Leslie S Sloan, PhD

Grant revenue is not revenue. I'm all for non-dilutive funding, if and only if the SBIR/STTR-funded project accelerates your strategy with development of a product that will be sold (so science fair projects). However... *grant revenue is not validation dollars on the top line.* What you have shown is an ability to write grants, the basis for the research that led to the startup (in the case of academic spin-outs) in the first place. What you have not shown is 💸 the desire for customers to purchase your product(s) ➡ an ability to articulate a go-to-market plan, or 🔐 a down in the trenches understanding of product-market fit. Startups are a game of the quick and dead -- take the time and money you would spend writing these grants early in the life of your company and hit the road, listen to your customers, learn where and how your products fit, and start selling. Your P&L shows me your real progress there -- As an investor and advisor, I would rather see $10,000 in revenue from sales from a handful of customers in 2 quarters than a X% chance you get a $1M grant in 9 months.

33

18 Comments

An Introduction to Integrating AI into Your BPR Strategy: Myths vs. Realities We hear a lot about how AI is transforming Business Process Re-engineering (BPR), but some of the talk is full of misunderstandings. These myths can make AI sound intimidating or out of reach, stopping companies from taking advantage of what it actually has to offer. So, let's clear up a few common myths—and see the reality behind them. Myth #1: AI Will Replace All Human Roles Ever worry that AI's going to come in, take over, and leave us all out of jobs? It's a big fear, but the truth is, AI's role is more supportive than that. Reality: AI is here to handle the boring, repetitive stuff. When AI takes over those routine tasks, it frees people up to do work that actually requires a human touch. Instead of replacing us, AI's more like a helpful team member, working behind the scenes so we can focus on high-level strategy, innovation, and those things that only humans can provide. Myth #2: AI is Complicated to Implement Yes, there are AI tools and solutions that are complicated and require tech-savvy or highly-trained users. But there are also simpler solutions: while a lot is going on under the hood, the simple user interface and ease of use make both implementation and onboarding quick and easy. Reality: You just need to find the AI solution that matches the level of complexity your organization is ready for. AI is actually far more accessible than people think. Many businesses start with a pilot program in one department, see how it goes, and then expand from there. This gradual approach keeps costs manageable and lets you test the waters before diving in headfirst. Myth #3: AI is Costly and Only for Large Enterprises A lot of smaller companies think AI is something costly and complex that only big corporations can afford or implement, leaving SMEs on the sidelines. But it's no longer something that only huge companies with massive budgets and tech teams can afford. Reality: AI has come a long way, and it's more affordable and adaptable than ever. Many AI platforms today are specifically tailored to small and medium-sized enterprises (SMEs). AI can help SMEs improve customer service, streamline inventory, manage workloads—things that small businesses care about just as much as big ones do. In fact, for SMEs, AI can be a huge competitive advantage, letting them scale smart without ballooning overhead. Why Breaking Down These Myths Matters If we can get past the misconceptions, we can see AI for what it really is: a powerful, flexible tool that's there to help us grow and adapt. Companies that keep an open mind and approach AI strategically are setting themselves up for long-term success. They're the ones able to serve customers better and faster and improve efficiency and cut costs. So, what's the biggest misconception you've heard about AI in business processes? Let's set the record straight!

7

This post offers a perspective from an employer's point of view, addressing the increasing trend of employees criticizing toxic micromanagement cultures. I’ve noticed a growing number of posts from employees highlighting toxic work environments, and it’s clear that this mindset is fueling the demand for more AI and automation in the workplace. Reflecting on my experience at a biotechnology company in the U.S. many years ago, I was often tasked with researching ways to develop automation systems to reduce the need for employees. Even two decades ago, management pointed out the challenges of effectively managing people. The reality is that professionals are hired to fulfill specific responsibilities, and it’s disheartening to see a growing sense of irresponsibility among the current workforce, particularly in India. Rather than addressing issues directly, many seem quick to walk away without engaging in constructive dialogue, opting instead to seek out another job. In my next post, I plan to explore how this mindset among today’s youth could ultimately harm India’s economy.

10

2 Comments

I have intuitively always placed tremendous importance on autonomy, agency, personal freedom in my style of managing people. I get very worried about groupthink, it's my biggest fear in organizational health. I try to actively nourish strong but informed dissenting voices in my teams, reducing the influence of the "carrot and stick" antiquated view of management. The article is an interesting read. "If you want to provide a framework in which humans flourish, you need to help the people under you find their own intrinsic motivation and then give them the freedom to decide how exactly to work towards those goals. Autonomy is the secret sauce of all great leadership. "We found that consistently connecting people to the 'why' of their actions, providing choices in how tasks get done, and giving meaningful feedback results in people being more likely to share ideas and to be more collegiate," explained senior author James Donald of the University of Sydney Business School. "Managing people with controlling, carrot and stick strategies led to people being less likely to share, cooperate, or help others.""

4

#BigPharma's growing interest in the #cellandgenetherapy space has the potential to reshape the industry's future. At this year's Cell & Gene #MeetingontheMesa, industry leaders highlighted that large pharma companies' significant resources and expertise are uniquely positioned to address the complex challenges of developing and commercializing these therapies. From high #manufacturing costs to navigating #regulatory hurdles, Big Pharma is playing an essential role in scaling innovations that smaller biotechs often struggle to bring to market. Their partnerships will prove critical to bringing life saving treatments to patients who need them most. As the sector continues to evolve, collaboration between Big Pharma and biotech can help shape the future of cell and gene therapies.

49

1 Comment

Wow, think I might be breaking some actual NEWS here 😝 Just got sent the original unredacted copy of the Pavers' lawsuit. There were 2 redactions in that document, shown unredacted in yellow below. So, now it's very clear why Illumina had them redacted: the board bought $300M (😳) of insurance right before the GRAIL transaction and paid $100M (🤪) in annual premiums for it. This is absolutely insane for two reasons: (1) Illumina previously held $120M in D&O coverage so $300M is more than doubling coverage in the face of increased risk from GRAIL. So they were VERY NERVOUS about this deal. (2) Normal premiums for D&O are about $100K per million in coverage. So Illumina paid more than THREE TIMES the normal rate for this insurance. This means the insurance company was also VERY NERVOUS about the deal. (Think about how risky this situation is - imagine if you owned a $600K house and the insurance company charged you $200K a year in premiums😱). The bottom line here is that (not a lawyer 🤣) it is very clear that the Illumina board knew it taking an extraordinary risk in closing this deal in the face of massive antitrust opposition. Not a good look for them in any of these lawsuits accusing them of well, taking too much risk - and $300M is a giant prize for the winners of these cases. WTF? Why did they do it? 😱😱😱

73

24 Comments

I wonder if change in a mature industry is incremental or disruptive? I've been on the road last 3 weeks. One of my realizations is that the pharma/biotech industry is having a really hard time understanding the implications of AI in their field. Our conversations are centered on how AI might augment our old way of doing things. Not so much on will there be newer ways of doing things? Biological research is a complex balancing exercise between mechanistic understanding and pure empirical evidence. We are progressively better at understanding - or as I would say hypothesising - about how a disease works and how a drug might 'cure' it. A submission of mechanism of action is more common in IND applications but as far as I can tell it's not a pre-requisite. The greatest successes of drug research are solid empirical hit and trial. Very successful ones at that. The hay day of drug research in the 60s to 90s was because big pharma figured out how to do compound screening effectively at scale. Will AI give us new ways to do this in more effective ways? I would be extremely surprised if that were not to be the case. a. we have never had access to the kind of data that we do now b. we have never had a tool like modern AI to sift through data Those two combined will give us ways to do empirical research like we haven't done before. That much is clear. Will it change the relative dearth of blockbuster drugs? That is a whole another subject. What is clear to me is that the current focus on mechanistic understanding will have to evolve to incorporate AI. We will have newer ways to do things - not necessarily change or abandon old ways. Link to a blog that Abhishek wrote in 2020 which seems truer than ever before.

36

1 Comment

This week we’re scheduled to get some clarity on FDA’s Elevidys Accelerated Approval. There are three main categories that the FDA is due to weigh in on – each precedent-setting in its own way: The first is whether the current narrow Elevidys label will be expanded beyond 4- and 5-year-old Duchenne patients. Recall, the EMBARK Confirmatory trial enrolled patients ages 4-7. Sarepta’s sBLA submitted in December ‘23 also included some early subset data from ENVISION (and older supporting data from ENDEAVOR) that could potentially support age expansion. Sarepta has treated patients as old as 25 years old with Elevidys in the context of clinical trials. Sarepta believes their Elevidys label should be age agnostic. The second is whether Elevidys will remain on market with Accelerated Approval or be converted to a full approval, at least for the 4-5 year olds. Recall, whether granted access to the market via accelerated approval or full approval, the price is likely to remain $3.2M. Sarepta does not appear to be discounting or offering outcomes-based agreements or warranties so $3.2M is probably the actual price tag (with Sarepta making minor pricing concessions to distribution channels). Finally, because the sBLA included supporting subset data from ENDEAVOR and ENVISION, Sarepta is asking for removal of the ambulatory requirement that is currently in the Elevidys Accelerated Approval label. Alas, analysts see the evidence for efficacy in non-ambulatory patients as too limited and preliminary to warrant approval. But time will tell. Since back in the Garabedian days, I’ve learned to never bet against Sarepta. If Sarepta gets all that it has asked FDA for, after this week, Elevidys’ will have full approval with a label open to all age Duchenne patients, regardless of ambulatory status. But that scenario is unlikely; the FDA response will probably be more mixed than binary. However, any expansion of label has implications for payers, as more patients from the prevalent Duchenne population would have access immediately. And at $3.2M per patients, insurers, reinsurers and self-insured employers will be watching because...$3.2M here and $3.2M there and pretty soon you’re talking real money. Sarepta has assured the investment and patient community that it is ready to meet product demand, regardless of how the FDA chips fall. So there you have it.  We should know by week's end. #sarepta #elevidys #cgt #atmp #acceleratedapproval #reinsurance #duchenne

75

13 Comments

Full disclosure, I am several 483s (plus other items) behind in posting - and perhaps you are grateful for that? In any event, this latest OUS 483 dated 23 APR 2024, was one I had wanted to post about last week due to the 'local press [ https://lnkd.in/eks5skDz ] . But I decided to wait and see what happened and something did - the actual 483 was posted mid-day today. It certainly put flesh on the bare bones of the article - "the USFDA conducted an inspection at the injectable manufacturing site .... The inspection closed with 10 observations", There were 10 observations indeed -spread over 18 pages. The image below was 'only the 10th.' You know this was my favorite GMP sections, but when this observation around data integrity (and CSV) comes last - don't you want to see the first 9? Some teasers - Obs. 1 was over 7 pages about incomplete or inadequate investigations. Obs. 2 was about to failutr follow sampling plans for another 3 pages, followed by a brief Obs. 3 about microbiological issues. And you will find a long Obs. 5 about procedures or the lack thereof. If those jottings don't encourage you to read the full document, consider the signature line - this is the work product of the team of "Boyd and Shields." There is no surprise that it is lengthy and detailed. And given the 483 posted about in this space recently for this firm, as in just 2 weeks ago today, [ https://lnkd.in/eGHu5XHk] it is not perhaps surprising that they had "a lot to work with"? Enough of my wanderings, here is the link - read and evaluate the situation for yourselves: https://lnkd.in/eMwPQHiU Comments and questions are always welcome. It really should be good reading, at least I think so. #fda #dataintegrity #sterilemanufacturing #moda

108

39 Comments

A nice overview of Alzheimer's One question-- should trials be large just because diseases are large? I think Peter Kolchinsky's philosophy (? hopefully I am not stating it wrong) which seemed quite intriguing is that there are subsets of rare disease within the common disease. Maybe in an AI/ML sense defining some of the most severe populations and then rolling it back to less severe populations if it seems to work there. (Not sure if there is a path forward for that). (Note that I say this--but it doesn't necessarily seem easy). Since Alzheimer's, for instance, seems to have such diverse behavior across different genetic populations, then populations selected may influence the trial outcomes and make signals hard to decipher. Anyway Alzheimer's is so challenging because trials are likely to take a long time. And many other factors.

9

7 Comments

No one is immune to typos. Not even Fortune 500 companies with their established proofreading workflows and sizable quality control departments. We analyzed over 75% of Fortune 500 companies: -90% featured typos (e.g., ‘the the’) or spelling mistakes (‘receive’) -56% had 10+ errors -26% had 25+ errors That's right, companies like PayPal, McDonald's, Nvidia, and Hilton (to name just a few examples) all have typos on their websites. Our favorite (by far) is NVIDIA.com, which features ‘technolgies’ and ‘modles’. If Nvidia can’t spell technologies or models correctly, what hope is there for the rest of us? Unlike Fortune 500 companies, whose reputations and brands have been cemented over decades, your company is most likely still being introduced to new users. That means that while a silly typo on McDonalds.com won’t stop you from ordering a cheeseburger, it hasn’t stopped me, it may cause one of your site visitors to take a pause. And that’s all the friction you need to lose that customer for good. Don’t be like Nvidia. Proofread your website.

11

1 Comment

"The returns are actually better when you invest in women." Show Her the Money is pushing the bounds of what is possible for women in the venture capital space. Only 2% of investment dollars per year are going to women-founded companies, and it's time for that to change. Join WEST - Women in the Enterprise of Science and Technology at Agios Pharmaceuticals for an exclusive screening of the movie that's changing venture capital for women and an intimate discussion with a celebrity panel of women following the film. This could be one of the most impactful events of the year! #VentureCapital #WomeninVC #WomeninVentureCapital #WomeninSTEM #STEM #Science #Technology #Engineering #Mathematics #Research #Bio #Biotech #Pharma #Pharmaceuticals #Finance #Fintech #Invest #Investing #AngelInvestor #Money #ShowHerTheMoney #Exclusive #Panel #PanelDiscussion #Equality #Women'sEquality #Diversity #Inclusion #DEI #Nonprofit #WESTevents #Boston #BostonEvents https://hubs.ly/Q02NK74J0

15

1 Comment

Why do folks in drug discovery talk about Eroom's law and the decrease in NMEs/$ (or per $B to make the numbers sane) and try to compare that to the progress in semiconductors as exemplified by Moore's "law"? The proper comparison would be NMEs/$ to Chip fabs/$, not transistors /IC (or transistors/$ as Moore's law is often misdescribed). I'd say we're actually doing pretty well as an industry. Admittedly we're comparing apples to pineapples here but I don't think the ~30x cost to bring a drug to market over 5 decades is something people should be freaking out about and using to indict the industry for its supposed lack of productivity. Drug development is hard, slow, and expensive, and much of the low hanging fruit has been picked (apples, not pineapples, I guess) but it's still one of the most amazing and important endeavors undertaken by us humans. (Thanks ChatGPT for the handy table - take with a grain of salt)

26

4 Comments

CONFLATION. definition: the merging of two or more sets of information, texts, ideas, etc. into one. If this isn't commonplace enough in everyday conversations, imagine this in the context of life sciences. It's **really** challenging. This is why, when we'ee working on how we talk to each other, those inside and outside of our spheres of interaction (be it business or Scientific communities) that we work out damned hardest not to conflate. Reasons why conflation is detrimental for marketing your science. ➡️ Two conversations could become four because two of you will be trying to talk about one topic from and angle of understanding and contextualising ➡️ It's easy to conflate, so if you're talking about clinical trials and safety, some folks will also want to talk about eligibility in the same breath as they go hand in hand. Fine for discussion, not so much for communicating direction. ➡️ Drawing key points from that conversation will be hard to disentangle and keep things concise. Imagine writing meeting notes from a science heavy conversation? This actually all sounds a good in theory and something exciting to conflate topics. But if you're trying to get a point out ⛔ Consider not conflating when trying to drive a conversation or discussion involving science.

8

1 Comment

Another bombshell complaint against Illumina/GRAIL filed in Delaware. Eighty pages with a lot of new information from legal discovery, will probably take a few posts to cover. Key points: - Filed by the Comptroller of New York, a good reminder that these lawsuits aren't the usual shareholder-lawsuit blackmailers looking for some corporate ransom spare change to go away. These are serious, deep pocketed folks loaded for bear. - Defendants include the usual deSouza et al group but for the first time includes Illumina's general counsel Dadswell; he's mentioned 28 times in the complaint, and is the only officer-defendant still employed by the company. Interestingly, my sources noted that Chuck came into court with his own legal representation, separate from that being used by all the other defendants. Can't be a comforting thing for them to see - not a lawyer (🤣) but from law & order I know this is what you do if you're planning to turn on your co-defendants 🤔. - Very detailed breakdown of the extraordinary conflicts of interest present in the negotiation of the acquisition deal 🤯 - Focus on the resignation of Jay Flatley from the board of Illumina 🤔 - This complaint comes as legal action is accelerating: I'm hearing of another major amended complaint filed next week and that the SEC investigation personnel interviews have ramped up sharply 😳 Part 1: Conflicted Deal Process "GRAIL was co-founded by Alex Aravanis. On May 4, 2020, Illumina announced the appointment of Aravanis as CTO reporting directly to deSouza. At the same time, Illumina’s former CTO, Mostafa Ronaghi... joined the GRAIL Board of Directors. At the time he became Illumina’s CTO, Aravanis held GRAIL stock worth approximately $10 million. There is no indication that Aravanis’s GRAIL holdings were ever disclosed to the Board or that anyone on the Board inquired as to his ownership in GRAIL." "On August 5, 2020, shortly after he left GRAIL to rejoin Illumina, and despite his self-interest in securing a high price for GRAIL, Aravanis was tasked with presenting a potential GRAIL acquisition to the Board. Notably...deSouza made a $6 billion offer to acquire GRAIL on August 3, 2020, before the Board could give him authorization to pursue a GRAIL transaction." "The presentation put together for this meeting was authored and presented to the Board by Aravanis and two other members of management. The presentation portrayed GRAIL as “poised to revolutionize oncology screening and monitoring” and stated that “an acquisition is the best way to enter this market. It stated GRAIL was “the best target given it is the furthest along (2021 screening test launch),”priced a deal between $8 billion and $10 billion, and requested that management (including Aravanis) receive “approval to engage". [Out of space, much more to come, some good weekend reading 🧐 ]

98

2 Comments

I've highlighted more of this book than I haven't! Such smart, practical, tangible frameworks. I can't get enough! Scaling People: Tactics for Management and Company Building https://lnkd.in/ekzNn3tM #companybuilding #leadership #management #business #growth #goals

6

Being an early hire in a startup can be exhilarating. But it can also lead to disillusionment and disappointment if you don’t recognize the natural trajectory of new companies as they grow. Read more: https://lnkd.in/eS-7uGMi

1

1 Comment

This STAT piece is right that clin trials struggle to achieve pt centricity, but only partially right about reason (outdated tech to manage processes). Also key factors: tension between push for simplicity/minimalism (eg Recovery study) and value of collecting potentially exceptionally valuable and rare information/data from actual people (as I recently discussed on LI w/ Kim Branson in context of his recent podcast interview w/Vijay Pande, PhD). Another factor: skittishness (we'll call it) of companies in disclosing entry criteria and other trial info helpful for patients, as poignantly shared by Bess Stillman, M.D., as I've discussed here: https://lnkd.in/eWBFX4gK . cc Amy Abernethy who I'm sure had great additional perspective on these challenges...

39

2 Comments