Harnessing real world evidence to shape our future
Pat Forsythe sees the way forward: It’s real world data (380 words, 3 min)
Four emerging technologies—machine learning, genomics, accessible data sources and blockchain—may be valuable tools that will help the pharmaceutical industry harness real-world data and evidence, according to Pat Forsythe, General Manager of Eisai Inc.
“Real world evidence is derived from the analysis of real world data,” Forsythe (photo below) explained during the 15th Annual National Pharmaceutical Congress.
“There have been advances in digital [technology] and analytics, and an explosion of data. Regulators are much more open than they ever have been, and Covid and vaccine development have put real world evidence in the public eye.”
Machine learning and AI are coming to Pharma, Forsythe said. He noted that some new pharmaceutical start-up companies operate using an artificial intelligence (AI) drug development platform. He also said that Merck & Co. recently demonstrated an automated system that could identify patients with peripheral artery disease from EMR records at a much more effective and efficient rate than traditional clinical examinations.
“Because of our large data sets, there is a place for genomic [research using AI],” Forsythe added. “Flatiron Health and Foundation Medicine have together created a database of 82,000 oncology patients. They know the patients’ genomic profiles and drug outcomes.”
In addition, Forsythe pointed out that researchers can examine patient-level clinical data and determine how this information can improve patient care.
“[There is also] the ability to share healthcare outcomes and adverse events on social media,” he said. “Add to that cloud computing and pooled data—it is a rich source of data we have not seen before.”
“Finally, there is blockchain, which is great for creating consistent data sets in a confidential manner,” Forsythe added. “If we took all the data we have today, and could use blockchain to facilitate access to records, data reporting, clinical trials, privacy and consent management, the efficiencies alone would be worth it.”
“We are going to see increased partnerships in generating and using data,” Forsythe predicted.
“We are going to have a better understanding of subgroups, which is great for rare diseases. The costs of gathering information could be done more effectively and efficiently. And with our analytics capabilities, we will have more insights [regarding] which products will deliver the most value.”
THIS WEEK 02/15/22
AbbVie announced that the company has reached an agreement with the pan-Canadian Pharmaceutical Alliance (pCPA) for re-imbursement of the costs of VENCLEXTA (venetoclax) in combination with azacitidine for the treatment of newly diagnosed acute myeloid leukemia (AML) in patients who are 75 years or older, or who have comorbidities that dissuade the use of intensive induction chemotherapy. This re-imbursement coverage is now in effect on the Quebec, Saskatchewan and Manitoba formularies.
Bausch Health Canada announced that Health Canada has approved TRULANCE (plecanatide) for the treatment of irritable bowel syndrome with constipation (IBS-C) in adults.
Novavax, Inc. announced that NVX-CoV2373, its recombinant nanoparticle protein-based Covid-19 vaccine, met its primary effectiveness endpoint in the pediatric expansion of its PREVENT-19 pivotal Phase 3 trial. NVX-CoV2373 demonstrated an 80% efficacy overall at a time when the Delta variant was the predominant variant in the U.S. The study involved 2,247 participants between the ages of 12 and 17 years across 73 sites in the U.S.
Seegene Inc., a Soth Korean molecular diagnostic company, announced that the company has signed a supply deal with the Ministry of Health of Brazil to deliver four million Covid-19 tests. The tests, known as Allplex SARS-CoV-2/FluA/FluB/RSV Assay, are reported to be capable of identifying various respiratory viruses including Covid-19, Flu A/B and Respiratory Syncytial Virus.
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Michel Lavoie, President of Dermtek Pharma, talks about growing up and into the family business, the pandemic’s affect on therapeutic skin care products, and keeping up with clients in an increasingly virtual world.
He joins our co-hosts Mitch Shannon, Jim Shea and Mark McElwain, in the sixth episode of our sixth season.
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 vocation and inspire 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.
2007 Inductee
Lorena Di Carlo
Currently based in Singapore
Editor’s Note: Isabelle is Senior Vice President Region Asia at Lundbeck.
“I’ve been fortunate enough to be part of a dynamic company which most people in the industry recognize as being a great place to work,” says Lorena Di Carlo, Vice President, Marketing, Lundbeck Canada. Being part of the Lundbeck “world” for over 12 years has been exciting, says the 15-year veteran of the pharmaceutical industry who made her industry debut in the early ‘90s at Burroughs Wellcome.
Di Carlo would get her first taste of pharma life right out of university as a customer service rep at BW. After one year, she would find herself in the role of a medical rep in downtown Montreal, where she earned a Representative of the Year award for her work managing a territory generating over $1 million annual sales of antiviral medications.
Just three years later she would be recruited by the start-up Canadian subsidiary of the Danish-based pharma company Lundbeck to become the “first Lundbeck representative in North America.” Having worked for Lundbeck “pretty much from day one,” Di Carlo credits the company with allowing her “tremendous latitude.” Only six months after she was groomed as a specialty hospital rep, Lundbeck, a company that specializes in treatments for CNS disorders, would recognize her efforts by promoting her to product management and entrusting her with the launch of its flagship antidepressant, Celexa.
The launch, says Di Carlo, was one of the most successful in Canada, reaching peak sales of $150 million and helping countless patients overcome their symptoms of depression.
In 2000, Di Carlo was appointed to Marketing Manager, Psychiatry and a year later rose to the challenge of Marketing Director, a test of her leadership skills as she guided her team through the launch of Lundbeck’s newest antidepressant, Cipralex and Ebixa, a novel treatment for Alzheimer’s disease. The experience set the stage for Di Carlo’s promotion to Vice President, Marketing in 2005.
These days, Di Carlo’s time is devoted to her executive duties in the Canadian subsidiary, but she also actively contributes to the company’s global brand strategies as a member of the Global Brand Board in Denmark. “I speak four languages and I love learning about new cultures. What I appreciate about Lundbeck is that I get the opportunity to meet people from around the world and be exposed to a host of international projects.” In fact, Di Carlo recently lived in Copenhagen for six months working on an assignment with the company’s global Strategic Marketing team.
It’s just one more thing that Di Carlo loves about her job– and there are many more that have made her marketing career at Lundbeck “special.” For one, the company credo-- Imaginative, passionate, responsible--are values that she says “resonate most with me.” She also applauds her team of “really good, competent, and dedicated” people. “We work in an environment where respect is highly regarded. We can challenge each other but there’s always a respect for the individual,” she says.
“Treating suppliers like true partners, involving them in our company, and integrating them into our strategic planning process makes them an extension of our team. Our philosophy is to treat partners like our own employees--this is a common understanding throughout my team and throughout the organization. I think our partners appreciate this and it makes them committed to helping us achieve our objectives.
NEXT WEEK
In the 02/22 edition of the NPC Healthbiz Weekly, more from the powerhouse panels of the 15th Annual National Pharmaceutical Congress. 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 week.