Mr. Chachad is an approved Senior Consultant at Appleton Greene and he has experience in information globalization, management and marketing. He has achieved a Master of Science in Clinical Pharmacology, a Post-graduation Diploma in Pharmaceutical Marketing Management, a Bachelor of Medicine and a Bachelor of Surgery. He has industry experience within the following sectors: Pharmaceutical; Biotechnology; Healthcare; Consultancy and Education. He has had commercial experience within the following countries: United States of America; United Kingdom; Netherlands; India and China, or more specifically within the following cities: Newark NJ; London UK; Amsterdam NL; Mumbai IN and Beijing CN. His personal achievements include: developed new medicinal products; filed complex generics, biosimilars, vaccines; served as QPPV, led pharmacovigilance; expert signatory to clinical regulatory modules and facilitated clinical regulatory innovation. His service skills incorporate: clinical development; due diligence; medical affairs; medical writing and pharmacovigilance.
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Every pharmaceutical company or biotech company undergoes some or the challenges during development of medicinal products, whether these are new chemical entities, novel biologics, differentiated products, complex generics, biosimilars, vaccines, herbal products, medical devices or advanced therapies. Since the end-users are patients, it is of utmost importance to safeguard human well being and ethics, thereby ensuring that the medicine is safe and efficacious. In order to develop a quality product, that meets regulatory expectations, patient safety, patient compliance, effectiveness in the intended disease condition, company should be able to navigate formulation development challenges, manufacturing challenges, regulatory challenges and ensure successful clinical development. Rather the most time consuming element in the entire sequence of product development is clinical development. Robust designing of clinical development programme and quality execution with a favourable study outcome is the key to obtain successful marketing authorisation and launch of the medicinal product into the target market.
The service is customised according to the needs of the pharmaceutical or biotech company who is seeking consultation to develop new medicinal product. The markets of interest for commercializing the new medicine are understood, and accordingly the medico-marketing landscaping is done. Thorough evaluation of the company developing new product is carried out with regards to parameters including, but not limited to the company’s existing product portfolio, presence in key therapeutic segments, geographical presence, competitive intelligence of marketed products and other products under development, R&D infrastructure, financial bandwidth, company’s risk appetite, regulatory requirements in chosen regions of development. Due diligence is conducted based on the company’s existing data on the proposed product followed by gap analysis to supplement the development programme. If the company has done preclinical studies including pharmacokinetics, pharmacodynamics, tissue distribution, safety pharmacology or in vitro studies, this data is reviewed for completeness and accuracy. Early clinical data if generated is also evaluated. If the human data is unavailable, the study programme is designed to prove the safety and efficacy of the investigational medicinal product in line with the regulatory requirements. Communications with the healthcare authorities in the form of pre-submission meetings, controlled correspondences, and written or face-to-face scientific advice meetings are facilitated if needed during the course of clinical development to increase the probability of successful clinical outcome and product approval. Necessary preclinical and clinical expertise is provided during such meetings or communications with the healthcare regulators in order to gain consensus on the best possible clinical development strategy for achieving successful registration of the product. Post registration support for the authorised medicine in form of pharmacovigilance obligations is also provided to the company, as needed.
Companies can elect whether they just require Appleton Greene for advice and support with the Bronze Client Service, for research and performance analysis with the Silver Client Service, for facilitating departmental workshops with the Gold Client Service, or for complete process planning, development, implementation, management and review, with the Platinum Client Service. Ultimately, there is a service to suit every situation and every budget and clients can elect to either upgrade or downgrade from one service to another as and when required, providing complete flexibility in order to ensure that the right level of support is available over a sustainable period of time, enabling the organization to compensate for any prescriptive or emergent changes relating to: Customer Service; E-business; Finance; Globalization; Human Resources; Information Technology; Legal; Management; Marketing; or Production.
Service mission: Dr Chachad is a highly experienced pharmaceutical physician with over 20 years of global experience in the areas of medical affairs, medical marketing, clinical regulatory affairs, medical writing, drug safety in clinical trials and post authorization era, preclinical development and clinical development of new medicinal products including innovative drugs, complex generics, branded generics, biologics and biosimilars, medical devices, herbals, nutraceuticals & cosmetics, advanced therapies and even vaccines. He is a strategic leader in translational research, medical affairs and drug safety with expert knowledge of legal and regulatory requirements across these areas of expertise. He is a strong proponent of clinico-regulatory innovation, digital transformation and patient centricity in the development of new medicines. His understanding of global clinical requirements has yielded successful product registrations in most regulated markets across the globe including developed markets such as EU and US, as well as emerging markets such as India, Russia, China and Brazil. He is an acclaimed speaker at various international seminars and conferences on clinical research and pharmacovigilance, and an expert faculty in the functional areas of drug development and patient safety at the teaching and training institutes in Asia and Europe. He has published extensively in the peer-reviewed journals and has authored a book chapter on clinical development in reputed Burger’s Medicinal Chemistry, Drug Discovery and Development. As an expert consultant, he provides a strategic drug development solution to pharmaceutical and biotechnology companies thereby accelerating regulatory filing, approval and market launch of new medicinal products, and enabling patients to gain early access to affordable, quality, safe and effective medicines for better and healthier life.
The following list represents the Key Service Objectives (KSO) for the Appleton Greene Clinical Development service.
- Global Development
Product development is a complex journey, not only driven by science, but also by varying regulatory requirements in different geographies. Although ICH (International Council for Harmonisation) exists for more than four decades to standardize the technical requirements for pharmaceuticals for human use, there still lies many differences between the specific product development requirements, may it be a new drug product, biologic or a generic. In case of a new chemical entity, the process starts with identification of target in the pathophysiology of the disease condition. Then the chemical or biological compounds are screened against these targets in preclinical studies and bioassays resulting in identification of the lead candidate that is taken for further development. Preclinical studies on the lead compounds include toxicity studies, pharmacokinetic studies, pharmacodynamics studies, tissue distribution studies. Lead compounds are optimized by making changes to improve their pharmacokinetic and / or pharmacodynamic (PD) profile or reduce toxicity. The extent of preclinical studies also depends on the market of interest for the new product registration. Optimized candidate becomes a potential product ready for human clinical trials, which are then carried out in different phases: phase I, phase II, phase III and phase IV. Both strategic and operational support will be provided to the company for their complex clinical developments ensuring that the new medicines get expedited regulatory approvals in developed markets (such as EU, US, UK) and in emerging markets (such as India, Russia, China & Brazil). So, the crux here is to design and conduct appropriate preclinical and clinical program for a medicinal product, based on which the company can achieve successful marketing authorization worldwide.
- Clinicoregulatory Innovation
Clinical development of a new medicinal product is driven by formulation development challenges, regulatory challenges, and increasing focus on the patient centricity and digital innovation. It is important that the new drug product or medicinal product undergoes appropriate clinical evaluation to ensure that ultimately quality medicine with proven safety and efficacy is delivered to the end user i.e. patient who consumes it for health benefit. Taking into consideration the factors such as the region specific regulatory requirements, clinical operations feasibility, research cost & time optimization, the companies will be provided with the best clinico-regulatory approach for early registration and commercialization of the drug products in global markets. In case of new chemical entities, new therapeutic entities (line extensions and label expansions), novel biologics, preclinical and clinical development is a very costly and time-consuming process. On an average, bringing a molecule from its first human trial to marketing application takes 10 years; and the average cost has nearly tripled over the past two decades to be higher than US$2 billion. It is also a high-risk business. The phase-to-phase transition rates are 64% (I–II), 32% (II–III), 60% (III to marketing application) and 83% (regulatory approval), resulting in a low overall success rate of 10%. The innovation in clinical regulatory approach will maximize the probability of successful clinical outcome in the studies and new product registrations will be achieved with cost and time excellence so that the prescribing doctors and treated patients get the benefit of newer and better medicines faster.
- Patient Safety
Safety evaluation is a central component in all stages of the drug development lifecycle. Regulatory agencies around the world and the pharmaceutical industry are taking a more comprehensive and holistic approach to safety evaluation in drug development. Prior to the marketing authorization of a drug, rigorous safety monitoring and evaluations from preclinical to all stages of clinical trials are required. Pharmaceutical sponsors need to adequately characterize the safety profile of the product in order to obtain regulatory approval and marketing authorization. The approved product label contains the essential information about the product’s benefits and risks. In case of clinical trials, if there are unexpected serious adverse reactions to the investigational medicinal product, the companies are obliged to report these to the regulatory bodies of those regions where these trials are carried out and intended for submission. Pharmacovigilance in the post-authorisation era or continued vigilance in safety is also critical as more data and experience is gathered from a broader patient population once the product is on the market. Healthcare regulators across the globe have defined guidance documents and regulations in place to ensure good pharmacovigilance practices. These include appointment of a qualified person for overseeing and maintaining the company’s pharmacovigilance systems, creation of pharmacovigilance system master file to provide an overview of company’s authorised medicines, timely reporting of adverse events to the regulators, risk management planning, signal management activities, and regular trainings and audits to ensure research compliance and marketing of only those products who have positive risk benefit ratio.
- Medical Writing
It is extremely crucial that the documentation is prepared appropriately for the clinical development, regulatory submission and for pharmacovigilance purposes. The purpose of this service objective is to help clients by preparing clear and comprehensive non-clinical and clinical overviews for regulatory dossier (modules 2.4, 2.5, 2.6 and 2.7), Addendum to Clinical Overview as part of renewals, Paediatric Investigation/Study Plan, Orphan drug designation dossier, target product profile creation (TPP) in case of new drug products, clinical development plan, clinical study documents (including study protocol, investigators brochure, clinical study report), clinical and nonclinical parts of the investigational medicinal product dossier (IMPD), manuscripts for publications, regulatory communications including briefing books for scientific advice meetings, and pharmacovigilance documents such as standard operating procedures, safety data exchange agreements, pharmacovigilance system master file, aggregate reports and risk management plans. Once the marketing authorisations are granted to the pharmaceutical and biotech companies for their new medicinal products, promotional activities begin to garner sales from their new medicine launches into respective territories. However, the promotion of medicinal products is governed by local advertising laws and regulations to ensure that the safe and effective medicines ultimately reach the patients. So the companies have to ensure that the medical marketing materials such as patient information leaflets, labeling information, flyers, digital advertisements, social media posts, health journal articles are written in such a manner that these are not misleading and only safe and effective medicines are promoted for the benefit of public health. With effective medical writing across stages of product development life cycle, the company is committed to highest quality standards for the developed new medicines.
- Due Diligence
Given the increasing complexities of new medicinal product development, stringent regulatory requirements from most healthcare authorities and increasing clinical development costs, day by day it is becoming more and more challenging for pharmaceutical and biotechnology companies to invest into new medicinal product developments. These technical and commercial complexities apply not only to the development of new chemical entities but also when the companies are developing novel therapeutic entities (including novel drug delivery platform technologies, drug repurposing) and even complex generics such as liposomal formulations, depot injections, peptides, inhaled drug device combinations and topical products. Business alliances and co-developments are hence becoming increasingly popular in these aforementioned areas. Therefore, before investing money, resources and efforts into research and development, it is very important to do thorough due diligence and gap analysis of licensing opportunities. This will include detailed review and evaluation of the existing data on the quality, production and control of the medicinal product being developed as well as the data generated so far from nonclinical and clinical studies to demonstrate the safety and efficacy of the new medicinal product With the right in-licensing opportunity chosen, the companies can maximize the probability of successful product development and market launch. Further one of the key challenges in global clinical development of complex products is the diversity in nonclinical and clinical requirements for the same product from different healthcare regulators. At times, there are uncertainties despite regulatory guidance documents. In such cases, it is essential that you identify right clinical research partner who helps you to navigate this situation, design strategic development plan and even represent you at the scientific advice meetings with the regulators, may it be a pre-IND/pre-NDA/pre-BLA meeting with the FDA or pre-submission meeting with any of the National Competent Authorities in the Europe.
“Under high pressure to swiftly respond to the FDA’s inquiry, the ability to deliver a comprehensive and thoroughly researched document in just two days was a key component of our successful response to the inquiry. Commitment to excellence, rapid delivery, and profound understanding of the subject matter played a pivotal role in the overall success of our response. Without a doubt, Dr. Chachad’s exceptional performance significantly contributed to our ability to meet the tight deadline and present a well-crafted response to the FDA’s question. His dedication and expertise make him an invaluable asset, and I wholeheartedly recommend him for any future projects that demand excellence, precision, and an unwavering commitment to success.”
“The company has initiated the development of a new combination product and wanted to explore the way forward for its clinical development in pursuance of registration in key markets such as US and Europe. The objective was to understand the most optimal preclinical and clinical development programme that will be acceptable to both the key regulators and that can be executed successfully within reasonable timeframe and at an optimal cost. A thorough due diligence on the in vitro studies was done including published literature surveillance in order to substantiate the available study data. The pre-IND document for the meeting was fine tuned with a robust clinical programme to meet most regulatory expectations (yet with an optimal package including a waiver request for the most routine preclinical/clinical studies).”
“I have worked closely with Dr Chachad while I was responsible for regulatory submission to Europe and Australia. During this period, he had almost single-handedly offered support to Regulatory submissions in Europe and Australia with respect to clinical modules. He used to understand regulatory guidelines in a holistic manner besides paying attention to details and differences in requirements of different Health authorities. This helped us to tackle query responses in timely manner. Due to his scientific acumen and can-do attitude, Dr Chachad was always a dependable partner in the clinical and nonclinical medical writing work where submission tasks are highly time bound.”