In an endeavour to encourage research and innovation in the rapidly evolving field of formulation development and drug delivery, Express Pharma and The Indian Express Group hosted the inaugural edition of FDD Conclave at Novotel Airport, Hyderabad. Held on 16-17 June, 2017, it saw attendance from over 100 leading scientists and R&D heads representing prominent pharma organisation and top biotech companies
Day 1: 16 JUNE, 2017
FDD Conclave 2017
- Welcome Address
- Lighting of Lamp
- Release of the FDD Leaders Handbook
- Address by Chief Guest
- Special Address: Formulating a program for formulation development of complex products
- Q&A with Dr Hussain
- Advances in film coating technology
- Advances in the world of probiotics
- Networking tea break
- PANEL DISCUSSION: Expanding India’s talent pool in formulation development and drug delivery: Innovative approaches
- Networking lunch
- FDD LEADERSHIP AWARDS NITE
- Welcome Address
- Introduction to FDD Leadership Awards 2017
- Presentation of Awards
- Vote of Thanks
- Gala Dinner
Inaugural Ceremony
The first edition of FDD Conclave kickstarted on an auspicious note with the ceremonial lamp lighting ceremony. Viveka Roychowdhury, Editor, Express Pharma gave the Welcome Address. Speaking to the august audience, she said, “It is my honour to welcome all the stalwarts and champions in pharma research to the inaugural edition of FDD Conclave. Express Pharma has partnered the pharma sector lived through it many phases of evolution. Today, it is common knowledge that the sector, both globally and in the country, face myriad pressures. Escalating R&D expenses.
Government push to reduce prices. An increase in patient demand and expectations. I could go on, but then, every challenge is also an opportunity. We believe that the journey that we start today, with the inaugural edition of the FDD Conclave, will put us firmly on the path to winning this race.”
The FDD Leaders Handbook, featuring over 40 leading scientists in the field, was also unveiled at the event.
Chief Guest’s Address
The Chief Guest, Ravi Uday Bhaskar, Director General, Pharmexcil, lauded Express Pharma for creating such a platform and and spoke on the need for it to drive progress in formulation development and drug delivery.
He went to speak on his long tenure in drugs control administration, and then his shift to the Pharmaceutical Export Promotion Council (Pharmexcil), a completely different ball game. He gave insights on the focus areas of Pharmexcil and how it assists in tackling the issues faced by the Indian pharma industry globally.
He also spoke on the evolution of the formulation development and drug delivery segment in India. Recalling some major achievements since his college days, he marvelled at how far we have come in terms of developing novel drug delivery systems.
Speaking on Express Pharma’s long association with the industry, Bhaskar recalled the time when All India Drugs Control Officers’ Confederation (AIDCOC ) was formed in 1995 and the news was carried in the Express Pharma (then Pharma Pulse). He lauded Express Pharma for reporting exclusive, high quality, news and chronicling all the major happenings in the pharma industry for over two decades.
He also said that Pharmexcil would like to collaborate with Express Pharma in organising events to promote pharma exports as well.
Special address: Formulating a programme for formulation development of complex products
Dr Ajaz S Hussain, Former Deputy Director of Pharmaceutical Science, US FDA, gave a special address at the FDD Conclave 2017 through a video presentation on, ‘Formulating a programme for formulation development of complex products’. His detailed and in-depth presentation addressed various pertinent aspects of product development and ensuring regulatory compliance while thriving in a complex environment.
He also spoke on the measures needed to drive continuous product value and functionality. He examined strategies to cope with design complexities in pharma formulations while maintaining time to market and profitability.
He gave a rundown on the importance of quality by design in dealing with complexities and how formulation development will evolve in times to come. He explained the good practices in formulation development and stressed on the need for their adoption to ensure regulatory compliance. He also pointed out that the companies need to anticipate how to stay pertinent in a dynamic environment and emphasised on the need to invest in R&D of complex products to do so. He said that investing $10 in R&D of complex products would give $150 in terms of revenue.
Dr Hussain also interacted with the audience over Skype to answer their queries on the changing regulatory scenario in formulation development and the steps needed to stay updated and relevant in these times.
Advances in film coating technology
Mike Easterbrook, CTO, Ideal Cures took stage to give insights on the advances in film coating technology. He spoke on current industry requirements which needs Employment of innovative technologies to improve product quality and process efficiency and retention or enhancement of product safety and efficacy within commercially acceptable cost constraints.
Then, he elucidated on Ideal Cures’ efforts towards development of products and systems meeting the above requirements which includes very high solids/ low viscosity coatings offering time savings combined with excellent uniformity and smoothness and innovative film systems mimicking sugar coat appearance but with more
economical process times and opportunities for automation.
He also gave a detailed presentation on InstaCoat 4G, an offering from Ideal Cures, and elaborated on its advantages which include dry powder system for aqueous reconstitution, high solids capability, high productivity, high adhesion, ideal for friable cores, enhanced bulk tablet flow properties, demonstrated performance in all types of conventional, side-vented and continuous coating equipment etc. He used real case studies to demonstrate the actual benefits accrued through the product for its users.
He spoke on the need to stay at par with the advancements in the dynamic segment of formulation development and drug delivery and assured that Ideal Cures can prove to be a good partner in this journey.
Advances in the world of probiotics
Hongwei Wang, Applied Nutrition Manager, DuPont Nutrition & Health talked about the ‘Advances in the world of Probiotics’. He provided a brief on DuPont Nutrition & Health and the services the company offers. he said that the company has in-depth knowledge of food and nutrition with current research and expert science to deliver unmatched value to the food, beverage and dietary supplement industries. He also said that they draw on deep consumer insights and a broad product portfolio to help their customers turn challenges into high value business opportunities.
He also touched upon different topics like gastrointestinal microbiota in health and disease, introduction to probiotics and their characteristics, reported clinical benefits and proposed mechanisms, manufacturing of probiotics and DuPont Danisco range of probiotic strains and delivery formats at the FDD Conclave.
Wang’s detailed presentation enlightened the audience about the different levels of action of probiotics and the effects of probiotics in maintaining good health. He also drew inferences from a study
conducted by DuPont in Hyderabad to understand the effect of probiotics on diarrhea affected kids. The objective was to understand whether it can help reduce incidence of diarrhea or improve their health status. Summing up, Wang said that probiotics can help in improving the immune system and help improve resistance to infectious diseases.
Panel discussion: Expanding India’s talent pool in formulation development and drug delivery: Innovative approaches
The first panel discussion of the FDD Conclave 2017 revolved around a critical issue — ‘Expanding India’s talent pool in formulation development and drug delivery: Innovative approaches’. In this session, an expert panel comprising Dr Himadri Sen, Chairman, STEERLife India as the moderator; Vinod Kumar Arora, Principal Advisor, IGMPI; Dr Pawan Bhat, Executive Vice President, Technical Operations-R&D, Natco Pharma; Jaya Abraham, Head – NCE, NDDS, Generic Formulation, Packaging, IP Development, Torrent Pharmaceuticals; and Dr Mahesh Burande, Director, Skill Development and Professor, RMDIPER, highlighted various challenges faced by the sector due to qualitative and quantitative paucity of talent.
Dr Sen initiated the discussion by examining the current scenario and raising several relevant questions for the panelists to deliberate upon. One such query was where are gaps in talent management and which are the major focus areas? Do we need the talent in drug discovery development, new formulations, new generics, drug delivery system, innovative dosage forms or complex generics? He also raised a query on the role of academic institutions and how they are poised to create better talent in terms of quality and quantity.
Arora highlighted three vital points — lack of industry readiness in the students and the gap between academia and the industry. Secondly, he suggested that we look into novel drug delivery systems along with product development of generics as the cost benefits are marginal. He further recommended initiation of continuing education programmes (CMEs) which will give hands on training to students for better understanding of the industry.
Abraham also agreed that the current syllabus needs to be revamped to create better talent in formulation development and briefed on the need for critical thinking, data analysis, interpretation, logical conclusion and designing experiments. She also stressed on application-oriented knowledge to be imparted by the institutes.
Bhat elaborated on the subject of education and said that there is need to have different approaches to deal with talent at different levels. He elaborated on the need to revise the syllabus to bridge the gap between the freshers calibre and índustry’s expectations. He also opined that mushrooming of institutes without proper emphasis on quality could be the reason for dilution of standards in talent creation. He also addressed issues such as lack of knowledge in graduates about compliance, regulations, IP etc. Burande, quoted from a report that revealed investments in R&D by pharma companies have substantially increased from Rs 2000 crores in 2010 to Rs 8000 crores in 2017. He informed that the Indian pharma industry holds the third position in the world in terms of volume but when it comes to value, we lag behind.
Despite, 1300 degree pharmacy colleges along with 800- 900 post graduate courses run in most of these institutes, he reiterated the fact that the quality of talent is deteriorating as against quantity, which is increasing. He mentioned lack of proper emphasis on skill development as a reason for the lag. Urging the experts to come up with a platform which involves academicians as well in creating adequate solutions, he referred to examples of various developed countries like South Korea, Japan, Germany who work towards skill development and ushered the industry to take lessons from these nations. He added that a provision needs to be devised for application-based training of the teachers by industry experts to bridge the gaps in skill development.
The expert panel also recommended measures like finishing schools, better industry – academia collaborations, reform in educational curriculum to improve talent management in this evolving segment. An interactive audience also share their views and recommendations which made the panel discussion even more interesting.
Express Pharma honours leading formulation scientists in India
Organised by Express Pharma and presented by Ideal Cures, FDD Leadership Awards recognised the stellar achievements of these scientists in furthering research and innovation in formulation development and drug delivery
Express Pharma hosted the first ever FDD Leadership Awards to recognise the stellar achievements of Indian scientists and R&D heads of reputed institutions and organisations for outstanding research and innovation in the field of formulation development and drug delivery. Ideal Cures was the Presenting Partner for the awards.
Held concurrently with the FDD Conclave, on June 16, 2017, at Novotel Airport, Hyderabad, the awards night began with an address by Viveka Roychowdhury, Editor, Express Pharma, who welcomed the delegates, explained the rationale behind the initiative and elaborated on the methodology of the awards.
Subsequently, Roychowdhury, alongwith Ravi Uday Bhaskar, Director General, Pharmexcil and Suresh Pareek, MD, Ideal Cures, alongwith the eminent jury of FDD Leadership Awards 2017 – Vinod Kumar Arora, Principal Advisor, Institute of Good Manufacturing Practices India; Dr Girish Jain, President, Research and Development, Alkem Laboratories; Seetaraju Gembali, Director, GSR Pharma Research and Pramod Pimplikar, Managing Director, Shalina Laboratories, presented the awards to the winners.
15 leading professionals received the FDD Leadership Award for Outstanding Achievement in Formulation Development and Drug Delivery. The Lifetime Achievement Award was also presented
to an industry veteran who has traced a glorious career in this field.
The jury members were also felicitated by Express Pharma and Ideal Cures to appreciate their invaluable efforts in helping choose the deserving winners. The events night came to close on a celebratory note and ended with a gala dinner.
The winners of FDD Leadership Awards 2017 share their vision to make India a hub for formulation development and drug delivery
Lifetime Achivement Award
We need to expand our current talent pool for the next generation of scientists and technologists, to sustain our leadership position in generics. We also need major thrust and focus on drug delivery and creation of innovative platforms
– Dr Himadri Sen, Chairman, STEERLife India
Outstanding Achivement in Formulation Development and Drug Delivery
Nurturing talent and targeting unclassified therapeutic segments to serve the society at affordable costs will make India a global hub for formulation development and drug delivery
– Arun Kumar Pandey, Senior Vice President, Alkem Laboratories
Outstanding Achivement in Formulation Development and Drug Delivery
Demonstrate speed in developing advanced formulations technology and regulatory approvals for differentiated products. New IT software systems should be implemented in formulation development for online experiments, data recording and acquisition
– Ashish Gogia, Executive Vice President, R&D, Medreich
Outstanding Achivement in Formulation Development and Drug Delivery
By promoting entrepreneurship, incubation, Intellectual Property Rights (IPRs) and technology transfer, we can make India a hub for formulation development and drug delivery
– Geena Malhotra, Global Head of Integrated Product Development, Cipla
Outstanding Achivement in Formulation Development and Drug Delivery
R&D is a unique function wherein diverse and completely different skills like formulation, analytical, packaging, bioequivalence and regulatory etc. have to work in isolation in their respective expertise areas, but at the same time be in tandem to create a unique product – the Dossier!
– Dr Jayant Karajgi, Chief Scientific Officer, Wockhardt
Outstanding Achivement in Formulation Development and Drug Delivery
India’s young talent pool should have their own approaches for innovation, patient engagement, data and proof of value. We need to be openminded, inquisitive and mentally prepared for a rigorous grind with patience and perseverance to get maximum mileage of the winds of change
– Jaya Abraham, Head – Formulation/Biopharmaceutics/ Reverse Engineering Analytics, IPR Landscaping and Strategy design, Packaging, Torrent Pharma
Outstanding Achivement in Formulation Development and Drug Delivery
We need to focus on niche technologies, invest on development of differentiated products and delivery systems like non-invasive technologies, ease of administer dosage forms like subcutaneous dosage forms and patches
– Dr Krishna Murthy Bhavanasi, General Manager – Formulation R&D, Natco Pharma
Outstanding Achivement in Formulation Development and Drug Delivery
Continued supply of talent with enhanced capabilities to handle future challenges of complexities with respect to molecules and dosage forms would help India become a FDD hub
– Makarand Avachat, Senior Vice President, Pharma Research, Lupin
Outstanding Achivement in Formulation Development and Drug Delivery
The industry and academics should concentrate on innovation-driven developments. The industry should concentrate and invest more on latest drug delivery technologies rather than vanilla generic developments
– Rajesh Kshirsagar, Chief Technical Officer, Microlabs
Outstanding Achivement in Formulation Development and Drug Delivery
We need to seriously work around creating a talent pool, establishing a conducive industrial research environment to encourage innovation, and encourage practical models for effective industry – academia collaboration with active engagement from Government of India
– Ravinder K, Senior Director, Head of PSAI Formulations, Dr Reddy’s Laboratories
Outstanding Achivement in Formulation Development and Drug Delivery
Focussed efforts with a long-term vision will create enough opportunities to attract or generate talent pool. The industry needs to take a lead on training new graduates as well as visiting faculties from academia, as it will be mutually beneficial.
– Dr Shirish Kulkarni, Senior Vice President, R&D, Sun Pharma India
Outstanding Achivement in Formulation Development and Drug Delivery
We have to enter into collaborative R&D arrangements with brand and generic companies to supplement their R&D productivity. There is a need to control R&D operating costs, formulation development costs, packaging costs and reduce cost of existing formulations to increase profitability
– Srikant Pimple, Head – Formulation Development, Unichem Laboratories
Outstanding Achivement in Formulation Development and Drug Delivery
We can surely leverage the infrastructure built by the generic industry to make the leap forward into drug delivery. The ecosystem which is required to make India a hub of drug delivery includes universities and research centres which not only provide talent pool but also serve as nurseries of innovation
– Dr Sukhjeet Singh, Senior Vice President – Pharma Research, Panacea Biotec
Outstanding Achivement in Formulation Development and Drug Delivery
Industry leaders need to help academics to generate high quality applied research results in the field of formulation and clinical research
– Sushrut Kulkarni, Senior Vice President & Head Pharmaceutical Technology Center, Zydus Cadila
Outstanding Achivement in Formulation Development and Drug Delivery
During the last 20 years, Indian pharma has grown significantly and become one of the major exporters to US and other markets. It will be good if we work in alliance and market our skill sets to the pharma companies who are looking for it.
– Ulhas R Dhuppad, Executive Vice President (CMC), Glenmark Pharmaceuticals
Outstanding Achivement in Formulation Development and Drug Delivery
The industry should tie up with universities or institutes for research-based programmes with sponsorship. Research needs to be encouraged through good government policies. Institutes should also get into semester exchange programmes with foreign universities
– Dr Vijay Sinh Chauhan, Senior Vice President – Research and Development (Formulation Finish Products), Intas Pharma
Day 2: 17 JUNE, 2017
FDD Conclave 2017
- Changing the way we make and take medicines
- Excipients in pharmaceutical formulations – A regulatory perspective
- Lipids as pharmaceutical excipients in drug formulations – Challenges and opportunities
- The journey of Ideal Cures
- PANEL DISCUSSION: FDD strategies to increase compliance in special population segments
- Trends in injectable packaging
- Keeping up with evolving regulations
- Superior polymer technologies to meet emerging drug delivery demands: Dry enteric coatings
- Role of high resolution mass spectrometry in peptide impurity characterisation
- Improve coating efficiency and yield by using best technology
- PANEL DISCUSSION: The way forward in FDD
- Vote of thanks
Keynote address: Changing the way we make and take medicines
The second day of the FDD Conclave 2017 commenced with a key note address from none other than Dr Himadri Sen, Chairman, STEERLife, the doyen of formulation scientists in India. He drew from his commendable experience spanning over four decades to share learnings to create an effective synergy between engineering sciences and pharma applications to change the way we make and take medicines.
Detailing the inefficacies and inefficiencies in the current batch manufacturing processes which include time consuming sample collection and testing processes, sub-optimal yield and inconsistent quality, Dr Sen recommended the adoption of cleaner, flexible, more efficient continuous manufacturing processes. He outlined the manifold benefits and advantages of continuous manufacturing process and underlined how it can have significant impact on the growth of the industry. He also said that it is time we moved completely from quality by testing to quality by design.
Dr Sen opined that it is high time we changed the way we looked at process R&D and unlearnt some of current ways to make a significant difference. He gave examples of misuse of antibiotics and its pitfalls to state his point.
Dr Sen also elaborated on the next-gen technologies which would usher an era of change in formulation development and drug delivery. For instance, novel hot melt extrusion (B2C–E) replacing conventional hot melt extrusion; hot melt fragmentation* (B2C-F) replacing spray drying and spray congealing; activated granulation (B2C–G) instead of conventional wet, dry and melt granulation.
The session ended with the audience interacting with Dr Sen to gain more insights on this topic and clarify their doubts.
Excipients in pharmaceutical formulations – a regulatory perspective
SR Salunkhe, Former Assistant Commissioner, FDA Maharashtra, gave an insight from a regulatory perspective on the use of excipients is pharma formulations. Highlighting the need to produce, safe, effective and quality drugs, he pointed out that the current quality mechanisms often fail on safety and efficacy fronts. He also drew attention to the fact that this negligence has often caused several serious mishaps in the past and how good manufacturing practices (GMP) were put into place to avoid them.
Giving a rundown on excipients, Salunkhe elaborated on their functionality and role in enhancing product identity, safety and efficacy. He explained how the physio-chemical and biological properties of the drug excipients influences the drug’s product stability, bioavailability and manufacturability. He also spoke on various laws which govern the use of excipients in pharma processes.
Salunkhe then detailed on the differences between commercial and pharmacopoeial excipients and how it is important to use the right excipient to get optimum results. He also pointed out that testing the quality of excipients only in finished products would not suffice and that it needs to be done at various levels of the manufacturing process.
He explained various complexities and considerations involved in the use of excipients and threw light on the standards that need to be maintained to add them to pharma formulations. He pointed out that as per International Pharmaceutical Excipients Council (IPEC) standards, the material used in the pharma drug product is required to be manufactured under appropriate GMP and it is not appropriate to use a non-pharma grade excipients as a drug component.
Lipids as pharmaceutical excipients in drug formulations – Challenges and opportunities
In this session, KD Yadav, Senior VP (Technical), AAK Kamani elucidated the importance of lipids as excipients in drug formulations for the pharma industry. Reiterating Dr Himadri Sen’s view on how quality is not defined by testing, but by design, he highlighted why they are integral to formulations as well as active drugs which are oil solubles. He also elaborated on various kinds of lipids available in the market, such as fatty acids, natural oils and fats, mono, di, and triglycerides (e.g. GMS, GMO), polyethylene glycol (PEG) derivatives of glycerides and fatty acids, polyglyceryl fatty acid esters, phospholipids etc. Explaining the functionality of lipids in detail, he said that they are required to make a stable emulsion when there is a need to improve shelf life.
Dr Yadav also briefed the audience on the rich history of his company and the milestones it has achieved in a journey spanning six decades. He also briefed about AAK Kamani’s offerings to pharma as well as veterinary industry and the myriad applications of these offerings in these industries. He also spoke on the company’s manufacturing facilities and capabilities.
Giving a rundown on the various kind of oils used in the pharma industry, he also pointed out the importance of right processing of oils to improve their effectiveness and efficacy.
The Journey of Ideal Cures
In a very interesting session, Suresh Pareek, thanked the audience for being a part of the FDD Conclave, as it was the first of its kind event for scientists and R&D heads. He went on to congratulate all the winners of the FDD Leadership Awards.
Then, he spoke on his entreprenurial journey and narrated the story of how it all began. From resigning a plum job to venture into the unknown terrain of entrepreneurship, to the myriad challenges he had to overcome to hold his own in a competitve industry, he went on to narrate several interesting incidents from his life’s journey.
He also informed that Ideal Cures was not his first foray into entrepreneurship, he had pursued other avenues without noticeable success. Then, Pareek decided to enter the film coating industry, a new ball game as his experience was in the paint industry. he had to compete with already established players and bring in significant value additions to make a mark for himself. Pareek also narrated incidents of dealing with obstacles on the personal front such as health issues while trying to build a flourishing business.
However, he persisted and his perseverance paid off. In 2003, he set-up his first GMP facility in Vasai and later on set up plants in Jammu and Sikkim. The company today has offices in Milan, Italy and a second office in Israel to work with Teva. At present, the company has four plants. Thus, Ideal Cures is a renowned name in the industry today.
Pareek ended his inspirational session by saying “Only you can empower yourself to walk on the path you want.”
Trends in Injectable Packaging
FDD Conclave 2017 had a session by Siva Prasad Reddy, Technical Support Engineer -India, West Pharma who gave a presentation on trends in injectable packaging. He spoke on the challenges in injectable packaging. Reddy informed the audience about the growing demands for parental drugs but also highlighted the growing challenges in terms of increased regulatory scrutiny; more complex devices and combination products; higher focus on quality risk management; more advanced and rigorous testing and inspection of final drug products; etc.
Reddy went on explain the risks in container closures and the need for increased scrutiny by regulatory agencies to enable better preservation of drugs or biologics, which comprise various factors such as chemical compatibility and leachables formation; variability in quality at particle levels and visual defects; reliability with device delivery in terms of dimensional control and functionality; sterile component equivalency, consistency in bulk, nest and port bags etc.
Talking about major concerns with glass containers across the world, Reddy highlighted pain points such as interaction with sensitive biologics; breakage; dimensional variation; variable silicone distribution; amount of silicone coverage and quality etc.
Further, he briefed the audience on the various products offered by his company to serve the changing requirements of the pharma industry. He also informed that West Pharma is among the top 25 companies and 35 injectable biologics and they have customers across the world.
Panel discussion: FDD strategies to increase compliance in special population segments
The two-day FDD Conclave 2017 saw several insightful sessions addressing myriad critical aspects of formulation development and drug delivery. The panel discussion on ‘FDD strategies to increase compliance in special population segments’ held on the second day of the event was one of them. Prominent representatives of the industry and academia comprising Seetaraju Gembali, Managing Director, GSR Pharma (Moderator); SR Vaidya, Director, Bliss GVS Pharma; Anwar Daud, Managing Director, Zim Laboratories; Dr Bharani Sanjay Sogali, Professor & Head, Department of Pharmaceutics, Krupanidhi College of Pharmacy came together to discuss this important issue and deliberate on various considerations to take into account while developing formulations for special populations.
The session covers three variant formulations developed inline to meet the need of special population segment requirements.
Setting the stage for the discussion, Gembali, the moderator of this session, briefed the audience about special populations and informed that they comprise paediatric and geriatric population, people suffering from dysphasia and those who are mentally challenged. He highlighted the importance of focussing on this population as it is increasing each day. For instance, he pointed out that of the total world population, eight per cent population is geriatric. By 2050, this will increase to 16 per cent which comes to 1.5 billion people. Hence, it is essential to prepare drug formulations keeping this special population in mind so that we are geared for the future.
Then, each panelist gave a short presentation on the upcoming trends, opportunities and challenges in this sphere. They spoke on suppositories and pessaries, orally soluble dissolving films, inhalation therapy, transdermal patches etc. in connection with the topic.
Vaidya talked about the importance and benefits of pessaries and suppositories over traditional formulations. He also explained how conventional drugs can have side effects which can be mitigated if we opt for better formulations. He cited several examples to prove his point.
Daud presented on oral thin films as an effective option for formulations to cater to the special population segment. He elaborated on their myriad benefits and their relevance to the special population and highlighted the challenges in developing these formulations. He also spoke on future technologies and their role in creating effective strategies to deliver innovative approaches to formulation development which would offer significant benefits to the patients.
Dr Sogali gave a presentation on inhalation therapy and informed that it can be used widely for paediatric as well as geriatric population. She also gave a rundown on the challenges and potential of inhalation therapy and emphasised on the important parameters to be considered while developing inhalation therapies. She also explained the different applications of nanotechnology for inhalation and how to improve patient compliance using inhalation applications.
The audience also got a chance to interact with the panelists and understand more on the subject, thereby making it a very informative session.
Superior polymer technologies to meet emerging drug delivery demands: Dry enteric coatings
Another technical session at FDD Conclave 2017, covered the topic of dry enteric powder coating and demonstrated how it is one of the superior polymer technologies to meet emerging drug delivery demands. Nitin Bhusane, Director, Shin Etsu Chemical Tylose India, he speaker in this session, gave in-depth information about the use of coating technologies, their need and role in improving the efficacy of the formulations.
He also drew a comparative analysis between conventional coating systems and dry enteric coatings. He highlighted the advantages and disadvantages of different technologies. He also gave details on the application of these technologies in various pharma formulations. Bhusane drew attention to the disadvantages of conventional methods which include low productivity, low polymer concentration, long coating time, difficult to apply to water sensitive drugs and
environment pollution.
Speaking on the advantage sof dry powder coating, Bhusane said that dry powder coating is high in productivity and solid content. It will consume less time in comparison to conventional methods. It is easily applicable to water sensitive drugs and there is no harm to the environment in using dry powder coating.
Bhusane also gave a detailed pictorial presentation on the right way to apply dry enteric coatings to achieve best results. He further said that his company recommends for dry powder coating to the industry.
However, he pointed out that his company has other offerings in the form of powder mixtures and liquid mixtures as well.
Keeping up with evolving regulations
Dr Bobby George, VP & Head Regulatory Affairs, Reliance Life Sciences, in his session, addressed a vital topic, keeping up with evolving regulations. He also threw light on the government’s mandate which involves removing regulatory bottlenecks, enhancing ease of doing business, successfully engaging with stakeholders, etc.
Giving a rundown on the current regulatory scenario and the challenges faced by companies in ensuring compliance, Dr George also spoke on the measures taken by the government to enable a more effective and transparent regulatory system across pivotal areas such as clinical studies, manufacturing, e-governance, evolving regulations, pharmacovigilance etc.
He also examined the effectiveness and efficacy of some significant measures like tightening the noose around irrational FDCs; New Medical Device Rules, 2017; audio video recording of consent, manufacturing test license validity, annual joint inspections of facility, risk-based inspections, establishing and empowering Life Science Skill Development Council, reporting of adverse drug reporting (ADRs) for marketed drugs, National Regulatory Assessment by WHO etc.
He also analysed the potential of some of the steps on the anvil which includes regulation of online pharmacies; streamlining the process for handling of NSQ samples; amendment of Schedule H list; separate set of rules for New drugs and CTs; setting up mini drug testing labs at port offices etc., to bring in a positive change and create a more efficient ecosystem.
Role of high resolution mass spectrometry in peptide impurity characterisation
The FDD Conclave 2017 witnessed several technical sessions which are of importance to the formulation development and drug delivery industry. In one such session, the focus was on the importance of identifying impurities in the development process of drugs. Dr Annu Uppal, Global Demo Lead and Manager Application Support for Biopharma Applications, Sciex, spoke on the role of high resolution mass spectrometry in peptide impurity characterisation.
She also informed the audience that impurities and the amount in which they exist can be deterrents in the efficacy of peptide-based drugs. So, Sciex has developed a software named Metabolite Pilot to ensure accurate identification of impurities.
Talking about the advantages of the software, Dr Uppal highlighted that Metabolite Pilot is an all-in-one integrated software tool for ID confirmation, structure elucidation and correlation. It has advanced peak finding algorithms optimised for Sciex accurate mass platforms. It consists of known transformation database for related impurities identification and also correlates with an analog database for related impurities identification. It assists in integrated MS/MS fragment interpretation, structural assignment, high throughput batch analysis and sample to sample correlation.
Dr Uppal also spoke on how one can leverage high resolution mass spectrometry for characterisation of these impurities.
She emphasised on the importance of identifying, characterising and quantifying the impurities in API and pharma products as these impurities can lead to the side effect, toxicity and impact the drug activity.
Improve coating efficiency and yield by using best technology
Another technical session at the FDD Conclave was on improving coating efficiency and yield by using best technology. The speaker, Devendra Chaudhari, Marketing Head, Anish Pharma Equipment, gave detailed insights to the audience on the latest coating technology available in the market and the his company’s offerings in this sphere.
Giving an overview on the company’s history, he informed that the group was founded in 1992 to manufacture some semi-solid equipment. At present, it has six manufacturing facilities at Nashik, with a total area of 50,000 sq ft. and a dedicated fat facility. Currently, there are 150 plus professionals working at Anish Pharma to provide support to the customer.
Chuadhari also spoke about their seamless process development facility which boasts of the latest equipment for manufacturing oral solid dosages. He informed that the facility is well equipped with all the accessories and controls like steam, chiller, humidifier, instrumentation, latest offerings in process technology etc. It allows the company to manufacture batches from 100 gm to 60 kg at Nashik.
Chaudhari also briefed the audience on the advantages, capacity and features of the equipment available with Anish Pharma such as APCG 175C, APCG 300C, APCG 450C, Extruder Spheronizer etc.
Chaudhari also highlighted the advantages of a conical machine offered by his company, in the manufacturing of MUPS. he pointed out the advantages of the machine in maintaining superior and consistent quality products with the help of the conical machine. He assures that the conical series machine will give high efficiency and higher spray rate with less electrostatic charge.
Thus, he spoke on his company’s capability to partner progress in formulation development and drug delivery.
Panel Discussion: The way forward in FDD
The last panel discussion of the FDD Conclave 2017 ensured a befitting finale to the two-day event which saw attendance from leading formulation scientists and R&D heads of renowned pharma companies. Titled, ‘The Way Forward in FDD’, it saw an interesting exchange of views on the paths that professionals in FDD need to tread to encourage and drive innovation in the formulation development and drug delivery sector of India.
The session comprised an eminent panel of Vinod Arora, Principal Advisor, IGMPI (Moderator), Dr Girish Jain, President, Research & Development, Alkem Laboratories, Seetaraju Gembali, Managing Director, GSR Pharma Research and Pramod Pimplikar, Managing Director, Shalina Laboratories.
Arora, the moderator of the session, set the stage by giving an overview on the current scenario in FDD and said that India is at crossroads. Now, it has to take some crucial decisions and choose between continuing with vanilla generics or moving to super generics or super super generics. He also pointed out the opportunities for growth in these emerging areas and explained that they can help meet India’s huge unmet medical needs. Arora also opined that this move would be more affordable than getting into new chemical entities (NCEs) which require huge investments.
Dr Jain reiterated these views and said that NCEs don’t always guarantee returns on investment. It might be a better bet for India to go the complex generics route to sustain its growth momentum in the pharma industry. He urged the industry to encourage innovation in formulation development of super generics or complex generics and administer them through novel drug delivery systems to gain profits and emerge as a leader in the pharma industry.
Gembali offered a counter-view and said that India should not completely disregard development of NCEs. On the contrary, India should look at developing NCEs in a big way as it would usher more innovation in the sector and if successful, reap huge financial returns. However, he also admitted that there are bottlenecks that need to be cleared before India can grow as a major hub for NCE development. He said that this would take our achievements to the next level and help us gain more recognition in the global arena while making the industry more profitable as well. Nevertheless, he agreed that super generics and complex generics offer great growth avenues as well.
Pimplikar gave a rundown of the opportunities and challenges in the formulation development and drug delivery sector of India in the current scenario. He said that while India has sufficient talent and brain power to become a pharma powerhouse, challenges like funding, data security, etc are hampering the industry’s progress. He also spoke on the need to be more capable to deal with competition from countries like China. He also urged India to focus more on innovation to drive growth. Pimplikar was also of the opinion that getting into NCEs would require more deeper pockets and at this point of time, India might not be equipped to engage in these activities. But, with the right measures, soon India can look at extending its focus areas and leveraging opportunities which has not been tapped yet.
The panelists also interacted with the audience and there was knowledge-sharing galore at the second panel discussion of FDD Conclave 2017.
FDD Conclave hosts power discussion on future of film coating
Senior formulation scientists and R&D heads discussed the need to look beyond obvious and simple solutions as the level of complexity in the pharma industry would only increase in the coming days. This was the consensus of a power discussion on ‘The Future of Film Coating’, held on the second day of the FDD Conclave.
The hour long brainstorming session saw formulation scientists, R&D heads and members of the jury for the FDD Leadership Awards, discuss how regulations in various markets were set to change the film coating industry. They exhorted technology solution providers to look beyond the obvious simple solutions, which could be easily replicated. They emphasised that as the issues would only get more complicated, the solutions too needed to be of a higher degree of complexity. While the initial investment in researching such solutions would be considerable, this complexity could ultimately give far sighted technology providers an edge over their competitors as well as endear them to current and prospective pharma customers.
Suresh Pareek, MD, Ideal Cures; Girish Kumar Jain, President, Research & Development, Alkem Laboratories; Vinod Arora, Principal Advisor, IGMPI; Seetaraju Gembali, MD, GSR Pharma Research; Pramod Pimplikar, MD, Shalina Laboratories; Shirish Kulkarni, Senior VP- Formulation Development, Sun Pharma; Makarand Avachat, Senior VP- Pharma R&D, Lupin; Krishnakant Gandhi, Director, Delivery Manager-Generics Product Delivery Team, Dr Reddy’s Laboratories and few others were the part of the power discussion. The discussion began with a brief note by Pareek who opened the discussion by asking participants to discuss trends and issues faced by formulation scientists, their expectations from technology providers in terms of new techniques, technologies and the future of film coating.
One of the jury members suggested that there should be some mechanism to control the initial release. The present requirement is of sustained release. He further explained the difficulties of replicating the same standards between batches and pointed out that if a vendor could come out with that kind of mechanism, it would herald a new generation in film coating.
Such a solution would also be more convenient for the formulation scientist to use as the current practice involves changing the composition of the formulation and also tweaking the composition of the coating mix. The film coating industry provides coating substances in a particular pattern leaving the formulation scientist to play a role only in the composition of the formulation itself.
Discussing the requirements and expectations of pharma manufacturers from coating providers, participants explained the need to reduce the use of solvents, as the industry is moving away from solvents to aqueous. The next phase would be the move from aqueous to deposition of powder but that would be another 10 to 15 years away from now.
The participants also shared their views on technical issues faced by the coating manufacturer in coming up with the dry powder coating. They also touched on evolving regulations and how these were influencing trends in the coating industry in both domestic and global markets.
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