Trialect

Active

Drug Development value Chain: from Idea to Commercialization

Senior Project Lead at Novo Nordisk

Rupa Shree Appa-Pind is a Senior Project Lead at Novo Nordisk, she is participating in this fellowship in her personal capacity to help educate and mentor professionals in drug development. This program is not affiliated with, endorsed by, or promoted by Novo Nordisk. Any views expressed during the fellowship sessions are her own and do not represent the views or policies of Novo Nordisk.

Main Areas of Interest

This one-on0ne online tutoring program will provide participants with a structured understanding of the end-to-end drug development process, from concept to regulatory approval and commercialization. The key areas covered include:

Target Identification & Validation – Identifying and confirming biological targets for drug development.
Hit Identification & Lead Optimization – Screening and refining drug candidates ( biologics /small
molecules) for potency & efficacy
Preclinical Development – Covering pharmacokinetics (PK), pharmacodynamics (PD), and toxicology.
Good Laboratory Practices (GLP) & IND Submission – Preparing regulatory documentation for clinical entry.
Good Manufacturing Practices (GMP) & Scale-Up Considerations –high level understanding of CMC upscaling and Good Manufacturing Practices
Regulatory Pathways & Market Access – High level understanding of the regulatory
pathways from IND to submission to authorities

Specialties

Endocrinology and Diabetes

Obesity

Pharmaceuticals

Techniques You Will Learn

This program will focus on understanding key methodologies rather than providing hands-on training. Participants will gain insight into:

Target Identification & Screening

High-throughput screening (HTS) and in silico modeling
Structure-based drug design (SBDD) and computational chemistry

Preclinical Evaluation

In vitro and in vivo pharmacokinetic/pharmacodynamic (PK/PD) modeling
Toxicology and safety assessment approaches
AI/ML applications in preclinical drug discovery

Regulatory & Compliance Considerations

IND preparation and submission strategies
Good Laboratory Practice (GLP) guidelines and compliance requirements
Good Manufacturing Practice (GMP) principles at a high level

Scale-Up & Commercialization

Clinical trial design considerations for early-phase development
Manufacturing and supply chain strategies for drug commercialization

Modules

Module 1: Idea to Drug Lead Candidate

The drug discovery process – trends in pharma
Target Validation
Role of AI in drug design
Drug candidate development – screening and refining drug properties
Challenges in lead optimization

Module 2: Preclinical Studies & IND Submission

Preclinical safety, toxicology
Pharmacokinetic (PK) studies, Physiological based PK modelling
Allometric scaling
IND submission: Preparing regulatory dossiers and overcoming hurdles

Module 3: Clinical Development & Regulatory Approvals

Phases of clinical trials and key considerations for study design
High level briefing on FDA, EMA, and ICH regulatory pathways
Fast-track, breakthrough therapy, and accelerated approval processes

Module 4: Chemistry Manufacturing & Controls & Scale-Up

Chemistry Manufacturing & Controls scale-up
Overview of GMP and regulatory requirements in biopharmaceutical manufacturing
Process development and analytical validation

Module 5: Commercialization & Launch

The transition from clinical development to commercialization
Market access, pricing and reimbursement strategies
Lifecycle management and Loss of Exclusivity

Program Fee


Total Number of Modules	5
Time duration of Each module	45 minutes
Total Program Cost	$656.25

This program allows Merit Applications. This program allows merit-based applications for virtual and onsite clinical and research programs. If you are successfully awarded under this category, Trialect or the host mentor will cover the tuition fee only. All applications will be evaluated based on merit. Due to the high level of competition, the chances of being selected under the merit category are quite limited.

Who Can Apply

All professionals interested in drug developments

Host Details

Host Name: Rupa Shree Appa-Pind

Affiliation: Senior Project Lead at Novo Nordisk

Address: Bagsværd, Denmark

Website URL: https://www.researchgate.net/profile/Rupa-Appa

Disclaimer:It is mandatory that all applicants carry workplace liability insurance, e.g., https://www.protrip-world-liability.com (Erasmus students use this package and typically costs around 5 € per month - please check) in addition to health insurance when you join any of the onsite Trialect partnered fellowships.

Legal & Affiliation Disclaimer

Affiliation Disclaimer: Trialect operates independently and is not affiliated with, endorsed by, or supported by any sponsors or organizations posting on the GrantsBoard platform. As an independent aggregator of publicly available funding opportunities, Trialect provides equal access to information for all users without endorsing any specific funding source, content, organization, or sponsor. Trialect assumes no responsibility for the content posted by sponsors or third parties.

Subscription Disclaimer: Upon logging into Trialect, you may choose to SUBSCRIBE to GrantsBoard for timely notifications of funding opportunities and to access exclusive benefits, such as priority alerts, reminders, personalized recommendations, and additional application support. However, users are advised to contact sponsors directly for any questions and are not required to subscribe to engage with funding opportunities.

Content Ownership and Copyright Disclaimer: Trialect respects the intellectual property rights of all organizations and individuals. All content posted on GrantsBoard is provided solely for informational purposes and remains the property of the original owners. Trialect does not claim ownership of, nor does it have any proprietary interest in, content provided by third-party sponsors. Users are encouraged to verify content and ownership directly with the posting sponsor.

Fair Use Disclaimer: The information and content available on GrantsBoard are compiled from publicly accessible sources in alignment with fair use principles under U.S. copyright law. Trialect serves as an aggregator of this content, offering it to users in good faith and with the understanding that it is available for public dissemination. Any organization or individual who believes their intellectual property rights have been violated is encouraged to contact us for prompt resolution.

Third-Party Posting Responsibility Disclaimer: Trialect is a neutral platform that allows third-party sponsors to post funding opportunities for informational purposes only. Sponsors are solely responsible for ensuring that their postings comply with copyright, trademark, and other intellectual property laws. Trialect assumes no liability for any copyright or intellectual property infringements in third-party content and will take appropriate action to address any substantiated claims.

Accuracy and Verification Disclaimer: Trialect makes no warranties regarding the accuracy, completeness, or reliability of the information provided by sponsors. Users are advised to verify the details of any funding opportunity directly with the sponsor before taking action. Trialect cannot be held liable for any discrepancies, omissions, or inaccuracies in third-party postings.

Notice and Takedown Policy: Trialect is committed to upholding copyright law and protecting the rights of intellectual property owners. If you believe that content on GrantsBoard infringes your copyright or intellectual property rights, please contact us with detailed information about the claim. Upon receipt of a valid notice, Trialect will promptly investigate and, where appropriate, remove or disable access to the infringing content.