Our Life Science business is fully dedicated to supporting small, biotech companies with cutting edge technologies. Besides technical aspects of molecule development and production, fundraising is omnipresent. This webinar will provide insights and perspectives from Merck Ventures, BV, a subsidiary of
Merck KGaA, Darmstadt, Germany.
At Merck Ventures, BV, a subsidiary of Merck KGaA, Darmstadt, Germany, the strategic corporate venture capital arm of Merck KGaA, Darmstadt Germany, we drive innovation and back entrepreneurs through equity investments and hands-on support. We focus on areas that impact the vitality and sustainability of our current and future businesses.
This webinar will provide you with the ABCs of venture capital including:
• How venture capital works
• The role of a corporate venture capital
• How we look at opportunities
Document Security Systems (DSS) is a multinational company operating businesses focused
on brand protection technology, blockchain security, direct marketing, healthcare, real estate,
and securitized digital assets. Its business model is based on a distribution sharing system in
which shareholders will receive shares in its subsidiaries as DSS strategically spins them out
into IPOs. Its historic business revolves around counterfeit deterrent and authentication
technologies, smart packaging, and consumer product engagement. DSS is led by its seasoned
leaders with decades of industry experience.
Document Security Systems (DSS) is a multinational company operating businesses focused
on brand protection technology, blockchain security, direct marketing, healthcare, real estate,
and securitized digital assets. Its business model is based on a distribution sharing system in
which shareholders will receive shares in its subsidiaries as DSS strategically spins them out
into IPOs. Its historic business revolves around counterfeit deterrent and authentication
technologies, smart packaging, and consumer product engagement. DSS is led by its seasoned
leaders with decades of industry experience.
Insurance M&A activity in the US rose to unprecedented levels in 2015, surpassing what had been a banner year in 2014. There were 476 announced deals in the insurance sector, 79 of which had disclosed deal values with a total announced value of $53.3 billion. This was a significant increase from the 352 announced deals in 2014, of which 73 had disclosed deal values with a total announced value of $13.5 billion. Furthermore, unlike prior years where US insurance deal activity was isolated to specific subsectors, 2015 saw a significant increase in deal activity in all industry subsectors.
Medical Facilities Corporation - Investor Update - March 2020SharePitch
Investor update presentation for Medical Facilities Corporation following their announcing fourth quarter and year end results for 2019. Medical Facilities Corporation's common shares are listed on the TSX under the symbol DR.
This document brings together a set
of latest data points and publicly
available information relevant for
Financial Services Industry. We are
very excited to share this content and
believe that readers will benefit from
this periodic publication immensely.
Equities remain in vogue as bond yields adjust, the spread on SB/Junk continuing to narrow, this dynamic should be enough to see appetite remain for equity investments. The gains in the S&P 500 were the broadest since 1994, every instance where 80% of the 500 companies gained was followed by additional gains the following year. Caution against unbridled optimism, corporate valuations are the richest since 2000 and margins the highest on record. Shiller P/E, the cycle adjusted P/E ratio, is now at 25.6, 55.2% higher than the historical mean of 16.5.
Genetic Technologies Limited is a diversified molecular diagnostics company developing tools for the prediction and assessment of chronic disease risk to help physicians proactively manage patient health. The Company’s lead products, ‘GeneType for Breast Cancer’ and ‘GeneType for Colorectal Cancer’, are clinically validated risk assessment tests that are first in their class. The Company signed a multi-year distribution agreement for its COVID-19 Risk Test and remains on track to launch its revolutionary Multi-Test, covering up to 70% of mortalities and morbidities, including major oncological, metabolic, and degenerative diseases. Genetic Technologies recent acquisition of EasyDNA has significantly accelerated the Company’s commercialization strategy, providing established revenue streams and direct-to-consumer marketing channels that include 70 websites in 40 countries. Listed on the ASX in 2000 and NASDAQ in 2005, Genetic Technologies has been a leader in the development and commercialization of genetic risk assessment technology for 20 years.
One of the fastest growing concerns on insurers’ enterprise risk agenda is model risk
management. From being a phrase that primarily actuaries and other modelers used, “model risk” has become a major focus of regulators and the subject of intense activity and debate at insurers. How model risk management has evolved from ad hoc efforts to its currentproactive stage is an interesting story. But more interesting still is
what we believe could be its next stage – generating measurable business value.
The Role of BPOG Extractables Data in the Effective Adoption of Single-Use Sy...Merck Life Sciences
The successful adoption of single-use technologies in a biopharmaceutical process largely relies on confidently selecting the right components for use in the fluid path of a product, within a specific process. An important step in choosing such components requires generating an extractables profile, which can be done by carefully selecting the solvent streams and extraction conditions to model the product and process steps complemented with the right analytical strategy.
In this webinar, you will learn:
● An approach to adopt the BioPhorum Operations Group (BPOG) extractables protocol as a baseline testing strategy.
● How to apply extractables data to a specific process followed by a systematic, risk-based safety assessment approach used for comparing known safety concern thresholds.
● The important stages in the risk assessment process as demonstrated by case studies from typical drug manufacturing processes where single-use components were used.
Rapid Methodologies for Biosafety Testing of Biologic TherapeuticsMerck Life Sciences
Learn about existing and emerging methods to accelerate biosafety testing of biologic therapies.
Speed to market for biologic therapeutics is ever more critical. However, the critical safety tests for these molecules, for example screening for adventitious agents such as viral contaminants, can be time consuming as well as challenging and laborious. Join us for this webinar as we explore how rapid methodologies are being used to not only accelerate this process, but also enhance quality by reducing testing complexity. Existing technologies as well as emerging trends will be discussed, along with the implications these may have on the regulatory landscape.
In this webinar you will learn:
● Which existing and emerging technologies are having now, and will have in the future, an impact on biosaftey testing.
● The benefits as well as risks of employing rapid methods for biosafety screening.
● How the regulatory agencies are reacting to rapid testing methods as alternatives to existing methods.
Insurance M&A activity in the US rose to unprecedented levels in 2015, surpassing what had been a banner year in 2014. There were 476 announced deals in the insurance sector, 79 of which had disclosed deal values with a total announced value of $53.3 billion. This was a significant increase from the 352 announced deals in 2014, of which 73 had disclosed deal values with a total announced value of $13.5 billion. Furthermore, unlike prior years where US insurance deal activity was isolated to specific subsectors, 2015 saw a significant increase in deal activity in all industry subsectors.
Medical Facilities Corporation - Investor Update - March 2020SharePitch
Investor update presentation for Medical Facilities Corporation following their announcing fourth quarter and year end results for 2019. Medical Facilities Corporation's common shares are listed on the TSX under the symbol DR.
This document brings together a set
of latest data points and publicly
available information relevant for
Financial Services Industry. We are
very excited to share this content and
believe that readers will benefit from
this periodic publication immensely.
Equities remain in vogue as bond yields adjust, the spread on SB/Junk continuing to narrow, this dynamic should be enough to see appetite remain for equity investments. The gains in the S&P 500 were the broadest since 1994, every instance where 80% of the 500 companies gained was followed by additional gains the following year. Caution against unbridled optimism, corporate valuations are the richest since 2000 and margins the highest on record. Shiller P/E, the cycle adjusted P/E ratio, is now at 25.6, 55.2% higher than the historical mean of 16.5.
Genetic Technologies Limited is a diversified molecular diagnostics company developing tools for the prediction and assessment of chronic disease risk to help physicians proactively manage patient health. The Company’s lead products, ‘GeneType for Breast Cancer’ and ‘GeneType for Colorectal Cancer’, are clinically validated risk assessment tests that are first in their class. The Company signed a multi-year distribution agreement for its COVID-19 Risk Test and remains on track to launch its revolutionary Multi-Test, covering up to 70% of mortalities and morbidities, including major oncological, metabolic, and degenerative diseases. Genetic Technologies recent acquisition of EasyDNA has significantly accelerated the Company’s commercialization strategy, providing established revenue streams and direct-to-consumer marketing channels that include 70 websites in 40 countries. Listed on the ASX in 2000 and NASDAQ in 2005, Genetic Technologies has been a leader in the development and commercialization of genetic risk assessment technology for 20 years.
One of the fastest growing concerns on insurers’ enterprise risk agenda is model risk
management. From being a phrase that primarily actuaries and other modelers used, “model risk” has become a major focus of regulators and the subject of intense activity and debate at insurers. How model risk management has evolved from ad hoc efforts to its currentproactive stage is an interesting story. But more interesting still is
what we believe could be its next stage – generating measurable business value.
The Role of BPOG Extractables Data in the Effective Adoption of Single-Use Sy...Merck Life Sciences
The successful adoption of single-use technologies in a biopharmaceutical process largely relies on confidently selecting the right components for use in the fluid path of a product, within a specific process. An important step in choosing such components requires generating an extractables profile, which can be done by carefully selecting the solvent streams and extraction conditions to model the product and process steps complemented with the right analytical strategy.
In this webinar, you will learn:
● An approach to adopt the BioPhorum Operations Group (BPOG) extractables protocol as a baseline testing strategy.
● How to apply extractables data to a specific process followed by a systematic, risk-based safety assessment approach used for comparing known safety concern thresholds.
● The important stages in the risk assessment process as demonstrated by case studies from typical drug manufacturing processes where single-use components were used.
Rapid Methodologies for Biosafety Testing of Biologic TherapeuticsMerck Life Sciences
Learn about existing and emerging methods to accelerate biosafety testing of biologic therapies.
Speed to market for biologic therapeutics is ever more critical. However, the critical safety tests for these molecules, for example screening for adventitious agents such as viral contaminants, can be time consuming as well as challenging and laborious. Join us for this webinar as we explore how rapid methodologies are being used to not only accelerate this process, but also enhance quality by reducing testing complexity. Existing technologies as well as emerging trends will be discussed, along with the implications these may have on the regulatory landscape.
In this webinar you will learn:
● Which existing and emerging technologies are having now, and will have in the future, an impact on biosaftey testing.
● The benefits as well as risks of employing rapid methods for biosafety screening.
● How the regulatory agencies are reacting to rapid testing methods as alternatives to existing methods.
Time is of the Essence: Creating a New Synergy Between Single-Use Adopters an...Merck Life Sciences
Biopharmaceutical companies race to achieve milestones, advance promising molecules, improve productivity and reduce costs. In addition to perfecting the biology, companies must grapple with challenges such as standardization of process technology, supply security and process economics, especially in light of the burgeoning interest and adoption of single-use systems. Efficient implementation of single-use systems is more than incorporating disposable components into the process. It requires a new approach by suppliers of these systems to nimbly and effectively address such challenges.
This session will highlight best practices for creating a new synergy between biopharmaceutical companies and single-use suppliers to strike the right balance of design flexibility, supply predictability and reliable lead times necessary to beat the clock. A case study describing a more efficient and practical “bottoms-up” approach to configuring and delivering single-use assemblies will be presented.
In this webinar, you will learn:
- How to choose single-use assemblies that are best suited for your process
- Risk reduction strategies that incorporate stock or specialized single-use assemblies vs. custom solutions
- Best practices to strike the right balance of design flexibility and supply predictability
Integrity testing is a critical operation, especially for sterilizing grade filters used in biopharmaceutical processing. When performed correctly, an integrity test is a fast, definitive, non-destructive way to assure filter retention performance. Fortunately, there are few ways a non-integral filter will pass the integrity test, eliminating the possibility a non-retentive filter is used undetected. Unfortunately, there are a lot of ways an integral filter can fail the integrity test, resulting in retests, lost time, productivity and potentially lost product.
In this webinar you will:
- Gain confidence in your integrity testing results
- Provide justification for retests
- Understand specific challenges and eliminate them to assure the integrity test can be performed correctly the first time
Are you involved with planning tech transfer of your drug product? Join this webinar to learn more about the regulations and considerations you need to consider and learnings from a case study.
According to ICH Q10, “The goal of technology transfer activities is to transfer product and process knowledge between development and manufacturing, and within or between manufacturing sites to achieve product realization. This knowledge forms the basis for the manufacturing process, control strategy, process validation approach, and ongoing continual improvement.”
As a result, there is an expectation for transfers to be performed in an organized, methodical manner with appropriate documentation. It is also expected that they happen between one Process Development group to another or to a Pilot Lab, from Process Development lab to clinical or commercial manufacturing, or from Process Development to external clinical manufacturing. Lastly, they may also happen between two company facilities at commercial scale, or between a company and an external contract manufacturing at commercial scale.
This presentation will cover points to consider for successful tech transfers with a focus on cGMP training requirements, and include lesson learned from real cases.
Presented by Guillaume Plane on September 22, 2016
Modern BioManufacturing: Single-Use Technologies in Configurable, Prefabricat...Merck Life Sciences
A co-webinar describing a solution to biopharma's challenge of rapidly and rationally expanding capacity by employing single-use technologies, a templated process train, and pre-fabricated mobile/modular cleanrooms.
Biopharmaceutical companies on the verge of investing into manufacturing or facilities expansion face many questions and challenges. Speed, agility, and flexibility are becoming more critical to executing their changing production and distribution strategies. Platform facility designs which integrate the latest process technologies within innovative pre-fabricated cleanrooms are critical for addressing the trending desire to implement 'clonable' modular facilities that can be delivered in a timely fashion across multiple locations. Companies like Merck KGaA, Darmstadt, Germany and G-CON Manufacturing are working together to combine their technologies and develop simple yet robust platform solutions for industry.
As bioprocessing technologies intensify performance, volumetric requirements become less. As such, 2000L single-use bioreactors - or multiple bioreactors of similar or less volumes - now suffice for the production of novel or biosimilar recombinant proteins. Such a shift in the industry enables the development of more mobile, modular facility designs. We will describe the rationale for this collaboration and its result: a turn-key solution that integrates a templated process train with a rapidly-deployable facility platform. By combining the unique advantages found with the G-CON POD construction and the bioprocess technology expertise from within Merck KGaA, Darmstadt, Germany, the goal of creating a cost-effective, pre-fabricated alternative to historical 'stick built' facilities is being achieved. Additionally, the flexibility inherent to our approach provides for a greater configurability that confers more user-specified choice into the selection of options. Simple in concept, this solution is also robust, cost-effective, and conducive to tight timelines for implementation.
In this webinar you will learn:
- Basic options for facilities/capacity expansion
- The value of templated process trains employing single-use equipment
- How modular, prefabricated PODs® outfitted with such single-use bioprocessing equipment represent an attractive, cost-effective strategy for capacity expansion
POD® is a registered trademark of G-CON Manufacturing, Inc.
An Integrated Approach to Ensure Viral Vector and Gene Therapy Commercial Rea...Merck Life Sciences
Come learn more about our integrated approach to ensure viral vector and gene therapy commercial readiness. We will discuss topics relating to process development for viral vector manufacturing, biosafety testing and commercial readiness.
Significant progress has been made for the use of viral vectors for gene therapy. Promising clinical trial results as well as recent FDA approval for CAR-T cell therapy to treat certain children and young adults with B-cell lymphoblastic leukemia have signaled advancements in the field. This marks a historic action, providing opportunities for new viral vector technologies to transform medicine and the way patients are treated and even cured. The need for process development for viral vector manufacturing to improve yield to meet patient demand, biosafety testing for product characterization, potency and safety and commercial readiness to accelerate therapy to-market are critically important. Here, we emphasis an integrated approach that allows our customers solutions to ensure viral vector and gene therapy commercial readiness to meet the growing market need.
In this webinar, you will learn:
● Process development advances for production scale-up of viral vectors for gene therapy
● Methods specific for viral gene therapy product characterization, purity, potency, safety and release testing
● Commercial readiness through our US and UK Centers of Excellence for viral product manufacturing
Discover solutions for all phases of product development for genetox assessment from in silico analysis, screening, mode of action assessment, or GLP regulatory required assays. Our BioReliance® Genetic Toxicology Services director will share specifics and rationale for each assay category.
In this webinar you will:
- Learn the required regulatory assays
- Understand why each assay is used and how to employ different assay designs
- Learn different assays and techniques to screen potential compounds and understand mechanism and mode of action
Presented by Rohan Kulkarni, Ph.D., ERT, Director Toxicology, Study Management on February 9, 2017
Serum-free Media for Therapeutic Cell Manufacturing – Challenges and InnovationsMerck Life Sciences
The need for high quality materials that are animal origin-free and compatible with a limited number of downstream processing steps will increase as cell therapies achieve clinical success. Large scale manufacturing necessitates transition from planar culture to technologies such as stirred tank bioreactors where culture of suspension cells or adherent-dependent cells on microcarriers is enabled.
This webinar will discuss challenges and solutions to the elimination of animal-derived components from cell culture processes, with focus on human mesenchymal stromal/stem cells (hMSCs). Fetal bovine serum in particular is associated with regulatory, supply, and consistency challenges, yet a wide range of performance has been observed between different serum-free media formulations for expansion of hMSCs in planar formats. Moreover, a positive performance in static culture is not necessarily predictive of that under agitated conditions with microcarriers, highlighting ongoing challenges to the generation of a fully chemically-defined and scalable cell culture medium. Through use of pharma-grade basal media manufactured with advanced milling technology and EMPROVE® raw materials, as well as transition to serum-free supplementation and process development activities, the robust expansion of hMSCs across platforms has been achieved.
Presented by Aletta Schnitzler, Senior Scientist on 5/5/16
Considerations for Manufacturing Commercial Antibody Drug Conjugates (ADCs) -...Merck Life Sciences
ADC manufacturing presents a unique set of challenges as compared to the well established practices employed for more traditional biologic products.
The development and commercialization of key intermediates, complex small-molecule APIs and biologic drug substances shouldn’t be such a headache. The uniqueness, versatility, and complexity involved in each project only means you need to make sure you’re well informed when it comes to the dos and don'ts of manufacturing commercial Antibody Drug Conjugates (ADCs). Tune in to hear a CMO perspective for an in-depth understanding on the subject of manufacturing commercial ADCs. Our team will discuss all of the considerations that must be addressed to successfully manufacture ADCs.
In this webinar you will learn:
- Facility Design and Cleaning Validation
- Advantages of Single Use Systems
- Process Control and Regulatory Strategies
Viral Risk Mitigation Strategies: Key Considerations in the Prevention and De...Merck Life Sciences
Regulatory guidelines have defined industry best practices around adventitious virus contamination and risk mitigation in terms of patient safety.
Today, the industry is taking a closer look at minimizing the business risk associated with viral contamination and is taking a more directed view of risk mitigation. This approach includes virus prevention and detection, in addition to removal.
From cell culture seed train to final fill vial, this presentation will describe:
-Potential risks associated with different areas of biotech processes
-What can be done to minimize adventitious virus risk in those areas.
The overarching strategy of risk mitigation will include evaluation of raw materials, modified expression systems, environmental controls, upstream and downstream processing, as well as testing and regulatory considerations.
Delivering More Efficient Therapeutic Protein Expression Systems Through Cell...Merck Life Sciences
Historically cell line performance has been enhanced through media, feed and process optimization, primarily through trying to meet the basic nutritional requirements of the cells so that they can sustain high growth and productivity throughout the production runs.
However, the omics (genomics, transciptomics and metabolomics) era, sequencing of the CHO genome and enhancements in genome editing technologies over the past several years have enabled scientists to take a more direct route in cell line optimization through the modification of specific genes that have direct implications on cell culture performance, protein quality attributes and upstream and downstream manufacturing processes. These targets include but are not limited to genes that may be involved in cell cycle regulation, cellular metabolism, cellular transcription and translation, the secretory pathway and protein glycosylation or other post-translational modifications.
In this webinar we will discuss specific genetic modifications that have been made to CHO cell lines and how these modifications can lead to more efficient expression systems.
Presentation by Steve Scott, Lorna Neilson, Mary Canady, and David Welch at the San Diego Biotechnology Network's Bootstrapping Biotech event October 29th 2009.
TCF...CIF..WTF(unding)? How to prepare a winning applicationTEDCO
TEDCO's TCF..CIF..WTF(unding) workshop covers the key points that Maryland entrepreneurs need to know when they are applying to TEDCO's funding programs.
Guest lecture corporate venture capital (herman kienhuis)Herman Kienhuis
Guest Lecture about Corporate Venture Capital by Herman Kienhuis for Corporate Venturing course, MSc Business Administration, Amsterdam Business School (University of Amsterdam - UvA)
Investment Analyst Guy Wallace explores the fundamental principles of venture capital and the different pathways into the industry for Textbook Ventures.
Presentation created by Investment Manager from the Slovak startup and innovation studio. Experienced Launcher's team member, Michal Nešpor, held the speech at Startup Pirates event in Bratislava: worthful overview and explanation from the investment universe. The important aim of the presentation was to show aspiring entrepreneurs what is the business side of startups and how to understand terms as pitch, crowdfunding and investor's mindset. The worldwide event Startup Pirates is focused on such topics, at most to show new projects how to develop a business idea successfully.
The Viscosity Reduction Platform: Viscosity-reducing excipients for improveme...Merck Life Sciences
Protein viscosity is a major challenge in preparing highly concentrated protein formulations suitable for subcutaneous injection. Recently, the Viscosity Reduction Platform (VRP) was introduced and its technical key features and benefits for formulations were discussed. However, highly viscous solutions do not only pose a challenge when administering a drug to a patient, they can also impose technical limitations in the manufacturing process.
This white paper evaluates the effect of the excipients in the Viscosity Reduction Platform on ultrafiltration processes used to produce a highly concentrated formulation of a monoclonal antibody (mAb). Two filtration methods are demonstrated in this work.
Find more information about the Viscosity Reduction Platform on our website: https://www.sigmaaldrich.com/products/pharma-and-biopharma-manufacturing/formulation/viscosity-reduction-platform
Use of Excipients in Downstream Processing to Improve Protein PurificationMerck Life Sciences
Excipients are used to improve the stability of protein-based therapeutics by protecting the protein against a range of stress conditions such as temperature changes, pH changes, or agitation. Similar stresses are applied to proteins during downstream purification. Shifts in pH during Protein A chromatography, subsequent incubations at low pH for virus inactivation, and changes in conductivity in ion exchange chromatography can lead to aggregation, fragmentation, or other chemical modifications of the therapeutic protein. Given the potential impact on the protein’s structural integrity, there is a need for approaches to reduce the risk presented by the conditions during downstream processing. For example, integration of a solution to prevent aggregation of proteins would be a more efficient strategy than implementing steps to remove multimeric forms.
This white paper highlights the results from a recent paper by Stange et. al., in which protein stabilizing excipients such as polyols, sugars, and polyethylene glycol (PEG4000) were used as buffer system additives. Effect of the excipients on elution patterns, stabilization of the monomer antibody, host-cell protein removal, virus inactivation rates and binding capacity of cation exchange chromatography were explored.
Exploring the protein stabilizing capability of surfactants against agitation...Merck Life Sciences
Agitation of therapeutic protein solutions during manufacturing, shipping and handling is one of the major initiators for protein aggregation and particle formation during the life history of a protein drug. Adsorption of protein molecules to liquid-air interfaces leads to the formation of highly concentrated protein surface films. The rupture of these protein films due to various mechanical processes can then result in the appearance of protein aggregates and particles in the bulk solution phase.
One technique to stabilize proteins against stress induced by liquid-air interfaces is the use of non-ionic surfactants. About 91% of antibody formulations commercially available in 2021 contained a surfactant. Polysorbate 20 and 80, composed of a hydrophilic polyoxyethylene sorbitan and hydrophobic fatty acid esters, made up the largest part being employed in 87% of said formulations.
Despite their frequent use in parenteral drug products, concerns have been raised for decades about the application of polysorbates as surfactants in biopharmaceutical formulations. Autoxidation of polysorbate, caused by residual peroxides in polysorbates, can damage the proteins and can further drive the oxidative degradation of polysorbate. Chemical and enzymatic hydrolysis of polysorbate may lead to the formation of free fatty acid particles, which may become visible; and both mechanisms eventually lead to the reduction in polysorbate concentration. Therefore, the purpose of the current study was to compare various molecules for their capabilities to reduced agitation-induced protein aggregation and particle formation; and furthermore, investigate their underlying protein stabilizing mechanisms.
The Viscosity Reduction Platform: Viscosity Reducing Excipients for Protein F...Merck Life Sciences
Protein viscosity is one of the major obstacles in preparing highly concentrated protein formulations suitable for subcutaneous injection.
This whitepaper examines how combining an amino acid with a second viscosity-reducing excipient circumvents adverse effects on protein stability and improves viscosity-reducing capacity.
To find more information about the Viscosity Reduction Platform, please visit our website: https://sigmaaldrich.com/products/pharma-and-biopharma-manufacturing/formulation/viscosity-reduction-platform
Characterization of monoclonal antibodies and Antibody drug conjugates by Sur...Merck Life Sciences
Watch the presentation of this webinar: https://bit.ly/3Pjpjvr
Highlights of this webinar:
- Surface plasmon resonance as a powerful tool for biologic characterization including mAbs and ADCs.
- SPR allows rapid binding analysis in real time without using labels for SARS-CoV-2 receptor binding domain mutations.
- Kinetic data is indicative of possible neutralizing activity allowed assessment of neutralizing ability of therapeutic monoclonal antibodies.
- The application can provide preliminarily efficacy information and facilitated mAbs/ACDs candidate selection process
Detailed description:
Characterization of therapeutic monoclonal antibodies (mAbs) or Antibody drug conjugates (ADCs) is challenging due to their ability to bind to a variety of proteins via their Fc and Fab domains, giving rise to diverse biological functions associated with each domain. The Fc domain of mAbs interacts with Fc receptors with varying affinities, which can influence biological processes such as Complement-dependent cytotoxicity (CDC) and Antibody-dependent cellular cytotoxicity (ADCC), transcytosis, phagocytosis, and/or serum half-life.
An important characteristic of an antibody is its Fc effector function. Antibodies can be engineered to obtain desired binding of the Fc region to Fc receptors expressed on effector cells. Hence, it is crucial to evaluate the binding interaction of mAbs/ADC with Fc receptors in the early phase of drug development to understand the potential biological activity of the product in vivo.
Surface Plasmon Resonance (SPR) is a powerful technique to establish binding kinetics in real-time, label free, and high sensitivity with low sample consumption. Along with target antigen binding, it is crucial to evaluate the binding interaction of antibodies and ADCs with Fc receptors. Our SPR case studies investigated the impact on binding kinetics of ADCs with different linkers and the binding interactions of SARS-CoV-2 spike protein variants and evaluated the neutralizing ability of therapeutic mAbs. SPR characterisation can be facilitated in all stages of the product life cycle to ensure the quality and safety of mAbs and ADCs.
The Role of BioPhorum Extractables Data in the Effective Adoption of Single-U...Merck Life Sciences
Regulatory expectation does require patient safety evaluations with supporting data for manufacturing components that directly come into contact with drug manufacturing process streams. Readily available extractables data can help manufacturers using singleuse technology to accelerate product qualifications, risk assessments and process optimization
This white paper guides you on how to save time and resources with supplier-provided single-use system extractables data and gives you an overview about the overall strategy for Extractables & Leachables. At the end you will find a case study.
Find more information about filters and single-use components on our website: https://www.sigmaaldrich.com/DE/en/services/product-services/emprove-program/emprove-filter-and-single-use-component-portfolio
Watch the recording of this presentation here: https://bit.ly/3zTOpe4
Detailed description:
SARS-CoV-2 showed us that technology supports us during our inspection activity even if on-site visits are not possible. Travel restrictions of various kinds will remain a risk in the future. The use of new technologies has shown that inspections and audits can be carried out despite these restrictions. We will focus on what possibilities the new technologies offer and take a look at the future of inspections and audits.
In this webinar, you will learn:
• Regulatory overview of remote audits
• The technologies needed to support the audit process
• What types of inspections are possible with the use of these technologies
• How audits may look in the future
Presented by:
Daniel Buescher, Product Manager - Digital Solutions
Moving your Gene Therapy from R&D to IND: How to navigate the Regulatory Land...Merck Life Sciences
Watch the recording of this presentation here: https://bit.ly/3SqOsoP
Novel therapies, including cell and gene therapies, continue to be central to innovation in healthcare and represent the fastest growing area of therapeutic medicine. As a consequence, the number of gene therapies undergoing clinical trials has increased significantly in the last five years.
Manufacturing processes for these novel therapeutics are very complex with a high risk of contamination. Regulatory agencies world-wide have responded by issuing guidance to outline their expectations for development and manufacture of cell and gene therapies. Currently, regulatory guidance is not harmonized globally and can often lead to confusion within industry and increased risk of non-compliance.
In this webinar, we'll answer:
• Which regulatory guidelines do you need to comply for your INDs?
• When do you start implementing GMPs and validated assays?
• How do you get your QC testing strategy ‘right the first time’?
• How do you ensure testing is not your rate limiting step for the IND submission?
Presented by:
Manjula Aysola, Senior Regulatory Consultant
Dr. Alison Armstrong, Sr. Director, Technical and Scientific Solutions
Identity testing by NGS as a means of risk mitigation for viral gene therapiesMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3RijkHC
Detailed description:
Imagine you’ve just completed a manufacturing run for your viral vector. Identity testing is performed to confirm the vector sequence. But when the results come back the data reveals unexpected sequence variants! With an appropriate risk mitigation testing strategy, this situation can be prevented.
The situation described above is not hypothetical, and happens more that you think, costing valuable time and resources.
Investigatory testing has shown that sequence variants present in starting materials (e.g. plasmids) are likely to make their way to the final product. Adequate identification of low-level variants with an appropriately sensitive method is critical in ensuring the quality of the final product. A risk-based testing strategy, in the context of identity, for viral vector manufacturing will be presented, focusing on key testing points. NGS assays for identity and variant detection will be highlighted due to their extremely sensitive nature compared to traditional approaches.
In this webinar, we'll explore:
• Regulatory requirements for identity testing
• NGS applications for identity testing as compared to traditional methods
• A case study on the impact of not establishing a proper risk-based testing strategy
Presented by: Bradley Hasson, Director of Lab Operations for NGS Services
Latest advancements of melt based 3D printing technologies for oral drug deli...Merck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3A2WcH4
The application of polymer excipients in 3D printing manufacturing is usually limited due to the concerns of filament strength, high processing temperature and large scale manufacturing.
Latest technology developments are targeting a direct melt deposition to simplify the process and enable a constant and efficient process. Two different processing approaches will be presented:
The advanced melt drop deposition, where individual three dimensional geometries can be created by depostition of polymer droplets and the MED® 3D printing technology which allows by precise layer-by-layer deposition to produce objects with well-designed geometric structures.
In this webinar, you will learn:
• Latest advancements of melt based 3D printing approaches
• Application examples for the individual technologies
• Deep dive in the MED® 3D printing technology to design dedicated drug release profiles
Presented by:
Dr. Thomas Kipping, Head of Drug Carriers
Dr. Xianghao Zuo, Deputy Director of R&D, Triastek
CAR-T Manufacturing Innovations that Work - Automating Low Volume Processes a...Merck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3NDNIKe
Automated, fit-for-purpose tools are essential in CAR-T processing to support sustainable manufacturing of clinical and market-approved cell therapy products. This webinar will discuss how the ekko™ Acoustic Cell Processing System uses acoustic technology as a touchless approach to manipulate cells, enabling a modular tool across the CAR-T manufacturing workflow. Typical performance of templated ekko™ System processes for DMSO washout of leukapheresis material, low volume and high cell concentrate for electroporation preparation, and harvest of expanded T cells will be reviewed.
This webinar will also give an early glimpse at the ekko™ Select System for unmatched T cell selection.
In this webinar, you will:
• Uncover how the ekko™ System supports the broad industrialization of cell therapy, with particular focus on how to achieve low volume, high concentrate cell product for critical transduction and transfection steps
• Discover how ekko™ System for wash and concentrate processes throughout the cell therapy workflow achieve high cell recovery, viability, and effective residual removal
• Preview to ekko™ Select, our cell therapy selection platform, to achieve unmatched ease-of-use with direct processing from leukopaks reducing the need for preparation steps
Presented by:
Benjamin Ross-Johnsrud, Acoustic Technology Expert
Robert Scott, Mechanical Engineer III
Viral safety of biologics: What's changing with the ICH Q5A revision?Merck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3t7X9tg
How does the ICH Q5A revision impact viral safety strategies for biologics?
Biologics continue to grow at a fast pace. Manufactured using cell lines of human or animal origin, these are at risk of viral contamination making safety strategies critical. A comprehensive risk mitigation strategy using multiple orthogonal measures is a regulatory expectation. ICH Q5A, the globally-harmonized guideline outlines the expectations. ICH Q5A is currently being revised to address recent scientific advancements including novel therapeutic modalities, new manufacturing paradigms, updates in viral clearance applications, and alternate detection technologies. We’ll discuss the expected changes and potential impact on viral safety strategies with case studies and examples.
In this webinar, you will learn about:
• The Importance of virus testing in biologics products
• Regulatory landscape, expectations for the Q5A revision
• What's new and changing
• Examples of alternate testing schedules, impact on viral clearance
Presented by:
Manjula Aysola, Senior Regulatory Consultant
Alison Armstrong, PhD, Sr. Director, Technical and Scientific Solutions
Improve Operational Efficiency by Over 30% with Product, Process, & Systems A...Merck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3adaxWh
When implementing new automation systems, organizations must consider things like deployment time, user adoption, and costs.
They must also consider the cost of doing nothing – that is, what competitive advantage is lost in standing still? What time and quality is lost in repetitive, manual tasks rather than an automated, digital workflow? What operational efficiencies are lost?
In this webinar we examine how a product, process, and system agnostic automation platform can be deployed faster than traditional system specific software while bringing greater operational efficiencies (in many cases over 30% improvement).
To remain competitive in the market, biopharma manufacturers must adopt automation and digital technologies, but most plants still have island of automation consisting of independently functioning, standalone unit operations. This results in operational inefficiency, regulatory concerns, and a poor understanding of the process and product life cycle.
Taking the first, right step must include considering risks, costs, timelines, and technology alternatives. Traditional automation approaches tied to specific systems, processes, and products are, by their nature, limited; while an agnostic platform will address current biomanufacturing business challenges and ensure future readiness. With the right platform, a phased automation implementation can yield operational efficiency gains of up to 30% and improved product quality and regulatory compliance.
In this webinar, let's explore:
• Challenges of automation and digital technology adoption
• What a product, process, and system agnostic platform entails
• Applications and benefits of a process orchestration platform
• Ensuring future readiness with process orchestration
Presented by:
Braj Nandan Thakur, Global Product Manager - Automation
Insights from a Global Collaboration Accelerating Vaccine Development with an...Merck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3Nbb5ug
Get insights and best practices from a multinational team establishing a platform for vaccine production. See how a long-term collaboration on a bench-scale process used to produce a Virus Like Particle (VLP) vaccine for SARS-CoV-2 was successfully converted to a robust GMP-compatible, scalable process.
The COVID-19 pandemic further emphasized the need for collaboration in the development of urgently needed vaccines and therapeutics. In this webinar, we take you behind the scenes of our collaboration with Technovax and Innovative Biotech in which a scalable VLP vaccine platform was optimized for use in a production facility in Nigeria in response to the need for local production of SARS-CoV-2 vaccines. The flexibility and robustness of the platform will enable its rapid deployment to support the West African pandemic readiness program. Initial development of the VLP process began in late 2019 and by March 2020, was already adapted for production of a SARS-CoV-2 vaccine.
In this webinar, you will learn:
• About building a priceless collaborative network with integrated solutions
• Virus-Like Particle Vaccines
• Process Development Overview and Challenges
• Pre-clinical Results and Next Steps
Presented by:
Jose M. Galarza, PhD,
President and Founder of TechnoVax
Naomi Baer,
Business development consultant, Emerging Biotech, BioProcess division
Youssef Gaabouri, Eng. ,
Associate Director, Head of Sales Middle East & Africa, BioProcess division
Risk-Based Qualification of X-Ray Sterilization for Single-Use SystemsMerck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3vQf0qv
In the single-use bioprocess industry, X-ray irradiation warrants consideration as an alternate sterilization technology. Using a risk-based qualification testing strategy is important when evaluating and implementing equivalent ionizing irradiation sterilization methods.
The urgent need for life-saving therapies as a result of the global pandemic has reinforced the criticality of flexibility in pharmaceutical manufacturing, including sterilization. The single-use bioprocess industry traditionally has employed gamma irradiation sterilization. X-ray irradiation is being considered as an additional sterilization technology for business and supply continuity. We will share a risk-based qualification testing strategy including Extractables and data generated to support comparability of gamma irradiation and X-ray irradiation as equivalent ionizing irradiation sterilization methods.
In this webinar, you will learn about:
• The comparison of gamma and X-ray irradiation sterilization
• A risk-based qualification test strategy
• Data evaluation of gamma versus X-ray sterilized single-use components
Presented by:
Monica Cardona,
Global Senior Program Manager
Paul Killian, Ph.D.,
R&D Director, Analytical Technologies
Rapid replication competent adenovirus (rRCA) detection: Accelerate your lot ...Merck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3MJ4u9V
Testing for presence of replication competent adenovirus (RCA) is a key component to ensure patient safety and a requirement for all biologicals manufactured using adenoviral vectors. For many adenoviral-based products, the RCA assay is a rate-limiting assay for lot release.
Join this webinar to learn about a rapid RCA detection assay currently in development, which combines a 7-day culture assay with a highly sensitive molecular endpoint specific for RCA. The method can detect presence of as little as 1 RCA in adenoviral vector material at an approximate concentration of 5x107 - 2x108 vector particles (VP)/mL, making it a suitable method to meet regulatory requirements while accelerating your lot release timelines.
In this webinar, you will learn about:
• Regulatory framework for adenoviral vector products
• Considerations for lot release testing of adenoviral-based therapies
• Advantages of a rapid method for RCA testing on production lot material
Presented by:
Axel Fun, Ph.D.,
Principal Scientist
Alberto Santana, MBA,
Product Manager, Biologics Biosafety Testing
The High Intensity Sweeteners Neotame and Sucralose: 2 Ways to ace the Patien...Merck Life Sciences
Watch the presentation of this webinar here: https://bit.ly/3vQyN7K
Bitter medicines are an important issue, especially for pediatric applications. As several APIs have bitter tasting components, high intensity sweeteners for taste optimization are of great interest. Join our webinar to discover our new sweetener toolbox enabling safe and stable formulations.
Mask bitter aftertaste for a sweeter pill to swallow! Patients’ compliance and the therapeutic benefit are supported by a pleasant taste of pharmaceutical formulations. With the high intensity sweeteners Neotame and Sucralose, you have efficient tools at hand which are superior to other sweeteners in many aspects:
• excellent sugar-like taste profile
• outstanding sweetness factors
• use effectiveness
• enhanced stability
We will present our new toolbox of two high performance sweeteners and focus on aspects of stability, safety, the application in various dosage forms, and market perception.
In this webinar, you will learn:
• How to optimize the patients' taste experience of your pharmaceuticals
• How sweeteners can be differentiated by their sensory profiles and features
• How our new product offering Neotame can be effectively used in your targeted formulations
Presented by:
Almut von der Brelie,
Senior Manager Strategic Marketing
Excipients for Solid Applications
The Developability Classification System (DCS): Enabling an Optimized Approac...Merck Life Sciences
This whitepaper by Dr. Daniel Joseph Price outlines how poorly soluble drug formulations can be designed using the developability classification system (DCS).
The DCS identifies the root cause of low solubility and enables lean, cost-effective and effective formulations to be developed.
#solubility #pharmaceuticalmanufacturing #oralsoliddosage #drugdevelopment
In this webinar, you will learn about:
The advantages of using advanced intermediates to develop ADC therapies
How to increase ADC solubility and efficiency
Fast, small-scale ADC library generation
Seamless supply chain with reduced complexity and regulatory support
The ADCore product line offers versatile intermediates that simplify the synthesis of common ADC payloads (dolastatins, maytansinoids, and PBDs) by greatly reducing the number of synthetic steps. This translates to savings in development and manufacturing costs and shorter timelines to the clinic. To address the poor solubility of many ADC payloads, ChetoSensar™ was developed to significantly increase the hydrophilicity of the drug linker, which has been shown to also substantially increase the efficacy of ADCs and broaden the therapeutic window.
Lastly, the ADC Express™ service leverages conjugation chemistry and analytical expertise to help design and quickly synthesize sets of potential ADC therapies suitable for screening to simplify candidate selection and get ADC therapies to market faster.
CHAPTER 1 SEMESTER V PREVENTIVE-PEDIATRICS.pdfSachin Sharma
This content provides an overview of preventive pediatrics. It defines preventive pediatrics as preventing disease and promoting children's physical, mental, and social well-being to achieve positive health. It discusses antenatal, postnatal, and social preventive pediatrics. It also covers various child health programs like immunization, breastfeeding, ICDS, and the roles of organizations like WHO, UNICEF, and nurses in preventive pediatrics.
The dimensions of healthcare quality refer to various attributes or aspects that define the standard of healthcare services. These dimensions are used to evaluate, measure, and improve the quality of care provided to patients. A comprehensive understanding of these dimensions ensures that healthcare systems can address various aspects of patient care effectively and holistically. Dimensions of Healthcare Quality and Performance of care include the following; Appropriateness, Availability, Competence, Continuity, Effectiveness, Efficiency, Efficacy, Prevention, Respect and Care, Safety as well as Timeliness.
India Clinical Trials Market: Industry Size and Growth Trends [2030] Analyzed...Kumar Satyam
According to TechSci Research report, "India Clinical Trials Market- By Region, Competition, Forecast & Opportunities, 2030F," the India Clinical Trials Market was valued at USD 2.05 billion in 2024 and is projected to grow at a compound annual growth rate (CAGR) of 8.64% through 2030. The market is driven by a variety of factors, making India an attractive destination for pharmaceutical companies and researchers. India's vast and diverse patient population, cost-effective operational environment, and a large pool of skilled medical professionals contribute significantly to the market's growth. Additionally, increasing government support in streamlining regulations and the growing prevalence of lifestyle diseases further propel the clinical trials market.
Growing Prevalence of Lifestyle Diseases
The rising incidence of lifestyle diseases such as diabetes, cardiovascular diseases, and cancer is a major trend driving the clinical trials market in India. These conditions necessitate the development and testing of new treatment methods, creating a robust demand for clinical trials. The increasing burden of these diseases highlights the need for innovative therapies and underscores the importance of India as a key player in global clinical research.
QA Paediatric dentistry department, Hospital Melaka 2020Azreen Aj
QA study - To improve the 6th monthly recall rate post-comprehensive dental treatment under general anaesthesia in paediatric dentistry department, Hospital Melaka
Medical Technology Tackles New Health Care Demand - Research Report - March 2...pchutichetpong
M Capital Group (“MCG”) predicts that with, against, despite, and even without the global pandemic, the medical technology (MedTech) industry shows signs of continuous healthy growth, driven by smaller, faster, and cheaper devices, growing demand for home-based applications, technological innovation, strategic acquisitions, investments, and SPAC listings. MCG predicts that this should reflects itself in annual growth of over 6%, well beyond 2028.
According to Chris Mouchabhani, Managing Partner at M Capital Group, “Despite all economic scenarios that one may consider, beyond overall economic shocks, medical technology should remain one of the most promising and robust sectors over the short to medium term and well beyond 2028.”
There is a movement towards home-based care for the elderly, next generation scanning and MRI devices, wearable technology, artificial intelligence incorporation, and online connectivity. Experts also see a focus on predictive, preventive, personalized, participatory, and precision medicine, with rising levels of integration of home care and technological innovation.
The average cost of treatment has been rising across the board, creating additional financial burdens to governments, healthcare providers and insurance companies. According to MCG, cost-per-inpatient-stay in the United States alone rose on average annually by over 13% between 2014 to 2021, leading MedTech to focus research efforts on optimized medical equipment at lower price points, whilst emphasizing portability and ease of use. Namely, 46% of the 1,008 medical technology companies in the 2021 MedTech Innovator (“MTI”) database are focusing on prevention, wellness, detection, or diagnosis, signaling a clear push for preventive care to also tackle costs.
In addition, there has also been a lasting impact on consumer and medical demand for home care, supported by the pandemic. Lockdowns, closure of care facilities, and healthcare systems subjected to capacity pressure, accelerated demand away from traditional inpatient care. Now, outpatient care solutions are driving industry production, with nearly 70% of recent diagnostics start-up companies producing products in areas such as ambulatory clinics, at-home care, and self-administered diagnostics.
Welcome to Secret Tantric, London’s finest VIP Massage agency. Since we first opened our doors, we have provided the ultimate erotic massage experience to innumerable clients, each one searching for the very best sensual massage in London. We come by this reputation honestly with a dynamic team of the city’s most beautiful masseuses.
Telehealth Psychology Building Trust with Clients.pptxThe Harvest Clinic
Telehealth psychology is a digital approach that offers psychological services and mental health care to clients remotely, using technologies like video conferencing, phone calls, text messaging, and mobile apps for communication.
CRISPR-Cas9, a revolutionary gene-editing tool, holds immense potential to reshape medicine, agriculture, and our understanding of life. But like any powerful tool, it comes with ethical considerations.
Unveiling CRISPR: This naturally occurring bacterial defense system (crRNA & Cas9 protein) fights viruses. Scientists repurposed it for precise gene editing (correction, deletion, insertion) by targeting specific DNA sequences.
The Promise: CRISPR offers exciting possibilities:
Gene Therapy: Correcting genetic diseases like cystic fibrosis.
Agriculture: Engineering crops resistant to pests and harsh environments.
Research: Studying gene function to unlock new knowledge.
The Peril: Ethical concerns demand attention:
Off-target Effects: Unintended DNA edits can have unforeseen consequences.
Eugenics: Misusing CRISPR for designer babies raises social and ethical questions.
Equity: High costs could limit access to this potentially life-saving technology.
The Path Forward: Responsible development is crucial:
International Collaboration: Clear guidelines are needed for research and human trials.
Public Education: Open discussions ensure informed decisions about CRISPR.
Prioritize Safety and Ethics: Safety and ethical principles must be paramount.
CRISPR offers a powerful tool for a better future, but responsible development and addressing ethical concerns are essential. By prioritizing safety, fostering open dialogue, and ensuring equitable access, we can harness CRISPR's power for the benefit of all. (2998 characters)
1. Jeroen Bakker, Associate Healthcare
Cheryl Zimberlin, Associate Healthcare
Merck Ventures BV, Amsterdam, the Netherlands, a
subsidiary of Merck KGaA, Darmstadt, Germany
An Insider's View
Venture Capital
Funding
2. Emerging Biotech Webinar | 10.10.2017
The life science business of
Merck KGaA, Darmstadt, Germany
operates as MilliporeSigma
in the U.S. and Canada.
3. The ABCs of Venture Capital
Venture Capital – Everything you wanted to know about Venture Capital
Corporate Venturing – The in’s and out’s of a Corporate Venture Capital
To invest or not to invest? – How we look at opportunities
Emerging Biotech Webinar | 10.10.2017
4. A poll will now occur
Emerging Biotech Webinar | 10.10.2017
5. Every type of funding aligns with the content and goals
An overview of the funding environment
Fundamental
Research
Applied Research
Translational
Research
Drug Discovery Drug Development
Research Grants
Translational Grants
F&F, Venture Capital
License, Sale, IPO
Consider the following!
• Your intention
• Ownership
• Timelines/governance
• Expectations
Emerging Biotech Webinar | 10.10.2017
6. What is Venture Capital precisely?
Definition: Venture capital is financing that investors provide to start-up companies
and small businesses that are believed to have long-term growth potential.
Annual revenues
of ~$10 billion
Development costs
of ~$2.5 billion
?
Emerging Biotech Webinar | 10.10.2017
7. LPs, GPs, fund life and exits & the difference between a VC and CVC
The VC Business Model: Simplified
$10m
Company A
$4m
Company B
$8m
Company C
$7m
Company D
$100m
Venture Capital Fund
(General Partner)
$25m
Investor I
$25m
Investor II
$50m
Investor III
$100m
IPO
$100m
Acquisition
$450m
Option deal
Companies
XYZ… $
$
Venture
Capital Firm
(Management
firm)
Limited Partners (Investors in the fund)
Emerging Biotech Webinar | 10.10.2017
8. How much money flowed into the system?
Despite a decrease in funding amount, VC is still on the rise!
$-
$10.0
$20.0
$30.0
$40.0
$50.0
$60.0
$70.0
$80.0
$90.0
$100.0
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
$billionraised
Venture ($ billion) IPO ($ billion) Follow-on ($ billion) Other ($ billion)
$-
$2
$4
$6
$8
$10
$12
0
50
100
150
200
250
300
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Numberofrounds
Volumeoffinancings($billion)
Europe U.S. Europe U.S.
Money raised by biopharma VC financings of EU and US biopharma
Source: BCIQ: BioCentury Online Intelligence. Data as of 25-4-2017; internal analysis
Emerging Biotech Webinar | 10.10.2017
9. One way of creating a return for shareholders
The IPO window is still open for all of us
0
10
20
30
40
50
60
70
$-
$1.00
$2.00
$3.00
$4.00
$5.00
$6.00
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
#ofdeals
Dealvolume($billion)
Europe U.S. Europe U.S.
0
10
20
30
40
50
60
70
80
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
No.ofIPOs
Discovery Preclinical Phase I Phase II Phase III Registration Marketed
IPO activity in EU and US IPO activity by development stage
Source: BCIQ: BioCentury Online Intelligence. Data as of 25-4-2017; internal analysis
Emerging Biotech Webinar | 10.10.2017
10. Going public is not the only route to a return
Tradesales offer a lucrative exit besides an IPO
218
147
313
202
332
373 376
475
658
881
185
94
119
97
201
141
190
306
272
439
72
38
62 54 73 62 53 54 55 66
0
100
200
300
400
500
600
700
800
900
1000
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
AverageValues($m)
Average Total Transaction Value
Average Upfront Transaction Value
Average Invested Capital
$4.4 $2.4 $1.8 $2.3 $4.0 $2.8 $3.4 $5.1 $7.4 $9.8
$5.2
$3.6
$4.7 $4.7
$6.7
$7.4 $6.8
$8.4
$18.9
$20.0
31
25
18
28 27 28
23
25
36 35
$0.0
$2.0
$4.0
$6.0
$8.0
$10.0
$12.0
$14.0
$16.0
$18.0
$20.0
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
#Tradesales
Transactionvalue($bn)
Upfront value Overall value Companies sold
Tradesales of VC-backed companies Deal metrics of tradesales
Source: HBM Pharma/Biotech M&A Report 2017, internal analysis
Emerging Biotech Webinar | 10.10.2017
11. The ABCs of Venture Capital
Venture Capital – Everything you also wanted to know about Venture Capital
Corporate Venturing – The in’s and out’s of Corporate Venture Capital
To invest or not to invest? – How we look at opportunities
Emerging Biotech Webinar | 10.10.2017
12. A poll will now occur.
Emerging Biotech Webinar | 10.10.2017
13. Know the investor!
The Venture Capital cuisine has different flavours
Institutional VC
Corporate VC
Sauces
Company creation
Early Stage
Late Stage
Sides
Geography
Therapeutic Area
Technology
For 2 or more
Syndicate
Lead, co-investor
Emerging Biotech Webinar | 10.10.2017
14. Corporate VCs focuses more and more on early stage financings
11 20 17 23 18 18 20
31 35
58 52
86
99 94 99 94 118 107
82 117
77 9611%
17% 15%
19%
16%
13%
16%
27%
23%
43%
35%
0
50
100
150
200
2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015
Without CVC in syndicate
With CVC in syndicate
OverallVCfinancingSeed&SeriesA
Source: Pitchbook & BioCentury BCIQ, internal analysis
CVC investments in
biotech doubled from
8% (2005) to 17%
(2015)
In Seed and Series A
financings, CVC
participation tripled
from 11% (2005) to
35% (2015)
Early stage financings is
the ideal playing ground
for CVCs
Number of Financings Dollars Invested
The role of CVCs is evolving
Emerging Biotech Webinar | 10.10.2017
15. Why do Corporate VCs focus on early stage financings?
Biotech is highly suitable for high risk projects
15
Biotech is able to go from
Hit Discovery to IND at a
much lower cost and higher
efficiency than pharma
does
Capital spend on R&D
through a CVC is much
more efficient, i.e. it is
leveraged with external
capital
CVC playing ground ideal
for high risk projects
Emerging Biotech Webinar | 10.10.2017
16. Corporate VC is an important tool for pharma
• Most pharma and some larger biotechs have a CVC arm
• Tool in reaching strategic goals, and, potentially profitable business unit
Early involvement is ideal playing ground for Corporate VCs
• Enables first access to novel technologies at a limited cost
• Develop good understanding of technologies through close involvement
Early alignment with pharma expectations for data package
• Product development strategy informed by what pharma wants (built-to-buy)
• Potential to educate to prepare for deal making
Corporate VC investment seen as ‘stamp of approval’
The what and why of Corporate Venture Capital
Corporate venture
funds in pharma since
1973:
Johnson & Johnson,
Pfizer, Lilly, GSK (SR
One), Novartis, Amgen,
Roche, Novo, Amgen,
Boehringer Ingelheim,
Astellas, MSD,
Medimmune
Emerging Biotech Webinar | 10.10.2017
17. CVC participation translates to increased value creation
The numbers backing up the story
17
Objectives of CVCs
20%
50%
15%
15%
Strategic objectives are essential
investment objectives for 85% of CVCs
CVCs have proven to create higher likelihood of an exit while the
majority of CVCs pursues strategic objectives
Primarily financial,
strategic value
is a requirement
Primarily strategic,
financial return
is a requirement
Strategic value only
Financial return only
Trends in VC-backed financings
& exit events (2001-2015)
VC-backed companies with CVC
participation (2001-2015)
Biotech with CVC participation creates
relatively more exits
Increase in exit potential is a
sustained trend for the past 15 years
Source: BCIQ: BioCentury Online Intelligence; internal analysis
Emerging Biotech Webinar | 10.10.2017
18. An example of a
Corporate
Venture Capital
fund
Emerging Biotech Webinar | 10.10.2017
19. How do we add value?
Pharma-quality focus but with biotech creativity and speed
• Design ‘killer’ experiments
• Emphasis on business development
• Top tier investment syndicates
• Through network management, board & SAB
• Hands-on board support
• Interim C-level/executive support
P
A
R
E
N
T
Leverage R&D expertise for “wet due diligence”
Nurture assets: active R&D, BD, commercial involvement
Offer access to manufacturing, screening capabilities, etc. in exchange for equity
Early front-row seat, early due diligence, preferred relationship
Catalyze exchange and creation of novel ideas
Foster corporate entrepreneurship with the mother company
P
O
R
T
F
O
L
I
O
Emerging Biotech Webinar | 10.10.2017
20. The ABCs of Venture Capital
Venture Capital – Everything you also wanted to know about Venture Capital
Corporate Venturing – The in’s and out’s of Corporate Venture Capital
To invest or not to invest? – How we look at opportunities
Emerging Biotech Webinar | 10.10.2017
21. A poll will now occur.
Emerging Biotech Webinar | 10.10.2017
23. What are we looking for?
Building an investment bottom-up with good science
23
Co-
investors
Financing
need
Best team
Clear development plan
Sound experimental data,
validated MoA & good IP
Cutting-edge science with
innovative angle in strategic TA
Value when we sell the company
Financing need
Value before investing
Cost-effective
development plan
Best team
IP, data
OR
Emerging Biotech Webinar | 10.10.2017
24. Selecting the best 0.5%
Our investment process
24
Sources for deal flow
Investor conferences, Advisory firms, Other Venture Capital firms,
Academic Technology Transfer Offices, Websites
Due diligence activities
• Scientific/IP/financial diligence, Site visit, Internal/external KOL
consults, Potential syndicate discussions
Portfolio company
• We actively manages investment: board seat/C-roles, Ongoing
non-conf discussions with divisional R&D/BD
Further exploration consists of
Literature research, Call/meeting with management, Non-conf.
discussion with divisional R&D
~1000
new investment proposals
per year
~300
investment proposals
further explored
5-10
due diligence
4-6
Emerging Biotech Webinar | 10.10.2017
25. Why are you different from the other 99.5%?
• Check the underlying biology. Does it
make sense against what has been
shown before?
• Is the observed effect actually
therapeutically relevant?
• What analysis has been used and,
how many times was the study
actually replicated?
• Is the scale of the y-axis consistent?
• Was there a positive control used in
the study?
• Do the reagents actually do what is
they meant to be doing?
What’s the problem and is this the best solution? Does your data back-up your story?
Emerging Biotech Webinar | 10.10.2017
26. Who’s going to drive the project?
Youngest driver in Formula 1
Seen as upcoming talent
Able to get funding for Formula 1
Won a race in his first year
Oldest driver in MotoGP
Won 9 titles
Best-earning MotoGP driver
Last title from 2009
Emerging Biotech Webinar | 10.10.2017
27. What exactly do you own as a start-up?
But also…
Can/is your final product (be) protected by
patents (with sufficient time horizon and
broad claims)?
What patent applications do you have, and
what is their likelihood of being granted?
Hard IP (patents) is clearly preferred,
although trade secrets can be sufficient in
some cases (reverse engineering risk of cell
therapy product vs. small molecule).
For an early stage company, most of the
company value for a VC is in the patent
portfolio.
Do you have freedom to operate for the final
product you envisage?
If not…
• Can you design around the FTO
hurdle?
• Can you obtain a license from the party whose
IP you are infringing
• Can we take the risk? (not if the IP belongs to a
big company)
Emerging Biotech Webinar | 10.10.2017
28. Selling is good but keep it real
28
“Lowering COGS of mAbs in the
ONC field significantly”
“We see no side effects at all”
“This mechanism is unique,
biologically”
“My professor has been working
on this for 20 years”“We can significantly reduce the
risks of drug development”
“We have a highly specific siRNA,
just need to solve delivery”
“We‘re the only ones in the
world, there is no competition”
Emerging Biotech Webinar | 10.10.2017
29. Check the boxes that apply to you
(Medical) need Yes No
Proprietary Yes No
Differentiation Yes No
People Personality Track Record Incentives
Potential Market size Competition Pricing / margin
Timing Time to market Penetration rate Exclusivity
Risk Development Regulatory Market
Cost structure Development Inflection points Commercial
Emerging Biotech Webinar | 10.10.2017
30. You will only have one first impression…
Come up with a strong, to the point plan (20-25 slides),
containing your:
• Concept
• In-house data
• Competitive positioning
• Development plan
• Team
• Use of Proceeds
Think big but also target the right investor with the right idea!
Emerging Biotech Webinar | 10.10.2017
31. You miss 100% of the shots you don’t take
You jump of a cliff and you
assemble an airplane on the
way down.
- Reid Hoffman, Founder of LinkedIn
Emerging Biotech Webinar | 10.10.2017