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FDD CONCLAVE 2019 Chairman of the Board Viveck Goenka Sr. Vice President-BPD Neil Viegas Asst. Vice President-BPD Harit Mohanty Editor Viveka Roychowdhury* BUREAUS Mumbai Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das, Prabhat Prakash, Tarannum Rana New Delhi Prathiba Raju, Akanki Sharma DESIGN Asst. Art Director Pravin Temble Chief Designer Prasad Tate Senior Designer Rekha Bisht Graphics Designer Gauri Deorukhkar Senior Artist Rakesh Sharma Digital Team Viraj Mehta (Head of Internet ) Photo Editor Sandeep Patil Marketing Team Rajesh Bhatkal, Ambuj Kumar Debnarayan Dutta, Ajanta Sengupta E Mujahid, Nirav Mistry Ashish Rampure PRODUCTION General Manager BR Tipnis Production Co-ordinator Dhananjay Nidre Scheduling & Coordination Arvind Mane CIRCULATION Circulation Team Mohan Varadkar
Express Pharma
FOREWORD INDIA'S GOT FDD TALENT! Express Pharma is honoured to present the third edition of the FDD Leaders Handbook. This continues our endeavour to shine the light on unsung heroes of the pharma sector, as part of Formulation Development and Drug Delivery (FDD) Conclave 2019. As in the past two editions, we had a tough time this year to convince formulation and drug delivery scientists that they deserve the recognition. One hopes that when we start on the next edition, the level of confidence in their abilities will rise and they come forward to be featured as role models for the industry. Set out in alphabetical order, our third compilation of FDD Leaders puts the spotlight on 25 personalities. And based on feedback to the past two editions, we've ended the book with a list of the leaders featured in the past two editions. This makes this year's edition a commendable roll call of India's most experienced as well as young, promising FDD talent. In keeping with our format from last year's edition, professionals included in the book had to fill out a form asking for details on their educational background, current designation, years of experience in the pharma sector, the areas of specialisation, number of patents filed, the awards/accolades achieved. They have also distilled their learnings and shared their success mantras, which we hope will make progress easier for many younger FDD professionals. In the same vein, their thoughts on the future of FDD give glimpses of the vast potential of this segment and we hope that it convinces more talent to follow in their footsteps and make FDD their calling. And because people are not one dimensional, we tried to get beneath the skins of these dedicated professionals and asked them about their lives beyond their work. For example, Dr C Muthulingam, Vice President – R&D, Mankind Pharma may have 20 patents filed but he is also a singer. Being part of the healthcare sector, most professionals have chosen to focus on their fitness. AV Kiran, Head Formulation Development, Excellence, Sanofi Synthelabo is a body builder since his university days and has represented Karnataka at the national level. Dr Sanjay Parbhatrao Boldhane, Sr General Manager - Formulation Development, Micro Labs has completed 12 half-marathons. Sauri Gudlavalleti, Head, Integrated Product Development Organisation, DRL is an avid cycler and also plays Carnatic classical music on the flute. But we are convinced that India's got more FDD talent that we need to discover. Do let us know what new features can be added to the next year's edition of FDD Leaders Handbook.
VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com FORMULATION DEVELOPMENT & DRUG DELIVERY CONCLAVE 2019 | 5
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CONTENTS 10
16
22
DR ABHIJIT DESHMUKH
CHIRAG SHAH
DR MD KHUBCHANDANI
12
18
24
BHARATRAJAN RAMASWAMI
HARANATH BABU BALANAGU
DR MANISHKUMAR JAYANTIBHAI CHAUHAN
14
20
26
DR C MUTHULINGAM
AV KIRAN
NAGESH NAGARAJU
6 | FORMULATION DEVELOPMENT & DRUG DELIVERY CONCLAVE 2019
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CONTENTS
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28
34
40
NITIN D SAWANT
SACHIN ARORA
SATYAVAN SHIVAJIRAO DHAVALE
30
36
42
DR PIYUSH YENKAR
SACHIN R MUNDADE
DR SANJAY PARBHATRAO BOLDHANE
32
38
44
DR RAJEEV SINGH RAGHUVANSHI
SANJAY C WAGH
SAURI GUDLAVALLETI
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CONTENTS 46
52
58
DR SWATI MUKHERJEE
VENKATA JAGANNADHA RAO BODAPATI
YOGESH BHIDE
48
54
T VIJAYA KUMAR
DR VIKRAM S GHARGE
50
56
UMESH SETTY
DR YAGNESH PATEL
8 | FORMULATION DEVELOPMENT & DRUG DELIVERY CONCLAVE 2019
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Inert spheres for drug loading or MUPS
Seal Coated Inert spheres for drug loading or MUPS
Microcrystalline Cellulose Spheres
Seal Coated Microcrystalline Cellulose Spheres
Colloidal Silicon Dioxide Spheres
Seal Coated Colloidal Silicon Dioxide Spheres
Tartaric Acid Spheres
Seal Coated Tartaric Acid Spheres Seal Coated Sucrose Spheres
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EDUCATION M. Pharm, Ph.D.
DESIGNATION Head of Global OSD and API R&D, Tech Services and Regulatory sciences, Mylan
NUMBER OF PATENTS FILED
EXPERIENCE IN PHARMA 45
21 years
SPECIALITIES Leading a team of more than 1000 scientists globally, in-depth knowledge and expertise in global generics, FTF/NDA 505B2 and NDDS formulation development, API development, scale up and technology transfer, bioequivalence studies, project management, global regulatory sciences and quality systems
AWARDS/ACCOLADES ●
●
Dr Abhijit Deshmukh
Represented the generic pharma industry at numerous FDA and ICH workshops Member of ICH Expert Working Group for drafting ICH Q13 guidance on continuous manufacturing for drug substances and drug products
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SUCCESS MANTRA
Dream big and work for it. Take bold steps and say yes to new adventures. Trust and believe in yourself, embrace failures and learn from them
THREE LESSONS AS AN FDD SCIENTIST
DID YOU KNOW?
●
He is a sports enthusiast and loves playing cricket and table tennis. He is also a pet lover
FUTURE OF FDD
Express Pharma
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●
Out-of-the-box thinking is the mantra for success. Identify, address and communicate the smallest of issues/challenge during product development for successful scale up, transfer and commercialisation Be open to learning and adapt to changes. Embrace innovation, quality and compliance your core tenets
Future formulation development will be driven by needs to actively investigate strategies for developing or improving drug delivery systems to address patient safety and convenience. It will focus on patient centric dosing, innovative and stable ways to deliver complex and combination of APIs, controlled and site-specific delivery and use of novel innovative excipients and technologies. Development will focus on accommodating emerging continuous manufacturing technology. Emerging market needs, cost and medicine access to all will also drive formulation development in future
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EDUCATION Masters of Pharmacy (Mpharm)
DESIGNATION Chief Scientific Officer (CSO), Marksans Pharma
NUMBER OF PATENTS FILED
EXPERIENCE IN PHARMA 25 years
NIL
SPECIALITIES Formulation development and ANDA
AWARDS/ACCOLADES
Bharatrajan Ramaswami
â—?
Internal company awards for outstanding projects, individual excellence and teamwork
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Be persistent and determined to overcome challenges. Go into the depth of issues and avoid superficiality
THREE LESSONS AS AN FDD SCIENTIST
DID YOU KNOW?
●
His hobbies include reading, travelling and listening to retro Bollywood music
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●
FUTURE OF FDD
Express Pharma
In formulation development and drug delivery, visual observations are important In FR&D, it is important to understand that excipients are not inert. They often have a significant role to play in initiating or participating with the active substance and lead It is a data-driven era. Even in FR&D, data would be the crucial differentiator
As Formulation development moves towards complex generics, it is essential to develop skills and competencies in this area. Data mining and data analytics will play a transformational role in formulation development
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EDUCATION M Pharm, PhD, PGDBIM
DESIGNATION Vice President – R&D, Mankind Pharma, Gurugram
NUMBER OF PATENTS FILED
EXPERIENCE IN PHARMA Over 18 years
20
SPECIALITIES Formulation development of complex generic drug products, time management and change management
AWARDS/ACCOLADES ●
●
●
Dr C Muthulingam
Member of research committees in various academic institutions to improve research and development of pharmaceuticals Awarded for best practices followed during implementation of time and change management at R&D Awarded for effective utilisation of resources and fast-track development of high-value products
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SUCCESS MANTRA
Look for a solution within the problem
THREE LESSONS AS AN FDD SCIENTIST
DID YOU KNOW?
●
He is a singer and enjoys listening to music greatly
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● ●
Use a simple strategical approach for complex problems Always use multiple strategical approach Realign the strategy as per current market requirements
Innovation in formulation development will continue to be driven by efforts to improve drug bioavailability but other factors such as patient-centricity and advances in processing and manufacturing technology will play an increasingly important part in shaping the industry
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EDUCATION M. Pharm, pursuing PhD
DESIGNATION Manager, Formulation Lead, Perrigo Laboratories
NUMBER OF PATENTS FILED
EXPERIENCE IN PHARMA 15 years
02
SPECIALITIES Formulation development for solid oral dosages forms for US, EU, JP. Expertise in modified release formulations, esp in pellets and MUPS. Technology transfer of products executed across globe in various countries
AWARDS/ACCOLADES
●
Chirag Shah
●
Employee Of The Year awarded by Watson Pharma Recognition by Actavis as a Special Contributor for product development
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SUCCESS MANTRA
Do not delve in the past. Treat each moment as a fresh opportunity to perform and excel
THREE LESSONS AS AN FDD SCIENTIST
DID YOU KNOW?
He has conducted various sessions on team building, positive attitude development, and change management for companies and colleges
FUTURE OF FDD
Express Pharma
● ●
●
Speed and flexibility are key to good business You have to understand the product to fasten development Critical and out-of-the-box thinking are a must for generic drug development
The new product pipeline is getting dry. Hence it has become imperative for the FDD community to innovate and have an out of box thinking approach. FDD needs to be flexible and open enough to look out for newer approaches to drug development in terms of sustainability and cost effectiveness
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EDUCATION M Pharma (Pharmaceutics), PG Diploma in Patents Law
DESIGNATION Head – Formulation & Process Development, Aspen Pharmacare
NUMBER OF PATENTS FILED
EXPERIENCE IN PHARMA 20 years
10
SPECIALITIES Formulation development of all dosage forms, manufacturing process development, project management, contract development and manufacturing, technology transfers to national and international sites, quality systems development, and management of complete product development cycle including dossier support
AWARDS/ACCOLADES ●
Haranath Babu Balanagu
Best performance award from his organisation
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SUCCESS MANTRA
Upgrade with new technologies and methodologies and application of basic principles to make logical and technical evaluations
THREE LESSONS AS AN FDD SCIENTIST
DID YOU KNOW?
Passionate about his work, possessing emotional balance, patience and loyalty. His hobbies are reading books and keeping a tab on current affairs
FUTURE OF FDD
Express Pharma
● ●
●
Maintenance of knowledge with integrity Collegiality is important as most of the activities are multi-disciplinary Passion, objectivity and commitment are critical
Formulation development and drug delivery mechanisms have the potential to come up with solutions for many drug-induced untoward effects and maximise the delivery of drugs to target optimally low concentrations
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EDUCATION M Pharm and Diploma in Production Management
DESIGNATION Head Formulation Development, Innovation and Manufacturing Excellence, Sanofi Synthelabo
NUMBER OF PATENTS FILED
EXPERIENCE IN PHARMA 22 years
N.A.
SPECIALITIES Specialises in generic formulation development using QbD principles, development of products with P-IV & first-to-file opportunities, bioequivalence study management, technology transfers, trouble shooting, new product launch and also has knowledge of site transfer projects
AWARDS/ACCOLADES ●
AV Kiran
●
Awarded with 'Best Employee' for the year 2009 while working for Teva Pharmaceuticals. Awards received for being the first-to-file successful ANDA application and its subsequent approvals
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SUCCESS MANTRA
Focus, hard work, teamwork, empathy, longevity and persistence - these are the words I live by
THREE LESSONS AS AN FDD SCIENTIST
DID YOU KNOW?
●
He is a fitness enthusiast and has held titles in many state and national level body building competitions
FUTURE OF FDD
Express Pharma
●
●
Good planning and a methodical approach can lead you on the path to success Beat the uncertainties with the same enthusiasm as when you found first ever opportunity Team building and empowering those around you who take decisions
Innovation and new technology will be the highlight of the future of FDD. We need to think strategically and adopt to the anticipated challenges to prepare for it as it will prove to be a highly competitive market where customer satisfaction is of supreme concern and where price competition is inevitable
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EDUCATION MPharm, PhD (Sagar)
DESIGNATION Technical Advisor, Aishwarya Group
NUMBER OF PATENTS FILED
EXPERIENCE IN PHARMA 37 years
03
SPECIALITIES Formulation development of all dosage forms, quality improvement and cost reduction of commercial products and trouble shooting
AWARDS/ACCOLADES ● ●
Dr MD Khubchandani
Received ‘Emerging R&D of the year 2002’ award for Alkem Developed several blockbuster products including Clavam, Zocef, A to Z, Taxim O and Shelcal CT
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SUCCESS MANTRA
Logical approach, based on scientific knowledge and experience
THREE LESSONS AS AN FDD SCIENTIST
DID YOU KNOW?
He has a Post Graduate Diploma in Yoga and practices pranayam and meditation on daily basis to keep himself fit and creative
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Express Pharma
● ● ●
PERT- cpm approach Techno-commercial evaluation USPs in the product to facilitate marketing
Future of FDD is bound to remain bright as basic research for NCE is cost-prohibitive
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EDUCATION M Pharma, Ph D
DESIGNATION Associate VP - Formulation and Process Development, Intas Pharmaceuticals
NUMBER OF PATENTS FILED
EXPERIENCE IN PHARMA 03
17+ years
SPECIALITIES Pharma formulation development of generic drugs for regulated market and experience in global technology transfer for oral dosage forms
Dr Manishkumar Jayantibhai Chauhan
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Positive attitude and continuous learning approach, open to accept and execute new ideas, new technology and innovations
THREE LESSONS AS AN FDD SCIENTIST
DID YOU KNOW?
He was actively involved in setting up a new state-of-the-art formulation R&D centre for Intas Pharmaceuticals
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Express Pharma
● ●
●
Develop cost-effective and robust formulation Speed is the key to success for generic industry. Work with a focussed and scientific approach as well as defined timelines Be updated with current industrial trends and regulatory requirements
The future of FDD is bright as a lot of new platform technologies are coming up. Product development with use of novel concepts will be the future
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EDUCATION M Pharma, MBA DPPM
DESIGNATION Associate Vice President, FRD Aurobindo Pharma
NUMBER OF PATENTS FILED
EXPERIENCE IN PHARMA 20 years
09
SPECIALITIES Product development using quality by design (generics/new chemical entity/branded), technology transfer projects, product life cycle management from identification to market launch. Dosage forms- solid, liquid and parenteral dosage forms, project, program and portfolio management, strategy development, coaching and team building, risk and quality program management
AWARDS/ACCOLADES
Nagesh Nagaraju
● ●
●
Make a difference’ award for outstanding leadership from Pfizer Received recognition for significant contribution from Tony Maddaluna EVP, President, Pfizer Global Supply Chairman’s Excellence Team award, Best Cross Functional team work and Complex Product Development, Best Cross Functional Initiative by Dr Reddy's Laboratories
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SUCCESS MANTRA
Knowledge, perseverance and dedication are necessary to develop any innovative technology
THREE LESSONS AS AN FDD SCIENTIST
DID YOU KNOW?
●
He has sound technical knowledge with good mentoring and team building skills
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Express Pharma
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●
Quality by design (QbD) principles are extremely crucial for product development Believe in yourself and leverage your strengths to deliver innovative formulations with a patient-centric approach Ensure that you are the first to launch a product to gain market share and for strong lifecycle management
The Indian pharma industry needs to invest wisely in R&D to sustain and grow globally. It is the backbone of pharma industry. There will be a spike in the need for cost effective medicines as the industry becomes more patient-centric. Shared learning platforms will speed up the learning of scientists
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EDUCATION M. Sc.
DESIGNATION Assistant General Manager – Formulation Development, J. B. Chemicals & Pharmaceuticals
NUMBER OF PATENTS FILED
EXPERIENCE IN PHARMA 29+ years
02
SPECIALITIES Development of oral solid dosage forms
Nitin D. Sawant
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SUCCESS MANTRA
Stop obsessing over limitations and start thinking in terms of possibilities
THREE LESSONS AS AN FDD SCIENTIST
DID YOU KNOW?
●
He believes very strongly in the power of positivity
●
●
Only those who have the patience to do simple things perfectly will acquire the skills to do difficult things easily. Think positively and positive things will happen in your life. To act with courage and dignity, and to stick to the ideas that yield definite results takes you on the path of success.
The future of FDD looks great. It is being built as we speak, and I am confident that despite the challenges, the industry will flourish
FUTURE OF FDD
Express Pharma
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EDUCATION M Pharm, PhD, MBA
DESIGNATION Chief Scientific Officer, Enaltec Labs
NUMBER OF PATENTS FILED
EXPERIENCE IN PHARMA 18 years
08
SPECIALITIES Pharma product development for complex generics and drug delivery systems with techno commercial strategic planning
AWARDS/ACCOLADES â—?
Dr Piyush Yenkar
Gold medal for first position in M Pharm from JSS College of Pharmacy, Mysore
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SUCCESS MANTRA
Success is the outcome of hard work, dedication, determination, conviction, perseverance, observation, innovation, creativity and decision making
THREE LESSONS AS AN FDD SCIENTIST
DID YOU KNOW?
I am an explorer and am passionate about travelling. I also harbour an avid interest in literature and performing arts.
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Express Pharma
●
●
●
Knowledge and understanding of all operational areas leads to successful product development Quick learning and better understanding of product technology, global regulatory scenario and market dynamics makes a product successful Believe in the power of failures. Learn from them and do not repeat the same mistakes
The future of formulation development and drug delivery will always remain great as the world is in a constant need of cost effective medicines and hence the search for innovative and novel formulations is a continuing event. A lot of innovation can come from developing a better understanding of the disease and targeting specific sites rather than investing only on the identification of new molecules. There is a lot of potential in identifying new indications for existing drugs, development of alternative delivery routes, need for combination products to reduce total daily doses of medication, etc.
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EDUCATION PhD
DESIGNATION Senior Vice President & Head of BRaIN, Dr Reddy's Laboratories
NUMBER OF PATENTS FILED
EXPERIENCE IN PHARMA 30 years
70+
SPECIALITIES R&D Leadership
AWARDS/ACCOLADES
●
●
●
Dr Rajeev Singh Raghuvanshi
●
Chairman’s Excellence Award for Most Innovative Team of DRL 2012 Chairman’s Excellence Award for development, filing and 1st cycle FDA approval of DRL’s 1st Innovative, auto-injector based 505b(2) product – 2016 Honorary Adjunct Faculty for Pharmaceutics at IIT – BHU, 2016-17 Frequently invited to speak on pharma innovation at national and international forums
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Challenge the status quo and look for innovation and opportunity in whatever you do
THREE LESSONS AS AN FDD SCIENTIST
DID YOU KNOW?
He led an FDD activity for six 505b(2)s and received first cycle approval for all of them from the US FDA
FUTURE OF FDD
Express Pharma
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FDD has become largely interdisciplinary, so expand your knowledge beyond what you know today Be grounded in science – there is no alternative to knowledge for an FDD scientist Learn from your team members- everyone has some knowledge to share
FDD has shifted significantly from simpler dosage forms. A good number of newer approvals in the US are based on collaborative development among scientists and technologists from varied fields, e.g., polymer chemists, product designers, computer scientists, mechanical engineers, material scientists and many more. So, success will come to those FDD scientists who are receptive, dwell on interfaces, have ability to join dots, get encouraged by failures, are risk takers, networkers and possibility thinkers. India is sitting on a huge opportunity and the future of FDD looks bright. Take the plunge, be a leader and show the path
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EDUCATION MS (Pharm), NIPER, Mohali
DESIGNATION Director, Dr Reddy’s Laboratories
NUMBER OF PATENTS FILED
EXPERIENCE IN PHARMA 16+ years
06
SPECIALITIES Oral solid dosage formulation development and scale-up, tech transfer of generic pharma products for regulated markets. Successfully led multiple teams for product development
AWARDS/ACCOLADES ●
● ● ●
Sachin Arora
● ●
Dr Anji Reddy Awards for Excellence 2019 – Best R&D Team Category – Integrated Development Team Six Sigma Green Belt Certified from ASQ Ranbaxy Appreciate Programme – Team Excellence Award 2011 Ranbaxy Appreciate Programme – Team Excellence Award 2010 Ranbaxy Appreciate Programme – Team Excellence Award 2007 GATE (2001): All India Rank 1st
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SUCCESS MANTRA
Success is the result of perfection, hard work, learning from failure and persistence. Stay focused and be open to learning
THREE LESSONS AS AN FDD SCIENTIST
DID YOU KNOW?
●
A perfectionist by nature, he is always strives to be better than yesterday in all walks of life
●
●
FUTURE OF FDD
Express Pharma
Applying a structured and well-analysed approach at an early stage reduces risk in product development process, avoids costly late-stage failures, and helps achieve targets on time Constant investment is required in innovative processes and newer technologies to meet the needs of the ever-more demanding markets in a better way Ability to perform individually, and in a team, is key to high creativity, problem solving and productivity
The future of FDD lies in making efforts in the direction of improving manufacturing technologies, outsourcing and innovation towards customised and targeted drug delivery. There is a great opportunity for innovation, considering the shift towards personalised medicines and continuous manufacturing. Global regulatory challenges, quality, patient compliance and consumer preferences, along with cost consciousness will be the future drivers of FDD. Green and eco-friendly technologies are also likely to gain global acceptance. Disruptive innovation in both, conventional and unconventional dosage forms, may change the existing trends in FDD
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EDUCATION M Pharm – Pharmaceutics
DESIGNATION Senior General Manager, Micro Labs
NUMBER OF PATENTS FILED
EXPERIENCE IN PHARMA 20+ years
28
SPECIALITIES Product and process development of solid dosage forms and sterile formulations; bio equivalence and regulatory requirements for various markets of the globe, patent analysis, proficient in technology transfer
AWARDS/ACCOLADES ●
●
Sachin R Mundade
Speaker at Pharma Leaders Conclave on ‘Transfer of Technology in Pharmaceutical Manufacturing’ Speaker in QBDCON – National Conference on Recent Developments, Practical and Regulatory Aspects of Quality by Design
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SUCCESS MANTRA
Action is the foundational key to all success
THREE LESSONS AS AN FDD SCIENTIST
DID YOU KNOW?
●
He is associated with social groups which take up tasks to save Mother Earth
FUTURE OF FDD
Express Pharma
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●
Be the best at what you do Envision your future and develop a plan of action to achieve it, remember vision without execution is hallucination To be a successful scientist have a constant thirst for knowledge, be creative and agile
The pharma industry is going through a difficult yet interesting phase. In the current scenario, there is an increased pressure on price which is creating demand for value-added products, but has also been impacted by declining product pipeline. In order to take on these challenges and exploit new opportunities, it is imperious for pharma industry to keep pace with emerging technologies and adopt competent and agile operating models. A switchover from product-centric to patient-centric approach to deliver better outcomes at lower costs is a must-have strategy for companies to succeed
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EDUCATION MPharm, DBM
DESIGNATION Vice President, Lupin
NUMBER OF PATENTS FILED
EXPERIENCE IN PHARMA 23 years
10
SPECIALITIES Pharma product development and technology transfer (generic medicine, drug delivery systems, QbD and NCE formulations)
AWARDS/ACCOLADES â—?
Sanjay C Wagh
Young Achievers Award presented by Lupin
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SUCCESS MANTRA
Self belief and hard work will always earn you success
LESSONS AS AN FDD SCIENTIST
DID YOU KNOW?
He successfully implemented QbD-based development for regulated market in his current organisation
FUTURE OF FDD
Express Pharma
â—?
â—?
Innovation, speed and doing things first time right are keys to success in the generic pharma industry Robustness cannot be tested into a product It must be incorporated into design and development of the product
The entire pharma sector is in need of innovative technological solutions enabling the development of targeted drug delivery, especially in anti-cancer therapy. Similarly, for generic pharma industry, this is the period for complex generics. Complex generics could have a complex active ingredient, complex formulation, complex route of delivery, or complex drug device combinations. Focus on complex generics will deliver more value to patients by addressing additional unmet needs and enable companies to achieve market differentiation and opportunities for higher margins.
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EDUCATION M.Pharm (Bio Pharmaceutics)
DESIGNATION Associate Vice-President (Formulation & Development) Intas Pharmaceuticals
NUMBER OF PATENTS FILED
EXPERIENCE IN PHARMA 06
18 years
SPECIALITIES Designing and formulation development of various dosage forms for global market. Viz Regulated,Emerging & Domestic.; specialises in complex development products for solid & liquid oral; development of novel process and formulation of rare, incompatible drugs in fixed dose combinations
Satyavan Shivajirao Dhavale
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SUCCESS MANTRA
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Dedication and hard work are the keys to success. Be positive towards challenges in both professional and personal lives
THREE LESSONS AS AN FDD SCIENTIST
DID YOU KNOW?
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He is a sports enthusiast. He also has a passion for cars and loves to go on long drives
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Express Pharma
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Be optimistic and strive towards achieving your goals, no matter the challenges Change with change and keep pace with the world's speed Failure is not the end but a stepping stone to success
Formulations manufactured in India constitute 20 per cent of the global generics market by value. Moreover, the overall share of Indian manufactured formulations is as high as 46 per cent in the generics segment in the emerging markets, claiming a unique share in the global market by leveraging the latter's strengths and enhancing its regulatory and technical maturity. FDD has been always a platform for scientists to excel and showcase their talent, providing a benchmark for a vast pool of trained pharmaceutical scientists and researchers. This opens up avenues for collaborative thinking, gaining updates on novel research for new drug discoveries
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EDUCATION M Pharm, Ph D
DESIGNATION Sr General Manager Formulation Development, Micro Labs
NUMBER OF PATENTS FILED
EXPERIENCE IN PHARMA 18
23 years
SPECIALITIES Drug delivery, solid dosage forms, sterile dosage forms and topicals
AWARDS/ACCOLADES â—?
Dr Sanjay Parbhatrao Boldhane
Best Scientists Award by Abbott in 2010
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Work with basic science and use it for innovative and differentiated product development
THREE LESSONS AS AN FDD SCIENTIST
DID YOU KNOW?
He likes to deliver lectures on physical pharmacy and research methodology. He is also a fitness enthusiast and has completed 12 half marathons
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Plan the experiment properly by considering all the variables, then evaluate and interpret the results carefully Keep learning newer concepts and technologies Develop the product considering cost and benefits to the patients
It can provide a common platform for scientists and regulators to design and develop products that cater to unmet medical needs
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EDUCATION BTech, MS and MBA
DESIGNATION Head — Integrated Product Development, Dr Reddy’s Laboratories
NUMBER OF PATENTS FILED
EXPERIENCE IN PHARMA 08
04 years
SPECIALITIES R&D management across industries, product/portfolio management, product design to value, cost optimisation and product development for emerging markets
AWARDS/ACCOLADES ●
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Sauri Gudlavalleti
President of India Gold Medal for best paper in Journal of IE(I) 1995 MIT Student Activities Leadership Award 2001 Gold Medalist at IIM Ahmedabad 2009 13 publications in variety of journals and conferences
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SUCCESS MANTRA
When working in any new area, get into as much depth as possible. When working with new people, always assume they mean well
THREE LESSONS AS AN FDD SCIENTIST
DID YOU KNOW?
He is a mechanical engineer who leads a pharma R&D centre. An avid cycler, he plays carnatic classical music on flute
FUTURE OF FDD
Express Pharma
Accelerate formulation development and manufacturing through: ● Automation ● High throughput screening ● Continuous manufacturing
There are many other industries where formulations are made – and some of them are more advanced as compared with pharma. Maybe there is something we can learn from there
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EDUCATION M. Pharm, PhD (Pharmaceutics)
DESIGNATION HOD, Formulation R & D, Kusum Healthcare
NUMBER OF PATENTS FILED
EXPERIENCE IN PHARMA 16+ years
10+
SPECIALITIES Formulation development of conventional and modified release pharma dosage form. Experience in diversified dosage forms like solid orals, semi solids for topicals, oral liquid, suppositories, inhalers and nutraceuticals/dietary supplements
Dr Swati Mukherjee
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Stay positive and learn from failures.Stay updated with recent trends in the pharma industry. Do the best for your organisation and your team
THREE LESSONS AS AN FDD SCIENTIST
DID YOU KNOW?
An ardent book lover. She is also associated with an NGO that works for education for underprivileged children
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Formulation development requires both passion and dedication. Keep an open mind for innovation and learning Be observant while analysing data and evaluation of products. Sometimes small changes in data trends could lead to success or failure Stay updated with changes in regulatory policies and patent interpretation for different markets while formulation development
R&D is crucial to any pharma company for a continuous product pipeline and to gain a competitive advantage. Even more so as the concept of personalised medicines becomes the new way of treatment. This will lead to opportunities for the formulators to think out of the box and custom formulate for specific needs of specific age groups. It may also lead to formulation of an interesting combination of medicines with dietary supplements. So, we need to be updated with ever changing challenges in the field of technology, regulation and quality compliance. As part of a knowledge-based industry we should embrace success and failure with an open mind
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EDUCATION M Pharm
DESIGNATION Senior Vice President—Pharma Research, Sun Pharma
NUMBER OF PATENTS FILED
EXPERIENCE IN PHARMA 25 years
20
SPECIALITIES Development of speciality products in inhalation, ophthalmic and oral segments, expertise in complex product and process development, proficient in regulatory and IP strategy development. Expertise in getting unconventional strategies approved from regulatory agencies (FDA/Health Canada/MHRA/ANVISA)
T Vijaya Kumar
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There is no substitute for hard work. Disciplined and focussed execution is the key to success
SUCCESS MANTRA
THREE LESSONS AS AN FDD SCIENTIST
DID YOU KNOW?
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An avid cricket fan, he loves playing and watching cricket. He also loves reading books
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To succeed in a crowded space one has to be ahead of others and this is achieved by compliance-oriented thinking In the fast-changing regulatory environment, working with the FDA to develop strategies will enable faster regulatory approvals There is no alternative to in-depth scientific understanding of domain knowledge
With more and more treatment options available in markets, FDD has multiple opportunities to improve patient experience by serving their unmet needs. However, with more complex drug delivery systems available in the market, it also increases the risk of failure due to limitations of understating product behaviour in the body. FDD gives the opportunity to collaborate with information technology experts, device engineers, clinicians and many more to bring optimal products to market
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EDUCATION Master of Pharmacy
DESIGNATION Senior Vice President (Formulation development), Caplin Point Laboratories
NUMBER OF PATENTS FILED
EXPERIENCE IN PHARMA 07
17 years
SPECIALITIES Working on challenging, tough to develop projects for regulated markets
Umesh Setty
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SUCCESS MANTRA
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Any productive activity should not be delayed. Also, steer clear from any politics at the workplace
THREE LESSONS AS AN FDD SCIENTIST
DID YOU KNOW?
Mentoring is his passion, he has helped many freshers kickstart their career in the pharma industry
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Develop skills in converting the bulk to dosage form Have a strong hold in pharmacokinetics Having good scale-up skills are a must
Formulation development is always flourishing. Different dosage forms are coming with many patent/BE/scalability challenges. All countries are making their regulatory norms more stringent and this opens more opportunities for pharma R&D personnel. Innovator companies are extending the lifecycle of molecules by changing dosage forms or adding side chains to molecules giving new opportunities to formulation scientists. Nowadays, with China strengthening their regulatory norms for generic formulations with generic consistency evaluation, big opportunities are coming up for formulation scientists of India
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EDUCATION M Pharm (Pharmaceutics)
DESIGNATION Vice President—R & D Medle Pharmaceuticals
NUMBER OF PATENTS FILED
EXPERIENCE IN PHARMA Over 24 years
02
SPECIALITIES Pharma and nutra products development, development of solid oral dosage forms, multi-unit particulate system products, liquid orals and ophthalmic products. Product and process development and optimisation using DOE. Proficient in regulatory and quality systems
AWARDS/ACCOLADES
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Venkata Jagannadha Rao Bodapati
R&D award for implementation of Project Kavach at R&D
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Be creative and innovative, and grab opportunities at the right time
THREE LESSONS AS AN FDD SCIENTIST
DID YOU KNOW?
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Avid cricket fan. Kapil Dev is his favourite cricketer. Loves to travel and explore nature
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FUTURE OF FDD
Express Pharma
Curiosity, out-of-the-box-thinking, excellent analytical and problem-solving skills are the key qualities required to be successful as an FDD scientist Be a quick learner and work with enthusiasm and zeal. With continuous evolution of new technologies and rapidly changing regulatory framework, it is important to be abreast with new technologies and regulatory guidelines Be a role model to the team and lead the team to achieve organisational goals with dedication and hard work
Future of FDD lies in the discovery of new active pharma molecules and developing new platform technologies and targeted drug delivery systems for diseases like cancer and diabetes. Moreover , successful and affordable development of biosimilar formulations is important for the future of FDD. There are untapped opportunities and potential in plant-based and nutraceutical products. So, tapping these opportunities and developing scientifically-proven formulations is also important
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EDUCATION PhD, M.S., B.Pharm
DESIGNATION Associate Director, Emcure Pharmaceuticals
NUMBER OF PATENTS FILED
EXPERIENCE IN PHARMA 20 years
07
SPECIALITIES Pharma product development and process development. Proficient at building quality systems
Dr Vikram S Gharge
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Set a goal and acquire the required knowledge using the 3Ds - Determination, Dedication and Devotion
THREE LESSONS AS AN FDD SCIENTIST
DID YOU KNOW?
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He is a voracious reader and reads across multiple genres. He also enjoys extempore speaking
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Express Pharma
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An innovative mind can bloom technologies Be a quick learner, and stay up to date with the rapidly changing requirements Adapt to new technologies and equipment to fasten the development processes
It is important for the industry to put research efforts in creating new technologies to have outside-in approach. Another factor is time. FDD scientists are often working against time, keeping in mind the competitive nature of the pharma sector. Delays could mean a loss of market share while poor quality could mean batch recalls and loss of reputation. Forecast by ICRA says that FDD scientists will have to stretch their budgets, and yet be more innovative and creative in their development strategies. The future of FDD lies in having insights in development of complex generics and ensuring regulatory perspective in pharma formulation. We also need to expand India’s talent pool
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EDUCATION MPharm, PhD (Pharmaceutical Sciences)
DESIGNATION General Manager— Contract Pharmacal Corporation
NUMBER OF PATENTS FILED
EXPERIENCE IN PHARMA 14+ years
NA
SPECIALITIES Pharmaceutical product development of generic solid oral dosage forms, product development and scale up using QbD
AWARDS/ACCOLADES ●
Dr Yagnesh Patel
Gold medal for being the university topper in B Pharmacy
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SUCCESS MANTRA
Never give up and trust your crazy ideas
THREE LESSONS AS AN FDD SCIENTIST
DID YOU KNOW? He is involved in the setting up of formulation lab for his current organisation to serve regulated markets. Besides, he strongly believes in exercise to keep himself healthy and fit
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Research needs focus, patience and determination Focus on simple yet innovative and cost-effective formulation Keep updating yourself in the fast-growing market to be in the competition
Formulation development is an art. However, the road to success can be fraught with many obstacles and challenges. Two important skills that are essential for formulators are a strong command of science and theory, and excellent communication. Formulation is an art based on science and theory. There are tremendous opportunities in drug delivery systems to minimise side effects. However, scientists need to integrate pharma science with advanced technology in a costeffective manner, considering patients' needs
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EDUCATION M.Pharm, MBA
DESIGNATION Senior General Manager, F&D, Indoco Remedies
NUMBER OF PATENTS FILED
EXPERIENCE IN PHARMA 24 years
10
SPECIALITIES Specialised in product development for India and ROW markets for various dosage forms
Yogesh Bhide
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SUCCESS MANTRA
Innovation is as important as invention
THREE LESSONS AS AN FDD SCIENTIST
DID YOU KNOW?
He loves Indian classical music and is a voracious reader with interests ranging from ancient history to current affairs
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Express Pharma
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There is no shortcut for quality products Failures at R&D Lab can be the foundation for sustained success Revisiting a concept opens up newer possibilities for innovation
FDD is an ever-changing field. In pursuit of offering improved, better and safe formulations, this area is deriving expert knowledge from diverse fields that otherwise can be thought of as unconventional . Thus, it is indeed interesting and enlightening to be part of such a fraternity wherein inventions and innovations go hand in hand
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FDD LEADERS 2018 DR AMIT MUKHARYA
DHANANJAY SAPRE
DR KAVITA INAMDAR
DR NARENDRA SONI
DR ASHOK OMRAY
ELAYARAJA NATARAJAN
KISHOR DEO
NITIN DESHMUKH
ANANDARUP DATTA
GANESH N PHADTARE
MANJURAHAMAD S MOMIN
PANKAJ SMANDPE
ANIL KUMAR R
HEMANT B NARKHEDE
DR MANISH CHAWLA
DR PACKIARAJ JEYACHANDRAN
ARJUN SINGH DASOONDI
I. SRINIVAS
DR MANUTOSH ACHARYA
DR PRAVEEN KHULLAR
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DR PUSHPALATHA HB
DR RAVEENDRA PAI
SUBHRANGSU SENGUPTA
JATIN GAJJAR
DR RAJAN VERMA
DR RAVIRAJ PILLAI
DR TG CHANDRASHEKHAR
PANKAJ SMANDPE
DR RAJESH SIRWANI
SAPNA RAMESH
DR VALLABH PANSURIYA
PREETI P RAUT
DR RATNAKAR P MEHENDRE
DR SRINIVAS ARUTLA
DR VENKATARAMANA NAIDU
DR RAHUL S DABRE
DR SUMEDHA NADKAR
DR BIJAY KUMAR PADHI
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FDD LEADERS 2017 DR HIMADRI SEN
PRAMOD PIMPLIKAR
DR VIJAYSINH VANVIRSINH CHAUHAN
RAJESH KSHIRSAGAR
RAMESH JHAWAR
SEETARAJU GEMBALI
MAKARAND AVACHAT
SRIKANT V PIMPLE
DR MILIND BIYANI
DR SHIRISH KULKARNI
DR JAYANT KARAJGI
JAYA ABRAHAM
VINOD KUMAR ARORA
ARUN KUMAR PANDEY
SUSHRUT KULKARNI
ULHAS DHUPPAD
DR GIRISH KUMAR JAIN
RAVINDER KODIPYAKA
SUKHJEET SINGH
DR KRISHNA MURTHY BHAVANASI
DR SUNIL B ROY
DR PRAKASH SHETIYA
PVS NARASIMHAM
SANDHYA SHENOY
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DR GOUTAM MUHURI
CHANDRASHEKHAR KANDI
KRISHNAKANT GANDHI
NAGAPRASAD VISHNUBHOTLA
DR PANKAJ KUMAR KHAPRA
JAGDISH C KOSHTI
DR PAVAN BHAT
DR. (MS.) MONIKA SRIVASTAV
PRATIBHA OMRAY
KAMAL S MEHTA
SUNIL TIWARI
HITESH KUMAR MAHESHWARI
DR VEERABABU TADURI
SARABJIT SINGH
DR RAKESH BHASIN
DR J SURYAKUMAR
DR PRAFULLA S CHAUDHARI
DR DEEPAK GONDALIYA
DR AMIT BISWAS
ASHISH GOGIA
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INSTACOAT FILM COATING SYSTEMS
PHARMA ACRYLIC COPOLYMERS
Immediate Release Film Coatings
L 30D 55
Moisture Barrier Film Coatings
L100 55
Delayed Release Film Coatings
L100
Sugar Film Coatings
S100
INSTAMODEL BLEND
EXTENDED COOLING BOOSTERS
Tailor made ready-to-use ploymer blend
Available as Pellets, Solution and Powder
Inert spheres for drug loading or MUPS
Seal Coated Inert spheres for drug loading or MUPS
Microcrystalline Cellulose Spheres
Seal Coated Microcrystalline Cellulose Spheres
Colloidal Silicon Dioxide Spheres
Seal Coated Colloidal Silicon Dioxide Spheres
Tartaric Acid Spheres
Seal Coated Tartaric Acid Spheres Seal Coated Sucrose Spheres