Crisper Pill will replace antibiotics but it still requires years of research before it reaches to consumers

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 Pakistan Pharma Summit-III Proceedings

Crisper Pill will replace antibiotics but it still requires
years of research before it reaches to consumers

DRAP must come up with responsive and responsible Guidelines
for biological drugs and Gene Therapy - Sarfraz Niazi

Pharma Industry cannot change the Government
but it must strive to change its behavior

LAHORE: Pharmaceutical industry cannot change the Government but it must strive to change it behavior to provide business friendly environment to the pharmaceutical industry so that it can progress, grow and compete in the developed world. This was stated by Dr. Sarfraz K. Niazi a pioneer in Biosimilar, writer, teacher, author and founder of Therapeutics Proteins and Biosimilar Company, USA. He was one of the invited guest speakers at the Pakistan Pharma Summit-III organized by Pakistan Pharmaceutical Manufacturers Association here from July 24-25, 2017 which was largely attended by representatives from the pharma industry, regulatory agencies, officials from the Punjab government as well as Federal Government.


Dr. Sarfraz K. Niazi

The topic of his presentation was “New Emerging Therapeutics and Regulatory Imperatives”.   To begin with he referred to a book “A Brief History of Medidcine: From Hippocrates to Gene Therapy” and pointed out that the best way to predict future is to invent it. If we look in the past, present and future, it was traditional medicines in 1950s and in 2010 we had all Pharma based therapies. Now we are moving towards disease death solutions. Speaking about the Body’s Internal Pharmacy, Dr. Sarfraz Niazi remarked that when Socrates died at the age of seventy years around 399 BC, he did not die of old age but instead by execution.  Is it not ironic that ancient Greeks lived into their 70s and even beyond that but almost over two thousand years later, we are not living much longer?

What is now emerging is antibody technology, Nanomedicine, Drug Resistance, rDNA, Molecular and cellular and Gene therapy. Some of the Bio therapeutics which were currently in the pipeline include Recombinant DNA, Gene for Human growth Hormone, DNA insertion, DNA recombination and Human cell. This is going to be the ruling technology of tomorrow. By 2020 the drug market is likely to be oncology 21%, Insulin’s 10%, immunosuppressive agents will account for 10%, Autoimmune 9%, and pure vaccines 7%, Infections 7% while others will be about 16%. We at Adello Biologics the Biosimilar developer at New Jersey USA, Dr. Sarfraz K. Niazi said share a passion for making a difference. I have authored Hand Book for testing biosimilars in two volumes. It has redesigned the entire technology of manufacturing. I am the largest solo inventor of Bioprocessing and was offered Global Generics and Biosimilar Award in 2014.  I also had the distinction of getting one of the fastest patent ever issued by USPTO. He then displayed a list of the 2020 leaders which included Humira, Opdivo, Tecfidera, Entresto, Enbrel, Xtani, Keytruda, Eylea, Prevnar 13, Harvoni, Avastin, Soliris, Eliquid, Remicade etc. Speaking about Ex Vivo gene Therapy Dr. Sarfraz K. Niazi said that Gene therapy is specific to future. Days are not far off when we will have customized therapies. Crisper Pill using Crisper technology will replace antibiotics but still it requires years of research efforts before it gets to the consumers. One of the drugs from Novartis for cell therapy has been recommended for approval by FDA Advisory Committee. This drug is meant for treatment of Paediatric young adult B. Cell ALL. The question is how to provide practical solutions as oncology demands ideal solutions, he remarked.


Dr. Sarfraz Niazi then talked about Bio Waivers and how Generics industry started in USA. Now FDA has called for public comments on Bioequivalence testing for Generic Drugs. As a result of Regulatory Transformation, FDA has created a new Divisions. These include Alternative Medidcine and Botanical Guidance, Molecular Medicine Division, Biosimilar Guidelines and Experts Committee. I myself has contributed a great deal to these. Now we are moving towards filing free system to ensure expedited review because medicine delayed is medicine denied. They are also taking help from experts external reviewers. What is important for DRAP is to ensure accessibility of drugs to the entire population which is very low at present. It must come up with responsive and responsible Guidelines for biological drugs and Gene Therapy. DRAP must accelerate its approval process because delayed is denied. It should work on risk based approval. It can take help from external reviewers, Ex-Pakistan and follow the EMA model. Approval should be fee based and DRAP should establish collaboration with other agencies besides participating in post marketing surveillance.


Mr. Zahid Saeed, Mian Asad Shuja ur Rehman, Kh. Shahzeb Akram, Mr.Jawed Akhai, Mr. Haroon Qasim,
Mr. Zaheer Baig photographed along with some other delegates at the Welcome dinner reception
during
the Third Pakistan Pharma Summit held at Lahore recently.

His advice to the PPMA was that if it wishes to achieve Five Billion USD drugs export by 2025, it must enter the regulated market. It should work on graduating from simpler to more complex drugs, plan to include biologics, establish Global partnerships, and get advice from Global Regulatory agencies. Self-inspection and coaching is much better than policing. Instead of working individually, plan and opt for collective efforts from the PPMA platform. What is relevant for everyone in Pakistan i.e. pharma industry, regulators, policy makers was to have passion, vision, goals and objectives. This is an exercise which is unfortunately widely ignored. We need a robust business model to support our Vision to sell globally. There was an urgent need to Connect, Communicate and Collaborate. Making safe medicines accessible should be our goal. He reminded the pharmaceutical industry that they have to succeed despite the hurdles created by the Government. You cannot change the Government but try to change their behavior. Jump into value added products instead of making cheap Generics and expensive Generics because it is not the answer.


In the last part of his presentation Dr. Sarfraz Niazi talked about Pharmaceutical GMPs for the 21st Century: A Risk Based Approach. FDA’s risk based inspections include Matrixed approach which is based on product type, potential harm and population size. The System Based Inspections revolves around six systems i.e.  Quality, Materials, Laboratory Controls, production, Packaging and Labelling besides facilities and equipment. Speaking about Botanical Drugs Development, Dr. Sarfraz Niazi said that these drugs are most urgently needed but there are safety issues, it has some difficult challenges. Education and Historical perspective based issues. He also briefly referred to Biosimilar Guidance and while talking about Collaborative Passion laid emphasis on Safety of drugs, Education, Internal inspection modules, Shared vendor qualification, commonly owned APIs and Risk-based cGMP with DRAP. He concluded his presentation by stating that their Vision was Global provider of Safe, Accessible Biosimilars.  Now the emphasis is on Safe products rather than effective products.

Dr. Aisha Bilal whose Report on Evidence Based Research and Potential of the Pakistan Pharma Industry was formally inaugurated during the meeting also briefly addressed the participants.


Mr. Adnan Rizvi from Deal Advisory was the next speaker who talked about “Pursuing Growth through Mergers and Acquisitions”. Increasing market share, enter new markets, gain cost efficiency, enhancing capabilities, improving industry position, achieve higher competitiveness, take advantage of low handing fruits, he said, were some of the reasons why mergers and acquisitions were taking place in the industry. Combination of investor’s pressure and narrowing window of opportunity are some other important reasons for mergers and acquisitions taking place all over the world. More recently the emphasis in the pharma industry is on Bioteches over conventional pharma assets. In recent years we have witnessed series of biotech acquisitions. According to reports Chinese healthcare M&A activity amounted to over fifty billion US$ in 2015 while Indian M&A activity accounted for forty Billion US$ during 2015.  In the Chinese market large pharma companies acquired small domestic biotech Research & Development firms. In India the primary driver behind Mergers and Acquisition activity locally was  due to drug deficit in the global pharmaceutical industry especially those with US FDA approved facilities. Constant pressure on manufacturing cost reduction and making India the final destination for production since cost in India is much cheaper as compared to the developed markets in the West.

During the last few years both China and India, Mr. Adnan Rizvi said have been very active acquiring pharma companies overseas. Chinese are aiming to obtain world class technology so that they use it to add on their current product develop skills. Indian pharma companies are being attracted by companies which have large distribution and marketing networks which enables them to market their own products internationally. Looking at the global trend, Pakistan Pharma industry, Mr. Adnan Rizvi stated, should actively participate in M&A activity. Lot of opportunities exist in Pakistan locally. Either one should grow or sell it over. It is time that we open up to business realities. They should attract foreign capital or enter into partnerships. They must grow in order to keep pace with the market. India and China both have set up joint ventures with big US bases companies. In Pakistan we have seen some mergers and acquisitions during the last few years. Cross border M&A opportunities exist as demonstrated by India and China. His advice to the pharma industry was that both acquisition and financing strategies should be carefully developed in consultation with experienced advisors to identify suitable targets and attract funding from international financial market.

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