The Chronicle of Healthcare Marketing - August 2020 by Derm City

WEBINARS, PODCASTS AND MORE: Highlights from recent NPC panel discussions and industry interviews • 4 CORPORATE THINKING: Interview with Gerard Fernandes of Alexion Pharma Canada • 8

MY TURN: Gene therapy appraisals may limit new drug approvals in Canada • 14 $7.95 ● August 31, 2020 ● Covering Canadian and Global Pharmaceutical Economics ● www.pharmacongress.info

Healthcare

The good trip: Medical psychedelics n Developing and delivering therapy with psilocybin and other molecules requires new approach to Tx model by John Evans, of THE CHRONICLE OF HEALTHCARE MARKETING

SYCHEDELIC MEDICATIONS COULD

Sanofi-Genzyme wins 2020 CDA Public Education Award “The World’s Most Uncomfortable Bed”, a campaign to raise awareness about the challenges faced by people with atopic dermatitis, took home the Canadian Dermatology Association (CDA) 2020 CDA Public Education Award in the industry category. The awards, announced in late June during the CDA’s virtual conference, were established to acknowledge excellence in furthering the understanding of dermatologic issues and encouraging healthy behaviour. The campaign was spearheaded by Kristy Douglas-Smith, marketing head for Dupixent (dupilumab). https://tinyurl.com/y54fnnhh

Pharma

Covid-19: Shipping, supply issues hit pharma n Suddenly, companies are forced to search for alternatives By John Evans, of THE CHRONICLE OF HEALTHCARE MARKETING

HE COVID-19 SITUATION HAS HAD a significant impact on transportation, with flights grounded and tighter scrutiny at border crossings. Pharmaceutical companies and their transportation partners have had to take steps to ensure raw materials and finished products can reach the places and people where they are needed. “As the Covid-19 pandemic has evolved, decisions such as the travel bans, border closings, airport closures and flight suspensions across the globe have made delivery of medicines, vaccines, and consumer healthcare products more complex,” said Alex Romanovschi, country medical director of GlaxoSmithKline Inc. (GSK) Canada, in an email to THE CHRONICLE OF

HEALTHCARE MARKETING. Similarly, Mathieu Aman, Mississauga site lead for Pharma Technical Supply, Global Product and Supply Chain Management at Hoffmann-La Roche Limited, also said his company had experienced a step-by-step reduction of global logistics capabilities as restrictions on movements, including border closures, were implemented around the world. ALTERNATIVE SHIPPING PLANS

“This required us to explore and find alternative means to get products shipped to their destination,” said Aman. “As pharmaceutical products are sourced globally and often shipped in the cargo hold of passenger aircraft, the grounding of airlines has led to a severe lack of physical transport means. On top of this, we noticed restrictions at customs and de-

lays in customs procedures.” Aman noted that while international borders are, in general, still open, many customs operations are running with reduced staff, which can lead to extended processing time Romanovschi and delayed deliveries. Political tensions, too, have raised concerns related to international medical trade. In a statement from April 3, 2020, Turn to Covid-19 page 7→

represent a new class of products for treating depression, anxiety, and post-traumatic stress. In this article, four industry experts share their observations on the potential value of these molecules, but also approaches to managing the challenges to bringing them to market. Some lessons can be taken from the pharma industry’s forays into medical cannabis and cannabinoid products, they agree, but medical psychedelics are different enough from medical cannabis or other psychiatric medications that specialized approaches will be required.

WHY PSYCHEDELIC MEDICATIONS?

Investigating psychedelics for use in mental health applications is not novel, said Dr. Roger McIntyre, professor of psychiatry and pharmacology at the University of Toronto and head of the mood disorders psychopharmacology unit at the University Health Network, Toronto. Dr. McIntyre is also CEO of Champignon Brands Inc., a research and pharmaceutical development organization with an emphasis on ketamine and psychedelic medicine based in Toronto. “Decades ago, it was actually a practice in some centres of psychiatry around America to supplement psychotherapy with Ecstasy,” he said. “That fell out of favour for a number of reasons.” Turn to Psychedelics page 10→

TOP TEN SIMPLE MYTHS THAT CHANGED THE WORLD. KING ARTHUR

ALCHEMY Attempting to turn base metals into gold was even practised by Sir Isaac Newton, and is credited with forming the foundation of modern chemistry.

There was no Arthur, Knights of the Round Table or Sir Lancelot, but this enduring myth symbolizing chivalry is woven through Western culture.

THE EARTH IS FLAT

VIKINGS DISCOVERED AMERICA

It sparked debate between scholars and theologians for centuries. The early Greeks got it right and—surprise—even Columbus knew it was round.

It was a myth up until 1960, when conclusive proof showed the Vikings beat Columbus to America by 500 years and rewrote history.

Image: 3.bp.blogspot.com. FlatEarth

VAMPIRES The vampire is the most popular fictional character of all time. Escapist entertainment for millions, this myth goes back thousands of years to our fear of the powers of darkness.

Image: web-proekti.ru/archives/tag/xristiani

WITCHCRAFT

THE COELACANTH

Centuries of upheaval, persecution and death—yet witchcraft doesn’t exist. Theorists say we keep myths like this around to help us sort out good from evil.

Extinct for 64 million years, the mythical coelacanth turned up off the coast of South Africa in 1938 and turned the world of paleontology upside down.

SECOND JFK SHOOTER Despite almost 50 years of forensic study, no conclusive evidence exists to disprove the most famous myth of the 20th century.

THE HOLY GRAIL The chalice Jesus supposedly drank from at the Last Supper is never mentioned in the Bible. (Historians agree it would have been a wooden cup anyway.) But the search for it continues to this day.

THE FOUNTAIN OF YOUTH Ponce de Leon wouldn’t have discovered Florida in 1513 if this myth hadn’t beckoned him. The search for eternal youth is even more active today.

Strategic Partnerships • Innovative Approaches • Impactful Tactics • Consumer Initiatives • Educational Programs • Engaging Events Joshua Reynolds 647 241 4651 • www.antibodyhc.com

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The Chronicle of Healthcare Marketing

NOCs of Note: Summer 2020 Significant TTP approvals of Rxs for human use Biologic 07-14 Dalteparin sodium (Fragmin, Pfizer Canada Comments: Updates to the product monograph, solution, IV and subcutaneous, 2500 UNIT/0.2ML, 3500 UNIT/0.28ML, 5000 UNIT/0.2ML, 7500 UNIT/0.3ML, 10000 UNIT/0.4ML, 12500 UNIT/0.5ML, 15000 UNIT/0.6ML, 25000 UNIT/ML, 10000 UNIT/ML Antibiotic 07-10 Lefamulin acetate (Xenleta, Sunovion Pharmaceuticals Canada) Comments: 10 MG/ML (calculated as base) IV solution, 10 MG/ML (calculated as base) tablet Biologic 07-09 Abemaciclib (Verzenio, Eli Lilly Canada) Comments: Updates to the product monograph, 50 MG/TAB, 100 MG/TAB, 150 MG/TAB, 200 MG/TAB, oral tablet Antiparkinson agent 06-24 Benserazide HCL/levodopa (Prolopa, Hoffmann La Roche Ltd.) Comments: Supplement to a new drug submission, benserazide HCL 12.5 MG/CAP/levodopa 12.5 MG/CAP, benserazide HCL 25 MG/CAP/levodopa 100 MG/CAP, benserazide HCL 50 Turn to NOCs page 12→

August 31, 2020 · 3

has been given New Brunswick-based Up Here the green light by PULMONEM received What’s happening in drug marketing Health Canada Health Canada approval for the treatment for the Phase III ranof patients with domized clinical trial of severe symptoms of Covid-19 who have pneumonia and an oral Tx to reduce or prevent the development of severe require extra oxygen to breathe. It’s the first therapy aupulmonary inflammation caused by Covid-19. The candithorized by feds for the Tx of Covid-19 and the indicadate is a patented reformulation of dapsone. The Tx is betion comes with conditions including use only in lieved to prevent excessive immune reaction which is the facilities where patients can be closely monitored. A most frequent cause of worsening Covid-19 symptoms and small number of patients in Canada with Covid-19 have complications leading to hospital admissions, ICU stays and been treated with remdesivir through the Special Access fatalities. Program. HEALTH CANADA says it is willing to consider approving Covid-19 tests for use at home to screen for the virus, according to a Reuters report. The health authority previously said it would not review applications for home test kits over concern people may misuse the kits or misinterpret the results. Approval would allow for self-collection where samples are sent to a lab for processing. Additionally, Health Canada approval could spark the development of new tests to detect the virus at home. Laval, Que.-based BAUSCH HEALTH received Health Canada approval for its 0.01% halobetasol propionate/0.045% tazarotene (DUOBRII) topical lotion for psoriasis. Says Bausch main man Richard Lajoie: “Since psoriasis is a chronic skin disease, patients require continuous treatment in order to achieve optimal control of their symptoms. Now, with DUOBRII, Canadian healthcare professionals and their patients have a new topical treatment option that can help achieve those long-term goals.” Remdesivir (Veklury, GILEAD SCIENCES CANADA, LTD.)

Professional Pearls

NPC Webinar: The Covid-19 crisis has presented significant challenges to the pharmaceutical industry. During the National Pharmaceutical Congress’ Summer 2020 Webinar on June 23, two speakers outlined ways for pharma businesses to not just withstand the situation, but to leverage necessary change into sustainable advances in how business will get done.

Maximizing the benefit of a shift to virtual business: 4 key notes

Claude Perron, gee-em, Amicus Therapeutics Embrace the technology. It’s not perfect, but given the circumstances, it has done wonders. This remote reality allows someone to work from almost anywhere and provide value from wherever they are. It might be an opportunity for companies to employ talent from anywhere in the world without any need for them to relocate. This is an opportunity to reframe the value of what pharma brings to the healthcare systems and to patients. It is an opportunity to underline that again within our own companies. It’s important to ensure the robustness of supply chains processes—to look for ways to modernize, to secure processes for production and inventory management.

Redefining the role of the sales team in the virtual age: 3 key points

Danielle Portnik, product manager, Mallinckrodt Pharmaceuticals, and co-founder & prexy, Healthcare Businesswomen's Association, Toronto With the majority of field activity for sales teams having been halted by the Covid-19 pandemic, it is important to re-define their role and how the sales representative fits into an organization. One constant that remains during the Covid-19 pandemic would be the established personal relationships within marketing teams and the customers. With a shift to digital, there is going to be a movement to sales teams becoming something of a virtual extension of marketing teams, and evolving into experts on how best to engage healthcare providers.

4 · August 31, 2020

The Chronicle of Healthcare Marketing

Special Report

By Jeremy Visser, of THE CHRONICLE OF HEALTHCARE MARKETING

C OVID -19 ON THE P HARMA industry has been far-reaching and affects patient groups as well but, surprisingly, not all the changes have been negative. “Frankly, for us in the rare disease community, we’re having better than ever relationships with pharma,” said Durhane WongRieger, prexy of the Canadian Organization for Rare Disorders (CORD), in a recent interview for the first episode of the National Pharmaceutical Congress (NPC) Podcast. Hosted by Peter Brenders, founder and main man at Kontollo Health, the podcast is available on Apple iTunes, Google Podcasts, Spotify, Soundcloud and YouTube. HE EFFECT OF

PATIENTS HAVE LIMITED ACCESS

Wong-Rieger noted that she reached out to patients and pharma companies to gauge the impact of the pandemic and concerns regarding patient needs. She found the response of pharma companies to be quick and comprehensive. “We’ve had a great response,” said Wong-Rieger. With patients having limited access to hospitals and healthcare services while Covid-19 takes priority,

problems arose for patients trying to see their specialists or even obtaining access to medication. Pharma has stepped in to eliminate these barriers by finding alternative pathways, making arrangements for telehealth options or bringing the treatment to them at home. (The focus on the patient has been more vital than ever during the pandemic, which Mike Egli, Brenders gee-em of Aspen Pharmacare Canada Inc., and Patrick Massad, commish of the Pharmaceutical Advertising Advisory Board (PAAB), talk about in the sixth episode of the NPC Podcast.) EFFICIENT RELATIONSHIPS KEY DURING COVID-19

Relationships between pharma and the government have been collaborative and efficient during Covid-19, according to Wong-Rieger. Robin Hunter, gee-em at Mallinckrodt Pharmaceuticals, echoed this point in the seventh episode of the NPC Podcast, saying he’s never seen the government as proactive. “You could get somebody on the phone the same day, by just an email. They clearly knew that they needed to be responsive to

Image from rawpixel.com

The effects of Covid-19 on pharma’s interactions with patient groups

industry,” said Hunter. There is still room for improvement and WongRieger says she would like to see the same approaches taken to find vaccines for Covid-19 applied to the rare disease community. “We have not seen that kind of thinking,” said Wong-Rieger, “that what’s good for a patient with Covid is certainly good for a paWong-Rieger tient who has a rare disease.” She explained that the Patented Medicines Price Review Board (PMPRB) has not changed its view on strict price controls, which Pamela Fralick, prexy of Innovative Medicines Canada, and Christine Lennon, gee-em of Incyte Biosciences Canada, discuss in the third and fifth episodes of the NPC Podcast, respectively. Wong-Rieger would also like to see patients have early access to therapies before they become symptomatic. While technology and pharma intervention have helped patient groups during the pandemic, it has put a stop to in-person conferences for which Wong-Rieger believes there is no substitute, an opinion echoed by Dr. Shafiq Qaadri, Turn to Podcast page 6→

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6 · August 31, 2020

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Podcast: Engaging through social media is one of the important keys —continued from page 4 family physician, ex-Ontario member of provincial parliament and novelist, in the second episode of the NPC Podcast. Wong-Rieger describes the faceto-face personal relationships made through socializing between talks as the most important elements of conferences. With a current hold on these events—private, corporate and public—government has been paying more attention to and engaging with social media, which Lee Ferreira, Canadian

gee-em of Ferring Pharmaceuticals, addresses with respect to conducting relationships and engaging virtually in the fourth episode of the NPC Podcast. CORD recently held a webinar for a baby to gain access to therapy. “We’ve done it entirely through the internet and social media,” said Wong-Rieger. “It’s been a tremendous success.” However, without the capability for the interactions gained through physical events, it becomes harder to get access to scientific meetings or participate in policy groups. “We can only be effective

if we’re there in person,” said WongRieger. When asked for advice for pharma teams working with patient groups, her answer was simple: “start with the patient”. She explains that many times it is the patients who have gone out and found the researchers or raised the money that ultimately attracts the interest of companies in researching treatments. “The companies that have done the most and been the most successful are the ones that start with the patients, partner with the patients and really un-

derstand the patients,” said Wong-Rieger. She also encouraged companies to think about global access to drugs and to invest in places where there are no clinics. Successful clinics for rare diseases in Malaysia, Indonesia and China were started with companies building clinics from the ground up and supporting them. “Twenty or so countries are coming together to make sure that we have a vaccine for Covid-19, that it is going to be available globally,” said Wong-Rieger. “That’s where we need to be with rare diseases.”

NPC PODCAST LINKS Episode 01: Guest: Durhane Wong-Rieger https://tinyurl.com/yysbfpck Episode 02: Guest: Shafiq Qaadri https://tinyurl.com/y48d5ajl Episode 03: Guest: Pamela Fralick https://tinyurl.com/y6chvplw Episode 04: Guest: Lee Ferreira https://tinyurl.com/yypatjyr Episode 05: Guest: Christine Lennon https://tinyurl.com/y4adfmzu Episode 06: Guests: Mike Egli, Patrick Massed https://tinyurl.com/y2h2ekfa Episode 07: Guest: Robin Hunter https://tinyurl.com/y3anante Episode 08: Guest: Nancy White https://tinyurl.com/y5uhcdjg

WEBINAR LINKS Spring 2020 Webinar: After This Rude Interruption: What the Life Sciences Will Look Like After the Covid Crisis https://tinyurl.com/yyn9uau9 Featured particpants: Peter Brenders, Kontollo Health (lead panelist); Wendy Adams, Galderma; Dr. Wayne P. Gulliver, Memorial University of Newfoundland & Labrador; Robin Hunter, Malinckrodt; Richard Lajoie, Bausch Health; Mitch Shannon, Chronicle Companies (host) Summer 2020 Webinar: Pharma’s Purpose, People & Process PostCovid. Who Will Thrive? Who Will Be Left Behind? https://tinyurl.com/y4en5gyh Featured particpants: Peter Brenders, Kontollo Health (lead panellist); Mike Egli, Aspen Healthcare Canada; Ronnie Miller, Hoffmann-La Roche; Claude Perron, Amicus Therapeutics; Danielle Portnik, Mallinckrodt PharmacueticalsMitch Shannon, Chronicle Companies (host)

August 31, 2020 · 7

The Chronicle of Healthcare Marketing

Covid-19: Existing emergency plans have minimized disruptions

Photo by Craig Adderley

—continued from page 1 the 3M Company noted that the US Federal administration had requested—in addition to a request for increasing its imports of N95 masks from 3M’s overseas operations and prioritizing orders to the US Federal Emergency Management Agency—that 3M cease exporting resAman pirators manufactured in the United States to the Canadian and Latin American markets. While nothing came of that request, it did at the time raise the spectre of potential border closure. In an article on the logistics news website Freightwaves on April 6, Shawn Baird, president of the pharmaceuticalspecialized trucking company Sharp Transportation Systems Inc., said he did not believe a breakdown in cross-border medical goods trade between the US and Canada was likely. “It’s just completely illogical for both sides,” Baird was quoted as saying in the article. EXISTING EMERGENCY PLANS

At the time of the article, Cambridge, Ont.-based Sharp Transportation was sending 10 trucks to the US on a typical day. He said that he expected demand for pharmaceuticals would ramp up as treatments become available for Covid-19.

While these challenges are real, existing emergency plans, along with responses specific to the pandemic, have prevented notable disruptions. Romanovschi said that, to date, GSK’s manufacturing and supply for Canada, to date, has not been adversely affected. “GSK in Canada is collaborating with its global supply chain division to ensure products destined for the Canadian market continue to flow regularly into the country,” he said. “This includes ensuring that the pathway for product importation is clear of any hurdles and working with relevant Canadian and international stakeholders to ensure our products are continually available for the Canadian market. “We also continue to collaborate with GSK in the US and have taken measures including sharing charter flights with our US affiliate to facilitate transport into Canada,” said Romanovschi. Global logistics disruptions have happened before and will happen again, noted Aman. “[Roche has] business continuity plans in place as logistics disruptions are not new in the global world in which we operate. We were able to immediately activate these very early on when Covid-19 was already highly present in China,” he said. The longstanding relationships Roche has with airlines around the world has allowed the company to secure shipping capacity through long-term reservations—committing to moving certain

volumes of stock; chartering their own dedicated airplanes; or through collaboration with other pharmaceutical companies, Aman said. Transportation has not been the only challenge arising from efforts to contain the pandemic, Aman said. “We have had to quickly adapt our internal processes and manufacturing outputs to the logistics constraints we’re facing. We are ensuring that our critical logistics staff in charge of physical operations are protected on-site while having all others working from home.” Some businesses are finding that a capacity to respond quickly to changes in the pandemic and related guidelines is important. In a letter to its customers on March 24, 2020, pharmaceutical-specialized trucking company ATS Healthcare, Bryan McMahon, vice-president of sales, noted that the company is reviewing the changing landscape daily as part of their decision-making process. ATS is based in Vaughan, Ont. “Our entire executive team and other members of the BCP [Business Continuity Plan] team meet daily to review the previous day’s events and adapt our operating plans to ensure the safe distribution of your essential products.” “Our team will continue to work closely with customers in prioritizing transportation of critical products. We will also continue to work with all receivers of these critical products to ensure that deliveries are made as expected,”

McMahon wrote. It would be beneficial if authorities would consider steps to ease the flow of goods, said Aman. “Lift temporary importation and exportation restrictions, reduce and simplify paperwork, invest in the digitization of processes, and help their staff to work virtually when confronted with such a crisis.” NEXT STEPS

Taking these steps will help ensure that the business operations of their pharmaceutical industry partners are more resilient in the future should similar challenges be experienced again, he said. As for additional steps the pharmaceutical industry could take itself, Aman said: “We can also work on higher supply chain visibility and integration, further strengthen trusted partnerships and continue to invest into digitization of our internal processes as well as processes with external supply chain partners.” He also said that pharmaceutical companies should work on building alternative sources and ensuring the right level of inventory for the critical supplies needed, in order to make supply chains more resilient. “In terms of our employees, we know that giving them the opportunity to stay safe and work from home, supported by a well functioning IT infrastructure, is key,” said Aman. “Our people are our strength and we are committed to supporting them as they navigate the challenges associated with working from home through this pandemic.”

8 · August 31, 2020

The Chronicle of Healthcare Marketing

Corporate thinking

Meet Gerard Fernandes of Alexion Canada n The fourth in an ongoing series profiling exceptional leaders in the pharma community Gerard, can you tell us about your journey in life science so far?

n short, it has been an incredible experience thus far—with a great number of amazing learnings and exciting challenges to manage along the way. I started my career as a sales representative at Fournier Pharma, which is now Solvay. While there I had sales and marketing roles working on small molecule block bluster products in the cardio-

vascular and women’s health arenas. I then went on to successfully lead the prelaunch and launch of the first biologic for psoriasis in Canada at Biogen, while completing my MBA. At Biogen, I also

worked in the neurology franchise on multiple sclerosis and led the launch of Tysabri. I was then given the opportunity to help start UCB in Canada and was the third employee at that company. This ex-

This is the fourth in a series of profiles of exceptional leaders in the pharma industry. The series was developed by Rob Seguin and Christine Woodley from The Thrive Partnership Group, in conjunction with THE CHRONICLE OF HEALTHCARE MARKETING. In this issue, they speak with Gerard Fernandes, Launch Excellence Lead, International at Alexion Pharmaceuticals, Inc. to explore his experiences as a Canadian life science leader in a global role.

The OPMA

perience allowed me to wear many hats at the same time, learn about all functional areas and get heavily involved in growing the affiliate while creating and running the rheumatoid arthritis business unit. It also provided me with my first opFernandes portunity to run a P&L and conduct business reviews with executive committee members of the company. After this I was asked to help start-up and grow Alexion Canada. As the second office employee I was able to apply what I learned at UCB, which certainly helped lead to our success. At Alexion, I have been responsible for several roles: initially, Director of Marketing and Diagnostics, then Director of Sales. Next, I ran the $100M Complement Business Unit (hematology, nephrology and neurology). A year and a half ago I was given the opportunity to Lead Launch Excellence for the International region (all markets except US and Japan). What were your motivations for taking on the new international role?

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There were several factors: First, I am a strategic, dynamic and learning agile business leader. Being provided the opportunity to challenge myself and jump on a steep learning curve again was very exciting to me. Next, it was an opportunity to create a launch platform from scratch within an evolving organization. Also, at the National Pharmaceutical Congress a few years back I met Ronnie Miller of Roche, who is an industry leader and has coached many leaders to success over the years. During our conversation he provided me several sage pieces of advice. One was that taking on an international role would be a great opportunity to learn, challenge myself and develop. His advice was very accurate. In addition, I was excited about gaining a broad scope of understanding of our business and effectively applying my previous key learnings; working closely with a wide variety of functions and getting a deeper understanding of many cultures; and also to work closely with more company leaders and learn from meetings with company executives. What have you learned in this role?

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I have learned a great deal. First, how to create and run a launch excellence program which tracks progress, determines opportunities and barriers, and creates a path forward to capitalize on the opportunities and remove barriers—leading to Turn to Q&A page 9→

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August 31, 2020 · 9

The Chronicle of Healthcare Marketing

Social networking and healthcare Virtual stakeholder collaboration amidst the Covid-19 pandemic

IT’S NOT AN EXAGGERATION TO SAY THAT THE WORLD as we know it has changed in the first half of 2020. While the impacts of Covid-19 are vast and devastating for many individuals and industries alike, I’m hopeful that the lessons learned will help shape society for the better once we emerge on the other side. Covid-19 has forced companies to drastically rethink how they interact with stakeholders. For life science companies, it is important not to lose focus on what ultimately matters: the patients. As much as possible, daily activities need to go on, albeit in a physically distant manner. This means that Pharma needs to look at new ways of interacting with both internal and external stakeholders. The transition to virtual collaboration has been happening gradually for years. However, it has quickly moved from a “nice-to-have” to an absolute necessity. Different ways for Pharma to engage their stakeholders online Online meetings have evolved from basic video calls to an industry of its own. These days, teams can choose to interact with each other and their customers through either synchronous or asynchronous “touchpoints,” or using a combination thereof. There is also a myriad of virtual tools available to cater to their every need. Synchronous meetings involve participants being online at the same time whereas asynchronous touchpoints usually involve providing the participants with a number of questions to answer or documents to annotate via a secure web portal. They can complete these activities whenever and wherever it suits them best. With the tools available today, most internal and external stakeholder meetings can be moved fully or partially online. The virtual format is ideal

for advisory boards, co-author working groups, steering committee, and sales force meetings. It is also a great fit for medical education and training, speaker programs, case study discussions, journal clubs, grant review programs, and as a direct line of communication between MSLs and clinicians. Key strengths of virtual collaboration In addition to the obvious benefits in terms of eliminating the need to travel and the convenience of attending web meetings or completing activities from home, there are multiple other benefits to frequent online touchpoints over one-off in-person interactions. If done right, asynchronous online touchpoints give the participants time to pause, reflect, process and review others’ comments, resulting in more thoughtful and granular insights. They are able to interact with others and learn when they are at their “best” from a circadian rhythm standpoint. Further, the repetition that comes with regular online touchpoints allows for the development of consistency and good habits. For medical education, regular online touchpoints improve memory recall and speed up the overall learning process. In fact, hundreds of studies in cognitive and educational psychology have demonstrated that spacing out repeated encounters with the material over time produces superior long-term learning. Online learning also avoids forcing participants to take time away from their patients and busy clinics. For advisory boards, asynchronous touchpoints allow anonymous questions to be asked when sensitive subjects are discussed, making advisors more willing to share. They also multiply the advisor airtime whereas in-person meetings divide it. Other benefits include that asynchronous touchpoints allow for equal participation, irrespective of how verbose and extroverted an advisor is. By not having to wait for one’s turn to share an idea, there is less risk of “verbal traffic jams” and of the advisors becoming distracted and forgetting what they

meant to say (“production blocking”). Of course, the environmental footprint is also much smaller when the need to travel is removed. For the above reasons, asynchronous meetings often have higher completion and engagement rates than synchronous meetings. Conducting a series of touchpoints over time, moreover, helps create sustained and authentic relationships with the participants. It means that you can collaborate and gather insights from them throughout the year as new data become available or there are changes in the competitive landscape. It means being able to easily follow-up on previous insights and involving them from idea conception to execution. Adapting to the new normal At this time, it is too early to tell when things will get back to “normal.” Even after a vaccine for Covid-19 is developed and becomes widely available, it will take time for the economy to bounce back, and people’s work, travel and meeting habits may have changed forever. Again, I remain hopeful that the world will change for the better and I suspect that virtual technologies will continue to play major roles in the way Pharma communicates with colleagues and customers in the long-term. Natalie Yeadon is Managing Director, IMPETUS Digital. Impetus is an Online Customer Advisory Board expert, offering comprehensive B2B Online Customer Advisory Board solutions. Impetus helps drive brand direction and strategies through the retrieval of timely insights with customer executives and key opinion leaders through a series of project managed online touchpoints. To learn more about using the Impetus InSite platform for your next advisory board, contact Natalie at nyeadon@impetusdigital.com or call 416–992–8557.

Q&A: Canadians well-positioned to take on global leadership roles

—continued from page 8 exceptional results. Also, I’ve learned to work both on cross-functional and crossorganizational levels to develop and roll out a new global business model; in this case a launch excellence model. Next, I’ve developed an understanding of the critical success factors and ways of doing business in regions and countries around the world, as well as further insights on the information that matters when one is in an executive position and needs to make critical decisions. I would also add that it is critically important to develop a strong corporate culture—as it ties people together from diverse areas and ways of thinking. And, while this in not a new learning, I am constantly reminded of the importance of always prioritizing and focusing on high payoff activities that can have a dramatic impact. One person can make a difference in an organization:

•

• •

Championed and created a real-time repository of critical launch information (Single Source of Truth) that ensured all global functional stakeholders were able to discuss any inconsistencies in their understanding and therefore prevent significant issues; Identifying and removing significant launch barriers that could have had a significant negative impact on the business through persistence; Being a positive culture builder who helps motivate people; and Mentoring people as the opportunities arise, to help them grow and succeed both professionally and personally.

How does this role benefit your career going forward?

Chiefly, being exposed to a wide range of different ways of working and having a robust understanding of the global

healthcare environment, provides me with the knowledge to work in different regions around the world. Through this role I have participated on many cross-functional working groups—providing me with a deeper understanding of the nuances of our pharmaceutical business across most functional areas, which will allow me to transfer my skills to other functional areas. And lastly, with the breath of understanding that I have across geographies, therapeutic areas and functions, I believe I am now well-positioned to take on other roles including general management. What advice do you have for your colleagues in Canadian pharma who are considering their career options, including potential global roles?

First and most importantly, I would say spend the time to understand what your

objectives are for yourself, your family and your career. Also, discuss your goals and modify them with your partner/spouse and immediate family so that you are all aligned. Opportunities come up suddenly and you may need to make a quick decision. When considering opportunities look to work with people who can mentor you and help you grow. Canadians are well-positioned to take on global roles as we tend to have a broader understanding of the business. We often wear many hats or are directly exposed to many functions. Our cultural thinking also allows us to easily integrate into other environments. And finally, if you love learning and aren’t afraid of the spotlight don’t hesitate to take on a regional or global role. They are amazing opportunities to learn about the business and yourself.

10 · August 31, 2020

The Chronicle of Healthcare Marketing

Psychedelics: Cannabis has aided in re-emergence of psychedelics —continued from page 1 Currently the major academic interest in psychedelics as medical agents is what Dr. McIntyre describes as ‘reintegration psychotherapy.’ “The notion here, conceptually, is that a psychedelic affects the brain in a way where [the patient is] accessing thoughts and emotions that may not be as readily available at times other than when under the influence of the drug.” Psychotherapy—often called talk therapy—can then be used to aid the patient in integrating some of the newly accessible thoughts and feelings, allowing them to have less stress, anxiety and depression. A number of factors have led to a re-emergence of interest in the therapeutic use of psychedelics, said Ronan Levy, executive chairman at Field Trip Health. “The research resumed in earnest about 10 years ago with academic institutions such as Johns Hopkins University, New York University and Imperial College in London, starting to undertake research with psilocybin,” he said. Field Trip Health runs clinics in Toronto, Los Angeles and New York City where patients with mood disorders are treated with a combination of psychotherapy and psychedelic medications— ketamine in particular. In addition to encouraging findings from research there are other factors that are driving a business interest in psychedelics, Levy said. “One of these is certainly the re-emergence of cannabis and its acceptance as a therapeutic tool. That has been an instrumental part of accelerating the exploration and use of psychedelics.” Levy also said another factor that may be driving consumer interest in medical applications of psychedelics is a public perception that the treatment approach is somehow more natural. “I think we have seen a general distrust, legitimate or not, emerge around

the pharmaceutical industry, spurred in large part by the opioid crisis. And I think we have seen a trend toward more holistic, natural, plant-based medicines as a general societal trend in the West.”

WHERE DO THINGS STAND NOW?

John Holyoake, managing director of in-

Dr. McIntyre

Levy

vestment banking at the healthcare-specialized investment firm Bloom Burton & Co., said that he has been aware of the renaissance of psychedelics as a potential drug category and has been considering it within the paradigm of how biotech businesses typically operate. He noted that the care delivery aspect—such as in Field Trip Health’s clinic setting model— also needs to be recognized. “The agents themselves, with their profile you cannot just use them the way most pharmaceuticals are used,” he said, regarding the common therapy model involving combining psychotherapy with a supervised, in-clinic psychedelic experience, and how different that is from the take-home prescription model associated with conventional mood disorder medications. He also noted that many molecules currently being investigated by medical researchers for psychedelic therapy, such as psilocybin, MDMA and ketamine, are not patented molecules. While some companies are entering the market and aiming to treat patients with these molecules, others are working to develop new molecules to improve on the existing psychedelics. “There is a difference between those [companies] that are looking at developing new pharmaceutical products,

and those that are more oriented around the care-delivery piece, putting together clinics for that psychedelic-assisted psychotherapy,” said Holyoake. “On the drug-development side, I think we are already looking at 10-plus companies that are going at it in different ways.”

Holyoake

Kurji

Holyoake noted that some entries in the psychedelic space are early, minimally-funded companies and academic endeavours, looking for a point of entry to this new market. Other organizations working in this space, though, are quite well funded and well along in their research, he said, mentioning Compass Pathways, which is conducting research on psychedelic-supported psychotherapy for treatment-resistant depression, and is also developing a synthetic psilocybin formulation known as COMP360. “And then you have this interesting mix of not-for-profit companies such as Usona Institute,” he said. The Institute is a Madison, Wis.based non-profit medical research organization which supports and conducts pre-clinical and clinical research on the therapeutic effects of psilocybin and other psychedelic medicines. The Usona research group is also investigating psilocybin as a potential treatment of major depressive disorder. DEVELOPING AND DELIVERING CARE

The multi-day, clinic-based methods of using psychedelics to treat mood disorders currently being commonly tested represent some business challenges, noted Naheed Kurji, co-founder, president and CEO of Cyclica Inc.

The Other Pandemic: Can we cure it? —continued from page 14 say they identify with President Trump’s Republican party respond “very” or “somewhat” effective, while 32 percent think “not too effective.” ● Eighty-seven per cent of Republicans say they’ve heard about hydroxychloroquine being used to treat the coronavirus. ● Forty-two per cent say they’ve heard there’s a connection between 5G mobile-phone technology and the coronavirus. ● Thirty per cent of Republicans think Covid was intentionally created in a lab. And so on. Therefore, it may be concluded that while pharma’s research efforts are being applied unsparingly to the Covid pandemic, a leading root-contributor to Covid, the Stupidity

pandemic, remains unaddressed and is being allowed to proliferate unchallenged. Voila: a vicious circle. Ultimately, the direct and hidden costs of stupidity will make the trillions of dollars spent on Covid containment seem like a pittance. Because stupidity ensures that the same circumstances which allowed Covid to pose an existential threat to humanity will never vanish. Unless we in the Life Sciences are successful in finding a cure for stupidity, idiotic behaviours will reappear over and over again, in towns, cities and suburbs, in neighbourhoods near you, wherever climatechange deniers and racists choose to convene. So, the question must be asked: Can we cure one pandemic without addressing the other? Opinions expressed are solely the editorial judgment of this publication, and do not represent any other views. Rebuttals and comments are invited. Write to: health@chronicle.org

These approaches “are really only accessible to individuals who are suffering from those neuro-psychiatric issues who have the flexibility in their lives to be able to go to a clinic and actually take it,” said Kurji of the multi-day process. “[The patient receives] some psychometric analysis, some psychotherapy, they maybe have a day where they take the magic mushroom or psilocybin, which is an eight- to nine-hour journey, and then the next day they go through [psychotherapy] again. Individuals who cannot afford to take that much time off from their employment or other aspects of their lives cannot effectively access this treatment model.” Dr. McIntyre agreed that the resources involved in delivering the current treatment model will be difficult to scale. “It is very resource-intensive to have psychotherapy for about four to six hours,” he said. “That is a lot of human hours to deliver.” “Just from the scale of this and the administration of this, we will need to be thoughtful as to how in fact we will be able to offer the assisted psychotherapy. Because clearly, I think given how undersupplied we already are for therapists and mental health services, I do not think anyone would believe we are in a situation where we can dedicate one single therapist to spend six hours with one patient as part of the protocol in a large scale.” Some method of delivering psychotherapy more efficiently will need to be developed, Dr. McIntyre said, whether that be group therapy sessions, virtual sessions or some form of technological assistance for the therapists. On the other hand, some of the findings from published studies on psychedelics have suggested periods of remission from depressive symptoms for as long as five years, said Dr. McIntyre. If those sorts of outcomes are supported by further research, then reimbursement groups may need to consider whether it is worth paying a high upfront cost in contrast with the cost of an ongoing, daily prescription of a conventional antidepressant such as an SSRI, he said. Another challenge with bringing psychedelics to market as a medical product is there remains a significant taboo associated with psychedelic use among some portion of the population, Kurji said. Cyclica, a biotechnology company that leverages artificial intelligence and computational biophysics to streamline the drug discovery process, jointly founded with ATAI Life Sciences AG a new business called Entheogenix Biosciences Inc. in order to develop novel molecules from psychoactive seed small molecule compounds. Entheogenix is one of a number of Turn to Psychedelics page 11→

August 31, 2020 · 11

The Chronicle of Healthcare Marketing

Psychedelics: Conducting clinical trials present a challenge —continued from page 10 research groups, including Torontobased AltMed Capital Corp, exploring whether it may be possible to develop a derived molecule from a psychedelic precursor that would provide the medical benefits with a reduced, or no, psychedelic experience. “If we can cleave off the psychedelic experience, then we can maybe shorten the time frame [for the patient in clinic] from eight to nine hours to a couple of hours. And therefore make it much more accessible,” said Kurji. “And also, because it is not a psychedelic, and is a drug that we are going through the [US] FDA approval process for, these are things that people can get prescribed so they do not have to take time off or days off [to go to a specialist clinic] to do it.” CHALLENGES AHEAD

Conducting medical research with psychedelics has some unique challenges, noted Dr. McIntyre. “One of the main challenges that we have with psychedelic-based research is the preservation of blinding.” The experience of taking a psychedelic is so unique, and so obvious, any patient in a trial controlled with a conventional placebo would recognize whether they were in the active or control arm, he noted. “We call that functional unblinding,” he said. Levy noted that this problem with trial blinding raises the questions of how to establish a strong enough body of supporting evidence for a treatment modality in order to get through the typical Health Canada or FDA approval processes. Those processes typically require double-blind, randomized, and placebocontrolled trials, he said. “How do you get the quality of evidence that is typically sought?” “There are ways we get around that [blinding challenge],” said Dr. McIntyre. “Not entirely, but ways that we get around it that are valid.” The approach taken by Champignon is to use a sub-therapeutic dose of the same psychedelic as the control. “The low dose of psilocybin may be enough to give them some type of experience, but not really a robust experience. And we know from several lines of evidence that the low dose is unlikely to be therapeutic, but [the patient], as the person taking it, subjectively experiences this sort of milder trip. So they know they are on the drug. What they do not know is if they are on the therapeutic dose or if they are on the sub-therapeutic dose.” Levy said that there do not appear to be significant bureaucratic or political barriers to exploring this potential medical space. “There seems to be a lot of momentum and support in terms of researching these molecules.

However, he did note that the restricted nature of psychedelic agents is a challenge facing the psychotherapy-supported psychedelic treatment in clinic model that Field Trip Health is using, Levy said. “From a clinical perspective, the only challenge really is the laws. Right now in our clinics we will be using ketamine, which is a dissociative psychedelic. To the extent that our locations participate in clinical trials, we will work with the classic psychedelics like psilocybin and MDMA and LSD. But those clinical trials are not available to the general population base.” Even though the effects of these molecules are well understood and they have a very good safety record, the time it is taking to change the laws so that they become more available to patients who could benefit from them is understandable, if still unfortunate, he said. Holyoake, on the other hand, did not think regulation would be a particular challenge to businesses entering the psychedelic space. “Certainly, the regulated space of these products is something that will make R&D a little more complex,” he said. However, “people are able to de-

velop or have previously developed opioids and other scheduled substances. It is a barrier that makes it harder, but it doesn’t mean you can’t do it. Any company has to be able to navigate that process.” CANNABIS COMPARISONS

As restricted molecules that have been used recreationally and are being explored for medical applications, comparisons have been raised between medical psychedelics and medical cannabis. However, the two spaces are likely to be quite different, say the experts. Kurji said he expects any push for decriminalization or legalization of medical psychedelics will be driven by the medical community, rather than by the general public as cannabis legalization was. That, he said, is because a much smaller portion of the general population uses psychedelics recreationally, and the science supporting medical indications is stronger. “My guess would be five per cent in the general population has tried psychedelics, while 67 per cent of the population has tried cannabis at some point in time. The acceptance is very different,” Kurji said. “Medically, I think it is

the complete opposite. I think medically the data, scientifically, goes back to the ’50s and ’60s on the benefits of medical psychedelics, for a number of use cases.” The difference in scientific support is an aspect Holyoake remarked on as well. “We [at Bloom Burton & Co] were a little bit skeptical that the large number of potential applications that people were putting forward with these cannabinoids . . . would actually end up being realized as true therapeutics,” he said, noting that the science supporting the use of cannabis and cannabinoids in medical indications was not strong. “I think the psychedelics are a little different because there is a growing data that suggests that in certain of these psychiatric conditions, at least, there are quite significant activities and efficacy there, which is interesting,” Holyoake said. Should the ongoing clinical trials into the use of medical psychedelics confirm efficacy and safety, that will increase interest in this market, he said. But anyone entering the market at that point will “have to find a way to come up with a patentable method [for treating patients] better than what else is out there.” Patient Support in a Post-Pandemic World Pharma is facing unprecedented challenges in delivering benefit programs

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The COVID-19 pandemic has led to exceptional changes in the healthcare industry and in access to healthcare providers. An IQVIA survey of more than 400 HCPs conducted earlier this year showed that physicians are adapting to new ways of working under social distancing, but that these changes have also led to minimal interactions with sales representatives. A consequence of the change has been a negative impact on programs that provide financial and compassionate support to patients through product samples and prescription savings cards. Data has also shown a decline in patients starting on new medications across many major therapeutic areas. Rising unemployment rates and the loss of private insurance coverage is putting many patients under financial pressure which may see them forego needed medications. One Canadian company is looking to address this need by launching a solution that lets physicians facilitate access to programs which provide patients with financial benefits towards their medications.

Delivering Benefits in a Digital Environment

STI Technologies Limited is a Canadian leader in developing and managing patient benefit programs for the pharmaceutical industry. When the COVID-19 pandemic hit, they quickly pivoted their focus to develop a solution that aligned with an environment where access to physicians is limited, while continuing to meet the needs of patients. Over the past three months, the company has developed numerous eCard sites for their pharma clients. These sites allow reps or HCPs to generate digital cards that are sent to patients electronically. Patients then show the eCard at pharmacy to receive their benefit. Solutions like STI’s eCard program demonstrate that, despite the challenges created by the coronavirus pandemic, supporting the long-term health of Canadians is possible using a digital first approach.

12 · August 31, 2020

The Chronicle of Healthcare Marketing ments: 28 MG/SPR, nasal, solution

NOCs of Note: Summer 2020 Significant TPP approvals of Rxs for human use —continued from page 3 MG/CAP/levodopa 200 MG/CAP, oral capsule

vasc, Upjohn Canada) Comments: Response to an Advisement Letter issued by Health Canada to update safety-related information, 2.5 MG/TAB, 5 MG/TAB, 10 MG/TAB, oral, tablet

Monoclonal antibody 06-01 Satralizumab (Enspryng, Hoffmann La Roche) Comments: 120 MG/ML solution, subcutaneous Calcium channel blocker 05-

Amlodipine besylate (Nor-

Immunotherapy 05-28 Nivolumab (Opdivo, Bristol-Myers Squibb) Com-

ments: Fulfillment of commitment 7a from the post decision letter dated September 29, 2015 issued under the new drug submission control number 180828, 10 MG/ML, IV, solution Progestin 05-25 Etonogestrel (Nexplanon, Merck Canada) Com-

Kinase inhibitor 05-20 Nintedanib (Ofev, Boehringer Ingelheim (Canada Ltd.) Comments: Supplement to a new drug submission for new indication, 100 MG/CAP, 150 MG/CAP, oral capsule Anti-psoriatic 06-10 Tazarotene 0.045%/halobetasol propionate 0.01% (Duobrii, Bausch Health) Comments: lotion, topical Kinase inhibitor 08-27 Dasatinib (Sprycel, BristolMyers Squibb Canada)

Comments: Update to safety information, 20 MG/TAB, 50 MG/TAB, 70 MG/TAB, 80 MG/TAB, 100 MG/TAB, 140 MG/TAB, oral tablet Anti-acne therapy 08-26 Isotretinoin (Epuris, Cipher Pharmaceuticals Inc.) Comments: To make revisions to cartons and package insert and to strengthen the wording and risk minimization measures regarding rhabdomyolysis, 10 MG/CAP, 20 MG/CAP, 30 MG/CAP, 40 MG/CAP, capsule, oral Anti-platelet therapy 08-26 Ticagrelor (Brilinta, AstraZeneca Canada Inc.) Comments: To add a new indication to the product monograph, 60 MG/TAB, 90 MG/TAB, oral, tablet Biologic 08-07 Atezolizumab (Tecentriq, Hoffmann La Roche) Comments: New indication— Tecentriq in combination with bevacizumab, for the first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC) who require systemic therapy, 1200 MG/20ML, 840 MG/14ML, IV, solution

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Phosphodiesterase 4 (PDE4) inhibitor 08-10 Apremilast (Otezla, Amgen Canada Inc.) Comment: New indication, 10 MG/TAB, 20 MG/TAB, 30 MG/TAB, tablet, oral Phosphodiesterase 4 (PDE4) inhibitor 08-10 Dupilumab (Dupixent, Sanofi-Aventis Canada Inc.) Comment: New indication—Dupixent is indicated as an add-on maintenance treatment with intranasal corticosteroids in adult patients with severe chronic rhinosinusitis with nasal polyposis (CRSwNP) inadequately controlled by systemic corticosteroids and/or surgery, 150 MG/ML, solution, subcutaneous Estrogen 08-17 Estradiol hemihydrate (Imvexxy, Knight Therapeutics Inc.) Comment: 4 MCG/CAP, 10 MCG/CAP, insert, vaginal Antineoplastic agent 04-28 Glasdegib (Daurismo, Pfizer Canada LLC) Comments: 25 MG/TAB, 100 MG/TAB, oral, tablet

August 31, 2020 · 13

The Chronicle of Healthcare Marketing

New drugs: No long-term solution in place, still years away —continued from page 14 Environment in Japan). Canada, on the other hand, uses a system that results in separate and independent regulatory oversight that falls under environmental protection laws for clinical research and marketing authorization. In Canada, this regulatory arrangement originally added a potential delay of up to 120 days for clinical trial applications for new biological substances that fell under these regulations. This has recently been changed with an informal commitment to shortening this review to 30 days. While the Dr. Rawson government may be receptive to suggestions on how to address this issue, a long-term solution remains potentially years away. In the meantime, there’s concern that this Moir regulatory overlap and the completion of separate applications could cause delays, review redundancies, and uncertainty. It’s possible that these impacts could have a pernicious impact on innovation within this space. With many new medicines of this type on the horizon for testing in Canada, it’s time for the federal government to take positive action to harmonize environmental assessment requirements with other jurisdictions. It must reduce the additional regulatory burden imposed on Canadian academic investigators and drug developers, allowing them to be more competitive internationally. At a time when the world is seeking answers to a pandemic, requiring severe price reductions and the extra burden of a separate and independent environmental assessment that disincentivizes the bringing of important, life-changing new medicines to Canada will make even less sense when we eventually transition back into a more stable post-COVID-19 world. Dr. Nigel Rawson is a senior fellow at the Fraser Institute, and Mackenzie Moir is a Fraser Institute analyst. Copyright 2020 by Troy Media. Reprinted with permission.

contingent on an approval REVIVE Up Here from the US FDA. Pfizer THERAPEUTICS What’s happening in the world of drug marketing said they expect to enroll announced it has off its generic drug unit, which will the 30,000 patients they originally entered into a clinical trial agreement merge with the generic drugmaker sought for its final-phase clinical trial by with the University of Wisconsin to Mylan. Additionally, investors have mid-September. conduct a study focused on the use of been concerned about several patent expsilocybin in adults with methamphepirations coming up for Pfizer in 2026 ASTRAZENECA announced a woman tamine use disorder. Psilocybin is a when the company is scheduled to lose who received an experimental coronavichemical found in magic mushrooms exclusive rights to five major drugs over rus vaccine developed severe neurologused to treat a variety of diseases and three years. Pfizer’s spot on the index ical symptoms causing the drugmaker to disorders. was filled by Amgen. * In other Pfizer pause testing. A participant in late-stage news, head honcho Albert Bourla says testing reported symptoms consistent PFIZER has been removed from the he is confident the US will have a with transverse myelitis, a rare inflamDow Jone Industrial Average Index Covid-19 vaccine ready for the public mation of the spinal cord, according to as part of a reshuffling of the index. before the end of the year. Bourla told an AstraZeneca spokesperson. An indePfizer has had a rough few years. The CBS he is “quite comfortable” that the pendent committee is reviewing the company was among the Dow’s worst vaccine Pfizer is developing in partnerstudy’s safety data before a decision is performers in 2019 after investors reship with BioNTech SE is safe and will made on whether the research can acted poorly to the company’s anbe available to Americans before 2021, continue. nouncement in late July it would spin

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August 31, 2020 · 14

The Chronicle of Healthcare Marketing

The Other Pandemic

That’s one of the striking consequences of Covid. Each of us, everyone, has become focused on EMEMBER WHEN THE ENTIRE PHARMA SECTOR the topic of health. Although, yes, there are one or was held in contempt by media scolds, charactwo exclusion zones, as you would expect, where terized as profiteering pariahs deserving of routine you’ll find the President of the United States of vilification? Recall how Ottawa policy-makers were America along with his enablers, explainers, and cultplanning for the disgorgement of drugmakers’ earnfollowers. ings? And wasn’t all that just a mere 180 days ago? It’s not necessarily that the cohort of virus-deWell, what a difference a global pandemic can niers, or “Trumpies” as they are known, have a spemake. Pity that it took nearly 30 million Covid cases cific intent to cause harm to themselves or others. and close to a million fatalities (at this writing) for They’ve just refused to comply with, or even accept, the value proposition of the Life Sciences industry the codes of behaviour that are required to prevent to attract some recognition. But, just look where the virus from spreading⏤which is also known as we’ve landed. No more is pharma the red-headed denying scientific reality. stepchild of the economy, no longer society’s favouThe Trumpies are an eccentric group, one that rite figure of derision. Suddenly, all the cool kids can be broken into several factions. Many appear infrom government, private investment, and IT want capable of absorbing and processing information, to hang out with us⏤and there’s an unaccustomed owing to factors such as cognitive impairment and respect in their voice when they ask with nervous substance abuse. Some may be of relatively sound indeference how those vaccines we’ve got simmering tellect, but possess forms of character deficiencies that away back in the lab are coming along. make them easily led toward destructive purposes. Others seem to harbour misconceptions regarding appropriate means of goal-attainment, with regard to personal financial gain, individual freedom, and the recognition of authority. And, doubtless, quite a few are proud specimens of what the August 31, 2020 • www.pharmacongress.info 20th-century social observer Jackie PUBLISHER Mason would categorize as the farMitchell Shannon schimmelt and fercockt. (A translation would be: The Stupids.) EDITORIAL DIRECTOR EDITORIAL ASSISTANT It is this latter grouping that R. Allan Ryan Jeremy Visser has received insufficient attention SENIOR EDITOR MANAGER, OPERATIONS John Evans Cathy Dusome

ASSISTANT EDITORS

Dhiren Mahiban Cory Perla Kylie Rebernik

COMPTROLLER

during the pandemic. A truism in the health professions is that you might successfully prevent or cure many diseases, but there ain’t no way to fix stupid. This point is reinforced by witnessing each day’s news feed, which depicts the Trumpies tightly assembled in enclosed spaces in close proximity, their voices lustily raised. What a delectable banquet for viruses they are. A Covid-tracking device would be useful for following the progress of these two-legged petri dishes, from their political rally to wherever they next choose to amble: the IHOP near the airport for late-night flapjacks, maw-maw’s house on the west side to pick up little Logan and Mason, and off the next morning to the parking lot of Dunder Mifflin or the Springfield nuclear plant for another day of commerce. A smartphone tracking app will not slow down the virus’s advance, but it would allow a more careful examination of the migration of the other pandemic of 2020, the one that has the consequence of exacerbating the Covid contagion. We refer to the Stupidity Pandemic, which, in lockstep with Covid, is sweeping many parts of the world but is disproportionately prevalent in the USA. Think we’re embellishing? Just take a look at http://tiny.cc/stupid-pandemic, where the Pew Research Foundations keeps tabs on what many Americans think. Following are some illustrations. Pew asked: “As far as you know, how effective are at-home treatments for serious cases of the coronavirus?” Forty-three per cent of respondents who Turn to The Other Pandemic page 10→

M y Tu r n

Rose Arciero

Gene therapy appraisals may limit the launch of new drugs in Canada

Published four times annually by the proprietor, Chronicle Information Resources Ltd., from offices at 555 Burnhamthorpe Rd., Suite 306, Toronto, Ont. M9C 2Y3 Canada. Telephone: 416.916.2476; Fax By Nigel Rawson and Mackenzie Moir, Special to THE CHRONICLE OF HEALTHCARE MARKETING 416.352.6199. E-mail: health@chronicle.org Contents © Chronicle Information Resources Ltd., 2020, except where noted. All rights reserved worldwide. The Publisher prohibits reproduction in any form, including print, broadcast, and electronic, without written permission. Printed in Canada. Subscriptions: $59.95 per year in Canada, $74.95 per year in all other countries. Combined rate including Chronicle MONDAY and Chronicle MIDWEEK newsletters: $240 per year in Canada, $360 per year in all other countries. Single copies: $7.95 per issue (plus 13% HST).

HE FEDERAL GOVERNMENT PLANS TO MOVE AHEAD WITH MAJOR REVISIONS IN REGULATIONS

governing the tribunal that sets ceiling prices for new prescription drugs in Canada. Revisions include: • replacing countries with relatively higher drug prices with lower price countries in the international price-comparison analysis; • enforcing hard thresholds for cost per quality-adjusted life year; • imposing a reduction in a drug’s price if its annual sales exceed a defined level; • requiring pharmaceutical companies to divulge information on confidential rebates negotiated with payers in Canada.

Canada Post Canadian Publications Mail Sales Product Agreement Number 40016917. Please forward all correspondence on circulation matters to: Circulation Manager, The Chronicle of Healthcare Marketing, 555 Concerns raised in the latest consultation on the revision indicate that clinical research will Burnhamthorpe Rd., Suite 306, Toronto, Ont. M9C 2Y3 Canada. E-mail: circuladecrease in Canada and manufacturers will delay bringing innovative new medicines to Canada tion@chronicle.ca ISSN 1209-0654 THE CHRONICLE OF HEALTHCARE MARKETING welcomes contributions from readers. In particular, we’d like to know what’s going on at your company, or organization, and you are especially welcome to keep us informed about new developments, new appointments, and new practices at your shop. If you’re submitting an article, opinion piece, press release, or letter to the editor for consideration, please bear in mind that we select material for publication from a large volume of submitted material, and that we may not be able to publish your submission in a specific issue (or at all) due to space constraints and other considerations. Our policies are: All material submitted to THE CHRONICLE becomes the property of Chronicle Information Resources Ltd., and is subject to the company’s usual editorial procedures; We will not consider for publication any material that has been simultaneously sent to other publications; Only original material or information will be considered; Payment at our established freelance rates will be offered upon publication for feature articles and for the following departments: What Lies Ahead: Original articles of approximately 500 to 700 words dealing with trends that shape the healthcare industry; and My Turn: Opinion pieces of approximately 500 to 700 words, offering original commentary on issues facing the healthcare industry. Please refer inquiries to: Editor, The Chronicle of Healthcare Marketing, 555 Burnhamthorpe Rd., Suite 306, Toronto, Ont. M9C 2Y3 Canada. Fax 416.352.6199, E-mail: health@chronicle.org

or not bring them here at all. Furthermore, early evidence suggests that adjustments in research activities are already being made. New clinical trials registered with Health Canada from Nov. 1, 2019, to Mar. 15, 2020, fell by more than 52 per cent compared with the same period in previous years, whereas new trials in the United States decreased by only 21 per cent. The changes to the pricing controls are not the only deterrent to clinical research in Canada, especially for novel genetic therapies that could be game changers in the lives of patients with cancer and other diseases. Cancer cellular immunotherapy trials increased to 1,579 in 2015 from seven in 1995, and the percentage of trials using genetically modified cells increased between 2006 and 2015 to a similar degree.

ENVIRONMENTAL RISK ASSESSMENT REQUIRED

Most genetic therapies are delivered to their target cell by a viral vector. Due to the potential ecological risk that cell and gene therapies may pose, an application for a clinical trial or for marketing authorization for these medicines requires an environmental risk assessment in most countries. These appraisals are the international standard for these therapies and are done not only in Canada but also in the US, the European Union and Japan. However, in each of these jurisdictions, except Canada, the evaluation is performed as part of a single review (the US and the EU) or jointly between ministries with regulatory overlap Turn to New Drugs page 13→ (Ministry of Labour, Health and Welfare and Ministry of

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Multichannel expertise

Intuitive interface

Lower cost and tailored model utilizing multiple types of HCP engagement for maximum impact

Field optimization engine through AshﬁeldGuide sales analytics & planning platform

Flexible customer-facing model optimized with a tailored mix of resources for each market and HCP Optimized mix

DIGITAL COMMS

TRADITIONAL REP PATIENT SERVICE REP

TRADITIONAL REP

CURRENT STATE

MEDICAL SCIENCE LIAISONS

CONTACT CENTER REP NURSE

HCP

KEY ACCOUNT MANAGER

Underpinned by Advanced Analytics ensuring dynamic, optimised physician targeting to maximize ROI Integrated multiple data sources

Model response

Call data Payer access

28 Calls

30 Calls/ HCP

30 Calls $

Effort

Ashﬁeld

Segments based on responsiveness 32 Calls

Impactable RX

IMS/ SHS

Select segmentation factors

7 Calls 5 Calls

Visit our website for more information: www.ashﬁeldhealthcare.com

6 Calls/ HCP