The special purpose acquisition company (SPAC), or “blank-check company,” originally introduced decades ago as a cleaner form of a reverse merger shell, has made an impressive comeback. A SPAC has one purpose: to merge with a company and take it public (“de-SPAC”). Typically, when a biotech company does an IPO, it raises cash to fund the development of its assets. Here, the money comes first, and the company has up to two years to find assets to acquire and build. Essentially, these deals are backed by the “bankability” of their celebrated founders.

According to NASDAQ, in 2014, SPACs represented only 3% of all IPOs. In 2020, SPACs represent nearly half of all IPOs. More than 81 SPACs have gone public, each raising about $400 on average. More SPACs went public in July than in the first six months of the year. There are currently about 120 SPACs actively seeking business combinations and 15% have specifically stated they are targeting healthcare and the life sciences.

Unlike IPOs, which can take months to do, require lengthy road shows, underwriters, a detailed prospectus, and heavy SEC regulation, a SPAC can be done in weeks. And in the midst of an economic shutdown due to the COVID-19 pandemic, SPACs are seen as an efficient source of capital with a clear path for funding.

The size of SPAC deals has increased, and the mechanism has gained newfound legitimacy by attracting high-profile executives from leading companies, married with high-profile investors.

SPACs offer investors protections, such as the right to withdraw capital with interest at the time of a proposed business combination, offering free optionality.

SPAC investors still must vote to approve any deals. Sponsors are highly aligned with their shareholders, often holding 20% of the SPAC, often with warrants to sweeten the pot even further. The sponsors have a strong motivation to do “good” deals and would likely not be keen to see shareholders redeem their shares for cash.

SPACs may also offer target shareholders greater certainty on valuation versus the way the traditional IPO route might, where ultimately, the market decides the valuation.

Earlier this month, ex-Allergan CEO Brent Saunders and Co-Founder Manisha Narasimhan raised $400 million in an IPO for Vesper Healthcare Acquisition Corp., with a goal of building a company that is a leader in the markets it will pursue, which will include aesthetics, ophthalmic, and health and wellness plays.

Other notable and “bankable” luminaries in the investment biotech world include Joe Edelman’s Perceptive; Rod Wong at RTW Health Sciences; RA Founder Peter Kolchinsky; and Jim Tananbaum, founder of Foresite Capital. Hedge fund manager and activist Bill Ackman is reported to be teeing up a SPAC that’s targeting raising $4 billion. However, unlike Saunders and Narasimhan, who are operators, these are all investors.

The work begins following the IPO transaction, when the sponsors and their teams must turn the strategy into action.

Interestingly, despite the boom, and the incentives sponsors have to succeed, most SPACs, historically, have not outperformed, and in fact substantially lagged behind their market indexes one year after the combination. But some have bucked the trend and the future may reap a different result. McKinsey did an interesting study that uncovered a recipe for success: prove operational experience. Operator-led SPACs outperformed non-operator-led ones by 40% and their sectors by 10% one year after merging.

It makes sense that operators would have the edge, right? They are specialized and take a larger role in the combination’s success, usually leading them and often assuming a board seat. These “operators” are:

More likely to identify their industry focus in the initial SEC filings, which are typically the areas they know best

Focused, which matters with scarce resources

Taking a more surgical approach to deal search, which may deliver better sourcing, more rigorous diligence

Better strategic plans for value creation

While the SPAC is definitely back, are these entities here to stay? Probably, but the future performance of the class of 2020 will likely determine whether today’s hot trend will sizzle.

is Founder, Barbara Ryan Advisors, and a member of Pharm Exec’s Editorial Advisory Board

Articles

Columns

The SPAC Makes a Comeback!

In a closed virtual roundtable on Aug. 20, Michael J. Hennessy Jr., president and CEO of MJH Life Sciences, parent company of 

, welcomed a panel of five biopharma CEOs to discuss the improving image of their industry. Hennessy commented that despite its many negative aspects, COVID-19 has provided the pharma industry a new opportunity to show its value. The panelists shared their insights on why the industry has been able to shift its image for the better and how to maintain the momentum moving forward.

Rob Jekielek, managing director at The Harris Poll, moderated the event. The organization, which has been conducting public opinion research for more than 50 years, decided early on in the pandemic to focus on gathering information that could be of public service. As a result, The Harris Poll has been looking closely at the pharmaceutical industry.

“We’re in such a different place today than we’ve ever seen in the data,” said Jekielek. “As we look at the last 20 years of perceptions around the industry, it’s been hovering closer to tobacco than to tech. As the numbers move…it’s basically a doubling of positive public perception, and that’s being massively accelerated since the beginning of this year.”

Jekielek referred to The Harris Poll’s 20-plus-year tracking of the industry’s positive reputation. An industry low of 26% positive reputation in 2008 barely improved over the course of a decade, sitting at just 32% in January of this year. But as COVID came into focus, pharma’s positive reputation jumped to 53% by July 2020.

As people process news stories and other public information about pharma’s response to the pandemic, and recognize companies’ willingness to collaborate and earnest efforts to develop vaccines, treatments, and testing, their perceptions are improving. Harris Poll research also indicates the public is receiving industry communications and advertising in a positive way. “They are picking up on much more than ever before,” said Jekielek. “And it has a much more positive pull-through.”

This increase in positive perception is a key opportunity for pharma. As Jekielek expressed, this is a “once-in-a-generation inflection point for the industry.” If companies can build upon the lessons they’ve learned during COVID—including the benefits of focusing on employees, patients, educating the public, and collaboration—they might be able to finally showcase their true value to society. The following are insights our CEO roundtable participants shared regarding what’s driving the change, and how they can continue it.

Employees arose as one of the most critical components driving image. From the way employees are treated to how they showcase their efforts in the community, this perception “cuts through the clutter of any message,” said Jekielek.

Liz Barrett, president and CEO of UroGen Pharma, talked about Disney’s management model: Instead of focusing on consumers, the company focuses on instilling its mission in employees, who deal with customers at the forefront. “We need to do that,” said Barrett. “We need to ensure that all of our employees feel valued, that they feel like this is a place where they want to come to work and they want to give.”

At the onset of the COVID crisis in mid-March—amid various business concerns such as financial stability and drug shipments—John Crowley, chairman of the board and CEO of Amicus Therapeutics, launched Amicus Cares, a program to listen to and connect with his team about their concerns during this disruptive time. “Within the first 30 days, I had small group sessions with every one of our 500 employees,” he said. “The first thing we did in those first 72 hours, we added a $1,000 bonus to every non-executive paycheck that Friday. We said, ‘We don’t know what extraordinary expenses you have, but here’s some help.’ It was also a symbol to people that we’re in this together and we’re here for you, and that proved incredibly important.”

At Global Blood Therapeutics (GBT), Ted Love, MD, president and CEO, focuses on the three Ps: a commitment to patients; people, or employees driven by those patients; and pennies or money to make it all work. “What we’ve really tried to do is to create a unified force,” he said. “There’s a line that people will work for money. People will work even harder if there’s a great culture that you create. But people will work the hardest if they feel they are on a critical mission. In our industry, we really have the capacity to be about a critical mission.”

Karyopharm, which had a partner in China with access to masks, lotions, wipes, and other hard-to-get items during COVID, showed it cared by delivering each employee a care package full of items. In addition, some were sent to local businesses, allowing them to remain open; veterans’ facilities in need; and patient advocacy organizations to distribute to patients who needed them to receive treatment at clinics. “I think it showed that we really do care,” said Michael Kauffman, MD, PhD, CEO and co-founder of Karyopharm.

Michael Bailey, president and CEO of AVEO Oncology, talked about how his company tapped into its core tenets of respect, trust, and transparency during the pandemic. “One of the reasons we’ve been able to adapt to this circumstance so well is because our mission is for the greater good and what we do for other people,” he said.

Bailey found the office changes around COVID to be a litmus test of those precepts and reported that the pandemic had only reinforced them within the company. His leadership team has responded to employees’ voiced needs effectively. At the same time, employees have respected the company by keeping their requests within reason. Trust has come into play in regard to working remotely. Before COVID, Bailey was not convinced that work from home could be successful, but since quarantine, he said he’s been “impressed by the increase in productivity and professionalism that the team has demonstrated.” Remote work has also eliminated the “walkabout management” model he believed in. Now, without the ability to see people face to face, AVEO has increased its formal communication with more regular and robust meetings and messages, which have increased transparency.

“At the end of the day, pharma companies are not entities,” said Bailey. “They’re a collection of people with a common mission. And to just make sure that achieving that mission is doable is one of our key responsibilities.”

Love expressed his pride in how employees at GBT, which focuses on sickle cell disease, supported each other during COVID. “It’s interesting that during this pandemic we’ve had issues around social justice, and sickle cell patients are 90% African American in the United States,” he said. “Those are patients who not only have a devastating disease but also suffer tremendously from social injustice in our country, social injustice in our healthcare system as well. So this has been a very powerful time for us.”

Amicus’ Crowley stated he was most proud of his team’s ability to deliver its medicines around the world, especially during the height of the crisis. “These medicines are the lifeblood for these patients,” he said. “Without these medicines delivered on schedule, people will suffer and, in some cases, could die.”

Karyopharm experienced an unexpected bump in activity when Xpovio, a drug for diffuse large B-cell lymphoma (DLBCL), proved successful in inhibiting coronavirus. “That necessitated us becoming a virology company sort of overnight, which as a small company in the middle of everything is not a good idea—especially when you’re dealing with a virus that nobody understands,” said Kauffman. He applauded his team for coming together amid the heavy workload of filing a new drug application (NDA) and getting approval for the DLBCL indication.

At UroGen Pharma, Barrett led her small team through COVID at full steam also, as the organization had to switch to a virtual launch of its first drug. UroGen worked closely with FDA to receive product approval ahead of its scheduled April PDUFA date. “I’m grateful and really proud of what the team has done to, one, ensure we got our approval, but, two, really to make sure that [Jelmyto] is accessible for patients.”

UroGen’s Barrett put a premium on the need to transform advertising and communication to connect with patients. “One thing that has hurt our industry is that the general population is uninformed about what we do,” she said. “What they hear are the sound bites of a politician or the amount of money they have to pay when they go into a pharmacy. And we’ve actually, as an industry, been reluctant to do too much around education and information in advertising because we usually get criticized for it. But we have to continue to educate the population…as to what we do. I think back to my time in Novartis where we launched Kymriah, the CAR-T therapy, which is truly a cure for these patients; but we don’t really talk about it like that,” she said.

Karyopharm’s Kauffman said the industry has done an “abysmal job” of highlighting the breakthroughs that could be used to project pharma’s worth. He mentioned GBT’s sickle cell drug, Oxbryta; the many life-changing cancer and heart failure drugs; the cure for hepatitis C; and numerous new drugs for orphan diseases as examples that could have been used better to promote pharma’s value in society.

Getting the industry to work together to send unified messages is now more important than ever. With a COVID-19 vaccine on the horizon, educating the public and building an image of trust can help foster a level of comfort that makes people amenable to receiving it.

While pharma has a natural focus on patients, to really connect with them, companies need to understand the true patient experience. “It’s a mindset more than anything,” said Crowley, whose own family has battled rare disease. At Amicus, he works to build a patient-focused culture. When making decisions, he asks employees every day to consider the child or parent perspective, with self-directed questions such as: Where would you build the factory? What type of person would you hire? Where would you put your precious dollars? How would you price the medicine? How would you make sure that there’s access?

To reinforce that, Amicus has a patient hub that supports both patients and physicians. It also has a team of patient advocates within the company who act as a bridge to patient communities. The group is led by a C-suite-level executive who holds the title of chief patient advocate, Jayne Gershkowitz. “All of us should represent that patient perspective,” said Crowley. “But I ask Jayne to always be the conscience of the company. And if we’re deviating from what’s best for patients, remind us and drive us back to that true north.”

Love commended Amicus’ work in this area and said his company tries to follow a similar model. He said GBT was involved in the patient community even before it had its drug in the clinic. He and his team participated in sickle cell walks around the country, donating their own money. And when they were designing their studies, they talked to patients and integrated patients’ insights into their plans. “If we all focus on the patient, we will never get lost,” he said. “If we compromise on the patient for financial success, it will lead to failure and it’ll lead to something that we’re not proud of.”

AVEO’s Bailey said “it boils down to our responsibilities.” In the case of oncology, companies need to improve quality of life and the overall patient experience, which includes tolerability of therapies and access to treatments. “We need to think about the whole patient experience,” he said. “Getting an extra two months of life and being absolutely miserable because you’re taking a terribly toxic therapy is probably not a great tradeoff.”

Bailey lauded how the industry has evolved in this respect, moving away from a “chemotherapy poison era to targeted therapy” and encouraged pharma to continue that trend.

UroGen’s new upper tract urothelial cancer therapy is a good example of improving patients’ journeys. The treatment allows patients to avoid getting a kidney removed—something especially welcome during the COVID-19 crisis. Barrett also had patients in mind when she questioned the original protocol for Jelmyto, a six-week therapy followed by maintenance. With no evidence that the maintenance was actually helpful, Barrett ended it, instead focusing on retreatment. “There’s no drug that is benign,” she said. “[Patients] only should take the amount of medicine they need to get better. Developing our clinical studies with the idea of what’s in the best interest of the patient is important.”

Kauffman also dealt with quality of life issues in regard to Xpovio, Karyopharm’s drug that launched last year with some tolerability issues. “You don’t want to make people miserable, especially if they have two, three months to live,” he said. His team invested in supportive care to address this.

“It is remarkable that our entire messaging got weighted down on supportive care, making sure the patient felt good, almost to the detriment of the efficacy of the drug,” he added. Patient advocates’ YouTube and Twitter presence helped convince people that supplementing the treatment with some standard anti-nausea remedies was worth the benefits of Xpovio.

As individual companies pulled together through COVID, so did the industry as a whole. “We have collaborated around data and information,” said GBT’s Love. “You publish patents not only to protect you but to teach people how you did it. It provides the pathway that if they can improve upon your invention, they can have a new product. It’s very unusual to teach people how to beat your product, but our industry actually does that. That is an indirect form of collaboration even across companies which are competitive.”

UroGen’s Barrett said now that biopharma organizations have reached out to working with one another, it would be hard to do otherwise. “In the past, I think it’s been about how can I maximize,” she said. “[But] we’ve got to be willing to share the success, and I think this is demonstrated that you can get to success faster and probably bigger, and so sharing it is a good thing.”

Bailey said collaboration and strategic partnerships have been integral to AVEO’s success—not just to share in the successes but to diversify the risk. Many times, small companies don’t have the resources to develop assets in an effective way.

“Seeing the importance of advancing these therapies and maybe losing some of the value of them, but for the greater good, to get these products to the patients that we serve is a cornerstone to what we do,” he said.

Bailey was proud of the strategic partnerships that have occurred as a result of the pandemic, such as the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) partnership, which brought together more than a dozen biopharma companies to develop an international strategy to address COVID research. “It’s very refreshing to see,” he said.

Bailey hopes that example of collaboration can be extended beyond COVID. For example, he mentioned the various oncology immunotherapies that could potentially be combined with other drugs to continue progress. “Not many people have multiple drugs within their portfolio that they can combine, so seeking out those kind of collaborations to ensure they increase in efficacy and overall quality of patients’ lives is very important,” he said.

While pharma has always had collaboration, especially in drug development, Amicus’ Crowley said COVID prompted two welcome things: increased transparency and working fast. “Look at the regulators’ response—this isn’t the typical ‘I’m going to send in my type-C meeting request and hope to get a face-to-face in 60 days,’” he said. “You’re on a cell phone call that night with regulators who have stepped up unbelievably well. And the FDA and EMA and other organizations are collaborating in a way they never have. If we can build upon that notion of collaboration, I think it would be for the benefit of everybody.”

Bailey pushed the envelope on the topic of collaboration amid competition by raising the idea of common control arms in clinical trials. In multiple studies exploring the same opportunity or disease state, such as COVID, many patients have received suboptimal or no therapy. Creating a common control arm across these studies could reduce the number of patients not receiving treatment.

“This concept, along with master protocols, were referred to by Scott Gottlieb at a conference I attended,” said Bailey. “Is there a possibility to minimize the number of patients who get nothing and ultimately identify the best solution? COVID is a perfect opportunity for that.”

Kauffman, who experienced a few logistical delays with FDA, was equally impressed with the industry’s collaboration during COVID.

“We had a protocol turned around in six or eight days, with about three back-and-forths,” he said. “People jumped on it, and it’s been great. Institutions got their ethics committees and their IRBs together quickly. Nobody was messing around here. There was…seven days a week, 24 hours a day energy. This industry is stepping up, like it always does, and they’re moving about as fast as they can.”

The COVID-19 pandemic has certainly changed pharma’s usual way of doing business. Recognizing these shifts as new opportunities to meet current needs will be important to maintaining the industry’s image.

One new driver to consider is time. Whereas in the past, patients may only have thought about quick access to medicines if they became very ill, people now value getting treatments faster. This new emphasis on access will likely carry over, according to Crowley.

“The notion of broad access to medicines for all—universal access—is implicit in this whole COVID world, and that needs to be an important principle going forward,” he said.

Cost is another element that has been cast in a new light, thanks to the COVID-19 outbreak.

“This is not a time for price gouging,” said Crowley. “You’re seeing very responsible behavior in pricing. A fair return for risks; but you’re seeing that notion of responsibility in a way that maybe we hadn’t seen.”

GBT’s Love explained the importance of breaking through old ways of thinking by comparing it to racial inequities in the US. Though many individuals have tried to stand against injustice throughout the years, the executive felt the George Floyd incident was a turning point because it changed the discussion.

“It’s all about controlling the narrative,” he said. “The pharmaceutical industry is no better today than it was a year ago. Police violence is no worse today than it was a year ago, but we have changed the narrative. And, unfortunately, our industry has been the target of politicians who, in order to get elected, really focus on the one issue our industry did not create, which is out-of-pocket costs.”

Pharma’s unique commitment to keeping patient costs low can help lead the narrative going forward. “In how many industries do their products get cheaper?” said Love. “How many industries…if you can’t afford the product, the companies provide it free? There is a tremendous amount to be proud of, and we should make sure that our politicians and others who do control the narrative are telling the truth and not using us as a tool to influence their probability of being elected. We have to make sure we never let the narrative become anything but about the truth.”

Maintaining the positive image that has begun to emerge since COVID will require continued effort on all levels—from within companies to across the industry. But pharma is off to a good start in rebranding its overall message.

“We’re not just in it for the profits,” said Barrett. “We are in it because we believe that we truly make a difference in human health and that we’re needed, and the industry has come out to demonstrate that.”

Pharm Exec’s Senior Editor. She can be reached at

Features

A recent roundtable moderated by Rob Jekielek of The Harris Poll gathered five biopharma CEOs to discuss the industry’s shifting reputational landscape in the public eye.

Leadership and Industry Image

Last spring, COVID-19 quickly swept the nation and forced the healthcare industry to adapt just as swiftly. In-person physician visits dropped precipitously as people stayed at home, afraid to expose themselves to the virus. They were scared and delayed elective treatments. Providers were busy changing the way they did business. They coordinated remotely with their nurses and office staff and scrambled to adopt new technologies in order to help patients.

As the void between patient and provider widened, it was an ideal opportunity for hub services to step in. These patient support groups ensured patients received the handholding they needed to navigate prescription and insurance issues. They also took the pressure off of physicians by providing innovative options for doctors to electronically engage patients.

During such an uncertain time, these groups proved to be a valuable asset for everyone.

The uncharted territory of COVID caused disruptions at every point on the patient care continuum, from diagnosis through initiation of therapy to continuation of therapy. But the root of the pandemic’s impact on pharma was the reduction in patient visits to the physician’s office. According to Epic Health Research data, mid-April was the peak for telehealth visits, with 69% of total doctor visits being virtual.

This shift has resulted in fewer preventative screenings, and as a result, diagnosis has dropped for some therapeutic areas, such as those for breast and colon cancers.

“As much as it’s having an impact right now, there’s likely to be longer-term impact, because not only are patients not getting diagnosed right away, but some are not getting initiated on therapy in a timely fashion because of the need to get some pre-initiation lab tests and scans done,” says Janardhan Vellore, vice president at Beghou Consulting, a biopharmaceutical commercial strategy and operations consulting firm.

Pharma is noticing the effects. For example, Novartis’ Q2 sales numbers came in below expectations. Vellore attributes that to the company’s ophthalmology and dermatology drugs underperforming due to decreased patient demand. Lucentis, which needs to be administered as an injection into the eye in the physician’s office, and Cosentyx, which requires a subcutaneous injection under the physician’s guidance, were impacted by a slowdown in new patient starts and maintaining patients on therapy. As companies move forward, many are revising their 2020 sales guidance as a result, Vellore says.

Tommy Bramley, PhD, president of Lash Group, a patient support service company that is part of AmerisourceBergen, says his analytics team closely monitors the dynamics of prescription volumes and copay volumes, and both have been down since the pandemic began. He directly attributes that to patients avoiding in-office visits.

Arming patients with information about hub services can help them get ahead of their fears and avoid making choices that produce suboptimal therapeutic results. “Educating patients on a variety of hub services can help ease some of their treatment anxiety and provide supplemental options to navigate their access,” says Nicole Hebbert, a member of 

’s Editorial Advisory Board and senior vice president, head of patient support services, at United BioSource (UBC), a provider of pharmaceutical support services. “This allows them to focus on their health and their families in an informed and empowered manner.”

UBC provided hub services for SK life science’s drug Xcopri, a treatment for partial-onset seizures that launched in May. Because Xcopri has a titration schedule, SK life science sought a partner that could help with that process, to ensure patients got started and continued their therapy as appropriate.

“For patients who don’t want to go to the pharmacy or leave their house, the product is being delivered to their door, and we’re ensured a proper start, the right dosing, and the patient is put off on the best foot,” says Robert Polans, vice president of market access and trade at SK life science. “The main reasons why we launched in a COVID environment is because we have this program and it was the right thing to do for the patients. This program made us more confident that the launch would be executed in a better fashion.”

While the average American was concerned about where to find toilet paper and hand sanitizer in the early days of COVID, patients had the added stress of worrying about how they were going to see their physician and receive the medicines they needed to survive. “Patient education and hand-holding have never been as important as now, because patients are scared,” says Vellore. “Engaging with the patient at each step of the way is really critical.”

As physicians’ offices are forced to adapt to new models, they don’t have the time and energy to educate patients on support programs. In the absence of that, hubs have had a proactive role to play.

“We normally rely on a doctor, nurse, or office staff to teach the patient about our program and what to expect, and that’s not happening, because maybe the doctor is talking to the patient on a telemedicine visit, but the nurse or the office manager never gets to,” says Meghan Szczech, senior director, patient services, at SK life science. “We have to think about how we approach those patients differently.”

Hubs are actively figuring out alternative pathways to reach patients, such as educating individuals through virtual programs and making connections through visiting nurses. The good news is that patients are receptive to their efforts.

“I think people are more willing to ask for help right now,” says Szczech. “They’re more willing to see what we can do.”

Jennifer Lim, director of commercial operations at UBC, says the need for patient assistance has been on the rise. While some services, such as availing a nurse to engage with patients, may have seemed “extra” before, patients are demonstrating a need to connect with a professional who can verify that they have everything in place or talk about specific challenges they might be going through that may not be drug specific.

“It’s just that ear, that trusted, credible resource that has proven so valuable,” says Lim. “We’ve been able to have a lot of discussions around the importance of staying on therapy. We have resources here that can help patients through any challenge.”

Initiating treatment in a COVID era is no easy task. To make the process easier, a spotlight has been shone on patient centricity and flexibility. Many pharma companies are developing novel strategies to ensure access:

Zeposia, a multiple sclerosis (MS) drug recently launched by Bristol Myers Squibb, requires pre-initiation testing—bloodwork, an electrocardiogram, and in some cases an eye exam—before the treatment can be prescribed. To help patients, BMS is offering a visiting nurse to complete these tests in the patient’s home so that patients can avoid the lab and physician’s office.

Ultragenyx’s X-linked hypophosphatemia drug Crysvita is usually administered by subcutaneous injection by a visiting nurse. However, some nurses are not comfortable visiting patients in their homes because of COVID. The company is now working with payers to authorize and approve self-administration by the patient.

Biogen is exploring in-home infusions for the organization’s MS drug Tysabri, which currently is administered via in-office infusion.

Merck & Co. reduced the dosing frequency of its immunotherapy drug Keytruda to 400 milligrams versus the 200-milligram dose that was initially approved. This allows patients to get administrations every six weeks instead of every three weeks, lessening the number of visits to their doctor’s office.

Likewise, Lash Group decided almost immediately to increase the day supply on drug refills so that patients would have their medicines on hand.

Looking toward the future effects of COVID-19, Bramley also has been planning for what might be required of patient assistance programs and access programs when it comes to therapeutics and vaccinations.

All of these various programs need to be coordinated, and having a central place for patients to turn to makes the process easier. “The patients left to themselves will just say, ‘You know what, this is too much of a headache. I’m not going to do this now,’” says Vellore. “To help overcome that problem, biopharmaceutical companies have their hub support team reaching out to the patient saying, ‘Let me help you.’”

The virtual-induced world of COVID has certainly had an effect on how companies use technology to connect with patients (see the Q&A beginning on facing page). Though physicians have historically been hesitant to adapt new technologies, the coronavirus crisis gave them little choice. As a result, there has been an acceleration of new technology as well as greater adoption of digital practices that were already in place.

“The pandemic really has forced our stakeholders’ hand in a lot of ways,” says Hebbert. “Manufacturers and physicians alike have had to be more flexible in how they’re going to engage and take advantage of the patient support services. They have opened up to new technology and new processes that enable speed and efficiency. As many offices had to limit staff and patient visits, it became increasingly important for them to see how they can still work effectively by leveraging the clinical support, the adherence support, and the reimbursement and prior authorization support that’s out there to help patients get on the medications that they’re prescribing.”

Some technologies being developed by hubs and adopted by physicians and patients include:

Mobile messaging applications to get patient consent.

Virtual education sessions with patients for in-home self-administration.

Digital signatures and digital assistant tools within the adherence space.

YouTube channels to educate patients before the point of contact.

Universal patient portals to upload documents via smartphone.

“We want to make sure that we have a variety of ways to communicate with patients and make sure there’s multiple modes of interaction between them,” says Bramley. “Some of these digital companions and digital tools were already in place and we’ve just seen quicker adoption of them. What may have taken three to five years, in terms of adoption with patients, now has maybe been condensed down into three to five months.”

In addition to developing new electronic tools, companies are using the power of technology in an analytical way. By combining anonymized patient-level data with machine learning, they can assess patients and situations.

“At Beghou, we help companies find emerging commercial opportunities—growth opportunities as well as risks, such as who is going to be noncompliant—and proactively predict some of these emerging situations so that targeted actions can be taken,” says Vellore.

As the economy struggles through the COVID pandemic, unemployment and the resulting loss of insurance coverage are additional causes for concern.

Though it may not be fully evident now due to lingering government assistance, this impending gap is something to plan for in the near future.

“As you see unemployment climb, there are insurance benefits still in place,” says Bramley. “However, those are going to dissipate, and there are going to be more people uninsured who are going to need to rely on the patient assistance programs. We help them in terms of insurance options available to them and we help them in the form of free medications through foundations. As commercial insurance wanes with higher unemployment, those two areas are going to be very important.”

Insurance companies are already addressing issues with a variety of temporary and emergency measures, especially regarding the prior-authorization and appeal processes. Some have become more lenient with their qualifying criteria, some have eased up their review process, and others have offered situational extensions to existing prior authorizations.

To help with coverage, most companies offer some form of patient assistance that targets the uninsured, underinsured, and functionally uninsured (those who have insurance, but aren’t covered because of the payer’s formulary). There are also programs to aid those with financial hardships.

Bridge programs are another useful way to ensure access to medicines, which may become more important in the coming months. “There is a whole host of barriers patients have to go through to get a specialty, rare disease, or oncology drug covered, and so that takes time and effort,” says Vellore. “In the bridge program, the patient hub works with the payers to help the patient get coverage approval eventually, but in the meantime, the patient doesn’t have to wait. They get a free starter kit and continuous supply at no cost for a limited duration.”

Zeposia provides a 30-day supply for up to 24 months in its bridge program. This is for people starting out on the therapy and for those who are going to lose coverage. Though bridge programs are very expensive, they are a good way for a launch brand like Zeposia to have some initial adoption when entering a competitive market. They also reduce uncertainty in the minds of physicians and patients.

Launching a hub program in a COVID environment certainly has it challenges. Due to the complex nature of some products, it can be difficult to design a successful program. There is no cookie-cutter approach (see related story on page 35).

“You have to be flexible,” Szczech told 

. “We launched our HCP portal a week after we initially launched. Since then, we’ve had four different sets of updates and additions. It’s helped us think outside the box more than we ever had to and push the line further to make significant changes to differentiate ourselves.”

Until now, companies have been trying to quickly adapt to COVID to make sure patients have access. However, as the pandemic lingers on, they will have to start evaluating all these new strategies and technologies to determine which are the most valuable. This will certainly be something to think about as 2021 budgets are devised.

How ramped-up support and educational services have helped bridge the chasms and ease fears along the patient care continuum.

Assets in Anxious Times: Patient Hubs Demonstrate Value During COVID-19

COVID-19 continues to impact us all. It has changed the way we work and how we engage with each other. From a global health perspective, it has highlighted the need for integrated healthcare systems that can effectively manage both chronic and infectious diseases with equal focus.

Across all countries, the pandemic has forced governments and their healthcare systems to address a threat that is tangible, versus various threats that are not as easily identifiable, such as non-communicable diseases (NCDs). Choosing to focus on infectious diseases and diverting from chronic diseases can be problematic, as NCDs not only affect human health but also jeopardize development and economic progress.

Emerging countries account for 85% of premature NCD deaths.

While these figures are alarming and unacceptable, there is an opportunity to lead the conversation in changing these outcomes.

This change will require us to address troubling trends we are seeing globally due to COVID-19. These trends include the reassigning of NCD care staff to support COVID-19 efforts, the postponement of public NCD screening programs, and reduced utilization of primary healthcare services. While some actions are required due to overburdened healthcare systems and the immediate need to address the threat of COVID-19, it is still worrying, as it causes a significant disruption in the prevention and treatment of NCDs, especially, in low- and middle-income countries.

These steps also do not take into consideration the burden that unaddressed NCDs place on healthcare systems and, by proxy, the economy. By reallocating resources away from the prevention, treatment, and management of NCDs, we are creating an environment that puts added pressure on the system. An example is hypertension, which is often asymptomatic and requires acute care when not diagnosed or poorly managed, leading to further complications.

The microeconomic burden from NCDs is exerted directly through loss of productivity, not only from patients but also their caregivers, as well as indirectly through out-of-pocket expenditure on medical care.

The world is at a critical juncture. In this current landscape, our mission to relieve the burden of NCDs for every patient everywhere is a commitment we are tirelessly working toward and is greatly needed, given the deadly interplay between the COVID-19 pandemic and the NCD epidemic.

As you read this, you may ask “What can be done given the significant threat of COVID-19?”

As healthcare systems allocate resources and develop strategies, we must keep in mind that despite COVID-19’s rapid spread, it is still unlikely to overtake the prevalent figures of NCDs. In fact, it is the high prevalence of NCDs that provides the conditions that make people so vulnerable to COVID-19.

Addressing this interplay between the pandemic and NCD epidemic requires a multisectoral approach. All stakeholders, including governments, patient groups, medical societies, healthcare providers, and the private sector must be committed to work collaboratively to address the threat NCDs pose while also managing the COVID-19 pandemic.

As we begin the development of plans to help healthcare systems address a multitude of issues, including NCD care guidelines, the financial strain this pandemic and NCDs place on healthcare systems, digital solutions to ensure patients have continuity of care during and after this pandemic, and the mental health impact of COVID-19, let’s keep in mind the importance of focusing on both chronic and infectious diseases.

World Economic Forum and Harvard School of Public Health. The Global Economic Burden of Non-communicable Diseases.​ 

https://www.weforum.org/reports/global-economic-burden-non-communicable-diseases

 https://www.who.int/news-room/fact-sheets/detail/noncommunicable-diseases

Moving Towards Optimized Noncommunicable Disease Management in the ASEAN Region: Recommendations from a Review and Multidisciplinary Expert Panel. 

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7371561/

President, Emerging Markets, Upjohn, a division of Pfizer.He can be reached at 

Amid attention on coronavirus, efforts to address the burden of non-communicable diseases are at a critical juncture.

The Interplay Between COVID-19 Pandemic and NCD Epidemic

Dealing with the COVID-19 pandemic has been disastrous for FDA. A series of actions signaling premature support for unproven treatments promoted by the White House has undermined confidence in the agency’s decisions and independence. Now with hopes high for a safe and effective vaccine against COVID, industry and public health authorities seek to prevent political interference in approval decisions that can drive confusion and vaccine hesitancy across the nation.

FDA stumbled early on in efforts to assess much-needed diagnostics when initial COVID lab tests authorized by the Centers for Disease Control and Prevention (CDC) proved inaccurate. Then the agency signaled support for treating ill patients with certain long-used malaria drugs —an approach loudly praised by President Trump and his advisors, but questioned by researchers and clinicians. FDA then had to rescind an emergency use authorization (EUA) for administering hydroxychloroquine to COVID patients when subsequent clinical studies found no clear benefit, and serious potential risks.

More damaging was a series of events in August related to emergency use of convalescent plasma to treat hospitalized patients. In a press conference, FDA Commissioner Stephen Hahn joined President Trump and Health and Human Services (HHS) secretary Alex Azar in a chorus of praise for this “major advance” in COVID care. Hahn’s support for the initiative was startling, as it came right after Trump lashed out in a highly public tweet about the “deep state” at FDA, implying that FDA officials were deliberately delaying product development until after the Nov. 3 election. Meanwhile, the White House continued to predict access to a COVID vaccine this month, which heightened fears that political pressure will lead to some kind of FDA authorization of a new vaccine before the Nov. 3 election, even if studies are incomplete.

The situation prompted industry leaders to speak out publicly on the importance of rigorous clinical research and full study data for any authorization or approval of new COVID vaccines or treatments. Leaders of the Biotechnology Innovation Organization (BIO) issued a letter in August calling on FDA to maintain its “historic independence as the gold-standard international regulatory body” to assure the public that its decisions reflect the “highest standards of scientific and medical integrity.”

Five pharma CEOs similarly said they would not seek early authorization or approval of a new COVID treatment without a clear demonstration of product safety and efficacy from randomized clinical trials. During a virtual press conference organized by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), Pfizer Chairman Albert Bouria stated that his company “will not cut corners” or take any action that would tarnish Pfizer’s scientific reputation. Eli Lilly will publish all data and “subject it to scientific scrutiny,” stated chairman David Ricks, also IFPMA president. Merck Chairman Kenneth Frazier and others urged reliance on FDA advisory committees to gain added transparency to approval decisions and guard against political influence.

And FDA’s senior leadership took the unusual step of publishing a strongly worded opinion piece asserting the integrity and independence of the agency in a move to fend off political interference in vaccine approval decisions. CBER Director Peter Marks, CDER Director Janet Woodcock, now on detail to the office of the commissioner, and six other top officials acknowledged that FDA operates in a political environment, but that if the agency loses credibility and trust, the public will doubt its recommendations and fear to use regulated products important to improving health and overcoming COVID-19. They ensured that regulatory decisions are based “on our unbiased evaluation of the scientific evidence.”

These statements aim to protect the integrity of the regulatory process from outside political interference as vaccine data moves through the pipeline. Manufacturers recognize that premature approval of any product would erode FDA’s coveted gold-standard reputation. Biopharma companies have much to gain from producing and distributing effective treatments able to slow or halt the lethal COVID pandemic, and even more to lose in reputation as well as financial health from allowing patient access to sub-potent or risky products. 

Pharm Exec’s Washington Correspondent. She can be reached at jillwechsler7@gmail.com.

Missteps threaten agency’s independence as vaccines seek finish line.

FDA Struggles to Retain Credibility

Setting up patient services programs is a critical endeavor that can help make or break a product launch and the ongoing success of a product during “normal” times. In the wake of the novel coronavirus pandemic and increasingly uncertain coverage scenarios, the role of hub services is even more critical for pharmaceutical and biotechology companies to ensure patient access to therapy and to help patients navigate the healthcare system.

When well-designed, these programs tailor services to make it easier for patients to learn about and receive appropriate care, with services that may include disease state education, support for understanding insurance coverage, and financial assistance for those in need. Understanding that no one-size-fits-all template for patient services programs exists, this article provides best-practice guidance on choosing your support service model, as well as design and implementation strategies.

As you prepare to launch your product, one of the most important steps is to determine which hub model to implement. Should your team rely wholly on a third party, a hybrid of outsourced and insourced components, or all in-house resources?

To begin, based on your product strategy, potential patient pool, and planned services to be built into your program, assess the infrastructure needs of hosting and managing a patient services support program, spanning:

Technology and data management, such as the systems and technology to support secure handling of patient information, the complexity of business rules, and workflows associated with patient services administration.

Legal and regulatory compliance, such as organizational structure and bandwidth to support oversight of patient services in-house, regular monitoring, and remediation processes.

Human capital and staffing, considering that patient services generally rely on people resources and an investment in ongoing recruiting, hiring, and support for hub staff, as well as leadership and management for oversight.

Training and quality management, e.g., the structure and ongoing support needed to implement and maintain hub programs.

Facilities, including the infrastructure for the necessary equipment (computers, phones, etc.) and space to support a hub program, as well as secure areas to keep patient information safe.

Patient service management, considering the expertise needed to support the design, development, and ongoing operations of patient service programs.

Product service, such as the necessary processes and controls to meet a product’s specific requirements, e.g., Risk Evaluation and Mitigation Strategy (REMS).

Then, weigh those needs against your current organizational structure, as well as the intended focus of your enterprise and the product being launched to identify the hub model that best fits your organization.

Let’s say your enterprise is focused on science and delivery of novel life-changing therapies and the product you are preparing to launch is an oral oncolytic. An outsourced model might be ideal in this situation because it will provide the people, process, and technology to support your launch, while your team focuses on research and development. In this case, you will need to find the right vendor based on the combination of capabilities needed (such as bridge program and financial assistance) and the account management approach (such as dedicated staff and partnership strategy). While the vendor’s capabilities should align with the product need and the intended services to be provided to customers, the account management approach needs to align with what your team expects for day-to-day operations, strategic oversight, compliance requirements, and the vendor/client communication plan.

For example, a fully outsourced model for a physician-administered ophthalmology product that included reimbursement support and financial assistance enlisted a “right-sized” vendor to implement and run the day-to-day patient services program. As part of the strategic oversight plan, the manufacturer actively monitored and audited the program’s success through vendor-facilitated daily activity reports, weekly meetings to track progress against goals, and quarterly business review meetings of the overall program progress against milestones. This approach enabled the manufacturer to be confident the program was meeting its organizational goals and product strategy without the need to execute the hub services themselves. It also enabled them to adjust the services support as necessary.

For comparison, a hybrid model includes some services to be administered in-house, while others are outsourced. This model should be developed based on in-house infrastructure and skill set, as well as the desired customer experience. For example, in a recent case, the manufacturer preferred to keep the customer relationship management in-house, so it decided to focus on front-end customer support and outsource payer-related services like benefits verification and prior authorization. In a hybrid model, the integration of people, process, and technology is important. You want to be sure your in-house and outsourced functions own and are accountable for their respective areas, have proper handoffs between the two functions, and are working consistently and collaboratively to create a positive patient experience.

Some manufacturers prefer to manage the patient services support entirely in-house. The advantage of this approach is it enables you to tightly control every aspect of the product experience. The disadvantage is it requires having the necessary infrastructure, as well as the ability to develop and maintain the people, processes, and technologies required to fully support the program. This may work well when the target patient population is particularly small, or when the product is nuanced and has complexities in the manufacturing or distribution process. In addition, some large manufacturers elect to keep everything in-house, especially in cases where past outsourced experiences delivered underwhelming or even negative patient experiences.

Once your team determines the model that best aligns with your organizational goals, product strategy, and infrastructure, you can begin designing the patient services program. Here, it will be important to map the patient and provider journeys to determine and address any potential barriers to access. The design strategy should at once 1) help the right patients learn about the therapy option, its potential benefits to them, and the hub program offering and requirements; as well as 2) be convenient for clinicians to refer into, work within, and rely on to facilitate patient access and clinical outcomes. Depending on the therapy, key service offerings might include:

Reimbursement support to help patients navigate insurance coverage.

Fast-start or bridge programs to help patients initiate therapy quickly while working through access challenges.

Patient financial assistance in the form of free product for uninsured patients, financial assistance, or copay assistance for underinsured patients, or referrals to charitable organizations for government-funded insured patients.

Nurse educator support to provide individualized education and product support to patients and their caregivers.

Adherence support to help patients initiate and stay on their therapy.

REMS support to meet FDA-directed requirements to prevent, monitor, and/or manage a specific serious risk by informing, educating, and/or reinforcing actions to reduce the frequency and/or severity of such an event.

For example, in one recent case, a manufacturer of an oncology product with a REMS created a full suite of reimbursement, patient financial, and adherence support services to be able to address manufacturing specificity, multiple patient touchpoints, care coordination, provider requirements for receiving and administering the product, and ensuring coverage and access according to payer policies. For comparison, a product in the rare disease space implemented only reimbursement support and patient financial assistance for its hub program, because the therapy is administered in a controlled hospital setting in which adherence poses little risk.

Once the service components of your program are determined, begin developing the program. As a first step, thoroughly document program design parameters and key decisions, including program objectives, compliance considerations, program communication tactics, and service offerings.

Once the components and support tactics are planned, be sure to define metrics to track and assess program performance, and create a process to monitor and report metrics against key performance indicators (KPIs). Also, define actionable analytics for the report to be sure the right information is included, and create a process and plan to implement necessary changes based on results and learnings. It is also important to plan ongoing compliance reviews for marketing materials and correspondence templates.

A systematic approach for program management will ensure that issues are identified, mediated, and course corrected early in order to support long-term success. Your measurement tools should be used to monitor the progress and performance of the program, as well as to identify opportunities for improvement. With this in mind, build the program around the concept of continuous process improvement and plan for evolution.

To do this, plan to perform audits and regular monitoring to ensure operations adhere to standards and perform in line with expectations, and that KPIs align with SOPs. Consider incorporating independent audits to help reveal discrepancies or catch when the program evolves or strays.

Director, Lead for Patient Services, Life Sciences, 

Director, Global Life Sciences Governance, Risk Management and Compliance; both with Guidehouse

A look at best-practice approaches to aligning the strategy and design of hub service models with preparations for market entry of a new therapy.

Critical Connection: Patient Services and Product Launch

There’s no doubt scientific knowledge translates well from academia to industry, but the two work environments can be very different. Recognizing the differences and learning how to address some of those disconnects are key to a successful crossover for both employer and employee.

“In academia, you’re judged for the most part on how you do and how your individual programs move forward,” says Mark Genovese, MD, senior vice president of inflammation development at Gilead Sciences. “In industry, it’s how well your groups can move forward cross-functionally to achieve a common goal.”

Genovese, the James W. Raitt Professor of Medicine and clinical chief in the division of immunology and rheumatology at Stanford University for the past 22 years, joined Gilead in April. He now oversees the clinical development of an entire portfolio, including inflammatory diseases and NASH. Despite his success in academia, Genovese was eager to expand his research interests and long-standing collaborations with industry.

“I [welcomed] the opportunity to potentially build my program in a much larger way by working in industry, with greater resources—and I don’t just mean financial ones,” says Genovese. “I mean a talent pool that works cross-functionally to make things successful. I liked the idea that I would be able to work with a group to get more therapeutics in the diseases where there are unmet needs.”

The difference between academia’s emphasis on the individual versus pharma’s focus on teamwork is one of the most commonly quoted adjustments when moving between these two careers. To bridge that gap, companies should focus on the unique insights and skills people from academia can bring to the pharma table. In a video posted on the American Psychological Association website, R. Anne Hull, a career counselor and president of Hull Strategies, emphasizes certain academia strengths to seek and foster, including:

A bigger-picture view outside industry that offers objectivity

An expanded network and resources outside industry

Organization and project management skills

Pharma’s dynamic environment relies on diverse thinking and partnering to drive innovation within the company. Fortunately, people from academia excel in this area of inquiry. Their ability to freely ask questions and share ideas is one from which pharma can benefit.

Genovese believes his experience with the scientific process as a researcher and physician helped in this regard. He wasn’t afraid to ask people questions in order to understand the historical context of how and why things were done the way they were done, and how and why things would be done moving forward.

“It’s trying to rapidly identify where the issues are within programs but also within your own deficiencies, and then to try and correct them,” he says. “I have trusted that the people around me would give me enough runway to help me get there and that they would be responsive to my questions and provide me line of sight on things that I don’t know. I think it would be much harder if people weren’t open.”

Genovese was fortunate to have worked with Gilead as an investigator prior to joining the company. This provided a level of familiarity and trust that his new colleagues would support him through the transition. He says he is grateful that his new co-workers were comfortable enough to point out his blind spots and where he needed to educate himself.

Tips for rounding out the rough edges in crossover.

Pharmaceutical Executive-10-01-2020

The SPAC Makes a Comeback!

Leadership and Industry Image

Assets in Anxious Times: Patient Hubs Demonstrate Value During COVID-19

The Interplay Between COVID-19 Pandemic and NCD Epidemic

FDA Struggles to Retain Credibility

Critical Connection: Patient Services and Product Launch

Mastering the Transition From Academia to Industry

Smoothing Access Path

The COVID Boost to AI in Global Health

Pharmaceutical Executive, October 2020 Issue (PDF)

Speed and Sensitivity

New Views Point the Way

The Shifting Kaleidoscope of EU Pharma Policy

The Regulatory Engagement Conundrum