Somer Baburek, MBA

There's a rising tide of disengagement among Biotech professionals, but as an employer - if you're smart about it - this presents an opportunity.... Come learn more about this and other trends sweeping the Biotech talent market in 2024 at https://lnkd.in/eb_hGazM #biotech #biotechnology #talent #disengagement

2

Fast-forward 10 years when every bio company has access to highly performant models for in silico molecular design... Assuming this translates into many more high quality candidate molecules, there will be insatiable demand for already-scarce clinical development talent. Clinical development skillsets will become multiples more valuable. An optimist might argue we need to start preparing our clinical development regulatory and operational infrastructure for materially higher throughput.

114

13 Comments

🧓👵👴Long-Term Care Gets a Tech Boost: How New Advancements Benefit Seniors and Pharmacists? Here at TIB Pharmacy, we're passionate about empowering our patients to live healthy, independent lives. That's why I'm thrilled about the recent surge in technology designed to support seniors in long-term care facilities and even at home. As your pharmacist, I've seen firsthand how these advancements can benefit patients: **Improved Medication Adherence: Medication reminders and easy video calls with caregivers can significantly improve medication adherence, reducing complications and potentially lowering the need for additional prescriptions. **Early Detection of Health Concerns: Wearable health trackers can monitor vitals and activity levels, allowing for earlier detection of potential health issues. This means faster intervention and potentially fewer medication adjustments due to missed symptoms. **Promoting Independence: Technology like GPS trackers and video calls empowers seniors to manage their daily lives at home, reducing feelings of isolation and potentially decreasing the need for certain medications used to manage those conditions. Here's how I can help: **Educating Patients and Families: I'm happy to discuss these advancements with you and your loved ones, exploring how they can improve well-being and potentially reduce medication-related issues. **Partnering with LTC Facilities: Collaboration with LTC facilities ensures residents receive the medications they need while seamlessly integrating these new technologies. **Staying Current on the Latest Tech: The world of senior care technology is constantly evolving. I'm committed to staying up-to-date to best serve my patients. Technology is transforming long-term care, and at TIB Pharmacy, we're excited to be part of it. Let's work together to create a future where seniors can enjoy a higher quality of life with greater independence and better health outcomes. Let us know your thoughts about this, feel free to share it in the comments section! Call us! TIB Pharmacy T: (510)-573-0064 A: 5886 Mowry School Rd, Newark CA, 94560 #LongTermCare #MedicationManagement #BetterHealth #Teamwork #TIBPharmacy #NewarkPharmacy #pharmacyservices #longtermcare #LTCPharmacy #HospicePharmacy #EndOfLifeCare #hospicespecialized #ltcspecialized #ltcathome #enteraltherapy #MedicationManagement #PackagingPower #SimplifyYourHealth https://lnkd.in/gUWj3PGp

3

1 Comment

Last week, MedPAC, the Medicare advisory to Congress, delved deep into an often-ignored territory: the pricing matrix of generic drugs under the Medicare prescription drug program (Part D.) Why is this momentous? Because this constitutes a whopping 90% of prescription drug usage and nearly 20% of spending in Part D. Often overlooked for their flashier branded counterparts, the discussion this time centered on these generics. MedPAC scrutinized the pricing of 108 high-demand generics, which account for 60% of total generic spending. Their examination revealed a curious phenomenon - prices at the point of sale (POS) often exceeded cash prices, fluctuating between drugs and locations The big culprit? Post-sales fees imposed on pharmacies. So MedPAC did stakeholder interviews. Findings ... • For the most part, beneficiaries had either no cost-sharing or cost-sharing based on copayments so the variation didn’t impact them. • The variation on the prices of the drugs themselves came from the wholesalers – not generic manufacturers. Large chains obviously have more leverage in negotiation and this holds true for generics or brands. But many pharmacies are in tying arrangements where are locked into buying generic drugs (sometimes at a slightly higher rate) in order to get discounts on branded drugs (so they don’t lose money there, or at least as much money.) As an aside, I know it is crazy but wholesalers have traditionally lost money on branded drugs because of these discounts, they make it up on the generic side. • Generic reimbursement of pharmacies from the pharmacy benefit managers (PBMs) doesn’t acquisition costs. Reimbursement is based on Maximum Allowable Costs (MAC) although some pharmacies are moving to Average Wholesale Price. Either way, wide variation in reimbursement. • Pharmacies have a difficult time figuring out how much they are making on generic drugs because of the variation of reimbursement, dispensing fees and clawbacks of post-sale fees. Post-sale fees are not transparent – it difficult to know what pharmacies are getting paid and why and they really negotiate reimbursement with PBMs. Be ready for more decoding. MedPAC says they will keep monitoring this complex landscape. Want to make sense of the healthcare landscape? Stay tuned for more updates on pressing topics!

8

1 Comment

ONO PHARMACEUTICAL CO., LTD. is set to make its largest acquisition yet, purchasing Deciphera Pharmaceuticals, an American cancer drug maker, for $2.4 billion. 💼 The move comes as Ono seeks to fuel #growth with new drug candidates, especially as key patents on its Opdivo #cancer immunotherapy are set to expire in 2028. 🌱 Established in 2003, Deciphera is the maker of the Qinlock cancer drug available in the U.S. and Europe. 🩺 Qinlock boasts a unique mechanism that inhibits enzymes critical for cancer cell proliferation. 🛑 Additionally, Deciphera holds promising new drug candidates. 🌟 One such candidate, a treatment for benign tumors in joints, is in the final stages of clinical trials in #Europe and the #US, with approval slated for 2024. 💉 Deciphera is also developing a drug to address complications in blood cancer treatment. 🩸 #Japan #Pharma #Pharmaceutical https://lnkd.in/dppfbjsy

1

Just like how every software company is being asked what their AI strategy is, I believe every healthcare provider will be asked what their GLP-1 treatment strategy is. Reducing obesity is one of the most impactful things that can be done to improve society's health.

41

2 Comments

Thank you Outcomes Rocket for allowing me on this Podcast!!! Finding ways to get necessary medications into the hands of our loved ones faster is the heartbeat of RxLightning! Watch the rest of this podcast to learn more about what we do: https://lnkd.in/e_6FEtAk #podcast #specialty #medication #healthcare

41

Check out my latest post @Gilmartin Group LLC on the Return of the PIPE in 2024, where I cover biotech sector trends, ethical dilemmas, and controversies around market manipulation.

21

2 Comments

To discuss how to de-risk your viral vector prior to clinical trials, please reach out to our team at #ISCT2024 in Vancouver. Farzin Farzaneh, PhD Traci Kyes Makis Sigalas

23

How to blow $230 million/year: - Sell a big market forecast with Standard Model thinking - Confuse said big market forecast (i.e., metrics) for a strategy - Point resources and capabilities in the wrong direction - Change said wrong direction early and as often as possible - Assume expert knowledge of the past is the way to construct a future - Ignore, misread or pretend-away the 'ground truth' from the frontline And when the mathematical gymnastics packaged in the PowerPoint don't manifest NOW in terms of the 'next $1 billion in growth' or, even better, delivering on the true center of the American Way of Healthcare (i.e., more shareholder value), throw in the towel, announce layoffs and revert to the place you're comfortable with conceptually. Says Walmart in a statement to Endpoints News: "What we learned through Walmart Health centers will help us continue to innovate and support the healthcare needs of our communities through our legacy pharmacy and vision." Possible, but not probable. By definition, the only place a "legacy" vision can lead is back to the past. If there's a "learning" here -- the kind of thing Harvard Business School can package in a PowerPoint to sell as a new corporate/executive education program -- is that making big market innovation come to life is hard work. It isn't a solo sport (Walmart can/would have fared better collaborating with a big pharmaceutical company on the roadmap). And it doesn't start with a forecast that everyone knows is bullshit, particularly the people buying and selling it. The upside of a new market is unknowable at the start, just ask the team at Amazon/Amazon Web Services (AWS), who ten years ago invented what is now a $600 billion market for 'cloud infrastructure' services. They had no idea it could be that large. But maybe the biggest learning of all is that making a Big Dent happen, particularly in healthcare, takes time, a more original vision and a completely different starting point. Quoting from the epigraph to War and Peace: "The two most powerful warriors are patience and time." via Shelby Livingston

37

17 Comments

Deciphera Pharmaceuticals to be Acquired by ONO Pharmaceutical For $2.4 Billion WALTHAM, Mass.--(BUSINESS WIRE)--Apr. 29, 2024-- Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines to improve the lives of people with cancer, today announced that it has entered into a definitive merger agreement with ONO Pharmaceutical Co., Ltd. (ONO), under which ONO will acquire all outstanding shares of Deciphera common stock for $25.60 per share in cash through a tender offer followed by a merger of Deciphera with a wholly-owned subsidiary of ONO (the “Acquisition”), for a total equity value of $2.4 billion. The boards of directors of both companies have unanimously approved the transaction. Together, ONO and Deciphera will accelerate their shared vision to deliver innovative new drugs and serve patients around the world. Deciphera brings specialized research and development capabilities in kinase drug discovery, well-established commercial and sales platforms in the United States and Europe, and global clinical development capabilities. https://lnkd.in/dY_hDwFT

10

Ten years ago this guy in the hoodie was asking how to get more involved with industry. Now he’s teaching others how to do it! It wasn’t that long ago that Blake Williamson, MD, MPH, MS approached Leo Edward Otero and me, curious how to work with industry. It’s awesome that the recent YoungMD Connect has given Blake a platform to share these learnings with others. Congratulations Tamara Bogetti, MBA and the BMC team for creating this incredible forum for leaders like Blake, Ashley Brissette, Tarsus marketing VP Matt Rossen, and others to pay it forward! Here are some tips for physicians who want to collaborate with industry. Please share more! - Find products and disease states that you’re really passionate about - Develop a strong relationship with your SMA / MSL / sales rep to learn about opportunities on both the medical and marketing sides of the company. Customer facing leaders in industry will be your biggest advocates. - Choose companies whose values and culture you align with. You become an extension of that organization when you get involved with them - are they a good fit for your brand and are you a good fit for their brand? - Determine where you can make the biggest impact - are you a great presenter, researcher, writer, social media content creator, innovator, advisor? Be open about your talents and explore where you can make a fulfilling difference at the companies you collaborate with. - Read about the PhRMA and Advamed codes to understand what compliance guidelines will be in place and know that each company may each have additional guidelines to follow. - Review industry contracts carefully to ensure you’re comfortable with any restrictions - understand what scope of work is covered and be sure you’re not limiting other opportunities. - Realize that industry activities may happen after hours or on weekends and be willing to commit the time. - Leverage Industry gatherings like investigator meetings and advisory boards for networking with other physicians involved in industry to learn and share best practices. 💡Come to conferences like YMDC and learn from experts like Blake! 📸 photo cred: Pamela Marans Katz WILLIAMSON EYE CENTER Bryn Mawr Communications Tarsus Pharmaceuticals, Inc. #Pharmaceuticals #medicalaffairs #industry #physician #collaboration #ophthalmology #eyecare #YMDC

166

6 Comments

📈 These are the most notable of the 26 biotech & pharma financings in the past week, incl 6 newco launches… 👇 ➡️ NEWCOS ⬅️ 🎯 Santa Ana Bio, Inc. debuted with a $168M Series A/B led by Versant Ventures & GV (Google Ventures). Funds will advance their precision immunology therapies for autoimmune diseases, with the aim of entering the clinic in 2025. 🔶 Amber Therapeutics closed a $100M Series A to advance Amber-UI, a neuromodulation therapy for mixed urinary incontinence. Led by New Enterprise Associates (NEA), the round also included F-Prime Capital and Lightstone Ventures. 🧪 InduPro secured $85M in a Series A co-led by The Column Group and Vida Ventures, LLC. Funds will advance their proximity-based protein therapeutics for cancer and autoimmune diseases. 🎯 Adcytherix launched with a €30M seed round, led by Pontifax Venture Capital, to develop next-gen antibody-drug conjugates (ADCs). 🔬 Moleculent secured $26M in a Series A led by ARCH Venture Partners and Eir Ventures. Funds will advance their technology for spatial mapping of cell-cell communication to better understand disease biology. 😮 Syntis Bio launched with $15.5M in seed funding to develop SYNT-101, a clinical-stage oral therapy for obesity. Funds will also advance oral enzyme therapies for homocystinuria and maple syrup urine disease. ➡️ IPO ⬅️ 🧠 Rapport Therapeutics closed a $174M IPO, including full exercise of underwriters' option. Funds will advance RAP-219 for epilepsy, peripheral neuropathic pain, and bipolar disorder. ➡️ PRIVATE ⬅️ 🫀 Kardium Inc. secured $104M to support clinical development and a planned commercial launch of their Globe® System for atrial fibrillation treatment. 🧠 Alzheon, Inc. | Preserving Future Memories completed a $100M Series E led by Alerce Medical Technology Partners. Funds will support the pivotal Phase 3 study of ALZ-801, a first-in-class oral therapy for Alzheimer's. 🏥 Bright Peak Therapeutics raised $90M in a Series C led by Johnson & Johnson. Funds will advance BPT567, a first-in-class PD1-IL18 immunoconjugate, into Phase 1/2a trials for solid tumors. ➡️ PUBLIC ⬅️ 🧬 Avidity Biosciences, Inc. Biosciences priced a $400M+ public offering to advance RNA therapeutics for untreatable muscle diseases like DM1, DMD, and FSHD. 🧬 Ultragenyx raised $350M to develop novel therapies for rare and ultrarare genetic diseases. 🧫 ProKidney Corp. priced an upsized $130M public offering to advance cellular therapies for chronic kidney disease. 🦠 Replimune completed a $100M private placement to support a potential launch in 2025 of its oncolytic immunotherapies for anti-PD1 failed melanoma. 💉 Rezolute, Inc. priced a $60M public offering of common stock and pre-funded warrants to advance RZ358, a therapy aiming to treat hyperinsulinism (HI).

99

6 Comments

A recent analysis from Biomedtracker of clinical trial phase transitions between 2014 and 2023 suggests biopharma development success rates are falling. This poses several questions: what are the underlying reasons dragging success rates down and what does this mean for R&D productivity and the return on investment on pipeline spend? https://lnkd.in/ezX4Dsmb Citeline Commercial #biopharma #clinicaltrials #RnD

9

Ever wonder how the Inflation Reduction Act could impact biosimilar prescribing? BioPharma Dive provides a nice synopsis of a Harvard analysis that shows how removing economic barriers to prescribing in Medicare part D plans could increase biosimilar utilization. https://lnkd.in/edvvZ399: 2024-05-14 BioPharma Dive %5Bissue:62039%5D&utm_term=BioPharma Dive #IRA #biosimilars #biotech #insights 

5

Exciting news from Viridian Therapeutics, Inc.! The company is gearing up to kick off two phase 3 clinical trials, REVEAL-1 and REVEAL-2, for VRDN-003, an anti-IGF-1R antibody, in August 2024. These trials will focus on treating moderate-to-severe thyroid eye disease (TED). VRDN-003, designed for subcutaneous administration as infrequently as every eight weeks, aims to enhance patient access and adherence to treatment. REVEAL-1 and REVEAL-2 will involve around 84 and 126 patients, respectively, evaluating the proportion of patients achieving a minimum 2mm improvement in proptosis at week 24. With topline results expected in the first half of 2026, if successful, Viridian plans to file a Biologics License Application by the end of 2026. The company envisions launching VRDN-003 with an autoinjector pen for easy administration, believing it could set a new standard in TED treatment and improve outcomes for patients. To learn more about Viridian's groundbreaking trials and VRDN-003, 𝐜𝐥𝐢𝐜𝐤 𝐡𝐞𝐫𝐞: https://lnkd.in/dnaDkaM8 #ViridianTherapeutics #ClinicalTrials #HealthcareInnovation Atanas Atanasov Laura A Epelbaum 🦁

2

A nice and short article by the FDA on biosimilars that was just updated on 20/JUN/2024. Biosimilars can be advantageous in clinical trials for various reasons including shelf life and pricing. If you are looking to source or considering biosimilars for your study, let's connect and discuss how Inceptua is helping sponsors with these products.

13

I'm so proud to share that I wrote this year's CEO Pay Gap article for BioSpace. We found that despite the strong headwinds that battered the industry last year, CEOs were still often paid hundreds of times more than their median employees. A couple of standouts: 1 - Pfizer head Albert Bourla took a 35% pay cut, but remains one of the highest-paid CEOs across the industry. He takes home nearly 300 times more than the median employee. 2 - J&J CEO Joaquin Duato had the largest pay jump in BioSpace's list, increasing from $13.1 million to $28.4 million. He makes 338 times more than the median J&J employee. 3 - Topping this year's list is Israeli multinational Teva, whose CEO Richard Francis made nearly 400 times more than the median employee. There are more great insights in the article, and I invite you to dive into our analysis. Great work from Jennifer "Jef" Akst, Shawna Williams, and Tyler Patchen, and of course incredible graphics from Nicole Bean and Taylor Tieden. #biotech #biopharma #pharma #PayGap #CEO

11

6 Comments

Diversity enrollment is important. We need to ensure that we enroll diverse patient populations in clinical studies per FDA requirements. Check out another outake from a Humanitarian Horizons podcast wherein we discussed this important topic. Please contact us at info@affinitybiopartners.com to discuss how we can help you with your clinical trial enrollment. #podcast #clinicaltrial #enrollment #approval #diversepopulations #fda #humanitarianhorizons Affinity Bio Partners, LLC

1