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Pharmaceuticals and Biotechnology Manufacturing and Supply Agreements Trends Report 2024 with Directory of … – PR Newswire

DUBLIN, April 1, 2024 /PRNewswire/ -- The"Manufacturing and Supply Deals in Pharmaceuticals and Biotechnology 2019-2024" report has been added to ResearchAndMarkets.com's offering.

Manufacturing and Supply Deals in Pharmaceuticals and Biotechnology provides a detailed understanding and analysis of how and why companies enter manufacturing and supply deals. Fully revised and updated, the report provides details of manufacturing and supply deals from 2019 to 2024.

The report provides access to manufacturing and supply deal payment terms as announced between the parties. This data provides useful insight into the payment and other deal terms. Understanding the flexibility of a prospective partner's negotiated deals terms provides critical insight into the negotiation process in terms of what you can expect to achieve during the negotiation of terms. Whilst many smaller companies will be seeking details of the payments clauses, the devil is in the detail in terms of how payments are triggered and rights transferred - contract documents provide this insight where press releases and databases do not.

This report contains a comprehensive listing of manufacturing and supply deals announced since 2019 as recorded in the Current Agreements deals and alliances database, including financial terms where available, plus links to online copies of actual manufacturing and supply contract documents as submitted to the Securities Exchange Commission by companies and their partners.

The initial chapters of this report provide an orientation of manufacturing and supply dealmaking and business activities.

Chapter 1 provides an introduction to the report, whilst chapter 2 provides an overview and analysis of the trends in manufacturing and supply as well as a discussion on the merits of the type of deal.

Chapter 3 provides an overview of the structure of manufacturing and supply deals.

Chapter 4 provides a review of the leading manufacturing and supply deals since 2019. Deals are listed by headline value. Where the deal has an agreement contract published at the SEC a link provides online access to the contract via the Current Agreements deals and alliances database.

Chapter 5 provides a comprehensive listing of the top 25 most active manufacturing and supply dealmaker companies. Each deal title links via Current Agreements deals and alliances database to an online version of the full deal record, and where available, the actual contract document, providing easy access to each deal record on demand.

Chapter 6 provides a comprehensive and detailed review of manufacturing and supply deals organized by company A-Z, therapy, technology and industry type signed and announced since 2016 where a contract document is available. Contract documents provide an indepth insight into the actual deal terms agreed between the parties with respect to the manufacturing and supply deal.

The deal directory includes a comprehensive listing of all manufacturing and supply deals announced since 2019. Each listing is organized as a deal directory by company A-Z, therapeutic area and technology type. Each deal title links via hyperlink to an online version of the deal record including, where available, the actual contract document.

Key Benefits

Manufacturing and Supply Deals in Pharmaceuticals and Biotechnology includes:

Analyzing contract agreements allows due diligence of:

Key Topics Covered:

Executive Summary

Chapter 1 - Introduction

Chapter 2 - Trends in manufacturing and supply dealmaking 2.1. Introduction 2.2. Definition of manufacturing and supply deal 2.3. Trends in manufacturing and supply deals since 2019 2.3.1. Manufacturing and supply dealmaking by year, 2019-2024 2.3.2. manufacturing and supply dealmaking by phase of development, 2019-2024 2.3.3. Manufacturing and supply dealmaking by industry sector, 2019-2024 2.3.4. Manufacturing and supply dealmaking by therapy area, 2019-2024 2.3.5. Manufacturing and supply dealmaking by technology type, 2019-2024 2.3.6. Manufacturing and supply dealmaking by most active company, 2019-2024 2.4. Reasons for entering into manufacturing and supply partnering deals 2.5. The future of manufacturing and supply deals

Chapter 3 - Overview of manufacturing and supply deal structure 3.1. Introduction 3.2. manufacturing and supply agreement structure

Chapter 4 - Leading manufacturing and supply deals 4.1. Introduction 4.2. Top manufacturing and supply deals by value

Chapter 5 - Top 25 most active manufacturing and supply dealmakers 5.1. Introduction 5.2. Top 25 most active manufacturing and supply dealmakers

Chapter 6 - manufacturing and supply deals including contracts directory 6.1. Introduction 6.2. manufacturing and supply deals with contracts 2019-2024

Deal directory Deal directory - manufacturing and supply dealmaking by companies A-Z Deal directory - manufacturing and supply dealmaking by therapy area Deal directory - manufacturing and supply dealmaking by technology type

For more information about this report visit https://www.researchandmarkets.com/r/2zj9s3

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Biotechnology CEO and inventor of SiriusXM Satellite Radio Martine Rothblatt to deliver graduation address to the … – EurekAlert

image:

Martine Rothblatt PhD, JD, MBA, Chairperson and CEO of United Therapeuticsand inventor of SiriusXM Satellite Radio.

Credit: United Therapeutics Corporation

University of Maryland School of Medicine (UMSOM) DeanMark T. Gladwin, MD, announced today thatMartine Rothblatt PhD, JD, MBA, Chairperson and CEO of United Therapeutics, and inventor of SiriusXM Satellite Radio, will deliver the keynote address for this years graduating medical student class. The UMSOM MD graduation ceremony will take place at the Hippodrome Theatre on Thursday, May 16, 2024.The ceremony will begin at 1:00 pm. Details for faculty members arehere. Details for students/guests arehere.

Dr. Rothblatt is a trailblazing pioneer of several innovations in biotechnology, pharmaceuticals, and satellite communications. After developing SiriusXM, she founded United Therapeutics, in an effort to find a cure for her daughters life-threatening illness, pulmonary arterial hypertension. Under Dr. Rothblatts leadership, United Therapeutics, headquartered in Silver Spring, Maryland, has become a large biotech company focused on engineering cell biology to develop new therapeutics and manufactured transplantable organs. Its monoclonal antibody has been approved to treat neuroblastoma, and its genetically modified pig hearts and kidneys were the first to be transplants into humans.

The biotech company funded and helped establish the Cardiac Xenotransplantation Program at the University of Maryland School of Medicine, which led to the worlds first two transplants of genetically-modified pig organs into living patients. Both patients were transplanted with pig hearts to treat their terminal heart failure and lived for more than a month.

The historic procedures were performed at the University of Maryland Medical Center byBartley Griffith, MD, Professor of Surgery and The Thomas E. and Alice Marie Hales Distinguished Professor in Transplantation at UMSOM andMuhammad M. Mohiuddin, MD, Professor of Surgery and Scientific/Program Director of the Cardiac Xenotransplantation Program at UMSOM.

We are thrilled to have Dr. Rothblatt address this distinguished class of up-and-coming physicians, said Dr. Gladwin who is the John Z. and Akiko K. Bowers Distinguished Professor and Dean of UMSOM, and Vice President for Medical Affairs at University of Maryland, Baltimore.Her contributions and groundbreaking developments in addressing lung disease, cancer, and the chronic organ shortage have had an immeasurable impact on the field of medicine. Shes a role model for our medical students, demonstrating that if you have the will to have a substantial impact, you can make it happen.

An attorney-entrepreneur, Dr. Rothblatt is a tireless advocate for human rights. In 1992, she led the International Bar Associations efforts in drafting the Universal Declaration on the Human Genome and Human Rights and has been a leading advocate for transgender acceptance. For her impacts in satellite communications, she was elected to the International Institute of Space Law and has represented the radio astronomy communitys scientific interests before the Federal Communications Commission.

Celebrated as a visionary, thought leader, and published author, Dr. Rothblatt is named One of 100 Greatest Living Business Minds byForbesand Most Powerful LGBTQ+ People in Tech byBusiness Insider.Her pioneering book,Your Life or Mine: How Geoethics Can Resolve the Conflict Between Private and Public Interests in Xenotransplantation, anticipated the need for global virus bio-surveillance and an expanded supply of transplantable organs. She is also the recipient of a Lifetime Achievement Award from the Maryland Tech Council.

Dr. Rothblatt is currently the inventor and co-inventor on nine U.S. patents, with additional applications pending.

She earned her PhD in Medical Ethics with a thesis in xenotransplantation from the Royal London College of Medicine and Dentistry and earned her JD and MBA from UCLA. She also studied astronomy at the University of Maryland College Park.

About the University of Maryland School of Medicine

Now in its third century, the University of Maryland School of Medicine was chartered in 1807 as the first public medical school in the United States. It continues today as one of the fastest growing, top-tier biomedical research enterprises in the world -- with 46 academic departments, centers, institutes, and programs, and a faculty of more than 3,000 physicians, scientists, and allied health professionals, including members of the National Academy of Medicine and the National Academy of Sciences, and a distinguished two-time winner of the Albert E. Lasker Award in Medical Research. With an operating budget of more than $1.2 billion, the School of Medicine works closely in partnership with the University of Maryland Medical Center and Medical System to provide research-intensive, academic, and clinically based care for nearly 2 million patients each year. The School of Medicine has more than $500 million in extramural funding, with most of its academic departments highly ranked among all medical schools in the nation in research funding. As one of the seven professional schools that make up the University of Maryland, Baltimore campus, the School of Medicine has a total population of nearly 9,000 faculty and staff, including 2,500 students, trainees, residents, and fellows. The School of Medicine, which ranks as the8th highestamong public medical schools in research productivity (according to the Association of American Medical Colleges profile) is an innovator in translational medicine, with 606 active patents and 52 start-up companies. In the latestU.S. News & World Reportranking of the Best Medical Schools, published in 2023, the UM School of Medicine isranked #10 among the 92 public medical schoolsin the U.S., and in the top 16 percent(#32) of all 192 public and privateU.S. medical schools. The School of Medicine works locally, nationally, and globally, with research and treatment facilities in 36 countries around the world. Visitmedschool.umaryland.edu

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Branched chemically modified poly(A) tails enhance the translation capacity of mRNA – Nature.com

Sahin, U., Karik, K. & Treci, . mRNA-based therapeuticsdeveloping a new class of drugs. Nat. Rev. Drug Discov. 13, 759780 (2014).

Article CAS PubMed Google Scholar

Weng, Y. et al. The challenge and prospect of mRNA therapeutics landscape. Biotechnol. Adv. 40, 107534 (2020).

Article CAS PubMed Google Scholar

Rohner, E., Yang, R., Foo, K. S., Goedel, A. & Chien, K. R. Unlocking the promise of mRNA therapeutics. Nat. Biotechnol. 40, 15861600 (2022).

Article CAS PubMed Google Scholar

Baden, L. R. et al. Efficacy and safety of the mRNA-1273 SARS-CoV-2 vaccine. N. Engl. J. Med. 384, 403416 (2021).

Article CAS PubMed Google Scholar

Walsh, E. E. et al. Safety and immunogenicity of two RNA-based COVID-19 vaccine candidates. N. Engl. J. Med. 383, 24392450 (2020)

Article CAS PubMed Google Scholar

Colln, A. et al. VEGFA mRNA for regenerative treatment of heart failure. Nat. Rev. Drug Discov. 21, 7980 (2022).

Article PubMed Google Scholar

Mullard, A. mRNA-based drug approaches phase I milestone. Nat. Rev. Drug Discov. 15, 595 (2016).

Article PubMed Google Scholar

A study of VERVE-101 in patients with familial hypercholesterolemia and cardiovascular disease. Clinicaltrials.gov https://clinicaltrials.gov/ct2/show/NCT05398029?term=verve101&draw=2&rank=1 (2023).

Rybakova, Y. et al. mRNA delivery for therapeutic anti-HER2 antibody expression in vivo. Mol. Ther. 27, 14151423 (2019).

Article CAS PubMed PubMed Central Google Scholar

Gillmore, J. D. et al. CRISPRCas9 in vivo gene editing for transthyretin amyloidosis. N. Engl. J. Med. 385, 493502 (2021).

Article CAS PubMed Google Scholar

Ramaswamy, S. et al. Systemic delivery of factor IX messenger RNA for protein replacement therapy. Proc. Natl Acad. Sci. USA 114, E1941E1950 (2017).

Article CAS PubMed PubMed Central Google Scholar

Jiang, L. et al. Dual mRNA therapy restores metabolic function in long-term studies in mice with propionic acidemia. Nat. Commun. 11, 5339 (2020).

Article ADS CAS PubMed PubMed Central Google Scholar

Karik, K. et al. Incorporation of pseudouridine into mRNA yields superior nonimmunogenic vector with increased translational capacity and biological stability. Mol. Ther. 16, 18331840 (2008).

Article PubMed Google Scholar

Karik, K., Buckstein, M., Ni, H. & Weissman, D. Suppression of RNA recognition by Toll-like receptors: the impact of nucleoside modification and the evolutionary origin of RNA. Immunity 23, 165175 (2005).

Article PubMed Google Scholar

Kormann, M. S. D. et al. Expression of therapeutic proteins after delivery of chemically modified mRNA in mice. Nat. Biotechnol. 29, 154157 (2011).

Article CAS PubMed Google Scholar

Leppek, K. et al. Combinatorial optimization of mRNA structure, stability, and translation for RNA-based therapeutics. Nat. Commun. 13, 1536 (2022).

Article ADS CAS PubMed PubMed Central Google Scholar

Asrani, K. H. et al. Optimization of mRNA untranslated regions for improved expression of therapeutic mRNA. RNA Biol. 15, 756762 (2018).

PubMed PubMed Central Google Scholar

Wesselhoeft, R. A., Kowalski, P. S. & Anderson, D. G. Engineering circular RNA for potent and stable translation in eukaryotic cells. Nat. Commun. 9, 2629 (2018).

Article ADS PubMed PubMed Central Google Scholar

Chen, R. et al. Engineering circular RNA for enhanced protein production. Nat. Biotechnol. https://doi.org/10.1038/s41587-022-01393-0 (2022).

Schlake, T., Thess, A., Thran, M. & Jordan, I. mRNA as novel technology for passive immunotherapy. Cell. Mol. Life Sci. 76, 301328 (2019).

Article CAS PubMed Google Scholar

Thess, A. et al. Sequence-engineered mRNA without chemical nucleoside modifications enables an effective protein therapy in large animals. Mol. Ther. 23, 14561464 (2015).

Article CAS PubMed PubMed Central Google Scholar

Koch, A., Aguilera, L., Morisaki, T., Munsky, B. & Stasevich, T. J. Quantifying the dynamics of IRES and cap translation with single-molecule resolution in live cells. Nat. Struct. Mol. Biol. 27, 10951104 (2020).

Article CAS PubMed PubMed Central Google Scholar

Bloom, K., van den Berg, F. & Arbuthnot, P. Self-amplifying RNA vaccines for infectious diseases. Gene Ther. 28, 117129 (2021).

Article CAS PubMed Google Scholar

Sonenberg, N. & Hinnebusch, A. G. Regulation of translation initiation in eukaryotes: mechanisms and biological targets. Cell 136, 731745 (2009).

Article CAS PubMed PubMed Central Google Scholar

Kahvejian, A., Roy, G. & Sonenberg, N. The mRNA closed-loop model: the function of PABP and PABP-interacting proteins in mRNA translation. Cold Spring Harb. Symp. Quant. Biol. 66, 293300 (2001).

Article CAS PubMed Google Scholar

Hinnebusch, A. G. The scanning mechanism of eukaryotic translation initiation. Annu. Rev. Biochem. 83, 779812 (2014).

Article CAS PubMed Google Scholar

Eisen, T. J. et al. The dynamics of cytoplasmic mRNA metabolism. Mol. Cell 77, 786799.e10 (2020).

Article CAS PubMed PubMed Central Google Scholar

Wang, Z., Day, N., Trifillis, P. & Kiledjian, M. An mRNA stability complex functions with poly(A)-binding protein to stabilize mRNA in vitro. Mol. Cell. Biol. 19, 45524560 (1999).

Article CAS PubMed PubMed Central Google Scholar

Mangus, D. A., Evans, M. C. & Jacobson, A. Poly(A)-binding proteins: multifunctional scaffolds for the post-transcriptional control of gene expression. Genome Biol. 4, 223 (2003).

Article PubMed PubMed Central Google Scholar

Bernstein, P., Peltz, S. W. & Ross, J. The poly(A)-poly(A)-binding protein complex is a major determinant of mRNA stability in vitro. Mol. Cell. Biol. 9, 659670 (1989).

CAS PubMed PubMed Central Google Scholar

Aditham, A. et al. Chemically modified mocRNAs for highly efficient protein expression in mammalian cells. ACS Chem. Biol. 17, 33523366 (2022).

Article CAS PubMed Google Scholar

Sawazaki, R. et al. Characterization of the multimeric structure of poly(A)-binding protein on a poly(A) tail. Sci. Rep. 8, 1455 (2018).

Article ADS PubMed PubMed Central Google Scholar

Khn, U. & Pieler, T. Xenopus poly(A) binding protein: functional domains in RNA binding and protein-protein interaction. J. Mol. Biol. 256, 2030 (1996).

Article PubMed Google Scholar

Coombes, C. E. & Boeke, J. D. An evaluation of detection methods for large lariat RNAs. RNA 11, 323331 (2005).

Article CAS PubMed PubMed Central Google Scholar

Katolik, A. et al. Regiospecific solid-phase synthesis of branched oligoribonucleotides that mimic intronic lariat RNA intermediates. J. Org. Chem. 79, 963975 (2014).

Article CAS PubMed Google Scholar

Escorihuela, J. et al. Direct covalent attachment of DNA microarrays by rapid thiol-ene click chemistry. Bioconjug. Chem. 25, 618627 (2014).

Article CAS PubMed Google Scholar

Greenberg, M. M. Attachment of reporter and conjugate groups to the 3 termini of oligonucleotides. Curr. Protoc. Nucleic Acid Chem. https://doi.org/10.1002/0471142700.nc0405s02 (2001).

El-Sagheer, A. H. & Brown, T. Single tube gene synthesis by phosphoramidate chemical ligation. Chem. Commun. 53, 1070010702 (2017).

Article CAS Google Scholar

Kalinowski, M. et al. Phosphoramidate ligation of oligonucleotides in nanoscale structures. ChemBioChem 17, 11501155 (2016).

Article CAS PubMed Google Scholar

Ehret, F., Zhou, C. Y., Alexander, S. C., Zhang, D. & Devaraj, N. K. Site-specific covalent conjugation of modified mRNA by tRNA guanine transglycosylase. Mol. Pharm. 15, 737742 (2018).

Article CAS PubMed Google Scholar

Zhang, D. et al. Site-specific and enzymatic cross-linking of sgRNA enables wavelength-selectable photoactivated control of CRISPR gene editing. J. Am. Chem. Soc. 144, 44874495 (2022).

Article CAS PubMed PubMed Central Google Scholar

Fantoni, N. Z., El-Sagheer, A. H. & Brown, T. A hitchhikers guide to click-chemistry with nucleic acids. Chem. Rev. 121, 71227154 (2021).

Article CAS PubMed Google Scholar

Warminski, M., Kowalska, J. & Jemielity, J. Solid-phase synthesis of RNA 5-azides and their application for labeling, ligation, and cyclization via click chemistry. Curr. Protoc. Nucleic Acid Chem. 82, e112 (2020).

Article CAS PubMed Google Scholar

Khn, U. & Wahle, E. Structure and function of poly(A) binding proteins. Biochim. Biophys. Acta 1678, 6784 (2004).

Article PubMed Google Scholar

Deo, R. C., Bonanno, J. B., Sonenberg, N. & Burley, S. K. Recognition of polyadenylate RNA by the poly(A)-binding protein. Cell 98, 835845 (1999).

Article CAS PubMed Google Scholar

Vogel, A. B. et al. BNT162b vaccines protect rhesus macaques from SARS-CoV-2. Nature 592, 283289 (2021).

Article ADS CAS PubMed Google Scholar

Gilleron, J. et al. Image-based analysis of lipid nanoparticle-mediated siRNA delivery, intracellular trafficking and endosomal escape. Nat. Biotechnol. 31, 638646 (2013).

Article CAS PubMed Google Scholar

Wang, X. et al. Three-dimensional intact-tissue sequencing of single-cell transcriptional states. Science 361, eaat5691 (2018).

Article PubMed PubMed Central Google Scholar

Zeng, H. et al. Integrative in situ mapping of single-cell transcriptional states and tissue histopathology in a mouse model of Alzheimers disease. Nat. Neurosci. 26, 430446 (2023).

CAS PubMed Google Scholar

Zeng, H. et al. Spatially resolved single-cell translatomics at molecular resolution. Science 380, eadd3067 (2023).

Article CAS PubMed Google Scholar

Xiang, K. & Bartel, D. P. The molecular basis of coupling between poly(A)-tail length and translational efficiency. eLife 10, e66493 (2021).

Article CAS PubMed PubMed Central Google Scholar

Li, X. et al. Generation of destabilized green fluorescent protein as a transcription reporter. J. Biol. Chem. 273, 3497034975 (1998).

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Ambition and urgency: Biotechnology and Biomanufacturing in the EU – EURACTIV

The Initiative Boosting Biotechnology and Biomanufacturing in the EU offers the promise, although not yet the commitment, for biotechnology in the EU at the scale and vision needed for global significance. EuropaBio looks inside and to the future.

Dr Claire Skentelbery is the Director General of EuropaBio.

Ambition, vision and urgency are the calls from EuropaBio for this promising initiative. The next Commission must combine long-term vision and bold ambitions with immediate and urgent attention to resolve existing barriers to growth. The world is accelerating industrial outputs from biotechnology, and we need to move with it. EuropaBio will be a partner and champion every step of the way to deliver Europes biotech future. Dr Claire Skentelbery, Director General of EuropaBio.

Europe welcomed the Biotechnology and Biomanufacturing Initiative on March 20. It brought recognition from the EU that biotechnology is one of the major global technologies shaping our health, food, and providing an industrial footprint with innovation, sustainability and resilience. The Initiative also recognizes the main bottlenecks, regulatory fragmentation, access to finance, value chain obstacles and informed public recognition.

Finally, it recognised the economic footprint of biotechnology and its vital role within a globally competitive region. Between 2008 2021, employment growth from biotech was seven times higher than Europes average, Gross Value Added grew 1.5 times as quickly, and productivity was 2.5 times higher. Europes research has thrived within biotechnology, creating thousands of start-ups, and enabling companies of all sizes to mature economic and societal value.

Let us not be modest about what biotech achieves. Healthcare biotechnology is becoming the primary source of new therapies, bringing previously untreatable diseases within reach, and transitioning from manage to cure with increasing frequency, freeing patients, families and healthcare systems.

Industrial Biotechnology holds the key to sustainable and innovative manufacturing, delivering novel products and more sustainable replacements, reducing reliance on fossil resources including energy, relieving pressure on ecosystems and strengthening supply chains, including food production, which are essential as the world aims to both ameliorate and adapt to climate change.

From Initiative to implementation

This is not the first policy roadshow for biotechnology in Europe. Way back in 2007, the Lead Market Initiative opened with the statement Developing an innovation-driven economy is crucial for competitiveness and in 2024, whilst biotech is showing its commercial speed, the EU lags other global regions for biotech performance.

This Initiative, released in the closing days of the current Commission has to take root, grow and flower quickly. It must rapidly transform rhetoric into policy and legislation action for competitiveness, enabling innovators to thrive, and creating long-term investment into infrastructures, employment, and skills in Europe. The ambition for a Biotech Act is laudable, but there is urgency for action now. Reports tomorrow are not a substitute for progress today.

A global game is Europe a player?

Europe is late to the game in recognizing and utilising biotechnology and biomanufacturing. EuropaBio has watched global regions publish comprehensive, funded, time and target-driven strategies, with the US, China, Japan, India and the UK building from their strong science foundations. The winners of this global race for biotechnology will hold primary market positions for novel medicines, resilient local manufacturing, and global supply chains, all underpinned by high value, high employment and high skills technology. It is essential that the EU is in this race to be a player rather than a customer.

The Initiative acknowledges the importance of global dialogue, shaping biotechnology above Europe. The WHO, WTO, Convention on Biological Diversity and its Cartagena Protocol on Biosafety, as well as the Kunming-Montreal Global Biodiversity Framework are all part of a harmonised global framework for biotechnology where the EC must have a clear voice.

Call it by its name

The Initiative directly references important applications and components of biotechnology; food and feed, environmental remediation, novel and alternative molecules for application across processes and sectors, advanced healthcare, with terminology including microorganisms, enzymes, mRNA, ATMPs, biorefineries, and bio-based products. This needs to continue and expand (fermentation is notable by its absence) as part of the visibility and recognition of biotechnology for all stakeholders, including policymakers at national and European level and the citizens whom benefits already reach.

Legislation for biotechnology innovation today

Recognising biotechnology innovation should be integral to our own legislative DNA, and yet at EU and Member State levels, we are already tying our own shoelaces together:

Built for biotechnology, built for Europe

The Initiative rightly identifies regulation as a critical component for economic and societal success of such a cross-cutting frontier technology. Complex, uncertain and opaque regulatory pathways create a market pathway too slow, costly and vague for investment.

Europe needs a future-looking and cross-cutting framework built for biotechnology, recognising its unique requirements and not retrofitting its systems built for chemistry, and streamlining and removing obstacles in existing regulations.

The introduction of regulatory sandboxes and simplified, accelerated pathways to market recognising the parameters of biotechnology are core to this. Regulation must mature alongside innovation and is part of successful industrial growth from Europes strong research base. An EU Biotech Hub will also provide welcome additional support for companies in navigating the complex and often overwhelming regulatory framework in all sectors.

The Initiative importantly identifies regulatory obstacles that arise at national or other governance levels which impede an effective single market which is urgent to address now. As the Enrico Letta report comes closer to publication, there is a risk of single market fragmentation for biotechnology products and processes through lack of coherence across the EC and MS. This represents an opportunity for Europe to lead global coherence for biotechnology.

Beyond regulations, the proposed Product Environmental Footprint (PEF) review brings a much needed focus on the sustainability benefits from products through the assessment of fossil-based and bio-based products to ensure equivalence. Biomass is another vital conversation for Europe as part of the initiative, with a fundamental need for sustainable, including primary, biomass. This creates a pathway for delivery for biotechnology throughout the value chain, from innovation to market and consumer.

A framework for finance

The Initiative addresses finance but must be more ambitious for investment growth, particularly for scale up and technology maturation to market, and it must also be explicit and vocal on technologies that it seeks to champion if the EU is to lead informed and engaged public narrative. Europes investment landscape is more fragmented and conservative than other regions.

Improving the investment landscape to enable the creation, financing, and maturation of European biotech companies will contribute to the restoration of the innovation ecosystem but also other industries. The easier emerging and small biotech will find it to secure investment and partners in Europe, the more likely they will be to stay and grow in Europe.

EuropaBio will be a travelling partner for the Initiative, from its promising early days to its delivery through legislation and implementation, with success measure in ambitions achieved and benefits measured for people and planet.

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Ambition and urgency: Biotechnology and Biomanufacturing in the EU - EURACTIV

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Veterinary scene down under: Australian animal biotechnology company wins 2024 Pet Care Inno-vation Prize, and … – DVM 360

Shining a light on the illegal wildlife trade

Cameron Murray, BSc, BVMS, working with wildlife in Africa (Image Courtesy of Cameron Murray)

Away from the 4 small animal veterinary practices he co-owns, Cameron Murray, BSc, BVMS, has a strong interest in wildlife conservation. Starting with his involvement with SAVE African Rhino Foundation he is now also a director of the charity organization Nature Needs More, which is focused on demand reduction projects to diminish the illegal global wildlife trade.

Murrays passion for wildlife conservation has led him to playing a vital role in raising awareness of wildlife trafficking and educating veterinarians about how they can help make a difference. Nature Needs More works on tackling the key systemic enablers of the illegal wildlife trade, including consumer demand for wildlife products and the deficiencies in the legal trade system under the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES).

To give an understanding of the scale of the wildlife trade on a global basis, legal trade is currently estimated to be worth as much as USD$260-320 billion annually and if you include illegal trade this may be as high as USD$500 billion. The legal trade is monitored, regulated and managed, however that the legal and illegal trade are currently functionally inseparable, and until steps are taken to modernize the management of legal trade, the issue of illegal trade will remain an unwinnable battle, Murray explained to dvm360. Through Nature Needs More, were advocating for a program of modernization of CITES. This is because the landmark Intergovernmental Science-Policy Platform on Biodiversity and Ecosystem Services (IPBES) Global Assessment Report on Biodiversity and Ecosystem Services report of 2019, suggested that 1 million species in the world face extinction, and that direct exploitation through trade was the biggest single threat to marine species and the second largest behind habitat loss for terrestrial and fresh water species.1

Analysis of CITES wildlife trade records and published literature has revealed massive numbers of animals are traded live every year, with many presumably destined for the exotic pet market. These records highlight the staggering numbers of species caught up in the global wildlife trade, with over 500 species of birdapproximately half of which are parrots, almost 500 species of reptilemostly turtles, lizards and snakes, and over 100 species of mammalmostly carnivores and primates, said Murray. For Australia this has particular relevance for our reptiles, which can be relatively easily smuggled. Sadly, smuggling Australian native species is considered a low-risk crime and there is significant financial motivation for criminals to illegally export Australian wildlife for the overseas exotic pet trade.

fieldofvision/stock.adobe.com

A 2021 report compiled Australian seizure data and international online trade data pertaining to shingleback lizards, found that all 4 subspecies were involved in illegal trade.2 This is important as 2 of these shingleback subspecies come from very limited ranges and populations. As such, a trade of this nature poses a real threat to species survival and biodiversity loss. All of us should be concerned with regard to the issues of biodiversity loss but in addition, the trade in wildlife also raises issues around animal welfare, zoonotic disease spread, biosecurity issues and more, Murray said.

Veterinarians can play an important role by having a stronger voice for change in the trade of wildlife, and as veterinarians we are well placed to play a stronger lead in the area. We should also be aware of the fact that there is active poaching of native species and be vigilant to this possibility. We also have an opportunity to see that penalties associated with wildlife crime are more of a deterrent and finally, I would encourage everyone to look behind the management systems of wildlife trade and consider joining me in advocating for a modernization of CITES, Murray added.

After working as a veterinarian for almost a decade, Peter Lau, BSc (Hons), BVMS, MBBS, FRACP, PhD, changed his focus and graduated in human medicine in 2007 before becoming a specialist medical oncologist. Currently based at Sir Charles Gairdner Hospital and Harry Perkins Institute of Medical Research in Perth, Lau and his colleagues Jonas Nilsson PhD, and Zlatibor Velickovic, PhD, are now at the forefront of cancer research in Australia with cellular immunotherapy for human melanoma patients.

Cell therapy using Tumor Infiltrating Lymphocytes (TILs) involves surgically removing a patients melanoma deposit, extracting out the T cells or lymphocytes which act against the cancer. We then grow those cells in a specialized laboratory expanding them to extremely high numbers in the order of billions. Patients are admitted into hospital, receive chemotherapy and then are injected with the TIL treatment which destroys the tumor. The technology for cellular immunotherapy was developed in Europe and the US but is not currently available in Australia. Our recent grant funding will go towards manufacturing this treatment for the first time in Australia, Lau explained exclusively to dvm360.

For decades metastatic melanoma has been a terrible cancer to treat but with immunotherapy such as pembrolizumab we can now literally save lives. These conventional immunotherapies dont work in all patients hence the need for new treatments like cell therapy. We do have a way to go in terms of curing everyone from the disease but cell therapy research like this can help close that gap. Its very satisfying to be at the forefront of treatment and cancer research.

Although Lau no longer works as a clinical veterinarian, he credits his early career in the veterinary profession with setting him up for success in the adjacent field of human medicine. My interest in immunology started a number of years ago listening to a talk from professor [Peter Doherty, PhD] at an Australian Veterinary Association Conference many years ago. Professor Doherty originally trained as a veterinarian and made key discoveries in how the immune system recognizes cells infected with viruses which led to a Nobel Prize. It was quiet an inspirational talk and I ended up in medicine as a result. Vet training did teach me a lot about persistence which is really needed with research, Lau said. Canine melanoma is also treated with similar drugs as we use in humans so its quite nice to see the benefit of these immunotherapies for our 4-legged friends.

VetChip, an Australian animal biotechnology company, won the 2024 Pet Care Innovation Prize, earning a cash prize and support from Purina. VetChip was 1 of 5 pet care startups from across the world that pitched their businesses to pet industry influencers and investors at the recent Global Pet Expo in Orlando, Florida.

The biotechnology company is dedicated to improving animal health and welfare through pioneering technology that monitors, analyses, and detects pet health issues. VetChip cofounder and veterinarian Garnett Hall, BVSc (Hons), travelled to the US for the event.

Garnett Hall, BVSc (Hons),VetChip co-founder (Image courtesy of VetChip)

"The VetChip team and I are extremely grateful for the support we have received from Purina through the Pet Care Innovation Prize. Developing technology like ours is incredibly difficult, and partnerships with leading animal health and technology companies are essential for us, said Hall exclusively to dvm360.

2024 is off to a great start, and the remainder of this year will see us commence pre-commercial trials in several of our key markets. I am looking forward to using our technology to improve the health, welfare and performance of military dogs and and performance horses before the end of the yearmore to announce soon.

VetChip has developed an innovative implantable smart microchip for animals that can monitor the animals temperature, heart rate, respiratory rate and tissue oxygenation. VetChip has many applications, including in companion animal practice, for primary producers enabling better herd health management, and for in equestrian sports and horse-racing.

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Veterinary scene down under: Australian animal biotechnology company wins 2024 Pet Care Inno-vation Prize, and ... - DVM 360

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EU sets out plan to simplify biotech regulation and speed up approvals – Science Business

The European Commission is to look into how to speed up approvals for biotechnology, with a view to launching an EU Biotech Act in the next mandate, executive vice president Margrethe Vestager has announced.

Europe will not be attractive to businesses worldwide if permitting and other administrative procedures take much longer than in other parts of the world, she said, presenting the Commissions biotechnology and biomanufacturing initiative on 20 March.

In the meantime, it will establish an EU biotech hub by the end of this year, to enable biotech firms to better understand existing regulation, she said. The sector is already set to benefit from streamlined permitting procedures under the Net-Zero industry Act.

Applications of biotechnology and biomanufacturing range from replacing fossil fuels, to the discovery and development of new drugs for rare diseases, and bio-based alternatives to plastic and other materials. The EU funds research in the sector predominantly through the Circular Bio-based Europe Joint Undertaking (CBE JU), and more support is needed to help innovators scale up their technologies in Europe.

Regulatory complexity is one of three key obstacles to European competitiveness the new plan aims to address, alongside access to finance, and difficulties moving from research to the market.

The Commission is promising to review its Bioeconomy Strategy by the end of 2025, which could include a stronger industrial dimension.

To help companies scale up, the Commission will advocate for the inclusion of specific challenges on biotech and biomanufacturing in the European Innovation Council (EIC) accelerator work programme for 2025.

Europe cannot remain only a fantastic cradle of ideas for the rest of the world. What is born here should also have the opportunity to grow here, Vestager said.

To support the uptake of bio-manufactured products, the Commission will conduct an impact assessment for bio-based requirements in public procurement. It will further develop methodologies to ensure a fair comparison between fossil-based and bio-based products, as the latter are usually more expensive and their environmental benefits are not always apparent to consumers.

The EU is also betting on the potential of artificial intelligence to help companies scale up their operations. The 500 million GenAI4EU initiative aims to stimulate the uptake of generative AI in industries including biotech and biomanufacturing, and the Commission wants to give biotech firms access to EuroHPC supercomputers.

We want to make Europe a global biotech leader, said Vestager. With the potential to solve some of our most pressing problems, biotechnology also largely supports Europes economy, and it provides high-quality jobs.

Biotechnology can also pose a risk due to its dual-use potential, and the Commission is working with member states to assess the risk of technology leakage.

Biomanufacturing can be used to synthetically manufacture new molecules, said Vestager. These new molecules can have basic civilian uses, to produce sustainable pest repellents for instance. They can also be used in the military to produce new fuels for missiles.

Great first step

The biotech industry welcomed the announcements, which, coming so close to the European elections, mostly amount to identifying the major challenges and promising to address them at some point in the future.

To be competitive, the bio-based industries will require further action, including a sustainable supply of biomass and more stimulating measures for market uptake, such as bio-based content requirements under the new Ecodesign for Sustainable Products regulation, said Rob Beekers, chair of the Bio-based Industries Consortium, which represents the private sector in the CBE JU.

The new EU Parliament and EU Commission should make the bioeconomy and bio-based industries a political priority. Implementing the actions proposed in this communication would be a good start, he said.

Pauline Grimmer, policy manager at international nonprofit and think tank the Good Food Institute Europe, was also pleased to see the Commission recognise the measures that are needed.

While this is a great first step, for alternative protein startups to deliver on their potential to provide future-proof jobs and green growth, we now need to see this ambition translated into firm actions such as R&D funding, support to scale-up production and provide a clear and transparent regulatory framework, she said.

Claire Skentelbery, director general of industry association EuropaBio, said the initiative shows the Commission has listened to the industrys priorities. I think it's as promising as it can be for something that is a theoretical exercise. It shows intent to pick this up in the next Commission, she told Science|Business.

Clearer and faster regulatory pathways in the US are currently a major obstacle to European competitiveness. If you've got investors within the EU, they are going to push you to launch in the US first, Skentelbery said.

While a future EU Biotech Act is a positive long-term goal, theres a lot we can do in the short term thats going to be more beneficial, she added.

For example, the Commission and member states should work together on more standardised guidance for manufacturing using industrial biotechnology, while regulatory agencies are also in need of more resources to speed up approvals.

As the focus turns to implementation in the months and years ahead, EuropaBio wants to ensure any changes benefit startups and SMEs. Because its frontier technology, it really lies with the small innovators that spin out and start up companies around scientific advances, Skentelbery said.

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