Tag Archives: pharma

Rick Chan, PhD, Vice President, Research & Development at LTS Lohmann Therapy Systems

Rick Chanl

Dr Rick Chan is a pharmacist, who obtained his postgraduate degrees from the University of London. He joined LTS in 2011 and is responsible for oral thin film R&D work globally. Prior to LTS, he was a Senior Director with GSK and its legacy companies in Product Development, New Product Research and New Opportunities, most notably in Pain Management and Smoking Cessation. He has worked internationally in Australia, Asia Pacific, Japan, and in the USA, and was a member of the GSK Drug Delivery Technology Steering Committee.

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

It is a broader reach to a larger audience around the globe. This makes dissemination of information more effective. Apart from that, my business partner thinks it is a great idea!

2. What will the audience gain from attending your webinar?

Understand the potential applications of oral thin film and their suitability  when evaluating drug delivery systems for their molecules.

3. What’s your favourite thing about presenting to a live audience?

Engagement and interaction

4. Who or what inspired you to get into the industry?

I worked in community and hospital pharmacy in the summer vacations during my undergraduate years. I found them rewarding. When I was about to finish my final year of study, I was encouraged to apply and won an scholarship for my MSc in Pharmaceutical Technology at  University of London. I was privileged to have met my mentors – Prof Neiton Pilpel and Prof Mike Newton; both of whom became my academic supervisors at different stages in my PhD study. As they say, the rest is history!

5. What one item would you take with you to a desert island?

My guitar and sheet music.

Join Rick who will be presenting in LTS Lohmann Therapy Systems webinar ‘Oral Thin Films: New opportunities for oral drug delivery?‘ on 5th May at 3PM London/10AM New York.

Prof. Dr. R.H.N. van Schaik, PhD, Professor in Pharmacogenetics, Department of Clinical Chemistry

Prof. Dr. R.H.N. van Schaik

Ron H.N. van Schaik, PhD is a registered European Specialist Laboratory Medicine (2003) and Full Professor Pharmacogenetics (2013). He is working at the department of Clinical Chemistry (AKC) at the Erasmus University Medical Center (Erasmus MC) in Rotterdam since 1998. He studied chemistry at Utrecht University (specializations Biochemistry, Clinical Chemistry and Molecular Biology) and received his PhD in 1992. He was trained in molecular biology at Cold Spring Harbor Laboratories in New York. From 1992, he worked as post-doc at the Erasmus University (Dept. Endocrinology & Reproduction) and the Academic Hospital Rotterdam (Dept. Pathology, Dept. Clinical Chemistry) on translational research involving molecular biological testing. Currently, he is head of the AKC unit Specialized Research & Development (BO&O) and of the Pharmacogenetics Core Laboratory AKC.

Prof. van Schaik leads a research group on pharmacogenetics, in which the translation to implementation for patient diagnostics is the main topic. Current lines of research include Transplantation/immunosuppression, Oncology, Psychiatry, Pain treatment, anticoagulation and HIV. He has published over 150 articles on pharmacogenetics, and participates in national (NVKC, KNMP) and international (AACC, IFCC, IATDMCT, ESPT, IUPHAR, EMA) advisory committees on this topic. As a second line of research, he is involved in studies on new markers for the detection of prostate cancer.

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

I have been asked to be a speaker for this webinar on behalf of Luminex, as we are in close cooperation for pharmacogenetics

2. How did you get into the industry?

I studied biochemistry in Utrecht and learned molecular biology and wanted to focus on clinical use. Pharmacogenetics was just emerging so I started working on that during my residency at the department of clinical chemistry at Erasmus MC Rotterdam.

3. What do you most enjoy about your role?

Implementing new knowledge for a better cure of patients.

4. What has been your best holiday and where would you recommend visiting?

Sardegna, because of the weather, nature, kind people, good food and relaxed atmosphere.

5. What motivates you?

Improving people’s health.

Join Prof. Dr. R.H.N. van Schaik in Luminex’s Webinar ‘Pharmacogenetics in Clinical Practice: Can we still do without?’ on 6th May at 3PM London/10AM New York.

Stability Issues Related to Soft Gelatin Capsule Development

Procaps Webinar

Stability issues are a challenge and never ending concern for formulators. The reactivity of formulation depends on many factors, but it is generally recognized that labile drugs in aqueous forms are sometimes the worst case scenario, and this should be a true statement for the development teams that work with softgel development. Although product development has been described by many authors as a cycle, we would refer to it as a tower, where pillars are the preformulation phase. Most of the reference information about the API(s) and the excipients are gathered at this stage in order to guide the next steps and to build the product documentation for filing. What was not disclosed is that based on that definition, preformulation would be highly consuming in both time and resources in order to guarantee success at the final product. It was only stated many years later by introducing the QbD concept!

It would help to illustrate the concept, thinking about the preformulation phase as the way to solve the incognita ABC through the equation: A+AC+B+BC=ABC, being A the fill formulation, C the stability conditions (temperature, humidity, light), B the gelatin formulation and ABC the softgel product. In the same way, since the gelatin softgel is a primary packing for the medicine, it would also help to apply the same reasoning of packing development to formulation development. Then, why is it not the same criteria applied to gelatin formulations since they are the primary packing of the drug? Using the same packaging, would be a particular gelatin formulation proper to any climate conditions?

Formulation of pharmaceutical products has been considered a tailor-made approach for each product and according to this, defining a formulation guide is somewhat controversial. However, to establish a guide with multiple considerations on formulation is a great help as the first step to discard predictable incompatibilities and to avoid the most common formulation non-compliances. Here, a starting point would be to define the complexity of the system: Is a same gelatin formulation indicated to formulate both hydrophilic and lipophilic fill contents? On the other hand, some incompatibilities are difficult to detect at a lab. Usually, there is a constraint to obtain capsules at a small scale, to test the system as a whole and evaluate migration phenomena: one of the causes of the most of the defects in softgels (dissolution non-compliance, opacity, blooming, etc). Then, the question is what to do? What are the lab tests and the analytical tools that help to make it easier? Shortcuts are highly desirable therefore we will discuss them in our upcoming webinar.

What about the timings? From the beginning we anticipated that preformulation in spite of being the safe side, is a time consuming phase. In this regard, one of the questions needed to be considered would be: In a project framework, how much time is foreseen to cover difficulties in preformulation? Here, using a weighted punctuation for the product complexity to estimate formulation times would be a recommended approach. What about the scale? Is there any way to make preformulation at lab conditions or will final results depend on final capsules? Here, there is another concern in the way to make preformulation as profitable as it could be and that is to determine if lab tests correlate well with pilot scale (adding more work!). In general, it could be reliable at least to test the excipients, when process parameters are kept as controlled as possible at a lab scale.

What about the results? We started the QbD framework some years ago and what we´ve learned about gelatin preformulation is the importance of consolidating the lessons, building the decision diagram and feeding the formulation bank. This includes the criteria for the selection of a gelatin formula or another, on a general basis as well as in some specific cases. The QbD approach offers an exploration space that covers the most relevant aspects of development. It is important to bear in mind that this approach doesn´t guarantee that you don´t have to go back during the process, but if it happens, you will certainly return with qualified information. This gives you a criteria of what to do and what not to do, as well as the knowledge of what are the most probable causes of non-compliance. In brief, it is for sure a matter of time: the saved time from non-compliances and reformulation!

Finally, as the purpose of this space is to share knowledge and experiences, we would like to hear from you regarding the questions stated above as well as your own questions. To learn more insights on this matter join us in our upcoming webinar on Application of QbD principles in the development of the gelatin shell formulation of softgels.

Register now here.

For more information on our company and services visit www.softigel.com or contact us at [email protected]

Claudia Silva, New Platforms Development Director from Procaps

Claudia procaps - spotlight

Claudia graduated from Universidad Nacional (Colombia) gaining a degree as a Pharmacist. She also holds a European PhD in Food Science and Engineering from Universidad de Santiago de Compostela in Spain.

Claudia went on to become a senior researcher with experience in formulation, development and industrial transference for new products. This integrates her background and expertise in; rheology of natural hydrocolloids, leading the project management on new platforms for research, design and development of new delivery systems and new pharmaceutical dosage forms, the evaluation of new materials, equipment and technologies as innovative proposals and the evaluation of gelatin substitutes for product development.

Claudia has authored several scientific research papers and attendant to various International Congresses in the area of rheology and research and development of thickening systems.

1. Why did you decide to do a webinar with us?

The decision was the result of some criteria such as the support in the pharmaceutical community (pharmaceutical editors), the hosting services, the sort and quality of media sources, the ranking and our experience as attendants in different webinars in BRW platform. All these aspects were considered as relevant to our purpose to offer a space on sharing different technical standpoints and hold fruitful discussions on current subjects that concern the global pharmaceutical industry

2. How did you get into the industry?

I have been working with Procaps for 4 years now. I was part of the R&D team in the nutritional gummies facility and then moved to the Headquarters to lead the team of New Platforms, having the opportunity to deal with the newest Product Developments. It has been the role that has allowed to me to combine the background in Pharmacy and the expertise on natural polymers rheology.

3. What do you most enjoy about your role?

The most rewarding experience of this role is to learn new things each time and to access to specific and detailed knowledge. Our team believes that most things are possible and that our main objective is to make them real.

4. What motivates you?

I am motivated by being involved in creative processes and thinking about different ideas, challenging situations and competitions. Through that, I have learned that to overcome difficulties, persistence, patience and optimism are required. During my free time, I enjoy taking part of writing competitions, trying new things and working with a theater group, activities that include some of these motivations. At work, they have been a driving force to find different ways to solve particular problems and keep working on successful projects.

5. What has been your best holiday and where would you recommend visiting?

Taking holidays is a whole process. I enjoy planning as well as travelling and coming back home. All the holidays have been different and therefore unique. I lived in Spain for some years and there is always a reason to come back there. I recommend Santiago de Compostela and Seville, both quite different but charming.

Claudia will be presenting with Diego Monterroza in Procaps webinar ‘Preformulation and formulation activities during development of soft gelatin capsules’ on the 30th April at 3PM London/10AM New York.

Diego Monterroza, Corporate R&D Manager at Procaps

Diego procaps - spotlight2

Diego holds a degree in Organic Chemistry from Universidad del Atlántico and a Master’s degree in Pharmaceutical Sciences from Universidad Nacional in Colombia. He has more than 15 years of formulation and analytical development experience with soft gelatin capsules products, including products for the US, EP and Canadian markets.

Diego has led formulation development for liquids, semisolids, and suspensions, contained in soft gelatin capsules, including lipid formulations and self-emulsifying drug delivery systems. In his current role, Diego leads the product and analytical development of pharmaceutical products for PROCAPS S.A. covering diverse solid and liquid dosage forms, mainly, soft gelatin capsules and associated technologies.

1. Why did you decide to do a webinar with us?

The decision was the result of some criteria such as the support in the pharmaceutical community (pharmaceutical editors), the hosting services, the sort and quality of media sources, the ranking and our experience as attendants in different webinars in BRW platform. All these aspects were considered as relevant to our purpose to offer a space on sharing different technical standpoints and hold fruitful discussions on current subjects that concern the pharmaceutical industry

2. How did you get into the industry?

I have been at Procaps for about 15 years passing for different areas like QC, Tech Services, Analytical Development, Regulatory Affairs and now Product Development. Through this time I have been in contact with regulations from several countries including LATAM and highly regulated markets, working interesting and challenging formulations in softgels and advanced technologies for big pharma companies and many other customers located in more than 42 countries.

3. What do you most enjoy about your role?

The possibility of facing new challenges adapted to the specific requirements of customers and regulatory entities. I also enjoy very much leading a multidisciplinary, heterogenic team, dealing with tough requirements and strong positions that need to be agreed through experimentation and science-based decisions.

 4. What motivates you?

The changing challenges that each project represents. The need of applying specific knowledge to each project but at the same time meeting timelines and very strict commitments.

5. What has been your best holiday and where would you recommend visiting?

Best holyday was my honeymoon in Peru. I definitively recommend this country not only places are magical, but the food is incredible and most important, the hospitality of the Peruvians is amazing.

Diego will be presenting with Claudia Silva in Procaps webinar ‘Preformulation and formulation activities during development of soft gelatin capsules’ on the 30th April at 3PM London/10AM New York.

Christer Johansson, CEO/Owner, BiQ Pharma and AQPS Academy of Quality in Pharm Science

Christer JohanssonMr. Johansson has over 40 years’ experience in the pharmaceutical industry and currently serves as the CEO/owner of BiQ Pharms and AQPS Academy of Quality in Pharm Science. Mr. Johansson also worked at Biotechvalley AB as the CEO and a senior consultant, quality director at Pfizer, Fresenius Kabi, Pharmacia, and the head of analytical laboratory at Astra. Mr. Johansson received his Master of Science in chemistry from KTH Royal Institute of Technologhy in 1980 and his MBA from Uppsala University in 2000.

1. Catalent are a loyal customer of ours and have delivered an extensive number of webinars with us; can you tell us what you have learnt from running this webinar?

Start planning with BRW as early as possible and touch base regularly to make sure there is flawless execution. Better understand your targeting audience and select the right timing, title and content.

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

 To speed up the efficacy and time to market I see the necessity to  make an early and coordinated start of the formulation of candidates parallel with preclinical and clinical testing. I’ll  emphasize the need of setting target profiles and built in quality in every step in a project. Project planning and coordination of the  specialized companies involved ,towards the set targets are essential to reach success and reaching project objectives.

3. If you could only ever listen to one song forever, what song would it be?

This is not an easy question but something with Deep Purple for example – Smoke on the water!

4. If you had to live in a TV show for a month, which would you choose?

If there is a TV-show on an old sailing ship over the Atlantic otherwise something with a connection to  nature (walking and talking).

5. What would you like to achieve in the future?

I want to play a role in the Swedish pharmaceutical landscape to make the national pharma industry more international competitive. 

Christer will be presenting Catalent’s webinar ‘Early Technology Selection for Optimized Drug Development‘ with Dr. Janet Hoogstraate, Director Biovation Park, Acturum Life Science AB and Julien Meissonnier, Director of R&D, Catalent Pharma Solutions. You can register for their webinar taking place on the 23rd March at 11am New York/3pm London here.

 

Dr. Janet Hoogstraate, Director Biovation Park, Acturum Life Science AB

Janet Hoogstraate

Janet Hoogstraate obtained her PhD from Leiden University in the Netherlands in Biopharmaceutical Sciences and an executive MBA from Hult International Business School in London, UK. She is associate professor at the Department of Pharmaceutics at Uppsala University. During her research career she has worked at the University of Utah, University of Iowa and in various positions at AstraZeneca R&D. As the director of DMPK in AstraZeneca she headed a group of 63 scientists working in the entire value chain of pain and neurology drug development projects. 

She is co-author of more than 45 papers and book chapters. Currently, Janet holds the position of director of Biovation Park at Acturum Life Science AB building a business and science park and incubator in Södertälje for life science companies and academic groups. She also hold various board positions such as chairman of the board of the Stockholm Brain Institute.

1. Catalent are a loyal customer of ours and have delivered an extensive number of webinars with us; can you tell us what you have learnt from running this webinar?

Start planning with BRW as early as possible and touch base regularly to make sure there is flawless execution. Better understand your targeting audience and select the right timing, title and content.

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

Drug development is challenging in many aspects. Often scientists focus on strong pharmacology in the discovery phase and less on delivering the pharmacology to the right target in the body in on optimal time and concentration profile. That leaves a big hurdle to overcome in early development. Selecting technologies and planning your development early yet in a flexible way can provide a smoother way though drug development.  

3. If you could only ever listen to one song forever, what song would it be?

With music now so easily and abundantly available I don’t want to think about listening to only one song! But one I can listen to over and over again is Personal Jesus by Depeche mode, especially in a live version.

4. If you had to live in a TV show for a month, which would you choose?

I would love to be part of an expedition or a travel program. Spending time in a different country getting to now both the culture and exploring the nature would definitively be an good way to spend a month.

5. What would you like to achieve in the future?

My professional ambitions are to revitalize life science by connecting small companies and researchers and finding ways to deliver new treatments to patients by new constellations and smart processes. Outside professional life, I would like to advance my off-piste skiing skills. 

Janet will be presenting Catalent’s webinar ‘Early Technology Selection for Optimized Drug Development‘ with Christer Johansson, CEO/Owner, BiQ Pharma and AQPS Academy of Quality in Pharm Science and Julien Meissonnier, Director of R&D, Catalent Pharma Solutions. You can register for their webinar taking place on the 23rd March at 11am New York/3pm London here.

 

Trials fail due to poor design. Don’t let yours be the next!

Flawed methods in clinical trials have had a big part to play in the poor track record for Neuroscience drug development with consequences for both patients and the pharmaceutical industry.  Nowhere are the consequences for patients more acutely felt than in the area of Alzheimer’s drug development where the industry counts just three Alzheimer’s drug wins in 13 years and 101 losses, according to Pharmaceutical Research and Manufacturers of America (PhRMA). Failed trials also have big consequences for companies, often losing organizations billions in capitalization. In many cases the losses could be avoided through better trial design[1].

Research has shown that clinical programs have a high failure rate, even when drugs are known to be effective. For example, Khan et al. (2002)[2] reviewed the data from nine antidepressants approved by the United States Food and Drug Administration between 1985 and 2000. Of the 92 treatment arms reviewed, less than half showed statistically significant separation from placebo.

Surely we can be doing more at the trial design stage to avoid failed trials. Newer methodologies, such as adaptive designs, patient enrichment and risk based monitoring have been discussed extensively but adoption by the industry has been slow.

In the upcoming webinar sponsored by Covance Inc., leading industry experts share their insights and experiences gathered in the design and execution of novel trial designs in psychiatry – designs focused on speeding availability of effective treatment to patients, selecting patient subgroups most likely to respond and minimizing placebo response rates.

Scott Berry, PhD, President and Senior Statistical Scientist at Berry Consultants, shares his thoughts on how adaptive designs can reduce length and increase flexibility in exploratory trials. Prospective subgroup analysis and wider dose ranges can be studied without increasing sample size allowing for more efficient use of trial budgets.

Sanjeev Pathak, MD, Senior Medical Director at Alkermes Inc., will review how his group has adopted methodologies that reduce the impact of placebo response while lowering sample size by 20-40%. He outlines his group’s reasons for adopting novel trial designs and lessons learned from discussions with regulators.

By attending the webinar you will –

  • Explore how novel trial designs can benefit your Neuroscience development program
  • Examine the pros and cons of implementing adaptive and enrichment designs
  • Identify barriers to adoption and how to overcome them, including organizational, regulatory and resource related barriers

If you’d like to hear more about how trial design can help improve your chances of success, then join me on November 17th for the Covance-sponsored webinar “Innovation in psychiatry trial design – How to improve the probability of success”.

Webinar Details and Registration
Monday, November 17, 2014
10 am New York, US/15:00 London, UK
60 minutes including Q&A

[1]Becker RE, Greig NH. Why So Few Drugs for Alzheimer’s Disease? Are Methods Failing Drugs? Curr Alzheimer Res. 2010 November 1; 7(7): 642–651

[2]Khan A, Leventhal RM, Khan SR, Brown WA. Severity of Depression and Response to Antidepressants and Placebo: An Analysis of the Food and Drug Administration Database. Journal of Clinical Psychopharmacology. February 2002 – Volume 22 – Issue 1 – pp 40-45