Back Bay Life Science Report

As ovarian cancer research enters a pivotal new era, Back Bay Life Science Advisors' Dr. Pete Bak is joined by Director Mavra Nasir and Consultant Trent Gordon for a deep dive into one of oncology's most active and rapidly evolving therapeutic landscapes.Despite ranking as one of the top causes of cancer death among women worldwide—with a five-year survival rate still hovering around 50%—ovarian cancer has historically suffered from a sparse treatment pipeline. That is changing fast. This episode traces the field's major inflection points, from the landmark approvals of bevacizumab and PARP inhibitors in 2014, to the game-changing 2022 ADC approval of Elahere, to the recent Keytruda approval in high PD-L1 expressors—and looks ahead to a wave of innovation that could fundamentally reshape how patients are treated.Pete, Mavra, and Trent break down the competitive ADC landscape, discuss next-generation entrants targeting folate receptor alpha and beyond, and examine what a crowded pipeline means for clinical development strategy in a space where the standard of care is moving fast.Podcast topics include:The ovarian cancer patient landscape: why late-stage diagnosis remains the norm and what that means for treatmentKey historical milestones in ovarian cancer drug development and why the pace of innovation is now acceleratingElahere's approval, efficacy profile, and the real-world challenges of ocular toxicity and patient eligibilityNext-generation folate receptor alpha ADCs from Genmab, Lilly, and AstraZeneca—and how they may differentiate on payload, ORR, and sequencingEmerging targets beyond folate receptor alpha: B7H3, B7H4, NAPI2B, and CDH6The role of ADC stacking and sequencing as the platinum-resistant setting becomes increasingly crowdedBispecific antibodies and the potential to convert immunologically "cold" ovarian tumors into candidates for immunotherapyAbbVie's strategy to expand Elahere into earlier lines of therapyHow clinical trial sponsors can future-proof development programs against an evolving standard of care—adaptive protocols, investigator's choice comparator arms, pre-specified amendment triggers, and FDA alignment strategiesThe importance of competitive intelligence, NCCN/ESMO guideline tracking, and reimbursement analysis for drugs in developmentThank you for listening. You can find previous episodes of the podcast on our website.We’d love to hear from you—questions and feedback are always welcome.

As the life sciences industry turns the page to 2026, Back Bay Life Science Advisors’ Dr. Pete Bak and Dr. Mavra Nasir take a detailed look back at FDA drug approvals in 2025, a year marked by regulatory turbulence, shifting policy signals, and several category-defining product launches.Despite a dip in the total number of approvals compared to prior years, 2025 delivered meaningful innovation across oncology, rare disease, pain, infectious disease, and beyond. In this episode, Pete and Mavra break down the key approval trends at both CDER and CBER, highlight standout commercial launches, and discuss what last year’s data may signal for drug development and regulatory strategy going forward.The conversation spans blockbuster forecasts, novel modalities, and evolving FDA expectations—from compressed review timelines to the potential phase-out of animal toxicology studies—offering listeners both a retrospective and a forward-looking view of the regulatory landscape.Podcast topics include:• Key FDA drug approval trends from 2025 and how they compare to prior years• CDER approvals and standout launches, including Insmed’s brensocatib in non-CF bronchiectasis• Vertex’s non-opioid pain drug Journavx and the commercial realities of first-in-class pain therapies• The continued rise of antibody-drug conjugates, with a focus on Daiichi Sankyo’s TROP2 ADC• A wave of innovation in hereditary angioedema, including RNA therapies and oral acute treatments• New approvals in antibiotics, women’s health, and pulmonary fibrosis• CBER approvals, including gene therapies, vaccines, and nonprofit-led commercialization models• What a slowdown in cell and gene therapy approvals may indicate• FDA policy developments to watch in 2026, including priority vouchers, streamlined pivotal trials, and alternative preclinical requirements• A prediction (and friendly wager) on whether 2026 will surpass 2025 in total approvalsThank you for listening. You can find previous episodes of the podcast on our website.We’d love to hear from you—questions and feedback are always welcome.

In this DNB//Back Bay Healthcare Capital Markets podcast episode, Jim Cirenza, Head of Fixed Income and Equities at DNB, Kristoffer Braaten, Director and Head of Equity Capital Markets at DNB, and Vasilios Kofitsas, Partner and Managing Director of Investment Banking at Back Bay Life Science Advisors, review the performance of the healthcare markets in 2024, offering insights into what 2025 could bring. With a detailed analysis of market trends, IPO activities, and investor behaviors, they evaluate the past year's challenges and the cautious optimism prevailing in the sector as the new year unfolds. As well, there's an emphasis on the importance of European investor engagement for companies looking to list in the U.S. market.Learn more about the DNB//Back Bay Partnership and read our disclosures here.

The topic of bispecific antibodies has been an area of interest in the pharma space for a long time now. The recent news of the notable late-stage data from Akeso and Summit’s PD-1/VEGF bispecific antibody ivonescimab to treat non-small cell lung cancer that has captured the industry writ large encouraged us to revisit the topic. To date, there have been ten bispecific antibody approvals in oncology, seven of which are for hematological malignancies. Recently, there has been more traction in development pipelines for solid tumors. Most bispecific antibody approvals are currently or projected to be above the $1M annual revenue threshold. Podcast topics include: • The biologics of a bispecific antibody • The benefits of a bispecific antibody compared to autologous therapies • The buzz around Akeso and Summit’s PD-1 VEGF bispecific antibody asset • The broad state of bispecifics in approved products and development pipelines • The potential of trispecifics, bispecific conjugates and beyond

In this DNB//Back Bay Healthcare Capital Markets Episode, Vasilios Kofitsas, Partner and Managing Director at Back Bay Life Science Advisors speaks with Jim Cirenza and Kristoffer Braaten of DNB Bank in New York. They focus on key drivers affecting markets this year and discuss the recent news of the Fed’s decision to cut interest rates by 50-basis points. Topics in the podcast include: After two difficult years, the appearance of a healthy market rotation since July The Fed’s decision mid-September to cut rates by 50 basis points Healthcare IPOs: historical and recent activity – is the window opening?An outlook including headwinds and tailwinds that may impact the healthcare sectorWe welcome listener questions and/or topics you’d like to learn more about.You can listen to previous episodes here or submit your inquiries here.Learn more about the DNB//Back Bay Partnership and read our disclaimers at https://www.bblsa.com/dnb-back-bay-partnership.

After a summer away from podcasting, Back Bay Life Science Advisors’ Dr. Pete Bak and Christian Thienel are back on the mic to discuss current market dynamics in liver disease with a focus on one of the most closely watched space in hepatology, MASH. The big news includes a rebrand from NASH (non-alcohol related steatohepatitis) to MASH (metabolic dysfunction-associated steatohepatitis), the FDA approval of Madrigal Pharmaceutical’s Rezdiffra and real-time court rulings in Europe that may affect the rate of play for Ocaliva, a drug used to treat adults with primary biliary cholangitis here in the US. As Christian mentions in this episode, “The path to success is not always a straight line.”Other topics in this podcast include: Hepatology market dynamics over the past five years, including activity from Gilead, Novo Nordisk, Intercept and CymaBay How treatment for primary biliary cholangitis, an autoimmune condition, went from a one to a three-product market Payer monographs and what’s required for hepatology drugsThe EMA recommendation earlier this month to revoke Ocaliva’s marketing authorization Which companies are active in the rare liver disease space and how they differentiate themselves Thank you for listening. You can find previous episodes of the podcast here. We’d love to hear from you. Ask questions and submit your feedback.

In this DNB//Back Bay Healthcare Capital Markets podcast episode, learn about the key considerations, mechanics and timelines of going public on a US exchange. Topics in this podcast include: An overview of the decision-making process through execution for US-based and ex-US healthcare companies thinking about listing in the USCore considerations after deciding to pursue a US listing and how to prepare most effectivelyBuilding the “IPO advisory team”: types of advisors (legal, accounting, banking, IR firms, IP, etc.) and when to bring them inKey documents and associated timelines related to the SEC documentation as well as investor outreachWhat are the “don’ts” or mistakes companies make and how to avoid them You can listen to previous episodes here or submit your inquiries here. About our guests: DNB//Back Bay is a committed partner throughout the healthcare development journey, addressing positioning, partnering, financing, M&A strategies, and listing support and execution on US and Nordic exchanges. Our team of more than 100 healthcare strategy and financial specialists spans the globe. Learn more about the DNB//Back Bay Partnership and read our disclaimers at https://www.bblsa.com/dnb-back-bay-partnership. Cooley is among the top law firms for healthcare, tech and life science IPOs on both the issuer-side and underwriter-side. Their team of 1,300 lawyers is spread across 19 offices worldwide.

Guests: Pete Bak and Christian Thienel Length: 27 minutes In this episode of The Life Science Report, Dr. Pete Bak and Back Bay Director, Christian Thienel catch up on the area attracting the most industry interest over the past couple of years: the anti-obesity space. From big players looking to capitalize on the renewed interest in the obesity space to the staggering success of Novo Nordisk’s and Eli Lilly’s GLP-1 agonists (Ozempic, Wegovy, Mounjaro, and Zepbound) for glycemic control and weight loss, there’s a lot to cover. Topics in this podcast include:A brief introduction to glucagon-like peptide 1 (GLP-1) agonistsWhy GLP-1s’ popularity is skyrocketing as treatment for type 2 diabetes and obesityHow amylin and petrelintide (a long-acting amylin analogue) are being newly re-imagined for the obesity space, as well as muscle-targeted approaches like myostatin and activinsWhere BD and investor interest lies as these drugs are expected to have north of $150B in sales annually within the next decadeWhat’s happening in early to late-stage drug developmentWhat the future holds for this sector, possibly to include cannabinoid one receptor inverse agonists and mitochondrial targets for metabolic disease As always, thank you for joining us. Did you know we welcome listener questions? If there any areas you’d like us to explore further in metabolic disease and obesity, please let us know. Submit your questions here. Our Nordic-American Healthcare Conference 2025 will feature metabolic track. Learn more: https://nordicamericanhealthcareconference.com/ You can find previous episodes of the podcast here.

Welcome to another episode with the DNB//Back Bay Partnership for Healthcare.In this episode Jonathan Gertler, Back Bay CEO and Managing Partner, is once again joined by James Cirenza, Head of Fixed Income and Equities at DNB, Kristoffer Braaten, Director of US Equity Capital Markets at DNB, and Vasilios Kofitsas, Managing Director of Investment Banking at Back Bay Life Science Advisors, to talk about current market dynamics and the 2024 IPO outlook in the US and in Europe.Topics in this podcast include:Trends, cycles and the current state of capital markets in Europe and the USIPO performance for Q1 2024 vs. previous yearsTop characteristics of companies well-suited to go public and be successfulIPO market dynamics in Europe vs. the USExpectations and advice for companies contemplating going publicAs always we welcome listener questions and/or topics you’d like to learn more about.You can listen to previous episodes here or submit your inquiries to [email protected] more about the DNB//Back Bay Partnership and read our disclaimers at https://www.bblsa.com/dnb-back-bay-partnership.

Guests: Pete Bak and Christian Thienel Length: 37 minutes With the advent of COVID-19 in 2020 and 2021, we saw a tremendous amount of interest in not only COVID vaccines, but other companies riding the tailwind and developing vaccine therapies that span across viral illness, maternal infections and bacterial infections. In this episode resident immunologist Dr. Pete Bak and Christian Thienel discuss vaccine technology, up-and-coming areas of interest, such as RSV, and the vaccines currently in late-stage clinical development. Topics in this podcast include: Vaccine technology, vaccine types and their varying levels of durabilityThe ongoing interest of vaccine development for RSV, including data from GSK’s Arexvy and Pfizer’s Abrysvo vaccinesHow recommendations from the Advisory Committee on Immunization Practices (ACIP) influence commercial dynamicsThe interesting chess game of scheduling vaccines as they relate to COVID, flu and RSV (seasonality versus strains and antigens) Vaccine development and data as it applies to Cytomegalovirus (CMV) and Epstein-Barr (EBV)News from the bacterial front: MinervaX leading the way with a maternal vaccine against Group B streptococcus infections with a very large series B round for $54M; Pfizer’s recent Prevnar 20 against pneumococcal pneumoniaPricing, reimbursement and the interplay with ACIP guidelines As always, we welcome listener questions and/or topics you’d like to learn more about. You can listen to previous episodes here or submit your inquiries here.

A Podcast Discussion on the Trends and Investment Activity in Radiopharmaceuticals and PsychedelicsGuests: Pete Bak and Christian ThienelLength: 25 minutesHere at Back Bay we’ve seen a number of notable trends in the radiopharmaceutical and psychedelic spaces playing out over the past couple of years. Increasingly, investors have been asking our opinions and perspectives on these topics.Our team has written these whitepapers to address industry interest:The Radiopharmaceutical Renaissance: Radiating Hope in MedicineVision of Commercial Success: Investment and Partnering Landscape for PsychedelicsIn this episode, Dr. Pete Bak and Christian Thienel talk through the uptick of activity in these focus areas and discuss where the future of radiopharmaceuticals and psychedelics might be heading.Topics in this podcast include:A brief introduction into the history of radiation and radiopharmaWhy the early promise of first-generation radiopharmaceuticals like Zevalin and Bexxar didn’t turn out to be as commercially successfulKey advancements in manufacturing and production for second-generation products like Xofigo, Lutathera and PluvictoThe “theranostic” (therapeutic and diagnostic) potential of radiopharmaceuticalsThe growing investment and R&D support for psychedelics from private companies and academics, especially with the Otsuka and Mindset acquisition for $80M in 2023Realities within the new paradigm of novel treatments and patient/provider protocols adhering to the FDA’s Risk Evaluation and Mitigation StrategyThe evolving nature of the antibacterial space and some notable financing deals, three within two months (Antabio, Clarimedix and Revagenix)Listen to the full episode here.

As we move into 2024, Back Bay’s strategic advisors summarize key product approvals from three classes and indications over this past year, including the December CRISPR and Vertex approval of Exa-cel, Biogen and Sage’s August approval of an oral treatment for women with postpartum depression and Genmab and Roche’s May approval in oncology. In this episode: CRISPR and Vertex’s approval of Exa-cel, the first CRISPR-based genetic medicine approved by the FDA in the US The major depressive disorder vs. postpartum depression for Biogen/Sage GenMab and Roche approvals AbbVie acquisition of Cerevel Therapeutics strengthen neuroscience pipeline In 2023, on The Life Science Report, Back Bay covered a wide range of topics featuring stories from the frontline of healthcare development to the rising trends in cardiology to the transactional landscape of antibody drug conjugates. We always welcome listener questions or topics you’d like to learn more about. You can listen to previous episodes or submit your inquiries here. Back Bay provides a snapshot of the healthcare markets every Monday. For IPO, Follow-On and M&A updates, subscribe to our healthcare updates.

In our latest podcast, Back Bay Life Science Advisors focused on the chronic and rare disease development of kidney disease. Recently, there have been some changes in treatment, some recent commercial launches and certainly some interest from pharma consolidators, as M&A activity picks up in this area. In this next installment of The Life Science Report, Dr. Pete Bak and Christian Thienel of Back Bay Life Science Advisors talk about kidney disease and the various aspects of the renal disease landscape. Topics in this podcast include:The links between cardio and metabolic diseases and the therapeutic approaches and label expansions taking place in the renal disease landscapeHistoric evolutions beyond Chronic Kidney Disease (CKD), from rare diseases to all types of indications of CKDUnderstanding potential treatment priorities when some therapies have benefits in multiple indicationsRecent deals, including Novartis’ acquisition of Chinook Therapeutics and Novo Nordisk’s acquisition of KBP Biosciences’ ocedurenone, etc. The impact of Sodium-glucose cotransporter-2s (SGLT2s) in kidney disease over the last ~5 years, and how that has precipitated broader interest in renal indications across the industry

With the DNB//Back Bay Partnership for HealthcareIn the current markets, Healthcare continues to rally as the second-largest industry behind technology in the stock market, and in the US markets there’s been roughly $2.5B raised from an IPO standpoint YTD. In Europe, the markets have been more challenging, with IPOs for five companies going public this year, including Schott Pharma, Germany’s largest IPO earlier this year.In the first podcast episode with the DNB//Back Bay Partnership for Healthcare, Jonathan Gertler, Back Bay CEO and Managing Partner is joined by Jim Cirenza, Head of Fixed Income and Equities at DNB, Kristoffer Braaten, Director and Head of Equity Capital Markets at DNB, and Vasilios Kofitsas, Partner and Managing Director of Investment Banking at Back Bay Life Science Advisors, to discuss the current landscape of IPO and capital markets, optimal preparation strategies for companies hoping to go public and why it ultimately matters who you spend your time with.Topics in this episode include:Dynamics leading to the current IPO market and capital markets landscapeThe state of private and partnering markets and the renewed power of partnershipsCrucial roles of private investments, VC and other “mezzanine investors” for public emergence licensingThe importance of optimal prep and aftermarket support, and why spending good time in the preparation phase with both research and individual investor meetings is a key success factor, regardless of where companies are planning to listThe ever-important lesson of starting early

A conversation on the rising trends in the cardiology spaceCardiology has historically been a cornerstone of large pharmaceutical portfolios. The late 2000s and 2010s saw many pharmaceutical companies and investors abandon or severely deprioritize cardiology research and development in favor of oncology, immunology, and neurology.During this episode of The Life Science Report, Dr. Pete Bak and Christian Thienel of Back Bay Life Science Advisors discuss the major players in the industry and novel approaches to future cardiology applications.Episode topics include: Why pharma’s interest in specialty-like approaches has shifted towards cardiologyThe promise of “advanced modalities” and gene therapies, such as antisense oligonucleotides (ASOs) and small interfering RNA (siRNA)How these newer treatments stack up against traditional small molecule orals, like statinsClinical stage pipeline analysis across cardiology and visible trends on the horizonThis is the 20th episode of Back Bay’s podcast, covering all facets of healthcare development and transactions. For questions, be in touch: www.bblsa.com

In this episode, Dr. Peter Bak is joined by Trent Gordon and Dr. Mavra Nasir as they discuss their Bioprocess Online article published earlier this year, “The Transactional Landscape of ADCs: A Payday for Payloads.” This conversation explores the dynamics and data within the emerging ADC field, including:Background information on the class of therapeutics known as ADCs, which have been on the market since 2000The number of headlines around ADCs lately, especially the standing ovation the data from Enhertu received at ASCO in 2022, making waves in breast cancer treatmentDeal structures and the BD side of ADCs, and their extended revenue generation potentialWhere the field is headed, in terms of clinical, BD and commercial standpointsRead and connect with our authors: The Transactional Landscape Of ADCs: A Payday for Payloads

The world of health tech has changed dramatically since decades ago when physicians had to endure 11 keystrokes to prescribe a single aspirin. These days, AI-based radiology and AI-based pathology are transforming patient lives through machine learning and data analytics, in some cases offering early disease warning systems and improving quality of care while reducing healthcare costs. In this episode of Back Bay’s industry podcast, the Life Science Report, Jonathan Gertler speaks with Mikaela Odlander, Director of Digital Therapeutics at Orexo, and Edward Kliphuis, Partner at Sofinnova Partners, about the opportunities and challenges ahead in the realm of health tech and digital medicine. Topics in this episode include: - The misperceptions around digital therapeutics and digital medicine- The impact health tech has on care, fostering adoption, hurdles to reimbursement- The stark difference between the European and Nordic vs. US healthcare markets- Examples of AI machine learning and how digital medicine is providing personalized, efficient and effective healthcare- The major challenge of replication and scale for a company

For biopharma and medtech companies developing new treatments, capital for advancement and growth is invariably dependent on strategic preparation, differentiation, and persistence. Good preparation can mean funding or famine in a retracted market—and ultimately can impact the trajectory of a company and whether treatment reaches people in the clinical setting. In a down market, there are creative and thoughtful approaches companies can take to stand out as capital becomes more closely guarded and the competition becomes fierce. In this episode of Back Bay’s industry podcast, the Life Science Report, Jonathan Gertler speaks with Goodwin Procter life science partner Kristopher Brown about the current market landscape and how life science companies can recalibrate and prepare for capital raises—no matter the market outlook. This episode focuses on discussion of deal management in the current market, including: The current deal scape—difficult times ahead or par for the course in the life science sector?Approaches to deal preparation in a challenging environmentTentative M&A, licensing, partnering activity and public markets necessitate preparation and strategic focus ahead of capital raise, particularly:Thorough knowledge of asset differentiation - positioning, competitive intensity, pricing, milestone development/definition and valuation, among other activitiesCreative deal financing models – royalty monetization, tranced investments, debt financing, preferred stock, liquidation preferencesStructure and valuation disciplinePortfolio and selection management toward a deal, including the use of AI in population identification Find the video podcast and contribute to the conversation on Back Bay’s website: www.bblsa.com/podcasts

In our first podcast episode of 2023, Back Bay’s strategic advisors summarize some of the most compelling healthcare development stories from 2022. From CRISPR and gene editing advancement to cross-species organ transplantation and the latest in the evolving regulatory and reimbursement landscape, these stories captivated us and continue to herald progress in health and human care. Podcast experts include Brendan Wang, Christian Thienel and Peter Bak, with special thanks to Micheka Fenelon.

For biopharma and medtech companies, the decision to go public is predicated on many business decisions—what kind of capital can be raised? Is our investor base strong and interested? Is now the right time? The Nordic Markets offer some distinct advantages at the earlier stage, and also offer new possibilities for US companies to list abroad. And although the specific logistical and mechanical aspects are exceedingly important, at the end of the day, the decision to do something like this is predicated on an amalgam of strategic decisions. In this episode Back Bay Life Science Advisors and Nasdaq outline best practices for companies considering a public listing, including:Steps in best practice strategy in an increasingly complex marketAdvantages of listing with a smaller listing threshold marketSimilarities and differences between Nasdaq US and Nasdaq Nordic marketsThe strategic change and new dual listing option for US companiesThe unique way retail participation makes up a large portion of the Nasdaq Nordic market (>25% of trades come in from retail)Differences in support for emerging companies, Nordic v. US marketsJonathan Gertler is CEO of Back Bay Life Science Advisors and Managing Partner at Bioventures Medtech Funds. Maria Groschopp Dellwik is Nasdaq’s Head of Strategy and Business Development for Global Listing Services in the Nordics, where she manages new offerings and key strategic change initiatives to improve listing offerings and the Swedish capital market.Download “Preparing for a Public Listing: Best Practices for Biopharma, Medtech andHealthtech Companies” from Back Bay Life Science Advisors and Nasdaqhttps://bblsa.com/investment-banking-1

with Back Bay Life Science Advisors’ Dr. Peter Bak and Dr. Mavra NasirDr. Mavra Nasir recently published a thought piece in Biopharma Dealmakers outlining the current state of play in the promising field of protein degradation. In this episode, Dr. Nasir sits down with Peter Bak to discuss the recent surge of venture funding and partnerships surrounding TPDs.Read Dr. Nasir's article "From drug target inhibition to degradation: a TACtical strategy" here. Topics in this podcast include:An intro into targeted protein degradation (TPDs) and proteolysis-targeting chimeras (PROTACs)Industry advantages of TPDs vs. traditional antibodiesBiopharma and VC's growing interest in molecular gluesCommercial hurdles ahead in this spaceHow TPD companies can differentiate, from a pipeline and breadth of opportunities to select an indication, communicate to investors and drive valueIf you have a question about life sciences development, submit it here. We may feature it on an upcoming episode.Thanks for joining us!*Mavra Nasir, PhD is a senior consultant at Back Bay Life Science Advisors where she supports strategic engagements across a range of therapeutic areas including rare diseases, hematology/oncology and metabolic diseases for biopharma and MedTech. Dr. Nasir joined Back Bay after receiving her PhD in Quantitative Biomedical Sciences from Dartmouth College.

This is the first episode in our podcast series of Q&As on biopharma and medtech development—directly from active developers. Our podcast listeners, including Back Bay clients, have submitted timely and relevant questions about life science development and the daily challenges they face.Christian Thieniel and Brendan Wang, two senior members of the Back Bay Life Science Advisors team with a tremendous amount of experience in the life sciences, especially as it relates to scientific, clinical and commercial issues, offer guidance on issues related to pricing and early market access.Topics include:For early-stage clients, when is the right time to think about pricing and access, and why it is important to identify market access hurdles earlyFor later stage clients, how to get more granular on pricing and market access insights (narrowing the price range, broadening the payer sample, etc.)Which real-life and project examples lend clarity here, including an example from Back Bay’s past work in the anti-infectives space. How can upfront P&MA research lead to more confidence and varied project positioning in partnering discussions?Would you like us to include your life sciences development question in an upcoming episode? Please submit it here.Make sure to subscribe to our podcast on your favorite podcast platforms and follow Back Bay Life Science Advisors on LinkedIn.Thank you for joining us.

In this episode of Back Bay’s industry podcast, The Life Science Report, Dr. Peter Bak is joined by Mike Bogetofte Barnkob, a doctor with the Department of Clinical Immunology at Odense University Hospital in Denmark and a research fellow at the University of Southern Denmark, to discuss current perspectives—clinical, scientific and manufacturing—on the cell therapy space. Dr. Barnkob’s expertise spans basic and clinical immunology, with a particular interest in advanced cellular modalities, such as chimeric antigen or CAR T-cells. He studied at the Massachusetts Institute of Technology, in Back Bay’s hometown, and completed his PhD at Oxford University. Topics in this podcast include: The current clinical and academic uses of CAR T-cells and where they are headed in the near-termHow cellular therapies factor into a robust and thriving public healthcare-based systemOngoing questions of pricing and reimbursementChallenges and approval processes in getting these "living medicines" to peopleHurdles and considerations when building a Good Manufacturing Practice (GMP) cellular facility Do you have a question about development in the cell therapy space? Drop Back Bay a line.Make sure to subscribe to our podcast and follow Back Bay Life Science Advisors on LinkedIn.Thank you for joining us.

Biopharma companies looking to establish a footprint in Europe face country-specific decision-making processes. The health technology assessments (HTAs) in France and Germany, for example, look very different.Does this regional level of thinking make it easier or potentially more difficult to get medicines to market and into the hands of patients who need them?In this episode of Back Bay’s Life Science podcast, Pete Bak is joined by Alexander Natz, Secretary-General of the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), Europe’s principal trade body for companies working in the field of pharma, biotech, and medtech. Based in Brussels, EUCOPE provides expertise across a number of strategic issues such as regulatory paths and pricing and market access.Topics in this podcast include:A brief overview of EU HTAs as they pertain to novel technologies, including cell and gene therapiesThe differences and nuances between cell and gene therapies and best practices for companies during early clinical developmentWhere medication approval could be denied in the absence of specific dataThe right time to start talking to EU payorsHow the regulatory framework will continue to evolveImpact on drug indication choice and strategy and examples of where the regulatory process has gone well or falteredFor questions on regulatory and market access, reach out to Back Bay Life Science Advisors and check-in with EUCOPE at www.eucope.org.Follow EUCOPE on LinkedIn www.linkedin.com/company/eucope and on Twitter: @EUCOPE.Make sure to subscribe to The Life Science Report podcast, follow Back Bay Life Science Advisors on LinkedIn and sign up for our industry newsletter.Thank you for joining us.

Fifteen years ago, scientists discovered optogenetics, a technique of using light to stimulate light-sensitive receptors in order to turn brain cells “on” and “off" at the flip of a switch. Advances in optogenetics have allowed this technology to move from the laboratory to humans, and more recently biopharma companies have been quick to incorporate optogenetic therapies into their ophthalmology portfolios.In this episode of Back Bay’s Life Science Report, Peter Bak is joined by Kevin Norman to discuss the promise and commercial considerations of optogenetics.Topics include:The basic principles of optogenetics and the diseases it may be a treatment forHow Big Pharma, biotech and VC view the promise of optogenetics for the futureCurrent issues, technical challenges and functional endpoints for active therapy trials like those with Nanoscope Therapeutics, GenSight Biologics, Allergan, etc.The state of play for how optogenetics may be useful as a technology beyond the realm of ophthalmology, including cancerRead Back Bay Life Science Advisors' latest industry article on optogenetics in Cell & Gene here.Make sure to subscribe to The Life Science Report podcast and follow Back Bay Life Science Advisors on LinkedIn and Twitter. Thank you for joining us.If there's a question or subject you'd like us to cover, submit it here. It may be the topic of one of our upcoming podcasts.

Antibiotics act as a safety net for all of healthcare. They make medical procedures such as surgeries, childbirth and cancer treatments possible, but what happens when bacteria or other microorganisms become resistant to the drugs we use against them? Back Bay Life Science Advisors’ Managing Director Peter Bak sits down with Marc Lemonnier, a molecular and cellular microbiologist and CEO of Antabio, a clinical stage company located in France developing novel antibiotic therapies, for a conversation on the current clinical landscape of novel agents to address antimicrobial resistance and the regional and global initiatives to tackle the issue. Topics include: The growing rates of antimicrobial resistance (AMR) Which global organizations are at work on this issue and their list of priority pathogens a/k/a the world’s “most wanted deadly super bugs”?How COVID 19 and the pandemic exacerbated the issue of AMR Push and pull incentives and subscription models for innovative antimicrobials and how they work in various countries around the worldWhy global access is a real issue and how to solve the problem For more, read Back Bay Life Science Advisors' recent take on the role of investments in antimicrobials in STAT here. Learn more about Antabio, a private biopharmaceutical company developing novel antibacterials targeting drug-resistant pathogens that are deemed a critical priority by the WHO. www.antabio.comMake sure to subscribe to The Life Science Report podcast and follow Back Bay Life Science Advisors on LinkedIn and Twitter. Thank you for joining us.

Despite the heavy influx of capital over the past years, medtech or biopharma sell-side assignments can still be ripe with challenges. In this episode of Back Bay’s industry podcast, Back Bay Life Science Advisors’ investment banking team discuss best practices for successful sell-side licensing, partnering, and M&A, including: Best practices for readying vital aspects of deal preparation Identifying deal issues, red flags ahead of timeArticulation of the path forward, including indication and proof of concept and telling the story through to marketThe importance of choosing the right partner and alignment for stakeholders, management, board, investors, internal champions and othersThe most significant mistakes made in competitive intelligence, technology, position, IP regulatory strategiesNetworking, contacts and how to know who’s going to be responsible for what and whenMake sure to subscribe to The Life Science Report podcast and follow Back Bay Life Science Advisors on LinkedIn. Thank you for joining us.

Cell and gene therapies are currently among the hottest investments in the biotech space, both in the public and private markets. In this episode, Back Bay’s Managing Director and host Pete Bak, PhD is joined by Kyle O’Neil and Brendan Wang, who are returning to the podcast after attending the 2021 Cell and Gene Meeting on the Mesa. Tune in to hear their discussion on emerging investment themes and which ones were key topics of discussion at this year’s conference.Topics include:The next generation of gene-editing technologyCRISPR 2.0Off-target effectsNovel nucleasesPAM sequencesAutologous and Allogeneic CAR-T cell therapyEx vivo vs. in vivo approachesThe business model on gene therapiesFiguring out manufacturing capabilities firstHow to tap into larger marketsBuilding businesses around small monogenic diseasesLearn more, read Bay Life Science Advisors' latest white paper on gene therapy innovation here.Make sure to subscribe to The Life Science Report podcast and follow Back Bay Life Science Advisors on LinkedIn.Thank you for joining us.

“I have a deep belief that medtech and healthtech are going to carry us forward to markedly improve delivery and quality of healthcare.” - Jonathan P. Gertler, MD For years, biotech has been the dominant theme in life sciences development, offering a great deal in treatment advances and in terms of investing versatility and returns potential. But with promising system solutions serving broader swaths of patients, medtech is resurging. Medtech investment has grown dramatically over time, with scale and diversification capable of weathering economic storms and fueling expansion in the markets. Medtech is a significant driver of our healthcare economy, contributing to more meaningful patient care solutions and technology that continue to move care further from the hospital and more toward the home. In this episode of The Life Science Report, Back Bay Life Science Advisors’ industry podcast, Dr. Jonathan Gertler speaks with Paul LaViolette Managing Partner & COO, SV Health Investors about the varying elements of medtech investments, including structured deals and strategies, the regulatory changes that are driving medtech forward and how more cost-effective care will be a turning point for granting access to more and more patients. Topics in this podcast include: The role of investment in medtech and how to match capital to the asset or companyWhy “incremental" is a four-letter word in the world of ventureHow medtech is a systems solution provider, which differs from biotech as a disease modifier based on increasing patient segmentation How structured deals, traditionally the territory of biotech, have found their way deeply into medtech M&A and how the public markets are offering alternatives in a more robust way than recent history has shownThe regulatory changes for medtech in Europe and the profound impact this has on how investors and buyers make decisionsSubscribe to our industry podcast, The Life Science Report, and follow Back Bay Life Science Advisors on LinkedIn. Thank you for joining us.

One of the unexpected outcomes of the COVID-19 pandemic has been the rapid and widespread uptake of remote patient monitoring. Just ahead of the pandemic, investment in patient monitoring was booming; priming the system for quick uptake and innovation. As with vaccines, much groundwork had been done to prepare for dramatic innovation and widespread, rapid patient use, seemingly “overnight.”In this episode of Back Bay Life Science Advisors' industry podcast, Drs. Jonathan Gertler and Corinne Nawn discuss the clinical considerations of remote patient monitoring, including advances in sensing platforms, wearables, and the current investment landscape driving the innovations allowing patients and physicians to interact meaningfully and safely from different locations.Topics in this podcast include:Investment in digital healthcare companies The spectrum of financings, acquisitions, IPOs, and SPACs in this spaceNew ways of patient monitoring through wearable techUnderstanding the details of sensing and capturingCoordinating care based on analyticsCompany partnerships and/or acquisitionsRead about MedTech's ascendance from Jonathan Gertler here.Make sure to subscribe to The Life Science Report podcast and follow Back Bay Life Science Advisors on LinkedIn and Twitter. Thank you for joining us.

In this episode of our life science industry podcast, Dr. Peter Bak sits down with Brendan Wang and Christian Thienel of Back Bay Life Science Advisors to discuss how pharmaceutical companies price their drugs. They cover the ins and outs of health economics, how payers make sense of a high price, and ways this varies around the globe. With a focus on Biogen’s recent Aduhelm approval, the discussion includes how Biogen likely went about price setting and how this aligns with ICER’s initial evaluation and analysis.Topics in this podcast include:Relevant pricing analogsNet level pricing decisionsDemand and utilization of products affecting pricingPatient population levelsICER’s role in drug pricingThe price point of a drug, given its controversial approvalRead Back Bay’s perspective on early-stage market access and price setting in STAT News, here.Make sure to subscribe to The Life Science Report podcast and follow Back Bay Life Science Advisors on LinkedIn and Twitter. Thank you for joining us.

In this episode Jonathan Gertler, Back Bay’s CEO and Managing Partner, sits down with Dr. Peter Bak, Managing Director at Back Bay, to discuss Dr. Bak’s latest article in STAT News and to talk about the world of anti-infectives.Dr. Bak has more than ten years of expertise in infection and treatment. He began his research at Dartmouth Medical School and later continued at MIT, where he was an American Cancer Society Postdoctoral Fellow at the Koch Institute of Integrative Cancer Research.Topics include:-The landscape of antiinfectives, antimicrobials & antifungals -How commercial dynamics drive clinical unmet need -The role the pandemic played on development & investments -The deployment of cell therapies for viral diseases -Foundation support for anti-infectives -“Push incentives” to usher therapies into commercial stagesLink to Dr. Peter Bak's published article in STAT News, “Investment in antimicrobials was up in 2020, but much work remains," https://www.statnews.com/2021/04/28/investment-antimicrobials-uptick-2020-much-work-remains/

Welcome to Episode #2 of The Life Science Report. In this week’s episode Jonathan Gertler, Back Bay’s CEO and Managing Partner, is joined by Gregory Benning and Vasilios Kofitsas of Back Bay’s investment banking team to talk about the market of Special Purpose Acquisition Companies (SPACs).The feeling surrounding healthcare SPACs right now is almost...giddy. With enormous capital flowing into the biotech sector, SPACs have emerged as one of the hottest financing options. Last year, the market saw $80B in SPAC issuance, which 2021 will far exceed.We’re still in the beginning of this market shift, but is the SPAC vehicle the right vehicle to fund the strategy of science?Topics include:Traditional IPO markets vs. the hot market of SPACsHow COVID affected the SPAC landscapeThe delicate balance of near-term data, valuations & due diligenceCautions, concerns & the importance of use of proceedsRegulators & litigation risks in biotechThe potential of U.S. SPAC markets for European companiesRegister for the June 17th Endpoints News and Back Bay Life Science Advisors webinar, “Life Science SPACs” here. Thank you for joining us. To learn more about Back Bay Life Science Advisors, visit our website at www.bblsa.com or follow us on LinkedIn and Twitter.

Welcome to Episode 1 of The Life Science Report. In this episode our host, Dr. Peter Bak, sits down with Brendan Wang and Kyle O’Neil of Back Bay Life Science Advisors to discuss the field of gene therapies and insights from their recently authored piece in Cell & Gene, “The Next Decade In Gene Therapy Innovation — 6 Critical Questions (And Answers),” and their newly released white paper on BBLSA.com.Gene therapy has been talked about for many years, and it’s only in the past few years that we’ve begun to see some initial products make it to market. When many people think about gene therapies, they think they will be a curative treatment, but commercial positioning, pricing and the business model of gene therapies are still in flux.Topics in this podcast include:The scientific and commercial challenges of gene therapiesHow the space is evolving from a commercial standpoint -The complicated issue of deliveryThe investment of gene therapy & the outcome-based gene therapy business modelsRisk-sharing agreements, payment methodologies & pricing modelsThe unfolding future of gene therapiesCell & Gene guest columnBrendan Wang and Kyle O’Neil’s white paper on the Back Bay Life Science Advisors website. Make sure to subscribe to The Life Science Report podcast and follow Back Bay Life Science Advisors on LinkedIn and Twitter. Thank you for joining us.