When I was a young and idealistic doctor, I wanted to change the world. I was fascinated by research and by the challenge of discovering new drugs. Today, some 25 years later the one thing I’d like to fix is STOP CANCER!

The greatest challenge is to stop cancer cells from growing, dividing uncontrollably

and spreading- causing great suffering. Understanding how healthy cells divide and how the process can go wrong - is the foundation on which efforts to beat cancer are built.

Cancer is one of the most complex problems in modern medicine. There is no one way to stop it, as it manifests in more than a 100 ways and can arise from numerous causes. Thousands of cancer-causing gene problems have already been identified, but there may be many more yet to be discovered.

Cancer results from an accumulation of mistakes or abnormalities in genes that normally control cell survival, growth and migration. The resulting mass of new cells forms the primary tumour.Tumour cells can then spread (or metastasize) from the primary to other parts of the body.

Why do cells proliferate too much?Genes are the instruction manual for our cells, mutations are like errors in the base sequence. When these instructions are altered cells may begin to multiply uncontrollably.

What can cause gene mutations?Environmental factors may also be a factor in causing gene mutations. Some chemicals in tobacco smoke, viruses or bacteria, some chemicals or radiation. They disrupt the growth signalling pathway.

How can we reduce the risk of cancer? Stop smoking! Eat lots of fruits and vegetables. Protect yourself from too much sunlight. Don’t drink a lot of alcohol and smoke. Vaccines as advised by the doctor.

High Failure RateThe number of new drugs making the journey all the way to market is reducing. In Phase II clinical trials, typically around 70% of new molecules fail to progress further and a remarkable 50% more fail at Phase III.

Learning more and more about genes and cancer.The frame of reference for the field is continually changing. Each gene participates not in one pathway, but in many – possibly dozens. A disease may have many different pathways that take a wrong turn-A tangled knot rather than a straight road.

Turmoil and transition in Drug Development. Unprecedented challenges.*Time for products from competitors is falling.*Generic alternatives to existing drugs are commanding a growing share *Costs are rising but less than one drug in ten recovers this cost. *Drug development is very risky as the failure rate is high. *Knowledge is growing exponentially.*The regulatory bar is rising higher and higher.*Oncology’s overall success rate is so low 6.7%relative to other therapeutic areas 12%. Many fail in Phase III

So what is the answer? We still need to find a cure for cancer!

Reaching out from national boundaries into a new approach of emerging collaborative global networks for drug discovery and development

innovative collaborations will be the new model Multidisciplinary and multi-sector collaborations, pathway to patient benefit will be a collective effort

Profit TogetherNo pharmaceutical company will be able to “profit alone”. It will, rather, have to “profit together” by joining forces with a wide range of organisations, from academic institutions, hospitals and technology providers to companies new technologies to look deeper.

Bill Gates urges Stanford grads to focus on progress, not profit alone

.

The dinosaur becomes obsolete and is replaced by a fast nimble cheetah.

The model of Big companies retaining all the knowledge within has become obsolete. Managing partnerships in parts of the drug development cycle while retaining core assets and knowledge will be the challenge. Good communication skills will be needed as the industry moves from internal to external focus. Companies need to be nimble and quick .

Building an asset light- drug development company.

It started with outsourcing to contract research organisations but has now gone much further into a virtual world. Making smaller super specialized teams that work across international borders. The best people in the field are chosen to become members of the team. Outside expertise can be brought in whenever needed.

Changing the game.Being Patient centric-work closer with patients- making them the focus. Collaborating with doctors even before the search for new drug and integrating them early Scientists need to have collaborative ability.

Changing the mind-set on intellectual property rights An enabling Intellectual Property framework has become one of the prerequisites for global prosperity.

Continuing engagement with the public and government policymakers to better understand the challenges which drug discovery faces globally.

India AdvantageIndia can make drugs for the 6 billion people in the world who cannot afford Western prices. India pharmaceuticals can reduce the burden of disease not just in India but globally. The Biotechnology and life science sector can follow the IT sector and India can become the center of innovation and be the drug maker for the whole world. India can make drugs for a tenth of the cost in the West. (India’s successful Mars Mission was a tenth of the cost compared to

Western countries.)

The Early Cancer Detection is Key

0.13 mm3

= 500-3,000 cells

10 mm

10 m

m

103 mm3

= 0.5-3 billion cells

1 mm

1 m

m 13 mm3

= 0.5-3 million cells

Courtesy by Dr. Gambhir, Stanford University

• detecting relevant disease at the earliest possible stage and methods to predict and monitor therapies

• Molecular imaging using suitable probes is able to localize site(s) and characterize tumor status at an earlier stage

• Future cancer patient management will have implemented Molecular Imaging for:– Improved tumor detection and characterization – Better understanding of tumor heterogeneity /

biology– Tailored pathway-based therapies, individualized

therapeutic combinations / schedule variations, optimized external beam radiotherapy

– Early assessment of response

Using new technology – Molecular Imaging to Stop Cancer

An example- from Piramal Imaging.18F-labeled derivative of the natural amino acid glutamateSpecific transport via amino acid exchanger system xC-Strong accumulation in various tumor typesRapid blood clearance, low background in healthy tissuesPotentially guiding therapy decisions for improved outcomeCurrently in clinical development

Can this idea work?

Here is an example -Piramal Enterprises acquired the Molecular Imaging assets of Bayer in 2012. A small team of highly committed scientists working across international borders was formed to complete the trials and shepherd the science towards regulatory approval. FDA Approves Piramal Imaging’s NeuraceqTM (florbetaben F18 injection) for PET Imaging of Beta-Amyloid Neuritic Plaques in

the Brain. The group is trying to replicate the success with cancer diagnosis.

DRG- Decision Resources Group USA Oncology TeamMerron, Andrew AMerron@dresourcesgroup.com

Piramal Imaging GermanyDr Ludger Dinkelborg ludger.dinkelborg@piramal.comDr Andrew Stephens andrew.stephens@piramal.com

-Molecular Imaging Society of India.

Graphics- Anju Tikekar

Credits