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Biogen restructures R&D division as FDA approves second Alzheimer’s drug
Who: After over a year without a permanent R&D head, Biogen announced last week that it’s dividing the position into two roles. Under the new structure, Priya Singhal, current global safety and regulatory science leader and interim head of R&D, will take on development duties full-time and will temporarily oversee research as the company searches for her permanent co-executive.
Background: Singhal has a long history at Biogen. She first joined the company in 2012 fresh off a stint at Vertex Pharmaceuticals and served as senior vice president of global safety and benefit-risk, helping steer five drugs to launch. After over four years in the role, she left briefly for a position as head of research at Zafgen, a clinical-stage biotech focused on metabolic disorders, but returned to Biogen in 2020 to lead global safety and regulatory science.
When the company’s former R&D chief Al Sandrock left the position in late 2021 as controversy related to Biogen’s Alzheimer’s drug Aduhelm intensified, Singhal took the wheel.
Why it matters: The past year — which started with the implementation of Biogen’s $500 million cost-saving restructuring plan and ended with a congressional review concluding that FDA’s Aduhelm decision was “rife with irregularities” — has no doubt been rocky for Singhal. But the FDA’s recent approval of Eisai and Biogen’s second Alzheimer’s drug Leqembi, likely brings a sigh of relief.
The drug, scientifically known as lecanemab, directly targets amyloid plaques, thought to be a cause of Alzheimer’s. A late-stage trial found the treatment slowed Alzheimer’s-related physical and mental declines by 27% over 18 months.
Singhal’s official appointment as head of development, and the C-suite restructure, are also notably among the first major moves Biogen’s newly-crowned CEO Christopher A. Viehbacher has made since entering the role in November.
“We believe having two dedicated leaders will enhance productivity in bringing to patients worldwide medicines to treat some of the most challenging diseases, while assuring better risk management and resource stewardship,” Viehbacher said of the decision to divide the role.
Learn more: The FDA’s decision also marks the start of what is bound to be a big year for Alzheimer’s drugs. PharmaVoice spoke with top execs at Eli Lilly and Co. about its candidate donanemab, which is expected to report confirmatory phase 3 results later this year.
Longtime Novavax CEO set to retire at month’s end
Who: John Jacobs will take the helm of the vaccine-focused biotech Novavax later this month, upon the retirement of current CEO and president Stanley Erck.
Background: Jacobs previously served as CEO and president of Harmony Biosciences, leading the neurological disease company through its IPO, first FDA product review and drug launch. During his two-and-a-half decades in the pharma industry, Jacobs has gained a breadth of experience across commercial operations and disease areas, notably leading the generics-maker Teva Pharmaceuticals’ respiratory business unit and business-related positions at Cephalon, Wyeth and Pfizer.
Why it matters: Erck led Novavax through numerous milestones during his 12 years as head honcho, including bringing its COVID-19 vaccine to market in over 40 countries and developing a manufacturing network to support its global distribution. Unlike other vaccines on the market, Novavax’s shot uses more traditional technology that was seen as enticing for skeptics of mRNA options.
“Erck led Novavax from a clinical development organization to a global commercial vaccines company during a worldwide pandemic,” James Young, chair of Novavax’s board said. “This foundation puts Novavax in a strong position to execute on its long-term strategy.”
Learn more: The company’s regulatory head, Dr. Henrietta Ukwu is a 2022 PharmaVoice 100 honoree. Here, she discusses her leadership style, the companies plans for seasonal influenza, respiratory syncytial virus and more vaccines, and the importance of collaboration.
With extra cash in its coffers, Bluebird brings on new head of business
Who: Amid the launches of its two recently approved gene therapies, Bluebird Bio appointed Joseph Vittiglio as its new chief business and legal officer Jan. 3.
Background: Before joining Bluebird, Vittiglio served in a similar role at Finch Therapeutics, a Boston-based microbiome company, where he helped initiate an IPO in 2021 and raised over $130 million in capital. Vittiglio is well-versed in pharmaceutical and biotechnology operations, having spent the better part of his career in legal roles at various Massachusetts biotechs, including Flexion Therapeutics, AMAG Pharmaceuticals and AVEO Pharmaceuticals.
Why it matters: 2022 was tumultuous for Bluebird, to say the least. But, with two FDA approvals and an influx of cash to start off the new year, the biotech’s situation is looking brighter.
Last year, Bluebird was forced to lay off 30% of its workforce and move its headquarters as part of cost-saving measures. The company was hanging on by a thread in the fall, until it received back-to-back FDA approvals for its gene therapies Zynteglo to treat transfusion-dependent beta thalassemia and Skyson for cerebral adrenoleukodystrophy. Both approvals came with priority review vouchers, which give drug developers fast-tracked FDA processing for experimental medicines, and which the company has since respectively sold to Argenx in November for $102 million and Bristol Myers Squibb last week for $95 million.
While this year is likely to be less stormy than the last, Vittiglio still has his work cut out for him in the new role, as he’ll be tasked with guiding the company’s launches of the two rare disease therapies and with helping usher a third candidate, the treatment lovo-cel for sickle cell disease, through the FDA approval process.
Learn more: Bluebird wasn’t the only company with major gene therapy approvals in 2022. CSL Behring in November also received the go-ahead for Hemgenix to treat hemophilia B. We caught up with CSL’s head of R&D to discuss the historic approval, which is also now the world’s most expensive drug.
Klick Health hires McKinsey executive to lead commercial solutions
Who: The life sciences commercialization agency Klick Health tapped longtime McKinsey and Co. partner Brian Fox as its new president of commercial solutions and head of corporate development earlier this month.
Background: During his 18-year tenure at McKinsey, Fox gained a reputation as an innovative force in pharma commercialization. He notably led McKinsey’s foray into the use of artificial intelligence for precision marketing, even helping the Emirates Team New Zealand sailing team find victory in the America’s Cup with an AI bot, and brought many of those insights into his work developing patient adherence programs for pharma companies. A founding member of Google’s Healthcare Advisory Board, which brings together executives from across the industry to design digital marketing strategies, Fox has honed an expertise in launching products and creating campaigns to engage doctors and patients alike.
Why it matters: This is the second major personnel shake-up at Klick in the span of just a few months — with the agency appointing Google’s Ryan Olohan as executive vice president of growth in September.
Leerom Segal, the company’s co-founder and chair, said the changes are part of a strategy to strengthen Klick’s “position as the preeminent commercialization partner in life sciences.”
For his part, Fox outlined goals to bring “together commercial disciplines like #marketing, #sales, #marketaccess and #patientservices that typically are planned and executed quite separately,” in a LinkedIn post announcing his new role.
“We will build new connections between commercial, medical and clinical development functions. All of this will result in better care for patients, better support for prescribers and, ultimately, better performance for life sciences innovators,” he said.
Learn more: Fox’s new colleague and Klick’s chief brand strategy officer, Carl Turner, is a 2022 PharmaVoice 100 honoree.
ADC Therapeutics bolsters C-suite as competition heats up
Who: Former AbbVie Vice President and Global Head of Oncology Mohamed Zaki joined ADC Therapeutics, a leader in the antibody-drug conjugate space, as chief medical officer Jan. 3.
Background: An industry veteran, Zaki has spent over 20 years steeped in oncology and hematology, most recently at AbbVie. Prior to that, he led clinical development efforts at Celgene for nearly a decade, culminating in his role as vice president and therapeutic area head for multiple myeloma. He also worked briefly at Sanofi-Aventis.
Why it matters: Zaki is the latest executive to join ADC in what has been a C-suite hiring frenzy over the past few months. Last fall, it nabbed former Novartis exec David Gilman as chief business and strategy officer and, just before the new year, added Jose Carmona as chief financial officer.
The company received FDA approval for its first drug, a treatment for relapsed or refractory diffuse large B cell lymphoma, in 2021 and is looking to advance a pipeline of eight candidates, including one in phase 3 confirmatory trials that uses its proprietary targeted pyrrolobenzodiazepine (PBD) dimer technology platform.
And the ADC space is buzzing overall. Just last week, Amgen announced a $2 billion licensing agreement with the Amsterdam-based Synaffix to develop next-generation ADCs. Merck and Co. also attempted to enter the space last year, with a planned buyout of the oncology-focused Seagen, but the deal has reportedly stalled over finances.
Learn more: Ameet Mallik, CEO of ADC Therapeutics, spoke with PharmaVoice about how the company’s platform stands apart from its competitors and about the future of ADCs in cancer care.
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