Tag Archives: Pharmaceuticals

David J Brayden, Ph.D., Professor of Drug Delivery, University College Dublin

david-j-braydenDr. David Brayden is Full Professor of Advanced Drug Delivery at the School of Veterinary Medicine and a Fellow of the UCD Conway Institute. He received his Ph.D. in Pharmacology at the University of Cambridge and did a post-doctoral research fellowship at Stanford University. Afterwards, he set up Elan Corporation’s pharmacology laboratory in Dublin, where he became a senior scientist and project manager. In 2001, he joined UCD as a lecturer in veterinary pharmacology and rose to the rank of Full Professor of Advanced Drug Delivery. His major research interests are in oral peptide delivery. He is the author or co-author of more than 200 research publications and patents. In 2012, he was inducted into the College of Fellows of the Controlled Release Society. Professor Brayden serves on the Editorial Advisory Boards of several peer review journals. Professor Brayden works as an independent consultant for drug delivery companies.

1.       What was your inspiration to get into the industry?

I am a bit unusual in a European context because I went from academia to the drug delivery industry and back again to academia over a 10 year period.  My industrial appointment at Elan drug delivery in Ireland in 1991 came out of an opportunity and good timing and a realisation that I had technical skills around the understanding of epithelial biology that could be leveraged in industry.

2.       What is your favourite part of presenting to a live audience?

If a presentation is going well and you are reaching most of the audience, you can feel the connection in the room – it can be very powerful and can allow a talk to hit heights that you do not get in a practice.  It is also gratifying if you get good questions, because this means that you have engaged well.  Of course this doesn’t always happen!

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

I want this audience to realise that there is still potential for oral peptide delivery to be successful, but that the field is in a more realistic phase of what can be done with peptides that are of lower molecular weight and are more stable than the candidates of the past. The era of platform delivery technologies claiming 10-20% oral bioavailability is from the 1990s, whereas the modern view is that we have some technologies that are specific for individual payloads and that 5% bioavailability could be adequate for some.

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

I travel a lot and almost have second home at Dublin airport, so usually on weekends I take a walk on my own down Dun Laoghaire pier in Dublin or out to the Wicklow hills with family and friends. No matter where I am during the week, the beautiful areas near my home are  where I aim to be during time off.

Join David as he discusses ‘Overcoming Barriers to Non-invasive Delivery of Macromolecules‘ in the Catalent webinar. Register now!

Dr. Thomas Hille, Pharmacist, LTS Lohmann Therapy Systems

dr-thomas-hilleDr. Thomas Hille is a pharmacist and obtained his postgraduate degrees from University of Bonn. He joined LTS in 1986. Currently he is heading a R&D lab developing TDS and oral thin films. Prior to LTS, he was with Knoll AG, Germany, heading a R & D lab developing solid dosage forms. Dr. Hille is co-inventor in more than 70 patents.

In the last two years he gave presentations in Marburg University, and Concept Heidelberg dealing with the quality by design (QbD) concept in the development of TDS and he was speaker in the A.F.E.R.A. congress and A.W.A conference presenting the pharmaceutical requirements in pressure sensitive adhesives and release liners, when used in TDS.

What was your inspiration to get into the industry?

During my education I got the opportunity to join an R & D lab of Henkel in Düsseldorf as a workshop student and was assigned to work in industrial R & D.

What is your favourite part about presenting to a live audience?

Presenting to a live audience gives you real-time feedback without any delay. This allows you to immediately understand whether or not you are doing a good job whilst presenting.

What will the audience gain from attending your webinar?

TDS are a niche within the pharmaceutical business and so is the knowledge about adhesion and pressure sensitive adhesives. The audience will gain an understanding which kind of physicochemical properties make a polymer a pressure sensitive adhesive (PSA).

Why is it important for the audience to understand the requirements for Pressure Sensitive Adhesives?

The knowledge about TDS in general and about PSAs in specific are key when developing a TDS. The understanding of polymer chemistry and hands-on experience is an important basis to fulfill those challenges.

Where is your favourite place in the world and why?

My favorite place in the world is the Rhine Valley from Basel up to Rotterdam and Antwerp, as this region is the back bone of the chemical and pharmaceutical industry in all of its facets.

Be sure to join Thomas and LTS in their upcoming webinar, “Transdermal Delivery Systems: What are the Requirements for Pressure Sensitive Adhesives?”. Register now!

Dr. Gerallt Williams, Director Scientific Affairs, Aptar Pharma

Dr. Gerallt WilliamsAfter obtaining his Ph.D. from the University of Wales, UK in 1985, Gerallt has held various industrial positions at Monsanto Inc. (UK), Fisons Ltd (UK), Valois (France) and Inhale/Nektar Therapeutics (USA).

Gerallt is now in charge of scientific affairs for the Aptar Pharma Prescription division, Le Vaudreuil, France and is engaged in the development of new devices for nasal, inhaled and injectable drug products.

What made you partner with Business Review Webinars?

Aptar Pharma wanted to reach out to a more global audience in order to share our enthusiasm about intra-nasal drug delivery which is a relatively new drug delivery approach and creating a webinar in partnership with BRW offered us the possibility to achieve this goal.

What do you enjoy the most about your role?

Developing new products that will hopefully bring some relief to patients suffering with difficult medical conditions is ultimately what we are trying to do day in and day out in our roles in the drug delivery industry – the enjoyment is in the journey.

What is your favourite place in the world and why?

I’m Welsh and I’ve been living in various countries during my career including Wales where I was born and grew up, England, the US and France. I feel well in France because I can enjoy a variety of unique experiences … while being so close to the UK!

What about nasal drug delivery are you most looking forward to sharing with the audience?

Although nasal drug delivery is somewhat of a niche area in the pharmaceutical industry we hope to share with the audience the future potential of this drug delivery approach, how ground-breaking and innovative research is being pursued with the possibility to open up a brand new way to treat some very serious and debilitating conditions which are predicted to become more prevalent over the coming decades.  Intranasal route is simple to access and non-invasive, it can be versatile (self-administration vs third-party’s-administration) and used for local and systemic/CNS nose-to-brain treatments – “The nose is the only natural corridor where the brain meets the outside world”.

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

The webinar is part educational, part setting the scene in the market place and part science and technology. Hopefully the audience will find some new information by participating in the webinar and may be able to identify opportunities for developing products for some of the unmet medical needs in this area via the nasal drug delivery approach.

Join Dr. Williams in the upcoming Aptar Pharma webinar: The Nasal Drug Delivery Journey: from Systemic to Nose-to-Brain? Register Now!

Tim Moran, Director Life Science Research Product Management, BIOVIA

Tim MoranTim’s early research in the industry focused on Immunomodulation and Imaging to study of effects on T-cell lymphocyte homing. He held several managerial positions in Image Informatics and came to the organization in 2006 to begin work as Director of Image Informatcs. His role has expanded over the years to include Life Science Research Marketing and Product Management for Assay Management, Next Generation Sequencing, Sequence Analysis, Biotherapeutics, and Bio Registration.

1. What are you looking forward to discussing with the audience?

So many pharmaceutical and biopharmaceutical organizations are increasing their focus on biotherapeutic drug development in order to remain competitive in the market. Unfortunately, this can backfire when these organizations don’t take in to account the resources required for managing the additional complex data and processes involved. This can increase exposure to compliance risk, decrease overall productivity and extend the time to market for new products. I’m excited to have the opportunity to show the audience that there is a better way to not only manage, but leverage biologics data by eliminating inefficient paper-based workflows, reducing the effort for creating experiments, providing better understanding of processes and products, and much more.

2. You’ve mentioned that the biologics discovery workflow is similar to small molecule discovery at the highest level but that there are differences in the details. Can you explain what changes as an organization shifts toward biotherapeutic development?

In short, biologic discovery demands unique processes due to the added complexity of biological systems. Compared to small molecule discovery, biologics workflows generate a large amount and a large variety of complex data. However, being able to distill the information and track the genealogy of how to get to an end entity is critical. This requires some advanced data and workflow management.

3.  Why do you feel this topic is important?

In a recent market survey conducted by industry analysts IDC, it was shown that just 6 of the top-selling drugs in 2014 were biologics. In 2018 however, it’s estimated that over 50% of the top 100 prescription and OTC drug sales will be biologics. This clearly shows the strong industry trend shifting to biologics and with that industry shift, life science organizations will need a robust informatics solution to manage the increased complexity of biologics.

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

By attending this webinar, I hope the audience will see the true potential impact of transitioning from disjointed workflows and what has primarily been   a paper-based to an electronic Biologics solution covering all activities of the discovery process and how that positively affects their bottom line.

Join Tim in the BIOVIA webinar ‘Integrated, Predictive and Collaborative Workflows in Biologics Discovery‘. Register now!

Catalent Microsite: Resources for Solving Drug Delivery, Clinical Supply and Biologic Challenges

Catalent has recently launched their newCatalent_Image microsite within Business Review Webinars.

The site features recent Webinars, Videos and Case Studies detailing research across the full spectrum of challenges that pharmaceutical companies face with their pipeline molecules. Catalent is focused on helping their customers get more molecules to market by enhancing product performance and providing superior, reliable manufacturing results.

To learn more, please click here to be brought directly to the microsite.

Cyril Walsh, BIOVIA Sr. Solutions Consultant, BIOVIA

Cyril WalshCyril has extensive knowledge on the management of Quality and Regulatory affairs pertaining to automated content management. Cyril has implemented Quality based processes for the management of CAPAs, Deviations, Change Control and Complaint handling. Cyril also has in-depth experience in the services arena having previously worked for Accenture, before beginning his 13 year tenure at QUMAS, now part of BIOVIA, the leader in quality and compliance management solutions for the Life Science industry.

1. What are you looking forward to discussing with the audience?

The focus of our discussion will be defining a true Total Quality strategy and why it’s so critical for Life Science companies. We will give an overview of the challenges of implementing a solution for Total Quality as well as how to overcome them,  the required capabilities for  a Total Quality solution that spans the entire scientific product life cycle from ideation to commercialization and the benefits an organization will experience when implementing a Total Quality strategy.

2. You’ve mentioned that a Total Quality approach includes Quality Process Management, Quality Control and Testing, Materials Quality Management, Quality Document Management and Quality and Process Data Analytics. How would you implement these?

We definitely advise taking a phased approach for the implementation of a Total Quality strategy. Depending on the specific situation and the existing landscape of supporting systems the focus of the first stage can vary. While some of the areas are independent a QMS (Quality Management System) can be a good basis to go forward playing into all stages of the product lifecycle. Usually it is the core of the Total Quality strategy. And as consistent and traceable documentation is basic we recommend considering implementing a centralized integrated system for QMS and Document Management .But we should not forget that metrics are required to validate Quality and in Life Sciences consistent Quality Control procedures and processes are indispensable.

3. Is this topic only relevant for roles that are directly engaged in working with Quality?

Many capabilities play into the successful management and execution of Quality. This includes for example, the definition, documentation, submission, monitoring and management of quality related activities and tasks as well as the execution of quality tests. The BIOVIA approach will support the FDA mandate for deeper integration of Quality into end-to-end operations to design quality into products and processes as well as foster a quality culture across all areas of an organization from discovery to commercialization.

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

By attending this webinar, I hope the audience will which are the relevant aspects and capabilities and the true potential impact of a comprehensive Total Quality Strategy throughout the entire product lifecycle.

Join Cyril in the BIOVIA webinar ‘Bringing Your Total Quality Strategy to the Next Level‘. Register now!

Bruce L. Braaten, Regional Manager, Market Access, Covance

Bruce Braaten photoBruce currently serves as the Field Access and Reimbursement Director in the West Region. Mr. Braaten has over 20 years of experience in the biotech/device industry. Most recently he held positions with Roche serving in various leadership roles within the organization. Bruce brings experience as the Area Business Manager for the national Channel team for the purpose of building overall relationships, contract negotiations, securing coverage and reimbursement, and streamlining steps for smoother claims processing. He also held roles in leading field based teams, contracting with Managed Care Companies, sales leadership, project management and developing presentations for field use.

Bruce has a Bachelor’s Degree in Biology and has studied in areas of Healthcare administration, Healthcare policy, and Organizational Communication.

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

This is an important opportunity to present and discuss our Market Access directives which support and improve Patient Health.

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

Access is a challenging and a changing environment; however with the experience and overall knowledge of the market patients can receive the therapy their Health team prescribes they need.

3. How did you get into the industry and what do you most enjoy about your role?

My first experience in supporting patient access was on the medical device side for pain management. This confirmed in me how vital this type of role is and how strategy is crucial in care and coverage. My career has grown from Managed Care contracting; Distribution; patient support and sales leadership. My purpose in my work comes from the numerous successes of giving life back to individuals that are in great need and giving hope for a more fulfilling life.

4. What do you enjoy most about your role?

Currently my responsibilities include leading a team of Access Specialists in the West. This allows me the privilege of developing each individual with a greater skillset, to position our strategy for the purpose of patient care, and ultimately drive this ship in one direction.

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

Today it is Arizona where my Wife and Children are. Spending time with them recharges me. If it was a particular place; it would have to be Northern Minnesota on the lake.

Register now for our webinar with Bruce and his colleagues from Covance, “The Yesterday and Today of Market Access: Field strategy evolution“.

Roshani Poudel, National Field Director, Market Access, Covance

Roshani Poudel_ PhotoRoshani Poudel has over 9 years of reimbursement and market access experience at Covance as well as with other Biotech/Pharmaceutical companies. During these 9 years, Roshani has developed reimbursement strategies during different phases of product life cycle that encompassed successful launch of multiple In-house/Contracted Hubs, Patient Assistance Programs , Field Reimbursement Teams and Marketing initiatives. Roshani has also led multiple Market Access efforts to remove significant coverage barriers with Medicare, Medicaid, and Commercial Payers for various “Buy and Bill” products.

As Director, Field Market Access at CMA, Roshani is responsible for developing and managing a group of Field Managers who oversee teams that conduct field-based site visits and customer training to remove any access barriers. Roshani also serves as a strategic partner for clients to implement new initiatives and ensures that they are aligned with the clients’ vision.

Roshani has a B. S. in Business Administration from Alliant International University, San Diego, CA.

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

This is a great opportunity to discuss how Market Access strategy is crucial in providing patients access to the therapy they need.

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

I look forward to sharing some real-life cases of access challenges that were presented to Covance Market Access and how we were able to provide solutions to those challenges.

3. How did you get into the industry and what do you most enjoy about your role?  

My first experience in the industry was with Covance 9 years ago when I was hired as a program specialist. My primary responsibility was working with patients that required financial assistance and helping them access their medications through several patient assistance and referral programs. It was an eye-opening experience to see the number of patients that needed financial support and yet had very limited knowledge of all the available resources for them. It was very rewarding to work with patients directly and being able to walk them through the process which ultimately allowed them to obtain their much needed medications. Some patients even took time to send personal thank you notes with their stories and how the medications had help change their lives positively, which was a satisfying aspect of the role in a personal level.

4. What do you enjoy most about your role?

I mostly enjoy the diversity of responsibilities in my current role that allows me to wear different hats on a daily basis. While I represent Covance and follow our own ideals, I am also learning and adapting to each of my client’s strategies and values which keeps me engaged. I also enjoy team development and talent management.

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

Although I admire all historic cities around the world, Florence has to be on top on my list. From the narrow stone pavements that Da Vinci and Michelangelo once walked through to the distinctive architecture throughout the city, there is a reason why Florence is known as the “cradle of the Renaissance”.

Discuss “The Yesterday and Today of Market Access: Field strategy evolution” with Roshani in our webinar with Covance. Register now! 

William M. Fahey, National Field Director, Market Access, Covance

William Fahey_ PhotoWilliam works directly with the Field Managers and Field Reimbursement Specialists to ensure program
execution and strategic follow through based on client needs. In addition, he works as a strategic partner with the client to overcome hurdles and anticipate future opportunity specific to field team actions. He has directed teams within multiple therapeutic areas and lifecycle stages. 

Prior to joining Covance, Mr. Fahey has Over 15 years of experience in the pharmaceutical/biotech industry in various leadership roles within Sales, Sales Operations/Field Force Effectiveness, Marketing and Market Access. 

William has a BA in Philosophy/Political Science from the University of Arkansas.

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

I believe it is important to connect as an industry in order to address complicated issues that impact the ability for patients to access appropriate therapies.

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

I look forward to sharing opportunities that will address the above issues.  As access to therapies becomes more difficult, it is important to assess appropriate levers and partnerships that will potentially alleviate some of these market conditions and pressures for those involved.

3. How did you get into the industry and what do you most enjoy about your role?  

I spent several years both in sales and marketing within the tobacco industry.  This is what brought me into the healthcare sector.  Working on a daily basis and as a career on thoughts, processes and services that contribute to a person’s well-being is more rewarding than its polar opposite.

4. What do you enjoy most about your role?

Working with some of the top minds in the industry.  Learning and working on key issues that impact the industry on a daily basis provides a never-ending complexity that keeps a smile on my face.

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

While I enjoy the comradery and engagement on a daily basis, I very much enjoy the solitude of the desert environment regardless of location.  I will typically take an annual motorcycle trip to various locations in which I get the chance to reflect and decompress from everything.

Join William in the upcoming Covance webinar “The Yesterday and Today of Market Access: Field strategy evolution“. Register now!