We recently joined the Life Science Caucus and AstraZeneca in hosting legislators and other policymakers at the company’s thriving Newark manufacturing facility. This event was one of several site visits we’ve conducted over the last year with the purpose of giving state leaders direct exposure to everything happening in Delaware Bio member labs, manufacturing floors and incubation spaces.

The discussion and tour was timely – the Newark site has grown considerably over the last several years, adding hundreds of new employees and serving an increasingly critical role in the company’s global supply chain. The site visit also followed the August graduation of the first class of our BioConnect DE biomanufacturing training program, and AZ Newark’s hiring of several of these talented graduates.

We had a robust dialogue around industry issues including of course workforce development and the most fundamental matter of ensuring the treatments our industry creates get to those who need them the most.

Earlier this year we released a comprehensive policy agenda designed to accelerate life science industry investment and growth in Delaware and, critically, expand access to the innovation our members devote their lives to delivering.

Our plan would enhance the availability of these life-saving treatments and diagnostics through proposals that: reduce costs for patients and boost pricing transparency, invest in health IT and telemedicine, promote biotech solutions for preventative care, and include industry in public health initiatives.

As we actively work with Governor Meyer’s staff, the Life Science Caucus and legislators to advance these proposals, on Friday AstraZeneca announced a historic agreement to lower the price of their medicines across the US. The announcement comes in tandem with a $50 billion investment in US manufacturing by the company, underscoring the unparalleled, immense value of the life sciences across our economy and healthcare system.

Without patient access, there can be no innovation. They are two sides of the same coin and AstraZeneca CEO Pascal Soriot acknowledged this in his comments on the agreement, while also calling out other western (read European) countries for their failure to get that balance right (which I covered in last month’s newsletter):

“This new approach also helps safeguard America’s pioneering role as a global powerhouse in innovation and developing the next generation of medicines. It is now essential other wealthy countries step up their contribution to fund innovation.”

Regards,
MF 

As life science industry watchers, you will have noted with interest the unprecedented series of announcements by leading global biopharma companies on planned investments in their US manufacturing and R&D.

The sums are staggering – the latest being GSK’s $30 billion pledge towards US-based research and manufacturing operations. From Fierce Pharma:

The U.S. has enjoyed a surge of pharma investment in the wake of the Trump administration's import tariff threats, with Roche pledging to spend $50 billion, Johnson & Johnson unveiling a $55 billion plan that includes bolstering its medtech business, and Sanofi and Novartis each committing to spend at least $20 billion in the U.S. by the end of the decade.

And Eli Lilly recently announced that Goochland County, Virginia, will be the site of its new $5 billion manufacturing plant—the first of four that the Indianapolis drugmaker has planned as part of its own $27 billion U.S. pledge.

AstraZeneca also recently announced $50 billion in new US manufacturing investment and, of course, most noteworthy for Delaware, we have Merck’s recent groundbreaking on a $1billion biomanufacturing site at the CRISP campus just outside Wilmington, part of at least $21 billion in new R&D and manufacturing investment in the US.

All told, the investments in innovation and high-tech operations push well into the hundreds of billions.

As we have regularly discussed, this transformational reshoring of manufacturing capacity in the life sciences really began to accelerate in the earliest days of the pandemic, when it became starkly apparent that global supply chains for vital products and our country’s national security were jeopardized by a system overly reliant on foreign production – particularly with geopolitical rivals like China.

This massive wave of investment will mean long-term opportunities for US communities and domestic industry innovation. That includes hundreds of thousands of construction and contracting jobs and thousands more great careers with industry leaders.

The revitalized industrial capacity will also spark new technologies, startups and spinoffs – a whole new subsector of entrepreneurial activity around advanced manufacturing, efforts NIIMBL right here in Delaware is already facilitating. And it is inspiring new workforce development efforts like our own BioConnect DE – forcing smarter and faster approaches in engaging, mobilizing, training and deploying STEM talent into these exciting new roles.

Yet manufacturing is only one key area of industry investment and China has steadily eroded the US – and Delaware’s – global leadership perch in scientific innovation. As mentioned in earlier letters, we must continue to improve and expedite the process by which breakthrough therapies and technologies come to market. That requires a strategic, comprehensive approach that nurtures the life science ecosystem from the earliest stages, incentivizes and rewards investment in cutting edge science and catalyzes more productive university-industry collaboration.

Attending our neighbor’s annual conference in Maryland earlier this month, I was pleased to hear FDA Commissioner Marty Makary vow to hasten the FDA’s review process by leveraging technology more effectively – that’s welcome and long overdue.

For its part, Delaware can and should continue to benefit from this manufacturing renaissance, but that will mean understanding and meeting industry needs – being a place where they are dying to invest and grow their operations. This is a multi-generational opportunity we cannot afford to miss.

Regards,
MF 

One of the highlights of my time at Delaware Bio took place just a few weeks ago at Wilmington’s East Side Charter School, a joyful celebration of the first graduating class of the BioConnect DE biomanufacturing training program.

That July 28 event represented almost two years of planning – a thoughtful, diligent and intentional process – that included extensive listening and analysis of our industry’s workforce gaps and opportunities, assessment of best practices across the country, and ultimately the development and deployment of a training curriculum addressing specific employer needs. The result: 24 newly minted graduates – and an outstanding 96 percent program completion rate.

Our team’s efforts – led by Katie Lakofsky – made the day possible, along with multiple partner organizations including community groups and elected officials (a federal grant is funding about 70 percent of the three-year pilot program costs).

The ceremony drew to mind the specialness and rare impact of this kind of multi-sector collaboration, really unknown anyplace around the world but our country.

Alexis De Tocqueville is one of the most incisive students of the America experiment – in the early 19th century this French aristocrat, and author of Democracy in America observed the powerful role of “associations” in the life and success of our country, unique to the United States of America.

And by associations, he meant what we today call – and often take for granted - public-private partnerships. He wrote that “Americans group together to hold fetes, found seminaries, build inns, construct churches, distribute books … they establish hospitals and schools by the same method. If they wish to highlight a truth or develop an opinion by the encouragement of a great example, they form an association.”

We should recognize and appreciate just how unique and powerful this coming together of public and private interests and so many business and community stakeholders can be when done strategically and with a clear alignment around goals and ROI.

In this case, graduation is just one step in the process of delivering that ROI. Our focus for this first class is to match their graduation rate, by the successful placement of these students into great careers with Delaware Bio employers.

We thank and congratulate these students for their courage in being first, for their dedication and moxie and bringing all their intellect and energy to the classroom – all characteristics, shared by the men and women who come to work every day for our Delaware life science companies.

These graduates now take on a special charge and obligation - the American people have invested their precious resources in their success – that means their neighbors hard-earned tax dollars. The life science industry is committed to their career development. And Patients in need are counting on them.

This program must succeed because it is not a nice-to-have. As we rebuild our nation’s industrial foundations and manufacturing capabilities, growth of our STEM talent pipeline is truly a national security imperative, and certainly an economic necessity for Delaware.

The future of our country and state are relying on their success.

Regards,
MF

Amid all the noise surrounding the recently passed One, Big, Beautiful Bill Act (OBBBA), little note was made of two critical – and remarkably, BIPARTISAN – provisions in the legislation that will have a major positive impact on both patients and the life science innovation on which they rely.

One is inclusion of the ORPHAN Cures Act language fixing a serious flaw in the Inflation Reduction Act (IRA) that effectively discouraged and disincentivized research into additional applications for medicines treating rare diseases. Now researchers can explore new uses for effective orphan drugs without the specter of government price controls on any new indications.

This fix has broad support across rare disease patient groups and families as well as both Republicans and Democrats in Congress.

A second important provision in OBBBA is a long-need change to the tax code reinstating the R&D tax credit for growing science and technology companies. Small biotech companies here in Delaware can once again deduct R&D expenses and thereby have more resources to invest into their innovative product research, development and manufacturing.

It is unfortunate, but not surprising, these bi/non-partisan legislative wins for the American people haven’t gotten more attention. Put to a standalone vote, they would have passed with overwhelming majorities. Over the last several years we have actively advocated for their adoption, so it is great to see this win for patients and our members, regardless of the attention it may garner.

One more federal item: the SBIR (Small Business Innovation Research) and STTR (Small Business Technology Transfer) programs are two other essential and historically, extremely productive initiatives enjoying strong across-the-aisle support. These programs are set to expire on September 30, 2025, if not reauthorized by Congress. So as with ORPHAN Cures and the R&D tax credit, we will be communicating with our delegation and others in Washington just how important these programs are for our national security and competitiveness, as they provide key early support for small companies developing cutting-edge technologies.

I hope you are staying dry – rainy month!

Regards,
MF

I write this week from Boston, site of the annual BIO International Convention.

The annual event draws 20,000 biotech industry executives, researchers, investors, government officials and myriad other stakeholders from around the globe for several days of intense meetings, business development activities and sessions on topics ranging from scientific innovation to national security.

I’m joined by a few handfuls of Delaware Bio members and partners including representatives from companies of all sizes, folks from DPP, NIIMBL, UD, Innovation Space and more (and randomly ran into one De friend this morning I didn’t realize would be here!).

Each year the event begins with a meeting of the Council of State BioScience Associations – a group of my peers from across the country. These Sunday gatherings are an important venue for sharing best practices at the state level and forging mutually beneficial partnerships.

I’m looking forward to hearing from FDA Commissioner Marty Makary and Pennsylvania Gov. Josh Shapiro, both of whom will be interviewed on stage by BIO CEO John Crowley, who masterfully conducted a similar conversation at our May conference with AstraZeneca’s Joris Silon. I’m also interested in participating in and learning from other panel discussions on state and federal policy, biomanufacturing and workforce development, and AI and digital health investment trends.

The US is the indisputable global leader in life science innovation, as witnessed by this annual gathering of attendees flooding in from every continent and region, underlining the conference theme, “The World Can’t Wait.”

This is a precarious time for the industry with significant uncertainties in federal and international policies and questions over both private and public investment. Opportunities like this are critical to showcasing the immense value and impact of our sector and in aligning partners around strategies that secure our future success.

Enjoy the summer!

Regards,
MF  

PS: It was just announced that the BIO 2027 convention will be held in Philadelphia – so stay tuned for more on that big news for our backyard!

“Delaware is rising as a global hub for life science innovation; a sector deeply rooted in our economy and essential to our health and well-being”
- Gov. Matt Meyer

We were pleased to have Gov. Matt Meyer join our outstanding conference earlier this month, as he celebrated the Delaware bioscience sector’s momentum and opportunity.

The governor hailed the groundbreaking of the new $1 billion Merck Wilmington Biotech manufacturing facility as “a remarkable new chapter in Delaware’s economic story,” explaining it was “symbolic of what we are building statewide … a vibrant ecosystem where manufacturing, technology and science come together.”

The governor also underlined the state’s commitment to supporting life science entrepreneurs and growth companies.

“There are going to be emerging life science technologies invented somewhere …. that will transform lives, and potentially cities, counties and states. It is our job to make sure that those innovations happen here in Delaware. Our job is to make sure that this is the place to commercialize and scale new innovations that are already here.”

Gov. Meyer’s comments came at the end of a day that showcased the best of our Delaware Bio community, from world leading companies to exciting new startups to efforts focused on sparking more abundant – and productive – university-industry collaborations and delivering a STEM talent pipeline.

Earlier on the conference stage former Gov. John Carney – now Wilmington’s mayor – described the “30-year overnight success story” that is today’s life science ecosystem – a vital economic driver born from the ashes of industries that had been a mainstay of our state for generations.

For those of you who were unable to join us at the Chase Center on May 8, we do hope you can make next year’s big event. Feedback from participants has been overwhelmingly positive but also constructive, and we will keep working to expand and improve our content and offerings to ensure our annual conference is something you simply cannot afford to miss.

Thanks so much to all our speakers, sponsors, partners and attendees who made Delaware’s DNA: 2025 Life Science Conference a success.

Regards,
MF    

Amid the torrent of issues and news buffeting the life science sector, last week a major government report – quietly in development since 2022 – was issued, sounding an alarm that our country’s dominant position as the global leader in biotechnology is in jeopardy.

The National Security Commission on Emerging Biotechnology finding called for urgent action to catalyze “the full weight of American innovation” in the face of a rising biotech capability in China.

The Commission reports that the United States’ growing dependence on China for numerous critical supply chain elements is a national security vulnerability. Biotechnology can be the key to increasing supply chain security, resilience, and scalability, by allowing the U.S. to control its own access to critical components.

More:

This report comes to a sobering, even frightening, conclusion: China is quickly ascending to biotechnology dominance, having made biotechnology a strategic priority for 20 years. To remain competitive, the United States must take swift action in the next three years. Otherwise, we risk falling behind, a setback from which we may never recover.

The report comes at a time when our country and industry’s supply chain is rightly getting a lot of attention. Just this week, the Trump administration opened what is known as a Section 232 investigation into the pharmaceutical supply chain. This effort, conducted by the Department of Commerce, assesses the threat to national security of critical products and technologies. A separate analysis into semiconductors has also been launched.

One outcome of the investigation could be the imposition of trade restrictions, such as tariffs, which of course are already on the table.

Readers of this newsletter and followers of Delaware Bio will know that for the last five years we have been relentlessly sounding the alarm on the risks to American life science leadership. Some of those come from abroad – eg, China – and some of them come from within.

On that score, coincident to the timing of the Section 232 investigation, the Trump administration also this week issued executive orders regarding patient access to the innovative medicines our members devote their lives to developing. The orders are a bit of a mixed bag. As BIO CEO John Crowley put it, “the President ordered numerous actions that would affect drug prices in the United States. The Executive Order includes a long list of different directives – some which address key barriers to innovation; others which are challenging to the industry.”

Among the positives in the order is the request that Congress fix the “pill penalty,” an arbitrary, ill-conceived provision in the Inflation Reduction Act that unfairly penalizes companies developing innovative small molecule medicines. Despite being warned this policy would have a devastating effect on the biotech sector – which is enduring one of the most historically challenging times to raise investment funding, with significant ongoing cutbacks and layoffs as you will have seen from news items in this letter – Congress moved forward with the law with a party-line vote.

Now, a new study shows just how swiftly that financial penalty has extracted an impact: “Small-molecule drug investment has fallen 68%—and 74% for diseases mainly affecting Medicare patients—since the IRA was introduced.”

Fixing that onerous provision will be a good start in creating an environment where biotech innovation is incentivized to flourish.

Despite these troubling headwinds, I am confident that the courage and resilience of industry researchers – and the unique combination of our culture of innovation and experimentation, capital markets and protection of intellectual property – will keep America and Delaware pushing the frontiers of life science discovery, product development and manufacturing.

Delaware is certainly well positioned to do lead this effort – our nation’s health and security rely on it.

Regards,
MF    

With a new governor, legislative session and administration in Washington – and fierce regional and global competition for what we've got – we felt this was an ideal time to introduce a comprehensive series of policy recommendations to fortify and accelerate the growth of our state’s thriving life science sector and improve public health.

Of course, no matter the timing it is essential the state continue to advance a visionary, long-term strategy focused on supporting the dedicated Delaware scientists who devote their lives to bringing biomedical innovation to patients in need.

Developed in partnership with member businesses and academic research institutions, economic development organizations, government and elected officials and extensive assessment of best-practices from across the country, the Delaware Bio policy roadmap focuses on four key areas:

• Capital: Sparking and attracting life science innovation and investment
• Talent: Transforming our STEM workforce
• Infrastructure: Enhancing and integrating state economic & workforce development efforts
• Access: Expanding patient access to innovation and reducing costs

These initiatives fully align with priorities articulated by Governor Matt Meyer and the General Assembly including investing in STEM education and community quality of life, expanding economic opportunities for all and ensuring access to affordable, state-of-the-art healthcare.

We look forward to working with Governor Meyer and legislators to advance these thoughtful initiatives to leverage and build upon the significant commitment and ongoing investment of our member organizations to ensure a healthy, promising future for everyone in our state.

To read the Delaware Bio plan click here: https://www.delawarebio.org/page/2025-state-policy-plan

Regards,
MF   

Competitively awarded federal research funding has been an important asset in our nation’s ability to outpace global rivals and to continue to be the world’s hub of science and technology innovation.

Over the last two decades we have seen the US emerge as the undisputed leader in biotechnology and the life sciences – the product of American ingenuity, a rare entrepreneurial spirit and work ethic, our capital markets and system of protecting intellectual property (IP) and policies that incentivize investment and enable productive university/academic – industry research collaboration.

At a time of fierce global competition as well as rising deficits and debt, it is entirely appropriate that we have a national conversation about the benefits of strategic government investment in early-stage, cutting-edge research in the most critical areas for national security and health, as well as funding that builds and leverages our outstanding university and academic biomedical research capabilities. The purpose, benefits, value and impact of this activity – eg, taxpayer ROI – should be clearly understood and communicated.

Targeted public funding supporting the translation of foundational research can ultimately result in immensely positive social outcomes, including the private sector development of breakthrough technologies and therapies that save and extend lives and a thriving industrial and advanced manufacturing base employing people in every state of our country.

These merits should be clearly understood and appreciated – and as with all federal and state spending, consistently reviewed and refined to maximize outcomes that keep our country safe, healthy and always on the forefront of scientific achievement.

Regards,
MF  

Ok, that’s what you call mid-winter newsletter click bait. Sorry!

Not that our open rates are shabby - we’re clocking in a high-thirties/low-forties average, thank you very much – a solid A in this business.

Speaking of business, we kicked off 2025 with a fantastic BioBreakfast last week, an event light on formal programming and heavy on networking and our outstanding exhibitors. That clearly worked well, with a robust, buzzy crowd lingering into the morning thanks to great conversations and a dynamic mélange of researchers, business people, investors and entrepreneurs – our usual morning brew!

Members should be on alert that our next BioBreakfast will be hosted by Air Liquide at their impressive Innovation Campus in Glasgow – and due to limited capacity, this will be an event open to members so sign up ASAP.

For bio-world players who didn’t make our breakfast, there was also the JP Morgan Conference last week. This annual biotech bacchanalia tends to set the tone for the industry’s year to come – I encourage you to check out this write up in Forbes, where Juergen Eckhardt frames his top five takeaways from the conference: major dealmaking is in store, health policy issues will loom large, Chinese innovation is on the rise, the impact of AI cannot be overstated and real cell and gene therapy advances are right around the corner.

And on that last note, what could be a better hope for the new year?

Go Birds!

Regards,
MF  

For the last several years we have enjoyed participating in the Delaware State Chamber of Commerce’s ‘Principal for a Day’ program. This year 47 high schools were paired with more than 70 business leaders from 53 different businesses and organizations.

#PFAD is a valuable, memorable experience – I recommend it highly … providing a rare opportunity for candid discussions with school principals and their leadership teams, teachers and students. You witness and hear firsthand the constantly changing challenges and opportunities schools contend with in the extremely dynamic (and imperfect) market that is our education system. And whatever one’s line of work may be, there is no better way to learn than to walk the halls – our eyes don’t lie.

I was fortunate to spend my morning with Sam Postlethwait at Appoquinimink High School in one of our state’s fasting growing communities. My colleague Katie Lakofsky, who leads workforce development efforts for our industry, visited Conrad School of the Sciences. We both came away inspired and impressed by the leadership of those schools and the quality of the students. (My first time at Appo – what a beautiful campus!) Our time in school also reinforced the need for ever greater engagement and connectivity between employers of all kinds and our schools, school districts and government officials responsible for curriculum and funding. It is essential that our schools are educating students on the material that will best prepare them for successful futures whether that involves college or not. More and more jobs are becoming available that don’t require 4-year degrees and our schools must help ensure all students are aware of these career options and have access to training and classwork necessary to fill them.

As I shared with students at Appo, there are also fundamental behaviors and competencies that schools can both teach and in some cases more effectively reinforce: communications skills, decorum, professionalism, promptness …. manners!

Our thanks to the Chamber and the leadership of Appoquinimink and Conrad for their wonderful hospitality.

Regards,
MF

“I can’t wait to start my new life” - Kendric Cromer, 12-year-old Sickle cell disease patient.

The front-page story in yesterday’s New York Times powerfully detailed the ingenuity, complexity, immense potential and extraordinary courage involved in the development of cutting-edge cell and gene therapies.*

“Vanguard of Sickle Cell-Free Patients Finds a Long, Hard Road,” brings us the heart-wrenching but ultimately uplifting journey of Kendric, a Washington, DC boy whose life “has been punctuated by episodes of excruciating pain, requiring days in the hospital as doctors tried to control it.”

Sickle cell disease, which affects an estimated 100,000 mostly black people in the US, has “eroded his hip bones. It prevented him from riding a bike or playing soccer or even going outside when the temperature was below 55 degrees because cold often brought on intense pain.”

It is a difficult thing to read of a child and their family suffering through the brutal challenges of a hard-to-treat disease. All of us can imagine and see how the fight overwhelms their lives and hope is hard to find.

But for Kendric, there is indeed more than hope – there is real promise, rooted in the newly approved gene therapy he is one of the first patients to receive.

Kendric’s disease is caused by an inherited mutation that leads to blood cells that form crescent shapes – sickles – instead of discs. Trapped in blood vessels and organs, the cells cause damage and pain. Gene therapy fixes that problem by giving the patient’s blood-forming cells a new, normal hemoglobin gene.

The therapy Kendric is receiving is one of two approved by the FDA in December to treat sickle cell disease, both developed over decades of experimentation and clinical trials that cost hundreds of millions of dollars in investment -- as with any new treatment for a rare disease, an extremely complex enterprise that faced impossible odds of success.

As the Times article explains, from both a bureaucratic and medical standpoint, the process for being treated is with a gene therapy is almost equally complex, involving approving medical centers to deliver the treatment, the negotiation of unusual contracts and an arduous patient experience that includes extraction and treatment of stem cells, “intense chemotherapy to clear his bone marrow” and ultimately reinfusion of the treated cells, all requiring a one-month hospital stay.

It is complicated and costly, but we are living through the vanguard of a revolution in the treatment of brutal, deadly rare diseases – and, therefore, the way we address all chronic conditions. As science advances and systems improve and production scales, efficiencies will reduce costs and importantly, access will accelerate.

This is all possible thanks to the researchers, the investors and the patients who have sacrificed and risked so much to bring children like Kendric and their families an outcome we never thought could be possible: a cure.

His parents are contemplating what life without sickle cell will be like. “This is all we know,” Ms. Cromer said. “We will have to build a new way of life.” As for Kendric … he wants to learn to ride a bike and to play basketball.

“I really just want to be a kid.”

Regards,
MF

*In this digital age, "front page" is an obvious generational tell that I am in the dwindling ranks of "newspaper" readers

May 2024 

McKinsey consultant Olivier Leclerc is on a plane at least once a week from his home base in Los Angeles, and fortunately his peripatetic ways brought him to Newark last week for our first-of-a-kind conference at UD’s Clayton Hall.

Leclerc racks up the miles advising global life science clients on strategic and operational issues and he has seen multiple business cycles and ups and downs but he remains extremely bullish on the innovation engine at the heart of the biotech industry.

In fact, in his superb keynote talk at Thursday’s Delaware’s DNA: 2024 Life Science Conference, Leclerc affirmed the central role biotechnology continues to play in driving innovation and “outsized value” in health care and beyond.

In a subsequent panel discussion, Leclerc was joined by other top industry leaders and investors who all agreed that advances in AI, machine learning and modalities such as cell and gene therapy poise the biopharmaceutical industry to deliver transformational changes in the way we think about and treat disease and health care more broadly.

Yet as another conference session explored, there is no guarantee we will enjoy the full fruit of these opportunities if the wrong federal and state policies are put into place that stunt innovation and disincentivize investment in a field already heavy on risk.

Yesterday I spoke to the Delaware House Committee on Banking, Insurance and Commerce, sharing our views on one such measure that would expand a troubled federal program to the detriment of our state’s innovation-focused, R&D-based biotech sector. We will keep you posted as that bill moves forward.

The conference venue helped make it this our biggest and best event ever with more than 350+ registered – representing the full breadth and depth of our thriving life science community. The program offered a rich mix of panel discussions and spotlight research presentations, and through our partnership with the Innovation Space attendees were able to hear from investors and new fast-growing companies in a separate track throughout the day. Of course there was lots of time for networking and we hosted an exhibition hall featuring great local businesses and organizations.

Throughout the day the discussion focused on our key priorities of: Workforce development – delivering a STEM talent pipeline to drive industry success, sparking greater industry-university collaboration, nurturing a robust life science ecosystem, and creating more regional partnerships across the tri-or quad state area.

We greatly appreciate Gov. John Carney joining us and his excellent welcoming remarks, which rightly pointed to significant, exciting growth in our sector over the last eight years of his administration. Thank you Governor!

For those unable to attend we’ll be sharing some of what happened at our June BioBriefing – see you then!

Regards,
MF

Last week a delegation of Delaware economic development, university and life science leaders traveled to Ireland for a deep dive into that country’s remarkable transformation as a global powerhouse in biopharmaceutical manufacturing.

The group, led by Gov. John Carney and including National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) director Kelvin Lee and Kurt Foreman of the Delaware Prosperity Partnership (DPP), enjoyed in-depth discussions with top officials from Ireland’s National Institute for Bioprocessing Research and Training (NIBRT), the Irish Development Agency, Enterprise Ireland, the National Science Foundation, key innovation leaders at Trinity, Cork and Limerick Universities and major employers like AstraZeneca and Eli Lilly.

It was an enlightening, productive and inspiring visit. In less than two decades, Ireland has established itself as a force in advanced manufacturing, with billions invested by global biopharma and technology firms in cutting edge facilities. One-third of the country’s exports are innovative biopharmaceuticals manufactured in the country, reflecting a concerted, coordinated effort across government, industry and universities to develop one of the world’s most skilled and sought-after talent pools.

The Irish system isn’t perfect nor is it an exact analogue to Delaware – but our state shares characteristics with that small country that are compelling. This includes our native strength in the life sciences, a creative program to mobilize and train workers and serving as the home of NIIMBL, world-class research institutions and major companies like AstraZeneca and Incyte. But the key ingredient in our ultimate success is the spirit of collaboration demonstrated by the delegation and the commitment to accelerate our growth through concrete steps including mutually beneficial partnerships with our Irish colleagues. Stay tuned for more on that.

See you on May 9 at our big conference!

Regards,
MF

Yesterday, I attended a beautiful musical performance by the piano-playing sisters Christina and Michelle Naughton at UD’s Gore Recital Hall.

The captivating twins are literally world-renowned, having headlined at the globe’s great music halls from Boston to Berlin and Seattle to Sao Paulo. There’s not a sheet of music in sight, just the two of them side-by-side, prowling and battering away at the keys to serve up an intoxicating, at times rambunctious musical alchemy.

Their collaboration results in a gorgeous symphony, presenting a final product that doesn’t hint at the endless hours of work, organization, and experimentation that audiences can savor.

This “musical supply chain” came to mind following a discussion we helped arrange for Representative Lisa Blunt Rochester last Thursday.

A diverse, expert selection of Delaware Bio members sat down with the congresswoman and special guest, Assistant Secretary of Commerce Grant Harris, for a rich and productive dialogue about the need for a “proactive and strategic” approach to strengthening our nation’s supply chain. Hosted by Advanced Materials Technology (AMT) at their newly renovated lab and office space in Talleyville, organizations of all sizes shared ongoing challenges in obtaining critical supplies, including building materials and essential ingredients and components for the production of medicines and instruments as well as the need for skilled workers in roles key to business continuity.

The congresswoman discussed the goals and progress of her bipartisan Promoting Resilient Supply Chains Act. Secretary Harris shared the department’s efforts to ensure US leadership in key industries, including the life sciences. The robust discussion underlined the exciting opportunities to build on Delaware’s strengths in advanced manufacturing and identified areas where smart public-private partnerships can gird our national security, economic future and serve patients.

The noble work of developing and manufacturing innovative, efficacious medicines and diagnostics involves incredible complexity that most patients will never see, nor should they care to. It is essential that we do everything we can as a nation and state to reduce the headaches and unnecessary costs that inhibit the inspired efforts of those who devote their life to improving and even saving the lives of their fellow citizens.

We look forward to working with our partners in government at every level to make that happen.

Regards,

MF

  February 2024

The headline “Saudi Arabia launches plan to become biotech hub by 2040,” recently caught my eye – a report that might once have been derided, the oil rich desert kingdom’s life science ambitions are no joke.

According to the article, “the National Biotechnology Strategy will advance Saudi Arabia’s capabilities across four main areas: vaccines, bio-manufacturing and localization, genomics and plant optimization.”

Building a thriving biotechnology industry from the ground up (or top down) ain’t the same as launching a new golf tour, but Crown Prince Mohammed bin Salman’s advisors must believe they can deploy the same LIV playbook: use piles of cash to lure All Star researchers to Riyadh and create “an international biotech hub in 16 years.”

“By improving its biotech capabilities,” the article blandly, but accurately explains, “the country hopes to boost domestic production, spur job creation and drive economic growth and diversification.”

Money alone cannot an industry make, but it certainly doesn’t hurt, particularly at a time when the smaller companies that drive much of our biomedical innovation and new medicine pipelines are desperate for investor cash.

Last year was a historically difficult one for biotech fundraising, with biotech bankruptcies hitting a 10-year high. “More biotech companies filed for bankruptcy in 2023 than any year since 2010,” Fierce Biotech reported last week, “underscoring a brutal year defined by layoffs, company closures and pipeline reprioritizations, according to data from S&P Global Market Intelligence.”

The biopharmaceutical industry requires Job-like patience from investors – it can take a dozen years or more before backers see a return. So with a risk averse capital market and a health care system demanding ever-higher bars of innovation – read: extremely costly years of clinical trials demonstrating step-change improvements in efficacy – biotech companies face immense, growing challenges.

Yet that dynamic has not deterred American and Delaware life science researchers from passionately advancing their mission of bringing new therapies and technologies to millions of patients and creating enormous economic value, something that clearly has caught the eye of shrewd central planners overseas.

We are the undisputed global life science leader thanks to the ingenuity and productivity of these entrepreneurial scientists who either started a business or came here because of our rare assets: a fair, predictable intellectual property (IP) framework; effective collaboration between academic and industry researchers; and a marketplace that incentivizes and rewards long-term investment.

Yet these very pillars of our success are under threat from misguided policies.

One dangerous example is the proposal for the federal government to use "march-in rights" to control the price of drugs under the Bayh-Dole Act.

Few pieces of legislation have had the transformational impact on our economy or public health as Bayh-Dole, passed in 1980. The measure is responsible for the flourishing of university technology transfer, which has sparked thousands of innovative discoveries and the boom of research parks and innovation districts across the country. Indeed, since Bayh-Dole was enacted, over 200 new medications and vaccines have been developed through public-private partnerships.

The deeply-flawed “march-in-rights” concept – where government would effectively seize the patents of products developed by small businesses or universities who received any federal support (such as very early-stage research grants) – is roundly opposed by the research community as threatening the very future of places like the University of Delaware’s humming STAR Campus.

The Association of University Research Parks (AURP) says, “this rules change is much broader (than drug prices) and will impact the university startup community, angel and VC investors plus the developers of research parks and tech hubs seeking these tenants.”

The founder of a promising Delaware “tech-bio” startup has written the proposal “would have a chilling effect on academic research and its translation to medicine, and the US pharmaceutical and biotech industries across the board - drug developers, drug manufacturers, life science tools companies, and many others.”

Another concerning policy – one that is now law – is the “pill penalty” included in the Inflation Reduction Act. This measure mistakenly penalizes small molecule drugs (usually in pill form) by unfairly, arbitrarily limiting their protection from government price controls to nine years, versus the 13 years provided biologics or “large molecule” medicines (often delivered intravenously).

The pill penalty was born of fundamental misunderstanding of the development of medicines of all categories as well as the financial imperatives of investors and companies who may not see sufficient revenue to justify R&D expenses until a drug has been on the market a decade or more.

Fortunately, there is rare bipartisan consensus in Congress to oppose one of these (march-in-rights) and fix another (pill penalty). We support these efforts and will continue to work with our congressional delegation to ensure that Delaware’s thriving life science ecosystem – a mosaic of companies of every shape and size and university and academic researchers and all the businesses that support them – continues to grow right here, not in some wealthy foreign land.

Regards,

MF

  January 2024

The annual JP Morgan Healthcare conference has become the official new year kickoff for the life science industry and a UD Blue Hen had a big role in making it happen.

The event in San Francisco brings together the biggest hitters from across the biotech scene including investors, dealmakers, global companies and thousands of startups, entrepreneurs, businesspeople and media. The conference’s roots go back to 1983, when University of Delaware grad and legendary biotech investor Dennis Purcell started the event with colleagues at the investment bank of Hambrecht & Quist in 1983. Ultimately, through mergers H&Q was subsumed into JP Morgan and the conference has held that moniker since 2001.

Purcell went on to found the venture firm Aisling Capital and was responsible for some of the most successful public offerings in biotech history. He spoke at our version of the JP Morgan conference last year, our inaugural Delaware’s DNA: Life Science Conference, sharing the stage with other investors and analysts to discuss the opportunities and imperatives for Delaware in creating the kind of thriving science and technology ecosystem that so famously exist in places like Boston and the Bay Area.

These experts all agreed that nurturing a robust hub of scientific excellence and innovation with sublime industry-research collaboration was essential to attracting funding and spawning more exciting new companies. They also voiced a uniformly positive impression of what they saw was happening here in Delaware and a view that we were moving rapidly in the right direction.

In assessing some of the key takeaways produced in reports following the JP Morgan conference, it is clear that Delaware is putting shots on the right goals when it comes to the most cutting edge technologies that will transform healthcare. This includes companies and research institutions advancing work and products using CAR T, gene editing and CRISPR, mRNA technology, and more.

Just yesterday, I was just on a call with 90+ tri-state leaders planning what could be a new precision medicine hub in the greater Philadelphia region with Delaware at its core.

The year has just begun, and we are moving at a lightning pace meant for the moment. Buckle up!

Regards,

MF 

 December 2023

Blessings-counting is always a worthwhile and healthy exercise at the end of the year and for Delaware Bio, we are fortunate to have many as 2023 comes to a close.

They begin with our members – membership is at an all-time high of more than 170 organizations: businesses representing every segment of the life science sector from global leaders to one-person startups, world class research and academic institutions and nonprofit and economic development partners.

This was a year of growth for our organization and so many of our members and we are grateful for their partnership and support and the enduring impact they are making on our state’s economy and public health.

While this year told a story of success for many, the last 12-18 months have brought ever-mounting challenges to many of our members including, unfortunately, some that we’ve lost.

Yesterday I received a message from a small startup CEO, someone working 20 hours a day to build a company around cutting edge technology that would truly be transformational in the development of life-changing therapies for terrible diseases.

This founder cited a powerful BioCentury editorial outlining the extremely difficult environment small life science companies are facing, and the federal policy proposals that threaten to crush the innovative, entrepreneurial heart of America’s biotech juggernaut.

A short excerpt from the article:

Exponential medical progress and U.S. preeminence in the life sciences seem inevitable.

They aren’t.

Policies that have been enacted in recent years, and others that are being debated in Washington, threaten to dramatically slow the pace of medical product development, and could over the long run erode one of the few economic fields in which the U.S. clearly leads the world.

That doesn’t mean the industry will shrivel and die, and it isn’t the end of medical breakthroughs. But unless steps are taken quickly and decisively, the world’s ability to turn science into medicine will be diminished and the U.S. will lose its position at the forefront of an industry that is of vital strategic and economic importance.

Given biotech’s long development cycles, it may take a decade to discern a slowdown. At that point it could take another decade to revitalize the sector. Diseases won’t wait for humans to get their act together.

The system that has evolved over the past 30 years certainly isn’t perfect. Misguided attempts to fix its flaws are making things far worse.

Our founder member wrote:

This is sad but true. The recent noise around march-in rights and mandated price caps is devastating for companies and investors at a time when the industry is already fraught with layoff and bankruptcies everyday. Preventing M&A is also a death blow to many biotech companies as they way the pharmaceutical industry works is: VCs invest in biotechs because biotechs are nimble, innovative, and take risks to discover and develop innovative drugs

Too few of our policymakers understand how costly and risky innovative drug development is. If they have their way, they will bring innovation and progress to a grinding halt.

Take a few minutes to read this editorial – the wrong policies can quickly cripple the thriving life science ecosystem we have all done so much to nurture. In the new year we will continue to devote significant energy to working with our elected officials and their staffs at the state and federal level to ensure they understand the unique value and impact of our industry and are enacting policies that help incentivize continued investment in innovation, innovation that will bring cures and ensure our country’s global scientific and industrial leadership.

Back to blessings: we are indebted to our tremendous sponsors and community and government partners and board members who guide and support us in everything we do to serve our state’s life science ecosystem. Thank you – and Merry Christmas and Happy Holidays to one and all. We will see you in January and New Year that is already shaping up to be the most exciting and productive yet for Delaware Bio!

November 2023

Yesterday, we held our annual meeting of the voting members, as required by our bylaws. This was the 17^th such meeting since this organization’s founding.

The primary business was twofold: re-electing three members of our board and providing an update on the state of the organization.

I was pleased to again report that Delaware Bio is in exceptional shape from every standpoint: financially strong, strategically positioned, and with a growing membership.

We head into the final weeks of the year with membership at an all-time high – we have 175 members and added 35 new ones in 2023 (so far). Our new members represent the extraordinary breadth and depth of the Delaware life science community: global businesses like IFF, Datwyler, and WuXi Apptec, dynamic, fast-growing local firms such as AMT, and research and regional economic development partners including the Wistar Institute and Greater Philadelphia Chamber of Commerce. 

In full transparency, while our story is decidedly one of growth, we do lose members each year for a variety of reasons. Priorities and budgets can change, key personnel move on, and some firms close their doors altogether.

When that happens, it is a bracing reminder of the challenging odds facing small firms in our industry (and frankly any new startup business enterprise). The fundamental reality is that discovering, developing, and bringing an innovative life science product/technology/service to market is extremely difficult and challenging work. It requires immense amounts of scientific capability, business savvy, and a bit of luck at all the right moments.

That heroic journey is one our small team devotes considerable time to supporting. Every day, the Delaware Bio staff is working on solving problems and creating solutions and valuable connections for our members of every shape and size. We aim to know every one of our members and understand their unique barriers and goals. That is why we meet with every new member prospect before they join – we want to ensure we are in a position to support their business or organizational objectives. Doing just that is one of the favorite parts of our job.

So we thank all of our members – our core science companies, the exceptional associate members who provide world-class, expert services and counsel to them, and our members from education, training, research, and economic development. We exist simply to help you thrive.

I mentioned the election of board members above, and I also want to thank our entire board, including Paula Swain of Incyte, Bryan Fisher of Agilent, and Nikkia Squires of ChristianaCare, who were all reelected by unanimous vote. Our board represents the interests of our members and the community, and throughout the year, they give so much of their time and consideration to helping us succeed – their leadership is so greatly valued.

Have a wonderful Thanksgiving, and see you at the Holiday Hoppy Hour on Dec. 14!

Regards,

MF

October 2023

Last Thursday, we celebrated the 10^th Anniversary of Inspiring Women in STEM (IWSTEM) with our first-ever conference at UD’s Clayton Hall. The event was energizing, with over 250 active attendees, speakers including US Patent and Trademark Officer Director Kathi Vidal and Lt. Gov. Bethany Hall-Long, and a young, diverse, and dynamic crowd.

The full-day program featured interactive workshops, engaging panel discussions, mentoring sessions, and a conference app enabling one-on-one partnering meetings. Survey results aren’t all yet tallied, but I think it is fair to say it was the best IWSTEM ever.

Conceived by Jennifer Kmiec and Helen Stimson, the IWSTEM program has grown remarkably even since I joined Delaware Bio in June of 2020, to now include quarterly networking programs, the next one to be hosted by Incyte on December 7 (registration link in the October newsletter).  Jennifer and Helen saw an opportunity a decade ago to create a special venue and vehicle for female STEM professionals to network and provide mutual support. Their vision and the thoughtful evolution of the program under the leadership of Delaware Bio’s Jamie Pedrick and an ever-growing steering committee and a crew of great volunteers (including terrific students from Newark Charter High School) has become a national model.

We thank our board, member companies and organizations, and sponsors for their support – they were active and on stage throughout, including serving as panelists, interviewers, volunteers, and mentors. The community has helped make IWSTEM such a success and asset for women in STEM careers and now poised for a new decade of making an even greater impact.

Regards,

MF

September 2023

Prior to my joining Delaware Bio three years ago, my predecessor Helen Stimson, board member Ariel Gruswitz (then of DPP), Jennifer Kmiec of the Commitee of 100 and several key economic development and life science ecosystem partners identified the need for lab space as critical to the continued growth of the Delaware biotech industry.

Market demand was outpacing supply, and the state faced the prospect of home-grown biotech companies heading elsewhere to build their businesses while also losing opportunities to recruit out-of-town firms looking for space to expand.

The work of these individuals and organizations – including DESCA and more – was both visionary and effective. A series of stakeholder meetings to educate policymakers and the real estate development community on this opportunity ultimately led to a pilot program steered by DPP and supported by Gov. Carney. A new fund was created to support the construction of the expensive, complex life science lab space, and what was initially a $5 million annual state investment has grown to $10 million.

A crew from Delaware Bio and DPP recently had the opportunity to see firsthand the fruits of this program on a recent visit to Analytical Biological Services’ (ABS) beautiful new space in New Castle. Thanks in part to the support received from the state lab grant program, the fast-growing company was able to invest millions in upgraded facilities to service expanding customer business while also creating new space that can be leased by smaller startup firms needing both flexibility and state-of-the-art laboratories.

Just a few days later I toured the transformed lab and manufacturing facilities of another exciting company, Advanced Materials Technology (AMT), which happens to be the first recipient of a lab space grant. AMT has also invested many millions into their operations here in Delaware, just off Silverside Road in north Wilmington. Together, these projects represent more than $20 million in construction investment into our state that will benefit the entire life sciences ecosystem, helping to attract and retain great talent, putting hundreds of construction professionals and contractors to work and further establishing Delaware as a thriving hotbed for the sector.

Noah Olsen of DPP, who worked with both AMT and ABS on their applications for lab space grants, remarked that “the State’s Graduated Lab Space grant program is an exciting feature of our innovation ecosystem. Recognizing the importance lab users, especially in our growing life science community, is an important part of our priorities as an economic development group, and the state in supporting our businesses.”

There are other similar projects underway across the state and we look forward to showcasing these investments and available spaces at our October BioBriefing.

Regards,

MF

We recently visited Montgomery College in Maryland to learn more about their impressive biotechnology operations. This included a tour of their state-of-the-art lab space and a deep dive into their successful manufacturing training program (both certificate and associate degree).

Montgomery County has roughly the same population as Delaware – just over one million residents. And similarly, the county is home to a robust life science ecosystem, with biopharmaceutical manufacturing a key source of employment.

So it was a great opportunity to observe how that nearby area is prioritizing support for life science workforce training. The college is a leader in delivering effective, hands-on lab and biomanufacturing training for students and partnering with employers to place them. Our Delaware contingent included representatives from our Vo-Tech school district and it is clear there are so many ways we can strengthen the pathway from these and other high schools into industry-informed training programs that lead to great long-term career opportunities.

The trip to Maryland followed similar visits and discussions with biotech training organizations in Philadelphia, Research Triangle Park, NC and Boston. All of these conversations are helping inform an innovative pilot program we’re developing and look forward to sharing more on later this year, with an eye on launching in 2024.

Enjoy the rest of summer!

Regards,

MF

Delaware was well-represented at this month’s BIO Conference in Boston, where 20,000 attendees gathered to discuss the scientific innovation and business strategies driving sector growth, but also policies that are threatening to crush it.

I’ve written consistently over the last several years about the immense opportunity and momentum our country and region have in the life sciences, and the need for state and federal policies that ensure it continues. In Boston, industry leaders shared frank concerns for how recently passed legislation will imperil biomedical breakthroughs – and our country’s economic and strategic advantages that come with it.

The consensus at the conference is that provisions in the Inflation Reduction Act (IRA) intended to reduce medicine prices for patients will only result in disincentivizing investment and reducing options for those in need.

My personal view is that the drug pricing piece of the IRA – a central plank being the requirement that manufacturers negotiate prices with the government for small molecule drugs after 9 years on market vs. 13 years for biologics – was conceived in haste by Congressional staffers eager to gain agreement within their conference. We should never have passed such far-reaching and little-understood legislation with immense consequences for one of our nation’s most important and successful industries by a party-line vote.

The legislation reflects a lack of understanding for the staggering complexity of bringing new medicines to market – the significant risks, challenges, time, costs and brainpower involved, regardless of whether a medicine is a small or large molecule. It also shows that bill-writers don’t understand that most drugs are being developed small, pre-revenue companies.

Indeed, the largest and fastest-growing segment of Delaware Bio membership are companies with five employees or less, many of which have no commercial revenue.

A new study underlines the impact that could come from the law, such as:

• Lost Therapies: More than 80 currently available therapies of 121 identified for price setting – approximately 70% – would likely not have been developed had the pricing provisions been in place prior to their development
  
• Lost Innovation: More than 235 fewer FDA approvals of new medicines or new uses over a 10-year period. Impacts of the proposed policies will be felt most heavily in many areas of unmet need, particularly in oncology, neurology, and rare and infectious diseases
  
• Lost Jobs & Investment: Delaware companies are worried about the bill and its impact on their ability to invest and grow. The study estimates a loss of between 66,800 – 135,900 direct and 342,000 – 676,000 indirect jobs in the U.S. biopharma ecosystem.
  

You can learn more about the study here: IRA’s Impact on the US Biopharma Ecosystem

We continue to work with our members to ensure our Congressional delegation understands the need to fix this legislation so they can fully continue to focus on their mission of bringing breakthrough treatments to patients in need while fueling Delaware’s innovation economy.

Enjoy summer!

MF

In just under a month, we’ll be convening an unprecedented gathering of life science industry leaders – CEOs, top Wall Street investors and analysts, university executives and academic researchers, along with the hottest new start-up companies and Delaware Governor John Carney.

The May 11 conference will be an important first for the state and our sector, a special opportunity to showcase the vitality and impact of the regional life science ecosystem and the exciting potential for significant future growth.

This is a milestone event you don’t want to miss – be sure to get your tickets as they are moving fast. Complete conference details and links to registration can be found here.

Meanwhile, later this week we are hosting our bi-monthly BioBriefing, when we’ll highlight several neat elements from the conference including an app that will enable business partnering among attendees. We’ll also be raffling off two free tickets to the big event!

You’ll see in today’s newsletter we have been busy, notably engaging policymakers in Washington, DC and Dover to ensure their decisions support a landscape where bioscientific innovation is encouraged and incentivized. As will be so vividly demonstrated on May 11 at the Waterfall in Claymont, our country’s life science industry is leading the world in leveraging cutting-edge technology to transform lives, enhance public health, drive our economy and provide rewarding careers. It is critical we work together to ensure that continues.

Regards,

MF

On Monday, Lt. Governor Bethany Hall-Long stopped by our offices as part of a tour of the FinTech Innovation Hub on UD’s STAR Campus. She pointed out that it was three years ago to the day that our lives were all changed by the pandemic shut down.

Delaware life science researchers played a key role in combatting Covid-19 and the Lt. Governor noted a poster in our office highlighting that effort, commenting it is imperative our entrepreneurs, companies and scientists “keep the innovation going."

We spoke further about our focus on workforce development and she agreed there is nothing more important to innovation and our continued economic growth than delivering a pipeline of STEM talent. Last week’s events certainly underlined that point, as you’ll see from the newsletter we had a very productive round of meetings and briefings focused on workforce and strengthening relationships between industry and our academic and training institutions.

These include an excellent advisory committee meeting at Delaware Tech on Tuesday, hosted by our new board member Lakshmi Cyr. I was pleased to join the rich discussion with DTCC leaders, partners and several key employers/DE Bio member company representatives including Siemens Healthineers and Incyte. It provided an impressive review of the college’s programs and outcomes and a lot of energy and ideas for further enhancing student training and preparation for joining the workforce.

On Friday a group visited Brandywine Realty Trust’s B-Labs incubation space in University City, Philadelphia. That was a super interesting tour and meeting with the B-Labs team (they currently host/support 16 biotech companies). We’ll be doing a follow up meeting to explore possible collaboration around workforce training.

This all ties in with two articles on what I call Delaware’s “manufacturing moment” by the Delaware Business Times in the newsletter as well – Jake Owens details the immense opportunity before us (article), one that we can only full seize if we have the people to make it happen. And that will continue to be a significant focus of our time and effort on behalf of this wonderful sector.

Regards,

MF

It is always refreshing and intellectually gratifying to get away from the day job to consider one’s mission and work from a (hopefully) more objective distance. All the better when that perspective is informed by exposure to experienced, innovative colleagues.

And that’s what Jamie Pedrick and I did for a few days last week – participating in the Council of State Bioscience Association's (CSBA) annual retreat in Washington, DC. All of us who lead these state associations fundamentally share the purpose of supporting and growing the research-based life science industry and as a CSBA board member I have ongoing interaction with many of my counterparts from across the country. But there is no substitute for being together in person, talking through common issues, sharing business best practices and diving deep into topics where we have a significant collective interest.

One of those priority areas undoubtedly is workforce development – as I’ve mentioned in this space many times – and every state is facing the same challenge (albeit in varied forms) of delivering a talented, prepared and motivated workforce to help drive the life science sector’s future growth and success. A big part of addressing that challenge is ensuring people understand the immense opportunity and reward of careers in our industry, and the broad range of roles it offers.

Last week’s meeting provided an important forum for discussing strategies at every level to raise that awareness and engage underrepresented communities, better connect industry and training institutions and universities and ensure sufficient funding for new, creative programs that are showing results.

An example of just such an initiative is right here in Delaware – ZipCode Wilmington – and on Tuesday we had the pleasure of visiting with Desa Burton and her great team at their site in the Mill. ZipCode has transformed traditional thinking around recruiting and training in the very competitive realm of software coding, producing extraordinary results over their short 8-year tenure. We learned about the details of their model and discussed where and how it might be applied in the life sciences.

It was an inspiring visit that got our wheels turning about the possibilities of nimble, employer-driven training programs that result in great employees for partner companies and change student lives in the process. And I can’t think of a better two-fer objective worth pursuing as we head into the holiday season.

Have a wonderful one!

Regards,
MF

Serving as ‘Principal for a Day’ at two terrific Delaware schools recently –  Conrad Schools of Science and Odyssey Charter School - was energizing and enlightening. It certainly brought home the basic fact that there is nothing more important for the continued success of our life science ecosystem than the gifted scientists, entrepreneurs and leaders being developed right now in schools across the state and region.

These happen to be two of Delaware’s strongest schools, helping to produce student outcomes that unfortunately are the exception for our state.  The results of the latest standardized test results show that less than 25 percent of our high school students are proficient in math and fewer than half are proficient in reading. The scores show a particularly dramatic drop during the pandemic for students who were struggling most going into it.

These results are tragic and deeply concerning for all of us – and a clear call to be bolder and more creative in thinking about public education. This begins with setting higher expectations – there is no reason why a small, nimble state that is so good at so many other things shouldn’t lead the nation in educational innovation. And that begins with being creative about recruiting, training and retaining the very best teachers, experimenting more actively with school models that are flourishing here (like Conrad and Odyssey) and elsewhere and removing institutional obstacles from a teacher’s ability to inspire and instruct their pupils. It also requires real accountability and forward thinking about the skills that will be prized and necessary in the economy of the future.

We can and must improve these outcomes but we also should not expect public educators to bear sole responsibility for testing results that can reflect complex social challenges all too often associated with poverty – addressing these challenges requires a full community effort from all of us in business, neighborhoods and families.

Notwithstanding these latest results, our state and region is still one of the best places in the world for bioscientific talent. We do have many great public schools and are home to world class universities and research institutions. We have superb, fast-moving training colleges and vo-tech programs. There are so many great career opportunities for Delaware students to look forward to in our thriving life science sector – from cutting edge advanced manufacturing and operational roles to positions researching and developing innovative technologies and medicines – and strengthening our current and future talent pipeline is a central priority for Delaware Bio and our partners.

In collaboration with the Delaware Biotechnology Institute at UD, we are excited to have recruited  Dr. Katie Lakofsky to spearhead this critical work and are confident that together we will develop a roadmap that ensures this state and region continues to be a dynamic, exciting life science hub fueled by the best workforce on the planet.

So we are thankful for the opportunity ahead to make an impact by forthrightly addressing our challenges and being limitless in our thinking about solutions.

Have a wonderful Thanksgiving –

Michael Fleming 

It’s hard to tell, but that’s me in the photo next to the Delaware Bio slide. I was presenting last Friday to the Leadership Delaware (LDI) class of ’22, always a great experience.

When speaking to audiences like LDI and others, I invariably hear the comment: “I had no idea there was so much happening in the life sciences here!”

We heard that a lot last year when we issued the first major report on the sector with the Delaware Prosperity Partnership. The reported depicted a thriving biomedical research and commercial landscape, with more than 11,000 great jobs and 65% growth in biotech start-ups over a ten year period.

So a big part of our job is to tell that story and ensure our leaders, in particular, understand the immense value and future potential of our companies and entrepreneurs. And that is just what I was doing Friday prior to my talk with LDI – we spent Friday morning with US Congresswoman Lisa Blunt Rochester and her state and Washington staff visiting with Delaware Bio members.

One of those visits was with MRA Group and Prelude at the exciting CRISP development. Our congresswoman heard plans for an initial $500 million investment in the site by MRA, along with many millions more by Prelude in their new headquarters. We discussed the ever-increasing costs involved with this complex work due to inflation, supply chain issues and labor shortages. We heard about the risks and long timelines for bringing a novel therapy to market and the competition from other states to lure great businesses away.

Timing of the visit coincided with news that a new drug pricing measure has been agreed to in the US Senate. We have grave concerns about this bill and the potential impact on a sector that is already facing severe headwinds. As the Philadelphia Business Journal article featuring Prelude’s Kris Vaddi underlines (linked in today’s newsletter), the environment for small, pre-revenue biotech companies working on medicines and cures for some of the most complex and deadly diseases has become tremendously challenging. Unfortunately, the capital markets for the sector are quite unfavorable (down 85% this year) and we are starting to see some of the fallout with reduced investment and layoffs.

It is essential that any legislation support small growth companies that are the heart of our industry -- driving innovation for patients and creating great careers in our community. These small companies make up the majority of the industry and are truly the future of biomedical innovation and our state’s economic success.

BIO CEO Dr. Michelle McMurry-Heath issued this statement on the bill, it is strong and clear on the risks we take by deterring private investment into challenging research: New drug pricing deal could propel us "light years back into the dark ages of biomedical research" | BIO

We will continue to advocate and educate on your behalf to ensure the momentum and opportunity of the Delaware life science sector continues.

Enjoy the rest of the summer!

Regards,

Michael Fleming

(1st Picture): Michael Fleming with Sandy Almassou of MIDI Labs  (2nd Picture):  Michael Fleming with Berrett Stradford of  BIO and CEO Dr. Michelle McMurray-Heath      

A robust contingent of Delaware Bio community members was in San Diego this week for the BIO International Convention, the first one held since 2019 and drawing more than 13,500 delegates from around the world. Our Delaware numbers included representatives from NIIMBL, the Delaware Prosperity Partnership, the Innovation Space and several Delaware businesses.

One particularly noteworthy Delawarean who made the trip was Isha Kanchana, a Newark Charter School high school student who represented the state in the finals of the national BioGENEius competition. Isha presented her poster “AI Based Automated Algorithm to Measure Bacterial Type IV Pili Amount and Length,” which took top honors in the Delaware Biotech Institute’s statewide competition and drew wide praise from experts and judges at the meeting. I spoke with Isha and she shared that “it was a great experience being able to meet so many like-minded people who are interested in science and seeing all the creativity and innovation.”

The conference was packed with talks and programs on everything from scientific innovations to economic development to policy and regulatory topics to patient perspectives and market and investment matters. The Delaware BIO team participated in a Council of State Bioscience Association meeting, which was a great opportunity to meet many of our state colleagues for the first time.

We are coming home inspired with lots of ideas and best practices to accelerate our work of making Delaware the best place on the planet for life science innovation and investment!

Regards,

Michael Fleming

The pace of activity across the Delaware Bio community the last few weeks only seems to have accelerated … a glance at the news items below will give you a sense of the scope and importance of so many developments across the life science landscape: from the opening and announcements of major new facilities to the kickoff of an industry-university partnership to expansion of the state’s lab space grant program -- the sector is humming.

So the timing couldn’t be better for the launch of our new Developed in Delaware campaign, which you’ll also see highlighted in this month’s newsletter. The campaign features a diverse collection of some of the bright, talented and hard-working people of our industry, neighbors who every day come to their jobs inspired to bring life-changing innovation to patients as quickly as possible.

These “Faces of Delaware Bio” make us all so proud. Check out their stories here:

CLICK HERE TO READ ABOUT THE PEOPLE BEHIND THE CAMPAIGN

Regards,

Michael Fleming

Michael Fleming

Dear all,

In just the last few weeks the Delaware bioscience community has had a remarkable two-fer when it comes to transformational events.

The first was announcement of a several hundred-million-dollar-investment in a new pharmaceutical development and manufacturing facility in Middletown. This operation could employ as many as a thousand workers in a few years, across roles ranging from manufacturing to management to administration.

The second related item was news this week that NIIMBL – the National Institute for Innovation in Manufacturing Biopharmaceuticals, based at the UD STAR Campus – will receive $153 million from the US Department of Commerce to continue its mission of driving innovation in domestic biopharmaceutical manufacturing by developing flexible, agile and cost-effective manufacturing processes. The funds will also enable NIIMBL efforts to help prepare for future pandemics by developing better processes for manufacturing vaccines and therapeutics for COVID-19 and other coronavirus strains.

These major developments signal two important, related dynamics: first, that investment in US-based biopharmaceutical manufacturing is a significant strategic imperative both from a business as well as a national security standpoint. The pandemic has exposed the great risks of overreliance on foreign supply chains for our medicine and other essential good and the domestication of advanced manufacturing is only going to accelerate.

The second dynamic is all Delaware: our state’s life science sector is thriving, and with these announcements – along with plans for a new science and innovation park at the former DuPont Chestnut Run site – we are poised to be a global leader in advanced manufacturing.

Seizing that opportunity will require exquisite collaboration across private industry, higher education and government. You don’t need a Ph.D. for most of these great advanced manufacturing jobs of the future (or even a bachelors) but they do involve significant training – Delaware must be ready with a capable talent pool and the right programs to ensure we can deliver the workers these exciting new high-tech operations need.

The state also needs to continue to push policies that will incentivize and support investment in the growth of new science and technology businesses – and programs like the Site Readiness Fund and $10 million in funds for new lab space recently approved by the General Assembly will do just that.

This kind of moments – the chance to secure this state’s economic future based on innovation – do not come often. Let’s be sure we make the most of it.

Michael Fleming

Dear all,

Incredibly, June – and summer – are upon us! For Delaware Bio that means the launch of a new ‘lunch-n-learn’ series designed to help member companies grow their businesses and address important opportunities and challenges at each stage of growth.

This weekly series – just about every Wednesday at 12 noon for nine weeks – will share the expertise of associate member companies across a range of strategic and operational issues every life science organization will encounter. Be sure to check out the programs and register to join us here.

We exist to support the growth of our members and no organization can thrive without the addition of great new talent. Our redesigned website features a job board we want to make the #1 resource in Delaware for bioscience employers and job seekers. Already we’re seeing strong activity and connections being made - employers should be sure to take advantage of this tool for posting their open roles on the site. The process is simple, but please reach out to the Delaware Bio team if you have any questions about doing so.

As hopefully a post-pandemic normalcy begins to return to our lives, we can all be proud of the unprecedented role biomedical researchers played in leading the world out of the grips of a deadly plague. This scientific innovation was made possible by years of commitment, dedication and the investment of hundreds of billions of dollars and courageous risk-taking by entrepreneurs willing to put everything on the line to save and extend human lives.

We are so pleased to see our own Senator Chris Coons has joined with his colleague Roy Blunt to recognize this achievement in the most significant way: by honoring the scientific community with a Congressional Gold Medal for its work on the Covid-19 vaccine. The medal is the highest civilian honor Congress can award – bravo and thank you Senator Coons and Blunt for your leadership.

This unrivaled track record delivering public health and economic value should never be taken for granted but unfortunately, it is jeopardized by several misguided proposals being considered in Washington, DC. One would waive all intellectual property (IP) rights associated with COVID-19 products – including not only patents, but data exclusivity, trade secrets, and other proprietary technology. In effect, this would hand over technology developed over decades by Delaware companies and researchers to local manufacturers in places like Russia and China.

This would be a grave mistake – ineffective in addressing the Covid crisis but also setting a dangerous precedent for the future making it easier for foreign governments to forcibly transfer technology from American companies. Intellectual property rights are fundamental to the work of researchers everywhere, and at the heart of the era of innovation that delivered Covid vaccines and treatments in record time. Be assured we are working closely with BIO and other organizations to communicate to our leaders in the strongest terms just how damaging this proposal would be to our economy and the patients our researchers dedicate their lives to serving.

I’ll end on a high note: with restrictions on gatherings easing we are looking forward to seeing you all in person soon. Keep an eye out for news about upcoming in-person events – one a reception at the end of September then our BioBreakfast planned for November. We can’t wait to be with you!

Dear all,

Newark Charter School senior Rohan Kanchana has been selected as one of just 161 US Presidential Scholars in the country – joining four other exceptional Delaware students in receiving this prestigious distinction.

While interning at the Gene Editing Institute (GEI) at ChristianaCare, Rohan helped develop a novel software program called DECODR that helps researchers see the impact of CRISPR on tumor cells.  Rohan is also co-author on a manuscript, published in the CRISPR Journal, that “describes an elegant analytical tool to unravel the products of CRISPR-directed gene editing in human cells” says GEI director Dr. Eric Kmiec.

“We have heard repeatedly from scientists throughout the world that it is the best tool for doing that complex task,” said Dr. Kmiec.

Rohan’s achievements are remarkable and indeed worthy of recognition by the Presidential Scholar committee and the admissions folks at MIT, where he’ll be heading in the fall.

But to me they also point to something very special about the Delaware bioscience community, and the American industry more broadly. There is really no other place where students can join with world class researchers at first-rate institutions and have the opportunity to make the kind of impact Rohan has had.  Our industry uniquely thrives on collaboration across multiple scientific disciplines – coding, data science, biochemistry, genomics, etc. – as well as multiple research sectors: industry, academia, health care providers and nonprofit institutes.

It is this special recipe that has led to an unprecedented biomedical renaissance in our country over the last decade or more. I write about this in a piece just published in the Delaware Business Times.  Please take a few minutes to read it – I am sure you will agree that US life science innovation has been one of the great gifts to the world, leading humankind out of a pandemic while driving economic growth here at home.

We should never take this kind of success for granted. Our thriving bioscience landscape has inspired and engaged gifted students like Rohan so their talents can be put to the greatest benefit those in need.  Let’s make sure that continues with smart policies at the federal and state level.

Dear all,

By now I hope all of you have had a chance to check out our marvelous new website – it’s filled with great information about our organization, members and mission. You’ll find videos and fact sheets about our industry and of course the latest news and events from across the Delaware life science community. And for members, we’ve launched a terrific new portal to share information and engage.

That would be such a mistake.

Dear all,

This week’s BioBreakfast will be exploring the critical question of how we can expand the pool of talent in life science research to include more people from backgrounds and communities that have historically been underrepresented in our industry. Our phenomenal panel will be sharing learnings, strategies and challenges they’ve encountered in working to achieve this goal – a range of experience and programs that includes exposing high school students to STEM career opportunities to provide mentoring and internship opportunities at the college and graduate level to companies recruiting and retaining the very best talent.

There is still time to register for Thursday’s event – you can do soright here on our website.

As we begin to see the light at the end of this long and terrible pandemic tunnel, it is clear that some tools and ways of working we’ve relied on so heavily will continue to be important to how we conduct business. For Delaware Bio, that certainly includes the use of technology to engage with and provide value to our members. In that regard, we’re excited to announce we’ll soon be launching a freshly redesigned website and members-only portal. The new site has a clean and updated look, improved navigation, and expanded functionality that will allow members to:

• Connect and engage with other members
• Share news, event announcements  and research queries
• Post and search job openings
• Register for upcoming events
• Join or renew your membership online; pay via credit card or check
• Easily maintain your profile
• Search the member-only directory
• And much more

Keep an eye out for communications in the coming weeks about the new site including important instructions on accessing the member-only portal, and invitations to join instructional webinars.

I hope you and your families and colleagues are staying healthy and we look forward to hopefully seeing you in person later this year.

Dear All,

Two recent announcements underscore the extraordinary momentum of the Delaware bioscience community.

One is the approval of an important pilot program that will help growing science companies expand into much needed new lab space, while also helping to attract new firms to Delaware. Today’s newsletter details the state initiative that will provide funding to grow the availability of “ready-to-go” lab space.

Dear All,

The new year is already off to a fast, exciting start for Delaware’s bioscience community as you’ll see from today’s bustling newsletter.

We’re looking forward to our first BioBreakfast next week featuring leading experts from UD, Incyte and CompassRed on data science and artificial intelligence. Be sure to sign up for this terrific program on Thursday Jan. 21 event by clicking here.

You’ll also see in our news section that last year’s momentum across the Delaware life science sector is continuing – our members are innovating and growing with product developments, new stock offerings and major government contracts while also supporting the community with critical charitable efforts.

The COVID-19 vaccine is a vivid example of the unmatched value of the bioscience industry and the power of effective business-academic-government partnership. Check out my op-ed – COVID Vaccine underscores life-saving value of bioscience innovation – that appeared across local media.

On that topic, today’s newsletter includes important information on how your organization’s workers involved in essential manufacturing, production and research and development can gain access to the vaccine, to help ensure that the life-saving products you create get to the patients who need them.

As a new administration takes office in Washington this month, we can all take pride that a Delawarean – President-elect Joe Biden – will be leading it. Keep an eye out for more on our Life Science Leadership “Conversation with US Sen. Chris Coons” scheduled for February 16 – the senator is sure to have some fascinating insights on the new dynamics in our nation’s capital and their implications for a thriving life sciences landscape.

We send our warmest congratulations to the new president and all the very best wishes in his work to come leading our special, miraculous country.

Dear All,

As the first Covid-19 vaccine begins to be rolled out with our front-line healthcare workers and those most at risk in Delaware and across the country, the entire bioscience community can take great pride in this extraordinary, life-saving achievement.

Biopharmaceutical industry researchers have delivered one of the most historic accomplishments in modern science: a safe, effective vaccine against a global plague, developed in record time.  And there are hopefully more to come soon, often the product of successful collaborations between companies and academic researchers, boosted by government support.

This story is a shining example of the transformational impact the life science industry can, and is having on the world, every day.

While the pandemic will unfortunately continue to ravage our society in the coming months, at this special time of year we can be thankful for the bioscience innovation that will ultimately end this crisis.

We are so grateful to all of you who devote your lives to finding the vaccines, cures, treatments and producing the equipment, tests and devices that will help ensure 2021 is a healthier, safer year than the one we are putting behind.  We wish you a wonderful holiday season with your family and loved ones, and look forward to celebrating your continued successes in the New Year.

Happy Holidays!

PS – Take two minutes to check out this wonderful short video on the inspiring work of the Delaware bioscience community

Dear All,

It has been quite a few weeks for your team at Delaware Bio, as we are just coming off our first-ever Igniting Innovation Week. And what a week it was – if you were unable to tune in for our daily presentations you are in luck: each day’s videos are posted right here (be sure to check out the ‘grand finale’).

We are so thankful to all of you – sponsors, elected officials, participants and attendees – who helped make the week such an inspiring celebration of our industry. Special thanks to Governor Carney for the official proclamation!

And just yesterday morning during our BioBreakfast we were delighted to feature Dr. Kelvin Lee of NIIMBL, as well as our annual member showcase. The program underlined the breadth of the caliber of the people and organizations that make Delaware Bio so special.

As we plan for 2021, despite the promising news of a Covid vaccine the near-term public health situation is still daunting. Therefore, as I signaled back in September at our annual meeting, we will be continuing to conduct virtual-only events through at least the first six months of next year. As we get into the spring, we hope to have a better view as to when we will be able to host you in a live setting. Thankfully, we are confident we can continue to deliver the outstanding program content you’ve come to expect – there will be more to come on some exciting new additions to our 2021 lineup.

This is certainly a time of pride for all Delawareans as our own Joe Biden has been elected president of the United States. We congratulate President-elect Biden and look forward to working with his administration, our congressional delegation and all our public leaders to ensure Delaware continues to be a robust hub of bioscience innovation and investment (congratulations to the newly-elected members of the General Assembly as well!). Communicating the immense value – from both a public health and economic standpoint – of our industry and advocating for smart policies that ensure its growth will continue to be a priority for Delaware Bio as we head into the new year.

I hope you have a healthy and joyful Thanksgiving with your families.

Regards,

Dear Friends,

Just a few weeks ago our community celebrated a remarkable achievement by a member company, as Prelude Therapeutics conducted a successful IPO.

This rare milestone is significant for many reasons – so very few start-ups ever get to this stage – but most notably because the capital it raised will accelerate Prelude’s mission of developing innovative therapies for hard-to-treat cancers. That’s great news for patients and their families.

Regards,

We were honored to be joined by Governor John Carney at last week’s BioBreakfast – an event that showcased the extraordinary innovation underway across the Delaware bioscience community focused on combatting the COVID-19 pandemic. More than 150 joined virtually to hear from several members on cutting edge research and product development happening every day in our state.

It was great to hear the governor affirm the immense value of our industry, both from a public health and economic standpoint. That fact is underlined by other recent news included in today’s newsletter – including the continued growth of Prelude Therapeutics and the novel CRISPR in a Box kit launched by ChristianaCare’s Gene Editing Institute and Delaware Tech, to name just two inspiring stories.

The momentum of the Delaware bioscience community is exciting, but we need to make smart decisions and investment as a state to ensure it continues to build. To that point, we are pleased to be co-hosting an update on the need for ready-to-go lab space on October 7 (you can register here). I urge you to join us for an important briefing on potential funding opportunities for companies in need of expanded facilities.

Of course, this home-grown bioscience innovation drives economic opportunity well beyond just the “core” bioscience industry; as R&D-driven investment increases in Delaware many other businesses and sectors benefit. Our outstanding associate member companies range from accounting and law firms to industrial service providers that all help make bioscience innovation possible. We thank and recognize them for their essential support and partnership.

Lastly, I’m delighted to welcome our newest members, Groff North America and Scientific Bioprocessing Inc. (SBI). I encourage all of you who appreciate the value of Delaware Bio to please always be thinking about potential new organizations you’d like to introduce to our special community.

August 2020

June 2020

Dear All,

It’s been a busy, productive and enlightening week since I started as your president last Monday.

During this time I have spoken or and been in touch with so many of you, connected with key partners and even visited a lab. Thanks to everyone who has given me such a warm welcome. One thing is clear: you all share a deep commitment to strengthening the bioscience landscape in Delaware.

My initial goals in this new role are to 1. keep the momentum going – Delaware Bio is in strong shape and we don’t want to miss a beat continuing to deliver value to our members, 2. showcase the innovation and value of Delaware’s bioscience community and 3. continue to build on Delaware’s heritage as a dynamic hub for scientific innovation and investment.

In that regard, I encourage you to check out BIO’s newly released report, “The Bioscience Economy,” which you can find by clicking here. The report underlines the unmatched impact of our industry on Delaware: 7,000 employees making an average of $114,000 and hundreds of millions in R&D expenditures, venture capital investments and NIH funding. This state punches far above its weight but it can do even better.

I look forward to meeting you over the coming months both virtually and as we are hopefully are able to once again get together in person – meanwhile, please don’t hesitate to contact me or the team if there is anything we can do.