< PreviousTHE ETHICS IN GENE EDITING30 Pharma Business International www.pbiforum.netAlthough Jiankui said he was proud of his work, there has been no independent confirmation of his claims and, tellingly, his work has not been published in any journal, where it would have been vetted by other experts. The research only involved one other scientist, the physics and bioengineering professor Michael Deem, who was an advisor at Rice and, it should be noted, holds a small stake in Jiankui’s two companies. What can be quantified, however, was that the research has been largely met with derision, scepticism and outrage from the scientific community. The Southern University of Science and Technology of China has distanced itself from Jiankui’s work, saying it “seriously violated academic ethics and standards”. State media, meanwhile, said he acted illegally and in pursuit of fame and glory with reports alleging his work was conducted without oversight and on his own authority. If some reports are to be believed, Jiankui may have even lied on consent forms, claiming he was working on an AIDS vaccine development rather than gene editing. Even setting aside the ethical concerns, lying on consent forms is not an encouraging sign. Some scientists have denounced the research as akin to human experimentation, while the Chinese government itself said the work was “extremely abominable in nature”. Although there were a few scientists on Jiankui’s side, Dr Kiran Musunuru, a gene editing expert from the University of Pennsylvania, probably caught the pervading attitude by describing the research as “an experiment on human begins that is not morally or ethically defensible”. It’s not CRISPR itself that’s controversial, at least not as far as regulators and the parents of sick children are concerned. For example, in 2015, a one-year-old girl with leukaemia was treated with genetically modified immune cells that cured her cancer. Yes, it was controversial, but all involved were praised. And the CRISPR space is a hive of innovation, taking aim at major health issues and even working to develop better antibiotics. So what’s the problem? The age of the baby isn’t the issue in © Shutterstock /vchal28-31.qxp_Layout 1 05/04/2019 13:29 Page 3© Shutterstock /pogoniciPharma Business International 31www.pbiforum.netTHE ETHICS IN GENE EDITINGdetermining whether or not a treatment is considered ethical, but rather which cells are altered. In the scientific community, there is a clear line in the sand between somatic cells – any non-reproductive cells – and editing germline cells – those involved in reproduction. Editing the germline involves altering a sperm, egg or fertilised embryo. As the edited embryo develops, any change made will propagate throughout every cell in the body, including the sperm and eggs passed on to the next generation. And therein lies the controversy. These changes can echo down the genome of progeny for generations. The use of genome editing in embryos for assisted reproduction in humans is banned in dozens of countries – including in the US and UK – because DNA changes carry to future generations and risk harming other genes. In the wake of the Chinese scandal, a new committee of the World Health Organisation called for an international registry to track studies that edit human embryos and suggested a five-year embargo of editing the DNA of human embryos that women intend to carry to term. The National Institutes of Health in the US, meanwhile, says that there is a lack of medical need surrounding this kind of gene editing, plus safety concerns and profound societal and philosophical issues. There’s no clearly defined answer when it comes to determining the ethics of gene editing. Bioethicists and researchers generally believe that human genome editing for reproductive purposes isn’t something that should be attempted at present. However, all gene editing carries with it a risk, as a scientist may accidentally alter cells near their intended target. Regulators and government agencies are trying to catch up with the dramatic pace of innovation seen in the gene editing space, keen to avoid another scandal. Yet this shouldn’t eclipse the possibilities of gene editing, a tool which can rapidly redefine how people are treated and how inherited diseases are managed. 28-31.qxp_Layout 1 05/04/2019 13:29 Page 4VITAFOODS EUROPE32 Pharma Business International www.pbiforum.netTaking place from 7-9 May at Palexpo in Geneva, Vitafoods Europe will bring the industry together to discuss key challenges such as sustainable sourcing, and wider trends including free-from, plant-based ingredients, and hemp extracts and CBD. This year, Vitafoods Europe is expected to attract 22,000 visitors and will play host to over 1,200 leading global suppliers active in ingredients and raw materials; dietary supplements; contract manufacturing and private label; and services and equipment, exhibiting thousands of quality ingredients and products. As a meeting point for the nutraceutical industry, Vitafoods Europe 2019 will offer visitors an opportunity to source innovative, high-quality ingredients and finished products conveniently at one location, saving both time and resources, and eliminating logistic difficulties. The event has also added to its portfolio and introduced a range of new features, including a brand-new Sustainability Square, which will showcase the latest consumer and market insights from across the industry, allowing visitors to make informed and future-focused buying decisions. To clear-up any confusion around updated or newly introduced EU and global regulations and allow manufacturers to speed up the process to market, Vitafoods has invited experts from the European Federation of Associations of Health Products Manufacturers (EHPM), who will be offering one-to-one consultations as part of a new Regulatory Clinic. While a new Clinical Trials Zone will offer a step-by-step guide to the clinical trial process, a Diversity & Inclusion Roundtable will open the discussion on the importance of establishing diversity in the workforce to create an inclusive environment and the benefits this will bring. Additionally, the Vitafoods Education Programme will return this year with a new flexible structure, giving delegates the chance to attend specific sessions, 32-33.qxp_Layout 1 05/04/2019 13:30 Page 1Pharma Business International 33 www.pbiforum.netVITAFOODS EUROPEindividual days or the full three-day agenda. Running throughout the event the programme will have 11 summits and over 50 industry and business experts, to discuss and debate breakout trends and the industry’s latest studies. To give visitors the opportunity to network in a more relaxed setting, supplementary events are also taking place across the three days, including the Community Breakfast, Diversity & Inclusion Roundtable, Nutrition Capital Network’s sixth annual European Investor Meeting, Good Manufacturing Practices (GMP) Training by EAS Consulting Group, NutraIngredients Awards, 5K Run and Yoga Wellness sessions. For more information and to register for free tickets to Vitafoods Europe, visit www.vitafoods.eu.com. Get involved on social media @VitafoodsEurope 32-33.qxp_Layout 1 05/04/2019 13:30 Page 2Sunday 14 – Wednesday 17 April World Vaccine Congress Washington 2019 Renaissance Washington, DC Downtown Hotel Visitors can use this event to meet with the manufacture and bioprocessing leads who need services for all of the latest manufacturing challenges – from formulating and manufacturing adjuvants, mRNA platforms, VLPs and viral vectors, to technology transfer and continuous manufacturing. To find out more, email tayyab.abbasi@terrapinn.com. Monday 15 – Tuesday 16 April 12th European Biosimilars Congress Berlin, Germany The European Biosimilars Congress brings together the largest assemblage of participants from the biologics and biosimilars community – including scientists, researchers, business development managers, CEOs, directors, IP attorneys, regulatory officers and CROs. Here you can meet your target audience from around the world focused on learning about biologics and biosimilars. For more information, visit www.biosimilars-biologics.pharmaceuticalconferences.com/ Europe. Pharma EVENTS34 Pharma Business International www.pbiforum.net© Narongsak Nagadhana / ShutterstockFor more information, email marketing@oxfordglobal.co.uk. Tuesday 21 – Wednesday 22 May Digi-Tech Pharma 2019 Hilton London Kensington Now in its third year, the annual Digi-Tech Pharma will provide a platform to all its participants an opportunity to interact, share Monday 6 – Tuesday 7 May Neuropharmacology Panorama Hotel Prague, Czech Republic This conference brings the global scientific community together for workshops, exhibitions, keynote presentations, oral talks, video and poster presentation sessions on topics such as neuroscience and pharmacology on top of the event’s overarching neuropharmacology theme. For more, email neuropharmacology@europemeet.com. Tuesday 14 – Wednesday 15 May Cell & Gene Therapy USA Congress Hynes Convention Centre, Boston This important congress will bring together more than 250 delegates representing leading biotech companies, global pharma organisations and internationally renowned academic institutions. It will feature over 20 presentations, case studies and panel discussions focussing on the key issues in cell and gene therapy development, commercialising, market access and clinical trial updates. The congress is co-located with Cell Culture & Bioprocessing USA Congress. Tuesday 16 – Thursday 18 April Korea Pharma & Bio 2019 Korea International Exhibition Centre Korea Pharma & Bio offers an ideal opportunity for announcing the latest materials and technologies to the Korean pharmaceutical and biopharma industries as well as the wider Asia-Pacific region. For more, visit www.koreapharm.org/eng.34-35.qxp_Layout 1 05/04/2019 13:31 Page 1and discuss the digitisation of the pharma industry. It will allow attendees to discuss the various challenges they face, new strategies, case studies and the use of innovative ideas in the field of digital pharma IT. It will also help attendees stay abreast of the latest trends in digital, social media and mobile. To find out more, email info@corvusglobalevents.com. Monday 3 – Thursday 6 June BIO 2019 Philadelphia More than 16,000 attendees from around the globe will gather at BIO 2019 for unparalleled partnering, education and networking, and to see all that the tri-state area has to offer, from universities to research institutions. For more information, email exhibit@bio.org. Tuesday 25 June Pharma Social Media One America Square, London This event will see 21 pharma industry leaders including Roche, Merck, Pfizer, GSK and more share their insights into driving patient & HCP engagement, demonstrating value and securing buy-in whilst ensuring compliance with targeted, impactful strategies which prove social media as a strategic for with measurable impact. To find out more, email info@pharmasocialconference.com. www.pbiforum.netPharma Business International 35© Dorti / Shutterstock© Shutterstock / FahroniMonday 20 – Tuesday 21 May Antibiotics, Antimicrobials & Antibiotic Resistance Radisson Hotel Narita, Tokyo, Japan This timely event is a stage to examine and find out about the most recent progressions in the field of antibiotics and antibiotic resistance. The two-day conference gathers professional from right across the healthcare, medicine and pharma fields to present their opinions through key notes and case study presentations. To find out more, email antimicrobials@asiaconferences.org. Tuesday 30 April – Thursday 2 May CPhl North America The Lakeside Centre at McCormick Place, Chicago This is your chance to establish new business relationships, meet global partners and discover the latest industry trends with fellow senior-level attendees. Network with your peers from across all sectors within the pharma and biopharma industry who specialise in R&D, purchasing and procurement, regulations, chemical development, drug development and more. For more information, visit www.cphinorthamerica.com.34-35.qxp_Layout 1 05/04/2019 13:31 Page 2FEATURES Gastrointestinal disease exposé Treating allergies AI in drug development Funding discovery Patents & IP BiosimilarsNext issue: Deadline - 29th May 2019REGULARS News Events M&A Round-up Eye on approvals Visit us at www.pbiforum.net where you’ll find the latest news as it breaks – and why not subscribe to our newsletters so you can have the latest news emailed to your inbox, in between printed issues?@pbiforumwww.pbiforum.netcompany/po-business-international36.qxp_Layout 1 05/04/2019 13:32 Page 1Next >