Conference Talk

Technologies to Improve Solubility/Dissolution Rate and Oral Bioavailability of Poorly Soluble Drugs

Sudhakar Garad
Sudhakar Garad, Global Head, Chemical and Pharmaceutical Profiling, Novartis

Talk Abstract: Dosage form (formulation) and enabling technologies to play a vital role in the success of new chemical entities transitioning from preclinical to clinical development through commercialization. The majority of new chemical entities being discovered in many disease areas have a poor aqueous and bio-relevant solubility. These are often available in the amorphous and chemically impure form of in-vitro enzyme assays, pharmacokinetic, pharmacological and toxicological studies in animal models.  These molecules are often dosed as a suspension/solution orally/parenterally respectively and candidate selection is based on results obtained from these studies. Therefore, it is very important to select a physical form as early as possible so that the same form can be used for preclinical and clinical studies, as changes in physical form or formulation principle could significantly affect the pharmacokinetic performance and formulation characteristics (i.e. stability/solubility/compatibility) and toxicity. The selected candidate must exhibit adequate physical and chemical stability during the formulation development process with desirable pharmacokinetic parameters. If pharmacokinetics parameters of these molecules are different due to different physical form or formulation selection, a significant delay may occur during development. It’s important to explore enabling technologies with existing molecules depending on the clinical/market need.  This presentation will cover early formulation strategies and novel technologies to improve the bioavailability of poorly soluble drugs.

Let us meet and see what new technologies Dr Sudhakar Garad, from Novartis, USA wishes to share with us. Register today for Novel Formulation Strategies

For more details, please contact Ms Shivalika Patial by Email – s.patial@selectbio.in or Call at 8283815050 or Whatsapp at 9041725050

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Conference Talk

CRO-Sponsor collaboration, a different way is possible

Dr Diego Herrera
Dr Diego Herrera, Almirall, Spain

There is no reason to be afraid of  CRO-Sponsor collaboration as, it started a long time ago in the late 1970s, so this relationship is nothing new. Additionally, CRO and Sponsor are sharing common goals to promote, conduct, oversight and ensure the compliance of a broad range of clinical trials type, data sources with high-quality evidence.

CRO-Sponsor evolved over the years because of continuous changes in the company ’s strategies, reorganizations, and growing clinical trials digitalization. The guidelines/regulations introduced by regulatory authorities have also played an important role in setting up of new services and business models, expanding the CRO-Sponsor collaboration horizon.

Transparency leads to a better collaboration. CRO-Sponsor should start early to design common plans for the entire study,  review these plans and patient data dynamically during the study to ensure final data integrity. Sponsor oversight is not only nice to have, it is actually mandated.

From the Sponsor and Data Management perspective, Dr. Diego Herrera in his presentation will be touching upon ongoing Regulatory and Market initiatives, current Clinical Outsourcing Drivers,  Common Issues, Emerging Trends and Organizational Changes to understand a different outlook at CRO-Sponsor collaboration.

Dr. Herrera’s current position is Head Global Data Management and Project Information, he is managing one senior team mainly focused to ensure document and data integrity in Clinical Trials and oversight CROs activities and services.

You can have his perspective @CRO/Sponsor Summit on Data Integrity “Quality, Compliance and Audit in Clinical Trials” #CROIn18.

Histone Acetyltransferase Inhibitors, From Screening to Optimization – A Tricky Track

Conference Talk by Dr Baell

jonathan baell
Jonathan Baell Professor of Medicinal Chemistry (MIPS), Monash University Australia

Talk Abstract: There is currently great interest in compounds that modulate epigenetics. With respect to some epigenetic targets, such as histone decacetylases (HDACs), many inhibitors have been successfully developed and are in clinical trials for a variety of indications. Similarly, bromodomains have been shown, somewhat unexpectedly by some, to be highly druggable. However, there is an elephant in the room, and that is the histone acetyltransferase (HAT) family, which is large but essentially “undrugged” and barely has any compounds that could be considered to be useful tools. Why is it so hard to find good tool compounds for these enzymes?

Not so long ago we undertook HTS against a MYST HAT and eventually discovered a genuine hit that we have recently just optimized to nanomolar levels of inhibition. However, we encountered many problems en route. In this talk we will discuss such issues and how these could help explain why there are so few, if any, useful tool compounds for these enzymes.

Grab the chance to get in touch with Dr Jonathan Baell, from Monash University, Australia at SELECTBIO MedChem 2017” meeting on 14- 15 September, 2017 at Hotel Le Meridien, Bengaluru.

Revival, Renewal and Renaissance in Ayurvedic Therapeutics as Paths to Natural Drugs

Conference Talk by Dr. Vaidya

Ashok Vaidya
Dr. Ashok Vaidya,  Research Director, MRC- KHS

Talk Abstract: Asian Health Systems offer a huge potential for the discovery of natural drugs. Ayurveda, used by more than 80% of Indians, needs ‘a bedside to bench’ R&D approach. Widely used therapies for common diseases can be revived systematically by Ayurvedic Pharmacoepidemiology (AyPE) and Observational Therapeutics (OT). Remedies and modalities currently not in common practice but described in classical texts/clinical notes, need to be renewed by the approach of a documented reversal of Ayurvedic pathogenesis, with validated clinical/laboratory markers and designs of n=1 studies and sequential trials.

Drugs in practice may be repurposed as convenient/novel dosage forms for new indications. A renaissance in therapeutics can be ushered in by trans-disciplines of Reverse Pharmacology (RP) and Translational Research (TR). There is an urgent need to train more Vaidya-Scientists, to create Centres of Excellence in AyPE, OT, RP, TR and to provide adequate infrastructure with resources. The hints, hits, leads and candidates from Ayurveda therapeutics do exist as naturals for cancer, diabetes, arthritis, neurodegenerative disorders and hepatitis.

Dr. Vaidya is from a lineage of Ayurveda and medicine; the heritage archives are a treasure trove for new leads from natural products. He evolved Reverse Pharmacology (RP) to explore this heritage. Dr. Vaidya has more than 290 research publications to his credit.  He has guided graduate students in basic and clinical drug research and Ayurveda.

Listen to this talk and interact with Dr Ashok Vaidya at Drug Discovery India 2017 meeting to be held on 14-15 September 2017 at Hotel Le Meridien, Bengaluru.

Determining Adversity in Toxicology Studies – A Toxicologist’s Perspective

Conference Talk by Dr. Venkatesha Udupa

Dr Venkatesha Udupa, Senior GM – Toxicology, Glenmark Pharmaceuticals Limited

Talk Abstract: A biochemical, morphological or physiological change (in response to a stimulus) that either singly or in combination adversely affects the performance of the whole organism or reduces the organism’s ability to respond to an additional environmental challenge is called ‘adverse effect’ in a repeat dose toxicology studies.

Adversity assessment represents empirical measurements (i.e., objective data), and integrated with well-informed subjective and professional judgments, and consequent designation of the No Adverse Effect Level (NOAEL) is the pivotal endpoint of repeat dose toxicology studies in animals which require analysis of results of all parameters evaluated in the particular study.  Differences in approaches and opinions related to using adverse effect data and NOAEL affect the assessment of human risk by regulators who may apply more conservative approaches to human dosing than otherwise necessary with better-prepared discussion and application of the concepts of adversity.

Clarity achieved through more consistent and transparent application of the adversity concept within nonclinical reports will improve communications in regulatory submissions, benefitting both clinicians and regulators charged with protecting human health. It is the ultimate responsibility of each organization to ensure that toxicology study documents and nonclinical overview regulatory documents for a given product include clear and cohesive interpretation of study findings, adversity and their relevance to humans.

Dr Venkatesha will be speaking at Metabolomics India 2017 in Hotel LeMeridien, Bengaluru.

 

What will make it an Overwhelming QbD Conference?

Dear Colleagues,

Many of you wonderful scientists must be having one or more of the following questions in your mind.

What is different in this QbD conference?

I have attended so many QbD conferences, why one more??

QbD is same always, what is new in this conference???

I am from XYZ department, will I gain anything????

I am busy, how should I take out time for this conference?????

However, we wish to tell you that our “QbD in Pharma Developement World Congress 2015 ” is going to be a great conference.  We have done efforts to make this conference the best possible with several happenings which have never been collectively there before at any QbD conference viz Problem Solving Software Training and discussion on the following and many more topics.

  • Question based Review and Continued Process Verification
  • Question based Approach to Product Development
  • Integration of Quality by Design from Product Development to API Production
  • Methods to Minimize the Impact of Uncertainty in Pharma Quality Attributes
  • Realization of Quality by Design in ANDA Submissions
  • How to Demonstrate the Relevant Diligence on Filing
  • Risk Based Approach for Efficient Development of the DS Control Strategy
  • QbD & QbR to Reduce Health Care Cost while Maintaining Quality
  • How to find the Robust Setpoint for Design Space Combining DOE Models, Monte Carlo Simulations and Design Space Concept
  • ATP and CQA For Analytical Methods
  • Risk Assessment In Aqbd and Design Space for Analytical Methods
  • Tools that Play a Critical Role in Implementation of Qbd for Biotech Processes
  • Five-D Concept of QbD
  • Live Demonstration on How to Utilize Tools of Qbd i.e. DoE & PAT
  • Industry Case-Studies Related to Implementation of PAT
  • How To Implement DoE & PAT Systematically & Effectively during Development & Manufacturing of Solid Oral/Liquid Orals/ Semisolids & Parenteral Dosage Forms
  • DoE for Development of a Modified-Release Tablet
  • Advanced DoE for Improved Process Understanding
  • Statistics in Product Development – Beyond DoE
  • Use of other Statistical Tools to Build Robust Products & Processes
  • Chemometric Tools in QbD -Chemometric Methods & their Advantages and Principle
  • QbD Based Systematic Development of Nanoemulsions for Natural Product
  • Analytical Quality By Design (Aqbd) Approach In RP-HPLC Method Development
  • Quality By Design (QbD) Approach in Formulation of Oral Delayed Release Tablet of LansoprazolFor details, please find attached the agenda of the conference. Looking into the above topics being covered, we feel that we have the answers to the above questions
  •  You were looking for the best QbD scientists and there they are.
  • This is not like the earlier conferences since the quality of talks is exceptionally high and specifically meant to enhance your process and product understanding.
  • QbD has to be implemented holistically and if you are a scientist from Quality assurance, Analytical development, API Development or Formulation Development, it is relevant for you.
  • You are entrusted with responsibility to develop products and processes of high quality for effective ANDA filings and that exactly the aim of this conference is.
  • You spend lot of time in sorting out QbD data related problems which your colleagues must be facing. Be there, get your data problems solved and save time.
  • Finally get tips on how to develop medicine in cost effective manner and give your company a return which is much higher than investment in this conference.

So what are you waiting for? Register now

Our worthy Speakers and we all will be doing our best and Now it is your presence which will make it an Awesome Conference.!!!

Looking forward to see you in Chandigarh.

How Question Based Development can Demonstrate Quality by Design and how it can Facilitate Continued Process Verification??

Ajaz Hussain2

How Question Based Development can Demonstrate Quality by Design and how it can Facilitate Continued Process Verification??

Recent organizational changes at CDER/FDA have created a new ‘supper’ Office of Pharmaceutical Quality to improve information and knowledge sharing and decision- making; (a) within New and Generic CMC Review function, and (b) between CMC Review and CGMP Compliance functions.  ‘Question based Review’ and ‘Continued Process Verification’ are two themes can be expected to have a significant impact over the next several years on how product development, validation and manufacturing is carried out in industry and how FDA will review and inspect these functions.

If the above issue is important for you and you would like to be enlightened on the same you ought to be in Chandiarh for “QbD in Pharma Development World Congress 2015” on April 16, 2015 in Chandigarh. Dr Ajaz Hussain, Former FDA Reviewer and Currently Executive Director, NIPTE, USA will be there to address this issue and many more.

Just SMS QbD at 7696125050 and we will get back to you with more details.