Jesse Boyd

Novo Holdings’ $16.5 billion Catalent Pharma Solutions buy leads 2024’s M&A deals so far Other notable deals include: - Bristol Myers Squibb' $14B acquisition of Karuna Therapeutics, doubling down on neuropsychiatry  - Vertex Pharmaceuticals's $4.9B purchase of Alpine Immune Sciences to expand into immunotherapy - Gilead Sciences's $1.7B antibody partnership with MacroGenics, Inc. and $1.5B collaboration with Merus N.V. While not yet matching the scale of 2023's mega-deals like Pfizer's $43B Seagen buyout, 2024 reflects a strong trend of targeted acquisitions and strategic partnerships reshaping the biopharma landscape.

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In this month's Newsletter, Kristin Owens and Marianne Doherty share The NemetzGroup LLC's experience with launch planning and the important role of governance in ensuring success. This is a longer newsletter but worthy of your time, especially if you are in launch planning mode! Enjoy #nemetzgroup #launchplanning #commercialization

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I respect Louis Garguilo's willingness to report the unpopular and provide additional perspectives on this contentious issue. While Congress debates the BIOSECURE Act and its aims to ban federally funded medical providers from using products manufactured or services provided by what it calls "foreign adversary biotech companies of concern"... Louis argues there are questionable actions happening in parallel (see article). 🤔 Should we assume the U.S. Congress, BIO and others see no risk of IP transfer to the China Communist Party (CCP) in any of these (and similar) deals, as they now seem to when working with a China-based CDMO? 🤔No concerns here regarding focusing biotech knowhow/jobs in China instead of investing/reshoring in the U.S. or Europe? 🤔Nothing to see here? I like how he wraps it up: What is raised here are concerns with the calling out of a currently well-respected and utilized CDMO – without details/proof or due process, and not applying a standard of inquiry across the industry. What do you think? https://lnkd.in/e75YP-dM #legislation #lobbying #BIOSECUREACT #cdmos #tradepolicy #electionyear #outsourcing

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Sanofi pulls off phase 3 LUNA landing, sparking race to regulators for BTK inhibitor Sanofi’s $3.7 billion Principia Biopharma buyout has delivered a phase 3 victory. The BTK inhibitor moved the needle in a clotting disorder, clearing Sanofi to file for approval of a “multi-indication blockbuster” that it predicts (PDF) could contribute to more than 10 billion euros ($11 billion) of drug launch sales.  The candidate, rilzabrutinib, is an oral, reversible BTK inhibitor that was already in phase 3 when Sanofi bought Principia. Researchers designed the candidate to have a lower risk of off-target effects and to be active at lower levels of systemic exposure than other BTK inhibitors, attributes that could support use outside of the B-cell mediated diseases typically targeted by the drug class.  Rilzabrutinib suffered a setback in 2021, when it flunked a phase 3 pemphigus trial, and missed the mark in a phase 2 atopic dermatitis trial last year. Yet, successes elsewhere have encouraged Sanofi to gear up for phase 3 trials in other indications as it enters a crucial run of readouts from rilzabrutinib studies. The first readout was positive, with Sanofi reporting the LUNA 3 trial hit the primary endpoint of durable platelet response in adults with persistent or chronic immune thrombocytopenia (ITP). Sanofi linked rilzabrutinib to a higher rate of durable platelet response than placebo. https://lnkd.in/e9_4VFXc

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I recently had an interesting conversation with a friend over lunch, delving into the distinct disparities between Clinical Finance and Financial Planning & Analysis (FP&A) and their unique roles within organizations. It's unfortunate that these nuanced differences often go overlooked by many organizations, yet they hold significant implications for managing clinical studies and related expenditures, particularly when the appropriate resources are not allocated or when reliance on service providers for critical performance data occurs. The following hopefully sheds some light on the differences between Clinical Finance and FP&A and the need for BioPharma organizations to engage Clinical Finance professionals: Clinical Finance   -  Clinical Finance primarily centers around both the financial management within specific clinical trials and its impact on operational performance at Clinical Research Organizations (CROs) and associated service providers. To execute their responsibilities, it necessitates a deep understanding not only of how clinical studies are conducted but also the intricate interactions between various functional components.   -  This understanding allows Clinical Finance professionals to be able to forecast the impact of expenditures (or lack thereof) on actual study performance, identifying negative or positive trends that may influence outcomes.   -  It involves tasks such as budgeting, financial planning, revenue cycle management, cost analysis, and financial reporting, all customized to support clinical operations, services, and research initiatives at the study level.   -  Close collaboration with internal functional staff, service providers, and finance teams ensures efficient resource allocation and optimization of financial performance while upholding high-quality study conduct. FP&A (Financial Planning & Analysis)   -  FP&A often spans a broader range of financial activities across all facets of an organization. It typically focuses on strategic financial planning, forecasting, budgeting, and performance analysis at the corporate level to support decision-making and foster business growth.   -  Professionals in this domain often collaborate with senior management and department heads to develop financial plans, analyze financial data, monitor performance against targets, and offer insights to optimize business operations and financial outcomes.   -  While FP&A functions are applicable across industries, they do not specialize in understanding or meeting the unique needs of clinical operations or research activities. In essence, Clinical Finance is tailored for planning and executing clinical studies, while FP&A has a wider application, concentrating on strategic financial planning and analysis to advance overall business objectives.

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FibroGen, Inc.'s new CMO, Deyaa Adib, MD isn't fazed by the competition in prostate cancer. Their FG-3246 boasts an impressive 8.7 months PFS in Phase 1, and they're calling out others to show their data! Here's the challenge: PSA isn't the only measure that matters, PFS is key. They believe FG-3246 stacks up well against competitors, even Novartis' Pluvicto. Intrigued? Different companies report data differently, making comparisons tricky. Stay tuned as more info emerges, but FibroGen seems confident they're in the fight! #ProstateCancer #ClinicalTrials #ADC #FibroGen FibroGen throws down the prostate cancer gauntlet | ApexOnco - Clinical Trials news and analysis (oncologypipeline.com)

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QTLs! Where are we going? An updated review of trends in the industry:

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When building a company-wide approach to extending your Life Sciences cash runway, CFOs and leadership teams must do the following:    - Understand investor expectations - Spend cash on what matters - Evaluate different scenarios for funding growth - Focus on right now   Read more: https://lnkd.in/euJ4fVqX #lifesciencecfo #cashmanagement 

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Good governance matters to an organization's performance. I joined the NACD (National Association of Corporate Directors) this year to improve my performance in the board room, peer group with other directors, access continuing education, and learn best practices. I recently completed the requirements to become a NACD Certified Director, passing the test earlier this month. If you are a director and are looking for a way to improve your personal and board's performance, check out NACD. Thanks to NACD New England Chapter for your excellent events. #governance

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📣 Over the years, I have discovered what truly makes a difference as a leader. It's good to focus on technical excellence and scientific innovation, but what truly motivates teams is our ability to cultivate human qualities that allow us to connect, understand, and inspire others. 💡 According to a recent Forbes article, soft skills are now essential to modern leadership. And I couldn't agree more. Empathy, flexibility, and creativity are essential skills that shape how we work together and tackle challenges. I have seen our teams overcome challenges through clear communication and mutual support. Most importantly, I have witnessed the profound impact of a leader who truly listens and adapts to the needs of their team.  As a team, we can create an environment where everyone feels valued and inspired to give their best. Read this article 👉https://lnkd.in/eKePuTUi  #Leadership #Human #SoftSkills #Innovation #Empathy #Creativity

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Curious about what we do at SK pharmteco? Interested in our latest endeavors with peptides and oligos? Check out the full interview with Rizwan Chaudhrey at #BIO2024 below! #Peptides #Oligos #BIO2024 #analyticalservices

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10 Key Takeaways from Neil Versel's Article for BioSpace on the Impact of the IRA on Pharma R&D and VC Investments 1. Federal Court Decisions: Johnson & Johnson and Bristol Myers Squibb's legal challenges to the IRA's drug price negotiations were dismissed by a judge in New Jersey, joining previous unsuccessful legal efforts by AstraZeneca and PhRMA. 2. Medicare Drug Price Negotiations: The Centers for Medicare and Medicaid Services are proceeding with negotiations for the first 10 drugs, with negotiated rates set to be implemented in 2026. 3. Shift in R&D Strategies: Big Pharma, including names like Pfizer, is adjusting its research and development focus towards biologics over small molecules due to the IRA's patent protection cap of 9 years for small molecules vs. 13 years for biologics. 4. Venture Capital Funding Trends: Venture capital funding has shown a significant preference for biologics, with a 50% higher investment in 2023 compared to small molecules, partly due to the IRA's influence as highlighted by John Stanford of Incubate. 5. Pharmaceutical Company Adjustments: Specific companies are revising their pipelines, with Pfizer shifting to antibody-drug conjugates and bispecific antibodies, while Vir Biotechnology, Inc. and Protagonist Therapeutics are stepping away from certain small molecule projects. 6. Eli Lilly and Company and Daiichi Sankyo US's Cautious Watch: Despite the changing landscape, companies like Eli Lilly and Daiichi Sankyo are observing Medicare negotiations outcomes before making significant strategic shifts, indicating varied industry responses to the IRA. 7. The IRA's Impact on Drug Launch Strategies: Christiana Bardon M.D. from MPM BioImpact notes that the IRA may alter how and when companies launch drugs, with a likely shift towards larger patient population indications at launch, potentially disadvantaging rarer diseases. 8. Medicare Part D Changes: The IRA introduces a cap on individual out-of-pocket drug expenses, projected by the Congressional Budget Office to reduce drug spending by $100 billion over a decade, impacting biopharma R&D budgets. 9. Investment Shifts to "Safer Science": The industry might lean towards lower-risk, "me-too" drugs due to the IRA's economic pressures, as indicated by John Stanford, affecting the variety and innovation in drug development. 10. Legislative Efforts and Future Uncertainties: While bipartisan legislation aims to equalize the patent protection period for all drugs, the industry remains in a state of flux with major pharmaceutical companies and investors adjusting strategies amidst legal appeals and potential policy changes. https://lnkd.in/eUMFvwVv

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Please stop by the booth if you are there and hear about what we can do to assist you in: 1) accelerating your regulatory filings, 2) relieving SMEs of the burden of technical writing (we write INDs, BLAs and NDAs from source documents) and 3) global regulatory strategy. Because we see so many INDs/BLAs/NDAs over the course of a year, we have a unique insight into what the regulatory authorities are focusing on and asking about today. We also do RTF and CRL remediation too but hopefully you will use us first so that remediation isn't needed!

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