BioSpace

BioSpace's Lori Ellis and Chantal Dresner are bringing live updates from #DIA2024 in San Diego this week where the first day kicked off with an inspiring story from Tom and Emily Whitehead of the Emily Whitehead Foundation, setting the tone for patient-centric discussions.

The following panel featuring Emer Cooke, Chair, ICMRA an Executive Director, European Medicines Agency; Peter Marks, Director, CBER, FDA; Carsten Linnerman, CEO, Neogene Therapeutics, AstraZeneca Group; Dean Kamen, Founder, DEKA; and Stacy Hurt, Chief Patient Officer, Parexel emphasized the imperative of collaboration to improve outcomes, between regulatory bodies as well as with patients.

Tune in this week to hear more from the event!

The big news of this week so far was Monday’s FDA advisory committee for Eli Lilly’s Alzheimer’s drug donanemab, where the vote was unanimous in support of the anti-amyloid antibody. If approved, donanemab would be a direct competitor of Biogen and Eisai’s Leqembi, but analysts believe there’s plenty of room in the market for

The mood was decidedly different from last week’s FDA

In other conference news, Eli Lilly and partners Boehringer Ingelheim and Zealand Pharma presented mid-stage results for their GLP-1 products in the MASH space at the Congress of the European Association for the Study of the Liver. These companies are eyeing a piece of the MASH market that Madrigal Pharmaceuticals first tapped into earlier this year when its therapy, Rezdiffra, was approved in March.

Finally, CBRE published a report on challenges in finding R&D and manufacturing talent, and thousands of layoffs continue to hit the biopharma industry. According to our Layoff Tracker, there have been 14,000 positions cut this year, with BMS and Bayer being the unfortunate leaders, each with more than 1,500 layoffs underway. Still, analysts

How do we ensure strategic vision and thoughtful implementation when pursuing new opportunities in science and technology?

Our guests discuss challenges around reimbursement, intellectual property, change management and the critical nature of early engagement. 

Additionally, we are joined by Tamei Elliott of DIA who shares insights on key discussions and themes of the upcoming meeting in San Diego.

This is the third and final episode in our preparation for the roundtable discussion: ⁠⁠Pioneering New Frontiers: Advanced Drug Delivery Technologies and Cell/Gene Therapies in Combination Products⁠⁠ taking place at the ⁠⁠DIA 2024 Global Annual Meeting⁠⁠.

James Wabby, Global Head, Regulatory Affairs, Emerging Technologies and Combination Products, AbbVie is chairing the discussion between Rob Schulz, President and Chief operating officer of Suttons Creek, William Daunch, Chief Technology Officer, Focal Medical, Inc, Andrea Gray, Biomedical Engineer Advisor, CBER, FDA, and Michael Lehmicke, Senior Vice President, Science and Industry Affairs, Alliance for Regenerative Medicine.

Lori Ellis will be covering DIA Global Annual meeting 2024, June 16-20 in San Diego.

Host 

⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Lori Ellis⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠, Head of Insights, ⁠⁠⁠BioSpace⁠⁠⁠  

Guests

⁠⁠James Wabby⁠⁠, Global Head, Regulatory Affairs, Emerging Technologies and Combination Products, ⁠⁠AbbVie, United States⁠⁠

⁠⁠Rob Schulz⁠⁠, President and COO, ⁠⁠Suttons Creek, Inc., United States

Tamei Elliott, Associate Director, Scientific Programs (Americas), DIA

Conference season kicked into high gear this week with the American Society of Clinical Oncology (ASCO) annual meeting in Chicago and the BIO International Convention in San Diego. Check out BioSpace’s ASCO24 Tracker with all the biggest data and other news from the cancer meeting, which wrapped up on Tuesday.

Among the trial results highlighted at ASCO24 were BMS’ Phase III study results in liver cancer. There was also a lot of news on non-small cell lung cancer (NSCLC): Pfizer presented results from a Phase III trial evaluating its ALK inhibitor Lorbrena, BMS provided three updates on its immunotherapy Opdivo and Opdivo-based combinations, while Gilead unveiled additional details on a failed Phase III trial for its antibody-drug conjugate (ADC) Trodelvy.

Currently, there is one ADC approved to treat NSCLC, AstraZeneca and Daiichi Sankyo’s Enhertu, for patients with HER2-mutated metastatic disease. While the companies’ investigational ADC Dato-DXd is making some headway against NSCLC, experts recently told BioSpace that more compelling surface targets for lung cancer are needed in order for ADCs to really make a difference.

When it comes to M&A, Big Pharma continues to show strong interest in oncology, particularly ADCs and radiopharmaceuticals. However, last week’s biggest deal was Merck’s $3 billion acquisition of EyeBio and its first-in-class trispecific antibody Restoret, marking the company’s return to the ophthalmology space after nearly a decade. For now, it appears Big Pharma favors smaller M&A over megabillion-dollar deals. Recent buying activity also indicates a potential resurgence in the appetites of larger companies for psychiatric drug development.

Regulators suggest developers engage in discussions early, however those conversations cannot take place unless developers are sure of the asset's category.

Existing confusion surrounding advanced therapy products may become more challenging as both science and technology evolve.

With both developers and regulators, two risk adverse entities, addressing this evolution and continually updated regulations, advanced therapy product development continues to be a collaborative process.

This is the second episode in our preparation for the roundtable discussion: ⁠Pioneering New Frontiers: Advanced Drug Delivery Technologies and Cell/Gene Therapies in Combination Products⁠ taking place at the ⁠DIA 2024 Global Annual Meeting⁠.

James Wabby, Global Head, Regulatory Affairs, Emerging Technologies and Combination Products, AbbVie is chairing the discussion between Rob Schulz, President and Chief operating officer of Suttons Creek, William Daunch, Chief Technology Officer, Focal Medical, Inc, Andrea Gray, Biomedical Engineer Advisor, CBER, FDA, and Michael Lehmicke, Senior Vice President, Science and Industry Affairs, Alliance for Regenerative Medicine.

Lori Ellis will be covering DIA Global Annual meeting 2024, June 16-20 in San Diego.

Host 

⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Lori Ellis⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠, Head of Insights, ⁠⁠BioSpace⁠⁠  

Guests

⁠James Wabby⁠, Global Head, Regulatory Affairs, Emerging Technologies and Combination Products, ⁠AbbVie, United States⁠

⁠Rob Schulz⁠, President and COO, ⁠Suttons Creek, Inc., United States

At its Investor Day 2024 event last week, AstraZeneca announced plans to reach $80 billion in total revenue by 2030—up from $45.8 billion in 2023—and to launch 20 new medicines by the end of the decade. Does AstraZeneca have the assets and developmental pipeline to hit this lofty target?

Meanwhile, Bayer, BMS and Pfizer are looking to conserve cash through cost-savings plans that include layoffs. It’s a trend we’ll be keeping a close eye on as companies face potential implications from upcoming patent expirations, the Inflation Reduction Act’s Drug Price Negotiation Program and investor expectations.

On the R&D front, Takeda took a deep dive into the hot molecular glue degrader space, signing a potential $1.2 billion exclusive licensing deal with China-based Degron Therapeutics. The new partners will be going after various oncology, neuroscience and inflammatory disease targets. Takeda follows Novo Nordisk, Roche’s Genentech and Merck, who have all recently struck R&D deals focused on molecular glues degraders.

And the conference season again kicks into high gear this weekend with the American Society of Clinical Oncology (ASCO)’s annual meeting starting Friday in Chicago and the 2024 BIO International Convention beginning Monday in San Diego. BioSpace’s Heather McKenzie will be moderating a BIO panel focused on closing the gaps in neuropsychiatric drug development, so if you’re heading to San Diego, please pop in and say hello!

With every new advancement in either science or technology there is increased excitement as we see the potential. Cell and gene therapies (CGT) as combination products are emerging as the stage in the evolution of technology and science merging together. While the potential benefits for patients are great, there are risks and challenges that must be carefully considered.

This discussion is part of one of a precursor of the roundtable discussion: Pioneering New Frontiers: Advanced Drug Delivery Technologies and Cell/Gene Therapies in Combination Products taking place at the DIA 2024 Global Annual Meeting.

James Wabby, Global Head, Regulatory Affairs, Emerging Technologies and Combination Products, AbbVie is chairing the discussion between Rob Schulz, President and Chief operating officer of Suttons Creek, William Daunch, Chief Technology Officer, Focal Medical, Inc, Andrea Gray, Biomedical Engineer Advisor, CBER, FDA, and Michael Lehmicke, Senior Vice President, Science and Industry Affairs, Alliance for Regenerative Medicine.

Lori Ellis will be covering DIA Global Annual meeting 2024, June 16-20 in San Diego.

Host 

⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Lori Ellis⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠, Head of Insights, ⁠BioSpace⁠  

Guests

James Wabby, Global Head, Regulatory Affairs, Emerging Technologies and Combination Products, AbbVie, United States

Rob Schulz, President and COO, Suttons Creek, Inc., United States

Bayer’s recent layoffs of 1,500 mark a step toward CEO Bill Anderson’s stated goal of removing managerial layers at the company—“fewer bosses, fewer rules,” he told  The Wall Street Journal. The move follows BMS’ announcement that it will let go more than 2,000 people.

In other news, J&J expanded its dermatology portfolio, paying $850 million in cash plus potential milestone payments for California-based Proteologix and its Phase I–ready atopic dermatitis candidate. J&J is competing with Eli Lilly, which continues to actively pursue this space as well, with positive Phase IIIb results for its candidate in March.

Roche’s Genentech is looking to jump into the hot GLP-1 space with positive results from a Phase Ib trial for its investigational weight-loss treatment CT-388. The once-weekly subcutaneous injection was part of Roche’s acquisition of Carmot Therapeutics in December for $2.7 billion—a hefty sum as Roche looks to compete with

We also touch on Novo’s latest positive study on Wegovy and a couple of big approvals last week, including BMS’ third indication for its CAR T therapy Breyanzi and Amgen’s Imdelltra, the first bispecific T-cell engager therapy for advanced small cell lung cancer.

Finally, we discuss this week’s special edition of ClinicaSpace, focused on psychedelics for mental health disorders. There’s a pretty extensive pipeline of therapies of psilocybin, DMT and more, for depression, substance abuse disorders and other neuropsychiatric diseases. The first psychedelic therapy for a neuropsychiatric disease—Lykos Therapeutics MDMA for PTSD—is up for FDA approval this summer. The FDA is convening an adcomm on June 4 to discuss the therapy.

Bayer made news this week announcing 1,500

In other news this week, Takeda took another deep dive into the Alzheimer’s space with a deal worth up to $2.2 billion with AC Immune for global rights to an immunotherapy that targets toxic forms of amyloid beta. And the BIOSECURE Act got an update, now naming WuXi Biologics among the Chinese firms that U.S. companies are expected to cut ties with, and setting a deadline of 2032.

Finally, we discuss the major takeaways from last week’s 2024 American Society of Gene & Cell Therapy (ASGCT) annual meeting. While the cell and gene therapy space faces many challenges, promising updates included Regeneron’s news that its gene therapy improved hearing in two young deaf children. And throughout the week, Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research (CBER), spoke with positivity on how the community is now working to address the challenges it now faces, touching on topics such as accelerated approval, global regulatory convergence and the Bespoke Gene Therapy Consortium, aimed at accelerating the delivery of AAV-based gene therapies for rare diseases.

12 billion dollars: one of the boldest women’s health research moves an administration has made for women’s health research. On a global scale, this has caused countries and sovereign states to start investing in women’s health.

But in the United States, the funding is not guaranteed. It depends on congressional approval, which is complicated during an election year. As the United States continues to grapple with politics and science meeting, the global healthcare sector is already beginning to reframe the language and invest in women’s health research.

Host 

⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Lori Ellis⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠, Head of Insights, ⁠⁠BioSpace⁠⁠  

Guests

⁠⁠Sans Thakur⁠⁠, Founder and Chairwoman of ⁠⁠Tower Capital⁠⁠

⁠⁠Chia Chia Sun⁠⁠, Chief Commercial Officer at ⁠⁠Fab Biopharma⁠⁠

⁠⁠Elisa Cascade⁠⁠, Chief Product Officer of at ⁠⁠Advarra⁠⁠

Shawana Moore, Medical Advisor on the ⁠⁠Advisory Council for Healthy Women⁠⁠

⁠⁠Katie Schubert⁠⁠,  President and Chief Executive Officer of the ⁠⁠Society for Women’s Health