How Scientist/Founders Lead Successful Biopharmaceutical
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Biopharmaceutical Sector Update: Market Outlook for 2021
Biopharmaceutical Sector Update Market Outlook for 2021 January 11, 2021 © 2021. All rights reserved. Securities offered in the United States are offered through Torreya Capital LLC, Member FINRA/SIPC. In Europe such services are offered through Torreya Partners (Europe) LLP, which is authorized and regulated by the UK Financial Conduct Authority. Table of Contents An Extraordinary Year: Top 10 Biopharma Events of 2020 4 Biopharma Sector Outlook for 2021 20 The Evolving World of Biotech Company Formation 26 Implications of the U.S. Election on the Biopharma Sector 31 Update on Covid-19, Capital Markets and M&A Activity 39 About Torreya 50 Key Topics in This Update In this report we discuss three topics that are front of mind in our industry: We have lived through an Given the exceptional performance of the biopharma extraordinary year for the #1 market in 2020, what does 2021 hold? biopharmaceutical industry. Given excellent protection data on two COVID-19 vaccines we now appear It appears likely that with widespread vaccination, #2 the COVID-19 pandemic will recede in 2021. What to be at the beginning of the end of does this imply for the biopharma sector? the COVID-19 pandemic. A “return to normalcy” appears possible in 2021 despite a very challenging situation What are the implications of the U.S. political #3 situation for the global biopharmaceutical sector? at present with the pandemic. 3 An Extraordinary Year: Top 10 Biopharma Events of 2020 4 Event #1 COVID-19 Vaccines Portend a New Normal The FDA has approved two COVID-19 vaccines as of Jan 2021 and more vaccine approvals are likely. -
The Future for Biosensors in Biopharmaceutical Production
Pharmaceutical Commentary BRACEWELL & POLIZZI The future for biosensors in biopharmaceutical production 2 Commentary The future for biosensors in biopharmaceutical production Pharm. Bioprocess. Keywords: bioprocess monitoring • bioprocess control • in-vivo biosensor • PAT Daniel G Bracewell*,1 • synthetic biology & Karen M Polizzi2 1The Advanced Centre for Biochemical Engineering, Department of Biochemical A defining feature of bioprocesses is the need straightforward. This is not to say there have Engineering, University College London, for measurement, monitoring and control; in not been significant successes: Torrington Place, London, WC1E 7JE, UK the context of biopharmaceuticals this need 2Department of Life Sciences & Centre • The world’s diabetic population depends is further heightened by the absolute require- for Synthetic Biology & Innovation, on blood glucose measurements to admin- Imperial College London, London, UK ment to ensure the quality of the product [1] . ister insulin based on an amperometric *Author for correspondence: This is evidenced by the size of bioanalytical based biosensor technology (enzyme elec- [email protected] endeavor found within the R&D programs trodes). This represents the largest single of the major biopharmaceutical companies biosensor application in terms of numbers and the supplier industry that caters for this of devices and market size; instrumentation need. It is a need that grows at a pace reflected in the initiatives involv- • Optical biosensors, largely surface plas- ing the regulatory authorities such as PAT mon resonance (BIAcore) has become central to the larger vision of QbD. At the the default method to directly mea- core of these attempts to improve biophar- sure protein–protein interactions in the maceutical production is the need for rapid, laboratory. -
Biopharmaceutical Notes
An Overview of the BioPharmaceutical Products and Market By Paul DiMarco, Vice President, Global Commercial Program, BioSpectra Inc. Table of Contents INTRODUCTION: ........................................................................................................................................ 2 History ....................................................................................................................................................... 2 Background information ........................................................................................................................... 3 Defining biological products ..................................................................................................................... 4 Small vs. Large Molecule Regulation and Registration in the USA and EU ............................................... 6 Controversial Regulatory Concepts: ......................................................................................................... 7 Extrapolation: ........................................................................................................................................ 7 Switching: .............................................................................................................................................. 8 Interchangeability: ................................................................................................................................ 9 Harmonization: .................................................................................................................................... -
Boosting Our Best Shot
NEWS FEATURE Boosting Our Best al orr a C rin Ma s by Shot ration Illust Vaccines work by training the immune system to target pathogens, but many types of shots need added substances called adjuvants to elicit a robust response. Despite the power of adjuvants, only one, called alum, is approved in the US. Charlotte Schubert looks at recent discoveries that could translate into a wider range of adjuvants and perhaps help provide future protection against diseases ranging from malaria to H1N1 ‘swine’ flu. © All rights reserved. 2009 Inc. Nature America, Max Theiler never thought it would be easy to particularly good at bumping up the immune FDA is poised to give the green light to such vanquish one of the biggest killers of his time. response. By comparison, most vaccines adjuvanted vaccines, lined up for approval in Yellow fever had already stumped a previous developed today rely on bits of microbes, such Europe, remains unclear (see sidebar). generation of microbe-hunters. And in the as short protein sequences—and they don’t For many years, researchers such as Theiler early 1900s it killed subjects who volunteered work quite so well on their own. To elicit an moved their vaccine candidates forward with for experiments in which they received bites immune response, these vaccines typically little mechanistic understanding of how they from mosquitoes, proving that the insects need a jolt from an adjuvant, a substance worked. That empirical approach is ending, transmit the disease. named from the Latin ‘adjuvans’, which says Bali Pulendran, an immunologist at the Theiler’s work was painstaking. -
Advances in BIOPHARMACEUTICAL TECHNOLOGY in CHINA New Second Edition!
Establish China partnerships Create Effective Strategies to EXPAND YOUR GLOBAL REACH! Advances in BIOPHARMACEUTICAL TECHNOLOGY in CHINA New Second Edition! A great opportunity exists in working with Chinese companies to establish scientific and business partnerships, and to create effective strategies. However, success in Asia in the new millennium will require changes in partnerships between Western and Asian companies. Every company faces the question “What should our China strategy be?” This volume, a co-publication of the Society for Industrial BY THE NUMBERS Microbiology and Biotechnology and BioPlan Associates, Inc., provides an overview of the biopharmaceutical industry, ● 102 Internationally and the state of technology in China. Recognized Authors ● 21 Peer-Reviewers Readers will be able to: ● 1,139 Pages 1. Assess the state of biopharmaceutical development in China ● 70 Translated Chapters 2. Understand general business practices ● 5 Case Studies and China Briefs 3. Analyze business opportunities and identify potential partners ● 200+ Tables and Figures A peer-reviewed, ready reference for all aspects of ● 300+ References biopharmaceuticals in China, including an understanding of the ● Over 2,000 Index Entries China biopharma current situation, and future opportunities. Readers receive a comprehensive assessment of the state-of-the- This authoritative, peer-reviewed study industry, trends, and analysis. Information on all types of organizations is produced in collaboration with the involved in biopharma in China, whether they -
Cancer Vaccines - Hope Or Hype?
DrugWatch Cancer vaccines - hope or hype? ➜ Anthony Walker* There have been many false dawns in the field of cancer vaccines, but some of the new products look distinctly promising. sing vaccines that stimulate the hysteria, safety, selectivity and potency not by normal tissues. There are numer- immune system to fight cancer remain the hallmarks of a vaccine, and ous variants: subunit and anti-idiotype Uappeals to many as a natural cancer vaccines promise efficacy with vaccines and immuno-gene therapy to approach that is both safe and effective. limited – or no – side-effects. Serious name but three. Much effort has been And, judging from a recent headline adverse events have been the exception directed toward high-tech solutions in in the UK newspaper The Times in the clinical trials of experimental vac- this area, but it has become apparent – “Vaccine jab could cure lung cancer” – cines conducted to date. At the same that tumours continue to mutate as the there is clear public interest in this area. time, there have been few glimpses of disease progresses, evading the immune Even big pharma is showing signs of real benefit, with numerous false dawns system by downregulating or losing the excitement. At a partnering conference and much disappointment. expression of the target antigen. one of the more traditional majors said But there was an explosion of interest in The third group, multivalent and ultra- cancer vaccines had moved from the ‘no this field after the unravelling of mech- valent vaccines, combine several anti- strategic interest’ category to ‘watchful anisms for triggering cytotoxic T-cell gens in one formulation to overcome waiting’ – an almost seismic shift to (CTL) response about 15 years ago. -
Cancer Vaccines Edge Towards Success
DrugWatch Cancer vaccines edge towards success ➜ Richard Harrop* and Stuart Naylor* A number of cancer vaccines are now entering the final stage of clinical development. Are vaccines finally on their way to enjoying mainstream success in the oncology arena? ver the past decade, vaccina- cines that have such a safety profile such as renal cancer and melanoma, tion strategies for the treat- may be readily integrated into current yet they offer only modest benefits and O ment of cancer have been standard-of-care regimens, particularly frequently lead to toxic side-effects. investigated with renewed vigour, per- in the first-line setting where combi- In between these two approaches haps catalysed by a greater under- nation strategies prevail over lie cell-based therapies, in which whole standing of tumour immunology and monotherapies. tumour cells or cell extracts are used as the clinical successes achieved with the immunogen. While tumour-specific monoclonal antibody and cytokine- TARGETED VS NON-SPECIFIC immune responses may be induced, based therapies. However, before vac- Cancer immunotherapies can broadly the precise target(s) of the response is cines become fully integrated into the be divided into two categories: not usually known. Furthermore, arsenal of weapons currently used to tumour-specific and highly-targeted immune responses against other com- treat cancer, they must show not only products, for example vaccines or mon tissue antigens may also be efficacy but also safety and limited or antibodies that target a specific induced. Despite the lack of fine no toxicity. Recently, a number of tumour antigen, and therapies which specificity of the immune response cancer vaccines have moved into the modulate the immune system in a induced and the labour involved in the stages of development where clinical non-tumour-specific way. -
Speaker Bios 2Nd FDA/PQRI Conference on Advancing Product Quality
Speaker Bios 2nd FDA/PQRI Conference on Advancing Product Quality Professor Bertil Abrahamsson, Ph.D. Dr. Abrahamsson has a broad experience of industrial drug development from more than 25 years of work with Astra and AstraZeneca. During this period he has had various line and project management positions. Presently he is a Senior Principal Scientist with emphasis on biopharmaceutics., In this role he is leading biopharmaceutics research and product development support on a global basis. In addition, as one of the most senior scientists in AZ Pharmaceutical Development he is also a member of the local as well as the extended global leadership teams. Dr. Abrahamsson is an internationally recognised scientist and he has published more than 80 papers in the area of oral biopharmaceutics and drug delivery. He is presently an adjunct Professor in Biopharmaceutics at Uppsala University. He initiated and is currently leading a major european private public partnership project in oral biopharmaceutics area ( http://www.orbitoproject.eu). Ilgaz Akseli, Ph.D., MBA Dr. Akseli is a Senior Associate Director in the Pharmaceutical Development department in Boehringer-Ingelheim Pharmaceuticals, Ridgefield, CT. He is the head of the Formulation Material Profiling and Computational Modeling Labs. Two labs are in the global level and his team is guiding and supporting the formulation and process development for drug candidates in assigned therapeutic areas. Dr. Akseli earned his BSc degree in Mechanical Engineering with a focus on Design of Powder Compaction. He has two MSc degrees; one is in Materials Science and Engineering from University College London with a focus on Metal Powder Compaction and the other degree is in Business Management from London School of Economics with a focus on Lean Six Sigma implementations in the Pharmaceutical Industry. -
The Economic Impact of the US Biopharmaceutical
THE ECONOMIC IMPACT OF THE U.S. BIOPHARMACEUTICAL INDUSTRY: 2017 National and State Estimates DECEMBER 2019 TEConomy Partners, LLC is a global leader in research, analysis, and strategy for innovation-driven economic development. Today we’re helping nations, states, regions, universities, and industries blueprint their future and translate knowledge into prosperity. The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading innovative pharmaceutical research and biotechnology companies, which are devoted to developing medicines that allow patients to live longer, healthier, and more productive lives. PhRMA companies are leading the way in the search for new treatments and cures. TEConomy Partners, LLC (TEConomy) endeavors at all times to produce work of the highest quality, consistent with our contract commitments. However, because of the research and/or experimental nature of this work, the client undertakes the sole responsibility for the consequence of any use or misuse of, or inability to use, any information or result obtained from TEConomy, and TEConomy, its partners, or employees have no legal liability for the accuracy, adequacy, or efficacy thereof. TABLE OF CONTENTS Executive Summary ......................................................................................................1 Introduction: An Industry Defined by Innovation .................................................... 3 The Broad Scope and Scale of the Biopharmaceutical Industry ............................5 Defining the -
Biopharmaceutical Release Testing
Biopharmaceutical Release Testing To support your commercial product and clinical trial material release testing needs, Eurofins BioPharma Product Testing offers the capacity and breadth of capabilities to test your formulated bulk, final product or in-process materials in a timely manner. We test materials against specifications for identity, purity, potency, impurities, physical properties and safety under strict cGMP compliance, and we customize individual programs to streamline lab documentation and reporting for the most efficient and quality-focused data deliverable possible. Our multi-shift laboratory operations are designed to provide extensive capacity for larger volume release programs, as well as flexibility for smaller programs in a manner that allows for aggressive cycle times. Our release testing services are backed by an outstanding scientific approach to problem solving and extensive expertise in Method Development and Validation. Why Choose Eurofins BioPharma Product Testing? • We have in-depth experience working with every Potency/Bioassay Services type of modality and have the flexibility and extensive • Development and validation of cell-based bioassays instrument capacity within our team to meet the using multiple formats, including absorbance, ever-changing demands of production schedules fluorescence, time-resolved fluorescence and and timelines. luminescence as well as binding and competitive ELISAs. • We are a center of excellence for development, optimization, and transfer of in vitro bioassays for • Assay optimization to eliminate sources of variability potency. and ensure consistent performance for QC release. • Our breadth of capabilities allows us to perform • Multiple software packages available for data all testing of even the most complex conjugated analysis, including Softmax Pro and StatLIA. -
2019 FDA Biopharmaceutical Approvals: a Record Year for Follow-On Products, but Is Innovation Lagging? Bioplan Associates, Inc
Confidential White Paper – Not for Distribution 2019 FDA Biopharmaceutical Approvals: A Record Year for Follow-on Products, But is Innovation Lagging? BioPlan Associates, Inc. January 2020 Introduction Although 2019 was overall a good year for biopharmaceutical product approvals, there was a lower percentage of approvals for fully new, innovative products compared with prior years. This may indicate problems with recent years’ pharmaceutical industry increased investment in biopharmaceutical vs. drug R&D, with a relative increase in resulting innovative product approvals not showing up yet. It may be too early to make conclusions regarding the extent of this pipeline trend, but the record portion of follow-on product approvals (63% of approvals) can be viewed as positive or negative for the industry. Biopharmaceuticals are here defined as prescription therapeutic products containing active agents manufactured using biotechnology methods, i.e., using living organisms (1). Figure 1 shows the numbers of recombinant and non-recombinant biopharmaceuticals approved by FDA since 1981, when the first recombinant protein received approval. Total biopharmaceutical approvals have increased over the years while remaining steady in the past few years. Figure 1: Numbers of Recombinant and Non-Recombinant Biopharmaceuticals Approved by FDA, 1981-2019 ©2020 BioPlan Associates, Inc, 2275 Research Blvd., Ste. 500, Rockville, MD 20850 (301) 921-5979 Page: 1 Confidential White Paper – Not for Distribution Approvals in 2019 In Table 1 we present approvals during 2019. Several oligonucleotide therapeutics, both antisense and RNAi, also received approval, but these are synthetically manufactured drugs and not considered biopharmaceuticals. Other products not included as biopharmaceuticals include medical devices, allergenic extract products, and diagnostics that receive biologics (BLA) approvals. -
The Biopharmaceutical Industry Is Leading the Way in Developing
The biopharmaceutical industry is leading the way in developing vaccines and treatments for COVID-19 The rapid spread of the novel coronavirus across the globe is a major public health threat for all, with profound health, social and economic impacts around the world. As a science-driven industry that aims to address some of the world’s biggest healthcare challenges, the research-based biopharmaceutical industry is uniquely positioned to respond rapidly to COVID-19. It has deep scientific knowledge gained from decades of experience working on developing solutions for combatting a range of infectious diseases such as MERS, SARS, Ebola and influenza, as well as experience working with health authorities and regulators to find a fast-tracked approach to bringing safe and effective medicines to market for patients. Biopharmaceutical companies are committed to developing solutions to help diagnose, treat and prevent COVID-19. Sharing the novel COVID-19 virus sequence helped to galvanise the research community The rapid virus sequencing by the scientific community enabled researchers to characterize and begin to understand the new threat posed by COVID-19. Biopharmaceutical companies with potentially relevant knowhow were thereby enabled to get their scientists to check their R&D libraries for potential assets that could fight coronaviruses. “Open Access” data-sharing channels are the backbone to securing a response capacity and have proven their worth with influenza networks. This speedy sharing of the novel coronavirus pathogen sequence was instrumental in galvanising global collaboration with the private and public sector: a pre-requisite for timely development of vaccines and treatments. The Global Initiative on Sharing All Influenza Data or GISAID Initiative, an open access platform partly funded by the private sector, played a critical role in sharing the first genome sequences of the novel coronavirus and centralizing their collection.