Ben Comer
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Chief Editor at Life Science Leader
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Articles by Ben Comer
BIO 2026: China, AI, And FDA Original
By Ben Comer, Chief Editor, Life Science Leader Bouncing around the San Diego Convention Center’s 2.6 million square feet for four days is its own kind of flustery exercise, but in the age of Zoom it’s a more-than-welcome excursion. It’s hard to complain about a summertime work trip to San Diego. BIO 2026 featured a mix of off-site events, onsite panels, scheduled and impromptu interviews, and some in-person Business of Biotech recordings (look out for those in the coming weeks, posted here).
Where Are They Now? Life Science Cares
By Ben Comer, Chief Editor, Life Science Leader Sarah MacDonald, CEO, Life Science Cares Then: Back in 2020, former Life Science Leader chief editor Rob Wright spoke with biopharma veteran Rob Perez about founding Life Science Cares, an industry philanthropic organization and platform for aggregating resources to impact poverty in communities where members operate.
On The Road: The Business Of Biotech In San Francisco For JPM2026
By Ben Comer, Chief Editor, Life Science Leader Each January, the J.P. Morgan Healthcare Conference helps to set the biopharmaceutical industry agenda for the coming year, and more suits can be seen on the streets of San Francisco than during any other week of the year. There were fewer ties in 2026 — a multiyear decline — but still plenty of suits.
12.13.25 -- Outsourced Pharma Best Of November
NOVEMBER'S BEST FEATURED EDITORIAL The Moral Economics Of Precision Medicine The most complex and expensive drugs to develop often target terrible diseases that affect only a small number of people and will never reach blockbuster status. Takeda Reimagines Biopharma Quality For The Digital Age Artificial intelligence, even in its current form, is especially good at synthesizing large data sets. Here's how one company makes the most of it.
12.13.25 -- Best Of November
NOVEMBER'S BEST FEATURED EDITORIAL MAPS founder Rick Doblin accused the FDA of changing the goal posts after Lykos's MDMA Complete Response Letter was released, and offered insights for other psychedelic developers. NOVEMBER'S BEST INDUSTRY INSIGHTS The Future Of Clinical Research Enrollment: A Patient-Centric Approach To address challenges such as limited patient awareness, mistrust, and logistical barriers, the industry must embrace technology-driven solutions and community-centered outreach.
Galien Forum: CEOs Talk FDA, China, Funding Sources
By Ben Comer, Chief Editor, Life Science Leader Recent reporting on FDA leadership and personnel issues, as well as the resignation of George Tidmarsh from his role as director at CDER, cast new light on FDA Commissioner Makary’s tenure at the agency, even as new, industry-desired pilot programs, AI adoption, and other changes go forward.
11.19.25 -- The Make-Or-Break Quality Attributes Of Plasmid DNA
Webinar: Addressing the Challenges of LNP Upscaling: A Reynolds Number-Driven Approach via Junction Mixing Technologies Scaling lipid nanoparticle (LNP) formulations from lab to GMP production introduces challenges in uniformity and reproducibility. This webinar explores how KNAUER’s Impingement Jets Mixing (IJM) technology provides scalable, physics-based control through constant flow conditions.
11.18.25 -- Makary Talks Faster Drug Reviews, 'Continuous Trials,' DTC Ads
Advanced iPSC Workflows: Accelerating Cell Therapy Development Induced pluripotent stem cells (iPSCs) are a powerful foundation for next-generation therapies, but their true potential depends on advanced, reliable workflows that enable consistency, safety, and scalability. By combining robust quality standards with innovative workflow design, iPSC-based programs can achieve greater reproducibility, reduce development risks, and accelerate timelines.
11.17.25 -- Makary Talks Faster Drug Reviews, 'Continuous Trials,' DTC Ads
Market Insights And Packaging Decisions To Meet Milestones Stay ahead in a competitive and fast-evolving market by optimizing packaging strategies that reduce risk, ensure compliance, and accelerate your path to market. Navigating The Complexities Of Pre-Filled Syringe Manufacturing Here, we highlight practical strategies and proven solutions designed to help navigate challenges and support the reliable, scalable production of high-quality PFS therapies for patients worldwide.
11.12.25 -- Makary Talks Faster Drug Reviews, 'Continuous Trials,' DTC Ads
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Webinar: Advancing Topical Formulations with Innovative Preclinical Models In this webinar, experts will explore strategies to improve drug candidate success rates by integrating robust formulation development and predictive preclinical models.
By Ben Comer Verified, Rachel Timberlake, Bend Bioscience, Michelle Gischewski, Louis Garguilo Verified
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Outsourced Pharma
Makary Talks Faster Drug Reviews, 'Continuous Trials,' DTC Ads
By Ben Comer, Chief Editor, Life Science Leader The FDA must "cut the idle time" that exists within the agency to bring drugs to market faster, said Commissioner Martin Makary, M.D., during a wide-ranging conversation at the Galien Forum in New York City on October 30.
Makary Talks Faster Drug Reviews, 'Continuous Trials,' DTC Ads
By Ben Comer, Chief Editor, Life Science Leader The FDA must “cut the idle time” that exists within the agency to bring drugs to market faster, said Commissioner Martin Makary, M.D., during a wide-ranging conversation at the Galien Forum in New York City on October 30.
Reading The FDA Tea Leaves On Psychedelics
By Ben Comer, Chief Editor, Life Science Leader In a candid discussion with members of the media last month, Rick Doblin, founder of the Multidisciplinary Association for Psychedelic Studies (MAPS) — the organization that birthed Lykos Therapeutics as a public benefit corporation to develop and commercialize MDMA — suggested that the FDA had “changed the goal post” following a contentious and emotional FDA Advisory Committee (AdComm) meeting in June 2024.
Partnering To Commercialize Radiopharmaceuticals
By Ben Comer, Chief Editor, Life Science Leader During a July episode of the Business of Biotech, Ebrahim Delpassand, M.D., founder, chairman, and CEO at RadioMedix, pointed out the importance of knowing, as a company, what you do best. It won’t be everything, particularly if you are developing a new radioactive diagnostic or therapeutic and are not among the ranks of Big Pharma.
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From Scientific Discovery To Next Generation Treatments For Obesity
By Ben Comer, Chief Editor, Life Science Leader Roger Cone, Ph.D., a professor at the University of Michigan and the founder and chair of the scientific advisory board at Courage Therapeutics, has been thinking about the biological mechanics of obesity and eating disorders for decades — long before the emergence and blockbuster sales of GLP-1 inhibitors.
07.22.25 -- Business Of Biotech Newsletter
June was a busy month for the Business of Biotech, which recorded its first-ever taping in front of a live audience during the BIO convention. Special thanks to Amber Salzman, Ph.D., CEO at Epicrispr Biotechnologies for an interesting and entertaining conversation, and for her willingness to try out the live recording format with us. It was fun, and I hope to do it again soon.
07.12.25 -- Life Science Leader Best Of June
JUNE'S BEST FEATURED EDITORIAL In a follow up to his recent appearance on the Business of Biotech, Tolga Tanguler explains how Alnylam is positioning Amvuttra's new ATTR-CM indication approval against competitors in the category. JUNE'S BEST INDUSTRY INSIGHTS What Is Direct-To-Patient Clinical Trial Recruitment? What is the direct-to-patient (DtP) recruitment, and how can sponsors and organizers leverage this approach to boost patient recruitment and achieve clinical trial goals?
Epic Bio's Big Swing In Epigenetic Editing
By Ben Comer, Chief Editor, Life Science Leader The Business of Biotech was taped in front of a live audience in Boston during the BIO conference last month, and we couldn’t have asked for a better guest to test out this new format. Amber Salzman, Ph.D., CEO of Epicrispr Biotechnologies (Epic Bio) regaled the audience with insights into the company's development of a new and novel drug modality — epigenetic editing — in spite of a challenging funding landscape.
BIO2025: Sanofi R&D, FDA's Martin Makary, Paying For New Therapies
By Ben Comer, Chief Editor, Life Science Leader The annual BIO International Convention, held this year in Boston on June 16 through 19, is a choose-your-own-adventure kind of meeting.
06.17.25 -- Business of Biotech Newsletter
In the business of Alnylam, Vir Biotechnology, Alltrna, and Mid Atlantic Bio Angels The Business of Biotech is live — and in full effect — at BIO this month, with an unprecedented episode taping in front of a live audience on the evening of June 17.
Companies To Watch: Vivani Medical
By Ben Comer, Chief Editor, Life Science Leader Overcoming adherence and tolerability issues in obesity and diabetes treatment. Snapshot Vivani’s subdermal implant NanoPortal device, a platform drug delivery technology, is designed to deliver a near-constant and minimally fluctuating dose of an active pharmaceutical drug for a duration of six months, and potentially one year.
05.20.25 -- Business Of Biotech Newsletter
In the business of Uniquity Bio, Insmed, Chinese biotech and investment trends. Who — and what — is a life science leader in 2025? In the first month of my tenure as host of the Business of Biotech, it’s clearer to me than ever that leading in life sciences requires a constellation of expertise: strong leaders in drug development, in finance and operations, in policy and commercialization, and elsewhere. A broadening set of calculations is needed, to take and manage the risks required to succeed.
Promoting A Newly Approved Indication Against Established Competitors
By Ben Comer, Chief Editor, Life Science Leader There are lots of reasons why physicians and patients (and payers) might prefer one drug over another for the treatment of a given disease. Efficacy and safety are paramount, of course, but there are other factors, including drug price (and rebates), administration method, drug mechanism, an individual’s unique patient profile and history, as well as personal preferences for specific drug benefits or safety risks, compared with others.
Building Uniquity Bio: Teams, Capital, And Strategy
By Ben Comer, Chief Editor, Life Science Leader On a recent episode of the Business of Biotech podcast, Brian Lortie, president and CEO of Uniquity Bio, offered up useful advice about the complex process of building and leading a biotech startup in today's uncertain and evolving landscape.
Amgen's Ian Thompson On Leadership And A Global Mindset
By Ben Comer, Chief Editor, Life Science Leader Riding for the British Cycling team was a foundational experience for Ian Thompson, SVP and general manager of U.S. business operations at Amgen. During a recent conversation about his 16-year tenure at Amgen, and what the future holds for one of biotech’s biggest success stories, Thompson consistently tied his approach to management and business strategy to lessons learned from cycling — uphill and down.
Companies To Watch: Imunon
Article | March 31, 2025 Source: Life Science Leader By Ben Comer, Chief Editor, Life Science Leader Using targeted therapy to transform the standard of care in advanced ovarian cancer Snapshot With the recent sign-off from the FDA on protocols for a pivotal Phase 3 trial of IMNN-001 in advanced ovarian cancer, Imunon is poised to bring its IL-12 DNA plasmid vector (encased in a nanoparticle delivery system) into late-stage clinical trials.
03.18.25 -- Business of Biotech Newsletter
By the end of this month, we'll have worked our way through the special series of Business of Biotech episodes recorded and filmed on-site at the JP Morgan Healthcare conference, where we were graciously hosted by some wonderful lawyers (those words don't have to be mutually exclusive) at the law offices of Alston & Bird. Big thanks to those folks, and to Life Science Leader's Ben Comer for joining me on several of these.
A CEO With A General Counsel's Perspective
By Ben Comer, Chief Editor, Life Science Leader Should aspiring biopharmaceutical leaders focus on deep specialization and expertise in a singular area, or seek new and variable experiences across different parts of the business, developing a versatile skillset that can plug and play into leadership roles as needed?
FCPA Enforcement Paused At DOJ, But Biopharma Shouldn't Pause Compliance
By Ben Comer, Chief Editor, Life Science Leader Over the last 15 years, biopharmaceutical compliance departments, and chief compliance officers, have been better resourced, with more direct reporting lines to company leadership, than ever before. A big part of that is thanks to the many Corporate Integrity Agreements (CIAs) companies entered into with government agencies in the late 2000s and up through the present (for background, see my 2013 article in Pharmaceutical Executive).
Where Are They Now? Tarsus Pharmaceuticals
By Ben Comer, Chief Editor, Life Science Leader Then: In the May 2023 issue of Life Science Leader, Bobak Azamian, MD, Ph.D., cofounder and CEO of Tarsus Pharmaceuticals, talked about the company’s formation in 2016, and the decision to focus on the eyelid as a drug target, and on demodex blepharitis — an inflammatory condition caused by an overabundance of demodex mites — as a specific condition to treat.
Day One Bio Aims To Shorten the Time Gap On Cancer Treatments For Kids
By Ben Comer, Chief Editor, Life Science Leader One of the biggest incentives for developing new therapies for rare pediatric cancers is the FDA’s rare pediatric disease Priority Review Voucher (PRV) program. If a drug in development meets the criteria for a PRV, the sponsor company, upon FDA approval, receives a PRV that can be redeemed for FDA priority review of a different pipeline product, or can be sold to another company.
Companies To Watch: Senti Bio
By Ben Comer, Chief Editor, Life Science Leader Using ‘logic gates’ to improve cell therapies in oncology Snapshot Senti Bio cofounder and CEO Tim Lu, MD, Ph.D., a Harvard and MIT engineer by training, invented a “logic gating” technology to reduce cell therapy toxicities in oncology. Logic gating, an electrical engineering term, refers (in this context) to a customizable “gene circuit,” or multi-gene construct capable of identifying cancer targets on both healthy and diseased cells.
01.11.25 -- Life Science Leader Best Of December
DECEMBER'S BEST FEATURED EDITORIAL The Fork In The Road: Personal Decisions That Change Our Career Trajectory Novo Nordisk SVP Blandine Lacroix shares her career story and discusses the importance of prioritizing your own personal needs, and the personal needs of others, in navigating a professional career. What Will The Incoming Trump Administration Mean For Drug Patents?
Where Are They Now? Teva Pharmaceuticals
By Ben Comer, Chief Editor, Life Science Leader Then: In an article published in the October 2013 issue of Life Science Leader, former executive editor Wayne Koberstein spoke with Teva’s then CEO Jeremy Levin about the company’s strategy to bridge the divide between follow-on generics and innovator branded products. The company’s future, Levin said, would depend on producing “high-value generics” and new drugs in CNS, respiratory, and other therapeutic areas.
FDA's Psychedelic Reckoning
By Ben Comer, Chief Editor, Life Science Leader The number of psychedelic drug developers reaching Phase 2 and Phase 3 clinical trials is growing, in recognition of the level of unmet need in many mental health disorders and other conditions.
Companies To Watch: Terns Pharmaceuticals
By Ben Comer, Chief Editor, Life Science Leader Developing small molecules for cancer and obesity Snapshot What is better than first to market? Best to market, says Terns Pharmaceuticals CEO Amy Burroughs, an executive with a diverse, 25-year career in life sciences who joined Terns Pharmaceuticals as CEO in February 2024.
CEO Panel Talks IRA Impact At Galien Forum
By Ben Comer, Chief Editor, Life Science Leader After a year of monitoring implementation of the Inflation Reduction Act (IRA), including the first cohort of companies going through drug price negotiations at the end of last summer, a panel of CEOs and industry leaders convened at the Galien Forum on November 7 in New York City to talk about the law’s impacts.
11.09.24 -- Life Science Leader Best Of October
OCTOBER'S BEST FEATURED EDITORIAL The Benefits And Risks Of An LLC Business Model In Biotech An LLC model in biotech brings specific advantages, such as streamlined deal-making, IP ownership, and capital reinvestment and return. However, it won't work for every company, as Abbas Kazimi, chief business officer at Nimbus Therapeutics, explains.
Where Are They Now? Ironwood Pharmaceuticals
By Ben Comer, Chief Editor, Life Science Leader Then: In 2016, when former Life Science Leader editor Rob Wright wrote about cofounder Peter Hecht and Ironwood Pharmaceuticals, the company was ascending. After its initial launch in 1998, the company developed and received approval in 2012 for its first drug, Linzess (linaclotide), indicated for irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) in adults.
A Bioethicist Weighs In On Obesity Drugs
By Ben Comer, Chief Editor, Life Science Leader By now, it’s likely that you know someone, a friend, family member, or associate who has been prescribed a GLP-1 inhibitor like Wegovy/Ozempic or Zepbound/Mounjaro for weight loss. Maybe you have taken it yourself. The most obvious outcome that I have noticed personally, based on conversations with people taking those drugs, is that they work. People are successfully losing weight, just as clinical trial data suggested that they would.
10.30.24 -- A "Flight Plan" For Achieving These 3 mRNA Development Milestones
It’s impossible to attend an event on the future of RNA therapeutics without hearing about the challenges we’re facing with targeted RNA-LNP delivery. In this final Advancing RNA Live discussion of 2024, we sit down with three LNP experts to parse out the current opportunities and unknowns facing the development of next-generation LNPs. Secure your spot today! Registration is free thanks to the support of Helix Biotech.
Companies To Watch: Spinogenix
By Ben Comer, Chief Editor, Life Science Leader Using small molecule drugs to restore synapses in neurological diseases. Snapshot Los Angeles-based Spinogenix, a privately held small molecule drug discovery and development company, is currently testing two clinical candidates in four diseases: SPG302 in amyotrophic lateral sclerosis (ALS), Alzheimer’s disease, and schizophrenia, and SPG601 in Fragile X syndrome. Both candidates are orally administered small molecules.
Hunting For Unicorns: Starton Therapeutics
Hunting For Unicorns: Starton Therapeutics 21 Jul 2021 • By Ben Comer Clinical-stage biopharma Starton Therapeutics is developing continuous delivery systems and transdermal technologies to improve the safety and efficacy of existing cancer medications, and eschewing VC firms in favor of retail investors. Chair and CEO Pedro Lichtinger recently appeared on Unicorn Hunters, an online reality TV show, to pitch the company to celebrity judges, and the public at large.
10.12.24 -- Life Science Leader Best Of September
SEPTEMBER'S BEST FEATURED EDITORIAL A Systems Approach To Parkinson's Disease New research into Parkinson's disease is strengthening the connection between an unhealthy gut and brain disorders. Google Life Sciences Leader Talks AI And 'Watch Outs' For Biopharma Shweta Maniar, Google’s global market leader for life sciences, spoke with Life Science Leader about how large and small biopharmaceutical companies are using AI to lower costs and expedite timelines.
Annovis Bio: Against The Grain In Alzheimer's Disease
By Ben Comer, Chief Editor, Life Science Leader What do Annovis Bio’s buntanetap, Pfizer’s Viagra, and Lilly’s GLP-1 drug Trulicity have in common? They could all end up being used together in combination as a new treatment focused on improving cognition in neurodegenerative diseases like Alzheimer’s and Parkinson’s, a project Annovis Bio founder and CEO Maria Maccecchini, Ph.D. is currently pursuing.
New Leadership At The Cancer Research Institute
By Ben Comer, Chief Editor, Life Science Leader Dr. Alicia Zhou, Ph.D., the new CEO at the Cancer Research Institute (CRI), aims to bring her experience in academia and the West Coast health tech startup scene to bear on a 70-year-old nonprofit institution with deep roots in cancer immunotherapy. Her experience using Big Data to improve molecular therapeutics, in both the academic and startup settings, has the potential to help CRI make even more of an impact in the future.
Where Are They Now? Carisma Therapeutics
By Ben Comer, Chief Editor, Life Science Leader Then: In a 2021 “Companies To Watch” article written by Wayne Koberstein, Carisma Therapeutics CEO Steven Kelly spoke about his three-pronged mandate to fund the (then) privately held company, build a team, and define a purpose.
Where Are They Now? Carisma Therapeutics
By Ben Comer, Chief Editor, Life Science Leader Then: In a 2021 “Companies To Watch” article written by Wayne Koberstein, Carisma Therapeutics CEO Steven Kelly spoke about his three-pronged mandate to fund the (then) privately held company, build a team, and define a purpose.
A Systems Approach To Parkinson's Disease
By Ben Comer, Chief Editor, Life Science Leader In August 2023, Gut, a journal published by BMJ, released a study of over 24,000 patients with Parkinson’s disease, finding that certain gastrointestinal disorders — such as difficulty swallowing, constipation, and irritable bowel syndrome (IBS) — might specifically predict Parkinson’s disease.
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