Dr. Cynthia Wooge has been in pharmaceuticals for over 20 years and is now responsible for the ADC and bioconjugation markets, as Manager Global Strategic Marketing for SAFC. Previous roles include 15 years managing Process Development with a focus on antibody drug conjugates, therapeutic proteins, and bio-organic polymers, as well as in project management and business development.

 

Dr. Michael Bienkowski has 28 years experience in the pharmaceutical industry related to discovery and development of both small molecule and biologic drugs in multiple therapeutic areas. In his current role as Manager Process and Analytical Development, he leads the SAFC Bio-Conjugation Center of Emphasis which includes the development and production of Antibody Drug Conjugates to enable clinical evaluation.

 

Are You Developing the Next Cure for Cancer?

If you are working on an ADC – an antibody drug conjugate – it’s a good chance you are.  How exciting is that to be able to say ‘YES, I am working on a cure for cancer’!  Ever since I was a young girl, I wanted to be involved in pharmaceutical development because I wanted a way to have my love of science help others have a healthier, disease-free life.  ADCs offer the promise of that ‘magic bullet’ – a way to treat cancer without the fear about cures that are worse that the disease.

Other than the joy of science, what gets me up in the morning? My family is very involved in hot air ballooning, so we see a lot of beautiful sunrises when the weather cooperates!  My husband, younger daughter and I are all pilots and have had the fortune to fly our balloons all over the US.  Also, I am very active in mission work through my church helping communities recover and rebuild from natural disasters.  I relax by spending time with my family, cooking, and playing handbells in choir when my work and travel schedule allows.  Mike also enjoys spending time with his family and traveling, and relaxes during his down time by playing ice hockey and guitar.

Both Mike and I have been involved in the pharmaceutical industry for over 20 years and have seen many advances in technologies, analytical tools, and regulatory strategies. Working for a leading CMO enables us to use our skills and expertise in a wider variety of therapeutic areas, and transfer those skills across disciplines. At our site in SAFC, we have biologists, biochemists, organic chemists, and analytical scientists all working within the same Process and Analytical Development group. It enabled us to readily take our existing knowledge of bioconjugates and apply it to the newly emerging field of ADCs when we first entered this arena in 2007.  Since then we’ve made over 130 batches of ADCs, with half of those being used in clinical trials and the others for use in development. Building a solid knowledge of the process chemistry and controls and along with characterization of the product, we can make your ADC very reproducibly upon scale up.

To get a preview of what you’ll hear in the webinar, check out the links to these papers and podcast:

“Process Challenges of Antibody-Drug Conjugates”, published by BioProcess Int’l

“Playing it Safe”, published by IPT Online

“Successful Strategies in the Development and Technology Transfer of ADCs”, published by ADC Review

“Comprehensive Approach to ADC CMC”, presented by Mike during BDP Week S.D. last Spring

Mike and I are hoping that this webinar on “Successful Strategies in the Development and Technology Transfer of Antibody Drug Conjugates” will help jump start your discovery programs or provide guidance as you progress through development of your clinical trial material.  You will need to register for the seminar to gain access.  Looking forward to having you join us on September 4 and hearing your comments and questions!

Please connect with us on LinkedIn!
Cynthia Wooge
Mike Bienkowski
SAFC

 

  Praveen Nagpal,

Global Product Application Specialist, Power Engines, Shell

Praveen has 20 years of experience working with power engines. After working for 12 years with an engine OEM in field service, operation & maintenance and technical services of power engines, Praveen diversified to the lubricant sector in 2007 and joined Shell in 2008. 

Since 2012, Praveen took on the responsibility of Global Product Application Specialist for stationary power engines and is responsible for managing relationships with key OEMs globally. Praveen works closely with sales & technical service teams and engine operators, providing guidance to identify, anticipate and resolve application problems concerning engine oils, and help optimise their operations.

1. Why did you decide to do a webinar with Business Review Webinars?

Webinar is an excellent forum which provide an opportunity to connect with large community with similar interest which is some time difficult to achieve through individual seminars or interactions due to resource constraints.

2. What are you looking forward to explaining to the audience?

Understanding the need of gas engine operators using Bio Gas a as a fuel, Shell has developed a dedicated gas engine Shell Mysella S5 S for Bio Gas engines. Our experiences has shown benefits to its users in terms of longer oil life, prolonged maintenance interval compare to conventional gas engine oils. This webinars offers a good opportunity to convey the key messages to larger end users of Bio Gas engines benefits of using a good quality gas engine oil and its relevance in optimizing operation of Bio Gas engines.

3. What is the ideal outcome you would like from doing the webinar?

Though this webinar, we expect the users of Bio gas engines to understand the role of a good engine oil for bio gas operation and how it can help in optimizing cost of their operation.

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

Though I travel to various part of World, India my home country is still my favorite place. It’s a unique place with integration of different cultures, climates, languages, lifestyles, food.

5. What motivates you?

Meeting end users of our product to get their inputs about performance of our products, identifying opportunities for new developments and finally their trust and confidence towards Shell.

Praveen Nagpal will be presenting the Shell webinar ‘Improving Operational Efficiency of BIog-Fuelled Engines’ on the 10th July at the following times:
3pm London / 10AM New York
9am London / 4pm Singapore

 

 

Paul Bird works for FUJIFILM Diosynth Biotechnologies as Head of Manufacturing Engineering Group where his responsibilities include the transfer of technology and processes from R&D to cGMP operations. Paul has a PhD in Biochemical Engineering (University College London) and recently completed the Supply Professionalism Programme at Warwick University. 

 

 Why did you decide to do a webinar with Business Review Webinars?

A project to automate a single-use closed final filtration and bulk fill operation carried out in collaboration with Parker domnick hunter raised a number of interesting and important issues that had to be addressed. Business Review provides the perfect forum  for a discussion within the industry around what best practice means in this case. 

What are you looking forward to explaining to the audience?

As a biologic API (drug product) process development and manufacturing organisation FUJIFILM Diosynth Biotechnologies is growing through the transformation of operational learning into smarter innovations and doing this faster in order to create a competitive edge from which we can meet our customers needs. This capability is required by our customers to meet the emerging challenges of modern health care systems where there is a demand not just for better quality but also better access to advanced biologic medicines.

Presented is a case study integrating automation with single use technologies to achieve site standardisation of bulk drug product final filtration and pack-off. This was achieved in a way which enhances quality compliance in support of right first time manufacture yet remains, by-design, flexible such that customer requirements are always fully met.   

What has been the best moment in your career?

As an employee of FUJIFILM I got to study at WMG, a department of the University of Warwick, assessing the effectiveness of the supply chain to generate customer value. One outcome of this study was the development of an innovative training and guidance system called ‘TAG’ which was short listed for the IChemE Awards for bioprocessing and won the NEPIC Award for Sustainable Manufacturing. 

The application of the TAG system to underpin compliance and right first time manufacturing is presented demonstrating its use to facilitate and strengthen the partnership with Parker domnick hunter so that the supply of operational knowledge is equal to that of other deliverables e.g. consumables. 

How do you relax in your leisure time?

I am a keen supporter of the Woodcraft Folk (http://woodcraft.org.uk/) a movement for children and young people to play and grow. Supporting and leading an Elfins group for 6 to 9 year olds is a lot of fun. Through our activities, outings and camps we better understand important issues like the environment, world debt, global conflict and, in recent years sustainable development. By encouraging children to think, we hope they will help build a peaceful, fairer world. We always welcome new supporters! 

Where would you recommend visiting in the world and why?

The best kept secret is the Northumberland Coast in North East England. The wind-buffetted beaches along this unspoilt coastal stretch seem to go on forever. With enchanting salt marshes, undulating sand dunes, and the boundless, shimmering blue of the perma-choppy North Sea, there couldn’t be a more fitting setting for a spot of wild camping. Some of the beaches are so enchanting I really must not tell lest the secret get out! 

Paul will be presenting the webinar alongside Nick Hutchinson, Market Development Manager, Parker domnick hunter on the 25th June at 3pm London. To learn more and register click here.

Jude Mason,

Director, Client & Product Services, NSF International

Jude has overall accountability for our UK and European trading law team and services provided to our clients in the retail and food service sectors. She is a specialist in food safety and technology with over 20 years’ experience in the retail food industry, covering product development, private label programme development, product launches, supplier auditing and supplier and product quality assurance. Jude also leads our client account management for larger global and multi-market clients, working in close liaison with our teams in the U.S., Europe, the Far East and Latin America.

1. What are you hoping to achieve from the webinar? 

People to attend and listen!  Once they are on the webinar I hope that people get a greater understanding of a challenging topic.

2. What are you looking forward to explaining to the audience?

The joys of FSMA and how all countries who go through legislative changes do not have all of the answers.

3. How did you get into the food industry? 

I love eating so it was a natural progression.  I completed a degree in food manufacture and the rest is history.  I got the food bug!

4. Where would you recommend visiting in the world and why? 

Grand Canyon, it combine natural wonder and space with a real sense of how small and insignificant we really are.

5. And finally…

Beach or skiing? Skiing
Gin or whiskey?  Gin
Sky dive or bungee jump? Sky dive

 

Frank Schreurs,

Global Managing Director of Consulting & Technical Services, NSF International

With over 29 years experience in quality and food safety management, training, auditing and consultancy, Frank works closely with many companies, national associations and NGOs to provide risk management solutions, developing and implementing HACCP systems, and training management and staff on food safety and risk assessment principles.

1. What are you hoping to achieve from the webinar?

Communication and outreach to the UK market and how NSF as U.S company can bring solutions and knowledge to that market.  Also hope to leverage my personal experience in Canada as the largest exporter of food products to the U.S. as a benefit to UK/EMEA clients.

2. What are you looking forward to explaining to the audience?

Awareness of the verbiage and/or language of FSMA and how it aligns or differs from current UK & EMEA practice.

3. How did you get into the food industry?

Its always about who you know.  I got an opportunity right out of University to work for the Kellogg Co. who were good at investing in their people. They were also investing a lot in technology so gained a lot of experience real fast on operational efficiencies associated with technology and food safety.

4. Where would you recommend visiting in the world and why?

I agree with Jude on the Grand Canyon.  A very awe inspiring experience!

5. And finally…

Beach or skiing? Beach
Gin or whiskey? Whiskey
Sky dive or bungee jump? Bungee Jump

 

Dominic Watkins,

Partner and Head of Food Group DWF

Dominic specialises in both contentious and non-contentious regulatory issues in three primary areas: food law, trading standards and safety advising household name retailers and food manufacturers. He has spent a significant amount of time on secondments to some of the UK’s best known retailers and food businesses, advising on a range of issues including food law. This experience has provided him with a clear understanding of the role that legal advice plays in making a commercial decision.

1. What are you hoping to achieve from the webinar? 

The FSMA is a significant change in the way that the US regulates the food industry and it is important that we all consider the practical challenges and opportunities that it provides.   I hope to help with this process and perhaps get a little insight from our North American colleagues about how it looks from their side of the pond.

2. What are you looking forward to explaining to the audience?

I will be focussing on what this is means for a EU audience familiar with the requirements of EU and highlighting some of the areas where there are similarities and others where systems will need to be adapted .

3. How did you get into the food industry? 

I have spent my whole career advising the food and food retail industries.  I love it as the issues are things that are real to us as consumers as well as being people in the industry.

4. Where would you recommend visiting in the world and why?

The USA – so many different experiences – it literally has something for everyone.  My favourite places are the national parks of Utah and also the Portland area of Oregon.  Both areas of incredible natural beauty.

 5. And finally…

Beach or skiing? Beach
Gin or whiskey? Neither, but I guess Gin over Whiskey
Sky dive or bungee jump? Sky dive

Jude, Frank and Dominic are presenting their webinar ‘The six essential steps to FMSA compliance’ on the 14th May at 10am New York/3pm London. Click here to register.

 

 

Cheryl Johnson is currently Global Business Development for PantoneLIVE, across Esko, X-Rite & Pantone. She has 26 years experience in the packaging and prepress industry spanning two continents. Starting her career in the repro house of England, and progressing to production/operations management in the US. She joined Esko 10 years ago in a sales capacity, spending the last two years at X-Rite Pantone being immersed in color, and heading up sales efforts during the launch of PantoneLIVE.

 

1. What is the most informative fact of the webinar?

That it is possible to achieve color consistency, there is effort that has to go into it, taking control of the color and the process is essential , however by embracing today’s technology and the digital world we live in, it is possible.

 2. Who or what was your inspiration for getting you into this industry?

I don’t remember, it was a long time ago… I think I always wanted to be a designer, and then discovered I really didn’t have the imagination for it. But I was very good at taking something and making it better. Like prepping a design for press, or mechanical artwork, so I fell into the pre-media side.

3. What’s the most interesting thing you’ve done within your current role?

It’s all interesting, I’m in color, for me this was always the most exciting part of packaging, and now I get to focus on it. I still find it exciting to call on Brands on whose products I use, and to see things on shelf I was involved with, I also get to travel quite bit which can be fun.

4. How do you relax in your leisure time?

I like to read, preferably on my swing chair in the garden… I’ve just spent 6 months reading the first 5 Books from a Song of Ice & Fire (Game of Thrones), I like to plant things too, love being outside, hanging with friends, driving my sports car.. I’m about to go exploring around Peru for a week.

5. And finally …

Porsche or BMW? Maserati!!

Laptop or Tablet? Laptop, if it’s a Mac

Red or white wine? I prefer Beer

Soccer or tennis? Tennis

You can register for for Cheryl’s upcoming webinar ‘Color Everywhere (and everywhere the same)’, which takes place on the 22nd May at 10am New Ytork/3pm London by clicking here.

Sri is a Silicon Valley entrepreneur and software executive. Sri is currently Vice President of Product Marketing at Intralinks, the leading beyond the firewall collaboration solutions provider for the life science industry. Before this he spent several years advising innovative technology start-ups such as Immunetech. Sri co-founded and served as President & CEO of Content Circles which provides a cloud-based solution for secure cross-company file sharing.

 

1. Why did you decide to do a webinar with Business Review Webinars?

Over the past few years, life sciences companies have been shedding core competencies and relying more on strategic outsourcing to streamline and augment their development efforts and go-to-market strategies. As a consequence, it has become essential for critical information to be shared with external partners in a timely, traceable and efficient way. In this talk, I’d like to share my thoughts on the challenges, as well as the benefits, of using cloud-based collaboration solutions for the purpose.

2. What are you looking forward to explaining to the audience?

A typical life sciences company has a myriad of external collaboration needs, from highly structured clinical trial management, to ad hoc content sharing between its employees and partners on a day-to-day basis. And there are over a hundred cloud-based collaboration solutions to choose from to address these needs! With so much choice, the enterprise has a critical choice to make: Adopt multiple point solutions or a single platform, to address its external collaboration needs. In this presentation, I’ll examine the pros and cons of both approaches, and propose a framework for choosing the right approach for any enterprise.

3. What is the ideal outcome you would like from doing the webinar?

First, I’d like to get in touch with the audience to better understand how they use cloud-based collaboration technologies to accelerate productivity of R&D processes while protecting their IP.  Second, I’d like to show the audience how they can indeed address all of their external collaboration needs with a single platform, securely.

4. How do you relax in your leisure time?

Whenever time permits, I like to be outdoors jogging or biking, and playing tennis with our two boys (17 and 13 years old) and board games with our daughter (9 years old).  I also enjoy reading books, generally biographies of economists and politicians.

5. What motivates you?

What motives me most is “doing the impossible” with a set of dedicated and like-minded people, whether they are colleagues, customers or partners. It all started out in college and then continued on in my career when I was fortunate to have had great mentors and colleagues who enabled me to do “impossible” things.

Sri will be presenting Intralinks’ webinar ‘Facilitating R&D Collaborations through the Cloud’ on 5th June at 3pm London time. Click here to see more details and register your place. 

As VP of Solution Strategy, Paul heads the overall strategic planning for the various market verticals and scientific domains that IDBS works in. By working both internally across IDBS and externally with customers and partners, Paul is charged with the exploration and creation of new products, solutions and service offerings. He joined IDBS in 2005 as part of the acquisition of his ELN company and has spearheaded the drive to make E WorkBook Suite the market leader. 

Prior to this, Paul founded a number of companies focused on combining science, technology and business. He started his career as a Post Doc and subsequently Senior Scientist at Sanofi-Synthelabo Toulouse (now Sanofi) for just under five years, where he managed a multidisciplinary molecular and cell biology department.

Paul obtained his PhD in Computational Biology from Essex University in 1996, and has authored over 25 scientific papers and book chapters.

1.  Why did you decide to do a webinar with Business Review Webinars?

At IDBS, we feel it’s important not only to communicate about our innovation in products, but also to share our knowledge and expertise on the latest trends in the R&D industry. Through webinars, we find great value in the live interactive Q&A. This helps us to get better understanding of our audience’s needs and challenges. We really see them as mutual learning and enrichment.

 This is our first webinar with Business Review Webinars, we chose them because we have been quite impressed with the targeted audiences they have across all industries we are operating in – pharmaceuticals, biotechnology, chemicals, energy, engineering, food and beverage, and consumer goods – and all over the world.

2. What are you looking forward to explaining to the audience?

The way that IDBS and its technologies are able to bring transformational business benefits to R&D organizations across many industries. IDBS have deep domain expertise in many areas of science and technology. Our customers vary across so many different areas, and yet they always reflect the same messages – how we help drive innovation, deliver massive efficiency gains and develop methods to capture and really leverage IP in a way that it becomes a knowledge base.

3. What is the ideal outcome you would like from doing the webinar?

We would like to provide our audience with forward-thinking and relevant inputs on how to improve collaboration and productivity in R&D. We would like our participants to perceive us as ahead of the game and raise awareness and interest among participants who maybe did not know IDBS before. We are looking forward to sharing ideas and interacting with them.

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

My favorite place in the world…that’s a tough one to narrow down. It varies per continent – in the USA it is San Francisco – because of the climate and great landscape, scenery and attitude. In Europe, it is Toulouse, France – I lived there for five years, and I love the culture and the friendliness and welcoming people. And in Asia it is Tokyo, Japan – which is so efficient and safe but also very culturally different and intense and exciting.

5. What motivates you?

Making a difference, leaving something good behind and learning new stuff.

Register for IDBS’ upcoming webinar on the 28th May at 3pm London. Paul will be discussing how you can transform the way you do R&D in just 5 years! Read more here.