Cell and Gene Therapy Industry - Source Material Survey

In a survey of >25 US blood centers' annual donor data 2010-2020 inclusive, donations were down in all age groups <55 (even after being normalized for COVID impacts) and donations in most age group were down 21-64%.

Access to large numbers of geographically dispersed and ethnically diverse donors of human blood-derived cells and cellular material of all types (healthy, sick, rare, etc) for use in R&D, testing, manufacturing reagents, and human therapeutics has been described, by some, as critical for the continued evolution of the cell and gene therapy industry.

We aim to gather and share intel on this potential emerging issue. Please participate in this survey to power sector intelligence.

Cell and Gene Therapy Industry Survey

Your participation is much appreciated!  

Lesson 2 for Mentees from a Seasoned Career-Changer (a series)

In this second lesson in my series of 'career-advice-I-wish-I-could-give-myself-30-years-ago', I treat two more popular career platitudes to my own irreverent perspective and take a shot at some of the most common excuses people use for not pursuing the career they wish they had.

Lesson 2 - more platitudes and a kick in the pants

I'm a big fan of having goals in mind. Having said that, while you can plan your next move, please don't even bother to pretend you can 'plan your career'. Okay some people make it look like you can (see my friend Larry from Lesson 1) but really all he did was set himself a goal, plan his 'next move' coming out of graduate school and - voila - that resulted in him having met his goal and determined his entire career (but that's also only true because 30 years later he wakes up every day and still wants it more than any other career). You don't have a magic periscope which allows you to see around the next corner let alone into the next decade so don't pretend you can plan for it or that your future self would even be happy with you if you could and did. What you should have a good sense of, however, is what you want now, what you want next, and what kinds of skills and experience would help get you there. 

    

    All good things come to those who wait (but not for those who wait around)

Please don't wish for your dream job to be handed to you out of school. You don't deserve it, you haven't earned it and 99 times out of 100 you'll suck at it. If you're still in school, the first thing you'll learn when you get into your first job is that you learned almost nothing worth knowing in school. Don't get me wrong. I'm a huge proponent of school. It's one of the most critical things you'll do but it certainly isn't the most important and definitely not the most educational. What it does give you, hopefully - aside from that door-opener degree you need - is a way to process information, a way of looking at things, a lens, and some basic tools. You'll walk into that first job and realize you have to learn almost everything immediately critical to surviving the job - none of which you were given in school. So... patience my young Obi-Wan Kenobi. You too shall learn from the masters and be handed the keys when you've earned them. Work hard. Listen harder. Plan a little. Execute a lot. And bide your time.

Patience is a funny thing. On the one hand, it is a virtue. Pushing things to happen your way on your timing almost never works out as well letting things evolve more organically. In part this is because people are way more accepting and supportive of things which they consider to be - at least in part - their idea rather than things foisted on them. On the other hand, sitting around waiting for the world to hand you what you want, when you want it, how you want it will NEVER work out. 

So somewhere in between - as usual - is the right balance (note: the world almost always favours balance). Patient but planned persistence. In other words, know what you want, plan for it, work toward it, put it out there and trust that it'll happen when it is right. I won't say "when its meant to be" as if the universe has destined your fate but I do mean that things tend to "just fall in place" when they are a natural fit for all involved rather than when you want them to happen. 

For the most part, jobs are given to those who earn them but not necessarily those that deserve them. You may deserve a job - you may have all the qualifications and more - but not be offered it because you didn't earn it. You may earn a job you don't really deserve. To earn a job involves people skills - its about more than you can put on paper, more than your credentials or accomplishments. It's the soft skills that can leapfrog you into places you don't belong. You've got to check some boxes but box-checking alone may leave you stranded in a job well below what you deserve but for your inability to 'earn' a better one. 

Almost every job I've been offered feels like it fell into my lap. It didn't. I positioned myself to be offered it, made it clear I wanted it - maybe even applied for it - but is was suddenly just 'there' either because I was actively recruited or because it just seemed like a perfectly natural fit to all around. Not because I'm a rock star or "all that" or was even particularly qualified (on paper) for the job but because by the time it came open, I was considered at least a good - if not an obvious - candidate for the position in the eyes of the decision-makers. Many times that's because I let myself in the side door and bided my time positioning myself for and earning my way into the job I really wanted -- but let me come back to that.

I remember the day in 2000 when I thought to myself for the first time that it would be cool one day to the CEO of a biotech company. At the time it was a ridiculously audacious thought. I had no business background, no science education and I literally couldn't even pronounce half the terminology on my screen on a daily basis. 

I didn't myopically focus on that goal. I didn't obsess about it. What I did do was two things. Firstly I tried to take jobs that seemed like they might be on the right path toward that goal and get me one step closer. Secondly, I tried to be painfully honest with myself about what I lacked to one day be offered that job and either fill that gap or compensate for my deficiencies in ways that were accessible to me. Let me give some examples.

Long before my vision for joining the biotech C-suite, I realized I was embarrassingly deficient in most things related to basic business and capital markets. I decided if I read anything every day it would be the business section of the daily newspaper. At first it was like trying to read hieroglyphics but eventually through stubborn osmosis I gradually started to absorb some basic concepts and also define questions I could ask friends, colleagues and mentors who I knew had the answers. 

Later, when I found myself surrounded by brilliant pioneers of stem cell research and cell therapy, I found myself ignorant of all things biotech so I began to (a) find ways to immerse myself in meetings and interactions where I could learn and occasionally ask a dumb question and (b) consume every piece of accessible literature on stem cell/cell therapy basics I could and particularly every corporate news release from any company in the sector. I didn't know how that was going to translate into a job opportunity but I knew I wasn't going to get any higher job in biotech without that basic knowledge. I also made it my job to meet and build relationships with people in cell therapy companies in a way that was well beyond my job expectations, in part because I believed doing so would pay off in some way yet to be determined. 

That passion for learning and consuming content resulted in the identification of an information gap in the sector which led to the launch of a publication, the information turned into an unparalleled dataset no one else had, and the network turned into a contacts list (rolodex my Dad used to call it). All that resulted in a job offer that relied on a broad (but needn't be deep) understanding of what all the companies were doing in the sector and knowing someone at each of those companies (or someone who knew that someone). That job was business development. It was the perfect job I didn't know I wanted until I had it and it just so happened to be the only job I would be offered with my limited education in science or business. Nonetheless I was actively recruited for the gig because while I didn't deserve it, I had earned it. Interestingly I had been offered a similar position two years earlier but it wasn't the right time and it felt 'forced' by both the potential employer and myself. Two years later it was a perfect fit. Patience rewarded both sides.

Even later in my career, I concluded I was going to hit the glass ceiling of education. Without an advanced science or business degree I determined (rightly or wrongly) that was I unlikely to be able to work my way up to the C-level suite without making my own way there. That was the genesis of my leaving a comfortable mid-level management position to become an entrepreneur and consultant. I would make it or break it on my own and return to the 'work force' when I was offered something closer to the C-suite than I was likely to earn trying to work my up to it as an employee. In retrospect I could likely have earned my way there if I'd been willing to relocate and worked in a big company. I was not. My other priorities dictated - at least heavily influenced - the path I chose.

Back to the side door. The other example of patience is knowing where you want to be even though it involves not being what you want to be for now. For example, when I was looking to jump out of practicing law, I chanced my way - through a friend-of-a-friend - into job interview at a tech company with one of the most interesting men I had ever met in the coolest office I'd ever walked into with one of the greatest views of the city I'd seen. I left thinking if he's crazy enough to give me a job, I'm crazy enough to take it even though I didn't have the faintest idea what they did or what I'd do there. He was crazy, I was crazy and the job I ended up in involved me doing a lot of things no one in their right mind should be doing with a law degree but I was in a milieu I loved and I would have paid to be there. It was the side door to the job I wanted but didn't know existed. I worked my way through, up and around the group of companies - some job offers I deserved, others I earned - until I earned my way out of there six years later into the kind of job many people would have expected to jump into immediately.  

That's the 'earn-my-way-up' side door. Another way is the consultant/contactor, part-time or internship side door. If you're trying to punch above your weight class and leapfrog your way into a job for which you barely have the required credentials or experience, you may need to present a potential employer with a low-risk way to determine if you deserve it - just earn your way in. The alternative to the low-level job side door is the 'try-before-you-buy' side door to career leapfrogging. Many a consultant, contractor, part-timer and intern has earned a full-time dream job (or least entrée position to the dream job) by earning their stripes on a test-drive basis.

    Be careful what you wish for you just might get it (so be prepared - go in eyes wide open)

I remember the day I was sitting in the high school honors algebra class I had no business trying to pass when I first thought being a teacher might be a good gig because my teacher was pretty cool. Six years later I was standing in front of my own high school class pretending to be infinitely more wise and experienced than  kids just a few years younger. They challenged me, tested me and dared me to rise to the occasion or whither in defeat.  At one point two of my students were rumoured to have been the subjects of sexually inappropriate behaviour by a teaching colleague and friend. As a young 25-year old teacher I was made aware of the rumour by other students who entrusted me with taking appropriate action - to treat the situation delicately but decisively. Handle this one wrong and it turns out to be false, it ruins the career (and life) of a wonderful teacher; handle it wrong and it turns out to be true, and I only aggravate the potentially devastating travesty done to these children. These are the moments you don't think about when you think to yourself... teaching might be cool. 

I've already told you about the day I first thought... maybe I'd like to be a biotech CEO one day. Four months after having been invited to become CEO of a biotech company for the first time, I had to lay off all my staff, sublet the entire office, sell all our furniture, and prepare the company for a complete restructuring. This was not stuff I imagined when I first thought to myself.... that looks like a cool job I would enjoy.

Both of those are a couple of my favourite jobs, hands down, but both brought elements I wouldn't have dared to imagine and certainly never dreamed about. In part, that's why you need hard-earned stripes before you get the job you wish for. You'll need them and they are never the things you learned about in school. 

    I can't. I don't have time. I'm not qualified. I'm over-qualified. I don't know how. And other lame excuses.

In case you can't tell, I'm not a fan of excuses. They are, after all, just that. Excuses. Most of the time they are not even good reasons. They are fictions we tell ourselves and then say out loud in the belief that they are real based on our experience that they very often are believed and work to relieve us of whatever obligation or opportunity we're trying to escape.

"I can't". Really? Have you seen the videos of the armless, legless motivational  speaker or a million other people doing unthinkable things well beyond what is expected to be their capabilities. Rethink what you "can't" do. It's a thinly veiled excuse for I don't want to bad enough and/or I'm too scared to try.

"I don't/didn't have time" is hands down the worst excuse ever invented. You didn't make time. You didn't make time because you had other priorities that you chose to dedicate your time to. If it was so important to you, you would find/make the time. I don't/didn't have time means it wasn't important enough to me to prioritize over the other things taking up my time. I'm not saying you should give up those other things, just be honest about them. If it turns out spending time with your children, or watching football, or gardening, or hanging with your friends is more important than burning the midnight oil getting your executive MBA, that's perfectly okay. Just know it. Say it. But to be perfectly clear, there are single Moms working full time jobs and earning their degree so if you decide not to then it's not because you don't have time it's because you chose to allocate your time differently.

Now to be fair, sometimes there just isn't enough time to get done all that is on your plate. Many times deciding what can be done in the time allotted is not entirely your choice. The point is, never use the "I didn't have time" excuse. Invite those assigning your work to help you prioritize. You are not expected to  create time but if it is not your job to assign your own priorities then you are expected to help your superiors or clients determine what you should prioritize in the time allotted. You are expected to not use lack of time as an excuse .. ever. The message here is that effective time management is about managing priorities and the honest excuse is "I didn't manage my priorities properly" rather than "I didn't have time".

"I'm not qualified" ranks right up there with "I can't". Again, literally millions of people are doing things they are not qualified for. I'm one of them.

"I'm over-qualified" simply means your ego won't let you do what you pretend you want to do but clearly don't want to do what it takes to get there.

"I don't know how" is even worse. In this age of content at your fingertips and people accessible with the click of a mouse, there is nothing you can't learn if it is important enough to you to find a way. Wealth isn't even a limiting factor here. Sure you may not be able to get a Harvard education but you can learn how to do almost anything on a shoestring budget if you want it bad enough.

I'm stuck in my job, my mortgage, my marriage, my gender, my life. Not true. To the extent it is true, please just be honest about your role in keeping yourself 'stuck' there. Everything can be changed if you want it bad enough. The only thing you can't change in life is that you have kids. You can pretend you don't have kids but whatever you do - or don't do - doesn't change the fact you have kids. Everything else can be changed. So if it is something other than the fact you have children, if you're unprepared to change it, chances are it's because you don't want it bad enough or at least you don't want it more than the other things preventing you from making that change. I'm not saying you should throw away your comfortable life to make radical change - not at all. I'm just saying you owe it to yourself to be honest about it. If you love the things standing in the way of making a change then admitting that to yourself is freeing. But if you really do want to make a change, you can make the change but it will inevitably involve a shift in priorities. It also involves admitting that the only thing preventing you from making that change you are pretending to want is yourself, your fear and your competing priorities.

Occasionally I'm disappointed because I don't have more money in a #firstworldproblem sort of way but when I'm perfectly honest with myself its because I've never made it a priority. I've chased my interests, my passions, my desire to learn, my hankering for change over money and financial security. I have to acknowledge that those were my choices /my priorities and be comfortable with the results.

Any excuse you can come up with just means that other things are/were more important to you than the thing you're trying to excuse yourself from doing or not doing and that's perfectly okay but please - for the love of humankind - just be honest first with yourself and then the other people around you. Just say you didn't make the time, you are afraid, you're unwilling to do what it takes or to start over, you love the things standing in your way even more than the thing you're pretending to need an excuse for not doing, etc.

So next time you hear yourself making an excuse for not fulfilling an obligation or chasing a dream, challenge yourself to just be honest and face what's really behind that lame excuse.

Lesson 1 for Mentees from a Seasoned Career-Changer (a series)

I've changed careers too many times and I've left a lot of money on the table but it has been a scintillating, inspiring, and educational adventure. 

In this first lesson I've taken three popular platitudes tossed around when giving career advice and given them my own treatment based on my experience and what I wish I could tell myself 30 years ago.

Lesson 1 - the platitudes

Platitudes, like stereotypes, biases, and gut reactions, exist for a reason - because experience and evolution has taught us there is some truth in them but they are not to be relied upon without rational input. Here are my thoughts on three of most common career-focused platitudes.

    Follow your passions 

I'm convinced almost everyone attempting to give career advice starts with "follow your passions". I won't break the pattern but what I will say is that I think most of the time the underlying assumption is that your career/job should (or would ideally) be aligned with your passion. That's great for those people for whom that is true but I don't think that is necessarily the ideal. You may be one of those people who enjoy their passion being different from what they get paid to do or one those for whom their passion is truly agnostic of a particular career, job, profession or discipline.

Some are blessed knowing their passions very early. A college friend, Larry, knew he wanted to be a professional trumpet player when he was 14 years old. He pursued that single-mindedly and successfully. I was never blessed with that kind of clarity early on. I only put my finger on it in my 40s. Sometimes your passion is conveniently packaged in a career like Larry's was. Sometimes its something quite outside your specific career but very much helps you define it. Sometimes your passion - like mine - is more amorphous and drives you to change careers to fully satisfy it.

My friend Brent's passion is about building financial independence. When he stumbled into a low-level job in a fast-growing company with almost endless upside career opportunity and stock options, he committed his entire career to the company that would be the vehicle to fulling his passion. His particular job - even the company - is simply a means to a very strategic and planned end. 

My friends Ron and Mike and Scott share a passion for saving money which drives them to avoid any behavior which risks their savings or ability to add to it. Consequently they stayed in the first secure professional job they got because it gave them the comfort of security with minimal risk and a secure vision for what their future looked like through to and into retirement. 

My friend Wayne is passionate about inventing which drove him to engineering school. When he was paid to invent stuff for a big multinational company he loved his job. When they eventually started to stifled his creativity, he did what most inventors do - started inventing his own stuff for his own company. He's not very good at the company stuff and is learning how to surround himself with people who let him invent and they manage the corporate side.

My friend John is passionate about music but refused to ever let himself defined professionally as a musician because he never thought it (or he) was legitimate enough or good enough or whatever his deal was. So he tried his hand at all kinds of things trying to make himself passionate about a career or job until he realized it was outside the workplace in the off-hours when his guitar was in his hands and he was surrounded by music, musicians, and creativity. He also realized he didn't want that to be his job or career - he loved it too much to want to depend on it financially.

My passion is learning. I just love learning and I love the feeling of being a little bit of a 'fish-out-of-water' - being thrown into the deep end of some pool of knowledge and paddling around finding my way to the edges and figuring out how to maneuver in this unknown discipline. I imagined at one point my perfect career path would be as a university professor - surrounded by halls of learning - but I've now come to realize I don't enjoy the narrowing of focus that comes with deep specialization. I want broad, surface-level exposure to a myriad of topics, disciplines, and industries.

Sometimes your passion is aligned with your work; sometimes your work is a means to affording your passion. Neither one is better or lucky or even necessarily more lucrative. What is important is the sooner you can identify your passions and decide how they fit (or not) with your career/job aspirations the sooner you can just get on with it - with being you, pursuing your passions, and living authentically. 

Of course there are limit to every such platitude. For example, don't 'follow your passion' if you've decided your passion is a vice or one of the seven deadly sins or illegal. Also, for every 'follow your passion' there are a million examples of where that can lead you astray. Sometimes it can make you sacrifice other things also important to you - like relationships. The insatiable need for balance pervades human existence. Sometimes - left unrestrained or properly channeled - it can lead to more chaos than you want. For example, my passion for learning new things can lead to me just - SQUIRREL (see what I did there) - lacking focus and seeing things through. Decide where your limits are and what other things are important to you that compete with your passion if imbalanced.

    Do what you love and you'll be good at what you do

Firstly, this doesn't mean you'll be good at everything you love (see Florence Foster Jenkins). My wife loves music more than I do but she can't sing and never wanted to learn an instrument. She would have made a great radio host with her  love of music and great speaking voice. Turns out she loved words even more than music and turned that passion into a career.

Conversely, you won't love everything you're good at. I was very good - at one time - at classical guitar but it never filled my soul. I love singing but I had no desire to do it professionally or to define myself as 'an artist'. 

Keep in mind that 'being good at it' does not - at all - mean you'll be financially successful at it. These two things are quite disconnected. The world of commercial success is filled with people who are quite mediocre and, even more so, wonderfully talented people are often impecunious. 

For those who are pragmatists, less romantic than I, they might say "love what you do, and you'll be good at it" which to me sounds way to much like resigning to one's fate and having to decide you just love what you do. However, there is some truth to that because even those people dedicate 12 hours per day to their 'love' will sometimes hate it. 

Finally, sometime your career is hidden in places your never imagined your passions - or talents - would lead you. Take me, for example. I didn't really like  science in grade school. I was fascinated by it much like one is fascinated by something completely foreign to them but I showed no propensity for it and my grades reflected that. Consequently I avoided all things science throughout the rest of my schooling. Now I wake up every day with PHD-envy and find myself happily surrounded by scientists talking science to them. What I discovered is a career in science that didn't require me to be a scientist but allowed be to be constantly fascinated and educated by everything they do. My passion to learn is well fed by immersing myself in a discipline in which I have no business being in based on my education. My passion didn't lead me to be a scientist but my passion led me science.

Okay so maybe I've just ripped this platitude to shreds. If you're not always good at what you love and you won't always love what you're good at, is there any truth to this one? There is. 

In every career, in every job, in every company - whether you think so or not - you have options to tweak what you do to match your passions (interests). You may not think so. You do. It may require you moonlighting to prove it but if you're passionate about it, that's no problem. I'll give you an example. I had a job as an association management executive. Many people told me that was my specialty and my job was to focus on the business of association management agnostic of the association's specialty (e.g., trucking, pharmacy, nursing, banking, etc). I disagreed. I found myself passionate about cell therapy and believed that to do the best job possible for the association I was managing I needed to learn as much as a non-scientist could about cell therapy and the challenges the members and industry were facing. That lead me to consuming massive amounts of information which I then decided since I was consuming anyway I might as well share, when lead to the creation of a newsletter, Cell Therapy News, which then lead to hiring a young graduate out of a science journalism program, which lead to the creation of a company that spun out more publications and lead me to blogging and Twitter and LinkedIn Groups, and eventually starting my own cell therapy consulting company and the rest of my career and that young woman I hired is now Vice President in a biotech company. No one asked me to learn as much as I could about cell therapy. No one asked me to launch Cell Therapy News - in fact I had to stay after-hours to build the content and add to the database. But eventually my newsletter caught the attention of the industry and advertisers and my boss and became part of my job and created new jobs.

So "Do what you love" doesn't always come up nicely packaged up for you in a career or job description. Sometimes you have to carve out of every opportunity you have what you love about it and make the most of that because you love it so much and eventually you create your dream job. 

    No risk, no reward 

I'll start this one by admitting there are plenty of people who are rewarded financially without taking much risk at all. The 'investors' who make it big with OPM (other people's money), the trust fund kids, the baby boomers who rode a real-estate wave and retired wealthy almost regardless of what they did, etc. Financial reward is not the kind of reward I'm addressing here. I'm not giving financial advice here; I'm giving heartfelt career advice. To have a rewarding career, one must take risk. That risk doesn't always have to look like the big gamble - like mortgaging your house to finance a startup. Sometimes its about trade-offs or sacrifices or taking the path few people agree is the right one.

Again, this comes back to following your passion and following your instincts. One of my favourite jobs was teaching. When I decided to take my Bachelor's of Education there were no teaching jobs - no one thought it was a smart career choice. I didn't know better, I just chose to ignore the common wisdom and follow my instincts - follow my interests, pursue my passion for learning (for which all things related to 'school' was a surrogate). I took that risk. A great teaching job was my reward. 

In 2006 (later in life), I left a great job with great pay with a great company with great growth potential in a great industry with a great mentor to start my own consulting company. No one thought that was a good idea. I took that risk. My reward was six years of the kind of education which only exposure to an enormous breadth and depth of companies, technologies, people, methodologies, and business models can provide. 

Sometimes the risk  you need is not making a change. For me, the risk of not exploring 'the alternative' is one of the hardest to accept. For the last few years, taking the risk of staying put and not chasing the next shiny opportunity has rewarded me with the lessons I needed to learn by seeing things through. 

There are others who consider the reward to be all about minimizing all avoidable risk.  "No risk is the reward" is their mantra but they are risking something - maybe it is living a more interesting life or seeking out the rewards of a life that takes risk

There is always a 'risk'. Whether you think so or not, every time you choose to do something you're inevitably deciding not to something else. Be conscience of that. Be okay with that. Be aware of the rewards of your decision - even ones you hadn't anticipated or were originally the basis of your decision - but also be aware to what you're not doing by putting yourself on a particular trajectory.

--

All that leads me to my own bonus 'platitude': trust your instincts as much as your logic. I wish my friend John had let himself be a professional musician because he would have rocked it but that wasn't his path and I believe he has been true to himself. I've been told so many times I should 'be' various things I was good at that were not my passion. Many of these things were very logical - clear job opportunities with lucrative and secure futures - but they did not align with my passion. I've also left things I was very much enjoying and passionate about to pursue things I was even more passionate about. 

You'll face those moments where you feel pressured to make the 'right' choice - by family or friends or advisors or even the logical side or your brain. Don't ignore that but - and this is particularly important for those of you who love math/science - logic/reason is much more contextual than most care to admit. Logic - in the philosophical sense - would not have you ignore your passions, your interests, your loves. The earlier you learn in life (and in your career) to follow what some might call your 'instincts', the happier you will be. 

So what has this lesson been about? Firstly, know yourself and prepare to be true to what drives you. Sometimes your job will be a means to affording your passion, sometimes your passion will decide your career, and sometimes you'll find - or even create - jobs which suit your passion. 

People often say "find your passion" as if it were some treasure which, when found, is the magic to happiness. I prefer - as the image says above - "live your passion" because it is a journey and you know what they say about journeys vs destinations.

Make choices to do what you love and love what you do and when you do you'll be good at it and that - quite simply - is the reward. 

6 Lessons for Mentees from a Seasoned Career-Changer (a series)

I've had wonderful mentors throughout my career. Recently I've had several invitations and opportunities to start paying back by being a mentor at work, through the ESP program sponsored by ISCT, and giving talks to young professionals. It has really made me think about my own career and what advice I would give myself 30 years ago.

As part of that exercise I've come back to this blog to write down some of the hard-earned, experienced-based lessons I take with me into the last decade (or so) of my career.

I've broken down my thoughts into "6 lessons" - a draft outline sketched out below - which I will write about over the coming weeks. It's a useful exercise for me as I consider what value I can share my mentees and since I'm doing it anyway, I might as well share it in hopes that it triggers others to use, engage with, and share what they find useful or things they might add.

Lesson 1 - the platitudes 

1. Follow your passions
2. Do what you love, and you'll be good at what you do
3. No risk, no reward

Lesson 2 - more platitudes and a kick in the pants

1. All good things come to those who wait (but not for those who wait around)
2. Be careful what you wish for you just might get it (so be prepared - go in eyes wide open)
3. I can't. I don't have time. I'm not qualified. I don't know how. And other lame excuses

Lesson 3 - its all up to you

1. It's your career. Manage it like a company
2. Perception is everything (or, at least, it is your reality)
3. Not deciding is the same as deciding (there's a time for thinking and a time for doing)
4. Pretending you know, helps no one. Be smart - look dumb - ask questions.

Lesson 4- its about the peeps

1. It's all about the people (invest in relationships)
2. Do unto others as you would have them do unto you
3. Never avoid conflict (but rarely engage in it - make the tough conversations the easiest ones)
4. Take time to be a mentor

Lesson 5 - be judged by how you helped

1. Make your mark by contributing (not boasting or boosting)
2. See a need - get on with (addressing) it
3. Small scale can scale so don't let the end scare you into not beginning
4. You can turn anything around, one person/thing at a time

Lesson 6 - thinking matters, doing matters more, thinking about what you're doing matters most

1. Goals are good, plans seldom work
2. Vision is good, execution is better
3. Never forget to spend some time looking at the big picture
4. Invest in your context

First allogeneic stem cell therapy approval in Japan

 In September 2021 Takeda Pharmaceutical's Alofisel (approved in the EU in 2018) was approved for the treatment of complex perianal fistulas in patients with non-active or mildly active luminal Crohn’s disease.

https://www.takeda.com/newsroom/newsreleases/2021/takeda-receives-approval-to-manufacture-and-market-alofisel-darvadstrocel-in-japan-for-treatment-of-complex-perianal-fistulas-in-patients-with-non-active-or-mildly-active-luminal-crohns-disease/

This was Japan's first allogeneic stem cell therapy approval.

Today, Japan’s reimbursement policy panel approved the listing of Alofisel, with an NHI price of 5.62 million yen (~USD $50,000). It will join the NHI price list on Nov 25. https://pj.jiho.jp/article/245593

Alofisel, granted RMAT designation in 2019, has not yet been approved in the U.S.

Foreign company pursuit of cell therapy commercialization in Japan: strategies and considerations

 I'm thrilled to announce that I will be presenting at the upcoming 5th Annual Cell & Gene Therapy World Asia, live streaming on 15th and 16th September 2021.

I will be presenting on "Foreign company pursuit of cell therapy commercialization in Japan: strategies and considerations" at 9:30AM (Singapore Time) on 16th September.

My presentation will cover the following topics:

·       Unique constraints and opportunity for regenerative medicine in Japan

·       Practical strategies for building a virtual team to support real progress

·       PMDA conditional approval -- not the only expedited commercialization pathway in Japan

In preparing for this presentation, I had opportunity to speak with Gladys Koh of IMAPAC to discuss

1.    key trends shaping the cell therapy industry moving forward in a post-pandemic world in Asia
2.    exciting technologies or developments that have caught my attention in the past year
3.    thoughts on how regulations pertaining to cell therapies can be evolved to allow the progress of the industry
4.    current struggles with respect to commercialization of cell therapies and how would they might be overcome
5.    key challenges this industry faces and is currently trying to overcome
6.    developments should the industry look out for from RepliCel Life Sciences Inc. in the coming year
8.    some of the key takeaways the audience can expect from my presentation

To view the interview, https://youtu.be/p2oZPbgFkMQ

Click here and here for a written advance peak at a few thoughts from some of the following speakers involved in the event such as:

Gregory Fiore, President & CEO, Exacis Biotherapeutics, USA

Zhimei Du, Global Head Process Cell Sciences, Cell/Gene Therapy, Merck & Co, USA

William Hung, Assistant General Manager, MariaVon, Taiwan

Hardy TS Kagimoto, Chairman & CEO, Healios, Japan

Pascal Touchon, President & CEO, Atara Biotherapeutics, USA 

Joy (Shuxia) Zhou, Head of Drug Product Development, Cell Therapy, Takeda, USA

Magali Taiel, Chief Medical Officer, GenSight Biologics, France

Andreas Weiler, Global Head of External Supply Cell & Gene Therapy, Novartis,  Switzerland

Seong-Wook Lee, President & CEO, Rznomics Inc., Korea

Yu Zhang, SVP & Chief Scientific Officer, VCANBIO Cell & Gene Engineering, China

Shi-Jiang (John) Lu, President and CEO, HebeCell Corporation

Devyn Smith, CEO, Arbor Biotechnologies, USA

Lee Buckler, President & CEO, RepliCel Life Sciences Inc.

Cell and gene data innovation and multi-stakeholder data transfer

Hello readers. It's been awhile. I'm pleased to be working with Reuters on some events including this upcoming webinar on how to utilize RWD in cell and gene therapies with speakers from Novartis, BMS and Salesforce. Click here for more info.

The requirements of complex and delicate value chains within cell and gene therapies (CGT) is something pharma has traditionally never seen before. Leaders in CGT are innovating data sharing approaches by utilizing RWE and RWD across the value chain, and achieving multi-stakeholder alignment, to ensure commercial success.

Join C&GT delivery trailblazers BMS, Novartis and Salesforce to learn how to turn data in to true insights: that enhance the science, reduce the cost of deliver, improve commercial decision-making and elevate the patient experience.

Sign up for the webinar “Cell and gene data innovation and multi-stakeholder data transfer” here.

When you join, you will learn how to:

•                 Reimagine the technology: digitally transform existing data integration models for cell and gene therapies

•                 Reach for the future together: develop a multi-stakeholder strategy collaboratively, that aligns on needs and capabilities

•                 Cross-capture and utilize data flow from R&D through to launch to win the marketplace with science and data

•                 Prepare for and address the major barriers to success: such as infrastructure non-readiness, digitally siloed stakeholders, underdeveloped partnerships, and data illiteracy

•                 Turn data in to true insights: that enhance the science, reduce the cost of deliver, improve commercial decision making and elevate the patient experience

Tune in live to the free webinar on July 29 at 11am ET/4pm BST, or sign up to receive the recording here.

Please also feel free to share with your colleagues working in C&G therapy, so they can benefit too. 

Lee