APRIL 2018 # 40
Editorial Upfront In My View Sitting Down With Stop and look at how far Preparing for the EU’s new What can algae teach us Sophie Kornowski-Bonnet, the industry has come data protection regulation about medicine design? Roche Partnering
09 10 – 11 20 – 21 50 – 51
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Power List 2018
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The Power List
The 2018 Power List, starting on page 24 of this issue, features 100 of the most inspirational professionals involved in A Scientist Walks into a Bar... format to the public”. Generally, drug development. The list was compiled it involves scientists speaking on a based on reader nominations and And gives a presentation as part variety of topics, from medicine, to feedback from a judging panel – but any of Pint of Science, a global science neuroscience, to robotics and more, in list will always be subjective. If there are festival. Taking place in May, the bars and pubs. Find out what’s on near names you would like to see on the 2019 Pint of Science festival aimsto deliver you by visiting the website. list then let us know by nominating now. “interesting and relevant talks on the latest science research in an accessible http://tmm.txp.to/0418/pintofscience http://tmm.txp.to/2019/powerlist
Easy as B to D?
The Trump Administration’s plans to move Medicare Part B drugs into the Part D system, and to change Part D formulary standards to require a minimum of one drug per category rather than two, would mean additional delays and cost barriers for patients. Angus Worthing, Government Affairs Committee Chair, American College of Rheumatology, gives his thoughts on the matter... http://tmm.txp.to/0418/worthing
www.themedicinemaker.com ISSUE 40 - APRIL 2018 Contents Editor - Stephanie Sutton [email protected] Deputy Editor - James Strachan [email protected] Deputy Editor - Roisin Mcguigan [email protected] Content Director - Rich Whitworth [email protected] Publisher - Richard Hodson [email protected] Bringing the future Sales Manager - Helen Conyngham [email protected] Head of Design - Marc Bird [email protected] closer to you. Junior Designer - Hannah Ennis [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 - Tracey Nicholls [email protected] Traffic & Audience Database Coordinator - Hayley Atiz [email protected] Traffic and Audience Associate - Lindsey Vickers [email protected] Traffic and Audience Manager - Jody Fryett [email protected] Traffic Assistant - Dan Marr [email protected] Events Manager - Alice Daniels-Wright [email protected] Marketing Manager - Katy Pearson [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] 14 Change of address: [email protected] Hayley Atiz, The Medicine Maker, Texere Publishing, Haig House, Haig Road, Knutsford, Cheshire, WA16 8DX, UK General enquiries: www.texerepublishing.com 03 Online This Month Upfront [email protected] +44 (0) 1565 745200 [email protected] 10 In the NIR Future Distribution: 09 Editorial The Medicine Maker (ISSN 2055-8201), is published monthly by Texere Publishing, How Far We’ve Come, by 11 T rials of a Medicine Maker Haig House, Haig Road, Knutsford, Cheshire Stephanie Sutton WA16 8DX, UK Single copy sales £15 (plus postage, cost 12 Gearing up for GDPR available on request [email protected]) Non-qualified annual subscription cost is £110 plus postage
13 Let’s Get Ready to Serialize! Reprints & Permissions – [email protected] The opinions presented within this publication are those of the authors On The Cover and do not reflect the opinions of The Medicine Maker or its publishers, Texere Publishing. Authors are required to disclose any relevant financial APRIL 2018 # 40 14 Blast From the Past arrangements, which are presented at the end of each article, where relevant. © 2018 Texere Publishing Limited. All rights reserved. Editorial Upfront In My View Sitting Down With How far the industry Preparing for Europe’s data What can algae teach us Sophie Kornowski-Bonnet, has come protection regulation about molecular warfare? Roche 09 10 – 11 18 – 19 50 – 51 Balloons, representing the Reproduction in whole or in parts is prohibited.
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Power List The Power2018 List Power Listers, lift drug 15 Business in Brief 2018 Celebrating the diverse personalities and passions in drug development 24 – 49 development UP! www.themedicinemaker.com 16 Fame and FOYAs Want to know more? Made better. By science. Visit www.capsugel.com Bringing the future closer to you.
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In My View Feature Reports
18 Algae are experts at molecular 24 The Power List 2018 16 The Medicine Maker x CRB warfare and there is much we Our annual Power List celebrates Keeping Fit with Age can learn from them when it the people and personalities comes to designing new driving drug development medicines, says Andrew Dahl. forward, from Masters of the Bench, to Industry Influencers, Sitting Down With 24 Personalized healthcare is a to Business Captains, to really exciting area, according to Champions of Change. 50 Sophie Kornowski-Bonnet, Sophie Kornowski-Bonnet, and Global Head, Roche Partnering. it goes hand in hand with digital technologies.
www.themedicinemaker.com Kelsey Kehrli Data Review Scientist PSG
| Active ingredients Dynamic people
Meet the experts you’ll enjoy working with and discover why we’re one of the biggest names in small molecule APIs.
DCAT Week, March 19–22, Lotte NY Palace, New York CPhI North America, April 24–26, Booth 613, Philadelphia www.cambrex.com
Custom development Generic APIs Controlled substances & manufacturing How Far We’ve Come Editorial Stop, for just a moment, to contemplate the marvels that pharma has achieved
hriving in today’s world is a challenge for both individuals and companies; lower wages butt up against higher living costs, lower profits clash with Thigher operating costs. Add political uncertainty to the mix, and it’s no surprise that depression, anxiety and low self-esteem are reaching record levels. In the midst of this turmoil, what’s our reaction? Taking time out to revel in how far we have come – and celebrating the individuals that make change possible. In March, I had the opportunity to visit Roche headquarters in Basel. As well as touring some of the labs, I also delved into the “Roche Archives” – a vault of company history, including building plans, staff photographs, published articles, and legal documents (even the original document founding the company, signed in 1896). There was also an old machine for making Kelsey Kehrli Data Review Scientist cough medicine, old diagnostic systems, company awards, PSG Roche coat hangers, Roche teddy bears… Countless objects and documents, each with their own part to play in Roche’s success story (photos on page 14). Several big pharma companies apparently maintain such archives – but only rarely are they the subject of a tour. My guide, Active ingredients Alexander Bieri, seemed pleasantly surprised by my wonder at | this room of history. But how can you not be awed by a century- old bottle of medicine (Sirolin)? Roche stores a sample of every Dynamic people medicine ever made by the company, from simple small molecule drugs to the more complex biopharmaceuticals that dominate global pipelines today. The result is an incredible visual reminder Meet the experts you’ll enjoy working of how far the industry has come. with and discover why we’re one of the Yes, it is well accepted that manufacturing processes in pharma tend to lag behind those in other industries. It is also biggest names in small molecule APIs. well accepted that the prices of medicines are spiraling beyond society’s ability to pay for them. And there are many treatments DCAT Week, March 19–22, that continue to elude science. But one day, I believe we will Lotte NY Palace, New York have the solutions to these problems. Everyone in the pharma industry today, no matter the job CPhI North America, April 24–26, function, is shaping the future of mankind. After all, good Booth 613, Philadelphia medicine underpins health and wellbeing. Celebrating the great and the good within our wonderful industry underpins www.cambrex.com our annual Power List issue. And so, on page 24, we highlight 100 of the most inspirational individuals advancing drug development and working hard to overcome the trials facing the industry today – and into the future. Custom development Generic APIs Controlled substances & manufacturing Stephanie Sutton Editor
www.themedicinemaker.com 10 Upfront
Upfront
Reporting on research, personalities, policies and partnerships that are shaping pharmaceutical development and manufacture.
We welcome information on any developments in the industry that have really caught your eye, in a good or bad way. Email: stephanie.sutton@ texerepublishing.com manufacturing is undergoing a paradigm In the NIR shift, from quality by testing to quality by design. The new approach demands Future more product and process understanding, process monitoring, analysis and control Could near infrared chemical rather than simply manufacturing a imaging offer improved ‘real- product using predetermined fixed time’ monitoring of tablet process parameters and “passing” or manufacture? “failing” based on quality specifications. Our main purpose in this research was to The pharmaceutical industry is in evaluate the feasibility of a new process continuous need of improved process analytical tool, NIR CI (which can analytical technology (PAT) for provide spectral and spatial information), monitoring, analysis, understanding, against existing technology, NIRS and control. We spoke to Himmat (which provides spectral information Dalvi, (Associate Professor, Department only), for feed frame monitoring (1). of Chemical Engineering and Biotechnology Engineering, and Why is it important to monitor Pfizer Industrial Research Chair at powder potency inside a feed frame? the Université de Sherbrooke, Canada) The feed frame drives powder blends into about a new analytical tool – near- tablet moulds. It operates within a high- infrared chemical imaging (NIR CI) – speed industrial tablet press, and offers that could help the manufacture of more the last opportunity to examine the uniform tablets (1). powder blend before tablet compression. However, it also applies considerable What inspired your research? strain onto the moving powder blends, Pharmaceutical dosage form which can lead to undesirable quality Upfront 11
phenomena, such as powder segregation. How did NIR CI compare? PAT tool for feed-frame monitoring. To protect the final product quality, we NIR CI not only performs on a par to It provides a visual presentation of the need to discover occurrences like this in NIRS for concentration monitoring, but process, which could be very useful for real time, so that intervention is possible. also shows potential in probing local process operators in spotting any adverse concentration variations, thanks to the quality phenomena, such as segregation, What are the limitations of NIRS? larger sample area it makes available to us. in real time. It could also be used for NIRS has not yet developed into a fully similar operations involving powder robust and understood PAT tool for What difference could your research samples in motion. feed-frame monitoring, as parameters, make? such as spectral baseline variations and Our research proves the feasibility of Reference the variable location of NIR probes NIR CI for testing moving powder 1. Himmat Dalvi et al., “Concentration on the feed frame, lead to variable samples, while also allowing analysis of monitoring with near infrared chemical concentration predictions from lab to an increased sample area – thus opening imaging in a tableting press”, J Spectral production, or batch to batch. doors for turning NIR CI into a robust Imaging, 7, a5 (2018).
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 12 Upfront
Gearing up for GDPR
New data protection regulations are coming to the • “The GDPR is intended to enable Companies outside the EU EU this May – and pharma will individuals to exercise control over • “The GDPR applies to all businesses be affected their data. Companies, contractors established in the EU and to and investigators will need to businesses worldwide who are offering The European Parliament adopted the understand how to respond to services in the EU, or monitoring General Data Protection Regulation access requests.” EU citizens.” (GDPR) in May 2016, four years after it was first proposed. This year, it will enter Clinical trials Ensuring compliance into force. The GDPR was created with the • “We are seeing uncertainty regarding • “The Data Privacy regulators continue aim of unifying data regulations among the impact of GDPR on clinical to issue guidance on specific issues European countries, and updating data research. When we surveyed EFPIA which companies then need to protection laws for the modern world – as members last year, it was clear that review in relation to their internal people share more personal data than ever there were many areas where the procedures. There is a big focus on before, new regulations are needed to give interaction between the GDPR and compliance as there will be for all individuals more control over how their the Clinical Trials Regulation was organizations. Particular issues for data is used and shared, both within and causing confusion. These include life sciences companies will be to be outside the EU. breadth of consent, data retention, clear about the basis on which they The new regulations promise to have and de-identification/anonymization are processing sensitive personal data a far-reaching impact for businesses obligations.” (in particular regarding the GDPR and organizations across the board, and • “The standard of consent has been scientific research exemption) while have generated a significant amount of raised under GDPR, but this has to taking into account the specific discussion. Some feel that pharma is simply be understood against the context safeguards of our sector, ensuring not prepared for the new rules (1) – but that the GDPR deals with consent that information notices are updated with little time left before they begin to be across all sectors. Consent processes where appropriate, and assessing enforced, the industry will have to adapt, within clinical research are already of the basis under which they are or face some serious penalties. a very high standard and are unlikely transferring data to third countries.” Brendan Barnes Director of Data to greatly change, although new • “The GDPR places a strong emphasis Protection, IP and Global Health at the information notices may be required. on accountability – a shift from EFPIA tells us more about the changes The GDPR makes extensive provision the directive that preceded it – and GDPR will bring. for research and acknowledges the contains very substantial sanctions need for specific treatment of research for non-compliance. Companies will Health data data. However, there is still a lot of find that they need to embed data • “A key concern for the industry is uncertainty. An example is the right protection in their processes and that the GDPR should support data- to be forgotten. While this is an educate staff to understand the issues. driven research and the text of the important right in a general sense (for This could involve general education regulation does this. It is very clear example, removing your data from sessions, specific staff training and that the ability to access and re-use a social media website), the right review of internal HR policies.” personal health data with appropriate needs to be reconciled with the need safeguards will be a very important to preserve data in a clinical trial, Reference driver of health system performance including data from subjects who have 1. Clinical Leader, “Pharma ‘not prepared’ for new improvement and of pharmaceutical withdrawn from the trial. Recent EU Data Protection Regulation”, (2017). innovation. These benefits are already guidance from the article 29 working Available at: bit.ly/PharmaGDPR. Accessed April being seen.” party has again put this in question.” 5, 2018. US DSCSA
Let’s Get Of the 146 pharma respondents that had DSCSA requirements, Ready to only 33% responded that they felt very ready to meet the deadline. Serialize! Some fundamental Packaging lines One third of pharma steps have been taken and trade partner companies claim they connections are the are “very ready” for the most incomplete upcoming serialization deadlines. But are they 90% 72% really? had taken felt prepared 13% 12% steps to prepare because they The US and EU serialization for master data understand of DSCSA say that most of deadlines are both less than a management the law and pharma their internal have enough companies packaging lines year away, with the EU Falsified resources Medicines (FMD) Directive coming acknowledged are ready that at least into force on February 9, 2019 and 80% 20% of their the US Drug Supply Chain Security volume is Act (DSCSA) coming into force believe 62% serialized 12% they will on November 27, 2018 – the latter be shipping began already having been delayed by have internal serialized preparing packaging lines one year. So how prepared are product before before the ordered and pharma companies? the deadline deadline installed Tracelink surveyed 660 companies across segments of the supply chain, including 174 drugmakers, to find out. In their Global Drug Supply, Safety and Traceability Report, EU they found that only one-third of respondents believe they are “very FMD ready” for serialization. The data also revealed that no single company has actually completed all the basic steps for serialization readiness. According to the authors, the survey proves “that Of the 95 pharma respondents that had EU FMD requirements, only 33% the companies who feel very ready believed they are very ready for the EU FMD deadline. are considerably ‘less ready’ than they think.” As with DSCSA, none had completed all of Reference 41% 27% 1. TraceLink, “TraceLink Publishes Full the basic steps. Analysis from the Global Drug Supply, say that most of believe they will Safety and Traceability Report, Industry’s their internal be sending serial Largest Survey on Life Science Companies’ 94% 46% packaging lines numbers to EU Readiness for Serialization Deadlines” are ready hub by deadline (2018). Available at: had taken steps said the majority https://bit.ly/2JvuQfP. Accessed April 10, 2018. to prepare for of their internal are not concerned master data packaging lines that equipment management were ordered 20% shortages would and installed affect compliance 14 Upfront
Blast From the Past
Photos from the Roche Archives beautifully illustrate the industry’s past
As mentioned on page 7, the Editor of The Medicine Maker, Stephanie Sutton, recently visited the Roche Archives in Basel. Roche was founded on October 1, 1896 by Fritz Hoffman-La Roche, who believed that the industrial manufacture of medicine would significantly help to fight disease. He was also keenly interested in the idea of branded pharmaceutical products. The company has been storing documents, photos, medicines, equipment and other items ever since it was founded. We thought you might enjoy some of the photos from her visit… Upfront 15
Clockwise from left: Airol powder wound • Alofisel (darvadstrocel) has become disinfectant (one of the first products launched by Business in Brief the first allogeneic stem cell therapy Roche). Initially it was not a success, although to receive central marketing today Airol is used to help treat acne. Consumer unit sales, stem authorization approval in Europe. Digalen heart tonic – in a heart-shaped bottle cell therapy approvals and The therapy is approved for patients – launched in 1904 and was considered a key beating counterfeits with with Crohn’s disease who do not medical innovation at the time. blockchain… what’s new for respond to current therapies. pharma in business? Sirolin, a non-prescription cough medicine launched • An encapsulated cell therapy in 1898, remained on the market for over 60 years for treating type 1 diabetes is on – this was the first big success for the company. Deals & acquisitions the cards for Eli Lilly, which has Shelves showing a plethora of awards, items licensed the technology from and equipment. • GlaxoSmithKline is acquiring Sigilon Therapeutics. Lilly will Novartis’ consumer health business use Sigilon’s Afibromar platform for $13 billion. The business was for islet cell encapsulation and the initially a joint venture between companies hope the treatment will the two companies and includes restore insulin production over products such as Nicotinell nicotine sustained periods without triggering patches, Panadol headache tablets an immune reaction. and Sensodyne toothpaste. • Pfizer and Allogene Therapeutics • Pfizer has also been looking for a have entered into an “asset deal regarding its own consumer contribution” regarding Pfizer’s health business. The company CAR-T portfolio. Allogene has been assessing options since will lead the development while October 2017. Potential bidders Pfizer will participate financially included GSK and Reckitt through a 25 percent ownership Benckiser, but both pulled out stake in Allogene. in March. Now, Pfizer has been reported by many to be in talks with Emerging technology Procter & Gamble. • Takeda has confirmed that it is • A collaboration between considering an offer for Shire with Parkinson’s UK and The Cure the aim of boosting its footprint Parkinson’s Trust to identify new in gastroenterology, oncology and treatments for the disease has neuroscience. No approach has yet won the inaugural BenevolentAI been made to Shire’s board and Award. The award was presented Takeda stressed that the offer was at through a competition run with a “preliminary and exploratory stage”. the Association of Medical Research Charities and will give Cell therapy the collaboration full research support from BenovolentAI, • A report from BCC Research, Cell which specializes in using artificial Therapy process: Global Markets intelligence for drug discovery. and Technologies, seems to confirm • DHL is partnering with Accenture the high expectations for the future to trial blockchain in pharma supply of the field. The reports claims that chains. In particular, the companies the cell therapy processing market is want to see if the technology can expected to see a compound annual help prevent the distribution of growth rate of 30.9 percent through counterfeit drugs by ensuring the 2022 and be worth $5 billion. improved accuracy of supply data.
www.themedicinemaker.com 16 Upfront
which was integrated alongside wastewater discharge, rainwater Fame and FOYAs eight other buildings and despite harvest system, and solar-powered significant space constraints. generation with photo-voltaic cells. ISPE announce the 2018 Facility • Operational Excellence – Another of the Year category winners… win for Shire in Los Angeles; for Honorable mentions were also given to the development of their “next Emergent BioSolutions for its BARDA The International Society for generation quality control lab”. Center for Innovation in Advanced Pharmaceutical Engineering’s (ISPE) Lean principles were incorporated Development and Manufacturing in Facility of the Year Awards (FOYAs) are in every aspect of project execution. Baltimore – a partnership between here again for 2018. Here, we highlight Organic Kaizen principles were industry and government that aims to those companies recognized for expertise also used. act rapidly to stop significant public and forward-thinking innovation in • Facility of the Future - Vetter health threats – and to the Government healthcare manufacturing facilities. Pharma-Fertigung GmbH & Pharmaceutical Organization (GPO) for Co.KG for the creation of its Center their Rangsit Pharmaceutical Production • Project Execution - BioMarin for Visual Inspection and Logistics. Plant 1 in Pathumthani, Thailand, which Pharmaceutical for Project Faith, According to ISPE, the facility uses quality by design and international which involved creating a gene features a number of flexible options best practices to manufacture affordable therapy manufacturing facility (the for utilizing space and expanding HIV medicines. first of its kind in the world). An the site to fit customer needs. The 2018 FOYA winners will be office and warehouse building in • Sustainability - Wyeth formally recognized at the ISPE Facility Novato, California, were converted Pharmaceuticals Co, a Pfizer of the Year Awards Banquet and Dinner into the 18,000 square foot gene Company, for the Pfizer Consumer in Philadelphia in November, where the therapy facility – with the buildout Health manufacturing facility overall winner will also be revealed. and commissioning of the facility in Suzhou, China. The facility finished in less than a year. features recycling of 100% of Reference • Facility Integration – Shire, for the treated wastewater for cooling 1. ISPE, “2018 ISPE Facility of the Year Award creation of a 120,000 square foot tower makeup, toilets and lawn, Winners Announced”, (2018). Available at purification facility in Los Angeles, zero nitrogen and phosphorus in bit.ly/2018FOYAs. Accessed April 6, 2018. www.themedicinemaker.com 18 The Medicine Maker × CRB
Keeping Fit With Age The saying goes that with age comes wisdom, but in manufacturing it can also bring about unreliable facilities and equipment. Proactive stress testing is a must to keep facilities fit and healthy.
By Allan Bream
Like everything else, sterile manufacturing facilities age and performance deteriorates over time. Many of the first and second generation biomanufacturing facilities are equipment designs tend not to be the most never try to fix it in a vacuum; it must be now 15-20 years old, so it’s no surprise that efficient anyway – they may have nooks and properly socialized and vetted among sterility issues and product recalls are on the crannies that complicate cleaning, or may all of the applicable departments, such rise. One of the early warning signs that a require significant manual intervention, so as operations and process staff, quality facility is in need of some attention is an it’s good practice to continuously evaluate assurance, validation, maintenance, quality increase in batch failure rates – companies newer systems. control etc – so that you can ensure the want batch failure to be less than 1 percent, Sometimes it is not necessarily the age solution doesn’t cause other issues down but the Parenteral Drug Association of a facility or its equipment that are a the line. However, it can be very difficult to has noted that it can be much higher: problem, but simply the fact that times identify what the root cause of the problem – “Alarmingly, 80 percent of respondents to and product demands have changed, a survey conducted by the Parenteral Drug and that existing equipment can’t keep Association in 2016 had batch rejection rates up. Problems in facilities of any age can of up to 4 percent due to a lack of sterility also stem from lack of operator training assurance or the potential thereof, and 15 or failure to follow standard operating “Sometimes it is percent of those respondents had rejection procedures. If procedures and training are rates of 5-10 percent” (1). not adequately documented, issues can not necessarily the Issues with facilities and equipment can arise as companies lose legacy employees lie dormant as operators or maintenance and bring in new operators or technicians age of a facility or technicians make small tweaks to – who may be eager but unwittingly undo compensate, but in time this can lead to procedures. I am sure that everyone reading its equipment that other problems. Increasing contamination this is also aware that it is all too common rates in older bioreactors are one common for one step to be skipped because it is a little are a problem, but problem, for example, and the kneejerk troublesome or because people don’t think it reaction is often to turn up the steam cycle matters… They might get away with it the simply the fact that or temperature, but this can lead to gasket first time, but then it becomes habit – and or other component failures. If equipment in time, other shortcuts or small problems times and product is becoming a source of contamination or will culminate to form a much larger issue. is difficult to clean, then it is likely to be demands have outmoded and you may need to consider Fit facilities replacement. Also, bear in mind that older When addressing a problem, you should changed.” The Medicine Maker × CRB 19
the time for future planning. For instance, 27% 37% if you have a piece of equipment that can Raw Materials Quality: Manufacturing only perform 50 batches a year, but you’re 2% Issues projecting the need for 75 batches in the Loss of next two or three years then you need to Manufacturing start planning how you will adjust. Also, Site don’t forget that your staff will need ongoing Reasons training as new technology is integrated and for Drug as quality standards change. Shortages Every now and then I come across 5% someone who says, “Why don’t we just Increased let things fail and then fix them? What Demand are the consequences of just waiting until 27% something breaks?” My biggest advice is to Quality: 2% Delays and always be proactive with your facility before Discontinuation Capacity issues arise. Once you have a problem, your capacity plan is at risk. Stress testing a facility proactively allows remediation or upgrades Reasons for drug shortages. Data from the FDA (https://bit.ly/2EqEX1I). Quality manufacturing to be planned, meaning you can choose the issues and quality issues related to delays and capacity are the biggest contributors to drug shortages. best time to shut down a facility for any work and fit capital spending into budgets. And and thus the best solution – actually is. In my arisen – in case they have had unexpected remember, the FDA expects a facility and its experience, people are very quick to assume effects. With engineering and validation, equipment to be designed and maintained they know what has caused the problem, but you can get a sense of how manufacturers for what you intend to produce in that facility I always recommend a thorough, unbiased have been tracking equipment performance – it is cGMP (current good manufacturing root cause analysis. When contamination by looking at equipment alarms that have practice) for a reason. The FDA emphasizes arises, various groups within an organization come up recently. And from there you follow the word “current” and grandfathering in an will often each have their own view of the the threads back… it is quite common for a old approach or an old piece of equipment source, leading to disagreements and months problem to start with an alarm that has been is no longer considered acceptable. Your of wasted time in chasing down assumptions ignored, or thought to be irrelevant. You technology does not have to be leading edge, that ultimately turn out to be incorrect. also need to talk with maintenance groups but it must be accepted and you must have Often, a root cause is not immediately and look at work orders, unscheduled data to back up your approach. discoverable until you have performed an maintenance, and maintenance frequency. In the pharma industry, all manufacturers impartial, passion-free analysis. Is it strictly time-based, or are they looking have a duty to ensure that their facilities I recommend using a full “stress test” to at how hard or how frequently equipment are up to scratch. The key goal is to identify problems and design issues that is run? In some facilities, equipment is run supply patients – contaminations and may require remedial action. This should close to 100 percent capacity – and in that drug shortages prevent medicines from examine all operations and determine case preventative maintenance and changes reaching patients and can cost lives. This is where the soft points may be – and may need to be made more frequently to something we have a duty to avoid. There whether the facility is still fit for purpose. avoid problems. is nothing worse than having a need in the A stress test is a comprehensive analysis market for a medicine you produce – and that should begin with discussions and Plan and prepare being unable to supply it. interviews with all of the different groups It could be that the stress test reveals no involved in maintaining the facility. You problems, which is fantastic news! But it Allan Bream is Associate, Lead should examine manufacturing processes, doesn’t mean you should be complacent – Biopharmaceutical Specialist, at CRB equipment, training and history, and be on you still need to plan for timely repairs and Raleigh, North Carolina, USA. the lookout for any deviations. Also look at replacements to ensure that your facility batch records, change control and corrective continues to be fit for purpose. If nothing Reference action plans for problems that may have requires immediate action then you can use 1. PDA Aseptic Processing Survey 2016
www.themedicinemaker.com 20 In My View
that has never been grown or consumed Algal Boom by humans or animals, and some of In My these could be very useful for new Algae have proven to be pharmaceuticals. experts in molecular warfare Algae are incapable of movement on View with bacteria – and now is the their own and are completely exposed time to apply that expertise to their environment. To regulate to drug discovery and their immediate environment and to In this opinion section, development. protect themselves, algae excrete many experts from across the different types of exogenous secondary world share a single metabolites. One of the biggest threats to most forms of algae is dissolved strongly held view or oxygen in the water, which can degrade key idea. the cell wall (even though algae produce oxygen as part of photosynthesis and Submissions are welcome. excrete it into the water). One protective measure is to allow certain types of Articles should be short, bacteria to form a plaque over the surface focused, personal and of the algae, but not so thick that it passionate, and may prevents light from reaching the algae’s chloroplasts; the bacteria will absorb deal with any aspect the oxygen and also produce a clear of pharmaceutical protective slime that protects both algae development or By Andrew Dahl, President and CEO of and bacteria. However, some bacteria ZIVO Bioscience. are more aggressive and begin to attack manufacture. the host algae, which responds with an They can be up to 600 Certain algal species have been arsenal of bioactive molecules that can words in length and cultivated in Asia as both a source of paralyze the bacteria – sometimes killing nutrition and as a traditional medicine it altogether – or fool it into thinking written in the first person. for centuries. What most people don’t there are already too many bacteria on realize is that algae range in size from the host algae and, thus, the bacteria Contact the editor at: microscopic cells floating in freshwater, stop reproducing. stephanie.sutton to the huge kelp beds off the California coast, and everything in between. The @texerepublishing.com very smallest, as you can imagine, are referred to as microalgae, and most of “Algae, much like the green stuff people consider seaweed is technically macroalgae. About many other natural 72,000 species of algae are known – and in my view there are probably double sources, have been that number yet to be discovered and classified. Of that enormous number, overlooked in only about a dozen are being cultivated commercially anywhere in the world. current drug Algae can be cultivated in natural and artificial ponds, on wooden frames set development in estuaries, in photobioreactors and fermentation tanks. There’s plenty of initiatives.” opportunity to cultivate something In My View 21
3D structures, predictive modeling and located in La Jolla, where marine algae high-throughput screening to comb metabolites are being investigated for “There’s plenty of vast libraries of seemingly random new cancer drugs. As of today, there are molecular combinations, looking for a handful of algae-based pharmaceuticals opportunity to a beneficial effect. Certainly, these in pre-clinical trials. As well as aiding are crucial developmental tools, drug discovery, algae can be modified cultivate something but it is unfortunate that the field to produce biopharmaceuticals, and in of pharmacognosy, or the study of some cases, more efficiently and safely that has never been medicines derived from natural sources, than other recombinant platforms. For has become somewhat esoteric and example, research presented in The grown or consumed uncommon in drug development circles. Proceedings of the National Academy of In Asia, especially Japan and China, Sciences has highlighted how a genetically by humans or research into algae-based drug candidates engineered strain of algae can be used to has been ramping up over the past produce a complex human therapeutic animals – and some two decades, and I think we will see a drug. According to researchers at the pipeline developing in time. Fascinating University of California-San Diego, of these could be very work is also taking place in the US – this particular strain, Chlamydomonas particularly the work of William Gerwick reinhardtii, can produce a wide range useful for new at the Scripps Institute in La Jolla, and of human therapeutic proteins more Stephen Mayfield’s work at the California efficiently than bacteria or mammalian pharmaceuticals.” Center for Algae Biotechnology, also cells (1). In fact, many of the algae
This warfare at the molecular level is why algae should be taken more seriously as a source for new and novel therapeutic agents. Algae can produce both small and large molecules – some are toxic, Serialization & Aggregation but most are not. The challenge is that a single strain of algae will produce ARE YOU READY FOR dozens, if not hundreds, of different compounds over the course of a single THE WORLD MARKET? day, and separating the active from inactive is a gigantic task. However, well-documented bioassays, as well as WE ARE! www.r-pharm.de knowledge regarding gene signaling, Full Service CDMO histopathology and mechanisms of We serialize and aggregate your action can help guide researchers to products according to all known particular metabolites. For the past 10 regulatory requirements years, I’ve been involved in testing select algal strains both in vitro and in vivo, We offer smart and convenient and the results are promising, especially customer onboardings with respect to immune/inflammatory modulation and hypercholesterolemia Benefit from our long-term modification, both in mammals. experience and join the Algae much like many other natural TRAcK & TRAcE UsER AcADEMY sources, have been overlooked in current Contact: [email protected] drug development initiatives, which instead focus on computer-generated 22 In My View
being investigated are modified strains work on the ability of genetically References designed to produce a therapeutic that’s engineered algae to selectively kill 1. M Tran et al., “Production of been previously produced by other cancer cells has been reported in Nature unique immunotoxin cancer therapeutics in recombinant platforms, such as yeast Communications (2) and a more algal chloroplasts”, PNAS. 2, 100, or E. coli. In the near future, popular comprehensive review of the role of algae 14 (2013). drugs like insulin, cytokines, monoclonal in pharmaceutical development has been 2. B Delatat et al., “Targeted drug delivery antibodies and subunit vaccines may be published in the Journal of Pharmaceutics using genetically engineered diatom silica”, produced by algae at a lower cost and and Nanotechnology (3). The field is Nat Commun (2015). higher purity. The variety of research developing slowly, but I’d like to see it 3. T Aditya, G Bitu, EG Mercy, being conducted with algae for the pick up pace and head towards more “The role of algae in pharmaceutical potential development of pharmaceuticals mainstream adoption. development”, Pharm Nanotechnol, 4, has been widely reported. For example, 82-85 (2016).
many people in the industry, including Celebrating the myself, are very excited by this concept and approach. Personalized healthcare “We are very Digital Age is about matching treatments to patients’ individual needs, often driven by their impressed with their Digital technologies could genetic profiles – and we are seeing transform healthcare, many advances in personalized cancer ability to build high including drug discovery, therapies in particular. development, clinical trials Personalized healthcare goes hand quality, longitudinal, and patient empowerment. in hand with digital technologies – for example, machine learning and other real world datasets, advanced analytic techniques can enhance drug discovery and development which have allowed by identifying new drug targets and effective surrogate markers. Research us to better and development at Roche focuses on the therapeutic areas of oncology, understand scientific ophthalmology, asthma, rheumatoid arthritis, neuroscience, inflammatory hypotheses regarding bowel disease and infections – and digital technology that allows us to whether people will deeply explore the science of disease and its genetic basis are incredibly respond to drugs By Sophie Kornowski-Bonnet, Head of important. As one example, we are using Roche Partnering, Basel, Switzerland. smart technology and genomic analyses or not.” to identify new antibiotics targeting At times, working in the healthcare gram-negative bacteria. industry can be very exciting, but also Roche’s neuroscience portfolio become life-changing medicines for challenging and frustrating. You may includes several compounds patients, but there is still the challenge have a very exciting drug candidate for neurodegenerative diseases, of developing them in a timely manner. in development, and yet you won’t be including potential therapeutics for With digital technologies we can able to get it to patients for a very long Alzheimer’s disease and Parkinson’s enhance our approach to clinical trials, time. One of the big focuses for Roche disease in advanced stages of clinical making them faster, more efficient and right now is personalized healthcare – development. These could potentially cost effective. Data is the key here. At In My View 23
Roche, we recently acquired Flatiron reviewing personalized and digital Health, a company which specializes healthcare technologies. We aren’t just “These could in real-world oncology data. We have looking for technologies that can aid been a partner of Flatiron for a very drug development, however; mobile potentially become long time, and we are very impressed technologies, apps and other systems with their ability to build high quality, that can empower patients are also vital. life-changing longitudinal, real world datasets, which Mobile apps can help collect data on have allowed us to better understand patient conditions and encourage medicines for scientific hypotheses regarding whether greater communication between a people will respond to drugs or not. patient and physician – which can only patients, but there We used their data to develop virtual lead to better health outcomes. I am control arms for one of our lung cancer really passionate about this area. is still the challenge drugs, resulting in faster patient access At Roche. we are not only focused on in Europe. I think it’s fantastic to developing better medicines, but also of developing them see companies like Flatiron thinking on getting the right medicine to the outside of the box and asking how right patient faster than we have in the in a timely clinical trials can be enhanced. past – and digital technologies are key As head of partnering at Roche, my to enabling this. manner.” role is to look for innovations that could fit with the Roche pipeline – and we Read more from Sophie in this month’s are spending a lot of time right now Sitting Down With on page 50.
Feature 25
100 Power List 2018
Celebrating the World’s Top 100 Medicine Makers Bringing new drugs to patients is an incredibly difficult task that involves numerous indispensable actors – from pioneering entrepreneurs and CEOs, to industry experts, to dedicated researchers, to regulators who keep everyone on the right tracks. And that’s why we have once again divided our annual Power List of the top 100 inspirational industry professionals into four categories: Masters of the Bench, Industry Influencers, Business Captains, and Champions of Change. The illustrious members of each group contribute, in various ways, to the life-changing, and often life-saving, work carried out by the biopharmaceutical industry. It is our great pleasure to present to you The Medicine Maker 2018 Power List, which was compiled based on nominations from readers and the input of an expert judging panel.
www.themedicinemaker.com 26 Feature
2. CHRISTOPHER J.H. PORTER
PROFESSOR AND DIRECTOR, MONASH INSTITUTE OF MASTERS PHARMACEUTICAL SCIENCES OF THE “I’m motivated by my next discovery; however big or small. I became an academic because of the excitement, BENCH wonder – and sometime panic! – that discovery can bring. I now have scientific awards, including the United many different tasks to get through, States National Medal of Science, and but the best part of every day is still the 2002 Charles Stark Draper Prize the anticipation of what the next 1. ROBERT SAMUEL (often considered the equivalent of the graph might show. I realize that this LANGER Nobel Prize for engineers). is a utopian and perhaps unrealistic It has been estimated that as many as aim, but I’d like to see a greater INSTITUTE PROFESSOR, two billion people may have had their emphasis on addressing unmet MASSACHUSETTS INSTITUTE OF lives touched by the technologies created medical need in a manner that is not TECHNOLOGY, LANGER LAB by Robert and his fellow researchers, driven by market size. Philanthropy and many of his former students have and public/private partnerships are The most cited engineer in history and gone on to great success in academia increasingly trying to redress this one of the most prolific inventors in all and industry. “Working with wonderful balance, and have been successful of medicine, Robert has nearly 1,300 students and doing work that can make in certain areas, but there is much issued and pending patents, many of the world a better place is what drives more that can be done.” which have been licensed or sublicensed me,” says Robert. “If I could change one to over 350 pharma, chemical, biotech thing about the industry, it would be to 4. DAVID BALTIMORE and medical device companies. He find a way to get more funding for basic has been honored with over 200 major research that could help pharma.” PRESIDENT EMERITUS AND ROBERT ANDREWS MILLIKAN PROFESSOR OF BIOLOGY, CALIFORNIA INSTITUTE OF TECHNOLOGY 3. CARL JUNE and his fellow “CRISPR Pioneers” were named as runners up in Time Magazine’s David Baltimore’s love for research RICHARD W. VAGUE PROFESSOR Person of the Year. “Success is the sum of was born after spending a summer IN IMMUNOTHERAPY, intelligence, energy and persistence – and seeing scientists at work at the UNIVERSITY OF PENNSYLVANIA ending the cancer epidemic is what drives Jackson Laboratory in 1955. Since me to succeed. In pharma, I’d like to see then, his achievements include Carl is also Director of the Center for more long-term vision, rather than quarter- a National medal of Science and Cellular Immunotherapies at the Perelman to-quarter milestones.” a Nobel Prize in 1975 for School of Medicine, Medicine Director of the discovery of reverse Translational Research Programs and transcriptase, which implied Director of the Parker Institute for that cancer could be caused Cancer Immunotherapy, both at by genetic means – a wide- the University of Pennsylvania. open question at the time. He is also Co-Founder and He has played a significant chief scientific advisor of role in the development of Tmunity Therapeutics. Carl biotechnology since the 1970s. 7. SHINYA YAMANAKA
DIRECTOR AND PROFESSOR, CENTER FOR IPS CELL RESEARCH 5. RODERICK MACKINNON Shinya’s pioneering work on stem cells has gained him huge scientific SCIENTIFIC CO-FOUNDER recognition. After reprogramming AND CO-CHAIR, adult mouse (2006) and human (2007) FLEX PHARMA somatic cells into what are now called induced pluripotent stem (iPS) cells, A Nobel laureate and an endurance he was awarded a Nobel Prize in 2012. 9. ANDREAS SEIDEL- athlete, Roderick’s 2003 Nobel “Working on the medical applications MORGENSTERN Prize was awarded for his work on of iPS cells is still my focus,” says ion channel activation. This work Shinya, “and I would like to see the DIRECTOR, MAX PLANCK went on to become the foundation of pharma industry collaborate more with INSTITUTE FOR DYNAMICS Flex Pharma’s clinical approach to academia to develop drugs for intractable OF COMPLEX TECHNICAL muscle cramping – and the company diseases.” Asked what piece of advice SYSTEMS, MAGDEBURG hopes to translate their findings into he would offer young researchers, treatments for patients with a range of he says “I wish I had improved my Andreas’ research focuses on neuromuscular disorders which cause English communication skills in my developing concepts to better muscle cramps and spasms. 20s, because English proficiency is link the various steps involved in crucial for scientists to better compete drug production. “I have a lot of 6. NICHOLAS A. PEPPAS or collaborate with researchers overseas.” ideas, and I am driven to evaluate their potential. This includes both PROFESSOR AND DIRECTOR 8.MICHAEL N. theoretical concepts as well as OF THE INSTITUTE LIEBMAN practical implementations. I see it as FOR BIOMATERIALS, a privilege that I can do this together DRUG DELIVERY AND MANAGING DIRECTOR AND with so many talented young people” REGENERATIVE MEDICINE, FOUNDER, IPQ ANALYTICS LLC says Andreas. “I would like to see THE UNIVERSITY OF TEXAS more continuous production process AT AUSTIN “There is an increasing need to applied in the pharma industry.” understand and address the complexities “This has been a banner year for my of disease in terms of clinical 10. CHI VAN DANG team, with achievements including presentation, patient diversity and our new treatment for hemophilia physician practice and this can only be SCIENTIFIC DIRECTOR, using oral delivery of hematological achieved through more critical analysis LUDWIG CANCER RESEARCH factor IX, and our work developing and less dependency on technology. drug delivery systems of siRNA and My career advice? There are no bad Chi is well-known for his contributions interferons. I am driven by a continuous experiences, only new opportunities to to the understanding of the Myc excitement to devise new treatments, learn and improve.” oncogene – his research has led to studies new therapeutic agents, and dedicated to the targeted disruption of new medical devices that aberrant cell metabolic pathways, with will help patients who the aim of developing drugs to inhibit suffer from debilitating cancer. “Patients dying of cancer remind diseases. I am me every day why I do what I do. As with particularly interested everyone else, my life has been personally in understanding touched by cancer, and as a trained the mechanisms medical oncologist, I am humbled by and providing cancer as a formidable foe. A career is innovative treatments a journey in continuous learning – I for autoimmune diseases.” learn something new every day.”
www.themedicinemaker.com 28 Feature
CHAS BOUNTRA JONATHAN BONES PROFESSOR OF PHIL TRANSLATIONAL MEDICINE, S. BARAN PRINCIPAL INVESTIGATOR, NUFFIELD DEPARTMENT NIBRT CHARACTERIZATION AND OF CLINICAL MEDICINE, DARLENE SHILEY CHAIR COMPARABILITY LABORATORY UNIVERSITY OF OXFORD IN CHEMISTRY, SCRIPPS RESEARCH INSTITUTE Jonathan joined NIBRT in 2007, and Before returning to Oxford, Chas was returned there in 2012 after spending Vice President and Head of Biology at Phil has racked up a number of some time at the University of Boston GlaxoSmithKline. He was involved in impressive natural product syntheses, studying glycomics and proteomics for a the identification of more than 40 clinical and won dozens of chemistry’s highest better understanding of mammalian cell candidates for many gastro-intestinal, accolades. His passion is “fundamental bioprocessing. “I’m still in the early stages inflammatory and neuro-psychiatric chemistry with rapid translational of my career, and what’s exciting is how diseases. More than 20 of these molecules potential” and a pivotal moment was fast the biopharmaceutical industry is progressed to patient studies, and over when he realized “one can’t trust in moving,” says Jonathan. “The industry is five progressed to late stage development. public funding alone to finance a lab.” so dynamic, and it continually requires us “Pharma is building increasingly porous Phil would like to see more partnerships to develop new approaches. Working with relations with academia. I am sure this with academic labs, and the appointment great people all driven by a common goal to will foster a broader appreciation of the of chemists to leadership positions. make better, safer more effective treatments difficulties we face, change the reputation for the patients who need them is of the industry for the better, and what motivates me.” accelerate the development of novel medicines for society.” CAROLYN BERTOZZI JONAS BOSTRÖM
ANNE T. AND ROBERT M. PRINCIPAL SCIENTIST, BASS PROFESSOR IN THE ASTRAZENECA; CHIEF SCHOOL OF HUMANITIES EXECUTIVE OFFICER, AND SCIENCES, STANFORD EDUCHEM VR UNIVERSITY MEINDERT “I really love what I do! I can’t imagine DANHOF Carolyn has been recognized for a better job than using computers and both her research and teaching combining new (and old) technologies in RETIRED accomplishments, including the innovative ways in scientific research, with Lemelson-MIT award for inventors, the grand purpose of treating diseases. I Meindert was Professor of Pharmacology the Ernst Schering Prize and the expect, and hope, that a lot of things will at Leiden University until his retirement Arthur C. Cope Award. Her lab become automated, with computers doing in 2017. His research at the Leiden studies the glycobiology underlying much more for us – from synthesis machines Academic Center for Drug Research diseases including cancer, inflammatory to AIs designing molecules with optimal focused on novel concepts of systems disorders and infectious disease, and properties, to using immersive technologies pharmacology, interfacing theories also works to develop new ways to like virtual reality to gain a deeper and from systems biology with quantitative perform controlled chemical reactions better understanding of the drugs we pharmacology. He is also a Past within living systems. Several of are developing. Without a doubt, President of the European Federation these technologies have go on embracing new technologies will of Pharmaceutical Sciences. He has to see commercial use, and allow us to push the boundaries been dubbed the “founding father” Carolyn has worked with of science, enabling new ways of pharmacological models for his several biotechnology of working while making work in developing pharmacokinetic- start-ups. speedier progress.” pharmacodynamic (PKPD) models. Feature 29
KENNETH GETZ CLAUS-MICHAEL LEHR
ASSOCIATE PROFESSOR AND HEAD, DEPARTMENT DIRECTOR OF SPONSORED OF DRUG DELIVERY, PROGRAMS, CENTER FOR THE HELMHOLTZ-INSTITUTE FOR STUDY OF DRUG DEVELOPMENT, PHARMACEUTICAL RESEARCH TUFTS UNIVERSITY SCHOOL SAARLAND, HELMHOLTZ DAVID DUNGER OF MEDICINE; FOUNDER AND CENTER FOR INFECTION BOARD CHAIR, CISCRP RESEARCH (HZI), SAARLAND PROFESSOR OF PEDIATRICS, UNIVERSITY UNIVERSITY OF CAMBRIDGE “Working with great people who share a passion for what we’re doing to help patients, “Being involved in various projects is a David Dunger is a Pediatric the public and the clinical research enterprise big driver of my research. This could be Endocrinologist who works closely with is what drives me. I’m on a personal crusade discussing exciting new data with my industry to develop novel medications to see clinical trial results summaries, in students, but also sharing and trying to for children with diabetes and endocrine plain non-technical language, provided to give some input to the problems of my disorders. He is an expert on the all study volunteers. It is the right thing to colleagues in the industry. But sometimes, growth hormone/insulin-like growth do and it sends a very strong and essential I also just look forward to my next sailing factor 1 (IGF-1) axis and its effects on message to our study volunteers that we trip or playing jazz with my friends!” metabolism, and his work in this area value their gift of participation. CISCRP has led to the first experimental and is making great strides in this area, and clinical studies of recombinant human I’m hopeful that it will become a standard IGF-1 in type 1 diabetes. practice among pharmaceutical and biotechnology companies.”
GRAZIELLA PELLEGRINI of the first stem cell-based advanced therapy medicinal product approved CELL THERAPY PROGRAM in Europe – Holoclar. COORDINATOR, CENTER FOR REGENERATIVE MEDICINE MICHELE DE LUCA “STEFANO FERRARI”, UNIVERSITY OF MODENA DIRECTOR, CENTER FOR AND REGGIO EMILIA REGENERATIVE MEDICINE “STEFANO FERRARI”, After studying chemistry UNIVERSITY OF MODENA AND and pharmaceutical REGGIO EMILIA Technologies, Graziella went on Michele is internationally recognized to become a leading as a leading scientist in epithelial stem figure in the field of cell biology, with a focus on its clinical epithelial stem cell application in regenerative medicine. He biology aimed at clinical played a pivotal role in developing epithelial applications in cell and stem cell-mediated cell therapy, and in gene therapy. She was demonstrating the feasibility of genetically involved in the development corrected stem cell-mediated ex vivo gene therapy for epidermolysis bullosa.
www.themedicinemaker.com 30 Feature Our Commitment, The Industry Leading Experience
PETER SEEBERGER
DIRECTOR, MAX- PLANCK-INSTITUTE OF COLLOIDS AND DOLORES INTERFACES; SCHENDEL PROFESSOR, FREE UNIVERSITY OF CHIEF EXECUTIVE OFFICER BERLIN AND CHIEF SCIENTIFIC OFFICER, MEDIGENE “Early on, I received a Fulbright scholarship Dolores has been a member of the to perform graduate German Research Foundation, work at the University German Cancer Aid and the European of Colorado with Marv Research Council, and developed her Caruthers, the inventor of interest in tumor immunology while gene synthesis machines and a working at the Sloan-Kettering co-founder of Amgen. It opened Institute in New York. She joined new perspectives and eventually led to Medigene as Chief Scientific Officer my work on automated glycan assembly, in 2014, when the company acquired which in turn resulted in novel vaccines Trianta Immunotherapy, and was and diagnostics. My work today focuses appointed CEO in 2016. on creating vaccines to protect everybody PCI offers flexible and globally compliant development, clinical and from deadly infectious diseases, and new JOHN TALLEY commercial scale manufacturing of multiple dosage forms including; tablets, methods to produce affordable drugs.” capsules, liquid and semi-solid preparations. CHIEF SCIENTIFIC OFFICER, EUCLISES Our strength lies in the integrated nature of our services, combining PHARMACEUTICALS formulation and analytical development with clinical trial supplies through to large-scale commercial manufacturing. “My passion is unraveling the role HAROLD VARMUS the co-winner of a Nobel Prize (alongside prostaglandins play in Our award-winning center of excellence for the development and
Michael Bishop) for the discovery of the immune surveillance manufacturing of highly potent molecules utilizes state-of-the-art contained LEWIS THOMAS UNIVERSITY cellular origin of retroviral oncogenes within the tumor PROFESSOR & SENIOR – how malignant tumors are formed microenvironment. engineering solutions advancing products from the earliest stages of ADVISOR TO THE DEAN AND from normal cells. I would also like to development through to commercial launch delivering speed to market for PROVOST, WEILL CORNELL see a return to the our customers. MEDICAL COLLEGE highly-regarded reputation of the A leading cancer geneticist, Harold p h a r m a c e u t i c a l We invite you to learn more about what our commitment Varmus has previously been industry – I’d like to the director of the National see the industry recapture can do for the success of your product. Institute of Health and the its reputation as a force for good National Cancer institute. in people’s lives. This might be He originally obtained accomplished by promotion of a degree in English the many tangible benefits to literature – with a desire individuals that are a consequence to be a writer – before of the industry’s research and © Copyright 2018 Packaging Coordinators, Inc. All Rights Reserved. AndersonBrecon (UK) Limited trading as Packaging Coordinators, Inc. is a company registered in England and Wales with company deciding to pursue a career development initiatives.” number 02543975 and VAT registration number GB 549 7026 19 whose registered office is at The Broadgate Tower, Third Floor, 20 pciservices.com in medicine. In 1989, he was Primrose Street, London, EC2A 2RS. Penn Pharma, a PCI company, is a Trading Name of Penn Pharmaceuticals Services Limited, Registered in England and Wales No.1331447 Registered Office: Tredegar, Gwent NP22 3AA UK. VAT Reg. No.762 3299 16.
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e5357 PCI Manufacturing Advert 210w x 266h Medicine Market.indd 1 16/03/2018 13:31 Our Commitment, The Industry Leading Experience
PCI offers flexible and globally compliant development, clinical and commercial scale manufacturing of multiple dosage forms including; tablets, capsules, liquid and semi-solid preparations.
Our strength lies in the integrated nature of our services, combining formulation and analytical development with clinical trial supplies through to large-scale commercial manufacturing.
Our award-winning center of excellence for the development and manufacturing of highly potent molecules utilizes state-of-the-art contained engineering solutions advancing products from the earliest stages of development through to commercial launch delivering speed to market for our customers.
We invite you to learn more about what our commitment can do for the success of your product.
© Copyright 2018 Packaging Coordinators, Inc. All Rights Reserved. AndersonBrecon (UK) Limited trading as Packaging Coordinators, Inc. is a company registered in England and Wales with company number 02543975 and VAT registration number GB 549 7026 19 whose registered office is at The Broadgate Tower, Third Floor, 20 pciservices.com Primrose Street, London, EC2A 2RS.
Penn Pharma, a PCI company, is a Trading Name of Penn Pharmaceuticals Services Limited, Registered in England and Wales No.1331447 Registered Office: Tredegar, Gwent NP22 3AA UK. VAT Reg. No.762 3299 16.
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INDUSTRY
INFLUENCERS 2. MARTIN VAN TRIESTE
IMMEDIATE PAST are people, including our families, friends CHAIR, PARENTERAL and ourselves. Many of the biggest DRUG ASSOCIATION impacts on modern life have come 1. RICHARD JOHNSON through better prevention and treatment “I would like to see a significant of diseases. Life expectancy and quality increase in R&D productivity, so that CHIEF EXECUTIVE OFFICER of life have dramatically changed in my significant therapies get to patients AND PRESIDENT, PARENTERAL lifetime, and any contribution that I can faster. There are two things that most DRUG ASSOCIATION make is an intrinsic good! But I would R&D organizations can do to be more like to see more focus on improving the effective: one, embrace productivity “I wish I had known the importance of manufacturing of pharma products. enhancing techniques, such as networking within our industry earlier The predominant business model is to lean, which their manufacturing on. So much of what I have learned focus on new therapies, but without a colleagues have embraced, and R&D is from colleagues, and I wish I had corresponding focus on improving the professionals have resisted; two, R&D recognized and cultivated this earlier. manufacturing of these products, many professionals must kill bad projects Day-to-day, I never forget that the patients will not receive the quality of faster, so that valuable resources can ultimate users of pharmaceutical products pharma products they need.” be redeployed on projects with greater potential for success.”
3. ANDY SKIBO 4. MICHAEL W. VANDIVER HEAD OF GLOBAL BIOLOGICS OPERATIONS & GLOBAL VICE PRESIDENT OF ENGINEERING, ASTRAZENECA/ MANUFACTURING & PLANT DESIGN, MEDIMMUNE JUST BIOTHERAPEUTICS
“I am passionate about ensuring that Michael has over 30 years of biopharmaceutical we (both AstraZeneca/MedImmune process development and manufacturing specifically, and our biopharmaceutical experience. At Just Biotherapeutics, he led efforts to industry as a whole) have a long-range bring the company’s J.Plant and J.Pod clinical and commercial biomanufacturing biologics supply capability,” says Andy. facilities online. “I would like to see the cost of biologics He would like to see the pharma industry driven down, as well as the expansion of global access to work closer with regulatory agencies to medicines, where cost savings are passed onto patients find ways to dramatically reduce the cost rather than increasing profit margins.” Looking of developing new drugs – specifically the back, Michael wishes he’d realized earlier that, cost of clinical trials – without sacrificing “you will fail more times than you will succeed, product safety or affecting patient risks. but failure is how you will learn.” 5. RINO RAPPUOLI 7. JOHN BOURNAS
CHIEF SCIENTIST AND HEAD PRESIDENT AND CHIEF EXTERNAL R&D, GSK VACCINES EXECUTIVE OFFICER, ISPE
Rino’s contributions have had a phenomenal John says he wishes he’d known about 9. JIM BREEN impact on the vaccines industry. He was the power of collaboration – sharing involved in the development of CRM197 knowledge and doing so respectfully VICE PRESIDENT, WORLDWIDE used in H.influenzae, N.meningitidis, across cultures and geographies – when ENGINEERING AND and pneumococcus vaccines, and has also starting out. “I truly believe that we TECHNICAL OPERATIONS, introduced several novel scientific concepts don’t impart or teach these concepts JOHNSON & JOHNSON – genetic detoxification (1987), cellular sufficiently. I realize that these are softer microbiology (1996), reverse vaccinology skills than the technical and operational “Even though the world is extremely (2000) and the pangenome (2005). initiatives that we are involved in as large and complex, you as an individual an organization, but my sense is that can make an impact each day if you are we should be aware of these early on focused and want to make a difference. in our careers. Afterall, international We all have the ability to improve the cooperation among professionals, lives of patients via collaboration on the academics and companies is increasing local and global level, challenging why as we confront common challenges in the we do things to streamline processes, global supply chain,” he says. and applying science to accelerate delivery of new therapies to patients. I 8. CORNELL STAMORAN would like to see the industry collaborate more and solve the unmet patient needs VICE PRESIDENT, CATALENT faster and more efficiently by utilizing 6. GIL ROTH new technologies such as data analytics, Cornell began his career as an accountant, machine learning, robotics, and so on. PRESIDENT, PHARMA & before joining R.P. Scherer (now Catalent) I believe collaboration will aid and BIOPHARMA OUTSOURCING in 1992. Cornell says he’s always learning accelerate global pharma and drug ASSOCIATION – and during his time at Catalent he has advances, and provide more patients worked across a number of areas, including with cost effective solutions.” “There are plenty of things I wish I’d strategy, marketing and press known when I first started out in my career relations, innovation, investor 10. MONCEF representing the contract manufacturing relations, and mergers and SLAOUI and development sector (distinct from acquisitions. Cornell also my previous role editing a magazine represented the interests PARTNER, MEDIXI covering that sector). I suppose I was of CDMOs as a member most naive about how much legislative of Pharma & Biopharma Moncef, former work would be involved. When I started Outsourcing Association’s chairman of vaccines the trade association, I thought it would generic industry GDUFA at GSK, says he is primarily be FDA-facing, and would deal II reauthorization driven by the potential with improving regulations, and building negotiation team. impact his work has bridges between our sector and the agency. on the lives of so many. I didn’t realize that in a lot of cases, FDA’s “I would like to see a greater regulations reflect the legislation passed by focus on our social responsibility in Congress. It’s been a rapid learning curve all choices and decisions we make, to understand the mechanics, personalities, paralleled by a dramatic improvement and dynamics of Capitol Hill, and to help in our perception as an industry by lay explain the sector to Congressional staff.” people,” he says.
www.themedicinemaker.com 34 Feature
GARY CUNNINGTON
GLOBAL HEAD OF CTSU BUSINESS CONSULTANCY, BOEHRINGER INGELHEIM HAROLD BASEMAN Gary regularly speaks at conferences CHIEF OPERATING OFFICER, about safeguarding patient data VALSOURCE during clinical trial supply. Nominators praised Gary for his Harold (Hal) has over 39 years of inspirational leadership and coaching JAMES experience in pharmaceutical operations, workshops. “It’s not just thinking AGALLOCO validation, and regulatory compliance. He outside of the industry confines, but has been very active in the Parenteral Drug changing the entire mind-set related PRESIDENT, AGALLOCO & Association, including a stint as Chair. “I to patient care. Inspiration is the key ASSOCIATES try to make a difference, make time to to empower individuals to create a give back to the industry, and do things to change of such magnitude,” he says. “What drives me day-to-day is help improve how industry manufactures trying to bring more science into the quality drug products so that those manufacturing of pharmaceuticals. products are safer, more affordable and MIGUEL FORTE One change I’d like to see in available to patients,” he says. the industry is more mentoring CHIEF EXECUTIVE of younger and less experiences MARC BISSCHOPS OFFICER, ZELLUNA employees. With corporate IMMUNOTHERAPY AND downsizing, frequent job changes, DIRECTOR CONTINUOUS CHIEF COMMERCIALIZATION contract employees and outsourcing, BIOPROCESSING, PALL BIOTECH OFFICER AND CHAIR OF it seems to me that the development COMMERCIALIZATION of employees is no longer a priority. “If I had known the challenges ahead of COMMITTEE, ZELLUNA Investing in employees is one of the me when I started my career, I might’ve IMMUNOTHERAPY soundest things a firm can do, yet chosen a different path! But overcoming it is increasingly hard to find that challenges comes with rewards and “The big change our industry needs commitment in the industry.” that’s something I probably would not (and it’s starting to happen) is the have been able to recognize as a young establishment and validation of a new MADHAVAN (MADHU) scientist. I’m driven day-to-day by the overall business value model – a model BALACHANDRAN ability to help – alongside my team – the that rests on new approaches to product industry become more efficient and agile. development, and that is particularly BUSINESS OWNER, MJB Continuous bioprocessing and process attentive to patient needs, expectations CONSULTANTS intensification is just one aspect of this, and contributions; a model that brings but it is one where a lot of advancements faster and more comprehensive market Madhu spent a number of years are happening as we speak. We still face access approaches, including regulatory working for Amgen and retired from challenges getting vital therapeutics approval, new payer and reimbursement the role of Executive Vice President to patients in need, models and customer education.” of Operations at the end of 2016. He however, and I is considered an outstanding leader look forward to and today sits on the boards of a world where Catalent and uniQure, among treatments others. He also runs his own are more consultancy firm. accessible.” Feature 35
MAIK JORNITZ
CHIEF EXECUTIVE OFFICER, AJAZ HUSSAIN G-CON MANUFACTURING
FOUNDER AND CHIEF “Working for patients and hopefully EXECUTIVE OFFICER, making a difference to improve FIONA GREER INSIGHT, ADVICE AND treatments and access to treatments is SOLUTIONS; PRESIDENT, what drives me day to day. I am very GLOBAL DIRECTOR, BIOPHARMA NATIONAL INSTITUTE passionate about the patient since this is SERVICES DEVELOPMENT, SGS FOR PHARMACEUTICAL the person we all work for – no matter TECHNOLOGY AND EDUCATION what position or function you are in. To “I wish I’d known that the career path improve the industry, I think we need from A to B is not always direct – it has Ajaz has previously served as Deputy to be able to make technology changes diversions, dead-ends, circular routes Director of the Office of Pharmaceutical much faster, especially when these and unmapped areas! This is all part of a Science at the FDA and led some of changes improve the safety, quality and learning process and good experience for the FDA’s major initiatives to develop efficiency of manufacturing processes.” dealing with change, both planned and regulatory policies. He has also held roles unexpected. For the future, I’d really at Sandoz, Philip Morris International like to see an increase in the efficiency and Wockhardt. He is passionate about of the R&D model of research-based transforming the sector by improving pharma and biopharma – not just cost assurance of quality and reliability of reduction, but increased innovation too.” pharmaceutical manufacturing.
CAROL LYNCH
PRESIDENT SANDOZ INC AND HEAD OF NORTH AMERICA DANIEL O’CONNOR Carol is currently Global Head of Biopharmaceuticals at Sandoz – a business she has successfully managed since September 2014. During this time EXPERT MEDICAL the business grew rapidly, reached $1 billion in sales ASSESSOR, MEDICINES AND annually, and the portfolio came to fruition HEALTHCARE PRODUCTS with 5 biosimilar approvals. Under REGULATORY AGENCY Carol’s leadership, Sandoz achieved the first approval and launch of a A medical assessor at MHRA, Daniel is biosimilar in the US, and last instrumental in the UK’s Early Access year saw the launch of the to Medicines Scheme (EAMS). “It next wave of biosimilars in is a privilege to work in a setting the EU. With the recent where you are contributing announcement of Sandoz’s positively to public health on a collaboration with Biocon, daily basis,” he says. What big the company has further change would he like to see in strengthened its pipeline. industry? More collaborative Effective March 1, working across different Carol Lynch succeeded stakeholders, including patients, Peter Goldschmidt. regulators and industry.
www.themedicinemaker.com ENGINEERING | ARCHITECTURE | CONSTRUCTION | CONSULTING 36 Feature MAKE YOUR FACILITY
RAM SASISEKHARAN A FIT FACILITY
ALFRED H. CASPARY CRB’S FIT FACILITY PROGRAM IS A SYSTEMATIC GUIDO RASI PROFESSOR OF BIOLOGICAL HEALTH CHECK THAT OPTIMIZES FACILITIES ENGINEERING AND HEALTH ASSESS EXECUTIVE DIRECTOR, SCIENCES & TECHNOLOGY, The Fit Facility program can be tailored to your unique circumstances. EUROPEAN MEDICINES MIT DEPARTMENT OF The preferred proactive assessment identifies discrepancies with AGENCY BIOLOGICAL ENGINEERING industry best practices, deficiencies requiring action, reliability issues, and areas where problems may be imminent. Guido is serving his second term Ram has been a professor at MIT as Executive Director of the EMA, since 1996 and served as the Director having served as the EMA’s Principal of the Harvard-MIT Division of Adviser in Charge of Strategy between Health Sciences & Technology terms. He previously worked for from 2008-12. His research on the Italian Medicines Agency, the complex polysaccharides has led Institute of Molecular Medicine of the to over 125 publications and over National Research Council in Rome, 50 patents. He is also a founder and as a physician. of Momenta Pharmaceuticals, Cerulean Pharma, and Visterra Pharmaceuticals. REPORT
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Thomas was highly ANDREW WITTY commended by the judging panel for his CHIEF EXECUTIVE,OPTUM dedication to industry and (EFFECTIVE JULY 1, 2018) innovation, particularly in antibody drug conjugates. He Sir Andrew graduated from the has over 24 years of experience University of Nottingham, UK, in 1985, in bioprocessing, having worked with a BA in Economics, and joined for Genentech (where he was GlaxoSmithKline the same year. He was part of the first generation of large appointed CEO in 2008 – a position he scale manufacturing processes held until April 1, 2017. From July 1, FIT for antibodies and recombinant 2018, Andrew will be chief executive of IS YOUR FACILITY READY proteins), Abgenix, Tanox, and UnitedHealth Group’s Optum pharmacy Your Fit Facility is fully prepared for regulatory audits Biogen, prior to Immunogen. benefit unit. FOR A CHECK-UP? and optimized to deliver a competitive advantage. Ongoing assessments make certain peak performance becomes part CRBUSA.COM | 877.4CRBUSA of your culture. ENGINEERING | ARCHITECTURE | CONSTRUCTION | CONSULTING MAKE YOUR FACILITY A FIT FACILITY
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2. JOSEPH JIMENEZ
FORMER CHIEF EXECUTIVE BUSINESS OFFICER, NOVARTIS CAPTAINS Joseph joined Novartis in April 2007 as Division Head, Novartis Consumer Health, after spending eight years running the North world spends 12 percent of its GDP on American, European and then Asian healthcare, the developing world spends operations of H.J. Heinz. He was less than 3 percent. The disease burden named CEO of Novartis in 2010, 1. KIRAN MAZUMDAR- is even more skewed. 80 percent of a position he held until earlier this SHAW non-communicable diseases are in the year. Joseph has served as President developing world, killing 30 million and of the European Federation of CHAIRPERSON AND MANAGING driving 100 million into poverty every Pharmaceutical Industries and DIRECTOR, BIOCON year. These deaths could be prevented Associations and as Chairman Elect if only they had access to essential and of Pharmaceutical Research and “There currently exists an ugly and life-saving medicines. For the vast Manufacturers of America. unethical divide between the billion who majority in the developing world, life is have health security in the developed about survival and the pharma and drug world and the nearly seven billion others development industry needs to throw who are vulnerable to disease and death them a lifeline by developing disruptive because of little or no access to health new technologies that can bridge the protection. Whilst the developed resource deficit.”
3. RAMAN SINGH at GlaxoSmithKline where he oversaw all aspects of the brand’s commercial operations CHIEF EXECUTIVE OFFICER, across its emerging markets. He has also held MUNDIPHARMA, SINGAPORE positions at Abbott as the regional director in Australia and New Zealand, and general Since Raman took the helm of the company manager for Korea, as well as various sales, in 2011, Mundipharma says it has enjoyed marketing and strategy positions at Bayer. growth of 40 percent every year and is now Raman was raised in the US and initially 4. EMMA WALMSLEY prominent in 128 countries. Mundipharma he expected to be an entrepreneur like won “Emerging Markets Company of his father. He has a degree in mechanical CHIEF EXECUTIVE OFFICER, the Year” at the 2016 Scrip Awards and engineering but has GLAXOSMITHKLINE Raman was awarded “Best CEO, focused his career Pharmaceutical Industry Asia” at the on healthcare. Before heading up GSK, Emma worked Business Worldwide Magazine at L’Oreal for 17 years where she held 2017 CEO Awards. Before a variety of general management and Mundipharma, Raman served marketing roles. Emma holds an MA in as vice-president of commercial Classics and Modern Languages from operations for emerging markets Oxford University. 5. BELÉN GARIJO
CHIEF EXECUTIVE OFFICER, HEALTHCARE, MERCK
Belén Garijo has been a member of 9. JEAN-PAUL CLOZEL the Executive Board of Merck since 7. SEVERIN SCHWAN January 2015. She is responsible for the CHIEF EXECUTIVE OFFICER, Healthcare business sector, comprising CHIEF EXECUTIVE OFFICER, IDORSIA the Biopharma, Consumer Health, ROCHE GROUP Allergopharma and Biosimilars Jean-Paul founded Actelion in 1997, businesses. Since 2013, she also acts as After completing his studies at the together with his wife and work President and CEO of the Biopharma University of Innsbruck in Austria, colleagues and friends, and has since business, where she started in 2011 as Severin joined the Roche Group in built Actelion from a start-up to a Chief Operating Officer. Before moving 1993 as a trainee in corporate finance. multi-billion market capitalization to the pharma industry, she was a Thirteen years later, he was appointed company – acquired by Johnson & practicing physician. CEO of Roche’s Diagnostics Division, Johnson for €27.9 billion in 2017. and in 2008 he became CEO of the As part of the transaction with J&J, 6. ROBERT A. Roche Group. Actelion spun out its drug discovery BRADWAY operations and early-stage clinical 8. ARIE BELLDEGRUN development assets into a newly CHAIRMAN AND CHIEF created company, Idorsia, which EXECUTIVE OFFICER, EXECUTIVE CHAIRMAN AND Jean-Paul now heads up. AMGEN CO-FOUNDER, ALLOGENE THERAPEUTICS 10. RACHEL In 2006, Robert joined Amgen HAURWITZ as Vice President of Operations Arie has founded several successful Strategy. He was appointed to biopharmaceutical companies, including PRESIDENT the Amgen Board of Directors Agensys, Cougar Biotechnology, and most AND CHIEF in October 2011, and became recently Kite pharma, acquired by Gilead EXECUTIVE Chairman in January 2013, and in 2017 for $12 billion dollars. In October OFFICER, CEO in May 2012. Before Amgen, last year, Kite Pharma’s Yescarta became CARIBOU he was a managing director at the second CAR-T therapy approved by BIOSCIENCES Morgan Stanley in London. In 2017, the FDA. And in April, 2018, Arie raised Robert was elected PhRMA board $300 to co-found Allogene Therapeutics, Rachel has a research background in chairman-elect. which will acquire and advance a portfolio CRISPR-Cas biology and holds several of off-the-shelf CAR-T therapies patents covering CRISPR-derived previously controlled technologies. She co-founded Caribou by Pfizer. in 2012 and Intellia Therapeutics in 2014, both of which are developing genome editing therapies. In 2014, she was named by Forbes Magazine to the “30 Under 30” list in Science and Healthcare, and in 2016, Fortune Magazine named her to the “40 Under 40” list of the most influential young people in business.
www.themedicinemaker.com 40 Feature
JOHN CHIMINSKI
PRESIDENT AND CHIEF EXECUTIVE OFFICER, CATALENT
STÉPHANE BOISSEL “Honestly, I wish I could’ve known that as STÉPHANE an electrical engineer, I would one day be BANCEL CHIEF EXECUTIVE OFFICER, working in the pharma and biotech industry. TXCELL Although my engineering background has CHIEF EXECUTIVE OFFICER, served me well, I would have spent more MODERNA THERAPEUTICS Stephane says he’s driven by “a passion time learning the life sciences disciplines of for working in an environment with biology and chemistry! What drives me? Prior to Moderna, Stéphane was an incredible purpose: saving and Being responsible for 1,000 customers and CEO of bioMérieux and he has improving lives. Also, making day- more than 11,000 employees at Catalent. The also held leadership positions at to-day decisions to address challenges patient is the common factor behind both of Eli Lilly. Moderna claims it can makes you forget how long, cumbersome these groups and ensures that our priorities generate proteins needed to treat an and random drug development can be.” and decisionmaking deliver safe and array of diseases by turning cells into What big change would Stéphane like effective medicines. I would like to see more “drug factories” with custom-built to see in pharma and drug development? standardization of regulatory requirements strands of messenger RNA. In 2017, “A little less greed and a lot more social across all global agencies. There are still Stéphane was named Ernst & Young responsibility.” significant differences in requirements, and 2017 New England Entrepreneur of how inspectors interpret these requirements the Year. ANNALISA JENKINS through their inspections, that lead to ‘patch- work’ solutions and processes. This, in turn, CHIEF EXECUTIVE OFFICER, leads to variability and additional costs that PLAQUETEC don’t necessarily equate to better quality ERIK GATENHOLM or control.” Annalisa began her first tour of duty with CO-FOUNDER AND CHIEF the Royal Navy as a medical officer, but EXECUTIVE OFFICER, has since climbed the ranks of pharma to CELLINK become a CEO and a member of numerous boards, including PlaqueTec – a UK Erik started his first diagnostics company developing a novel biomedical device approach to assess an individual’s risk for compa ny, BC coronary artery disease. “I’m driven by a Genesis, at age passion for making peoples’ lives longer, JEFF 18 in Virginia healthier and happier, ensuring that great JONAS USA, in 2008. science is translated effectively into new Now 28, he is the options for patients globally, and inspiring CHIEF EXECUTIVE OFFICER, CEO of CellInk, the next generation to make a difference. In SAGE THERAPEUTICS the first bioink the future, I’d like to see diversity at the top company in the world and recognized as a business and human right Jeff joined SAGE as CEO in 2013 and a leading bioprinter provider. Erik’s imperative, and girls in school embracing has more than 20 years of experience expertise lies in commercializing STEM. I’m also passionate about innovative on both the scientific and business biomedical technologies by and progressive business models sides of the pharmaceutical and disrupting industries. His drive that seek to ensure that healthcare industries, particularly in and passion, he says, comes the discoveries and the CNS field. He has published more from the fact that he truly products of our than 70 scientific papers and chapters, wants to change the world industry benefit authored more than 100 books, scientific of medicine for future every human being articles and abstracts, and has received generations to come. on the planet.” numerous awards. Feature 41
G. V. PRASAD VIVEK RAMASWAMY CO-CHAIRMAN AND CHIEF EXECUTIVE OFFICER, DR. FOUNDER AND REDDY’S LABORATORIES CHIEF EXECUTIVE OFFICER, ROIVANT G. V. has been a member of the board SCIENCES ANKIT MAHADEVIA of directors at Dr. Reddy’s since the year it was founded. He joined in a full-time Vivek founded Roivant, a PRESIDENT AND CHIEF capacity in 1990, when company revenues company that in-licenses late-stage drug EXECUTIVE OFFICER, were less than $50 million – today they are candidates and develops them through SPERO THERAPEUTICS over $2.5 billion. Prasad is a strong believer subsidiaries, in 2014. Axovant, Myovant, in sustainable manufacturing and Enzyvant, and Dermavant are Ankit was formerly a Venture Partner at business practices, and is also some of the company’s Atlas Venture where he supported the involved with charitable subsidiaries, developing formation of eight companies focused initiatives including the drugs for Alzheimers on novel drug discovery platforms and Andhra Pradesh chapter disease, women’s therapeutic products. He co-founded of the Worldwide health, rare diseases Spero Therapeutics – a clinical-stage Fund for Nature and and skin diseases, biopharmaceutical company focused the “Acumen Fund,” a respectively. on identifying, developing and nonprofit venture that commercializing novel treatments for uses entrepreneurial multi-drug resistant bacterial infections approaches to help – in 2013. He has been its CEO and eliminate global poverty. President since March 2015.
RAVI NALLIAH therapy products. And it’s regrettable that, due to the complexity associated with the CO-FOUNDER AND CHIEF manufacture and administration of these EXECUTIVE OFFICER, products, the price tag tends to be high. But RODGER TRAKCEL these treatments are curative, and I would NOVAK like to see healthcare payers considering TrakCel is described as a clinical the accumulative reduction in healthcare PRESIDENT AND CO- orchestration platform for regenerative costs once patients are treated with these FOUNDER, CRISPR and cell-based therapies. “As a passionate therapies.” THERAPEUTICS innovator working in a relatively conservative industry I thought that my Rodger is one of the three co- passion would win over my colleagues founders of CRISPR Therapeutics, when trying to create space for my which aims to treat diseases using the companies to innovate. However, for breakthrough CRISPR/Cas9 gene innovation to flourish, passion can only editing technology. In December get a leadership team so far. I now work last year, the company applied for hard to develop detailed cases for all permission from the EMA to test its activities so that my vision will appeal most advanced product, code-named to all the personality types in my CTX001, in patients suffering from leadership team. TrakCel’s software is beta-thalassemia. primarily used to support cell and gene 42 Feature CELEBRATING THREE YEARS IAN C. READ OF HUMANITY CHAIRMAN OF THE BOARD AND CHIEF EXECUTIVE OFFICER, PFIZER IN SCIENCE
Ian began his career with Pfizer in 1978 as an operational auditor. He is a past Chairman of The Humanity the Board of PhRMA in Science Award and currently serves DAVID SCHENKEIN recognizes and rewards as President of the scientific breakthroughs International Federation CHIEF EXECUTIVE OFFICER, that aim to have a real of Pharmaceutical AGIOS PHARMACEUTICALS impact on humankind’s Manufacturers & Associations. health and wellbeing. David joined Agios in August 2009 as CEO and board member, after working as senior vice president, In partnership with clinical hematology/oncology, at Genentech. He has been a hematologist and medical oncologist for more than 20 years and still sees patients once a week at Tufts Medical Center, where he started practicing as a doctor in 1983.
MARTIN TOLAR
FOUNDER, PRESIDENT AND CHIEF EXECUTIVE OFFICER, ALZHEON 2015 2016 2017 During his academic career, Martin served as an Assistant Peter Seeberger & Andreas Seidel- Waseem Asghar, Assistant Professor Richard Jähnke, Global Pharma Professor in the Department of Morgenstern, Directors at two at Florida Atlantic University, Health Fund (GPHF), developed and Working alongside Neurology at Yale University collaborating Max Planck institutes developed flexible sensors for the rapid continuously improved GPHF Minilab CSO George Yancopoulos, School of Medicine, where he in Germany, developed an innovative and cost-effective diagnosis of HIV – and – a “lab in a suitcase,” enabling resource Leonard has grown Regeneron, focused on movement disorders. process to manufacture the most effective other infectious diseases – in point-of- poor countries to rapidly identify which he co-founded in 1988, from Since then he has served as head drugs to treat malaria from plant waste care settings. substandard and falsified medicines. a small startup to one of the world’s of business development at Pfizer material, air and light. LEONARD SCHLEIFER leading biotechnology companies, with before founding Alzheon, a clinical- a number of FDA approved medicines. stage biopharmaceutical company PRESIDENT AND CHIEF Leonard is a licensed physician and focused on brain health, memory EXECUTIVE OFFICER, worked as a practicing neurologist and aging. REGENERON before founding Regeneron. Nominations will open soon for the 2018/2019 Humanity in Science Award www.humanityinscience.com CELEBRATING THREE YEARS OF HUMANITY IN SCIENCE
The Humanity in Science Award recognizes and rewards scientific breakthroughs that aim to have a real impact on humankind’s health and wellbeing.
In partnership with
2015 2016 2017
Peter Seeberger & Andreas Seidel- Waseem Asghar, Assistant Professor Richard Jähnke, Global Pharma Morgenstern, Directors at two at Florida Atlantic University, Health Fund (GPHF), developed and collaborating Max Planck institutes developed flexible sensors for the rapid continuously improved GPHF Minilab in Germany, developed an innovative and cost-effective diagnosis of HIV – and – a “lab in a suitcase,” enabling resource process to manufacture the most effective other infectious diseases – in point-of- poor countries to rapidly identify drugs to treat malaria from plant waste care settings. substandard and falsified medicines. material, air and light.
Nominations will open soon for the 2018/2019 Humanity in Science Award www.humanityinscience.com 44 Feature
CHAMPIONS OF CHANGE
2. J. CRAIG VENTER
“The world we live in is changing FOUNDER, CHAIRMAN AND constantly. As an incurable optimist, I CHIEF EXECUTIVE OFFICER, see opportunities every single day. In J. CRAIG VENTER INSTITUTE 1. TOMASZ SABLINSKI drug development, specifically, there are countless opportunities to improve John is regarded as a pioneer in the CHIEF EXECUTIVE OFFICER a 50-year old process using existing field of genomics – founding Celera AND CO-FOUNDER, and emerging technologies that will Genomics in 1998 to sequence the TRANSPARENCY LIFE SCIENCES bring life-saving medicines to patients human genome using tools and faster. I’d like to see the same curiosity techniques he and his colleagues According to Tomasz, it’s important to and creativity that drive software and developed. With Celera he also challenge the status quo, as fear is the technology development applied to drug worked to sequence the fruit fly, most significant barrier to progress. development.” mouse and rat genome. With his team at the J Craig Venter Institute, he created the first self- replicating bacterial cell constructed entirely with synthetic DNA. He is also founder, scientific strategy 3. STEVE DAVIS activist, Steve spent part of his career using advisor and executive chairman of his law degree to advance human and civil Human Longevity. PRESIDENT AND CHIEF EXECUTIVE rights. He is a member of the Council on OFFICER, PATH; LECTURER Foreign Relations, serves on the board of 4. ANDREW POLLARD ON SOCIAL INNOVATION, InterAction, and is a trustee of the World STANFORD GRADUATE SCHOOL Economic Forum’s Global Health Challenge. PROFESSOR OF PEDIATRIC OF BUSINESS INFECTION AND IMMUNITY, UNIVERSITY OF OXFORD As president and CEO of PATH, Steve combines his experience as a Andrew chairs the UK Department business leader, health advocate, of Health’s Joint Committee on and innovator to drive change Vaccination and Immunization, and save lives, especially in the European Medicines Agency low and middle-income scientific advisory group on vaccines, countries. PATH believes and is a member of WHO’s SAGE that social innovation (Study on global AGEing and adult is the key to changing health). His research focuses on the world. A strong developing and evaluating vaccines, proponent of gender including those for meningococcal equity in leadership disease and enteric fever. roles and a social and gay 5. ANTHONY S. FAUCI 7. SUBHASH KAPRE
DIRECTOR, US NATIONAL CHIEF EXECUTIVE OFFICER, INSTITUTE OF ALLERGY AND INVENTPRISE INFECTIOUS DISEASES (NIAID) Subhash established Inventprise in 2012 9. MARGARET Anthony first became Director of NIAID with the aim of developing cheaper, safer HAMBURG in 1984, where he oversees basic and vaccines. A previous board member of applied research on HIV/AIDS, respiratory the Serum Institute of India, he has over PRESIDENT, AAAS, FOREIGN infections, emerging diseases such as 44 years of experience in research and SECRETARY OF NATIONAL Zika, and many more – he was also one development. Under a project grant from ACADEMY OF MEDICINE of the principal creators of the President’s the Bill & Melinda Gates Foundation, Emergency Plan for AIDS Relief, which has Inventprise has created a liquid heat-stable A former FDA commissioner, saved millions of lives worldwide. Anthony Rota virus vaccine that can withstand Margaret now works with the was a clinical researcher at the NIH when temperatures of 50°C for 5 months. American Association for the the AIDS crisis began, and his interest in Advancement of Science. “Partnership the disease led to seminal contributions to is so important – we need to be able the understanding of how HIV destroys the to work across disciplines, sectors and body’s defenses. borders in order to make a difference. I would like to see better alignment between the opportunities in science and technology today with unmet 8. JULIE LOUISE medical care and public health needs.” GERBERDING 10. MARK PAXTON EXECUTIVE VICE PRESIDENT, COMMUNICATIONS, GLOBAL MANAGING DIRECTOR, POLICY, AND POPULATION ACCELERATORX HEALTH & CHIEF PATIENT 6. SUE DESMOND- OFFICER, MERCK, SHARP “Day-to-day, I am driven by the HELLMANN & DOHME excitement that there are tremendous opportunities to improve healthcare CHIEF EXECUTIVE OFFICER, Julie served as Director of the US Centers outcomes with high quality, safe and BILL & MELINDA GATES for Disease Control and Prevention (CDC) effective drugs. Educating the various FOUNDATION director from 2002 to 2009 – the stakeholders across the globe on first woman to be appointed to what this actually means is After training as an oncologist, Sue spent this role. She joined MSD in very important and there is 14 years as head of product development 2010, and is responsible for the a lot of collaborative work at Genentech – where she played a role company’s Foundation and that still needs to be done. in the development of Herceptin and “Merck for Mothers,” a global Currently, I am working Avastin. Next, she spent five years as the program to prevent maternal on a couple of initiatives first female Chancellor of the University mortality. Julie has also helped to accelerate the adoption of California, San Francisco. As the first with the development of the of digital connectivity of physician and research scientist CEO of Merck Women’s Employee Business drug products – especially with the Bill & Melinda Gates Foundation, Resource Group. She was selected as 2018 injectables. Such connectivity allows she draws on her public and private Women of the Year by the Healthcare for healthcare providers and patients to sector experience to combat infectious Businesswomen’s Association for her provide significantly more specificity disease and empower people – especially contributions to advancing gender equality regarding health outcomes than is women and girls. in the healthcare industry. currently measured in clinical trials.”
www.themedicinemaker.com DARIO CAMPANA
MRS. LEE KONG CHIAN CHAIR IN ADVANCED CELLULAR THERAPY, PROFESSOR, DEPARTMENT OF PAEDIATRICS, YONG LOO LIN SCHOOL OF MEDICINE, NATIONAL UNIVERSITY OF SINGAPORE; STEVE ARLINGTON SCIENTIFIC FOUNDER, UNUM THERAPEUTICS, NKARTA AND PRESIDENT, PISTOIA MEDISIX THERAPEUTICS ALLIANCE SÉGOLÈNE AYMÉ “I believe there is an innate resistance “If I had understood the power of cross- to new ideas and truly disruptive disciplinary working when I first started EMERITUS DIRECTOR OF technologies, and it often takes a my career, then I would have focused my RESEARCH, FRENCH INSTITUTE long time before these are valued. efforts on this way of working much OF HEALTH AND MEDICAL More effective therapies are urgently earlier. My aim in life is to make a real RESEARCH (INSERM) needed, and I believe that better difference in everything I do. I also interaction between industry and believe that you should focus on the Ségolène is a medical geneticist and chairs academia can help to facilitate the things you enjoy the most, as you do the Topic Advisory Group on rare diseases translation of basic discoveries into much better when you are having fun at the World Health Organization and clinical applications.” at work. I am particularly passionate the European Union Committee of about the pharma industry discovering, Experts on Rare Diseases. She is also developing, and launching affordable the founder of Orphanet, a portal which medicines that society really needs. In provides information on rare diseases and DALVIR GILL everything I do, I try to promote greater orphan drugs and the editor-in-chief of collaboration within and between the Orphanet Journal of Rare Diseases. CHIEF industry, the regulator, the payer, and EXECUTIVE the provider. With greater collaboration, OFFICER AND we will be able to harness the power of MEMBER OF THE new science and technologies such as BOARD OF DIRECTORS, genomics, AI and blockchain.” TRANSCELERATE BIOPHARMA
THOMAS CECH Dalvir Gill was appointed CEO of TransCelerate in January 2013 and has DISTINGUISHED PROFESSOR since pioneered a number of changes and OF CHEMISTRY AND improvements to the drug development BIOCHEMISTRY, UNIVERSITY process. As the CEO of TransCelerate OF COLORADO and its subsidiary BioCelerate, Dalvir has led a number of initiatives that have helped Thomas is an Investigator with the to make the research and development Howard Hughes Medical Institute, ecosystem more efficient, safe and and also a Distinguished Professor at innovative. Through TransCelerate, he the University of Colorado and Director he’d like to see in pharma, Thomas has made it a priority to not only engage of the university’s BioFrontiers Institute. says, “We need to see more risk-taking with patients about clinical trials, but to He shared a Nobel Prize in Chemistry for to make the big advances in meeting also offer higher value to patients and other the discovery of the catalytic properties unmet medical needs, not just me-too healthcare stakeholders through more of RNA in 1989. Asked what changes incremental improvements.” effective use of trial information. Feature 47
BRIAN OVERSTREET BEN GOLDACRE FAITH PRESIDENT, ADVERA HEALTH SENIOR CLINICAL RESEARCH OSIER ANALYTICS FELLOW, CENTRE FOR EVIDENCE-BASED MEDICINE, GROUP LEADER, HEIDELBERG Brian is the co-founder of Advera, an NUFFIELD DEPARTMENT UNIVERSITY HOSPITAL; analytics company that has introduced a OF PRIMARY CARE HEALTH PRINCIPAL INVESTIGATOR, predictive system that analyzes real-world SCIENCES KEMRI-WELLCOME TRUST drug outcomes data to improve RESEARCH PROGRAM patient safety and reduce Ben is a doctor, academic, writer, systematic healthcare broadcaster and campaigner for greater Faith has won multiple prizes for costs. Recently, transparency in the pharma industry. her research into the mechanisms Advera partnered He co-founded AllTrials, a project that of immunity against Plasmodium with technology advocates for all clinical trials being listed falciparum, and she aims to translate consulting firm on an open registry. He runs the EMB this knowledge into highly effective Booz Allen DataLab in Oxford which aims to create malaria vaccines. She originally Hamilton to useful tools using academic and health data, trained as a pediatrician in Kenya provide access to with its first output, OpenPrescribing, before specializing in immunology in social media data on providing a live view of individual practice Liverpool, later obtaining a PhD from adverse drug effects to prescribing data in the UK. the Open University, UK. spot adverse events faster. ROBIN ROBINSON ROSALIND SMYTH RETIRED MIKE REA DIRECTOR, UNIVERSITY During his time as Director of COLLEGE LONDON GREAT CHIEF EXECUTIVE OFFICER, Biomedical Advanced Research ORMOND STREET INSTITUTE OF IDEA PHARMA Development Authority (BARDA), CHILD HEALTH Robin developed patented platform “I’m leading the development of a code vaccine technologies Rosalind has based her career around of ethics for the industry. I wholly including virus- improving children’s health, and believe that we have to do the right like particles and is recognized as a leading things, and do them transparently, and subunit protein authority in the field. with full input from other stakeholders. vaccines Previously Professor of It took me a long time to realize just how for human Pediatric Medicine cool this industry can be – we need to pathogens – at the University of become more attractive to people leaving and led the Liverpool UK and university in order to compete with tech development Director of the UK and finance. I wish I’d realized earlier of the first Medicines for Children in my career that pharma is an industry avian influenza Research Network, she looking for people to change it!” H5N1 vaccine. has also chaired the UK Robin has also Pediatric Expert Advisory MELINDA RICHTER served on WHO Group of the Commission on international expert Human Medicines. GLOBAL HEAD OF JLABS, teams on influenza vaccines. JOHNSON & JOHNSON Top conferences 33rd International Exhibition for Fine and Speciality Chemicals and workshops o er “I had very humble beginnings, and as a valuable insights into ongoing young woman I always felt like I didn’t BRUNO SEPODES R&D projects! have the same platform that other people Agrochemical Lecture Theatre had and that I was straying into territory PROFESSOR OF Chemspec Careers Clinic PHARMACOLOGY AND Pharma Lecture Theatre where I didn’t belong. Growing up with Regulatory Services Lecture Theatre PHARMACOTHERAPY, five brothers and three sisters gave me RSC Lecture Theatre the competitive spirit and UNIVERSITY OF LISBON; Innovative Start-ups the independence to CHAIR OF THE EMA go there anyway. COMMITTEE OF ORPHAN My favorite quote MEDICINAL PRODUCTS is ‘courage is fear that has said its After studying pharmacy at university The industry’s premier sourcing and networking event prayers’. Our and then moving into toxicology, Bruno mission is to became an assessor for the Portuguese Some 400 international Fine and speciality chemicals for make it faster, medicine regulator INFARMED exhibitors o er bespoke various industries: Koelnmesse easier, cheaper and before moving to the European and earlier dialogue with regulators solutions and specifi c pharmaceuticals • agrochemicals • more exciting for Medicines Agency. From there, he in order for drug development to be as substances to enhance petrochemicals • cosmetics • adhesives & Cologne, Germany innovators and investors developed a passion for the regulation of smooth as possible. There are still several products or develop new sealants • paints & coatings • polymers • to deliver real value and impact for orphan diseases, creating incentives for missed opportunities of interaction with chemical solutions. biotechnology • colourants & dyestu s • patients. We want to make the business development and therefore improving regulators and we simply cannot afford food & drink • industrial cleaning • 20 – 21 JUNE 2018 of health just as productive, advanced, public health. He recently received the that, especially in some fields such as reprography & printing • water treatment sexy and as addictive to participate in as EURORDIS Rare Disease Leadership drug development for rare diseases,” and much more. www.chemspeceurope.com the tech industry.” Award. “I would like to see a better says Bruno. Organisers:
CSE_18_210x130+3mm_en.indd 1 14/03/2018 10:17 ABBE STEEL
CHIEF EXECUTIVE OFFICER, MATTHEW TODD HEALTHIVIBE ASSOCIATE PROFESSOR, Abbe has 27 years’ UNIVERSITY OF SYDNEY; experience in the FOUNDER, OPEN SOURCE life sciences industry, MALARIA and is the Founder and CEO of HealthiVibe, Matthew would love to see a “robust a company that helps and large-scale trial of open source drug pharmaceutical companies development as a competing model for gather patient insights to support the pharmaceutical industry, funded clinical trial design. Her passion she would like to see the industry through a mixed investment model lies in leading patient initiatives change to ensure that no protocol of public, private and philanthropic for clinical development and is finalized without incorporating support.” His passion is to improve post-marketing programs – and patient feedback first. efficiency in R&D through working with others, and making knowledge more available.
Top conferences 33rd International Exhibition for Fine and Speciality Chemicals and workshops o er valuable insights into ongoing R&D projects! Agrochemical Lecture Theatre Chemspec Careers Clinic Pharma Lecture Theatre Regulatory Services Lecture Theatre RSC Lecture Theatre Innovative Start-ups
The industry’s premier sourcing and networking event
Some 400 international Fine and speciality chemicals for exhibitors o er bespoke various industries: Koelnmesse solutions and specifi c pharmaceuticals • agrochemicals • substances to enhance petrochemicals • cosmetics • adhesives & Cologne, Germany products or develop new sealants • paints & coatings • polymers • chemical solutions. biotechnology • colourants & dyestu s • food & drink • industrial cleaning • 20 – 21 JUNE 2018 reprography & printing • water treatment and much more. www.chemspeceurope.com
Organisers:
CSE_18_210x130+3mm_en.indd 1 14/03/2018 10:17 Leading by Learning
Sitting Down With… Sophie Kornowski-Bonnet, Global Head, Roche Partnering. Sitting Down With 51
Did you always want to work in pharma? How did you move into When you move into a senior role, you My main interest was actually chemistry. business development? think you are ready to lead people – you I come from a family with a chemistry I got an MBA from the University of are motivated and driven; you think that and pharmacy background, and I always Chicago and then I joined a management being a good leader will be spontaneous. thought that chemistry had a magic touch development program at Abbott that In reality, you need to roll up your sleeves to it. It seemed amazing that you could be included a number of assignments, two and work on it. During the first 15 years sick, take a drug and then be less sick or even of which were key for my development. of my career, I learned how to be a pharma cured. I decided to go to pharmacy school One was in market research, which was executive, but it took another 15 years to and started working in pharmacy hospitals, interesting because I learned how to evaluate learn how to be a good boss. But if you work but during my studies I became really a physician’s perception of the impact of on it, it will change your life and have a passionate about the impact a company can innovative medicines, and how they often huge impact on the people around you. have on health. This was reinforced when make an immediate yes or no decision. The I started working for Abbott Diagnostics second was a sales representative visiting Some say there is a lack of women in the at the time of the launch of an HIV test. psychiatric hospitals. My focus was mainly industry. What is your view? The epidemic was just starting to take shape on manic depression and epilepsy, and I I actually think there are more women in and this test had the incredible ability to was shocked by the distress that existed in the pharma industry than in many other reliably/adequately diagnose people. I was psychiatric hospitals and the lack of effective industries. But it is true that you tend to find determined to stay in industry and learn drugs in this area. But the physicians were less women at the top. Women and men are more of the business side after that. very dedicated and had a real hunger for different; we think differently and express science and new medicines. I loved working those thoughts differently, I think – that is How did you join Roche? so close to physicians and the psychiatric the value of diversity. Of course, there are Roche asked me to run their affiliate in area. I remained in that area for a number challenges – you might be the only woman in France. The focus was on oncology and it of years before going on to run the business a boardroom – but if you stay focused, believe was really exciting because I hadn’t worked unit for neuroscience at Sanofi. in yourself and get the right training, then in this area before. I had the opportunity you can succeed no matter what. I have tried to launch many of Roche’s landmark What are the most challenging aspect of to develop skills to be comfortable in this medicines, including Avastin. your role? situation – and also to be a mentor to women. Eventually, I moved to Basel to take I need to empower my team so that they But sometimes I can’t nominate women for on my role in Roche Partnering to lead can find the best opportunities. If I want to leadership roles in my team because I don’t a group of around 80 people based in empower them I should let them do what have the right candidates at the time. I try different sites around the world. Our job they know best and run with it. But at the to be neutral to gender to focus on the right is to scout interesting opportunities that same time, I have experienced a lot; it can person for the right job, but I’m not neutral complement the Roche pipeline. Around be difficult to share your own experiences to the gender of my interview pool. My 30 to 40 percent of Roche medicines while still empowering people to make interview pool will always have an equal are externally sourced. Opportunities their own decisions. Sometimes I have to number of men and women. may include a very early research idea in encourage them to be more forceful or to be academia or a large company that already aware that something is too risky and not Why is pharma such a rewarding has a product on the market. We focus on worth pursuing. I am so proud when I see industry to work in? specific therapy areas, but we also look at my team develop – especially when they are As well as the difference you can make to personalized healthcare and healthcare IT, promoted and go on to become leaders in patient lives, I love that I can continuously where companies are working on artificial an area. When you are in a senior position learn. Recently, I visited a school in Basel intelligence, big data, or apps that can be you always end up feeling like you have a to talk to children about what they want applied by patients. Using AI, for example, lot of children. Finally, we all work really to study – I told them that the beauty of it should be possible to better understand hard and it’s rewarding to see the impact it the pharmaceutical industry is that you the impact of a drug on a patient and has on the company pipeline. continuously learn. Every day, I come home the results from clinical trials. These are smarter than when I left – but also more really exciting areas and should lead the What is the biggest lesson you have aware of my lack of knowledge; that’s not industry to a whole new level of discovery learned over your career? always a great feeling, but it always helps and development. To continuously work to be a good leader. you to progress.
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