Manufacturing priorities during a post-Covid launch
Ross Glover of Taiho Pharma discusses some of the pandemic-influenced challenges ahead for industry
NPC Healthbiz Weekly is presented to you in cooperation with Peak Pharma Solutions
When planning for a product launch in a post-Covid-19 environment, there are several key factors for Pharma executives to consider that can make or break the launch including access to the source ingredients, manufacturing, packaging and the importation process into Canada.
Ross Glover, the General Manager of Taiho Pharma Canada, discussed manufacturing and packaging priorities in a post-Covid-19 launch during his presentation at the 14th National Pharmaceutical Congress.
“What we have seen in the Covid-19 era are some significant delays,” said Glover (photo below). “Fortunately, once products have arrived in Canada, we have not seen a lot of delays in terms of distribution across the country.
“Our patients have been able to access the medications that are available. However, we have seen delays in source ingredients, manufacturing and in the packaging process.”
Glover notes that source ingredient delays can depend on the country that the company is working with to obtain the ingredients. Factors such as the degree of impact Covid-19 has had in the particular country, restrictions on importation and exportation and the actions of the government in the source country—they may have placed limitations on the circulation of medical products, for example—can all play a role in the delay of source ingredients, he said.
Manufacturing can be impacted or limited because of plant delays or closures related to Covid-19, Glover said. Further, when plants are open, they may be working with smaller crews and limited shifts. Additionally, manufacturing can be delayed while plants wait for Health Canada verification.
“You may have some delays in either your Good Manufacturing Practices (GMP) inspections or GMP updates that are required for plants that could lead to delays in manufacturing,” Glover said. “This needs to be taken into account and needs to be planned within the timeline after discussions with Health Canada.
“Overall, there are some productivity changes that affect how source ingredients can be resourced and manufactured.”
Regarding packaging, the location of the packaging process could play a role in potential delays or interruptions in a product launch, Glover admitted. There could be geographical delays, there could be priorities in that country placed on Covid-19-related medications, whether that be medications for Covid-19 or oral medications that have become more prevalent in use, he said.
“What we also have seen is some of the materials that are required for packaging, some of the packaging foils and the cardboard inserts have been in short supply and packaging companies have had to scramble to find some of these materials,” Glover explained. “So, you could have delays based on that.”
Glover added that getting the product to the importation zone could also lead to delays. In some countries, there could be reduced staffing in those zones.
“However, once the product gets to the Canadian side of the equation, we have not seen a lot of delays, thanks to some of the efficiencies that we have in place in our country,” he said.
The takeaway: To execute a successful product launch in a post-Covid-19 environment, Glover said collaboration between global teams, manufacturing teams, and partners or partner companies for source ingredients within the field of manufacturing and packaging will be crucial.
“It is important to get these resources on to Zoom or Microsoft Teams as early as possible to understand all of the limitations that may not have been communicated across global lines and that you understand how it can affect the Canadian situation,” he said.
Glover added that while these are challenging times, it is important to remember that Pharma it is an innovative and creative industry and that doesn't have to change because of the pandemic.
Further reading: Before this pandemic, it was rare for companies to have a contingency plan for a product launch during a global pandemic. Launch Team Incorporated, a B2B marketing company, has put together a list of strategies for launching during Covid-19. Story here.
YOUR HEALTHBIZ WEEK 02/09/21
Jazz Pharmaceuticals has agreed to acquire GW Pharmaceuticals, maker of the first drug derived from the cannabis plant to win approval in the U.S., for US$7.2 billion in cash and stock, according to a BNN Bloomberg report. GW sells Epidiolex a treatment for severe epilepsy in children that was approved by the U.S. FDA in June 2018. GW is also in late-stage trials for another cannabis-based product to treat multiple sclerosis, and is working on candidates for autism and schizophrenia.
The U.S. FDA authorized the marketing of a new prescription-only device made by eXciteOSA intended to reduce snoring and mild obstructive sleep apnea. This is the first device used while awake that is intended to improve tongue muscle function, which in time can help prevent the tongue from collapsing backward and obstructing the airway during sleep. The eXciteOSA device is a removable tongue muscle stimulation device that delivers neuromuscular stimulation to the tongue in order to reduce snoring and mild sleep apnea for patients who are 18 years or older. The device works by delivering electrical muscle stimulation through a mouthpiece that fits around the tongue. The device provides electrical muscle stimulation action in sessions that consist of a series of electrical pulses with rest periods in between.
Eisai announced it has received Health Canada authorization for its non-sedative prescription medication, DAYVIGO™ (lemborexant). Available in both 5 mg and 10 mg dosages, lemborexant is indicated for the treatment of insomnia, characterized by difficulties with sleep onset and/or sleep maintenance. Lemborexant has been approved for use in the United States and Japan for the treatment of insomnia. The Canadian authorization of lemborexant is based on two phase three studies, that established the efficacy and safety profile of the treatment.
NATIONAL PHARMA CONGRESS WINTER WEBINAR
The National Pharmaceutical Congress Winter Webinar is scheduled for tomorrow: Wednesday, February 10, 2021.
The webinar will be hosted by Peter Brenders (New Brunswick Health Research Foundation) and feature presentations led by Jim Shea (Council For Continuing Pharmaceutical Education), Paul Petrelli (Jazz Pharmaceuticals Canada) and Carol Stiff (Santen Canada)
As a reader of the NPC HealthBiz Weekly, you are invited to attend the webinar at no charge. Register now at pharmacongress.info.
Already registered and have a question for one of the panellists? Send your question to health@chronicle.org.
CANADIAN HEALTHCARE MARKETING HALL OF FAME
The Canadian Healthcare Marketing Hall of Fame awards were established in 2002 to honour healthcare marketers who have contributed to our avocation and are an inspiration to others.
More than 100 honourees have been selected during the past 18 years. In the selection committee's view, they stand for a representative cross-section of the qualities that make our business unique and fulfilling. Each week, NPC Healthbiz Weekly will acknowledge one past Hall of Fame Honouree.
2012 Inductee
Richard Fajzel
Pfizer Canada
Montreal
Editor’s note: Richard Fajzel is the CEO at Exactis Innovation—a non-profit cancer research organization established in 2014.
“I was facinated with strategic issues rather than pure marketing,” says Richard Fajzel, General Manager, Oncology Business Unit, Pfizer Canada. “I was more interested in overall business strategy and the power of marketing within the business strategy.”
Fajzel started his career at Sandoz Canada in Montreal, after earning a Bachelor of Arts from McGill University in Montreal and a Masters of Business Administration from Concordia University in Montreal. He first worked in market research, later joining the company’s sales force, and then becoming a brand manager for products like the anti-fungal therapy Lamisil and the Parkinson’s disease treatment Parlodel.
After being a brand manager for four years, I felt it was important to gain experience in working with products in the pipeline,” says Fajzel.
To get that experience, he joined Pfizer Canada in 1996 and focused on products in development, some of which would become blockbusters.
“It was a really exciting time,” he says. “Big drugs like Lipitor were coming down the pipe. There was a big basket.”
When the company implemented a team-based structure in 1997, Fajzel embarked on a new challenge, becoming a team leader and managing a cross-functional team.
“It was a pivotal phase where I learned a lot,” says Fajzel. “The people management elements were there, and there were some great lessons.”
Leading a cross-functional team set the stage for becoming Director of Marketing in 2001. The company ventured into uncharted territory by marketing Viagra to consumers at large, a move that was out of the ordinary for a Canadian pharmaceutical firm.
“We were making a decision regarding whether to advertise to consumers directly,” he recalls.
Since Canada’s laws prohibit prescription drug advertisements from stating what a drug does for patients, the company had to develop creative content for consumers that would convey the efficacy of Viagra. It selected the ad agency Taxi to help achieve that task.
The result was ads that were recognized with accolades in Canada and around the world, and Fajzel was selected Marketer of the Year in 2003 by Marketing Magazine.
“Everyone on the team worked well together, was highly passionate and motivated, and we utilized mass media in an innovative way,” says Fajzel.
Fajzel became Director of Sales for the company’s specialty market division after several years as Director of Marketing and began to familiarize himself with the company’s oncology and HIV portfolio, and found a new challenge in meeting the customer needs of hospitals that included development of account management capabilities in the team.
Since the start of 2009, he has held his current job and is in awe of the complexity of oncology therapies and the challenge of building a business unit around a therapeutic area.
“Oncology is at the leading edge of personalized medicine and genomically-guided drug development,” says Fajzel. “We are developing customized treatments for specific populations.”
Provincial governments and cancer agencies in Canada are recognizing the value of targeted therapies in oncology, adds Fajzel.
Outside of his professional life, Fajzel is an avid cyclist and skier who frequently hits the slopes in the winter with his family.
NEXT WEEK
The 02/16 edition of NPC Healthbiz Weekly will feature Pat Forsythe, General Manager of Eisai, on his views regarding the pros and cons of launching a product during Covid-19. It’s easy to get your no-charge subscription and have the issue sent to your phone or inbox each Tuesday at 6:00 a.m. sharp.
Stay safe, stay sure, and stay on your game. We’ll see you again next Tuesday.