Accelerating Startups with Michael Lyon

Some people talk about innovation. Others live it. Michael Lyon has built a career that bridges worlds most of us only dream about, from helping launch the first space tourists to diving miles beneath the ocean surface, and now mentoring the next generation of tech entrepreneurs. A Harvard Law graduate with experience spanning government, finance, and frontier industries, Michael has spent over 40 years helping bold ideas find their place in the real world. Today, he serves as a longtime mentor at the Creative Destruction Lab, guiding hundreds of founders in fields like space, ocean technology, and AI.In this conversation, Michael shares the hard-won lessons behind his new book, Accelerating Startups: Lessons from Mentors. He opens up about the questions founders don’t always stop to ask, like whether they’re truly ready for the risks, trade-offs, and constant pressure that come with building something new. Michael explains why it’s smarter to chase a real-world problem than to fall in love with a piece of technology, and how founders can stay grounded when money, time, and people all pull in different directions. What stands out is how he draws on the precision of a lawyer and the curiosity of an adventurer to illustrate the messy and rewarding nature of the startup path.We also discuss the human side of Tech Transfer, including how universities can better prepare innovators for the leap into business, what it means to listen to mentors truly, and why staying humble often opens more doors than any credential ever could. When the topic turns to AI, Michael keeps it practical, discussing where it helps, where it falls short, and how founders can utilize it without compromising their creative edge. His stories have a lived-in quality that makes you believe progress is built through patience, self-awareness, and the kind of mentorship that keeps you moving when things get hard.In This Episode:[02:15] How Michael helped launch the first space tourists and later mentored hundreds of ventures at the Creative Destruction Lab.[03:40] What inspired him to write Accelerating Startups: Lessons from Mentors, and how common startup challenges led to the book.[05:08] The “Section Zero” question and why founders should pause to ask if they’re truly ready to build a company.[06:45] The personal and professional sacrifices that come with startup life and how timing matters.[08:20] Why reflection, self-awareness, and resilience are critical traits for any founder.[09:30] The trap of “a solution looking for a problem” and how tech transfer teams can help avoid it.[10:45] Why falling in love with the problem, not the technology, is key to real market traction.[11:55] The role of early business plans in aligning co-founders and clarifying assumptions.[12:40] Customer discovery tips for academic founders and how to measure perceived customer value.[14:00] Blind spots Michael often sees in university-based startups and why being coachable changes everything.[15:28] The balance between technology development and commercialization within research spinouts.[16:45] How mastering a 30-second pitch can transform a founder’s understanding of their own business.[18:10] Why many companies struggle with active listening and how coachability affects mentor relationships.[20:25] Building the right founding team and why compatibility and trust matter more than equity splits.[22:30] Michael’s advice on founder “prenups,” equity vesting, and handling co-founder departures.[24:10] How startups should approach global markets early and the role tech transfer offices play in preparing them.[26:30] Inside the Creative Destruction Lab model—goal setting, mentorship quality, and science-based acceleration.[28:20] Legal pitfalls academic entrepreneurs often overlook and why strong agreements matter.[29:45] Michael’s take on AI in startups and how it can streamline, and where human creativity still leads.[31:20] His top three takeaways for new founders include building a business plan, refining your pitch, and staying open to learning.[33:00] Reflections on mentorship, trust, and the patient, disciplined path from idea to impact.Resources: AUTMAccelerating Startups: Lessons From MentorsMichael Lyon - [email protected] Destruction Lab

Fighting blindness requires science, strategy, and a great deal of heart. Today’s guest is Jason Menzo, CEO of the Foundation Fighting Blindness, the world’s largest private funder of retinal disease research. Since assuming the role in 2022, after serving as President and COO, Jason has helped raise nearly a billion dollars and is backing over 100 projects across 86 labs and clinical centers worldwide. With more than two decades in ophthalmology at Sun Ophthalmologics, Nycox SA, Bausch & Lomb, and Bayer, he brings sharp business instincts and a deep commitment to restoring sight.Before joining the Foundation, Jason co-founded and led several eye-care ventures focused on bringing breakthrough treatments to patients more quickly. That for-profit experience now fuels mission-driven innovation, new funding models, and partnerships that move discoveries from the lab to the clinic. A standout example is the early Foundation support for the research behind Luxturna, the first FDA-approved gene therapy for an inherited disease, demonstrating how bold, risk-tolerant philanthropy can transform medicine when academia, government, and industry collaborate.A hallmark of his leadership is the R&D Fund, a $160 million venture philanthropy model with an eight-to-one leverage ratio. This bridges academic research and commercialization, drawing in private capital to advance promising therapies. He has also championed a global network of over 40 clinical centers in 10 countries and strengthened the talent pipeline through fellowships and translational awards. Today, 88% of retinal treatments in clinical trials can be traced back to Foundation-funded programs.Today, we discuss where science, policy, and philanthropy converge to bring sight-saving treatments closer to reality. We discuss the proposed Venture Philanthropy Enhancement Act and look ahead to gene-agnostic therapies, cell regeneration, and whole-eye transplant initiatives with ARPA-H. In This Episode:[01:30] Jason reflects on his transition from the pharmaceutical world to nonprofit work and what drew him to the Foundation.[03:10] Discussion of Luxturna’s groundbreaking FDA approval and how early Foundation funding contributed to its success.[05:30] Jason explains how the Foundation balances basic and translational research to accelerate cures for retinal diseases.[07:45] Overview of the Foundation’s five-year strategic plan and its flexible approach to adapting research priorities.[09:15] Insight into the importance of collaboration among universities, the NIH, and industry partners to move discoveries into the clinic.[11:00] Jason highlights the creation and purpose of the R&D Fund, a venture philanthropy model launched in 2018.[13:00] The Fund’s success in achieving an 8-to-1 leverage ratio and attracting top venture capital partners.[15:10] How the Foundation conducts due diligence when selecting companies for investment.[17:30] Explanation of how the R&D Fund differs from traditional research grants and why selectivity is key.[19:00] Jason introduces the Venture Philanthropy Enhancement Act and discusses its potential impact on funding for rare diseases.[22:00] Story of a near-failed company that survived through philanthropic support and produced life-changing clinical trial results.[24:00] The Foundation’s suite of grants and awards supporting early-career and translational researchers.[26:10] Career Development Awards and their role in retaining top talent in retinal disease research.[28:00] How the Foundation partners with tech transfer offices to bridge the “Valley of Death” between discovery and commercialization.[30:00] Metrics beyond publications—how FFB measures its real-world impact on treatments and cures.[32:15] Jason shares the emerging technologies he finds most promising, including gene-agnostic and cell-based therapies.[34:10] Discussion on the global prevalence of blindness and the Foundation’s efforts to prioritize late-stage and restorative therapies.[36:00] Jason outlines upcoming funding opportunities and deadlines for university researchers.[37:30] Final reflections on hope, awareness, and collaboration shaping the future of vision restoration.Resources: AUTMJason Menzo - Foundation Fighting BlindnessJason Menzo - LinkedInJason Menzo - X

Not every university has the resources to build and maintain a Tech Transfer office, and for many smaller institutions, that has long meant sitting on the sidelines. In Kentucky, leaders decided to try something different. Instead of each campus building its own program from scratch, they pooled efforts into a single statewide network. That collaboration became Kentucky Commercialization Ventures, or KCV, a model that’s now showing what inclusive innovation can look like in practice.At the center of this work is Kayla Meisner, Executive Director of KCV, who has guided the initiative from an early concept into a growing program with national attention. Since its launch in 2020, KCV has more than tripled its funding, doubled its staff, and helped innovators at all levels find clear pathways into commercialization. By combining proof-of-concept funding with hands-on coaching and shared services, the team has turned early ideas into intellectual property, startups, and partnerships that feed back into Kentucky’s economy.In this episode, Kayla explains what it takes to build trust across institutions, how programs like the Innovation Fellowship and KCV Invent are preparing the next generation of talent, and why partnerships outside of academia are strengthening the state’s innovation ecosystem. She also reflects on what other regions can learn from Kentucky’s experience, from getting state economic leaders on board to setting up governance that keeps everyone invested in long-term success.In This Episode:[03:18] Kayla shares the origins of KCV and how it fits within the Kentucky Science and Technology Corporation’s 40-year mission.[05:24] She explains how state dollars are invested into proof-of-concept funding and stipends to support innovators.[06:30] Kayla describes the challenges Kentucky faced as an EPSCoR and NIH IDeA state and why collective action was needed.[09:37] She outlines the gap analysis that showed most partner schools lacked IP policies and full-time tech transfer staff.[12:15] The discussion turns to how KCV scaled its services while running on less than $1 million a year in the early days.[15:30] Kayla highlights the importance of coaching and mentorship in turning early-stage disclosures into IP.[17:40] The story of Dr. Rachel Tinius at Western Kentucky University illustrates how small investments can lead to major commercialization success.[18:26] Kayla talks about the KCV Innovation Fellowship and how it prepares students and faculty for entrepreneurship.[22:06] She explains how the fellowship has grown into a semester-based, cohort model that builds practical commercialization skills.[24:11] The conversation shifts to Kentucky’s six regional innovation hubs and their statewide economic impact.[29:01] Kayla details how KCV now requires assessments before opt-in, creating clearer pathways and buy-in for institutions and innovators.[32:37] The IMPACT competition is discussed, with KCV celebrating its first-ever community and technical college winner.[35:17] Kayla addresses the $8.25 million NSF EDGE award and the systemic barriers it is helping to solve at smaller institutions.[46:28] She reflects on the challenge of securing sustainable funding and the importance of demonstrating ROI.[49:57] Kayla highlights ecosystem partnerships with groups like the Kentucky Bar Association, USPTO, and Kentucky Distillers Association.[54:30] The conversation explores talent development through internships and the launch of KCV Invent, funded by the NSF Excellence Program.[56:43] Kayla offers three recommendations for other states interested in replicating the KCV model: build state relationships, conduct gap analyses, and establish governance.[59:45] She reflects on what has surprised her most about the centralized approach and why it has proven so effective.Resources: AUTMKayla Meisner - Kentucky Commercialization VenturesKayla Meisner - LinkedInKentucky Science & Technology CorporationDr. Rachel Tinius, Ph.D., EP-CBumptUp LabsUSPTO – Midwest Regional Office

A proposed shift in U.S. patent policy is sparking debate about the future of intellectual property. The idea on the table is a value-based tax that would replace, or sit on top of, the USPTO’s traditional flat-fee system. Instead of paying predictable maintenance fees, patent owners could face annual charges tied to the assessed value of their inventions. This move would dramatically change how portfolios are managed and funded.To walk us through the implications, we’re joined by Erin M. Daly, Ph.D., Esq., founder of Daly Law & Strategy. Erin started out in organic chemistry before moving into patent law, and she’s spent her career working with biotech companies and universities on everything from early-stage research to clinical programs. That combination of lab background and legal know-how gives her a practical view of how changes in patent policy land on the ground.We discuss why putting a dollar value on patents is never straightforward and how a tax like this could create big headaches for industries that depend on large portfolios, like biotech, semiconductors, and emerging green technologies. We also look at what startups and universities might face if they’re hit with new costs long before their patents generate any revenue. In This Episode:[01:57] The proposed value-based patent tax is outlined and contrasted with current USPTO fees.[02:50] Erin explains how the new system would resemble a property tax on intellectual property.[03:49] The U.S. has historically treated patents as a right supported by fees, not as taxable assets.[04:42] The proposal is still at the idea stage with no formal rule or bill introduced.[06:08] Patent valuation challenges are described, including subjectivity and lack of comparables.[08:07] Legal questions emerge about USPTO authority, due process, and potential litigation.[10:44] Erin outlines compliance concerns, audits, and paperwork burdens if the IRS were involved.[12:49] Biotech and pharma are identified as sectors most at risk under a value-based tax.[13:45] Semiconductor and AI industries could face massive valuation tracking costs.[14:40] Green tech companies may abandon patents if taxed before commercialization.[15:59] Strategic steps for tech transfer offices and companies to assess exposure are discussed.[17:39] Trade secrets may become more appealing as an alternative to patents in some cases.[18:24] Companies might restructure portfolios or shift filings internationally to reduce risk.[20:45] Erin emphasizes the importance of monitoring Congress, Federal Register updates, and IRS guidance.[22:55] Coalition groups and bar associations begin mobilizing to oppose the tax proposal.[23:33] Early legal challenges are expected to test the limits of USPTO authority and valuation disputes.[25:26] We close with a reminder that patent costs are under increasing scrutiny.Resources: AUTMDaly Law & StrategyErin M. Daly, Ph.D. - LinkedInDaly Law & Strategy - FacebookUSPTO (United States Patent and Trademark Office)Federal RegisterBIO (Biotechnology Innovation Organization)Intellectual Property Owners Association (IPO)

How do discoveries in a university lab make their way into everyday life? That question sits at the heart of AUTM’s Better World Project. When it first launched almost 20 years ago, it was just a small booklet with a handful of stories. Today, it’s grown into a global showcase with more than 600 examples of how technology transfer changes lives. In this episode, we’re taking another look at the project, what’s new, and why it continues to matter.I’m joined by RK Narayanan, Senior Director of Business Development and Technology Transfer at Cold Spring Harbor Laboratory. Since 2017, RK has been leading partnerships and collaborations there, but his path stretches across both research and commercialization. He earned a PhD in Molecular and Cellular Biology from the University of Arizona and an MBA from the University of Illinois Urbana-Champaign. Earlier in his career, he held research roles at Harvard Medical School and MIT before stepping into technology management at Illinois, where he oversaw more than 200 innovations in the life sciences. He brings a strong focus on value creation and mentorship to his work in tech transfer.Also joining us is Parag Vasekar, Business Development and Licensing Manager for Physical Sciences at Purdue Research Foundation’s Office of Technology Commercialization. Parag’s training covers the full spectrum of materials science. He holds degrees from Pune University in India, Vanderbilt University, and the University of Central Florida, where he earned his PhD. His career has spanned both academia and industry, and today he plays a key role in evaluating technologies and shaping licensing agreements at Purdue. He also serves as co-chair of AUTM’s Better World Project Committee, giving him an inside view of how the initiative has expanded and adapted over time.Together, RK and Parag walk us through the growth of the Better World Project from those early printed pages to today’s award-winning stories. We’ll talk about standout innovations like UMass Amherst’s PFAS-destroying water purification system, the artificial pancreas, and breakthrough cancer treatments. More importantly, we’ll hear why this project isn’t just about showcasing innovation, but about showing the human impact of university research on communities worldwide.In This Episode:[01:30] RK’s career path is highlighted, from research at Harvard and MIT to overseeing 200 innovations at Illinois.[02:00] Parag’s academic and professional journey is detailed, with expertise in materials science and licensing.[03:12] The Better World Project has grown from hundreds to more than 600 innovation stories.[04:57] Examples like the Honeycrisp apple, N95 mask, and Google show university research impact.[05:39] The project began as a way to highlight outcomes of the Bayh-Dole Act and has since gone global.[06:14] From print to online multimedia, the growth reflects the maturing of the field.[07:01] Parag shares what drew him to the project and how it connects the “what” of tech transfer to the “why.”[09:09] RK explains how the project’s expansion shows the maturation of tech transfer beyond transactions.[10:14] Impact is measured in healthier patients, cleaner water, and stronger communities.[10:49] Lisa references Kate Zernike’s call for better storytelling in academic research.[11:22] Parag outlines the Better World Project Award process and the criteria for submissions.[12:29] The committee reviews entries before finalists go to the AUTM community for a vote.[13:26] UMass Amherst’s PFAS-destroying water purification system is highlighted as the 2025 winner.[14:38] Judging criteria have broadened from blockbuster drugs to more holistic measures of impact.[15:48] The committee looks for “aha” moments where research curiosity directly impacts lives.[16:33] RK explains how the project highlights long-term value beyond licensing revenue.[17:04] Examples like the artificial pancreas and PFAS system show impact measured in human terms.[18:22] Representation matters: the project spans medical devices, agriculture, and consumer products.[19:03] A story from Pakistan’s NUST about a vibrational wave therapy device illustrates global reach.[20:25] The project’s role during the pandemic highlighted universities’ rapid responses and collaboration.[21:35] Stories included rapid diagnostic tests, open-source ventilators, PPE solutions, and vaccines.[22:27] The key lesson: urgency and collaboration enable universities to meet global challenges.[23:08] Parag describes how multimedia storytelling broadened the project’s reach and emotional impact.[24:46] Barriers for smaller offices include staff limitations and lack of marketing expertise.[25:31] AUTM staff provide editorial support and encourage frequent submissions.[26:11] Parag shares the committee’s vision for the next five years, focusing on global reach and diversity.[27:05] New story categories now include AI, sustainability, and social sciences.[28:39] RK explains how storytelling makes the impact of university research clear to policymakers.[29:28] With more than 600 examples, the project provides credible evidence of impact.[30:08] The initiative is adapting to showcase AI, climate change, and global health innovations.[31:42] Examples include carbon capture, agricultural advances, telemedicine, and vaccine technologies.[32:19] The call is made for institutions worldwide to submit stories by October 15.[33:38] The committee is currently full but encourages volunteering at future meetings.[34:11] RK highlights Spinraza, developed at Cold Spring Harbor, as a personally inspiring story.[35:19] The partnership with Ionis Pharmaceuticals shows the power of sustained collaboration.[36:49] Parag points to Allegra as a reminder that consumer products also emerge from research labs.[37:30] COVID-era stories reinforced how global tech transfer can adapt quickly.[38:08] Both guests share their hopes for the project’s legacy as more than just a collection of stories.[39:50] We encourage relentless storytelling and contributions to the archive.[41:11] The Better World Project has become a powerful advocacy tool.[42:27] Submissions for the 2026 Better World Project Award are now open.[43:18] Let’s keep making the world better through technology transfer.Resources: RK Narayanan - LinkedInCold Spring Harbor LaboratoryParag Vasekar - LinkedInPurdue Office of Technology CommercializationSubmissions for the 2026 Better World Project Award

Most people hear the phrase “research misconduct” and think it’s an issue reserved for academia. But the truth is, it can rock the entire innovation ecosystem. One altered image in a dissertation might sound small, but it can snowball into collapsed companies, hundreds of millions in losses, and a deep erosion of trust in science itself.Joining me to dig into this reality is Michael R. Samardzija, Senior Counsel at Womble Bond Dickinson. Michael’s career is unique because he’s lived on both sides of the technology transfer world. He earned his PhD in Physiology and a Master’s in Exercise Physiology from Loma Linda University, then went on to get his JD from the University of San Diego. Over the past two decades, he’s worn many hats including Vice President of Research Affairs at Loma Linda University Health, where he launched the N3eight business incubator, Director of Intellectual Property at MD Anderson Cancer Center, and leadership roles at firms like Dentons and Bracewell & Giuliani. That blend of academic and legal experience gives him a rare perspective on the challenges TTOs face every day.Michael recently put a name to something many of us have only seen in fragments what he calls “Research Misconduct’s Butterfly Effects”. It’s the idea that what looks like a single, contained problem in a lab can ripple outward, creating consequences for commercialization, partnerships, and the credibility of institutions. Today, he’s here to break down those connections and share what they mean for technology transfer professionals navigating this complex landscape.In This Episode:[01:29] Michael’s dual background in law and academia is outlined, including his leadership roles and IP experience.[02:11] Michael explains “Research Misconduct’s Butterfly Effects” and why it matters for technology transfer professionals.[02:59] Defining research misconduct with fabrication, falsification, or plagiarism, proven by preponderance of the evidence.[04:04] Misconduct in publications can invalidate patents, licenses, and commercialization efforts.[05:27] Michael shares how his career shaped his views on risk management for TTOs and the rising tide of retractions.[06:03] Licensees may begin requiring universities to warrant patents that are free of misconduct, a risk institutions must prepare for.[07:12] Tech transfer offices should consider sequestering underlying data to provide transparency for licensees.[07:51] Organized fraud networks, “paper mills,” and systemic pressures to publish are fueling misconduct at scale.[09:13] A student uncovers duplicate publications across different journals, leading to a retraction.[10:18] Publication mills profit by selling authorship or fabricated manuscripts, creating an industry of fraudulent science.[12:21] High-profile cases show faculty losing positions over fabricated or cherry-picked data, with countries like India now imposing strict punishments.[13:49] International collaborations bring value but also increase risk when oversight standards differ globally.[14:15] Case study of Athira Pharma illustrates how research misconduct spiraled into legal, financial, and reputational crises.[15:06] Faculty at Washington State University discover dementia drug candidate Dihexa and form a startup.[17:01] Millions in NIH funding and clinical trials follow, but manipulated images in early publications trigger scrutiny.[18:22] The former graduate student admits to embellishing images, yet fundraising and IPOs continue, raising over $400M.[20:04] A whistleblower files a False Claims Act suit, leading to DOJ involvement and company stock plummeting 40%.[21:16] The case settles for $4 million, with ongoing investigations, shareholder lawsuits, and SEC concerns.[23:02] Washington State University removes the student’s dissertation and launches an inquiry.[24:12] Athira’s valuation collapses from $670M in 2020 to $25M in 2025, showing the profound damage of misconduct.[25:00] Michael stresses the need for better due diligence, expert involvement, and clear standards on acceptable data/image alterations.[27:21] TTOs should resist warranties but offer licensees access to original data for their own investigations.[28:38] Retracted papers may serve as tools in patent prosecution or litigation, a double-edged sword for TTOs.[29:09] Practical steps for TTOs include careful fraud language in agreements and collaboration with research integrity offices.[32:01] Recommendations include close coordination with integrity officers, rapid response plans, and careful handling of inventor payouts.[34:24] Michael advises TTO professionals to self-report suspicions quickly to protect institutional reputation.[36:20] Tech Transfer professionals should innovate with integrity and stay vigilant against misconduct.Resources: Michael R. Samardzija - Womble Bond DickinsonMichael R. Samardzija - LinkedInMichael R. Samardzija - Loma Linda UniversityOffice of Research Integrity (ORI), HHS

What does it take to safeguard innovation while making sure the patent system truly serves inventors and society? That’s the heart of today’s conversation, and few people are better positioned to answer than Dr. Julie Burke.Today, she brings a unique perspective to the world of intellectual property and patent prosecution. Dr. Burke spent more than two decades in the U.S. Patent and Trademark Office, eventually stepping into the role of Quality Assurance Specialist in Technology Center 1600. Her path there was built on a strong scientific foundation: a degree in molecular biology, a Ph.D. in biochemistry, and postdoctoral work at Johns Hopkins School of Medicine, where she earned a grant from the Cystic Fibrosis Foundation to study the CFTR protein.At the USPTO, she examined applications in areas that changed the course of modern medicine such as cancer immunology and recombinant antibody technologies. She also handled more than 900 petitions and received multiple awards for her contributions to patent quality and international guidelines. After leaving the Office, Dr. Burke brought her expertise to Knobbe Martens, later founded IP Quality Pro LLC, and has since become a recognized voice through her expert witness work and widely published articles. She also advises Petition.ai and serves on the board of the Association for American Innovation, where she advocates for policies that encourage inventors to keep creating.Dr. Burke candidly opens up about her career journey, the culture inside the USPTO, and the systemic challenges that affect patent quality. She also points us toward a future where reforms, transparency, and a renewed commitment to excellence can strengthen the system while unlocking more innovation for everyone.In This Episode:[02:52] Dr. Burke shares her academic journey through Biogen, Imperial Cancer Research Fund, and Johns Hopkins, and how she was pointed toward the USPTO.[05:20] She reflects on family ties to public service and her idealistic start at the USPTO.[05:51] Early years as a cancer immunology examiner and later transition to Quality Assurance Specialist in TC1600.[08:26] She describes USPTO culture, personalities of examiners, and the complaints she fielded as a QA specialist.[10:36] Dr. Burke recounts being told that allowing a patent on first action would earn her a derogatory label, and what that revealed about PTO culture.[12:22] Discussion of the “reject, reject, reject” mentality and how examiners were pressured into repeat RCEs.[14:55] Dr. Burke introduces the Sensitive Application Warning System (SAWS) program and explains how it secretly blocked pioneering cases.[17:42] How SAWS expanded into looking at inventors’ backgrounds, including finances and character.[18:32] Comparisons to IRS “BOLO” lists and the chilling effect of having allowances pulled at the last moment.[28:48] Dr. Burke explains new challenges with petition review work, including restrictions and procedures that create extra burdens. [32:41] What needs to change to address some of these quality issues. [37:12] Hazing culture in the Patent Training Academy and high attrition among new examiners.[41:00] Impact of PTAB changes: trials scaled back, discretionary denials increased, and appeals expedited.[42:11] Loss of examiner tools like ChemDraw and SciFinder forces some to use personal computers, creating security risks.[52:28] Dr. Burke contrasts production bonuses with quality bonuses, and the damage this does to examination integrity.[55:12] Reports show 40% of litigated patents invalidated which goes back to flawed performance incentives.[58:40] Current restraints and cuts are hard on patent examiners and students and inventors. [01:02:15] We discuss examiner morale, loss of union protections, and management culture shifts.[01:05:47] She shares closing reflections on reforms needed for transparency, consistency, and examiner support.[01:09:32] Dr. Burke connects the role of professional “guilds” in maintaining quality, and draws parallels to historical trade guilds.[01:12:54] Optimism about the Association for American Innovation (AAI) and its independent reform agenda.Resources: Dr. Julie Burke - IP WatchdogDr. Julie Burke - LinkedInPetition AI

Biotechnology law has evolved from a niche specialty into one of the most complex and debated areas of intellectual property, and Dr. Jorge Goldstein has been at the center of that journey. A founding partner of Stern, Kessler, Goldstein & Fox, Jorge has spent more than four decades helping define the legal boundaries of the life sciences while working alongside scientists, startups, and global institutions at the very front edge of discovery. His career path, shaped by mentors who saw the future in biology and patents, offers a rare window into how law and science grew together during the biotechnology revolution.His new book, Patenting Life: Tales from the Front Lines of Intellectual Property and the New Biology, captures that history through the people, cases, and controversies that shaped modern biotech. From the Chakrabarty decision that opened the door for patenting living inventions, to the Wands case that created the well-known enablement factors, Jorge brings to life the courtroom battles and policy debates that continue to influence how research becomes innovation. He also shares behind-the-scenes stories from his own practice, including the Myriad Genetics dispute over gene patents and the still-unfolding CRISPR battles that pit leading universities and scientists against each other.We also talk about artificial intelligence as the next great test for intellectual property law. With AI already designing new drugs and synthetic proteins, it raises the question of inventorship as more pressing than ever. The law still recognizes only human inventors. Change will have to come from Congress, and future generations of lawyers will be tasked with rewriting the rules for a world where human and machine creativity overlap. This conversation connects a past, present, and future that underscores how much the definition of “invention” shapes the pace of discovery.In This Episode:[01:21] Jorge describes how he came from Argentina to study chemistry at RPI, pursued a PhD at Harvard, and was encouraged by mentor Frank Westheimer to study biology.[02:15] Auditing James Watson’s molecular biology course opened his eyes to the future of genetics during the early days of recombinant DNA research.[03:45] He recalls being unaware of groundbreaking advances like monoclonal antibodies while focused on his thesis work.[04:48] Jorge explains why lab research didn’t suit him, realizing his temperament wasn’t suited for years of trial and error and delayed gratification.[06:32] A Harvard Law student introduced him to patent law, and he quickly saw its potential in the emerging field of biotechnology.[07:20] The Chakrabarty Supreme Court decision allowing patents on living organisms solidified his decision to enter biotech IP law.[08:21] Jorge recounts co-founding Stern Kessler Goldstein & Fox with Robert Stern, combining expertise in biology and electronics for a future-focused law firm.[10:15] Early interactions with young biotech companies like Genentech, Amgen, and Genetics Institute showed the demand for lawyers fluent in science.[11:48] He credits Marvin Guthrie of Massachusetts General Hospital with mentoring him on IP strategy and diplomacy in academic-industry partnerships.[13:31] Jorge explains how Guthrie, a founder of AUTM, gave him access to top scientists and Nobel Prize winners, shaping his approach to tech transfer.[14:51] He introduces his book Patenting Life and explains his motivation to document the history of biotech commercialization through human stories.[17:02] A writers’ circle helped him shed legal and scientific jargon, making the book approachable for a broader audience.[18:22] Jorge revisits the Myriad Genetics case over gene patents, explaining why eligibility battles over isolated DNA became so significant.[21:15] He describes the shock when a district court ruled that isolated genes were not patentable, contrary to decades of biotech practice.[23:48] The Federal Circuit reversed that ruling, with Judge Lourie emphasizing covalent bonds, before the Supreme Court ultimately sided against gene patents.[27:10] Jorge reflects on how the Supreme Court’s unanimous decision in Myriad reshaped eligibility standards under Section 101.[30:45] He notes how subsequent cases, including Prometheus and Alice, further unsettled patent law in diagnostics and other industries.[32:05] Jorge turns to In re Wands, explaining how it tested enablement of broad antibody claims and became a landmark case.[35:10] He recalls oral arguments before the Federal Circuit, including Judge Pauline Newman pressing the Patent Office on the impossibility of requiring unlimited deposits.[39:32] The resulting decision established the eight “Wands factors,” which remain central to enablement analysis today.[41:42] Jorge highlights how Wands has been cited thousands of times and even survived scrutiny in the recent Amgen v. Sanofi case.[44:15] He shares a personal story about Jack Wands, who the case was named after and dedicating a chapter of his book to him before his passing in 2023.[46:01] The conversation shifts to the CRISPR patent battle between UC Berkeley/Vienna and the Broad Institute, one of the most high-profile disputes in biotech law.[49:25] Jorge explains the interference process under the former first-to-invent system and why it made the CRISPR case especially complex.[52:10] Statements from Jennifer Doudna expressing scientific uncertainty were used against her in the legal proceedings.[54:40] He outlines how these admissions shaped arguments around conception versus reduction to practice.[57:16] Jorge recalls the year-long wait for the Federal Circuit’s ruling, which ultimately found that doubts expressed by inventors should not determine conception.[58:38] The appeals court sent the case back to the Patent Office with instructions to apply the correct legal test, leaving the battle unresolved.[1:00:08] He turns to emerging concerns about artificial intelligence in biotech innovation, from drug repurposing to protein design.[1:01:15] Jorge notes that current law does not recognize AI as an inventor, creating challenges for patenting AI-driven discoveries.[1:02:29] He argues that Congress should update patent law to allow AI to be recognized as a co-inventor, since control of patent rights is ultimately what matters.[1:03:15] Jorge closes by urging the next generation of lawyers to focus on AI’s impact on inventorship and the need for law to adapt to new models of innovation.Resources: Jorge A. GoldsteinJorge A. Goldstein - LinkedInJorge A. Goldstein, Ph.D. - Sterne, Kessler, Goldstein & FoxPatenting Life: Tales from the Front Lines of Intellectual Property and the New Biology

Federal funding shakeups and new cost caps are hitting Tech Transfer offices from multiple angles. Jodie Richardson, Director of Customer Success at TechPipeline and Chair of AUTM’s Annual Meeting Planning Committee, has been right in the middle of these conversations. With a background in strategic planning, cross-functional leadership, and compliance, she’s been gathering insights from leaders across the country on how they’re coping along with what might come next.Her recent article, Weathering the Storm: How TTOs are Navigating Overhead Rate Caps and Federal Funding Challenges, dives into the real-world effects of these changes. In this conversation, Jodie talks about the hiring freezes and budget cuts many offices are facing, the drop in invention disclosures, and why those shifts could have lasting consequences for commercialization pipelines, startups, and research infrastructure. She also shares how teams are rethinking patent strategies, keeping industry relationships steady in a volatile climate, and preparing for an unprecedented level of federal compliance scrutiny.The discussion reaches into other stress points too including uncertainty around SBIR/STTR funding, the added hurdles in international collaborations, and the scramble to find alternative funding through alumni networks, foundations, and state programs. Jodie offers ideas for retaining talent, boosting staff morale, and making sure the public understands just how much academic research shapes everyday life. Even with all the challenges, she sees reason for optimism, pointing to the adaptability and problem-solving spirit that has always defined the tech transfer community.In This Episode:[01:12] Jodie explains what prompted her to write the article and how she brought together senior Tech Transfer leaders to talk through the fast-moving changes, challenges, and strategies.[03:22] She describes the anxiety and uncertainty created by daily breaking news affecting research and the innovation ecosystem.[05:19] The new 15% indirect cost cap from NIH, DOE, NSF, and now DOD is creating immediate concern, leading to hiring freezes, budget freezes, and reduced invention disclosures.[06:48] Staffing shortages are adding pressure to existing Tech Transfer staff who are trying to maintain operations and support faculty.[08:21] Researchers are spending more time securing alternative funding, adding to the workload for TTO staff who were already under stress.[09:40] Jodie outlines the potential long-term risks to commercialization pipelines, startup formation, and the wider innovation ecosystem if disclosure declines continue.[10:53] Patent strategies are shifting, with offices becoming more selective about filings, especially international patents, and focusing resources on cases with strong commercialization prospects.[12:17] Green energy, climate tech, biotech, and vaccine technologies are among the areas seeing greater selectivity.[13:04] Industry hesitation is impacting both sponsorships and licensing deals, with some master research agreements put on hold indefinitely.[14:57] Communication is key. Offices are proactively engaging with industry sponsors and licensees to understand concerns and salvage opportunities.[15:45] On August 8, the Trump administration announced a federal review of Harvard’s patents, threatening to exercise Bayh-Dole march-in rights.[17:35] Jodie talks about the unprecedented scale of this review and the short 30-day timeline to respond for thousands of inventions.[19:22] She stresses the importance of thorough documentation, compliance audits, and internal collaboration within the TTO.[22:41] The future of SBIR/STTR programs is uncertain, and startups are concerned about potential changes to qualification requirements and funding levels.[24:33] TTOs are partnering with venture support programs, industry engagement, and sponsored programs offices to help startups navigate possible funding gaps.[25:47] International collaborations face more red tape, with abrupt halts to some projects and tighter screening for partners in countries like China and Russia.[28:34] Ensuring licensees meet U.S. manufacturing requirements is becoming a greater priority in international deals.[29:21] Alumni foundations and state economic development programs are emerging as important sources of alternative funding.[31:28] Some states have increased funding to offset reductions in federal research dollars, though most cannot fully close the gap.[33:05] Jodie warns of the potential erosion of research infrastructure and loss of innovation leaders if talent leaves the U.S.[35:42] Institutions can help retain faculty and researchers by stepping in to support projects when funding is lost and easing the commercialization burden.[37:52] Shifts in research focus toward “safer” areas could reduce groundbreaking, high-risk innovations such as climate tech, vaccine development, and women’s health research.[39:35] Staff morale is being tested by uncertainty; transparent communication and safe spaces for discussion are critical.[42:21] National meetings like AUTM’s annual gathering provide opportunities for shared support, optimism, and advocacy.[43:40] Jodie sees a need for greater public education about how federally funded research works and the technologies it produces.[46:01] Even with the challenges, Jodie remains optimistic about the adaptability and resilience of the tech transfer community.Resources: Jodie Richardson - Tech PipelineJodie Richardson - LinkedInWeathering the Storm: How TTOs are Navigating Overhead Rate Caps and Federal Funding ChallengesSBIR/STTR Programs

America's leadership in global innovation depends on the critical link between federal policy and scientific funding. Cuts to research budgets, restrictions on international visas, and the rollback of diversity programs are converging to create uncertainty that threaten labs, universities, and communities that depend on them. What happens in the next budget cycle will determine whether the U.S. continues to set the pace for global discovery or risks ceding that ground to competitors eager to recruit American-trained talent.I’m thrilled to welcome back Kate Zernike, Pulitzer Prize–winning national correspondent for The New York Times. Kate brings both personal understanding and journalistic rigor to covering science policy. Her grandfather was Nobel Prize–winning physicist Frits Zernike, and she has spent decades reporting on the politics of research and innovation. She is perhaps best known for breaking the 1999 story of MIT’s admission that it had discriminated against women on its faculty. This reporting laid the foundation for her acclaimed 2023 book The Exceptions: Nancy Hopkins, MIT, and the Fight for Women in Science. Her distinguished career also includes a Pulitzer for explanatory reporting on Al Qaeda in 2002, underscoring her ability to connect complex issues to the human stories behind them. In this episode, we discuss her recent reporting on two pivotal articles: U.S. Scientists Warn That Trump’s Cuts Will Set Off a Brain Drain and The Surprising Scientists Hit by Trump’s DEI Cuts. She explains how uncertainty is pushing young researchers to reconsider careers in science, forcing labs to halt promising projects such as mRNA cancer research, and eroding public trust in the scientific enterprise after COVID. She also reveals a surprising twist where many of the scientists most affected by DEI rollbacks are rural, first-generation, and conservative-leaning students who depended on those programs to access research careers. We also take on the breaking news of the federal government’s unprecedented investigation into Harvard’s patents under the Bayh-Dole Act, a move that raises profound questions about intellectual property, peer review, and the future of university–industry partnerships.In This Episode:[02:10] We’ll discuss Kate’s June 3rd article on Trump’s proposed funding cuts and the potential “brain drain” in U.S. science.[04:45] The American Dream story of Nobel laureate Ardem Patapoutian and concerns from scientists at Harvard and Johns Hopkins.[06:00] Why U.S. science relies heavily on international talent and the risks of disrupting this pipeline.[07:23] Cultural differences and how countries like India prioritize science as a top career path compared to the U.S.[08:23] Evidence of China, France, Germany, and others actively recruiting American-trained scientists.[10:03] Historical perspective and the migration of rocket scientists after WWII and how talent shaped U.S. supremacy in science.[12:22] NIH and NSF budget cuts, with biotechnology and computer science research seen as most vulnerable.[15:30] How federal research funding connects to U.S. competitiveness and public misconceptions of science.[18:45] Making the case for better science communication and opening up opportunities in science. [20:35] We talk about DEI grant cuts and the impact on rural and socioeconomically diverse scientists.[21:35] Stories of researchers like Lucas Dillard, Gabrielle Merchant, Ashley Albright, and Nicole Gross losing critical grants.[23:50] The lingering resentment toward science post-COVID and challenges in rebuilding public trust.[24:48] Simultaneous threats including funding cuts, talent loss, DEI program eliminations, and IP risks are compounding uncertainty.[27:00] The taxpayer debate and making the case for return on investment from university research.[29:20] Key message to policymakers is that sustained funding is essential to avoid halting critical discoveries.[30:01] Cancer research and mRNA projects at risk, including prostate cancer studies being shut down.[31:30] What gives Kate hope includes pushback from within the government, and scientists’ enduring joy, and commitment to discovery.[32:54] Where to find Kate’s articles and book, and a call to policymakers ahead of the 2026 budget cycle!Resources: Kate ZernikeKate Zernike - New York TimesKate Zernike - LinkedInExposing Discrimination in Science: The Story of Nancy Hopkins and MIT with Kate ZernikeU.S. Scientists Warn That Trump’s Cuts Will Set Off a Brain DrainThe Surprising Scientists Hit by Trump’s DEI CutsThe Exceptions: Nancy Hopkins, MIT, and the Fight for Women in ScienceFrits Zernike