Dr Asoke has had a uniquely broad 3 decade career at the FDA, serving in 5 divisions, including oncology, analgesic and anesthesia, rheumatology, respiratory and ophthalmology. His contributions at FDA resulted in approval of several break through products, including Relafen, Fluticasone, Tramadol, Latanoprost, Restasis, Uloric and Actemra. Prior to the FDA, he was engaged in cutting-edge research in academia and industry on diseases resulting from disturbed immune modulation, and has edited a textbook on the development of immunosuppressant products.

He is a strong proponent of early involvement in the drug development process of an experienced regulatory scientist. In the early 1990’s when Dr Asoke joined the FDA, he interacted early with a sponsor who proposed a nearly 20-fold higher dose of an agent for Phase I/II trials. His interactions with the sponsor resulted in the development of a drug with a materially higher therapeutic index.

Because of the breadth of his background, Dr Asoke is able to help a broad range of clients, including those engaged in product development of small or large molecules, drug-device combination products, in a range of therapeutic areas, including arthritis, asthma, pain, cancer, glaucoma, and treatment of substance abuse, at all stages of development, from preclinical development to IND to Phase I-IV clinical testing, including submissions of NDA/BLA/505(b)(2), and venture capitalists and other financiers in due diligence and product development assessment. 

Expertise
 Based on extensive small molecule and Biologic experience, Dr Asoke has deep understandingfor developing agreements with FDA review Divisions and Fast Track development of INDs. Dr Asoke\\\\\\\'s contributions to clinical development involve following:
• Phasel-3 studies in Biosirnilar, Autoimmunity, Respiratory, oncology, Pain, controlled substances and ophthalmics
• Extensive history of successful FDA negotiations (Pre-IND, End of Phase2, Pre-NDA, Types A, B and C meetings, Advisory Committee hearings) involving drugs and biologics
• Development and review of non-clinical protocols, study reports, Package Inserts according to PLR format and recent lactation guidelines
  

Selected Consulting Experience

• Analyzed pharmacological mechanisms for developing products for multiple indications and marketing advantage
• Advice on development strategies for multiple indications ensuring shortest development time
• Advice on orphan product designation, development and drafting clinical protocol synopsis.
• Non-clinical study requirements, gap analysis and review of data for all phases of clinical development and registration.
• First in human (FIH) dose selection criteria for oral, parenteral and inhalation delivery of drugs
• Drafting eCTD summary for pharmacology, toxicology, PK and updating Investigators\\\\\\\' brochures
• Advice industries on developing strategic questions for obtaining Pre-IND agreements with the regulatory body.
• Identify issues related to the development of biosimilar, patient-controlled self injection systems, generic equivalents, 505(b)(2) applications.
• Development of Botanical products in USA
• Assisted analysts from venture capital and investment firms on current needs and feasibilities for new business investment.

Dr Subrahmanyam Vangala is currently Co-Founder and Chief Executive Officer at ReaGene Biosciences Private Limited (Bangalore, India), ReaGene Innovations Private Ltd (Hyderabad, India). He is an experienced pharma scientist and executive with more than 25 years of leadership experience with increasing responsibilities, at global pharma in USA (Wyeth, JNJ, Purdue Pharma and Shire) and Contract Research Organizations in India (Sai Life and Advinus). His industrial experience was focused on, but not limited to, new drug discovery and development with expertise in DMPK, Bioanalytical, Clinical Pharmacology and Toxicology. His Pharma experience produced more than 30 IND submissions, with at least six marketed molecules drugs including Zaleplon (short acting sedative-hypnotic), Tygacil (4th generation tetracycline antibiotic against vancomycin and methicillin resistant bacteria), Canagliflozin (targeted SGLT-2 inhibitor for type II diabetes), Tibsovo (targeted IDH1 inhibitor for refractory myeloid leukemia). Other areas he gained experience include predictive clinical drug-drug interactions, pre-formulation development, drug repurposing, specialty pharmaceuticals, generics, biologics/biosimilars, medical devices, pharmacogenomics, metabolomics and alternatives to animals in research. He participated in several due-diligence activities involving in-licensing activities.

He received his PhD Degree in Biochemical Mechanisms of Chemical Carcinogenesis from the Department of Biochemistry, Memorial University of Newfoundland, Canada. He conducted his postdoctoral research in Molecular Toxicology department at University of Colorado at Boulder, and continued as a Specialist Scientist in Molecular Toxicology at School of Public Health, University of California, Berkeley. During his PhD and postdoctoral research, he extensively studied DNA damage of electrophilic and free radical intermediates, of environmental pollutants and other mutagens/carcinogens for their risk assessment and related public health concerns. 

His current research interests include developing 3D bio printed human tissues as Alternatives to Animal models to support drug discovery, nutraceutical, agrochemical, cosmetics and environmental pollutant research. 

He is on the ICMR expert committee for Alternatives to Animals in Research and primary advisor/contributor of ICMR article on Indian Perspectives of Alternatives to Animals in Research. He is also on the Executive Committee for Society for Alternatives to Animals in India. He brings with him, unique insights into translational research for risk assessment. He is on the scientific advisory board of Bioagile therapeutics pvt ltd, Tranalab pvt ltd and on the editorial board of journals related to toxicology and analytical research. He has nearly 60 publications in peer reviewed journals including several invited book chapters. He has chaired several international symposia in drug discovery, predictive toxicology, idiosyncratic drug toxicity and DMPK and invited keynote speaker at many conferences/symposia.

Dr Kenneth V Phelps has 44 years’ experience in the pharmaceutical industry, including basic drug discovery, drug metabolism, analytical method development, quality assurance, quality control production technology and troubleshooting, regulatory registrations and information systems development. He has management experience in both large and small pharmaceutical companies. He has experience in NDA and ANDA development, preparation and regulatory processes, including electronic submissions. Experience in leveraging pharmaceutical and clinical science into sales and marketing of drug products. Experience in the development of physician and academic thought leaders for both opinions and post-marketing studies. Experience in design and analysis of replicate bioequivalence/bioavailability studies. Expertise in the validation of computer systems, analytical methods and drug production processes. Dr Phelps has solid computer skills including software selection, training and network design.

Dr Ambrish Srivastava MD; FCCM is a highly experienced (30+ years) pharmaceutical professional with expertise in clinical research, medical affairs, regulatory & pharmacovigilance. Done his M.D. in clinical pharmacology and Fellowship in Critical Care Medicine. Worked as faculty in Lady Harding Medical College, New Delhi. Worked in various Indian & Multinational pharmaceutical companies in the areas of medical affairs, clinical research, pharmacovigilance and regulatory.      

Have been involved in “End to End” clinical development (Phase I-IV) of NCEs, NBEs, biosimilars (both recombinant proteins and monoclonal antibodies) and others. Active member of product strategies and business development team in several therapeutic areas. Key speaker in various National & International conferences. Visiting faculty in various Institutions.   

Have 40 scientific publications in National & International journals. Authored a self-help book “Happiness- From Illusion to Science”. Recipient of Rashtriya Ratan Award by Governor of Gujarat for excellence in Medical Science in 2005 and Vishisht Chikitsa Medal by Governor of Andhra Pradesh In 1994.

Have high interest in community health and service to underprivileged people. Associated with charitable health organization to provide health care to masses. Currently doing medical practice and consulting various organization on clinical research & drug development.          

Dr Pan Pantziarka is Programme Director Drug Repurposing of the Anticancer Fund and coordinator of the Repurposing Drugs in Oncology (ReDO) project. His areas of research include drug repurposing, bioinformatics, computational biology and genetic cancer predisposition. He has worked to develop clinical trials with clinicians in the UK and mainland Europe. He is also the co-founder and chair the George Pantziarka TP53 Trust – the UK’s only charity dedicated to supporting people with the rare genetic cancer condition called Li Fraumeni Syndrome.

Dr. Rakesh Bhasin is currently placed as Vice President and Head-R&D (Formulation) at Biocon Pharmaceuticals Ltd, Bangalore. He has done his Masters in Pharmacy from UIPS, Panjab University and PhD in Pharmaceutical Sciences from JNTU, Hyderabad. He obtained his MBA from IGNOU, New Delhi. He is highly energetic, task oriented analytical and creative pharmaceutical executive with around twenty-six years of experience in R&D, Regulatory, Quality, Clinical, Pharmacovigilance, Compliance and Operations. He was associated in leadership role with various reputed Pharmaceutical companies like Cadila Pharmaceuticals, Ipca and Dr. Reddy’s lab

He has in-depth understanding of R&D functioning for generics including creation of system driven organization and improving productivity.

His repertoire of work includes novel drug delivery system, complex generics development, 505(b)(2), NCE and ODT’s. His expertise includes accepting challenges in various fields of drug delivery system.  He has an excellent track record of project management from initiation to timely launch of products by working closely with R&D, QA, Manufacturing and other related functions

He has several patents and publications to his credit. He has delivered seminars at various national and international forums

Dr. Rakesh Bhasin has been awarded FDD Leadership Award 2018 by Express Pharma Pulse (Indian Express) on 15th June’18 at Novotel Hotel, Hyderabad. This award has been given to him for contribution in the field of formulation development and drug delivery.

Dr Sree’s vivid 25-year career spans research areas of STEM, Portfolio Management, Entrepreneurship, Policy Making and Implementation for non-for-profit organizations connects industry, startups, and academia with the government organizations. Currently, he passionately promotes scientific entrepreneurship from young to seasoned researchers, students, and faculty to take up innovations in life sciences ranging from agriculture, biotechnology, healthcare, IT, and pharma/healthcare sectors. He also actively promotes IP/TechnologyTransfer of assets of life sciences. As an entrepreneur, he co-founded Theraxel Discoveries, and later founded INDRAS Pvt. Ltd. (www.indras.in) that consults, contracts, and collaborates on drug design aspects with researchers of industry and academia. His continued passion lies in research ranges from drug design and discovery (currently focusing on therapeutic mitigation of COVID-19, and solid tumors in Oncology. For his innovative technologies and research utilized by wide-ranging researchers at Ranbaxy, he is the recipient of Global APPRECIATE award by Ranbaxy for his outstanding contributions in R&D data digitization. He also established, promoted, and made self-sustenance scenario of the ASPIRE-BioNEST, the life sciences incubator of UoH, recognized as the “Best Emerging Bio-incubator” among all BioNESTs of India. He published about 25-peer reviewed articles in international journals, gave numerous lectures at domestic and international conferences.

Dr. Uday Saxena was “Mentor –in-Residence” and Professor of Translational Research at Dr. Reddy’s Institute of Life Sciences as well as Co-Founder of start-up Biotech Company.

He has held Executive and Leadership positions at Parke-Davis, AtheroGenics, Dr. Reddy’s Laboratories and Kareus Therapeutics.

He is responsible for leading teams that brought several drug candidates from idea into the clinic.

He received his PhD in Biochemistry from Memorial University, Canada and Post-doctoral training at Columbia University.

His current research interests are translational research in metabolic diseases and cancer.

His passion is to continue being an entrepreneur having initiated biotech companies in the US and India.

Dr Pratima Srivastava, M. Sc. Ph.D., Currently a Vice President and Head – Drug Metabolism and Pharmacokinetics, Aragen Lifesciences, Hyderabad, India. She has Research, Teaching and Management experience of 15 years in Druggability attributes of small and large molecules and Pharmacogenomics, in the field of Drug Discovery and Development in varied disease areas across Academia, Pharma and CRO functions. Innovation in Molecular Biology and Biochemistry of malarial parasites with reference to acquisition of drug resistance, elucidation of the maiden novel heme degrading pathway in malarial parasites and its implication in the development of resistant reversal agents.

Appeared in the Dec 2017 issue of Biospectrum: The Business of Bio and Health Sciences as Women Achievers: Walking with a Purpose; Recipient of INSA Young Scientist Award; ISCA Young Scientist Award; International Union of Biochemistry and Molecular Biology Young Scientist Award; Council of Science and Technology Young Scientist Award; Prof B.K. Bacchawat Young Scientist Award; IIIrd position in University in Graduation; 71-International Papers, 28-International Patents.
She is Owner of DMPK group in LinkedIn having close to 7500 connections in the field of DMPK, Bioequivalence, Biowaiver worldwide.  Visiting Scientist in Univ of Health Science Centre, San Antonio, Texas and Roswell Park Cancer Institute, Buffalo, NY, USA working on Pharmacogenomics of anticancer drugs and the interaction of p53 and ER.

Major Contributions

• In Pharmacogenomic: SNP found in the Indian population in drug metabolizing genes. Identification of the SNP responsible for Adverse drug reactions, Onset of disease; Biomarkers identification and its correlation with pharmacokinetics.
• Molecular Biology (Oncology): Demarcation of the Estrogen receptor positive and negative breast cancer as well as screening protocols towards the development of new anticancer drugs
• Alternative to Animals Models
• Maiden Innovative search for HEME Degradation Pathway in plasmodium. The pathway has been for the first time, included by Prof. Hagai Ginsburg in the Malaria Parasite Metabolic Pathways Hemoglobin digestion and Ferriprotoporphyrin IX Polymerization (http://sites.huji.ac.il/malaria/redox/html). ü It has also secured its place in the “Innovative India” edited by Prof. L.K.Sharma and Seema Sharma in the chapter entitled, “The challenge of malaria control” –2000.

Dr Manish Grover has been in top leadership positions in his industry assignments for more than a decade. He is a proficient leader, adept at building highly engaged and productive teams, leveraging his knowledge and experience to efficiently solve problems. He has managed large global teams across functions. Previously, he has worked in Cadila Pharmaceuticals, Ajanta PHarma Ltd, Dabur Research Foundaion, Zydus Cadila, Piramal Helathcare Ltd, Abbott Healthcare Private Ltd, Merck Group and Procter and Gamble.

Dr Grover holds a PhD degree in Drug Design, followed by diverse industry experiences that include setting up a production plant, product development labs and pilot plants, and developing various dosage forms for diverse markets.

He has added more than 300 products in the Indian market and more than 50 products in the global market. Was awarded twice with CEO’s award for positively impacting the business.

Dr. Wantanee Phuapradit has been confidently leading, directing, and making decisions on a large drug development portfolio in an entrepreneurial setting through all phases including early-stage product selection, product development, technology transfer, regulatory submission, FDA approval and commercialization. Leader of high-performing scientific and technical cross functional teams of pharmaceutical development scientists and other related CMC functions. Provides committed and inspiring leadership, stewardship and advocacy, striving for compound and manufacturing process knowledge development, continuous improvement, acceleration, risk assessment and mitigation, resource allocation and support. Ensures an effective Target Product Profile is in place which defines product characteristics and performance expectations to inform pharmaceutical development success.

Dr. Phuapradit has been serving as a scientific advisor and consultant in pharmaceutical R&D organizations. She previously served multiple R&D leadership roles with increasing responsibility including:

• Chief Scientific Officer at Tulex Pharmaceuticals
• Former Senior Vice President and Head of the Formulation Research and Development Group at Kashiv Pharma
• Former Senior Director of Barr/Teva
• 18 years with Hoffmann La Roche, including Senior Research Leader position

She holds a Ph.D. in Pharmaceutics from St. John’s University in New York City with over 30 years of experience in pharmaceutical oral dosage development, scale-up, technology transfer of generics, 505b2, and new chemical entities. Accolades include over 20 patents, 10 publications, and over 20 presentations/speaker events all specializing in pharmaceutical excellence.

Dr. Mukund Chorghade is a serial entrepreneur, President and Chief Scientific Officer, THINQ Pharma / THINQ Discovery, and of Chorghade Enterprises. He is the Chief Scientific Officer of Chicago Discovery Solutions, and has had Adjunct Research Professor / Visiting Fellow / Scientists appointments at Harvard, MIT, Princeton, Cambridge, Caltech, Univ. of Chicago, Northwestern, Strathclyde and several other universities. He provides synthetic chemistry and pharmaceutical drug development expertise to academic laboratories, pharmaceutical and biopharmaceutical companies. He also provides consultations on collaborations with academic, government and industrial laboratories. He establishes strategic partnerships and oversees projects in medicinal chemistry, chemical route selection, drug discovery and development. His current research interests are in Traditional Medicine derived New Chemical Entities and the discovery of the new “chemosynthetic livers” that find utility in drug metabolism, valorization of biomass and environmental remediation. He is a Certified CGLP / cGMP professional and conducts cGLP/cGMP compliance training / implementation in chemical laboratories.
Dr. Chorghade earned his B. Sc. and M. Sc. degrees from the University of Poona, and a Ph. D. in organic chemistry at Georgetown University. He completed postdoctoral appointments at the University of Virginia and Harvard University, visiting scientist appointments at University of British Columbia, College de France / Universite’ Louis Pasteur, Cambridge and Caltech and directed research groups at Dow Chemicals, Abbott Laboratories, CytoMed and Genzyme. A recipient of three “Scientist of the Year Awards”, he is an elected Fellow of the ACS, AAAS, AIC and RSC and has been a featured speaker in several national and international symposia.
He was privileged to become an American Chemical Society member in 1982, was section chair for Brazoria (1990) and of Northeastern Section in 2007 and is currently on the Board of Directors of the Northeastern Section. He heads the Professional Services, Public Relations Committees of the section and is an active participant in the activities of the ACS Career Services / Professional Development at the national level. He is involved with numerous activities for the IUPAC, was the Secretary of the Division on Chemistry and Human Health and served on the IUPAC Commissions on Biotechnology, Medicinal Chemistry, New Technologies and Special Topics as a Titular Member. He is currently on the US National Committee for IUPAC. He is on the Scientific Advisory Board of several corporations / foundations.
He has been honored by election as a Fellow to the Maharashtra, Andhra Pradesh and Telengana Academy of Sciences, Royal Society of Chemistry (Elected Fellow); New York Academy of Sciences; American Chemical Society (Elected Fellow), American Institute of Chemists (Elected Fellow); AAAS (Elected Fellow); Sigma Xi; Indian Society of Chemists and Biologists (Elected Felow).

Dr Poonam has 21+ years leading the Intellectual Property and Patent teams of multinational Pharma companies (Dr. Reddy’s, Ranbaxy, Dabur) & International research institutes (ICGEB). She has 7+ years in Product Development and Research with leading Pharma research organizations and 1+ year of entrepreneurship

She has Led a large tribe of IP experts responsible for API, Formulation & NCE. She has Built high performance teams and instilled a winning culture. Was a team member for 3 Iconic patent infringement/invalidation cases in Generic product history Atorvastatin, Esomeprazole and Valganciclovir.

Dr Poonam has aligned structure and optimized resources to enhance efficiency & productivity. She contributed to build multi-Billion-dollar global product portfolio. Ensured no unknown 3rd Party IP risk to the Product portfolio. Conceptualized effective IP risk mitigation strategy across the globe. Designed & Led IP litigation in Branded markets to drive double digit growth.
• Led & built a collaborative culture to encourage idea sharing and creativity. Devised invention review board to effectively manage the Patent Portfolio. Provided Strategic partnership to management on people issues.

Her education qualification is M. Pharm, Ph.D. in Pharmaceutical Chemistry.