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European Biopharmaceutical Review

Biopharm: Past, Present and Future

Biotechnology has seen many major developments in recent years. EBR interviews its new Industry Advisory Board to discuss the shape of this new landscape and how it will continue to change.

EBR: Which technological developments over the last five years have had the greatest impact on today’s biotech sector?

Emile Bellott: Genomics is shaping our ability to target new indications and to improve specificity and side effect profiles. I would also suggest that multiple strategies used to produce bulk drugs will prove significant.

Ludovic Lacaine: Researchers today more and more depart from the old ‘one disease – one medicine’model and now focus on understanding the pathways and molecular mechanisms of a given disease. They then apply this understanding to other diseases that share (at least partially) the same mechanism.New medicinal products have been developed by understanding the biological basis of a disease, but also by finding new indications for existing medicines.Another form of patient benefit is through creation of predictable outcomes based on diagnostic/ therapeutic combinations within new concepts like the so-called personalised medicine approach.

Adel Mahmoud: In the field of vaccines, there have been several considerable advances. For example, reassortant viruses and virus-like particles are proving to be excellent new concepts. Furthermore, the introduction of two new adjuvants after many years of testing has been another milestone.

Jon Weisberg: Each of us has a technology bias, and personally I lean towards the use of interoperable digital identities and digital signatures.This technology is built around the SAFEBioPharma digital standard. It is essential to help organisations transition from paper-based to fully electronic systems. This in turn supports R&D, regulatory and clinical affairs units and allows them to save significant time and costs.The days of patent-protected blockbuster therapies are behind and, hopefully, ahead of us. Now is the time to reduce operating expenses and improve operating efficiencies.The use of this time and costsaving technology needs to be adopted by manufacturing (for example track and trace and ePedigree) and, certainly, more thoroughly in clinical affairs (for example paperless clinical trials).

EBR: What do you think have been the most significant economic, commercial and legal changes for shaping your sector over recent years?

EB: Globalisation of the industry, M&A, pipeline productivity, the emergence of an externalised virtual pipeline business model, pricing pressure from payers and the increasing use of generic versions of biotech drugs have all been major influencers over the industry.There has also been major changes resulting from national policies on taxation, IP, regulation and healthcare provision.

LL: The financial crisis has had major consequences for the economy, and it might stretch over a long period of time, particularly affecting high-tech SMEs. Building a successful bioscience company requires significant funding from third party investors over a long period of time.The academic spin-out or very young company needs seed funding to prove a concept before starting development of a drug, the most common route being to approach venture capitalists (VCs).VCs have historically often looked for an exit through initial public offerings (IPOs); however,we have seen a decline of the public market in bioscience over the past five years.Trade sales are another form of exit for VCs and recently there has been a rise in the number of European bioscience companies exiting through a merger or being acquired by companies outside the European Commission.

AM: Again, in the field of vaccines, all the largest global pharmaceutical companies are currently involved in vaccines and biologics. It reflects great interest in the new economics of the market and new scientific pursuits.

JW: Internet communications present remarkable opportunities to save while creating significant privacy and security challenges.A group of biopharmaceutical visionaries from several global companies recognised this early in the decade and collaborated to create the SAFEBioPharma digital standard.Use of the standard mitigates the risks associated with the use of the internet to transmit secure and confidential information. It also provides a safe and effective way to manage cyber-identities.

EBR: What do you predict will be the big developments over the next few years?

EB: Significant mainstream practice of personalised medicine with oncology leading the way. I also anticipate seeing enabled rapid genotyping for targeted therapies at or near point of service, new business models to serve the developing world, the emergence of a significant commercial biotech sector in China and India, and new ways of funding discovery and development stage enterprises through the ‘valley of death’.

LL: From a legislative standpoint, the major change affecting R&D will be the revision (and later, the implementation) of the Clinical Trials Directive. A simplified legal and regulatory framework for clinical trials is needed, keeping in mind all the benefits for patients because there is a paradox in clinical trials and their regulation. From one side you need to have a framework that can guarantee that all the data you gather from the trials is robust, so in that case you need to have very strong regulatory framework. On the other hand you don’t want to have a regulatory framework so stringent that it will prevent innovation.

AM: Hopefully, vaccines will be developed and brought to market for major infections, such as respiratory syncetial virus and dengue fever.

JW: Regulators,physicians and patients want to know that they can trust medicines.We are in a prolonged period of global economic uncertainty, and that creates an environment for unscrupulous operators to provide substandard ingredients and counterfeit product.Some parts of the world have taken measures to protect against these product pirates and others will soon get on board.The ability to streamline sourcing and manufacturing functions by being able to trust and track the sources using interoperable digital identities is increasingly essential, and it is important that people with these areas of responsibility understand how they can meet the challenges ahead.

EBR: Where do you think the industry will be in five years’ time?

EB: Most of the top-selling drugs will be biologicals.Generic/biosimilar drugs will represent a much higher fraction of biotech industry sales and the first RNAi drugs will be approved in niche indications.

LL: We hope that personalised medicine will further realise its potential and be a major driver of change in the sector, bringing safer,more effective and cost saving therapies to patients.The principle behind it is to identify which patient will benefit most from a treatment – and who will not – by using appropriate diagnostic tools.This offers huge opportunities to increase the efficacy of treatments and potentially help national healthcare budget holders to allocate their resources more efficiently.However,my crystal ball does not see as far as five years.

AM: For the vaccine industry, there will surely be a doubling of its market. For the rest of the biotechnology industry, there is an urgent need to develop new financial models.

JW: The biopharmaceutical industry is in a state of change, but it will always be strong. Economic globalisation will force greater intellectual property protection in those countries that have had loose standards.Global media influence continues to promote a greater understanding of health and life-values, which underpin policy decisions about healthcare and its delivery. I expect that a greater focus on wellness, especially in the US, will help reduce or delay populations entering hospitals.And I hope we will start to come out of the research doldrums with new advances in effective and affordable medicines.


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Emile Bellott is a contributing author to European Biopharmaceutical Review and consultant based in the Boston area. With more than 25 years of industry experience, his pharmaceutical activities have focused on drug discovery and development, synthesis and design of small molecule therapeutics, and informatics and structural biology. He served as VP of Operations, and co-founder of two development-stage biotech companies and founder of a life science software company. His operational experience spans medical devices, pharmaceutical development and chemistry outsourcing. He earned a PhD in Physical Organic Chemistry from Harvard and a MBA from the Harvard Business School. Email: emile.bellott@gmail.com

Ludovic Lacaine is Director of Healthcare at EuropaBio. Previously Ludovic worked at Brandtectonics Europe (a Chandler Chicco Companies – CCC) based in London providing market access solutions to small molecule, biopharmaceutical and medical device businesses. Prior to Brandtectonics Europe, Ludovic led pan-European PR and policy programmes in oncology and HIV/AIDS at Weber Shandwick, Brussels. His policy work at Weber Shandwick also included the development of institutional stakeholder programmes, policy influencing and political landscape mapping. Email: l.lacaine@europabio.org

Adel AF Mahmoud is a Professor in Molecular Biology and Public Policy at Princeton University. He has recently retired as President of Merck Vaccines and prior to that served at Case Western Reserve University and University Hospitals of Cleveland as Chairman of Medicine and Physicianin- Chief. At Merck, Adel led the effort to develop four new vaccines including: combination of Measles, Mumps, Rubella and Varicella; Rota Virus; Shingles; and Human Papillomavirus. He was elected to membership of the Institute of Medicine of the National Academy of Sciences in 1987. He received the Bailey K Ashford Award of the American Society of Tropical Medicine and Hygiene and the Squibb Award of the Infectious Diseases Society of America. He is a past President of the International Society for Infectious Diseases. Email: amahmoud@princeton.edu

Jon Weisberg heads public relations and communications for SAFEBioPharma Association, the non-profit consortium of biopharmaceutical and related companies that develop and manage the SAFE-BioPharma global industry standard for digital trust. He is also President of Weisberg Communications Company, a public relations consulting firm. For 16 years, Jon was a Senior Public Relations Executive on the corporate staff of Bristol-Myers Squibb Company. Email: jon.weisberg@safe-biopharma.org
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Emile Bellott
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Ludovic Lacaine
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Adel AF Mahmoud
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Jon Weisberg
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