Pharma & IP Workshop

Novotel HICC, Hyderabad, 2023-08-26

Pharma & IP Workshop

Step into the world of pharmaceutical innovation and intellectual property at the "Pharma and IP Workshop." Scheduled for August 26th, 2023, this event is your gateway to understanding the intricate interplay between pharmaceuticals, regulatory compliance, and intellectual property strategies. Join us on August 26, 2023, at Novotel HICC Hyderabad to expand your knowledge and gain valuable insights in the Pharma industry.

Event Highlights:

Regulatory compliance and approval process.
Research and development for drug discovery.
Abbreviated New Drug Application (ANDA) requirements.
US FDA approval process and pathway.
Patent protection and exclusivity considerations.
Novelty criteria and trade secrets protection.

Speakers

Sumesh Reddy

Global head of IP
Cipla

Dr. Venkat Reddy Donthi Reddy

Senior Advocate

Dr. Krishnaji Rao

Divis Laboratories

Rajeshwari Hariharan

Founder
Rajeshwari & Associates

Gautam Bakshi

Head & Patent Counsel- IP Management
Unichem Laboratories Ltd

Tarun Khurana

Partner
Khurana & Khurana

Viswaprasad Varanasi

Head - Global IP Mgt & Portfolio Planning Shilpa Medicare Ltd.
Shilpa Medicare Limited

Ifrazunnisa Khan

Manager
Tatva Legal

Shikha Singh

Managing Associate
LexOrbis

Sridevi Kasu

Head-Intellectual Property
Aurigene Pharmaceutical Services Limited

Kirit Palsana

Director - India Operations (Software Development)
Knovos

Prof. (Dr.) Amit Kumar Tiwari

Senior Patent Associate
R. K. Dewan & Co.

Justice Sri C V Bhasker Reddy

Judge
High Court for the State of Telangana

Dr. Amaresh Panda

Head Technology Transfer Office
KIIT-TBI TTO

Priyanka Gupta

Associate Partner
LexOrbis

Jyoti Chauhan

Chief Manager-IPR
Gujarat Fluorochemicals Limited

Dr. Patnala Sri Rama Chandra Murthy

Director, Head - IPR department
Neuland Laboratories Limited

Dr.Pushpa Latha Raju

Managing Director and Founder
Dr. IP Essence

Dr. Krishnaji Rao

Divis Laboratories

About the speaker

I. EDUCATION

Ph.D. -Applications of Enzymes in Chiral resolutions - Kakatiya University, Warangal, 2006

PGDPL- NALSAR, Hyderabad, 2001

M.Pharm- College of Pharmacy, Manipal, 1995

B.Pharm- College of Pharmacy- Manipal, 1993

II. INDUSTRIAL EXPERIENCE (From 1995 to till date)

General Manager, Research and Development, Divis Laboratories Ltd.

Responsible for the development of novel economic/improved and industrially feasible processes for commercial manufacturing of Active Pharmaceutical Ingredients and intermediates therein, Synthesis design, evaluation of process feasible studies by considering EMS guidelines, technical advancement and commercial viability, patent non-infringement confirmation, FTO declarations, Process costing evaluations, quality Audits (ISO 9001, 14001, 18001 and 45001), regulatory inspections, statutory audits (Pollution control audits and Safety Audits), process troubleshooting studies, Root cause evaluation on impurities formation, mitigation and synthesis of impurities for validation studies, Qualitative and Quantitative analysis, Spectral data evaluation, 2D NMR structure analysis, and quantitative spectral analysis.

Custom synthesis and CRO for global innovator companies, handling of high energetic reactions and high potency compounds, handling of highly hazardous NBL/Cyanide/metals, high-pressure reactions, and cryogenic reactions.

III. ACADEMIC/TEACHING EXPERIENCE

Faculty, Pharmexcil (Pharmaceutical Export Council) of India, Ministry of Commerce, Govt of India

Faculty, Global conferences in the field of Pharmaceutical Sciences and IP.

Visiting Faculty, in the field of Pharmaceutical Sciences at Indian Universities

Research Director, GITAM deemed to be University, Visakhapatnam.

External Thesis examiner for Post graduation and Doctoral programs in Pharmaceutical sciences.

IV. LEADERSHIP (selected a few)

Member of the core team on Amendments of Newly Amended Drugs and Cosmetic Act 2021 regarding Rare Diseases and Orphan Drugs
Secretary, Indian Organisation for Rare Diseases.

Chairman Board of Studies Governing body, MRIPS, Hyderabad
Management Representative, Divis Research Centre, Hyderabad

VI. HONORS AND AWARDS (selected one):

• Recipient of Udyog Ratna Award from DTA, Hyderabad 2019

Rajeshwari Hariharan

Founder

Rajeshwari & Associates

About the speaker

Rajeshwari Hariharan is the founder of Rajeshwari & Associates, a full service law firm based at New Delhi (India), specializing in the field of Intellectual Property including Patents & Designs, Trade Mark, Copyright, Plant Variety Registration, Geographical Indicators, besides other regulatory and allied areas.

After completing her Master’s Degree in Biotechnology and Bachelor’s Degree in Law, she was admitted to the Bar in 1993 and practiced as an advocate before the courts in Pune as well as the High Courts at Delhi and Bombay.

Ms. Rajeshwari led the patent litigation practice and played a key role in managing and growing the patents team in a reputed and leading Delhi-based law firm. She parted as an equity partner from the firm after almost 14 years, to set up Rajeshwari & Associates.

With over 20 years experience in legal practice, Ms. Rajeshwari’s areas of practice include counseling on issues relating to patent and infringement including rendering patentability opinions, drafting technology transfer and know-how agreements, licences, assignments; prosecution of patent applications in the field of pharmaceuticals, biotechnology and biochemistry.

Ms. Rajeshwari was an active member of the legal team engaged for advising on issues related to reform initiatives in India. She has also advised clients on various aspects of Foreign Direct Investments, entry strategies, structuring of investments and acquisitions, drafting and negotiating of contract documents, as well as advised several clients on diverse high value and precedent-setting dispute resolutions.

She has rich experience in carrying out due diligence and handing of patent oppositions, revocations and appeals before the Patent Office and other higher for authorities. Currently, she handles patent and other litigations at the Supreme Court of India and various High Courts across India.

Besides authoring several articles, Ms. Rajeshwari is regularly invited to present papers and speak at various conferences and seminars in India and Abroad. Moreover, she has been rated by Chambers and Partners and Intellectual Asset Management magazine as one of the leading patent lawyers in the country.

Tarun Khurana

Partner

Khurana & Khurana

About the speaker

Tarun has over 17 years of experience in a broad range of Intellectual Property (IP) subject matters, and is the Co-Founding Partner and Patent Attorney of Khurana & Khurana (K&K) and of its Patent Research and IP Asset Management Firm, IIPRD, both of which are among the Leading IP and Commercial Law Practices with 10 Offices in India, and over 160 Professionals. The firms also have regional offices in US, Vietnam, Myanmar, Bangladesh, Malaysia, Sri Lanka, and Nepal.

Tarun is ranked among the top Patent Practitioners in India by IAM 1000 (and also by IAM 300 Strategists), and focuses on Patent Litigation, Portfolio Management, and Strategic Valuation and Commercialization matters for numerous Indian and International Corporates ranging from Small Start-ups to Fortune 5 companies. Tarun extensively focuses on representing clients at the various High Courts in India, along with other Judicial forums including the IPAB, Patent Offices, NCLT, and allied tribunals.

Tarun focuses on Core-Electronics, SEP, Telecom, Computer Implemented, and Mechanical subject matters, and has also represented Corporates/Institutes across other technical and business domains. He also overlooks the firm’s prosecution matters for representation of Indian and International Clients, also actively works with the Patent Support Team while representing numerous US and European Law and Licensing Firms and Corporates in providing Patent Support Services such as Conducting Patent Searches, Preparing Claim Charts, Preparing Specifications/Responses to offices actions, undertaking Landscape/Analytics, E-Discovery Support among other like mandates that IIPRD focuses on.

Tarun is well versed with US, EP, and Indian Patent Laws. Tarun has a Bachelors in Computer Science Engineering from Pune University, a Masters in Software Systems from BITS Pilani, Bachelors in Law, an MBA from IIM Lucknow, and is in pursuit of his PhD. He also has certifications from IIT Delhi, WIPO, Asian School of Cyber Laws, Indian Law Institute, and International Software Testing Board among many others. Tarun is also a regular speaker at numerous Institutes and Corporates including International Conferences such as GIPC, WIPF, CII, FICCI, along with at entities such as NTPC, Indian Oil Corporation, IITs, TIFAC, DIT, CSIR, Moserbaer, IIM Lucknow, Mahindra, Daimler, ASSOCHAM, Managing Intellectual Property (MIP), Indian Oil Corporation, NALSAR, ONGC, Delhi Technical University, and Tata Group Companies among many others.

Prof. (Dr.) Amit Kumar Tiwari

Senior Patent Associate

R. K. Dewan & Co.

About the speaker

Dr. Amit Kumar Tiwari is a chemist by education, patent agent and expert by profession, science journalist by interest, and educator by passion. He works in the Chemical, Pharmaceutical, and Lifesciences domain. He is a Graduate in Science from Bhopal University Bhopal, a Postgraduate in Pharmaceutical Chemistry from Devi Ahilya Vishwavidyalaya, Indore, and a Ph.D. degree holder in Chemistry with a specialization in Medicinal Chemistry from Jain University, Bangalore. He also earned Post Graduate Diploma in Cheminformatics from the Institute of Cheminformatics Studies, Noida, and a Post Graduate Diploma in Patent Law from the National Academy of Legal Studies and Research (NALSAR) the University of Law, Hyderabad. He is a certified IP professional in Intellectual Property Management from World Intellectual Property Organization (WIPO) World Wide Academy, Geneva Switzerland, and also certified in Intellectual Property and Cyber Law from the Asian School of Cyber Laws, Pune, India. Dr. Tiwari is well-certified by the European Patent Academy of European Patent Office (EPO), Munich Germany. Dr. Tiwari is a certified professional in competitive intelligence, acquisition, and mergers (Financial Management Training Center, Arlington). Dr. Tiwari is certified in Innovation Management from the Rotterdam School of Management, Erasmus University, Rotterdam, The Netherlands. Dr. Tiwari has completed with distinction a course in Business Management from Oxford, UK. Dr. Tiwari is also a certified healthcare professional from World Health Organization (WHO), in Geneva Switzerland.

Dr. Tiwari is engaged in the field of Intellectual Property primarily in the field of Patents for around 23 years. He is involved in patent information and patent analytics, drafting, filing & prosecution of patent applications in various fields including Generics, more particularly in active ingredients (AI), active pharmaceutical ingredients (API), and formulations. Dr. Tiwari was associated with premium research institutes such as the National Institute of Pharmaceutical Education & Research, Mohali Punjab, Regional Research Laboratory (CSIR) Bhopal, Indian Grain Storage & Management Research Institute (IGMRI) Hapur Uttar Pradesh, M.P. Council of Science & Technology Bhopal, Indian Institute of Science (IISC), Bangalore, etc. for his training and research work. He has worked in various national and multinational companies for over 17 years in the field of Intellectual Property Management and was the founder member (R & D). He is instrumental in setting up the Intellectual Property Department in Corporates & Academia. Dr. Tiwari was associated with Medicorp Technologies India Limited (Organic Synthesis, Chemical information & Patents), Jubilant Organosys Limited (Intellectual Property and Information Management API & Formulations), Orchid Chemicals & Pharmaceuticals Limited (Intellectual Property Management-– API & Formulations), Nectar Lifesciences Limited (Intellectual Property Management – API & Formulations), Micro Labs Limited (Intellectual Property Management-– API & Formulations), Hikal Limited (Intellectual Property Management – AI, API, Agrochemicals Formulations, Custom & Contract Manufacturing). Dr. Tiwari has several years of teaching experience in Chemistry and Intellectual Property, particularly Patents. Prior to joining R.K. Dewan & Co., he was the Professor, Head, and Founder of the Intellectual Property Department at Symbiosis Centre for Research and Innovation (SCRI), Symbiosis International (Deemed University), Pune, India (38th best university and 10th most innovative deemed university in India). He likes to work in interdisciplinary areas which cut across science, technology, legal research, and management. He has authored more than 33 research papers in various national and international journals and has credits for 14 patent applications filed in various countries. He is actively writing in Daily Newspapers and published various general articles in various fields of education, innovation, science & technology. Dr. Tiwari is a worldwide promoter of Patinformatics and has a blog Worldwide Updates on IP Events, which has a global reach of around 140 countries.

Dr. Tiwari is a renowned speaker in the field of Intellectual Property, particularly in Patent information, Patent analytics, and Patent data mining. He has been recognized as Top 100 IP Leaders in India by World Intellectual Property Forum in the year 2018. Dr. Tiwari is recognized as a Mentor of Change (Innovation, Incubation, Entrepreneurship, and Startups) by NITI-Ayog, Government of India in the year 2020. Recently recognized Mentor at Startup India Program. He was also recognized as MYNEP Ambassador (Government of India) for his valuable contribution towards promoting the National Education Policy 2020. Dr. Tiwari has received IP Excellence Award in Education and Training – 2021 from World Intellectual Property Forum. Dr. Tiwari is a recipient of the TIP Great Educators Award in year 2022 for Higher Education in Science & Technology. Dr. Tiwari is also a recipient of the Dr. APJ Abdul Kalam Education Excellence Award in the year 2022. His current interest is in IP awareness, IP protection, training, and development across India and globally to increase innovation and creation for a better life and self-reliant India.

Dr. Amaresh Panda

Head Technology Transfer Office

KIIT-TBI TTO

About the speaker

A Senior Intellectual Property Professional with first-hand experience in Technology Transfer with Masters in Pharmaceutics from Dept. of Pharmacy, Utkal University, PhD in Pharmacy (Pharmaceutical Technology) from Utkal University and LLB from University Law College, Bhubaneswar. Before joining the office of KIIT- TBI, Dr. Amaresh Panda had twelve & half years of rich experience in Intellectual Property & Portfolio Management, having worked across Big Pharma& Biotechnology organisations like Sun Pharma, Alkem Laboratories, Micro Labs Limited.Well-versed with all Intellectual Property related aspects viz. Product selection, Portfolio management, Patent drafting & prosecution, Licensing, Due-diligence, Patent analysis, Litigation management, Product commercialization, Trademark management, Regulatory affairs and other arenas for Human, OTC and Biosimilar formulations, APIs and Medical devices across the globe. Furthermore, Dr. Panda has couple of years of experience in teaching both Master & Bachelor students of Pharmacy and published five research articles & filed two patents.Also, he & his team have been awarded for IP Excellence in India by Questelfor the year 2016-17.

– Have good experience in pharmaceutical legislation, patent technology licensing. Able to explain legal situations/strategy to business and stack-holders. Have been key member of the Portfolio & Technology Transfer team for new product selection, early market entries, niche opportunities, planning and strategy decisions involving patent risk assessment.
– Have been strategizing with foreign lawyers and providing legal guidance for various development and business projects. Have worked with counsels and cross functional teams for Patent challenges and other matters for IP due diligence for potential acquisition targets.
– Have built organizational capabilities through education and implementation of IP with business functions, have built the skills and competencies within the team for handling IP related functions.

Jyoti Chauhan

Chief Manager-IPR

Gujarat Fluorochemicals Limited

About the speaker

Jyoti is Chief manager-IPR at MNC, Noida. She is IPR mentor, Startup india, Ministry of commerce. She is Dy.President in CIMSME (Confederation of Indian MSME). Also, She is Knowledge partner for ministry of MSME. She is a registered Patent & Trademark Consultant cum facilitator, SIPP, DIPP. She is also Technical member at ASSOCHAM in National IPR Council.She is also a Council member, National IPR councul, WICCI in association with WEF.
She is having vast years of experience in IPR/ patents & having also good exposure in dealing all domains of IPR like-Design, Copyrights, trademarks etc. She holds Master’s degree in Organic chemistry.
Eminent speaker in creating awareness programme/Ip trainings such as RGNIIPM training program conducted by IPO, DIPP, Delhi University, MDU Rohtak, & GBU(Gautam budh university) and at other events conducted by PHD Chamber of Commerce, ASSOCHAM, and CSIR.

Awards:-
• “Excellence in IPR” I National Commision of Women (NCW), Govt. of India I Shobhit University
• “Women’s pride award-2020”I Science & Technology (IPR)I Uttar Pradesh world records (UPBR)
• “Women leader-2020”I Featured profile in global business magazine i.e. “Insight Success” magazine
• “Naari Shakti puraskaar”I Among “50 most influential women-2019”I U.P. Govt.
• “Young women achiever in IPR, Patents”I PRISAL in collaboration with Bhabha university, Bhopal
• “Udaipur pride achievement award-2019”I “Science & Technology/IPR”
• “Global Achievers award-2019” - GKSSS Society, Gwalior Govt. of India
• Naari Shakti excellence award for excellence in IPR I Jhankar Society I Delhi Govt. at Hindi Bhawan,
• Award for excellence in IP I Aadishakti foundation I Ministry of Cooperate affairs
• National Ummeed Ratna awardI Rajasthan Chambers of Commerce, Jaipur
• Pride of WOSC-scheme, 2019 I Min. of science and technology (DST), TIFACI Speech on “International women day”, March 8,2019 I DD national TV for motivating women in IPR
• “Mentor for Patent agent examination I ISERD ( Intellectual’s Society for Entrepreneurship and Research Development) society

She has done all types of Patent-searches & having exp. in Patent prosecution (Worldwide) and having rich experience in Patent drafting in technology domains.

Jyoti has a vast experience of working with various industries (In-house IP) like-GSK pharmaceuticals, Polyplex Corporation, Minda industries etc. She is expert in dealing all types of queries arose by clients.

Agenda

Date and time is shown in (UTC +05:30) Asia/Kolkata

Pharma & IP Workshop

2023-08-26

08:00	Registration & Networking 1 hour Novotel HICC
09:00	Welcome and Keynote Address 30 minutes Novotel HICC
09:30	R&D Process, Drug Discovery & Clinical Trial 45 minutes Novotel HICC
10:15	Technology Transfer: Academia-Industry Alliance for IP Commercialisation 45 minutes Novotel HICC
11:00	Refreshment & Networking 30 minutes Novotel HICC
11:30	Abbreviated New Drug Application 45 minutes Novotel HICC
12:15	US FDA Approval Process 45 minutes Novotel HICC
13:00	Lunch Break 55 minutes Novotel HICC
13:55	Patent vs Exclusivity 45 minutes Novotel HICC
14:40	NCE Patentability 40 minutes Novotel HICC
15:20	Unlocking the Power of AI in Pharma Litigation 15 minutes Novotel HICC
15:35	Networking and Refreshments 25 minutes Novotel HICC
16:00	Trade Secrets 45 minutes Novotel HICC
16:45	Closing Remarks 15 minutes Novotel HICC

Tickets

SUPPORTING PARTNERS

KIIT-Technology Business Incubator (KIIT-TBI)

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Pharma & IP Workshop