Trump trade adviser, citing 'broken system,' calls for more drug manufacturing in Puerto Rico

Fiercepharma | June 01, 2020

Welcome to the FiercePharma political roundup, where each Monday we’ll highlight developments in Washington, D.C., and elsewhere that could affect drug pricing and how drugmakers operate. The COVID-19 pandemic has underscored key weaknesses in the biopharma industry’s complex global supply chain, and now a top adviser for the Trump administration is calling on Congress to push for more manufacturing in Puerto Rico. In an interview with the Washington Examiner, White House trade adviser Peter Navarro faulted a “broken system” that pushes manufacturing offshore. He called on Congress to use the next round of COVID-19 relief to incentivize manufacturing on the island territory.

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Although failure rates in drug development are still quite high, a lot can be done to mitigate the risk. This brand new infographic shows how smart design can increase the chance of success for drug development candidates.


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BUSINESS INSIGHTS

Catalent Announces New Operating Structure

Catalent, Inc | July 06, 2022

Catalent, Inc. the global leader in enabling biopharma, cell, gene, and consumer health partners to optimize development, launch, and supply of better patient treatments across multiple modalities, today announced changes to its operating structure and executive leadership team that went into effect July 1. This new organizational structure includes a shift from four reporting segments to two, each representing roughly half of the total company revenue. According to Alessandro Maselli, Catalent’s President and Chief Executive Officer since July 1, the segment changes reflect evolving customer and industry trends and position the company to deliver its next level of growth and achievement. “Our industry continues to demonstrate steady growth, and this new structure will allow us to be more agile in meeting and anticipating customer needs and expectations. Among other benefits, it will create commercial synergies for our customers, as they will be better able to access the full range of Catalent services applicable to their molecules.” Maselli Dr. Aris Gennadios was named Group President of Catalent’s newly formed Pharma and Consumer Health segment. The new segment consolidates the company’s prior Softgel & Oral Technologies segment, which Gennadios had led since 2013, and its Oral & Specialty Delivery and Clinical Supply Services segments. “Combining our businesses focused on the development and supply of pharmaceutical and consumer health products will provide our customers with more integrated solutions, streamlined service, and simplified delivery of the solutions they need to accelerate their path to patients and consumers,” said Dr. Gennadios. The new Pharma and Consumer Health segment will encompass the offerings of the three prior segments, including the company’s market-leading softgels, Zydis® fast-dissolve technologies, gummy dosage forms, clinical development and trial supply services, and global pharma manufacturing platforms. Dedicated teams will focus on Catalent’s pharmaceutical, consumer health, and clinical development and supply solutions to further drive value for customers and the opportunity for accelerated growth of these businesses. The scope of Catalent’s other reporting segment, Biologics, continues without any change. This organizational restructuring has also been accompanied by a few additional leadership changes. Jonathan Arnold, who previously served as President, Oral & Specialty Delivery, since 2017, is Catalent’s new Senior Vice President, Chief Commercial Officer, and Head of Transformation. He will be dedicated to ensuring a best-in-class customer experience and working closely with others on the leadership team to optimize the company’s growing portfolio. Additionally, Steven Fasman, who previously served as Senior Vice President and General Counsel since 2014, will be Catalent’s Executive Vice President and Chief Administrative Officer, a newly created position. Mr. Fasman will oversee certain administrative functions of the company, including legal & compliance, information technology, engineering, procurement, governmental affairs, and various ESG-related departments. Finally, Karen Flynn has announced her decision to retire from her role as Catalent’s Senior Vice President and Chief Commercial Officer. “Karen has played a critical role on the Executive Leadership Team since joining Catalent in early 2020. I am immensely grateful for her leadership, innovative thinking, and steadfast commitment to the company,” said Maselli. About Catalent, Inc. Catalent, Inc. an S&P 500® company, is the global leader in enabling pharma, biotech, and consumer health partners to optimize product development, launch, and full life-cycle supply for patients around the world. With broad and deep scale and expertise in development sciences, delivery technologies, and multi-modality manufacturing, Catalent is the industry’s preferred partner for personalized medicines, consumer health brand extensions, and blockbuster drugs. Catalent helps accelerate over 1,000 partner programs and launch over 150 new products every year. Its flexible manufacturing platforms at over 50 global sites supply over 70 billion doses of nearly 7,000 products to over 1,000 customers annually. Catalent’s expert workforce exceeds 19,000, including more than 2,500 scientists and technicians. Headquartered in Somerset, New Jersey, the company generated $4 billion in revenue in its 2021 fiscal year.

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PHARMACY MARKET

HKSTP and Boehringer Ingelheim Venture Fund Launch Co-Incubation Programme to Fast-track R&D in Infectious Diseases and Immunology

BIVF | June 18, 2022

Hong Kong Science and Technology Parks Corporation is partnering global research-driven biopharmaceutical leader, Boehringer Ingelheim Venture Fund Limited in a strategic co-incubation collaboration to promote and nurture startups on research and development for infectious diseases and immunology. HKSTP is dedicated to collaborating with sector leaders in building the strongest I&T eco-system to help startups via business development, mentorship and investment initiatives. In the last five years, the number of biotech companies at HKSTP have tripled from 50 to over 150, which has also synched with the Government’s strategic focus on biomedical technology with allocation of HK$10 billion to develop life and health technology as a key future growth sector for Hong Kong. This partnership between HKSTP and BIVF marks a key milestone to drive the Hong Kong’s biomedical technology development. Both local and global qualified startups in infectious diseases and immunology can apply to the incubation programme to access the full capabilities of the HKSTP ecosystem and BIVF’s extensive biotech funding network. Incubatees can access one-on-one coaching and assessment to track key research milestones, while receiving expert guidance from HKSTP on commercialisation, manufacturing, scaling-up and marketing strategy to ensure successful innovation, plus vital funding opportunities and investment insight from BI. “Hong Kong is now Asia’s largest and the world’s second largest fundraising hub for biotech. As HKSTP marks our 20th year of propelling success and innovation, our mission is to drive the growth of biotech to another level with world class leaders like BIVF. We will maximise the GBA growth opportunities for high-potential tech talents and early-stage startups to ensure the region emerges as a global I&T powerhouse.” Mr. Albert Wong, CEO of HKSTP Dr. Grace Lau, Head of Institute for Translational Research of HKSTP, said: “Our partnership with BIVF, provides early-stage startups and promising university spinoffs with vital support at the most critical stage of their long and challenging biotech innovation journey. Incubatees will have access to our Incu-Bio Programme, with total incubatees doubling up in the last five years. The startups can also access funding support of up to HK$6 million, with financial subsidies and upfront grants to cover regulatory activities such as clinical trials.” “The world has faced growing public health challenges in recent years. As Boehringer Ingelheim’s strategic investment arm, BIVF focuses on the development of new science in areas with huge unmet medical needs such infectious diseases and immunology,” said Dr. Frank Kalkbrenner, Global Head of the BIVF. “The co-incubation program jointly initiated by HKSTP and BIVF will enable us to identify more breakthrough technologies in the early stage of development. With the funding and infrastructure support offered by HKSTP and BI‘s expertise and experiences in the successful development of breakthrough mediactions for patients, we foster the startup companies and bridge the gap between science and industry for the local ecosystem. We look forward to developing together with HKSTP next-generation therapies in the fields of infectious diseases and immunology with long term partnerships.” “The innovation competency of biopharmaceuticals in Asia is rising quickly. To grab the opportunities in this market, Boehringer Ingelheim has set up the External Innovation Hub in China which brings our Research Beyond Borders, Business Development & Licensing and Venture Fund groups under one umbrella. Now we’re thrilled to see that the biopharmaceutical industry is picking up rapidly in the Guangdong–Hong Kong–Macau Greater Bay Area, it’s a great opportunity for us to partner with HKSTP to develop the local ecosystem, and further enhance China’s dual-circulation scheme. We hope to offer our continuous support to more home-grown innovations to be recognized on the global market and eventually benefit the patients worldwide.” said Mr. Felix Gutsche, President & CEO, Boehringer Ingelheim China. Programme incubatees will also benefit from HKSTP’s rapidly-growing biotech R&D capabilities including the HKSTP Institute for Translational Research (ITR), enabling biomedical startups to turn their innovative biomedical technologies to life-changing impact for patients and society. Also available to startups is HKSTP’s Incu-Bio program providing dedicated biotech mentorship, business matching, entrepreneur-in-residence, and access to R&D facilities and the Science Parks’ diverse talent pool. About Hong Kong Science and Technology Parks Corporation Hong Kong Science and Technology Parks Corporation (HKSTP) has for 20 continuous years committed to building up Hong Kong as an international innovation and technology hub to propel success for local and global pioneers today and tomorrow. HKSTP has established a thriving I&T ecosystem that is home to three unicorns and Hong Kong’s leading R&D hub with over 11,000 research professionals and over 1,000 technology companies focused on healthtech, AI and robotics, fintech and smart city technologies. Established in 2001, we attract and nurture talent, accelerate and commercialise innovation and technology for entrepreneurs on their journey of growth in Hong Kong, to the Greater Bay Area, Asia and beyond. Our growing innovation ecosystem is built around our key locations of the Hong Kong Science Park in Shatin, InnoCentre in Kowloon Tong and three modern INNOPARKs in Tai Po, Tseung Kwan O and Yuen Long. The three INNOPARKs are realizing a vision of re-industrialisation for Hong Kong. The goal is sectors like advanced manufacturing, electronics and biotechnology are being reimagined for a new generation of industry. Through our infrastructure, services, expertise and network of partnerships, HKSTP will help establish innovation and technology as a pillar of growth for Hong Kong, while reinforcing Hong Kong’s international I&T hub status as a launchpad for global growth at the heart of the GBA innovation powerhouse. About BIVF Created in 2010, the Boehringer Ingelheim Venture Fund GmbH invests in groundbreaking therapeutics-focused biotechnology companies to drive innovation in biomedical research. searching for significant enhancements in patient care through pioneering science and its clinical translation by building long-term relationships with scientists and entrepreneurs. BIVF’s focus is to target unprecedented therapeutic concepts addressing high medical needs in immuno-oncology, regenerative medicine, infectious diseases and digital health. These may include novel platform technologies to address so far undruggable targets, new generation vaccines and/or new biological entities, such as oncolytic virotherapy. About Boehringer Ingelheim External Innovation Hub China Established in 2020, Boehringer Ingelheim External Innovation Hub China unites three external innovation functions including Research Beyond Borders (RBB), Business Development & Licensing and the Boehringer Ingelheim Venture Fund. Through this innovative business model, Boehringer Ingelheim External Innovation Hub China is committed to providing one-stop solutions for biomedical innovators in China and. It is also dedicated to enriching the company's global R&D pipeline through external innovation collaborations so as to benefit more patients worldwide.

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PHARMACY MARKET

Standigm Signs MOU with Merck Korea for AI drug Discovery Research

Standigm | June 02, 2022

Standigm Inc. the leading workflow artificial intelligence (AI) drug discovery company, announced the signing of a Memorandum of Understanding (MOU) with Merck Korea, for AI-based drug discovery research. The MOU signing took place on May 30 at the headquarters of Standigm, attended by Sojeong Yun, CEO of Standigm, and Stephen Namkoo Lee, the Head of Science and Lab Solutions, Life Science business sector of Merck Korea. Under the MOU, Standigm will accelerate its drug discovery research by adopting Merck's AI software SYNTHIA™. which can help Standigm's novel compound synthesis. SYNTHIA™ is a computer-aided retrosynthetic design tool and unites network theory, modern high-power computing, and expert chemical knowledge to rapidly design synthetic pathways. "Applying AI to the drug discovery process can dramatically reduce time in discovering novel drug candidates and finding optimized synthesis paths. By pooling know-how in AI synthesis of Merck and Standigm's AI technology together, we expect better results in drug discovery faster, compared to the traditional AI drug discovery method," Sojeong Yun, co-founder and CEO of Standigm "Candidate chemical discovery using AI technology for new drug development is playing a crucial role in the growth of local bioindustry," said Stephen Nam-Koo Lee, Head of Science and Lab Solutions for South Korea, Life Science business sector, Merck Korea. As a leading workflow AI drug discovery company, Standigm has actively conducted research on AI technology in organic synthesis at its own Synthetic Research Center, established last year. About Standigm Standigm is a workflow AI-driven drug discovery company headquartered in Seoul, South Korea and Standigm has expanded its operations across the world, recently opening offices in the U.S. and UK. Standigm has proprietary AI platforms encompassing novel target identification to compound design, to generate commercially valuable drug pipelines. Founded in 2015, Standigm has established an early-stage drug discovery workflow AI to generate multiple First-in-Class compounds within seven months. Pursuing full-stack, AI-driven industrializing drug discovery, Standigm has achieved the automation of molecular design workflow, and the automation effort has been expanding to the whole drug discovery process based on Standigm AI platforms, including Standigm ASK™ for novel target discovery, Standigm BEST™ for novel compound generation. About Merck Merck a leading science and technology company, operates across life science, healthcare and electronics. Around 60,000 employees work to make a positive difference to millions of people's lives every day by creating more joyful and sustainable ways to live. From advancing gene editing technologies and discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2021, Merck generated sales of € 19.7 billion in 66 countries.

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BUSINESS INSIGHTS

ColubrisMX, Inc. Announces Corporate Rebranding to ENDOQUEST Robotics™

ColubrisMX | July 01, 2022

ColubrisMX, Inc., developer of the world's first flexible endoluminal robotic system which enables scar-free and less invasive surgical procedures, announced that the Company has rebranded to ENDOQUEST Robotics™. The Company also announced the simultaneous launch of its new website, www.endoquestrobotics.com. "Since being founded, our company has made rapid progress in the development of technologies that represent historic advances in endoluminal surgery, with the potential to bring millions of patients access to procedures that are less invasive and scar-free. This rebranding as ENDOQUEST Robotics reinforces our commitment to being the leader in innovation in flexible robotic technology for a wide range of needs in endoscopic surgeries in the years ahead." Kurt Azarbarzin, Chief Executive Officer of ENDOQUEST Robotics ENDOQUEST's advanced robotic platform enables therapeutic endoscopists and surgeons to perform endoluminal surgeries through the body's existing lumens, eliminating the need for incisions that lead to visible scarring. ENDOQUEST's Endoluminal Surgical System combines the flexibility of conventional endoscopy with the advantages of traditional surgical techniques that can improve control and precision. The Company's proprietary endoscope is a flexible and steerable overtube that functions as a robotic delivery system able to deliver two surgical instruments and a flexible videoscope to a surgical target. With the enhanced capabilities of the ENDOQUEST ELS System, advanced endoscopists and surgeons can access locations in the digestive tract through a body's natural orifice using traditional surgical techniques not previously possible. "Following completion of our successful $76 million Series C financing, we remain very encouraged by the growing levels of investor, gastroenterologist and surgeon interest in our ELS System technology and are working aggressively to advance this development program to an Investigational Device Exemption filing with the U.S. Food and Drug Administration," Azarbarzin added. "We look forward to providing an update on our progress on July 1, 2022 at the Society of Robotic and Digital Surgery's Annual Meeting at the Disney World Yacht and Beach Club Resort in Lake Buena Vista, Florida." About ENDOQUEST Robotics ENDOQUEST Robotics has developed the ENDOQUEST Endoluminal Surgical System, the world's first endoluminal robotic surgical system that makes it possible for therapeutic endoscopists and surgeons to perform upper and lower gastrointestinal surgery less-invasively through a trans-oral or trans-anal approach. ENDOQUEST's robotic platform combines the flexibility of endoscopy that is able to navigate the curvature of patients' anatomy with instrumentation that allows the physician to use a conventional two-handed surgical technique. The ENDOQUEST ELS System has further potential applications in a range of minimally invasive surgeries including appendectomy and cholecystectomy that can be performed with no external incisions.

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Spotlight

Although failure rates in drug development are still quite high, a lot can be done to mitigate the risk. This brand new infographic shows how smart design can increase the chance of success for drug development candidates.

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