APRIL 2019 # 52

Upfront In My View Profession Sitting Down With Taking inspiration from car What’s your Brexit How to get your research Magician of drug delivery, batteries for drug synthesis communications strategy? papers noticed Robert Langer

08 16 46 – 49 50 – 51

THE POWER2019 LIST

www.themedicinemaker.com | Your molecule Our mission

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Discover why we’re the small molecule company, with end-to-end capabilities and experts .you’ll enjoy working with

Valeska Taylor QC Analyst www.cambrex.com Online this Month

THE INNOV AWWA 2019

Celebrating People But talent and inspiring people aren’t been released (or is planned for commercial and Processes the only essential element for developing release) during 2019; and the technology today’s breakthrough drugs – technology must be expected to have a significant impact On page 18 you’ll find The Medicine is also needed. In December 2019, we on drug development or manufacture. The Maker’s annual Power List, which will celebrate some of the latest drug innovation can be a piece of equipment, celebrates 100 of the most inspirational development and manufacturing IT software, formulation technology, drug professionals involved in the pharma technologies to hit the market delivery method or any other innovation industry. Any list will always be throughout the year with our annual that you think will fit the bill. subjective – and if you’d like to comment Innovation Awards! The nomination We can’t wait to see all of the on this year’s list feel free to drop an form for the 2019 Innovation Awards innovations you nominate! email to the Editor at stephanie.sutton@ is now live. texerepublishing.com. The rules: the technology must have http://tmm.txp.to/innovations19-noms

www.themedicinemaker.com Contents

In My View

14 With many formulations failing to meet the needs of patients, Thomas Hein implores manufacturers to keep patients 18 in mind.

16 Neil Hunter explains how companies can use the ever- changing Brexit to their 03 Online This Month Upfront advantage.

08 Battery Powered Inspiration 07 Editorial No Hero Left Unsung, 09 Trials of a Medicine Maker Features by James Strachan 10 New Avenues 18 The Power List 2019 Celebrating the achievements of 11 (Un)Treatable pharma’s finest, The Power List On The Cover Cover is back! The most influential 12 Ready, Steady, Propel! personalities of the year are

APRIL 2019 # 52 Showcasing the best in class. Upfront In My View Profession Sitting Down With included in Masters of the Taking inspiration from car What’s your Brexit How to get your research Magician of drug delivery, batteries for drug synthesis communications strategy? papers noticed Robert Langer

08 16 46 – 49 50 – 51

THE POWER2019 LIST 2019’s Power List is finally here! Bench, Industry Influencers, Champions of Change and

www.themedicinemaker.com Business Captains. ISSUE 52 - APRIL 2019 Editor - Stephanie Sutton 46 [email protected] Deputy Editor - James Strachan [email protected] Deputy Editor - Roisin McGuigan [email protected] Assistant Editor - Maryam Mahdi [email protected] Content Director - Rich Whitworth [email protected] Publisher - Richard Hodson [email protected] Sales Manager - Helen Conyngham [email protected] Business Development Manager - Helen Johnson [email protected] Business Development Executive, Americas - Sarah Griffith [email protected] Head of Design - Marc Bird [email protected] Designer - Hannah Ennis [email protected] Junior Designer - Charlotte Brittain [email protected] Digital Team Lead - David Roberts [email protected] Digital Producer Web/Email - Peter Bartley [email protected] Digital Producer Web/App - Abygail Bradley [email protected] Audience Insight Manager DPO - Tracey Nicholls [email protected] Traffic & Audience Database Coordinator- Hayley Atiz [email protected] Project Manager - Webinars - Lindsey Vickers [email protected] Traffic and Audience Manager Jody- Fryett [email protected] Traffic Assistant Dan- Marr [email protected] Events Manager - Alice Daniels-Wright 50 [email protected] Event Coordinator - Jessica Lines [email protected] Marketing Manager - Katy Pearson [email protected] Marketing Executive - Sarah Botha [email protected] Social Media Manager - Joey Relton [email protected] Financial Controller - Phil Dale [email protected] Accounts Assistant - Kerri Benson [email protected] Chief Executive Officer - Andy Davies [email protected] Chief Operating Officer - Tracey Peers [email protected] Senior Vice President, North America - Fedra Pavlou [email protected] Change of address: [email protected] Hayley Atiz, The Medicine Maker, Texere Publishing Limited, Booths Park 1, Chelford Road, Knutsford, Cheshire, WA16 8GS, UK General enquiries: www.texerepublishing.com [email protected] +44 (0) 1565 745200 [email protected] Distribution: The Medicine Maker (ISSN 2055-8201), Profession Sitting Down With is published monthly by Texere Publishing Limited, Booths Park 1, Chelford Road, Knutsford, Cheshire, WA16 8GS, UK. 46 The Art of Writing 50 Robert S. Langer, David Single copy sales £15 (plus postage, cost available on request [email protected]) Want to get noticed? Don’t H. Koch Institute Professor, Non-qualified annual subscription cost is treat the preparation of papers Massachusetts Institute of £110 plus postage Reprints & Permissions – [email protected] The opinions presented within this publication are those of the authors as an afterthought. Technology, USA. and do not reflect the opinions of The Medicine Maker or its publishers, Texere Publishing. Authors are required to disclose any relevant financial arrangements, which are presented at the end of each article, where relevant. © 2018 Texere Publishing Limited. All rights reserved. Reproduction in whole or in parts is prohibited. www.themedicinemaker.com Our Commitment, The Industry Leading Experience

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Biotec Services International is part of Biotec Worldwide Supplies Group of companies, Registered in Wales No.3483803. VAT Registration No. GB 108216149. No Hero Left Unsung There are few things more inspirational than someone making a positive Editorial difference without the need for recognition – but you have to find them first.

hen I visited Dublin for the International Society for Pharmaceutical Engineering’s (ISPE) European conference, I was pleased to find a Wcopy of W.B Yeats’ collected poems sat on the bedside table in my hotel room. I’ve read more than one article pointing out the relevance of a famous line in The Second Coming to current times: “Things fall apart; the center cannot hold.” But I think that’s taking things a bit too far – after all, Yeats wrote the poem in the wake of the First World War, the Russian revolution and political upheaval in his native Ireland. Instead, I’d like to reflect on another line in the poem, “The best lack all conviction, while the worst are full of passionate intensity.” To me, Yeats’ line is about how turmoil energizes and empowers the worst of us, while leaving others unsure and afraid, but it also works more generally. During my time at The Medicine Maker, I’ve had the pleasure of speaking to many leading scientists, thinkers, and business people passionately working to make the world a better place. Though not lacking in conviction, these people are often remarkably humble, and can be reluctant to shout about themselves. Cornell Stamoran expresses a similar sentiment beautifully on page 25, “I’m frequently inspired by seeing the dedication of ‘unsung’ heroes – people who persevere and perform in important but less visible jobs every single day, without drama or the need to be recognized.” We understand that such people don’t need recognition, but it’s to our industry’s detriment if we fail to do so – whether they like it or not! The pharmaceutical industry does deserve its bad press at times, but is the coverage fair overall? It surely won’t be unless we showcase and celebrate the best our industry has to offer. And if people aren’t given the recognition they deserve, how will others be inspired, as Cornell has been? These questions get to the heart of why we’re proud to bring you The Medicine Maker Power List 2019 (page 18). Clearly, there are many inspirational and talented women and men who will not appear in this years’ top 100 – the limitation of a finite list. And so, I urge you to nominate your brilliant, yet underappreciated, colleagues for next year’s list, by emailing me directly: [email protected].

James Strachan Deputy Editor

www.themedicinemaker.com 8 Upfront

Upfront ReportingReporting on researcresearch,h, ppersonalities,ersonalities, ppoliciesolicies and partnerships that are shshapingaping phpharmaceuticalarmaceutical ddevelopmentevelopment andand mmanufacture.anufacture.

WWee welcome ininformationformation highly flammable and even explosive when on any developments in Battery Powered exposed to air or water. Though large scale Birch reactions are tthehe industrindustryy that have Inspiration few and far between, the Scripps team rreallyeally caughtcaught youryour eye,eye, were spurred on by a story of a successful iinn a good or bad way.way. A battery-like system could attempt. “Our motivation to accomplish our EEmail:mail: [email protected]@ help enhance the manufacture goal peaked when we discovered Pfizer’s of drugs kilogram-scale synthesis of the anti- ttexerepublishing.comexerepublishing.com Parkinson’s F1 drug candidate sumanirole, Electric cars are feats of engineering which employed a Birch reduction. What and technology that ultimately provide they had achieved was a rare and remarkable cheaper and cleaner transport options. achievement in chemical manufacturing! And their batteries have recently become Despite the risks, we weren’t prepared to a source of inspiration for scientists at shy away from the challenge,” adds Byron Scripp Research, who have developed a Peters, postdoctoral associate in the Baran system to help with small molecule drug Lab. Pfizer used customized equipment manufacturing (1). to administer lithium metal and enough The team, led by Phil Baran, a professor ammonia to fill three Boeing 747 airliners at Scripps Research and a member of in the gas phase. 2300 liters of flammable The Medicine Maker 2019 Power List, hydrogen gas was liberated on quenching developed the system in response to a the reaction. challenge set by Pfizer to synthesize a Baran’s team, however, have developed compound at the commercial scale using a method that avoids the dangers a Birch reduction. The reaction has been commonly associated with the process. a staple for organic chemists since the During their early experimentation, 1940s; reactive metals, like lithium, are they noticed the build up of solids on dissolved in liquid ammonia to manipulate the electrodes used in their reactions. molecules with ring-shaped structures. When they consulted their collaborators, “Although the Birch reaction is commonly Shelley Minteer, a professor at the used, the use of lithium and ammonia University of Utah, and Matt Neurock, make it highly unsafe and malodorous,” Shell Professor of Chemical Engineering explains Baran. Birch reactions on the and Materials Science at the University kilogram-scale are often avoided by of Minnesota, they realized that they chemists due to the risks that they present. were observing the formation of solid Ammonia is highly corrosive and irritating electrolyte interfaces (SEIs). SEIs to the eyes and the skin, while lithium is protect the lithium within electrodes Upfront 9

from overcharging or being consumed of the paper detailing the group’s research. able to achieve it in a safe, cost-efficient by surrounding media and are used Most excitingly for the team was the fact way,” Kevin Rodriguez, NIH Diversity in batteries, including those used for that they were able to scale-up the reaction Research Fellow at the Baran Lab says. electric cars, smartphones and laptops. to a 100-gram scale for less than $250 with “This adventure really shows off the Using their newfound understanding of the help of Asymchem, a CDMO based power of collaboration between industry SEIs to their advantage, the team began to in China. and academia, especially in identifying investigate a range of additives designed to The team is looking forward to and solving real problems that require manipulate the SEI layer’s thickness and using their electrochemical discovery a realm of interdisciplinary knowledge protect the integrity of the electrochemical in other avenues of synthesis and as a that spans beyond one’s own field.” cell. “With a more intuitive sense of how draw to entice more chemists to use to improve the reaction, we identified two electrochemistry as a synthetic tool. Reference cheap non-toxic reagents which enabled However, they are still firmly focused 1. P Baran, “Scalable and safe synthetic organic us to carry out the Birch reaction at room on developing scalable methodologies. electroreduction inspired by Li-ion battery temperature,” explains Solomon Reisberg, “Reaction scalability was our goal chemistry”, Science, 363, 838-845. (2019) Graduate Research Fellow and co-author from the outset. We’re glad that we were PMID: 30792297

For more adventures featuring Gene and Eva check out our website themedicinemaker.com/additional-data/cartoons If you have any ideas you’d like to see in future comic strips about bioprocessing then get in touch with us at [email protected] or look up #TrialsOfAMedicineMaker on Twitter.

Brought to you by GE Healthcare www.themedicinemaker.com 10 Upfront

How does ZINC compare with other screening platforms? ZINC is 100 times larger than the average high throughput screening library used in pharma. And although, in principle, DNA encoded libraries (DELs) are often reported to be of a similar size, we believe our library is much more chemically diverse because ours supports over 10 times as many bond- forming reactions to build it, and it is more tolerant of diverse chemical functionality. Many medicinal chemistry programs lead to candidates that resemble the initial hit they began with. Our approach should open up entire new areas of chemical space for medicinal chemists to explore.

Has the platform identified any potential drugs through its virtual screening process? Drug discovery is a long and arduous New Avenues What inspired the development of process, but we’re pleased to say that the platform? PZM21, an opioid analgesic, is currently Offering scientists the In 2016, my colleagues and I learned in preclinical development by Epiodyne (a opportunity to screen hundreds about Enamine, a Kiev-based company biotech company which produces small of millions of never-before- that produces novel building blocks molecule drugs). PZM21 was based on a made small molecules is ZINC, a (including chemical reagents, scaffolds discovery using our platform. virtual pharmacological library and intermediates) and screening libraries. By combining the various building blocks What’s next for ZINC? Docking is the most pragmatic approach using over one hundred standard chemical Constraints such as receptor flexibility, to discover new small molecules to reaction schemes, the company had a huge scoring function and ligand chemistry that modulate protein function. The process breakthrough in their ability to deliver once held researchers back are now gone. enables scientists to model interactions hundreds of millions of never-before- The platform offers them the opportunity between small molecules and proteins made compounds on demand at the cost to really make a difference within the at the atomic level and make predictions of around $100 per molecule. We were drug development space and its rapid about the preferred orientation of intrigued by their work and partnered growth means that we are on target to molecules. Researchers at the University with them with the hope of creating a have one billion commercially available 3D of California, San Francisco have used the new type of screening library. molecules in biologically relevant forms in docking technique for over two decades With the support of the National ZINC by the summer of 2020. It’s a huge to discover new drug-like molecules. Institutes of Health (NIH), we actively achievement and I can’t wait to see how it The work of the researchers has resulted began to add the compounds produced will contribute to improving patient lives. in the creation of ZINC, an enormous by Enamine to our open-access platform, virtual pharmacology database, which ZINC, and within the space of a few Reference will soon contain over a billion molecules. months our library had increased ten-fold 1. JK Lyu et al. “Ultra-large library docking Could some of these be the blockbusters in size and within the space of a year, fordiscovering new chemotypes,” Nature 566, of the future? John Irwin a professor of 100-fold! ZINC now houses 750 million (2019).PMID: 30728502. pharmaceutical chemistry at UC San different compounds within its library. Francisco discusses the development of The hits generated from the platform what they claim is the world’s largest can be downloaded in both 2D and 3D pharmacology platform. formats ready for docking. UpfrontUpfront 11

(NDA) to the FDA for the approval of to reconnect, thus improving synaptic (Un) a novel esketamine-based nasal spray for plasticity (the efficiency of information the treatment of TRD - and in February transfer through synapses – the junctions Treatable the drug was recommended for approval between neurons). Though there were by the FDA’s Psychopharmacologic delays in the approval process due to Could an esketamine Drug Advisory Committee and Drug the US government shutdown, Janssen nasal spray improve Safety and Risk Management Advisory has already filed for approval in the EU the lives of people with Committee (3). and intends to do the same in otherr treatment-resistant The drug will be used alongside international markets. depression? conventional oral antidepressants. “We decided to pursue development References Once a club drug of a bygone era, of an enantiomer - or one side of the 1. WHO, “Depression”. Available at https://bit. ketamine has found a new lease of life as ketamine molecule - because it could ly/2RKuN3v. Last accessed March 29, 2019. an FDA-approved therapy for treatment- be formulated as a nasal spray, allowing 2. Priory Group, “Supporting treatment resistant resistant depression (TRD). According to appropriate patients in need to have depression”. Available at https://bit. the WHO, depression is the leading cause access to it,” a spokesperson from Janssen ly/2RX3Mx2. Last accessed March 29, 2019. of disability worldwide (1) with TRD explained. 3. Janssen, “Janssen Submits Esketamine Nasal affecting 50 percent of all patients and Though the mechanism of action of Spray New Drug Application to U.S. FDA for carrying an increased risk of suicide (2). ketamine is not completely understood, Treatment-Resistant Depression” (2018). In September of 2018, Janssen it is thought that the drug acts upon Available at https://bit.ly/2Or6ZmZ. Last announced its New Drug Application the glutamate system allowing neurons accessed March 29, 2019.

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active propulsion to oral vaccines, we coated with a layer of red blood cell Ready, Steady, could facilitate their enhanced processing membrane to help cue the immune by the immune system. This would, in system and allow it to illicit Propel! turn, generate a much stronger immune appropriate responses.”nses.” response (in the form of higher antibody To allow thee motormotor Can micromotors give oral levels) compared with formulations that cores to adhere to tthehe vaccine technology the boost lack propulsion,” explains Ronnie Fang, intestinal walll lininglining it needs? an Assistant Project Scientist at UC and protect themhem the San Diego. harsh environmentent of the Although some oral vaccines can The motor vaccine formulation, stomach, the researcherssearchers stimulate immune cells in the mucus developed by the La Jolla based team, added additional cchitosanhitosan layer of the intestine to produce IgA (a consists of several components, but and enteric polymermer llayersayers class of antibody), insufficient at the heart of the drug is a to coat their molecules.olecules. potency has prevented most magnesium core coated in The team weree ableable toto of them from conferring titanium dioxide used to successfully feedeed their ample protection against propel the vaccine. formulation to micece aandnd ffoundound pathogens. Researchers “The titanium that the propulsionon mecmechanismhanism at the University of coating on the they had devisedd enabled bettebetterr San Diego, however, core is placed retention of the vvaccineaccine materiamateriall on have developed oral asymmetrically the intestine wall and greatergreater amounts vaccines with a twist: aallowing one side of antibody when compared with static they are powered by off the magnesium microparticles. They believe that the micromotors to target the cocore tot bbe exposed to concept of motor-based vaccines should mucus layer of the intestine. interactinnt rac wwithit ththe biological be applicable to any type of infectious “We hypothesized that by fluidsflui s ththatat ppowerowe ttheh motors,” disease, once its safety in humans has using micromotor technology to addd explainse pla nss Fang.Fang “The“The motmotoro coreis is then been tested. Biocompatibility Redefined.

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Don’t Forget swallowing much more complex. And swallowability is not the only issue to In My About the Patient consider; a declining loss of force and dexterity can make it challenging to even Pharma manufacturers are open packaging. In my view, however, View not embracing patient-centric difficulties swallowing tablets transcend design when it comes to all age groups. formulation. We need to go The idea of putting the patient at the In this opinion section, beyond tablets and capsules. centre of product design isn’t new, and experts from across the yet for many pharma companies, it is a world share a single paradigm shift from what’s gone before. For example, many pain relief and cough strongly held view or and cold medicines available on the key idea. market today contain APIs that were developed decades ago, when usability Submissions are welcome. By Thomas Hein, Director Sales & was a minor concern for companies. Business Development at Hermes Exacerbating the problem, however, is Articles should be short, Pharma, Germany. the fact that companies launching generic focused, personal and successors of these products often default passionate, and may Designing products that cater to the to the same dosage forms. Many simply specific needs of consumers/patients do not consider alternative user-friendly deal with any aspect seems logical for any competitive market. dosage forms that would better meet the of pharmaceutical In pharma, however, many companies are needs of patients and consumers, and development or still not designing truly patient-centric rejuvenate aging products. medicines. Tablets and capsules have been Tablets and capsules are often manufacture. the go-to dosage form for decades, but for considered the best option from a They can be up to 600 a significant number of patients, tablets regulatory standpoint, and are also words in length and and capsules can present problems. A cheap and easy to formulate. There are survey found that, of approximately 2000 relatively few manufacturers with the written in the first person. people surveyed in the US and Germany, specialist expertise and technologies over half reported difficulties swallowing required to make well-designed Contact the editor at: tablets and capsules, with many finding alternative dosage forms cost-effectively. stephanie.sutton that these dosage forms were too large, Regulatory authorities rightly require became stuck in the throat, or had an new medicines to be fully characterized @texerepublishing.com unpleasant taste or odor (1). As a result, and well-understood before they can be some of those questioned reported not approved, but the stringent regulation has taking their medicine in the intended led pharma companies to adopt a cautious way, such as by crushing conventional approach to innovation. User-friendly tablets or dissolving them in water – or dosage forms, such as effervescent and not taking them at all. chewable tablets, lozenges and orally These issues are particularly apparent disintegrating granules, are becoming in older patients. As explained in the more well known with established February cover feature of The Medicine manufacturing methods but their use Maker (2), elderly patients are more is still not the “norm”. With many susceptible to issues with swallowing. companies looking to bring their The natural aging process can cause medicine to market as quickly as possible, a weakening of the muscles of the tablets and capsules are often perceived as oesophagus and reduce saliva production, the quickest and easiest solution, despite which makes the intuitive mechanism of the fact that they create challenges for In My View  15

large numbers of patients and consumers. for instance, ODGs are much more disintegrating tablets, for example, stay User-friendly dosage forms present widely-used than in the US and UK, in the mouth for a long duration so taste many advantages. Orally disintegrating while in many Scandinavian countries, is very important, as well as mouth feel granules (ODGs) and effervescent the most popular dosage form for and even smell. But it takes significant tablets can be combined in a single dose painkillers is effervescent tablets. When expertise and experience to ensure that to overcome the issues associated with deciding on the best formulation route, compatible flavoring excipients are polypharmacy, for example, and coating it’s very important to understand subtle chosen that work in harmony with the technologies can be used to develop market differences, but always remember API. Appearance is also important for extended release formulations that deliver that modern patients and consumers some alternative oral dosage forms. If you APIs over a sustained period, reducing the increasingly expect convenience in all are developing an effervescent tablet that burden on patients who would otherwise areas of their life. If medicines can’t be dissolves in water, for example, you must need to take several individual doses. transported or fitted easily into routines choose excipients that will dissolve fully Patient-centricity is particularly then patients will look for alternatives, in water leaving no residues or creating important for over-the-counter medicines, if available. foam, and it’s important to ensure where patients will, undoubtedly, look for Of course, there are also differences the solution looks good in the glass. products that best match their individual when developing medicines for different Developing patient-centric products that needs and lifestyles. In our study, we age groups. Going back to elderly patients, appeal to consumers isn’t just essential found that around 9 in 10 people had although user-friendly alternatives may for over-the counter medicines, it can used effervescent tablets and lozenges. address their needs to a greater degree also help patients to better comply with In some countries, novel dosage forms than traditional tablets and capsules, prescription medicine regimes by making are more widely accepted; in Germany, there can be other challenges. Orally them feel good about their medicine. 16  In My View

While the pharma industry may largely because the industry takes its References often claim to be “patient-centric”, responsibility for safeguarding health 1. Hermes Pharma, “Swallowing many companies are thinking in terms very seriously. But companies are Difficulties.” Available at: of molecules or brands, rather than the recognizing that, with the right expertise https://bit.ly/2Wov2mW. Accessed March 25, patients who need to take the medicines. and technologies, these hurdles can be 2019. The one-size-fits-all approach still overcome, and the benefits that come 2. M Mahdi, “More Than Just A Number,” The dominates, and the needs of specific with a more patient-centric approach to Medicine Maker, 50, 23-33 (2019). patient groups remain unmet. This is product design are well worth it. Available at: https://bit.ly/2V0ksCp.

articles published in The Medicine Maker profile in the market, while their competitors Speak Up! – which frequently appear in most-read lists who declined to comment missed out. online – and elsewhere to appreciate the As long as you’ve done your homework The evolving Brexit landscape opportunities available. and what you’re saying is factually correct, provides ample opportunities For example, in 2016, a group of US the risks of talking about a controversial topic for companies to position senators proposed a new piece of legislation on like Brexit are low. In fact, the opportunity themselves as leaders and how cell and gene therapies were developed cost of not putting your position across in influencers. So long as they and approved. We had a client that put across press releases and interviews can be quite are willing to communicate. their thoughts on the legislation in a press significant. Effective communication release – what its implications might be, how means gaining influence and visibility they felt it could be improved. And within in the market. That in turn can result in five hours, we had the senator’s office ringing new customers, potential partnerships us up trying to broker a meeting to work out and investment – and can even impact the how the legislation could be amended to suit evolution of the landscape itself. If you’re the market better. That’s the moment you not positioning yourself as a thought realize your influence extends further than leader, gaining visibility, and shaping the By Neil Hunter, Life Science and even you thought! discussion in this way, you can be sure that Corporate Communications PR Director The key to effective communication on your competitors will be doing so. at Image Box PR, UK. controversial topics is to think strategically At the time of writing, we don’t know what about what value you can add to the the outcome of the Brexit negotiations will be. The biopharmaceutical industry, like many discussion. It can be useful to benchmark In the months following April, the Article 50 others, has felt the uncertainty surrounding what’s been said before – you may well be negotiations could still be ongoing; the UK the Brexit negotiations – and it’s quite putting forward an argument that contradicts could in a transitional period having ratified remarkable that, at the time of writing, what the market has previously put forward. the Withdrawal Agreement, negotiating the we still don’t know what the outcome will This isn’t a problem, but if you’re planning future relationship; or outside the EU entirely be. Brexit, especially a “harder” Brexit, on speaking to journalists then you’ll need after leaving without a deal. This means there certainly brings risk. But with an evolving to think carefully about how to justify what will be ample opportunities for companies landscape comes new opportunities to you’re saying without being insulting. to step up and make the case for what they shape that landscape to your benefit and to I’ve seen numerous examples of companies want out of the ongoing Brexit negotiations. the benefit of the industry, provided you’re making a success of talking about controversial Of course, the industry has largely been willing to communicate. political topics. Another example was just united in it’s support of a close relationship During periods of uncertainty, people after President Trump proposed a 20 percent between the UK and EU. And with the look to one another for answers, for the drop in the US healthcare budget, and a negotiators so far being unable to guarantee right questions, and for leadership. Some number of biopharma companies made such an outcome, some may be feeling companies will be reluctant to speak on strong cases for why such a move would apathetic about the whole thing. But just controversial topics – especially political indirectly impact their business. Even if they remember, the benefits of communication ones like Brexit. But you only have to weren’t able to change government policy, extend far beyond the ability to influence look at the reception to some of the Brexit they were able to gain some influence and the outcome. So don’t be afraid to speak up. COMPRESSION TOOLING

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THE POWER2019 LIST

Breakthroughs at the bench, novel technologies and groundbreaking policies and regulation have helped the pharma industry grow from strength to strength. After months of collating reader nominations and judging overseen by a panel of industry experts, we proudly present The Medicine Maker 2019 Power List, featuring 100 of the industry’s pioneers across four categories: Industry Influencers, Business Captains, Masters of the Bench, and Champions of Change. 20 FeatureFeature

INDUSTRY INFLUENCERS

JIM AGALLOCO

PRESIDENT, AGALLOCO & ASSOCIATES MADHAVAN (MADHU) BALACHANDRAN Jim has over thirty years of management experience in pharmaceutical BUSINESS OWNER, manufacturing and engineering. As MJB CONSULTANTS President at Agalloco & Associates, he provides a wide range of technical Since retiring from his position as services to the pharmaceutical and Executive Vice President at Amgen biotechnology industries in areas such in 2016, Mahdu hasn’t slowed down. as validation, serialization and facility Alongside running his own business, design. Over the last five years staying mjb Consultants, he currently serves active, physically, socially and mentally as a board member of Catalent, an has become a key focus in Jim’s life. “The independent director for the Stevanato time we are given is not infinite, so we Group, as well as a non-executive have to make the most of it!” director of uniQure N.V.

compliance. He has been very active starting out. “I truly believe that we in the Parenteral Drug Association, don’t impart or teach these concepts including a stint as Chair. “I try to make sufficiently. I realize that these are softer a difference, make time to give back skills than the technical and operational to the industry, and do things to help initiatives that we are involved in as improve how industry manufactures an organization, but my sense is that quality drug products so that those we should be aware of these early on products are safer, more affordable and in our careers. Afterall, international available to patients,” he says. cooperation among professionals, academics and companies is increasing as we confront common challenges in JOHN E. BOURNAS the global supply chain,” he says.

PRESIDENT AND CHIEF EXECUTIVE OFFICER, HAL BASEMAN INTERNATIONAL SOCIETY FOR PHARMACEUTICAL CHIEF OPERATING ENGINEERING (ISPE) OFFICER, VALSOURCE John says he wishes he’d known about Harold (Hal) has over 39 years the power of collaboration – sharing of experience in pharmaceutical knowledge and doing so respectfully operations, validation, and regulatory across cultures and geographies – when THE POWER2019 LIST

JON COFFMAN GARY CUNNINGTON

GLOBAL HEAD INNOVATION GLOBAL HEAD OF BUSINESS AND TECHNOLOGY, CONSULTANCY (CTSU), BOEHRINGER INGELHEIM BOEHRINGER INGELHEIM

As Global Head of Innovation and Gary regularly speaks at conferences Technology, Jon’s expertise lies in about safeguarding patient data during CMC development and continuous clinical trial supply. Nominators praised bioprocessing. He has served as the co- Gary for his inspirational leadership chair of the Recovery of Biological Products and coaching workshops. “It’s not just Conference for over 16 years. thinking outside of the industry confines, but changing the entire mind-set related to patient care. Inspiration is the key to JIM BREEN empower individuals to create a change CARLO DE of such magnitude,” he says. VICE PRESIDENT, LEAD NOTARISTEFANI BIOLOGICS EXPANSION, JANSSEN PHARMACEUTICALS EEXECUTIVEXEC UTIVE VICEVIC E PRESIDENT,PRES IDENT, GGLOBALLOBAL OPERATIONS,OPERATIONS, TEVA “The pace of change in the world today PPHARMACEUTICALSHARMAC EUTIC ALS is extremely fast and will only accelerate as we see the impact of technological “For“For qquiteuite some time, I have and digital innovation. Each of us deliberatelydeliberately soughtsought out thosethose whosewhose individually can make an impact views,views, perspectivesperspectives and prprioritiesiorities each day if we are focused and want areare didifferentfferent toto mine.mine. I I hahaveve hhiredired to make a difference. We all have the somesome of these people to my team ability to improve the lives of patients atat Teva and have engaged with via collaboration on the local and othersothers throughthrough ggeneraleneral ddiscussion.iscussion. global level, challenging why we do AAss a matter of practice, I encourage things to streamline processes, and debatedebate whenwhen ddecisionsecisions must bebe applying science to accelerate delivery mademade or strategic choices evaluated. of new therapies to patients. Our Of courscourse,e, tthesehese conversations must industry needs to collaborate more bebe constructive and fact-based to be to solve unmet patient needs through productive.productive. By seeking out these differendifferentt faster execution and delivery to the perspectives,perspectives, I havehave foundfound tthathat I not ononlyly patient. Use of industry forums to havehave a much better understanding of our help accelerate these innovations stakeholders,stakeholders, butbut at times I hhaveave aalsolso will provide our patients with the adjustedadjusted mmyy decisions and stratestrategiesgies medicines they need quicker.” as a rresult.”esult.” 22 Feature

MAIK JORNITZ

CHIEF EXECUTIVE OFFICER, DOUG HAUSNER G-CON MANUFACTURING

ASSOCIATE DIRECTOR, C-SOPS/ “Working for patients and DEPARTMENT OF CHEMICAL AND hopefully making a difference to BIOCHEMICAL ENGINEERING, improve treatments and access to RUTGERS UNIVERSITY treatments is what drives me day to day. I am very passionate about Doug’s work at C-SOPS has a strong the patient since this is the person emphasis on continuous manufacturing we all work for – no matter what and FDA initiatives, supporting position or function you are in. To quality by design. Doug believes that improve the industry, I think we “boundless energy and determination” need to be able to make technology are important when trying to gain new changes much faster, especially technical and soft skills. when these changes improve the safety, quality and efficiency of manufacturing processes.”

Tony has over 30 years of experience in the large-scale manufacture of biopharmaceuticals. As a founding staff member of Cobra, he has been responsible for the development of much of Cobra’s manufacturing technologies in the field of DNA and virus production. “A number of people have inspired me, both within the companies I have worked for and outside. A key person was David Thatcher who I worked with for over 19 years and had great scientific insight into the area of bioprocessing. I have also been fortunate to work with a wide range of customers, developing highly innovative and novel products. A key academic who has inspired me is Professor TONY HITCHCOCK Alvin Nienow, who I have worked with for over 20 years and at 82 is still teaching and TECHNICAL DIRECTOR, inspiring the next generation of scientists in COBRA BIOLOGICS the field.”

RICHARD JOHNSON Many of the biggest impacts on modern life focus on improving the manufacturing of have come through better prevention and these products, many patients will not PRESIDENT AND CHIEF treatment of diseases. Life expectancy and receive the quality of pharma products they EXECUTIVE OFFICER, quality of life have dramatically changed need. Exciting new therapies are coming PARENTERAL in my lifetime, and any contribution that I into the market: cell and gene therapies, DRUG ASSOCIATION can make is an intrinsic good! But I would and integrated drug, device, diagnostic like to see more focus on improving the products. We must also continue to focus “Day-to-day, I never forget that the ultimate manufacturing of pharma products. The on improving the manufacture of existing users of pharmaceutical products are people, predominant business model is to focus on therapies, that serve the vast majority of including our families, friends and ourselves. new therapies, but without a corresponding patients worldwide.” JIM MILLER

CONTENT ADVISOR AND CONSULTANT TO THE DRUG, CHEMICAL & ASSOCIATED TECHNOLOGIES ASSOCIATION (DCAT)

With a passion for the biopharmaceutical industry, Jim regularly speaks at pharmaceutical industry events including DCAT and CPhI. The industry expert founded PharmSource Information Services in 1996. The company was subsequently acquired by GlobalData 10 years later.

JOHANNES KHINAST

HEAD OF THE INSTITUTE FOR PROCESS AND PARTICLE ENGINEERING, THE GRAZ UNIVERSITY OF TECHNOLOGY; SCIENTIFIC RINO RAPPUOLI DIRECTOR, RESEARCH CENTER PHARMACEUTICAL CHIEF SCIENTIST AND HEAD ENGINEERING GMBH MICHAEL O’BRIEN EXTERNAL R&D, GSK

With an interest in the development PRESIDENT, NEXTGENTECH Rino’s contributions have had a of novel drug formulations, phenomenal impact on the vaccines Johannes has worked with numerous Michael has held executive leadership industry. He was involved in the pharmaceutical companies as an positions for over 20 years with development of CRM197 used in advisor for the implementation of companies including Pfizer and Sanofi- H.influenzae, N.meningitidis, and such technologies. With over 120 Aventis. He has served as the President pneumococcus vaccines, and has also peer-reviewed publications and of NextGenTech since November introduced several novel scientific awards including the NSF Career 2017. NextGenTech is made up of a concepts – genetic detoxification Award to his name, his passion multidisciplinary team of pharmaceutical (1987), cellular microbiology (1996), for pharmaceutical engineering industry experts who help companies reverse vaccinology (2000) and the is undeniable. achieve their businessess objectives. pangenome (2005).

www.themedicinemaker.comnemakere ANDREW D. SKIBO 24 Feature TECHNICAL ADVISOR TO EVP OPERATIONS AND IT; ASTRAZENECA GUIDO RASI “If you lead it, you own it – no EXECUTIVE DIRECTOR, excuses.” Andy has lived by this EUROPEAN MEDICINES AGENCY mantra throughout this working life. “It is imperative that a leader has an Guido is serving his second term as Executive unflinching accountability to those in Director of the EMA, having served as his charge. As the leader of a company the EMA’s Principal Adviser in Charge you must be able to prioritize products of Strategy between terms. He previously with the most potential. Some worked for the Italian Medicines Agency, development paths will inevitably the Institute of Molecular Medicine of the fail but some must succeed and every National Research Council in Rome, and as sinew of enterprise energy needs to be a physician. exercised in driving to that end result.”

DEEPAK SAPRA MONCEF SLAOUI GIL ROTH SENIOR VICE PRESIDENT & PARTNER AND MEMBER OF FOUNDER AND PRESIDENT, HEAD OF PHARMACEUTICAL SCIENTIFIC ADVISORY PHARMA & BIOPHARMA SERVICE AND ACTIVE BOARD, MEDICXI OUTSOURCING ASSOCIATION INGREDIENTS, DR REDDY’S LABORATORIES During his nearly 30-year career As President of the Pharma at GlaxoSmithKline, Moncef & Biopharma Outsourcing “My parents have been my biggest was an industry powerhouse who Association, Gil is trying to change inspiration; my mother for her belief championed advances in drug the outsourcing landscape for the in the goodness of people and that discovery and development. He better by giving CDMOs a unified empathy should be a key aspect of all now sits on the advisory boards of voice within the industry to address our interactions and my father for his Medicxi Ventures, the Agency for regulators with. Alongside his work continuous commitment to learning Science, Technology and Research, with the pharma industry, Gil and improving (he is in his late 70s and the Qatar Foundation, helping runs a podcast called The Virtual and pursuing a PhD in an area he feels to support the global industry with Memories Show. deeply about).” his pharma know how. CORNELL STAMORAN

VP OF CORPORATE STRATEGY AND GOVERNMENT AFFAIRS, CATALENT PHARMA SOLUTIONS

“I’m frequently inspired by seeing the dedication of “unsung” heroes – people who persevere and perform in important but less visible jobs every single day, without drama or the need to be recognized. The sense of mission that drives them to persevere despite large obstacles and relatively low return has truly influenced the way I have approached my career.”

BERNHARDT TROUT

RAYMOND F. BADDOUR, SCD, (1949) PROFESSOR OF CHEMICAL ENGINEERING, MASSACHUSETTS INSTITUTE OF TECHNOLOGY

Bernhardt has been a professor of MICHAEL VANDIVER chemical engineering at MIT since 1998. His work on small molecule VICE PRESIDENT OF crystallization, formulation, and MANUFACTURING & manufacturing has had a significant PLANT DESIGN, JUST JAMES N. THOMAS impact on the pharma industry. He BIOTHERAPEUTICS sights Margaret Rousseau, the mind CHIEF EXECUTIVE OFFICER behind the first commercial plant for Michael has over 30 years of AND FOUNDING PARTNER, penicillin production, as his inspiration. biopharmaceutical process JUST BIOTHERAPEUTICS development and manufacturing experience. At Just Biotherapeutics, Over the course of his career, Jim he led efforts to bring the company’s as contributed to the advancement J.Plant and J.Pod clinical and of many important therapeutics commercial biomanufacturing including Activase, Vectibix, Enbrel, facilities online. “I would like to see Prolia/Xgeva and Repatha, as well as the cost of biologics driven down, as numerous biosimilar programs. Jim well as the expansion of global access has built teams, departments and to medicines, where cost savings are functions passionate about creating passed onto patients rather than and using innovative technologies increasing profit margins.” Looking to deliver to the needs of patients. back, Michael wishes he’d realized Just Biotherapeutics was set up to earlier that, “you will fail more times improve the access of medicine to than you will succeed, but failure is patients worldwide. how you will learn.”

www.themedicinemaker.com STÉPHANE BANCEL

CHIEF EXECUTIVEIVE OOFFICER,FFIC ER, MODERNA THERAPEUTICSRAPEUTICS

Prior to Moderna,na, where he has served sincence OctoberOctober 2011, Stéphane wwasas CEO of bioMérieux and hashas alsoalso heldheld leadership positionstions at Eli Lilly. Moderna currentlyurrently has 20 messenger RNAA developmentdevelopment candidates in its portfolio,portfolio, with 11 in clinical studies. OLIVIER BRANDICOURT

CHIEF EXECUTIVE OFFICER, SANOFI

Oliver started his career as a physician working primarily on malaria – BUSINESS practicing medicine in the Republic of CAPTAINS the Congo for two years. In addition to his responsibilities at Sanofi – he became CEO in April 2015 – he is also Chairman of the Board of Management for PhRMA, Vice President of EFPIA, and an Honorary Fellow of the Royal College of Physicians in London.

ROBERT A. BRADWAY MINZHANG CHEN

CHAIRMAN AND CHIEF CHIEF EXECUTIVE OFFICER, EXECUTIVE OFFICER, AMGEN WUXI STA

Robert was appointed CEO of Amgen Minzhang Chen joined WuXi AppTec in May 2012. Before Amgen, he was a in 2008 and currently serves as CEO of managing director at Morgan Stanley in WuXi STA, the small molecule process London. Today, Robert is also the chairman development and manufacturing of the CEO Roundtable on Cancer, a subsidiary of WuXi AppTec. Under his member of the American Heart Association leadership, WuXi STA has grown from CEO Roundtable, and a member of the an early phase process research focused PhRMA board of directors. organization to a world leading contract development and manufacturing organization for small molecule APIs and finished dosage forms from preclinical to commercial. Prior to joining WuXi, he served as Director of Technical Operations at Vertex Pharmaceuticals where he led a team who successfully supported the process R&D, API contract manufacturing and commercialization of Incivek. JOHN CHIMINSKI our strategic plans, and other critical CHAIRMAN AND CHIEF activities, I request written narratives EXECUTIVE OFFICER, constrained by number of pages to THE CATALENT PHARMA SOLUTIONS force clarity and thoughtfulness. If POWER2019 you can explain your business strategy LIST Scheduling time to think and asking in a couple of pages, and sell it to for reports over PowerPoints are two investors, you have something to invest notable changes John has implemented the companies scarce capital in!” in recent years. “For most of my 30 KENNETH C. FRAZIER year career, I aggressively scheduled meetings and rarely gave myself enough CHAIRMAN AND CHIEF ‘block time’ to take a breath and work EXECUTIVE OFFICER, MERCK on more thoughtful and strategic SHARP & DOHME. activities that create long-term growth or future opportunities. Now, I have a A lawyer by training, Ken joined MSD better balance of an aggressive schedule in 1992 as general counsel. He held a with four-hour block times seeded range of senior management positions throughout the week,” he says. “And before being appointed CEO in 2011. when something is important, I ask In 2018, Ken was named on the Time for a written report. Nothing is better 100 most influential people list for his for demanding clarity from the writer, decision to leave President Trump’s and attention from the reader. For manufacturing council.

BELÉN GARIJO

CHIEF EXECUTIVE OFFICER, HEALTHCARE, MERCK

Belén has been a member of the Executive Board of Merck since January 2015. She is responsible for the Healthcare business sector, comprising the Biopharma, Consumer Health, Allergopharma and Biosimilars businesses. Before STANLEY CROOKE moving to the humans, I think there is a great need to pharma industry, CHAIRMAN AND CHIEF be a part of shared or collective dreams. she was a EXECUTIVE OFFICER, IONIS So to me, the most valuable commodities practicing PHARMACEUTICALS in life are big dreams and the leaders physician for who can share their big dreams with six years. “I am now fully convinced that the only others galvanicallyvanic creating a collective major difference between humans and with a higher, morem noble purpose. This other intelligent species is that humansmans is howw the presentpresen was created and how can dream collectively. In fact, foror most a bbetterer future willwil come to be.” 28 Feature

ERIK GATENHOLM extremely rewarding,” he CO-FOUNDER AND says. On the question of RACHEL HAURWITZ CHIEF EXECUTIVE luck, Erik believes that to do OFFICER, CELLINK amazing things, stars need PRESIDENT AND CHIEF to align and things need to EXECUTIVE OFFICER, Benjamin Franklin’s famous happen simultaneously. “It’s CARIBOU BIOSCIENCES words, “Don’t put off until challenging to predict these tomorrow what you can do things and even explain them Rachel has a research background today,” resonate well with Erik: in retrospect,” he says. “But in CRISPR-Cas biology and holds “We’re proud of the hard the thing with luck is several patents covering CRISPR- work we do – it’s very that the harder you derived technologies. She co- demanding, but work, the luckier founded Caribou in 2012 and the change we are you are.” Intellia Therapeutics in 2014, both doing in the field of which are developing genome of medicine is editing therapies.

STEVEN M. KLOSK

PRESIDENT AND CHIEF EXECUTIVE OFFICER, JEFF JONAS CAMBREX SANDY MACRAE

CHIEF EXECUTIVE OFFICER, “My luckiest break has been to join PRESIDENT AND CHIEF SAGE THERAPEUTICS Cambrex early in my career, because EXECUTIVE OFFICER, the experiences I have had and the SANGAMO THERAPEUTICS Jeff joined SAGE as CEO in 2013 and people I have shared my time with have has more than 20 years of experience given me 28 years of steady personal Sandy has twenty years of experience in in the pharmaceutical and healthcare and professional growth. What’s most the pharmaceutical industry, having served industries. In 2019, the FDA approved improved my life? Building a strong at Takeda Pharmaceuticals from 2012 to SAGE’s Brexanolon, the first new team of experts within Cambrex to March 2016, and GlaxoSmithKline from drug developed for women with ensure our success, and spending 2009 to 2012. Sandy took the top job at postpartum depression. quality time with family.” Sangamo in June 2016. ANKIT MAHADEVIA

CO-FOUNDER AND CHIEF EXECUTIVE OFFICER, SPERO THERAPEUTICS

Ankit co-founded Spero Therapeutics – a clinical-stage biopharmaceutical THE company focused on identifying, POWER2019 KIRAN MAZUMDAR-LIST developing and commercializing novel SHAW treatments for multi-drug resistant bacterial infections – in 2013. He values CHAIRPERSON AND “being mindful about listening first MANAGING DIRECTOR, before speaking in all situations,” and BIOCON considers “the opportunity to work with great mentors and great teammates who Kiran says that over the past five years, have enabled me to grow professionally her understanding of risk management and personally” his luckiest break. has greatly deepened. “I believe that I can now invest with greater confidence in some of the exciting VASANT NARASIMHAN new areas in immuno-oncology and digital technologies that will augment CHIEF EXECUTIVE the pace of research and innovation.” OFFICER, NOVARTIS She considers her luckiest break discovering the “ability to transform Vas was appointed CEO in February 2018 my original enzymes business into after previously serving as Global Head of biopharmaceuticals by leveraging Drug Development and Chief Medical the various microbial and rDNA Officer at Novartis. In 2018, four additional technologies in a strategic way.” Novartis products reached blockbuster status, and the company further invested in advanced therapy, including acquiring AveXis gene therapy, AAA and Endocyte radioligand therapies, and expanding global manufacturing capacity for Kymriah.

RAVI NALLIAH along with fellow executives,” he says. The CHIEF EXECUTIVE OFFICER, company grew quickly and was acquired TRAKCEL by one of the largest global contract services organizations. Ravi also credits his RODGER NOVAK In 2009, in the midst of the economic extensive travel over the past five years with downturn, Ravi decided to resign from a turning him into an avid reader. “I have CO-FOUNDER AND PRESIDENT, successful role as a senior manager with a diversified my reading material to cover all CRISPR THERAPEUTICS leading regional accountancy to join aspects from career and work-related a very small pharma contract material to autobiographies of Rodger is one of the three co-founders services company as an early my influencers and general of CRISPR Therapeutics, which aims stage employee. “Within life and wellbeing literature. to treat diseases using CRISPR/ the first six months, I This has all in some shape or Cas9 gene editing technology. The found myself on the form impacted my approach company recently announced that the board of directors and to life either consciously or first patients had been treated with thereafter quickly lead subconsciously and in the CTX001, a CRISPR/Cas9 therapy a management buyout main in a very positive way.” ਟ-thalassemia and sickle cell disease.

www.themedicinemaker.comwww.theme neemaker m LEONARD SCHLEIFER

FOUNDER AND CHIEF EXECUTIVE OFFICER, REGENERON PHARMACEUTICALS JESSICA RICHMAN “My luckiest break was convincing CO-FOUNDER AND CHIEF George D. Yancopoulos, Regeneron’s EXECUTIVE OFFICER, UBIOME President and Chief Scientific Officer, to partner with me to found and build RAMAN SINGH Jessica’s background (in addition to Regeneron. At the time, he was heading competitive bodybuilding) is in analyzing toward a prestigious career in academia CHIEF EXECUTIVE OFFICER, large-scale data sets, and the idea behind but, somehow – with a little help from MUNDIPHARMA, SINGAPORE uBiome was to transfer those same skills his father – he made the decision to to the realm of healthcare and emerging instead pursue breakthrough science “I joined the healthcare industry without genomics. In 2019, the company launched at our entrepreneurial biotech, through knowing the implications at the time, but the world’s first sequencing-based clinical which we have helped millions of because it offered me the opportunity to microbiome testing. patients since.” establish a healthcare business in Phnom Penh, Cambodia, from scratch. Little did I realize it would lead me to where I am today, allowing me in my own small way to play a role in impacting the human race.”

SEVERIN SCHWAN

CHIEF EXECUTIVE OFFICER, ROCHE GROUP

After completing his studies in economics and law at the University of Innsbruck in Austria, Severin, joined the Roche Group in 1993 as a trainee in corporate finance. Thirteen years later, he was appointed CEO of Roche’s Diagnostics Division, and in 2008 he became CEO of the Roche Group. The company’s cancer immunotherapy Tecentriq (atezolizumab), a PD-L1 inhibitor, this year became the first immunotherapy approved for breast cancer in the US. MARTIN TOLAR CLAUDIA ZYLBERBERG

FOUNDER, PRESIDENT AND CO-FOUNDER, CHIEF EXECUTIVE CHIEF EXECUTIVE OFFICER, OFFICER AND PRESIDENT, ALZHEON AKRON BIOTECHNOLOGY THE POWER2019 During his student days, Martin helped ClaudiaLIST sits on numerous boards and is also organize the Velvet Revolution that a member of ISCT’s Strategic Advisory toppled the communist regime in the Council, the National Academy of Sciences’ former Czechoslovakia. Since then, Regenerative Medicine Forum and the Martin served as an Assistant Professor Florida Organization of Regenerative in the Department of Neurology at Yale Medicine. In her spare time, University School of Medicine, where Claudia writes children’s books he focused on movement disorders, and kayaks. “The solitude and EMMA WALMSLEY and as head of business development the closeness to nature opens at Pfizer, before founding Alzheon up my mind to new thoughts CHIEF EXECUTIVE OFFICER, – a clinical-stage biopharmaceutical and ideas. It creates a space GLAXOSMITHKLINE company focused on brain health, without any background memory and aging. noise, where I can reach Before heading up GlaxoSmithKline, into my reservoir of Emma worked at L’Oreal for 17 years where creativity and look she held a variety of general management for solutions to and marketing roles. Emma holds an MA pressing issues in Classics and Modern Languages from or alternatives Oxford University. She also co-chairs to road blocks,” the Consumer, Retail and Life Sciences she says. Council, a business advisory group for the UK Government.

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MASTERS OF PHIL BARAN THE BENCH

DARLENE SHILEY CHAIR IN CHEMISTRY, SCRIPPS RESEARCH INSTITUTETUTEE

For his contributions to both industryindusstry LISA BRANNON- and academia, Phil Baranaran has receivedved PEPPAS numerous awards andd accolades. The professor, who has workedrked at ScriScrippspps OWNER AND CHIEF Research Institute sincence 20032003,, liveslives EXECUTIVE OFFICER, by the advice of his ddearlyearly ddepartedeparted PEPPCHEM CONSULTING friend, Professor CarlosCarlos Barbas: to pursue more translationallyranslationally Lisa is an internationally recognized meaningful projects inn the lab and researcher for her contributions to to make more time for ffamily.amily. nanoparticle research, biomaterials, controlled drug delivery, and structure- property relationships of biomaterials. As an independent consultant at PeppChem Consulting, Lisa believes that “being kind, patient and working towards saving a life every day” are the essential ingredients to a positive working life.

CHARLES COONEY

ROBERT T. HASLAM (1911) PROFESSOR OF CHEMICAL AND BIOCHEMICAL ENGINEERING, PAOLO COLOMBO EMERITUS, MASSACHUSETTS INSTITUTE OF TECHNOLOGY EMERITUS PROFESSOR, UNIVERSITÀ DEGLI STUDI As a chemical engineer, Charles has DI PARMA always been interested in reaching new frontiers and tackling unresolved issues “Collaboration on the basis of within the remit of his field. However, transparency, friendship and mutual over the past five years he has greatly consideration is key for anyone diversified his reading of both scientific interested in fostering positive and nonfiction literature. “I came to the foreign partnerships. It is becoming realization that innovation takes place increasingly evident that more needs more often at the interfaces of multiple to be done to combat orphan diseases. scientific disciplines, policy, business The deep involvement of international and society, and that without a deeper partners repurposing old drugs for new understanding of history as the context medicines using shared pharmaceutical one cannot appreciate the implications technologies is of crucial importance.” of discovery.” MEINDERT DANHOF

RETIRED

Dubbed the “founding father of E R pharmacological models,”TH WE Meindert’s research focused on novelPO concepts2019 of systems pharmacology andLIST interfacing concepts from systems biology with quantitative pharmacology. After retiring in 2017, he received the Emeritus Professor Status at Leiden CHI VAN DANG University. In March 2018, Meindert set up MD Pharmacology Advice SCIENTIFIC DIRECTOR, LUDWIG which provides training and scientific INSTITUTE FOR CANCER support on pharmacological models RSEARCH; PROFESSOR, WISTAR and intellectual property disputes. INSTITUTE

“As a biomedical researcher, the emergence of immunotherapies for cancer patients has provided me and others across the industry with such opportunities. The tangible impact on clinical outcomes of these treatments is evident. However, we are still challenged by why many patients don’t have durable responses and additional research will be critical to overcoming this barrier and achieving more cancer cures.”

MICHELE DE LUCA LLOYD CZAPLEWSKI DIRECTOR, CENTER FOR DIRECTOR, CHEMICAL REGENERATIVE MEDICINE BIOLOGY VENTURES “STEFANO FERRARI”, UNIVERSITY OF MODENA AND Lloyd has over 20 years of R&D REGGIO EMILIA experience under his belt across various therapeutic areas. He is the Michele has been involved in epithelial current Chief Scientific Officer at stem cell biology for regenerative Persica Pharmaceuticals, a company medicines for 20 years. His pioneering dedicated to the development of work has included the use of human novel therapeutics for Chronic epithelial stem cells for repigmentation Lower Back Pain, and Director at of vitiligo, life-saving treatment Chemical Biology Ventures Limited. of massive full-thickness burns, and piebaldism. 34 Feature ROBERT LANGER

DAVID H. KOCH INSTITUTE PROFESSOR, KENNETH A. GETZ MASSACHUSETTS INSTITUTEE OF TECHNOLOGY DIRECTOR OF SPONSORED PROGRAMS AND ASSOCIATE The most cited engineer in history PROFESSOR, TUFTS UNIVERSITY and one of the most prolific inventorsventors SCHOOL OF MEDICINE; FOUNDER in all of medicine, Robert has nearly AND CHAIRMAN,CISCRP 1,300 issued and pendingg patents,ts many of which have been llicensed “The development, continued regulatory or sublicensed to over 350 pharma, approval and commercialization chemical, biotech and medical device of immunotherapies will have the companies. He has been honored biggest impact on patients. The with over 200 major scientific awards, impact is expected to continue to grow including the United States National exponentially as immunotherapies Medal of Science, and the 2002 extend into disease conditions other Charles Stark Draper Prize (often than cancer.” considered the equivalent of the Nobel Prize for engineers). It has been estimated that as many as two billion people may have had their lives touched by the technologies created by Robert and his fellow researchers, and many of his former students have gone on to great success in academia and industry. “Working with wonderful students and doing work that can make the world a better place is what drives me,” says Robert. “If I could change one thing about the industry, it would be to find a way to get more funding for basic research that could help pharma.”

MICHAEL JENSEN

DIRECTOR, BEN TOWNE CENTER FOR CHILDHOOD CANCER, SEATTLE CARL H. JUNE CHILDREN’S RESEARCH INSTITUTE RICHARD W. VAGUE PROFESSOR IN IMMUNOTHERAPY, Renowned for his work in pediatric UNIVERSITY OF PENNSYLVANIA cancer research, Michael has served as the director of the Ben Towne With more than 350 published Center for Childhood Cancer manuscripts to his name and numerous at Seattle Children’s Research awards, including the American Academy Institute since 2010. Prior to his of Arts and Sciences and William B tenure at the hospital, he conducted Coley awards, Carl’s passions have always the first FDA authorized trial of been geared toward lymphocyte biology. T-cell therapies for children with His lab primarily focuses on developing recurrent neuroblastoma at City of new CAR therapies and new vectors for Hope National Medical Center. current and proposed indications. BRUCE LEVINE RODERICK MACKINNON PRESIDENT-ELECT 2018-2020, INTERNATIONAL SOCIETY FOR CO-FOUNDER AND CHAIR, CELL AND GENE THERAPY FLEX PHARMA

“My most rewarding habit over the Winner of the 2003 Nobel Prize last five years has been the joy and the for Chemistry and co-founder of responsibility of combining educating Flex Pharma, Roderick has had and mentoring in the exciting new many career highs. He currently field of cell and gene therapy. serves as an Investigator at the Medical innovations are resulting in Howard Hughes Medical Institute transformative therapies for many and the John D. Rockefeller Jr. patients, and have the potential to Professor, Laboratory of Molecular revolutionize treatments for many Neurobiology and Biophysics at The conditions. It is imperative Rockefeller University. however, that we augment our outreach and communicate and connect to the public, patients, regulators and governments to make our work more accessible.”

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CO-FOUNDER, CHIEF MEDICAL OFFICER AND MEMBER OF THE BOARD OF DIRECTORS, RESTORBIO

“Aging is the biggest risk factor for most diseases. Recent scientific discoveries in CHRISTOPHER J.H. the field will help in the development PORTER of drugs that target the biology of aging and may lead to new therapies to DIRECTOR, MONASH INSTITUTE improve immune function and reduce OF PHARMACEUTICAL infection rates in the elderly.” SCIENCES, MONASH UNIVERSITY

CHRIS MASON Chris has always had a strong interest in drug delivery systems and was FOUNDER AND CHIEF SCIENTIFIC awarded the American Association of OFFICER, AVROBIO; PROFESSOR Pharmaceutical Scientists lipid based OF CELL AND GENE THERAPY, drug delivery outstanding research ADVANCED CENTRE FOR award in recognition of his efforts in BIOCHEMICAL ENGINEERING, this area in 2009. However, he realizes UNIVERSITY COLLEGE LONDON that there is much to be gained from multidisciplinary approaches. “The With over 25 years experience, Chris insight available from those outside your has had a massive impact on the main area of focus can be remarkable.” field of cell and gene therapies. He is currently a Professor of Cell and Gene Therapies at UCL and Founder and Scientific Officer of AVROBIO, a clinical stage company with a focus on developing disruptive lentiviral-based gene therapies.

GRAZIELLA PELLEGRINI

DIRECTOR, CELL THERAPY NICHOLAS A. PEPPAS PROGRAMME, CENTRE FOR REGENERATIVE MEDICINE COCKRELL FAMILY REGENTS DOLORES SCHENDEL “STEFANO FERRARI,” THE CHAIR IN ENGINEERING #6; UNIVERSITY OF MODENA AND PROFESSOR OF CHEMICAL CHIEF EXECUTIVE OFFICER REGGIO EMILIA ENGINEERING, THE UNIVERSITY AND CHIEF SCIENTIFIC OF TEXAS AT AUSTIN OFFICER, MEDIGENE Holocar, the first ATMP containing stem cells to be approved by the “Over the course of the last 30 years, we Dolores has been a member of the European Commission was produced have seen developments that have ultimately German Research Foundation, German by Graziella and her team. She believes led to improved drug delivery, which was Cancer Aid and the European Research that a cohesive team is the key to success. previously unimaginable. To continue Council, and developed her interest in along this path it is essential that we tumor immunology while working at the remember that we are serving patients first Sloan-Kettering Institute in New York. and foremost. All the research we do and She joined Medigene as Chief Scientific the novel therapeutics we produce would Officer in 2014, when the company be meaningless without the intention of acquired Trianta Immunotherapy, and improving the quality of life of our patients.” was appointed CEO in 2016. PETER SEEBERGER

MANAGING DIRECTOR, MAX- PLANCK INSTITUTE COLLOIDS AND INTERFACES

With a focus on creating novel vaccines, THE Peter aims to help protect patients against ADRIAN WILDFIREPOWER 2019 infectious diseases and improve the LIST accessibility of drugs. “New technologies SCIENTIFIC DIRECTOR, SGS such as continuous manufacturing to produce known drugs and vaccines will “Self-belief is a person’s strongest asset. make them affordable to broader parts of You come to a time in your life where the world’s population.” you have to nail your colors to the mast. Looking over the remarkable discoveries made in the last 20 years from CRISPR-Cas9 to organ-on-a- JOHN TALLEY chip and meeting the people behind some of them I am struck by how CHIEF SCIENTIFIC OFFICER, they never gave up believing and how EUCLISES PHARMACEUTICALS they took dreams and theory and made them into something accessible “My passion is unraveling the role and practical. I like pragmatism and prostaglandins play in immune momentum – if you stop or spend too surveillance within the tumor much time looking backwards then microenvironment. I would also like to see the world has moved on.” a return to the highly-regarded reputation of the pharmaceutical industry. This might be accomplished by promotion of the many tangible benefits to individuals that are a consequence of the industry’s research and development initiatives.”

HAROLD VARMUS

LEWIS THOMAS UNIVERSITY SHINYA YAMANAKA PROFESSOR, WEILL CORNELL MEDICAL COLLEGE DIRECTOR AND PROFESSOR CENTER FOR IPS CELL A leading cancer geneticist and co-winner RESEARCH AND APPLICATION of the 1989 Nobel Prize, Harold Varmus has (CIRA), KYOTO UNIVERSITY previously been the Director of the National Institute of Health and the National Cancer As a 2012 Nobel Prize Laureate, Shinya Institute. Before training as a physician, Yamanka’s work on stem cells has he studied English Literature with the gained him international recognition. hopes of becoming a writer. Alongside Discovering the medical applications his work in cancer research, Harold of induced pluripotent stem cells has takes an active interest in biomedical been a major focus foror the researcher enterprise and consults companies and since he firstreprogrammed reprogrammed humanhuman academic institutions. cells in 2007.7.

www.themedicinemaker.comwww emakerer.comm CHAMPIONS OF CHANGE PETER B. BACH

DIRECTOR, CENTER FOR HEALTH POLICY AND OUTCOMES, MEMORIAL SLOAN KETTERING CANCER CENTER STEVE ARLINGTON Peter is a physician, epidemiologist, PRESIDENT, PISTOIA researcher, and respected healthcare ALLIANCE policy expert whose work focuses on the cost and value of anticancer “Professionally, I would say the most drugs. When asked what could significant thing that has improved be done to improve access to my career is that I am continually medicines he responded, “The price finding the power of many far exceeds of medicines should align with the trying to do things alone. Whilst it benefits they provide so that patients’ can be challenging in the beginning limited financial means are not used to get alignment and coordination, as a counterweight to higher than the time invested when collaborating justified prices.” is repaid many times over.”

DARIO CAMPANA

MICHAEL A. ARNOLD SCIENTIFIC FOUNDER, UNUM THERAPEUTICS, NKARTA AND SENIOR DIRECTOR, MEDISIX THERAPEUTICS; JOHN ARNOLD INVESTIGATIONAL PRODUCTS PROFESSOR, DEPARTMENT BUSINESS PROCESS OWNER, OF PEDIATRICS, NATIONAL FOUNDER AND CO-CHAIR, LAURA PFIZER UNIVERSITY OF SINGAPORE AND JOHN ARNOLD FOUNDATION Michael has worked in the “There is an innate resistance to new In 2010, John and his wife Laura, pharmaceutical industry for 36 years. ideas and disruptive technologies established the Laura and John Foundation. He is a licensed pharmacist in the in pharma. I believe that better The Foundation invests in sustainable state of Connecticut and was named interaction between industry and change in the US through its engagement “Pharmacist of the Year” by the academia can help to facilitate the in public conversation, the creation of new Connecticut Society of Health Systems translation of basic discoveries into policies, education and advocacy. Pharmacists in 2012. clinical applications.” THOMAS CECH

DISTINGUISHED PROFESSOR, UNIVERSITY OF COLORADO BOULDER

In 1989, Thomas won the Nobel Prize in Chemistry along with his colleague, MASSIMO DOMINICI THEHE Sidney Altman, for their discovery OWER of the catalytic properties of RNA. PO 20ASSOCIATE PROFESSOR, LIIST Thomas is currently an Investigator MEDICAL ONCOLOGY, with the Howard Hughes Medical UNIVERSITY HOSPITAL OF Institute, and also a Distinguished MODENA AND REGGIO EMILIA Professor at the University of Colorado and Director of the university’s While Massimo’s professional BioFrontiers Institute. passions lie in cell and gene therapies, running has helped changed his personal life. “I have been running all STEVE DAVIS my life, since 2017 I have been taking this very seriously: last year I did four CHIEF EXECUTIVE OFFICER, PATH marathons! Running is a way to leave unnecessary fears and concerns on As president and CEO of PATH, Steve the road and go back to family, lab, combines his experience as a business leader, patients and friends with a renovated health advocate, and innovator to drive change enthusiasm for life and its obstacles.” and save lives, especially in low and middle- income countries. PATH believes that social innovation is the key to changing the world. A strong proponent of gender equity in JULIE GERBERDING leadership roles and a social and gay activist, Steve spent part of his career using his law EXECUTIVE VICE PRESIDENT degree to advance human and civil rights. & CHIEF PATIENT OFFICER, He is a member of the Council on Foreign STRATEGIC COMMUNICATIONS, Relations, serves on the board of InterAction, GLOBAL PUBLIC POLICY AND and is a trustee of the World Economic POPULATION HEALTH, MERCK Forum’s Global Health Challenge. SHARP & DOHME

Julie has served as Merck’s Executive Vice President since 2016. Her career has seen SUE DESMOND- her previously work in advisory capacities HELLMANN to the National Institutes of Health, the American Medical CHIEF EXECUTIVE Association, CDC, the OFFICER, BILL & MELINDA Occupational Safety and GATES FOUNDATION Health Administration, the National AIDS Dedicated to improving the quality Commission, the of healthcare and the eradication of Congressional Office of disease, Sue is the current CEO of Technolog y Assessment, the Bill & Melinda Gates Foundation. and the World Health She is a trained physician and takes Organization.nization. pride in her philanthropic efforts. JOHN HAMMERGREN 40 Feature RETIRED. FORMER CHAIRMAN AND CHIEF EXECUTIVE OFFICER, MCKESSON DALVIR GILL CORPORATION

CHIEF EXECUTIVE OFFICER, John retired from his position as TRANSCELERATE BIOPHARMA CEO at McKesson in March 2019, after nearly 20 years. The American “People need access to accurate company focuses on the distribution information to make informed of pharmaceutical products and decisions. In today’s highly-connected technologies. During his leadership, world, people are not as informed about the company quadrupled its revenues their healthcare as they should be. to $208 billion dollars. Information on diseases and medicines is readily available with a few clicks, but we need to do a better job at providing accurate information to combat the misinformation that exists online. Empowering people with information will allow them to take better control of their health and ultimately improve access to medicines.”

JACKIE HUNTER

CHIEF EXECUTIVE OFFICER, BENEVOLENTBIO; BOARD DIRECTOR OF BENOVOLENTAI

BEN GOLDACRE Jackie is a board member and Chief Executive, Clinical Programmes & SENIOR CLINICAL RESEARCH Strategic Relationships of BenevolentBio, FELLOW, NUFFIELD the AI unicorn disrupting the pharma DEPARTMENT OF PRIMARY MARGARET HAMBURG industry through its approach to mining CARE HEALTH SCIENCES, and analyzing biomedical information. UNIVERSITY OF OXFORD; CO- CHAIR OF THE BOARD, In addition to her role at the company, FOUNDER, ALLTRIALS AMERICAN ASSOCIATION FOR she serves a professor at St. George’s THE ADVANCEMENT OF SCIENCE Hospital Medical School. A trained physician and member of the Royal College of Psychiatrists, Ben is Margaret is the current President-elect best known for his work as on Bad of AAAS. She was the longest-serving Science, a weekly column featured in FDA Commissioner (from 2009 to the Guardian newspaper from 2003 2015) after being nominated by President to 2011. This work discussed the Barack Obama for the position. She is the misuse of science and the issues of the current foreign secretary of the National pharmaceutical industry, particularly Academy of Medicine and chair of the its relationship with medical journals. Nuclear Threat Initiative. AMIR KALALI

CHIEF CURATOR AND CHAIRMAN, CNS SUMMIT

Recognized for his contributions to life sciences and clinical research, Amir has authored over 200 peer- reviewed publications and advised several pharmaceutical companies. As chair of the CNS Summit, he brings to together like-minded individuals from industry with a passion for innovation in the clinical development space. He believes that focusing on kindness FAITH OSIER makes all the difference in life. PRINCIPAL INVESTIGATOR, SUBHASH KAPRE KEMRI-WELLCOME TRUST RESEARCH PROGRAM; CHIEF EXECUTIVE OFFICER, PROFESSOR OF MALARIA INVENTPRISE LLC IMMUNOLOGY, UNIVERSITY OF OXFORD Subhash established Inventprise in 2012 with the aim of developing cheaper, safer For her research into the mechanisms vaccines. A previous board member of of immunity against Plasmodium the Serum Institute of India, he has falciparum, Faith has won multiple over 44 years of experience in research awards. As a trained physician, Faith has and development. Under a project specialized in pediatrics in both Kenya grant from the Bill & Melinda Gates and the UK. In 2014, she was awarded Foundation, Inventprise has created a the Young African Scientist Award liquid heat-stable Rota virus vaccine by EVIMalaR, and won the Merle A that can withstand temperatures of Sande Health Leadership Award and 50°C for 5 months. the Royal Society Pfizer Award.

MIKE REA

CHIEF EXECUTIVE OFFICER, IDEA PHARMA

Mike cites a number of people who have inspired him over the years, including the authors Michael Schrage, Steven Johnson, Stephen Jay Gould, Clifton Leaf, who took the time to capture their wisdom and insights for all to benefit. He’d like to see more medicine launches. “If we launched more medicines, we’d create a genuinely competitive environment,ent, where success is driven by morere than exclusivity – by innovation in commercial models and truly reflectingng unmetunmet neneeded i nin choi choicesc of outcome measureseasures aandnd patient rrelevance.”elevance.” MELINDA RICHTER

GLOBAL HEAD OF JLABS, JOHNSON & JOHNSON INNOVATION

“Improving access to medicines starts with shorteningng theth amount of time it takes to get a therapeutic into the handss ooff the patient or consumer. Typically, that process can take up to ten years and millions or even billions of dollars. This has to change! I’ve worked tirelessly to streamline this process for healthcare entrepreneurs, via our Johnson & Johnson Innovation – JLABS model, and will continue MARTIN VAN TRIESTE to work to shorten that development cycle and to make it more affordable to ultimately get medicines into the PRESIDENT AND CHIEF hands of those who need them most.” EXECUTIVE OFFICER, CIVICA RX

“From a professional perspective, I recognize ROS SMYTH now more than ever the importance of using my experience and expertise to DIRECTOR, UCL GREAT ORMOND help improve the safety and availability of STREET INSTITUTE OF vital medicines for patients. I feel a deep CHILD HEALTH responsibility to give back and influence improvements to the pharmaceutical Ros has a strong interest in systematic reviews supply chain in innovative ways – and that of treatments for childhood respiratory is incredibly fulfilling.” disease. In addition to her work at Great Ormond Street, she has chaired the Paediatric Expert Advisory Group of the Commission on Human Medicines and played an advisory role in drug regulation in the UK.

ABBE STEEL

CHIEF EXECUTIVE OFFICER, HEALTHIVIBE, LLC

“By far, having more empathy and compassion for patients and their families has improved my life. This has made me a much J. CRAIG VENTER better life science executive and, even more importantly, a more patient, caring person.” FOUNDER, CHAIRMAN AND CHIEF EXECUTIVE OFFICER, J. CRAIG VENTER INSTITUTE MATTHEW H. TODD J. Craig Venter is the founder, CHAIR OF DRUG DISCOVERY, chairman and CEO of the J.Craig UNIVERSITY COLLEGE LONDON Venter Institute. He is also the co- founder of Synthetic Genomics As founder of the Open Source Malaria Inc and Human Longevity Inc, a program, Matthew has a strong interest genomics and cell therapy-based in providing affordable and accessible diagnostic and therapeutic company medicines to patients globally. The project focused on extending the healthy, high is supported by Open Source Pharma. performance human life span. Life Science Integrates is delighted to introduce the inaugural Bio Integrates conference And you’re invited!

This one-day gathering of start-ups, SMEs and emerging companies will provide a platform to discuss the major challenges impacting the pharma and biotech sector, bringing together subject matter experts from the biotech and wider stakeholder community to examine and address the drivers and hurdles of today MARY KERR and resolve the critical business issues of tomorrow. Chief Executive Officer KaNDy Therapeutics & NeRRe Therapeutics Addressing topics such as precision medicine, cell and gene therapy, artificial intelligence, in silico and virtual trials, the focus will be on collaboration, involving stakeholders such as patient advocates, clinicians, CDMOs and CROs, charities, manufacturers, academics and medtechs.

Delegates will benefit from updates on industry wide initiatives, alternative business models, innovative deal structures, partnering with CROs, CDMOs and the wider supply chain. With dedicated networking sessions throughout the day providing an opportunity to engage with these experts, we together, as an industry can collaborate, innovate and share insights. JANE DANCER Chief Business Officer F-star Register now to secure your early bird discount and to network with high-profile speakers from Nightstar Therapeutics, Imperial College Health Partners, F-star, ApconiX, Francis Crick Institute, Domainex, Parkinson’s UK and more.

Are you a R&D Biotech? If so, included within the Early Bird rate of £595 +VAT* price is the opportunity to film a 5 minute video presentation. This offer is strictly limited and will be offered on a first come first served basis, so don’t delay… For more information please contact [email protected]. PRIYA MANDE Chief Operating Officer * Terms and conditions apply PsiOxus Therapeutics

REGISTER NOW TO MEET, LEARN FROM, AND NETWORK WITH THEM. Early bird rate £595 + VAT www.lifescienceintegrates.com/bio-integrates REGISTER NOW 2000+ Pharmaceutical Professionals Exhibition & Conference 200+ 30 April- 1 May Exhibiting companies 90+ 2019 Technical sessions Ricoh Arena, Coventry, UK

Register Now @makingpharma www.makingpharma.com Meet. Network. Engage. Attend the most comprehensive FREE To find out more about booking a stand contact us on to attend pharmaceutical conference 01892 518877 or visit www.makingpharma.com in the UK. Supporters: Media Partners Profession Your career Your business Your life

46-49 The Art of Writing Want to get your writing noticed? Experts share their tips for effective papers and posters. 46 Profession

importance. But first you have to be sure should prevail over ththee imimpactmppap ct ffactoractor offth thethhe The Art of Writing that your research is sufficient. The first and journal in which it is published.ublished ThTherefore,erefore most important question is whether you have you should choose a journal tthathat iss rereadadddb bby Publications are vital to discovered something new and interesting. a large number of people in your ownwn fieldfifieldd building your profile, but Good journal editors and peer reviewers for many scientists it’s less will quickly see through attempts to publish Great on paper of an art and more of an papers that present only an incremental Each journal has specific requirements afterthought. Here, we present development, such as separations of different for submitted manuscripts, which should a straightforward guide to compounds using a well-known method, or be read by all authors before they start preparing papers and posters jumping on the bandwagon of a hot topic to writing. Many authors have the impression that will get you noticed. publish a “me too” paper. You should also that the journal editors will correct their spend some time thinking about the major poorly formatted manuscript to make it By Paul R. Haddad, Emily F. Hilder and challenges of the work you carried out and publishable, but editors handle hundreds of Frantisek Svec whether you solved a difficult problem. If manuscripts each year (the vast majority of the answers to all these questions are “yes”, which are formatted incorrectly). Improper We have presented the “Scientific Writing then it is time to grab a coffee, settle down formatting will instead lead a submitted and Publishing” course at a number of at your desk and... manuscript to be immediately returned to analytical science conferences across the the authors for reformatting, causing a delay world, over the years. The origins of the Select a journal before the article can even be processed. course lie in discussions between the Once you have decided to write a paper, the While writing, authors should always editors of several major journals in the next step is to select the journal in which keep in mind the potential readers. For field about the common mistakes made by you want to publish. All journals are not example, though the use of abbreviations authors, especially young scientists. Here, created equal. It is critical to make sure makes the writing faster (and the manuscript we distill the course into a straightforward that your research lies within the scope of slightly shorter), too many abbreviations guide to creating journal articles and the journal, which is typically found in the make the manuscript difficult to follow posters that are clear and concise – but “Instructions for Authors” on the journal’s and can cause readers to lose interest. A that also catch the reader’s attention. website. It is also a good idea to look at a particularly common error is the use of few current issues of that journal to get a abbreviations in the title or abstract. Who The Write Stuff feel for the type of research that is being would understand the title “Development published. Submitting a manuscript to a of an analytical method to quantify How to prepare a manuscript journal that covers a completely different PBDEs, OH-BDEs, HBCDs, 2,4,6-TBP, for publication. field is a complete waste of time. EH-TBB, and BEH-TEBP in human Before you type a single syllable, A frequently mentioned parameter used serum”? Most readers would not care to ask yourself: are my results suitable to differentiate journals is the impact factor read even the Abstract. A better title would for publication? (IF), which indicates how often papers be “Development of an analytical method Publications are one of the important published in that journal are cited over to quantify polybrominated diphenyl ethers outputs of any scientific researcher. a defined period. Publishing in high IF flame retardants in human serum” Results that stay “in the drawer” and are journals contributes to the personal prestige Choosing the right keywords is also not shared with the community are of little of the author and improves the image of important, as these are typically used value to you or others. Publishing papers their institution, so a spot in one of these in computerized literature searches. A and presenting at scientific meetings journals is much sought after. However, keyword such as “Ultra-high performance serves not only the outside community, journals with a high IF are often highly liquid chromatography-Q Exactive hybrid but your own career, especially when you selective in the manuscripts they choose to quadrupole-Orbitrap high-resolution are starting out. Defending a PhD theses publish and their rejection rate is usually accurate mass spectrometry” is completely with no published papers is exceedingly very high. Plus, some of these journals useless. Instead, consider what keywords difficult at best, and your publication favor certain topics. After all, how many you would use when searching for your record is scrutinized by granting agencies chromatographic papers do we see in paper in PubMed or similar databases. when reviewing project proposals. Science or Nature, for example? Remember Figures are an important part of any Clearly, publishing your work is of utmost that the impact of the work you publish manuscript, but there are a number of ManuscriptManuscript pitfalls for the unwary. As some journals Submission MMistakesistakes restrict the length of a printed paper, Most journals usees similarlar onlinelin submissionubm ssio too many authors try to condense their platforms, structuredre to gguideid authorsaut rs TenTeT n of tthehe mmostost ccommonommon eerrorsrrrors mammadedee manuscript by combining several figure through the submission pprocess.ocess JuJustust as it byy authors.autu hoh rss panels into a single figure until each panel is important to formatt yyourrm manuscriptus ipt tto 1. SubmissionSuS bmissionbmb issionn ofof papersppapeerss thatthah t areare is so small that it is difficult to see the meet the journal’s specificc requirements,uir men iitt clearlycl arly outut off scopesscocopee details, rendering them next to useless. is essential that the journal’s ininstructionsuct s aare 2. Re Resubmissionsubmissions bm ion off a rejectrejectedjectedd A better approach is to show only the followed concerning the iinformationrm on andd manuscriptm nu ript (to( o thet samesa e or most important figures in the published files required. Without this informationor tio differentdiff ent jjournal)urnal) wwiwithoutthout paper and include all other figures in the it can be difficult or impossible for a revisionrevision electronic Supplementary Information. manuscript to be reviewed fairly and a lack 3. No Nott stickinstickingg to the formaformatt Despite the obvious importance of of information can also delay publication if required by the journaljournal graphics, authors continue to submit the manuscript is ultimately accepted. 4. TyposTy pos and grammar errors completely inappropriate, uninformative Authors should be aware that most 5. Ov Overzealouserzealous use of (undefined)(undefined) and unnecessary figures. journals now undertake an electronic abbreviationsabbreviations Finally, don’t forget the references. It is check of the manuscript for plagiarism – 6. PoorPoor selection of keyworkeywordsds easy today to generate a large number of a process that will identify any sections 7. Plagiarism,Plagiarism, esespeciallypecially ofof smallsmall references using computerized databases. of text that have appeared in previous parts ofof a paper Thus, manuscripts including more than publications or on the internet. If the 8. To Tooo manymany figuresfigures 50 references are becoming commonplace. overlap with previously published work is 9. PoorPoor llegibilityegibility ofof figuresfigures Unfortunately, not all authors read the considered to be excessive, the manuscript 10.10. ToTooo manymany references and references that they cite and it is not will be rejected. Take extreme care to avoid excessiveexcessive self-referencingself-referencing uncommon to find some that are completely plagiarism as this is considered completely irrelevant to the paper, which is unlikely to unacceptable – even if you are “borrowing” leave editors or reviewers with a favorable your own words from previous work. impression. Also, avoid including an excessive number of self-references – you are Why is the cover letter important? field and how it fits within the scope of the more likely to irritate than impress. Authors In addition to providing the core documents, journal. Editors will not reject a manuscript should also keep in mind that each journal including the manuscript text, figures and any because the cover letter is bad. However, a requires a specific format for references. It supporting information, a critical and often cover letter that piques the Editor’s interest is sometimes possible to recognize where a underappreciated aspect of the submission may accelerate the editorial progress of manuscript has been submitted previously process is the cover letter or justification your paper. just from the format of the references, statement. Almost all journals receive many immediately telling the editor that this more manuscript submissions than they can Nominated reviewers manuscript has been rejected previously. reasonably publish. Each journal will also Many journals ask authors to recommend So be sure to re-format the reference list have a defined target audience and thus will possible reviewers, which is an important before submitting to a new journal. consider not only the novelty of the work opportunity to contribute to the fair review but also the fit and interest for their target of your manuscript by appropriate experts Once More with Feeling audience. For this reason, it is very important in the field. By suggesting inappropriate that the authors carefully consider the aims reviewers, you send a clear message to How to navigate the review and and scope of the journal and provide a strong the editor: you are not familiar with the revision process. justification as to why their work will be of literature in your field or not confident in For many authors, the details of peer interest to readers; most journals now require your work. Here are some general guidelines review are opaque, making the process the authors to submit a cover letter and/or for choosing appropriate reviewers. confusing and disheartening, particularly justification along with the manuscript. for young scientists. Read on as we attempt Rather than a chore, it is an opportunity Inappropriate reviewers are: to demystify peer review and equip authors for the authors to communicate directly with the tools to participate constructively with the editor and explain why their work • Editors of the journal (or editors of as both author and reviewer. is novel, what contribution it makes to the other journals)

www.themedicinemaker.com 48 Profession

• The top scientists in the world in their area of specialization and can If you choose to submit your manuscript • Your research collaborators be very effective reviewers. elsewhere, you should revise the manuscript • People from your own institution appropriately before resubmission and never • A group of reviewers drawn solely Responding to reviewer comments resubmit the manuscript unchanged. The from your country One of the most challenging aspects of scientific community within a specialized • People without a publication record in the publication process is that you must area can be small, and it is very likely that the field. open your work to critical feedback – the same reviewers may see your manuscript and this feedback is not always positive. again. We suggest that when resubmitting Appropriate reviewers include: Remember that all authors, even the a previously rejected manuscript to a new most senior in the field, must respond journal, you should declare the history of • People who publish actively in the to criticisms of their work as part of the the previous submission in your cover letter field, especially in the journal publication process. Read the reviewers’ and also include the reviewers’ comments • People whose work you have cited and comments dispassionately and don’t take and your response showing how you have discussed in the Introduction of your offence – after all, the reviewers have addressed these comments. This makes the manuscript taken time to read your manuscript and new editor’s job much easier and in many • Members of the advisory board of the provide suggestions to improve it. In cases will greatly speed up the review process journal where you submit many cases, you will be asked to address – it may even result in your manuscript your manuscript. the feedback from the reviewers and requiring no further review. revise your manuscript accordingly. Be Though authors may be asked to sure to address all comments, including Parting Words recommend potential reviewers, the editor any specific instructions from the editor Getting a manuscript published in a good will ultimately decide who will review a and/or editorial office. We suggest journal is never easy; most journals have manuscript. The reviewers will provide preparing a document that lists each high rejection rates. There is no secret both a recommendation on whether the reviewer’s comment, your response to recipe for success – just some simple rules, manuscript should be published, and that comment, and what specific changes dedication and hard work. Authors should comments supporting this recommendation. have been made in the manuscript, each remember that editors are very busy people, It is a common misconception that the in a different color font. If a particular so it is in everyone’s interests to make the final decision by the editor will always reviewer’s comment is not clear you editor’s job as straightforward as possible. directly follow the recommendations of may request clarification through the Authors should cherish their work and the reviewers. Editors certainly do rely editorial office. take the greatest care in preparing their on reviewers to provide expert advice In some cases, you will receive a decision manuscripts properly. Finally, authors on manuscripts and their suitability for that your submission has been rejected must expect some of their submissions publication, but the final decision will be for publication. Though never welcome to be rejected. Rejection is a statistical made by the editor, who must balance news, rejection is something that almost inevitability – the important thing is to feedback from multiple reviewers. all scientists experience in the course of understand why the article was rejected For each manuscript that you submit their career – including the authors of this and incorporate this knowledge into for publication, a number of other article! In some cases, the editor will reject future submissions. Success will come if scientists will give their time to review a manuscript without review – sometimes you persevere. and provide feedback. To allow this referred to as a desk rejection – but it is not system to continue, it is critical that if necessarily a reflection on the quality of the Paul R. Haddad is Emeritus Distinguished you publish in the scientific literature, research. Rather, the rejection may be based Professor of Chemistry at the Australian you also actively support the peer review on other factors, such as the manuscript Centre for Research on Separation Science, process. For younger scientists, providing being presented in the incorrect form or University of Tasmania, Hobart, Australia. high quality and timely reviews is an written in poor English that prevents Emily F. Hilder is Director of the Future excellent way to increase your visibility. proper understanding of the work. Industries Institute, University of South And it also provides a very effective When a manuscript is rejected following Australia, Adelaide, Australia. Frantisek way to engage with editors and experts peer review, remember that you have Svec is a Professor in the Department of in your field. In our experience, young received the benefit of the reviewers’ time; Analytical Chemistry, Faculty of Pharmacy, scientists are often very well informed don’t ignore the advice they have given. Charles University, Czech Republic. results, conclusions, references and 1. Ensure that you attend your poster Poster Haste acknowledgements. The logical flow at the designated time. Most of the poster should be immediately conferences will assign each poster How to create and present an eye- apparent so that the reader can easily to only one or two poster sessions so catching poster. move from one section to the next the audience will expect you to be in the correct sequence. To assist present at your poster for the entire For most young scientists, the first this process, each section should be designated time. opportunity to present work to the scientific numbered and you might also wish to 2. Prepare a 1–2 minute overview community comes in the form of a poster include arrows to guide the reader to of the aims and major findings of presentation at a scientific meeting. Posters each successive section. your poster and be ready to guide are a unique and important form of scientific 3. Include a photograph of yourself (as the audience through your poster. communication because they allow direct the poster presenter) in a top corner When someone stops at your poster and personal communication between the of the poster so that you can be easily you can ask politely “May I give you presenter and the audience. However, there identified amongst the crowds of a 1 minute overview of my work?” are some major challenges associated with people at the poster session. People will rarely refuse this offer poster presentations. First, poster sessions at 4. Don’t forget to carefully check the as it is generally faster than trying major conferences are often crowded and very poster size requirements for the to read the poster themselves. This limited on time, so the primary challenge is particular conference that you are oral presentation must be focused to attract an audience by preparing a poster attending. Poster boards vary widely and clear, and you should rehearse that is arresting, visually appealing and and it is your responsibility to ensure it carefully. The audience can then scientifically exciting. Second, a poster must that your poster fits on the poster extend the discussion, or move on to be able to convey its major findings in 1–2 board which will be provided. Avoid the next poster. minutes through a logical and clear layout landscape formats as most poster 3. You may wish to provide an A4 copy and focused interaction between the poster boards will not accommodate this of your poster for people to take away presenter and audience. format. The safest approach is to use and read in more detail later. It is a portrait format printed in A0 size. also useful to have an open envelope Attracting an audience Laminating your poster improves at the bottom of your poster (many A primary feature of poster sessions is that its durability but the resulting shiny, conferences provide attendees can be selective about which reflective surface can be hard to read. this) so that people posters they will read and discuss with the 5. Legibility is the chief concern, so can leave their presenter. So how can you get people to keep text to an absolute minimum. business cards to stop at your poster rather than walking by? Given that most posters are printed request further These five points will help you to stand out: in A0 format (841 mm wide x 1189 information or a mm high) and are viewed from a reprint of your 1. Posters are a visual communication distance of approximately 1m, a good poster. tool, so graphic design is essential. way to check legibility is to print Think about the overall impact your poster on an A4 sheet of your poster in terms of layout, and hold it 25 cm from your photographs, figures, schematics, nose. If you can read the and so on, to convey information A4 version easily from this without words. Suitable use of color distance then your A0 poster throughout the poster is also essential. will be easily legible from 1 m. If you have a colleague or friend (whether or not they are a scientist) Getting your message across who is skilled in graphic design, it is Once you have managed to attract an a good idea to get their opinion and audience for your poster (remembering feedback on your poster layout. that the audience will normally be one 2. A clear and logical layout is also person), you must be ready to engage essential. Start with an informative with that audience in a friendly and open and brief title and then include manner. The following considerations clearly delineated sections showing might assist in these tasks. background, aims, experimental, A TOUCH OF DRUG DELIVERY MAGIC

Sitting Down With… Robert S. Langer, David H. Koch Institute Professor, Massachusetts Institute of Technology, USA. Sitting Down With  51

How has drug delivery research held This work was another turning point. of delivering nutrition, to aerosols, to your interest for so long? At the time, the literature suggested you vaccines. Working with the Gates Over the years, the field has grown couldn’t use polymers to deliver large Foundation meets all the criteria I ever tremendously and there are now a lot of molecules, but I didn’t read any of those wanted for my career – I always wanted journals devoted entirely to this space. articles and so I tried anyway! I found to see science do good and to help people. Ever since I started out in drug delivery, hundreds of ways of getting it not to new questions kept popping up. Can work, and one way to make it work. I How do you encourage industry to adopt we synthesize optimal biodegradable discovered a way to create microspheres, your research? materials? Can we target different which could deliver molecules of any size. I try to give companies as much data as cells? Would non-invasive delivery, like We published a paper in Nature in 1976 we can, and we also file a lot of patents, aerosols work? Can transdermal patches saying how we could do it and a paper which really helps on the business deliver complex molecules? I kept going in Science on the isolation of the first side. I enjoy working with industry. and my lab continues to keep going! angiogenesis inhibitors, but there was a lot In academia, we publish papers and We’ve recently published a paper in of scepticism; many said the papers were try to develop new principles and ways Science about a pill that could possibly wrong and didn’t make sense. of doing things, but you can only go deliver proteins orally, which has caused After my post doc, I applied for a lot of so far in academia. We need industry a lot of excitement. But beyond proteins different chemical engineering jobs, but to develop our work into commercial there are even more challenges – what no one wanted to hire me! Eventually, I products that really help people. about delivering RNA-based drugs got a job at MIT, but then the guy who or gene editing therapies? Challenges hired me left. And the rest of the faculty How do you work with young scientists? keep arising and we will keep trying to told me that I should leave too! It wasn’t a I’m really proud of my students. We have solve them. great start but I persevered! over 300 that are professors now both inside the US and internationally. When What have been the main turning points Since then, you’ve won dozens of awards I work with young scientists, I don’t tell of your career? and accolades. What moments stand out them what to do. At school, students are Working with Judah Folkman at Boston the most? judged by how good their answers are, but Children’s Hospital was the first major I’ve had a lot of honors (I sometimes when you grow up it’s not just about the turning point. By training I’m a chemical think some of them were given to me by answers but also about the questions you engineer. Almost all of my friends went mistake!). I’ve been to the White House ask. I want to help my students cross the into the oil industry, but I wanted to do several times to receive national medals bridge from people who can give good something different that would really help and I’ve also won international awards. answers to people who can ask good people. I applied for post doc positions in One really nice moment was when I won questions. I try to do that by encouraging medicine and I was turned down a lot. a Queen Elizabeth Prize for Engineering them to ask questions, and to strike out on I ended up working with Judah in the in 2015 for my work on controlled release their own to tackle problems. Of course, 1970s. I didn’t know much about biology drug delivery for large molecules. This is I am there to help as a guide. We have or medicine and I was the only chemical a wonderful honor and I also got to spend over 100 people in the lab so there are lots engineer at the hospital; the experience time with the Queen of England. of different people to talk to, which helps was eye opening. Judah was a visionary generate more ideas that we all get excited scientist and I was so lucky to have him as What are you working on now? about. Everyone works together and pulls a mentor. He had the idea that if you could There are a lot of different projects going together to help each other. stop blood vessels then maybe you could on in the lab and we’re always publishing stop cancer. And the work eventually led new papers. I never expected the lab to If you weren’t a scientist, what job to the world’s first angiogenesis inhibitors grow as it has done! A few years ago, would you have? (although they weren’t used in approved the Gates Foundation approached us Maybe I’d be a businessman – I’ve enjoyed drugs for many years). One of my jobs to ask about working together. We setting up companies over the years. But was to develop a drug delivery system to have a big effort in the lab now on I really love magic. It’s entertaining to deliver the molecules. I had the idea of creating drug delivery systems for the watch and I’ve done shows for kids at using a slow release polymer in the body developing world, ranging from long- MIT, which was great fun! So perhaps to release the molecule. acting oral systems to new types of ways I’d be a magician!

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