BIOPHARMA INFORMATIC, INC.

Advancing Medicine, Improving Lives.

Biopharma Informatic, Inc.

Site Management Organization

What is an Site Management Organization?

• A Site Management Organization is a service company involved in the clinical research industry. It works mainly with pharmaceutical companies and Contract Research Organizations (CRO’s) and facilitates research activities by finding suitable researchers and patients for participation in clinical trials.

What are the duties of an SMO?

• The job of an SMO is to recruit suitable researchers and patients for participation in these clinical research trials. The SMO also finds suitable locations to conduct the research like hospitals and clinics. For this reason, it has a decentralized operating structure with research sites situated at physician offices and hospitals leveraging existing infrastructure.

What are the duties of an SMO? (continued)

• Clinical trials are an industry in itself. Over 60 billion dollars are pumped into new trials as well as 60,000 - 80,000 trials initiated every year. Funding comes from both the U.S. federal government and private companies that have a financial interest in developing these drugs – mainly pharmaceuticals. On average, a single clinical trial can last close to 10 years and often costs more than 800 million dollars.

• The contract research industry is growing at 17% annually, currently valued at 13 billion dollars. The SMO sector is booming at 43% growth each year.

Our Goal

• Biopharma Informatic, Inc. aims to create a nationwide Site Management Organization. The company’s distinct business model enables rapid expansion into any locale where there are physician clinics. This means that the business can spread into every city in the U.S. It can also spread into foreign countries where there is currently high demand for research.

Our Experience as an SMO

• Role of SMO in Clinical Research Industry

• Different Models of SMO

• Responsibility of an SMO

• Revenue Resources of an SMO

Demand for SMO’s

• SMO’s are in high demand by pharmaceutical companies and CRO’s.

Demand for SMO’s (continued)

The gross margins are close to 50%, and the net margins (plus other income earned during the trial) are about 25% to 35%. Each contract represents a clinical trial, which from a business perspective is treated like a project. The cash flows in a lengthy project are spread out over the period of the contract. This means that liquidity and patience are two very important ingredients needed to arrive to the stage of profitability. The 2-year ROI stands at +250%.

What We Do?

• Biopharma Informatic, Inc., is in the business of recruiting patients for participation in clinical trials and developing physician networks for the conduct of clinical trials. Biopharma Informatic, Inc., is in the ‘Site Management’ sector and companies in this sector are commonly referred to as SMO’s – Site Management Organizations. Under Food and Drug Administration (FDA) industry classifications, this type of entity falls under the category of a biotechnology firm.

Mission Statement• Biopharma Informatic, Inc. is essentially a contractor and

facilitator among the many parties involved in drug development. We deal directly with business executives, researchers, bioethics professionals, government health officials, doctors, and patients. This role works well with our guiding principles as we hold a unique position in the industry structure. Our corporate and social responsibilities will allow us to “Advance Medicine.”

• The world of research is sparked by intellectual curiosity, motivated by the need to find cures and alleviate suffering, while it is naturally governed and made possible by the economic laws of the marketplace. We will strive to create employment opportunities for professionals in a rapidly changing industry landscape impacted by Technology and Globalization. Despite this changing landscape, however, the principles of good business always stay the same. Therefore, our overall goal from an entrepreneurial and research standpoint is to “Improve Lives.”

 

This mission statement is incorporated in our tagline:

“Advancing Medicine,

Improving Lives.”

Corporate Vision

• Our corporate vision is to set up the premier Site Management Organization in the contract research industry. This business model is truly unique and can be spread from coast to coast in the US. We shall strive to become an international SMO/CRO with sites worldwide, catering to global pharmaceutical research. Using a global model will allow us to lower development costs and time to market for medicines – ultimately benefiting global health.

Corporate Vision (continued)

• In 2004, PhRMA (Pharmaceutical Research and Manufacturers Association – a trade group consisting of the 30 top pharmaceutical and biotechnology companies in the USA) member companies invested an estimated 38.8 billion dollars in researching and developing new medicines, an increase of 12.6% over the previous year. When factoring in research and development by non-PhRMA biotechnology firm, an estimated 49.3 billion dollars was invested in biopharmaceutical Research and Development in 2004.

• The ultimate goal for pharmaceutical companies is to discover, develop, manufacture, and sell medicines to treat illness and disease. The government realizes the importance of investment in R&D. The government run National Institute of Health (NIH) contributes over 15 billion dollars annually to research institutions across the U.S. mostly research programs at universities

• Private and public companies, the government, non-profit organizations, and individuals all provide funding for R&D. The manifestation of this investment is ultimately the Clinical Trial – the testing ground for a new drug. In 2002, there were over 60,000 clinical trials initiated in the U.S.

Drug Discovery:

• Researchers first identify a target for a new medicine, such as a molecule believed to affect a particular disease. Then they screen (using computers) or create (using biotechnology) thousands of compounds, identifying hundreds of potential medicines. While most will never be approved for use in patients, each one will be evaluated to determine potential value compared to existing therapies, complexity of large-scale production, and other factors. Hypothetically, we begin this journey by screening 10,000 molecules.

Pre-clinical Testing: • Candidate drugs from the

discovery stage then receive 1 to 3 years of extensive testing in the laboratory and on animals to assess safety and show biological activity against a disease. In addition, chemistry tests establish a compound’s purity, stability, and shelf life. Manufacturing tests determine what will be involved in producing the medicine on a large scale. Studies explore dosing, packaging, and formulation (e.g., pill, inhaler, injection). We have spent 6 years in testing and have 250 promising compounds left out of the original 10,000.

IND Review:• Prior to allowing a company to initiate

tests on human subjects, the Food and Drug Administration (FDA) must review an Investigational New Drug (IND) application submitted by the drug’s developer to protect patients from unreasonable risks in clinical trials.

Phases of Clinical Trials:

• After approval from the FDA, the Clinical Trial is started. In three phases of clinical trials, which can take anywhere from 2 to 10 years, teams of physicians test a new drug in patients to learn if they are safe and effective. Only 5 compounds out of the 10,000 became eligible to enter trials.

Phases of Clinical Trials (Continued)

• Phase I, the medicine is tested for safety, safe dose range, and mechanism of action in 20 to 100 healthy volunteers.

• Phase II uses placebo-controlled trials, with 100 to 1000 volunteers who have the disease being studied, to establish that the medicine effectively treats the disease. Researchers also continue to evaluate the drug’s safety, look for side effects, and determine optimal dose strength and schedule.  

Phases of Clinical Trials (Continued)

• Phase III, the medicine is tested in large trials with 1,000 to 30,000 patients in hospitals and clinics to determine effectiveness and to identify side effects. These trials compare the experiences of randomly selected groups of patients with similar characteristics, some of whom take the new medicine being tested while others take a placebo.

• Phase IV, the aim is to further characterize the safety of the drug through the identification of unknown adverse reactions and to potentially research new therapeutic indications. Companies often use this phase to gain exposure to different physicians and clinics, which aids in the marketing of their product.     

• A clinical trial is a controlled scientific experiment – involving hundreds and sometimes tens of thousands of patients, even on a global scale. Activities that “remove risk” from the R&D process are the ones that confer greatest value on a new chemical entity or technology. Therefore, although drug discovery is where the R&D process begins, the progression to clinical trials is where greatest value is found. Completion of each stage of the clinical trial process (from Phase I to III) brings greater value to the company’s experimental medicine.

 

• It is in these various phases that suitable patients must be recruited for testing. Biopharma Informatic, Inc. offers this service to clinical trial sponsors. 

Phases of Clinical Trials (continued)

FDA Approval • The Food and Drug Administration (FDA)

scientists and advisory committees review all clinical trial results and the company’s NDA (New Drug Application). They decide whether the data justifies an approval for patient use and release in the marketplace. Approval is a big cause for celebration!

• On average it takes 10 to 15 years and costs more than 800 million dollars to advance a potential new medicine from a research idea to a treatment approved by the (FDA).

Players in the Business

• Pharmaceutical Companies

• Biotechnology Companies

• Contract Research Organizations

• The Government

GCP-ICH Guidelines

• GCP-ICH stands for “Good Clinical Practice and the International Conference on Harmonization”. GCP is an initiative by the FDA, to standardize and put in policy and instructional guidelines for the R&D industry. GCP applies to trial activities taking place around the world. Doing a clinical trial is a serious matter, as any trial done incorrectly will have erroneous results. Any action to develop a drug based on flawed data may have disastrous effects in the aftermath. So these guidelines have been marketed around the world and are slowly being adopted by all the countries that have significant research taking place. Europe and Japan, the two other significant global research hubs other than the U.S., have already adopted them. Now the focus is on developing countries, as more and more trial work is conducted internationally.

The ‘Site Management’ Sector

• What Happens at a Clinical Site?

• The Role of an SMO

Relationship Management

• Clinical Research Management is both an art and a science. Successful human relationships all have common underlying foundations – trust, dependability, and integrity. It takes these elements to create lasting bonds with both investigators and outsourcers. There are many types of parties and people that an SMO has to deal with. Our dedicated employees and Clinical Research Coordinators have to be trained, groomed, and motivated. Investigators are highly educated and must be treated like academics. In status, the investigator holds the upper hand to the SMO. Relations with our CRO benefactors must be extremely professional and time-conscious. They are busy managing several trials at once, and they take note of a company’s dedication to making their job easier. CRM is a central theme in this business.

Relationship Management(continued)

• The R&D industry is enjoying ever-growing investment from both private and government sources. The shift to outsourcing within the industry has led to the rapid emergence of the contract research industry - growing at 17% a year. The industry is in a growth phase.

• The ‘Corporate SMO’ model is the champion strength of this venture. It is what allows this company to effectively enter the business and the means to allow expansion to a national level. The corporate SMO model is in demand.

Relationship Management(continued)

• Management has an existing relationship network among CRO’s and pharmaceuticals that provide contracts. Obtaining these contacts is perhaps the most difficult part of the business. To start with, this asset in hand is a big advantage.

• Management enjoys a good reputation among CRO’s and pharmaceuticals. This is because of the superb relationship management skills of BI’s chief relationship manager.

• Visionary, ambitious, and experienced managers lead BI.

• The management team has a fair amount of business experience and solid chemistry.

Relationship Management(Continued)

• In this business, one’s relationships with investigators and especially outsourcers are where the real value lies – it’s as good as a tangible asset. Lack of contacts is the major barrier to entry, and startups struggle to gain any foothold in the market. However because site management is in demand, and BI’s primary relationship manager already has the necessary bank of relations with both investigators and outsourcers. BI has access to instant business. Biopharma Informatic, Inc. has a database of over 100 physicians and specialists across America. There is a very solid base of potential investigators and management has worked with many of these doctors before.

• A Site Management Organization is not at all a complex organizational entity. It has a very simple internal structure. Four major functions need to be addressed:

• Relationship management with sponsors

• Relationship management with investigators

• Financial Management

• Clinical Site Operations / Project Management

Active Studies• T2DM with Renal Impairment

• Report Study

• T2DM Acute Coronary Syndrome

• Flu Treatment Study

• T2DM in African Americans

• Multiple Rheumatoid Arthritis

• Adult Growth Hormone Deficiency

• COPD

• LCZ696B2314 Novartis

• Community Acquired Pneumonia

• Kidney Stones

• Romark Flu

• Pegasus

• T2DM Novonordisk 3846

• Chron’s Disease

• T2DM Novonordisk 3678

• Chronic Heart Failure

• Attention Deficit Hyperactivity Disorder

• Chronic Indophathic Constipation

• Chronic Plaque Psoriasis

• Chronic Obstructive Pulmonary Disease

• Dermatology Study with Botox Treatment

• Fecal Incontinence

• Gout Combination Therapy

• MPI Imaging Study PPD

• Growth Hormone Deficiency in Children

• Hepatitis C

• Hypertension

• Irritable Bowel Syndrome

• New Influenza

• Over Active Bladder

• Pediatric T2DM

• Multiple Rheumatoid Arthritis Studies

• Multiple T2DM Studies

• Ulcerative Colitis

• Generalized Anxiety Disorder

• Gout Monotherapy

Upcoming Studies

List of Principal Investigators in TexasMemorial Clinical Associates• Miguel Franco, M.D.

• Lisa Hitchins, M.D.

• Deborah Hodge, M.D.

• John Levins, M.D.

• Roger Schultz, M.D.

• Richard Pohil, M.D.

Dairy Ashford Clinic• Nan Jiang, M.D.

• Xin Wang, M.D.

Angio Cardiac Care• Masroor Khan, M.D.

• Amin Karim, M.D.

West Memorial Family Practice• Severino Pimentel, M.D.

Adult Primary Care Medicine• Barry Troyan, M.D.

Diagnostic Clinic of Houston

• Freemu Varghese, M.D.

• Anita Beneke, M.D.

• Brian Tulloch, M.D.

• John Turner, M.D.

• Ronald Colman, M.D.

Endocrine and Psychiatry • Vinita Bhagia M.D.

West Side Medical Clinic • Syed Ahmed, M.D.

Richmond Bone & Joint Clinic• Volkan Guzel, M.D.

• Fayyaz Ahmed, M.D.

• Thomas Rivers, M.D.

List of Principal Investigators in Florida

Internal Medicine and Cardiology Associates• Nasir Rahmatullah, M.D.

• Mehr Rahmatullah, M.D.

Pediatric Health Care• Raza Ali, M.D.

• Michelle Muriel, M.D.

List of Principal Investigators in Alabama

Choice Medicine

• Celia Lloyd-Turney, M.D.

The Huntsville Clinic

• David Calderwood, M.D.

Shoals Primary Care

• Faizullah Syed, M.D.

• Frank Gillis, M.D.

Scottsboro Quick Care Clinic

• Younus Ismail, M.D.

• Muhammad Amjad, M.D.

• Junaid Memon, M.D.

North Huntsville Health Care • Michael Johnson, M.D.

Office of Saadat Ansari, M.D.• Saadat Ansari, M.D.

Research Consultants Team

• Dr. Syed Naqvi – President & Director R & D

• Cortney Casey – Business Administrator

• Karen Musil – Personal Assistant to Director R & D

• Jenn Strempel – Administrative Assistant

• Shuja Naqvi – Financial Analyst

• Dr. Rakhshinda Javaid – Regional Manager

• Dr. Syed Javaid Mustafa – Regional Manager

Enlightened Health, Inc.

Our Non-Profit Organization

Main Objectives for Enlightened Health, Inc.

• To help the United States government in providing health care for people in need.

• To identify uninsured and underinsured who are potential people in need.

• To assist and collaborate with organizations working to provide health care, including finding a cure for cancer especially in children.

• To assist organizations working in clinical research and who are working to advance medicine and improve lives.

• To support third world countries in improving health and education.

• To operate and/or manage one or more health care clinics.

• To do such other and further things that a nonprofit corporation may do not inconsistent with the above and foregoing purposes.

Forms used by Biopharma Informatic,

Inc.

For More Information,

Please Visit Our Website:

www.biopharmainfo.net

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