All posts by Business Review Webinars

Spotlight Interview with Robert Topping, Scientist at CordenPharma

A Conversation with Robert Topping, distinguished Scientist at CordenPharma

 

Robert is currently a Distinguished Scientist at CordenPharma Colorado, continuing development and implementation of manufacturing processes for peptide and highly potent APIs.

 

 

  1. What do you hope the audience will learn from this webinar?

I hope the audience will take note of the need to identify, consider & understand the process changes that are often needed in order to control the manufacturing process so that it can deliver the same quality outcomes that are expected based on the smaller scale, discovery and development process knowledge.

  1. What discussions do you look forward to having with the audience?

I would like to hear feedback from the audience on issues they might have experienced and resolved. I think this webinar is an effective medium for sharing practical experience, technical knowledge and gaining insight into problems that others may not have encountered or resolved yet. Large scale peptide manufacturing can present a minefield of problems, but a gold mine of solutions.

  1. What do you enjoy most about your role?

I enjoy the challenge of figuring out what a molecule is doing, what influences the molecule receives, and then creating ways of controlling what that molecule does.

  1. How did you get into the industry?

After graduate school in chemistry, I felt the pharmaceutical industry, and its impact on global health care, was the most value-added career for me as a chemist. I was hired by Syntex in 1987 as part of a team to devise and develop a new, world-leading synthesis and manufacturing process what would soon become Aleve®.  That success nurtured a passion for seeing the whole process, from bench to commercializaton, and for insight into the value of critical medicines in the pharmaceutical industry.

  1. Where is your favourite place in the world and why?

The Olympic Peninsula in Washington state. It is a great place to experience a wide range of nature without being lost in it.

Join Robert on a webinar entitled ‘Scale-up Considerations for Large-Scale Peptide Manufacturing‘ by CordenPharma on 20th November at 8 MST / 10 EST / 16:00 CET.

CordenPharma – Peptide Webinar Blog

 

CordenPharma’s live webinar on Wed November 20th, titled “Scale-up Considerations for Large-Scale Peptide Manufacturing,” will present concepts that bear differences in the outcomes of peptide synthesis that are dependent on scale. The topics discussed can significantly impact quality and processability, and are often unexpected if scale-up planning only applies mathematical scaling of a small-scale lab synthesis.

The development & implementation in CordenPharma Colorado 15 years ago of the large synthetic process for Fuzeon promoted our strategy for large scale manufacturing and, by establishing bulk raw material networks, lowered costs for building blocks such as Fmoc-amino acids and functionalized resins, while also promoting academic and industrial endeavors for the advancement of synthetic strategies and further evolution of coupling reagents with targeted purposes. Today, all of these factors contribute to making peptide therapeutics more affordable and achievable. The commercial success of large scale peptide manufacturing by a synthetic route extended the horizon that scientists and the pharma industry would look to for developing such products.

The scientific beauty and challenge of peptide synthesis, and specifically the practical, safe & economical manufacturing of peptides, is that each peptide product brings its own unique fingerprint of chemical and physical properties that make it a unique chemical “species”.

The cursory evaluation of peptide synthesis as mere arrangement of a basis set of 20 natural amino acids, implying simplicity of the synthesis, fails to note the dramatic differences that the exponentially large number of permutations of those fundamental building blocks can generate, not to mention the “non-natural” permutations that medicinal discovery & development apply to peptide products for enhanced potency and activity.

As with all things in science, the evolution of the approaches & tools that can be applied to probe and achieve an ever-widening range and diversity of peptide products not only continues, but requires constant modification to transfer peptide discoveries into peptide production. Although many peptides have high levels of specificity & potency, patient populations for these therapeutics continue to dictate the need for large scale manufacturing.

Do you wonder what “peptide” therapeutics will look like in the next 10, 20 or 50 years?  Looking back in time at the size of peptides, the approach to their production and the relative molecular simplicity, compared to now, only our imagination limits us. The evolution continues.

Join Robert on a webinar entitled ‘Scale-up Considerations for Large-Scale Peptide Manufacturing‘ by CordenPharma on 20th November at 8 MST / 10 EST / 16:00 CET.

Navigating Injectable Combination Device & Drug Product Regulations

 

 

 

 

 

Hi,

I am Fabio Stevanon, Director of the Global Injectables Platform at CordenPharma International, a Contract Development & Manufacturing Organization (CDMO) which supplies Active Pharmaceutical Ingredients (APIs), Drug Products & Packaging for the pharma / biotech industry.

I am looking forward to our upcoming webinarNavigating Injectable Combination Device & Drug Product Regulations taking place on Sept 12thbecause it will give attendees a unique opportunity to hear from two speakers: Mark Chipperfield, Principal Consultant & Company Director of Corvus Ltd (one of the most skilled consultants in this industry) and myself, giving an overview of CordenPharma’s injectable capabilities & future strategy as a full-service CDMO.

We are very excited to take you on a journey through Injectable “Combination Products,” which were born out of the exploration on the part pharma companies to integrate medical devices with drug products in an effort to seek more convenient, user-focused drug delivery solutions. These quickly emerging solutions have caused regulations, guidelines and applicable standards to evolve rapidly, leaving many aspects of drug development and lifecycle management unsure how to proceed.

We hope you will learn what IS & what IS NOT a combination device-drug product, gain insight into the major regulation landscape for combined drug & device products (including some technical challenges for injectable Pre-Filled Syringes (PFS) & Auto-injectors), get an overview of how a sound injectable drug product strategy by a CDMO helps navigate industry changes to support drug development goals, and learn ways of partnering with a global CDMO to efficiently commercialize an injectable drug (with specific recommendations on finding solutions for injectable combination device-drug product challenges).

Because this is such a hot topic right now, there has already been a lot of interest in the webinar. Being as this is a journey, we would like to also gain an understanding of the challenges that arise in developing injectable combination products, which could affect various roles within the Injectable field of Device / Combination Product Development including Managers, Supervisors, Senior Staff, Clinical Supply, R&D Managers, Tech Transfer Managers & External Quality, just to name a few.

We also want to learn what you are looking for from a global CDMO in connection with this topic. Your feedback will be extremely useful for us to fine-tune our future strategy to expand our Injectable Drug Product portfolio with a sound mix of technologies (as of now strictly aseptic Fill & Finish, lyophilization, terminal sterilization), balanced a good variety of finished dosage forms (e.g. suspension in near future) and product / container ranges (ampoules, all vial ranges, PFS & cartridges).

 

SPOTLIGHT INTERVIEW WITH GARY HUTCHINSON, PRESIDENT OF MODALITY SOLUTIONS.

A conversation with Gary Hutchinson, Founder and President Modality Solutions and Daniel J. LittlefieldFounder and VP Engineering

 As a founder and the President of Modality Solutions, Gary Hutchinson has developed logistics processes and managed supply chain professional organizations in a variety of industries.

 

 Daniel Littlefield is a founder of Modality Solutions. He has helped establish Modality Solutions as an innovator in the cold chain logistics industry. Dan recently headed up Modality Solutions’ CDC-sponsored Ebola clinical trial operations project in Sierra Leone and NIH-sponsored clinical trial operations project in Liberia in 2015 and 2016.

  1. What do you hope attendees will gain at your event’s?

Gary: I hope attendees get a deep understanding on how to meet the changing regulatory expectations for monoclonal antibodies and most recently for the new class of immunotherapies. Expectations on drug product testing, the role of simulation and the changing requirements on the role of ASTM testing is all critical to new therapy approval.

Dan: I feel like we’ve really raised the bar on technical rationale for why and how we do simulation testing, and I’m excited to share our thoughts on how it all fits together. We want to share how our validation methodology flows logically from risk assessment through qualification results, and how the logic can be applied to the full spectrum of new treatments.

2. What discussions do you look forward to having with the attendees?

Gary: We love getting and sharing feedback received from regulators around the globe on cold chain validation strategies and expectations on execution. It’s great to see more and more harmonization on a global approach to cold chain validation focused on the patient. We are uniquely positioned to share information because of our involvement in cold chain validation for more than 75 therapies in the last 18 months, but we always love to learn about your experience, too!

Dan:  We work with a lot of very smart people in the industry who are developing new therapies, and a webinar like this helps us to broaden our knowledge base regarding the latest nuances in therapies.  Industry innovation is increasing, and we need to stay sharp about what’s out there, and what’s on the way, so we can ensure the robustness of all the work we do.

3. What do you enjoy most about your role?

Gary: Without a doubt, we love helping our clients navigate an increasing complex cold chain for the latest therapies. We enjoy being involved early in clinical trials to simulate the transport environment on early stage therapies and being part of great teams all the way through approval.

Dan:  We have a great team of engineers, and we’re always working to ensure client success.  We’re always excited when we hear of a successful submission or clinical trial, because we know we’ve done our part to make sure our clients’ patients are getting great new therapies.  Also, because I am an engineer, I personally enjoy the more technical aspects of our work.

4. How did you get into the industry?

Gary: My career in supply chain and logistics started more than 25 years ago after graduating from The Ohio State University in Columbus, Ohio with a master’s degree in business logistics and finance. I entered the life sciences industry in 2000 as part of the great medical device manufacturing team at Edwards Lifesciences.

Dan:  I’ve been an engineer for more than 30 years.  I’ve had a colorful career with a lot of great experiences.  I was fortunate to get my master’s degree in chemical engineering, which has given me more depth in my technical skills.  In addition, my 18 years with DuPont were great to broaden my skillset and address the more practical aspects of statistical and mathematical modeling, heat transfer, and thermodynamics.  As a founder of Modality Solutions, I’ve worked with almost every client, giving me a solid base in the biopharmaceutical industry.

5. Where is your favorite place in the world and why?

Gary: My favorite place in the world is blue water sailing anywhere in the world. I do not get out on the water as much before, but I take any chance I get to recharge out on the ocean.

Dan: My father and I have gone fly fishing together for more than 40 years.  The one vacation I manage to get is to travel to the Bighorn Mountains or Snowy Range in Wyoming.  Of course, I go in July and August, so there isn’t (much) snow, but the scenery is beautiful, and the fishing is pretty good too!

SPOTLIGHT INTERVIEW WITH JACOB JEWISON, ELECTRICAL ENGINEER AT NIDEC-KATO ENGINEERING

A conversation with Jacob Jewison, Electrical Engineer at Nidec-Kato Engineering

Jacob graduated from Minnesota State University, Mankato with a bachelor’s degree in Electrical Engineering, and has 6 years of experience with Nidec-Kato Engineering working as an Electrical Engineer.

1. What do you hope the audience will learn from this webinar?

I hope the audience will gain a better understanding of what certain machine characteristics are as well as what factors drive them.

2. What discussions do you look forward to having with the audience?

I look forward to discussing reactance requirements and motor starting.

3. What do you enjoy most about your role?

I most enjoy when a customer comes to us with a requirement that hasn’t been solved before, and I get to develop a new design that will fulfil the requirement.

4. How did you get into the industry?

I’ve had an interest in electricity since the 4th grade when in science class we made simple circuits using batteries, switches, light bulbs and motors. This interest led me to pursue a career as an electrician after high school.  Wanting to learn more about electricity, after a couple years I decided to go to college for electrical engineering.  After my first year of college it was my experience as an electrician that landed me an internship here at Kato in the insulation lab building and testing sample coils.

5. Where is your favourite place in the world and why?

My favourite place in the world is out on the hiking trails near Lake Superior in Northern Minnesota, because it’s great to get away from the technology from time to time.

Join Jacob Jewison on the webinar entitled ‘Generator Jargon‘ Nidec – Kato Engineering & Leroy-Somer on 16 July at 3PM London/10AM New York.

SPOTLIGHT INTERVIEW WITH GARETH EVANS, SENIOR FRAUD AND FINANCIAL CRIME PREVENTION CONSULTANT AT BAE SYSTEMS

A conversation with Gareth Evans, Senior Fraud and Financial Crime Prevention Consultant at BAE Systems

1. What do you hope the audience will learn from this webinar?

I hope the audience will gain an appreciation of the challenges and opportunities from the evolution of banking in particular around the challenges of customer experience against security.

2. What discussions do you look forward to having with the audience?

I’m interested to understand different perspectives around the best way to secure the bank in the most open way possible.

  1. What do you enjoy most about your role?

Going out and meeting customers and industry professionals and getting different perspectives on the various challenges we face.

  1. How did you get into the industry?

Right place, right time. I was starting my career at a bank when the internet came into our lives, as a result I started getting involved in internet banking and the challenges that came with this new world. I didn’t know very much and neither did anyone else back then, so we learnt as we went and 20+ year later here I am.

  1. Where is your favourite place in the world and why?

Too many to pick one. I loved driving down the Pacific Coast Highway in California, I love Sydney Australia (where I am lucky enough to be moderating an event at the end of July) and many other cities around the world (which is a good thing as this role has me spending a lot of time travelling).

Join Gareth Evans on the webinar entitled ‘How to strike the right balance between reducing fraud and creating a frictionless experience for your genuine banking customers‘ BAE Systems on 20th June at 10AM London/11AM CET.

Spotlight Interview with Paul Stone, Product Evangelist at FlowForma

A conversation with Paul Stone, Product Evangelist at FlowForma

 

With 27 years’ experience in the IT industry, Paul is a highly accomplished IT professional who has been involved in a vast array of projects, delivering bespoke SharePoint and .Net solutions, incorporating workflows, data gathering and reporting.

 

 

What do you hope the audience will learn from this webinar?

I know our community love to hear real world examples of how organizations are automating processes and accelerating digital transformation. I’m hoping our audience will enjoy hearing from our customer James Morgan, IT Manager of the A14 Integrated Delivery Team (a £1.5bn joint venture between Costain, Skanska and Balfour Beatty), he has great practical examples of what digital transformation really means – on the ground, here-and-now, in the cut-and-thrust of busy working days.

 

The theme of this webinar will be dominated by Automation, Visibility & Mobility, primarily discussing how the A14 brought complicated paper-based processes such as permission to dig, site visit request forms and labor requests online. This was achieved by implementing a no code Process Automation technology platform, into what is one of the largest road construction projects running in the UK.

 

The key learning objectives of this webinar are:

  • Learn why the time is right for process change
  • Learn how the A14 Joint Venture is automating large amounts of document generation, while centralizing and standardizing data across projects
  • Discover how the A14 joint venture rapidly deployed multiple processes, and increased efficiency and governance with a full audit trail
  • Hear how the intuitiveness and rich features of FlowForma’s no code process automation tool, make it very adaptable and easy for everyone to use

 

If you’re looking to utilize the power of a process automation tool, this webinar is perfect for you.

 

What discussions do you look forward to having with the audience?

James and I are looking forward to discussing common challenges that the energy and engineering sector are facing such as manual processes, excessive paperwork, logistical challenges etc. I’m excited for James to share how he overcame these pain points and more by automating processes with the no code FlowForma Process Automation tool for Office 365. James is keen to show attendees how they automated processes such as permission to dig and targeted risk monitoring. I’ll also give attendees a short demo of the FlowForma Process Automation tool. We’d love to make the webinar as interactive as possible, so please send us any questions you have for us to info@flowforma.com or just raise your hand during the webinar.

 

What do you enjoy most about your role?

I enjoy working with customers and prospects, understanding their challenges and finding ways that FlowForma Process Automation can improve their situation. I love helping organizations transform their ways of working and increase productivity through innovation.

 

How did you get into the industry?

I was interested in computing since childhood and my childhood hobby turned into a career! I joined the founding team at FlowForma after spending many years delivering bespoke data and workflow solutions in large organizations. I knew the pain of traditional software delivery methods and wanted to promote a new no code approach to empower business managers – now I get to help people.

 

Where is your favourite place in the world and why?

I have visited and worked in many places around the world, I’m always keen to experience new cultures. My favourite place is my homeland of Ireland, our people have a lot to offer and it’s so accessible! I’m lucky that I get to travel a lot in my role, visiting prospects and customers across the US, UK and Europe.

 

How To Take The Fast Lane To Process Perfection

 

On May 30th 2019, FlowForma and Business Review Webinars will co-host a webinarHow To Take The Fast Lane To Process Perfection’ with James Morgan, IT Manager of the A14 Project.

The theme of this webinar will be dominated by Automation, Visibility & Mobility, primarily discussing how the A14 IDT (Integrated Delivery Team) brought complicated paper-based processes such as permission to dig, site visit request forms and labor requests online. This was achieved by implementing a no code Process Automation technology platform, into what is one of the largest road construction projects running in the UK.

Putting into Perspective

A14 IDT

To understand the scale of this initiative, the A14 is a 31 kilometer stretch of new road being built between Cambridge and Huntingdon at an estimated cost of £1.5 billion. This joint venture has saw several large construction companies come together with Highways England to deliver.

Their key pain points were:

  • excessive paperwork
  • lost documents
  • distributed workforce
  • logistical challenges
  • poor governance

Interestingly, their number one reason for choosing the appropriate technology platform to solve these pain points was no code. Of course, costs play a factor – they always do – but the ability for their project teams to be empowered to build their own ‘process templates’ for one joint venture, to then lift and deploy them into other projects was a huge benefit.

Addressing the Pain Points

So how did the A14 approach the implementation?

So how did the A14 approach the implementation? They identified a key organizational specific process that was a real pain point for the project at that time – Permission to Dig. This process is typically an approval request procedure that involves downloading a document, filling it in, and sharing it with the team, however with FlowForma Process Automation this is now an automated and seamless electronic process – cutting out paper and saving time for employees across the site.

They then built a proof-of-concept, demonstrated this to the business and then built the process to go live. The wider organization quickly saw the benefits of this but then came all the new process project requests!  A key issue for James and the team then was prioritizing the process automation projects. They established a small cross-functional team across the business to agree priorities.

They then set out a number of criteria to measure each of these requests (e.g. potential Return on Investment / effort to build etc.) and then went from there. They also trained up other ‘superuser’ staff within the wider business to empower them to support the building of the processes, with IT providing the training and guardrails.

This is an approach we hear consistently from our most successful clients. ‘Land and Expand’ with your process automation projects and then empower the people who know the processes the best, while providing the right support structures.  

By Paul Stone

Join Us

This webinar is free to attend but registration is compulsory, secure your complementary place today.

Register here.

Global Counterfeiting: Alive and Kicking

Last year’s Global Brand Counterfeiting Report estimated that the counterfeiting industry worldwide will reach $1.82 trillion by 2020. This study also concludes online counterfeiting sales have robbed legitimate industries of $323 billion in 2017 alone.

“The report explicates that the problem of counterfeiting is long-standing and is growing more and more in scope and magnitude. The government and business organizations are concerned because of the adverse impact of such illicit activities. Counterfeiting also poses threats to the welfare of consumers, along with that it also disrupts the whole society on various levels and harms the reputation of the businesses.“

What industries and geographies are most susceptible? If you have a successfully designed, manufactured and globally (or even regionally) distributed product, someone will look to take advantage and counterfeit your product. Pharmaceuticals, toys, cosmetics, beverages, replacement parts, electronics and every other major manufacturing category are affected. And the consequences to the revenue, reputation and the safety of the consumers duped into buying fakes are exponential and heavily documented.

To help fight this, several studies show that brands are investing over $100 billion annually on anti-counterfeiting technology that gets added to packaging. But all of this spend on measures like holograms, special inks and other additive items is just not stopping the global wave of product counterfeiting. The reason is simply because counterfeiters are getting faster and smarter and the technology that most brands use has yet to evolve and outpace these bad actors.

This is precisely why Systech invented and introduced its digital e-Fingerprinting and authentication solution. Despite the numerous measures brands are putting in place to thwart counterfeiting, it continues and is a growing threat. Most compelling to me is the solution’s non-additive, covert nature—deriving a product’s unique identifier—its e-Fingerprint®—from the existing package itself.

Counterfeit organizations could never replicate this measure, thus making it a trusted solution to protect brands from the safety and bottom-line pitfalls of being counterfeited. The e-Fingerprint is based on an existing barcode on packaging and stored in a bank-safe secure cloud environment. This makes it completely immune to counterfeiting.

Smartphone-enabled field authentication by inspectors and even consumers on products protected with the digital e-Fingerprint will immediately detect counterfeit products. This can lead to much quicker investigation turnaround to discover and stop the parties responsible. Not to mention the consumer safety benefit of discovering counterfeit products sooner rather than later.

Are you ready to take your brand protection strategy to the next level to totally outsmart counterfeiters by using nothing but your existing packaging label?

Written by Steve Tallant

Tune into our webinar on April 17th to learn how you can keep your products authentic, safe and connected. You can change everything… without changing anything.

Register Here!

Dave Dejean – SVP Strategic Initiatives, Systech

A conversation with Dave Dejean, SVP Strategic Initiatives, Systech

 David DeJean is responsible for Systech’s strategic initiatives, which support and educate customers with proven offerings and best practices for implementing Enterprise Serialization, Track & Trace and Authentication solutions. DeJean brings a wealth of market knowledge, hands-on experience in solution design and development, and project methodology. His role includes staying abreast of international regulations, business and industry drivers, defining high performance project outcomes, and delivering cost-effective solutions that are integrated and expandable to meet future needs as market dynamics fluctuate.

BRW: Key strategies brands should keep in mind for protecting their products from counterfeiting and diversion across the supply chain:

Always stay focused on protecting your genuine products as they travel across the supply chain. Counterfeiting is now the largest criminal enterprise in the world and no product is immune to the ravages it can cause. Product diversion is also a major problem for many manufacturers and can eat away at brand and revenue protection.

There are many different types of product authentication solutions in the market. Many are “additive” labelling solutions such as taggants, holograms, special inks, and more, in addition to a label’s barcode or data matrix. Some help, some are flawed. There’s more that can be leveraged with an existing product’s packaging. Innovative technology is already being used by major global brands across industry to better track products in the supply chain and secure product safety.

BRW: Why is supply chain innovation so important for brands to stay focused on? 

Because you cannot fight new battles with old weapons, brands must continue to innovate. Product safety is key. Protecting the supply chain from counterfeiters has been on the regulatory agenda for a long time because counterfeiters are getting smarter and can replicate almost anything.

For example, the pharmaceutical industry has witnessed the implementation of compliance regulations to help combat the threat of falsified medicines and protect patient safety. But compliance does not equal brand protection or anti-counterfeiting. The problem is only getting worse on a global scale and is impacting many other industries including wine and spirits and cosmetics.

BRW: What do you foresee as being the biggest game changer in supply chain technology in the next few years?

New, all-digital approaches that connect physical product to digital records is a trusted solution that enables cross-supply chain mobility using technology such as Systech’s e-Fingerprint®. This also means that emerging technologies like blockchain can be employed, which combine digital identity with authenticated and trusted physical product identity offering complete visibility and more robust information and data capture, which can be used for competitive advantage.

BRW: Who is Systech?

Systech is revolutionizing brand protection. For over 30 years, global brands have relied on its advanced software to combat counterfeiting, prevent product diversion and meet regulatory compliance. Innovation is deeply ingrained in Systech’s DNA—from its start-up roots in advanced machine vision to pioneering pharmaceutical serialization and transforming traceability and non-additive authentication. Systech’s software solutions keep products authentic, safe and connected across the supply chain—from manufacturing to the consumer’s hands.

Join Dave DeJean on a webinar entitled ‘Secure Your Supply Chain with Authentic, Safe and Connected Products‘ by Systech on 17th April at 3PM London/10AM New York.

Register Here!