people think, and patience will be needed. That said, I’d expect recovery to be noticeable in mid-to-late second half of 2021 and have a full head of steam in first-quarter 2022.”
Mike DeLone, principal and national sector leader for life sciences at Deloitte Consulting LLP: “I expect to see remarkable collaboration and innovation continue and ultimately to see us in a much better spot a year from today.”
Elan Rubinstein, Pharm.D., principal at EB Rubinstein Associates: “There is a limited stock of vaccines. Mass drug distribution and mass drug administration systems are not fully ready.…Many of the rest of us may not be offered a COVID-19 vaccination until the summer of 2021 if vaccine supplies run short or if systems of drug distribution and drug administration run slowly.”
Todd Wills, managing director of consulting services at CAS, a division of the American Chemical Society: “The effort to develop a COVID-19 vaccine has truly demonstrated our global pharma innovation capability when focused on a single priority. Not only are the vaccine candidates themselves novel, but the focus in this area has accelerated progress on new and more efficient drug delivery platforms and processes that will pay dividends in other therapeutic areas as well. For example, many of the frontrunners have resulted from novel collaborations between Big Pharma and smaller organizations, and several of the leading vaccine candidates are messenger RNA vaccines, which is a relatively new delivery platform that has gotten a tremendous boost from COVID-19 vaccine research. There are also opportunities to apply lessons learned from the accelerated COVID-19 vaccine approval process to expedite FDA reviews and approvals in other critical areas.
“COVID-19’s adverse impact on clinical trials could translate to a reduced number of new drug approvals in 2021 as the pipeline of new drug candidates approaching the regulatory review phase experiences a temporary decline. The race for a vaccine will not be a winner-take-all situation, as vaccines from a number of manufacturers will be needed to meet demand in fighting the COVID-19 pandemic globally. Some vaccine candidates currently in the pipeline may have clinical or logistical advantages over the first ones to cross the finish line. For example, some do not need to be shipped and stored at extremely cold temperatures, and some only require a single dose, simplifying distribution and clinical protocols.”
What are some pharma issues to keep an eye on in 2021?
Danielson: “Top of mind for me is the question of if and when [President-elect Joe] Biden’s administration will roll back administrative rules based on President Trump’s executive orders targeting drug pricing and rebates. There are some pretty significant issues for the industry. The ‘most-favored-nation’ pricing, which is at its heart a federal price control measure, sets prices for certain drugs based on what’s paid by other nations. The other rule essentially brings back point-of-sale rebates to patients” (SMA 12/21/20, p. 1). “There are also questions whether the federal rule-making process was violated. The big question will be if the Biden administration waits to let the legal challenges work their way through the courts or if they choose to roll them back before then.
“At the macro level, control of the Senate will determine how aggressively the Biden administration can pursue additional health insurance reform. The idea of a public option may expand patient access to medications, but how much manufacturers’ margins will be impacted from these additional sales is a concern.”
DeLone: “All processes are being challenged in a new digital world — with every process, there is an opportunity to digitize, to create efficiencies in discovery, improve all aspects of clinical trials/operations, to create smarter manufacturing and supply chains, including entirely new ways of engaging with [health care providers] and patients. The life sciences industry has only just begun to scratch the surface when it comes to applying AI, and I think that will be an issue to watch in the coming year. Deloitte recently surveyed executives at biopharma and medtech companies to see how they plan to use AI in the future, and more than half said they planned to boost AI investments by more than 50% this year. We expect that trend to continue, but for some organizations, convincing researchers and scientists to have faith in AI-generated data can be a difficult obstacle to overcome. Companies that are able to adopt and scale AI will definitely be something to watch as the industry continues to quickly evolve over the next 12 months.
“I think there are some important trends we’ll continue to see — many of them spurred by the pandemic. Scientific breakthroughs, like we saw with the vaccine, will likely continue. I expect life sciences companies will continue to seek out the best science available, either through acquisitions, partnerships or collaboration. I think we’ll see AI become more integrated into life sciences organizations, now that leaders understand its value. We’ve also seen a huge emphasis on diversity and inclusion this year, and I think it’s a strategic imperative that will — and should — continue into 2021.”
Rubinstein: “I expect the Biden administration to address drug prices. However the new administration will have many compelling priorities, including COVID-19, the economy, immigration, foreign relations, infrastructure, budget/taxation and undoing the significant damage to policy, trust and to our democratic values done intentionally by the Trump administration during the last four years.”
Wills: “With structurally novel, small-molecule drugs more than twice as likely to receive breakthrough therapy designation by the FDA, the importance of continuing to push deeper into unexplored chemical space through further structural innovation is clear. As enabling workflow and predictive technologies continues to advance, allowing a larger number of candidates to be explored more efficiently, I anticipate we will see even greater structural diversity in drug candidates and approved drugs in the years to come. If some of the process efficiencies that were exercised to streamline clinical trials and regulatory processes for COVID therapies are able to be scaled more broadly, this could also lead to an increase in the total volume of approvals in years to come as well.”
Are there any expected competitors, including biosimilars and generics, to particular drugs or within a therapeutic class that you anticipate will have a big impact?
Danielson: “I am keeping an eye on inclisiran [Leqvio from Novartis Pharmaceuticals Corp. for hyperlipidemia] because of its MOA [i.e., mechanism of action] and dosing schedule. This application of RNA technology is interesting on its own. I am curious to see if the clinical trial results are replicated in the real world. I am also curious to see if the semiannual (every-six-months) dosing schedule is an advantage or not. [Novartis said on Dec. 18 that the FDA had issued a complete response letter regarding inclisiran’s new drug application ‘due to unresolved facility inspection-related conditions.’]
“I am also tracking [Iovance Biotherapeutics, Inc.’s] lifileucel (LN-144), which is essentially CAR-T [i.e., chimeric antigen receptor T-cell] therapy for solid tumors; this one is being tested in metastatic melanoma, head/neck carcinomas and NSCLC [i.e., non-small cell lung cancer]. This could be either a game changer for therapy in these tumor types and potentially other solid tumors, or ‘just’ another welcome addition to the oncology armamentarium.”
David Lassen, Pharm.D., chief clinical officer at Prime Therapeutics LLC: Big specialty drugs expected to see patent expiration, and potentially generic or biosimilar competition, in 2021 include “Forteo [from Eli Lilly and Co.] for osteoporosis, Sandostatin LAR [from Novartis Pharmaceuticals Corp.] for acromegaly, Pomalyst [from Bristol-Myers Squibb Co.] for multiple myeloma and Sutent [from Pfizer Inc.] for renal cell carcinoma, gastrointestinal stromal tumors (GIST) and pancreatic neuroendocrine tumors (PNET).”
In terms of the specialty drug pipeline, “gene therapies will be closely watched in the next couple of years. Multiple manufacturers are set to file for review with the FDA for their one-time administration gene therapies for disease states including Duchenne muscular dystrophy, aromatic L-amino acid decarboxylase deficiency, Wiskott-Aldrich syndrome and hemophilia A and B, just to name a few. ”
Mesfin Tegenu, R.Ph., president of PerformRx LLC: “There aren’t many big specialty drugs expected to see competition in 2021. [Roche Group unit Genentech USA, Inc.’s] Lucentis (ranibizumab), used for age-related macular degeneration, is expected to see biosimilar completion in the second half of 2021. The monoclonal antibody Xolair (omalizumab) [from Genentech and Novartis], used to treat eosinophilic asthma and chronic idiopathic urticaria, currently doesn’t have patent protection, but there isn’t any product close to approval, so we probably won’t see a biosimilar Xolair launch for more than a year. We may see a generic come out for the multiple sclerosis drug Gilenya (fingolimod) [from Novartis] in late 2021, but that’s far from a certainty at this time.
“We will likely see new CAR-T therapies come out fairly soon. There are two CAR-T therapies in the pipeline, both slated to be approved in early 2021. Breyanzi (lisocabtagene maraleucel) [from Bristol-Myers Squibb] is a CD19-directed CAR-T therapy in development to treat aggressive B-cell non-Hodgkin lymphomas, while Ide-cel (idecabtagene vicleucel) [from Bristol-Myers Squibb and bluebird bio, Inc.] is a B-cell maturation antigen (BCMA)-directed CAR-T therapy in development to treat relapsed or refractory multiple myeloma (RRMM).”
Michael Zeglinski, senior vice president and CEO of specialty and infusion pharmacy at OptumRx: “One new therapeutic area that could see biosimilar competition in 2021 treats various eye diseases such as wet age-related macular degeneration, diabetic macular edema, macular edema and diabetic retinopathy. There are several drugs in this category, and one manufacturer has already filed a biosimilar application for Lucentis that is targeted for approval and launch in 2021. These agents are administered into the eye under sterile surgical conditions.
“In 2020, additional categories of drugs such as insulins, growth hormones and pancreatic enzymes were transitioned to biologics and, thus, are now available for manufacturers to submit biosimilar applications.”
What might we see in terms of merger and acquisition (M&A) activity in 2021?
DeLone: “There was a very bullish outlook for the M&A pipeline in January of 2020, and while things slowed from March to May due to the pandemic, they really picked back up by July. Valuations stayed reasonably robust this year. We also saw companies doing a lot of tracking and sensing through new mechanisms to monitor for potential deals. I believe we’ll continue to see a bullish landscape in terms of M&A activity. We’ll see continued interest in vaccines and infectious disease, given how impactful the pandemic has been. Additionally, virtual health models have had a huge impact in 2020, and moving into 2021, all companies will need to consider it. With traditional care sites shifting to the home, companies will have to determine if their care strategies need to change, and biopharma will need to determine if it needs to adapt — and if deal-making and M&A are the ways to do that.”
Kedar Karkare, Ph.D., intelligence analyst at CB Insights: “2020 saw an increase in biopharmaceutical exits over 2019, from 163 to 215. Similar to 2019, IPOs accounted for the majority of exits (64%) compared to M&A (36%). With markets doing well, we expect this ratio to continue for the near-term.”
Is there anything I’ve neglected to ask about that you’d like to add?
Wills: “From a therapeutic perspective, the vast majority of chemical space is yet to be explored and represents a tremendous opportunity for those seeking cures for the most challenging diseases. However, being able to efficiently identify which structural frameworks offer the greatest potential for a particular disease target remains a critical challenge. Optimizing machine learning approaches to identifying and prioritizing new drug candidates with high-quality data sets and customized molecular representations is an area CAS is focusing on with partners across the pharma continuum. I see tremendous progress and potential for these technologies to scale for significant impact in the coming years, unlocking a new wave of innovation across multiple critical therapeutic areas.”
For more information, contact Danielson through Tess Rollano at firstname.lastname@example.org, DeLone through Ellen Conti at email@example.com, Karkare through Keith Swiader at firstname.lastname@example.org, Lassen via Jenine Anderson at email@example.com, Rubinstein at firstname.lastname@example.org, Tegenu at MTegenu@performrx.com, Wills through Cristina Tomeo at CTomeo@cas.org and Zeglinski through Jenny Pavlovich at jpavlovich@Diplomat.is.