DISCLAIMER AABPS is a non-profit, volunteer
Transcription
DISCLAIMER AABPS is a non-profit, volunteer
D I S C L A I M E R AABPS is a non-profit, volunteer-driven, professional organization. Information published in this magazine has been provided by individuals and organizations. AABPS is not responsible for the accuracy of the presented information. 2 AABPS CONVENTION 2014 CONVENTION Buffalo Niagara Marriott in Amherst, New York August 8 & 9, 2014 (Friday & Saturday) © All rights reserved by the authorities of American Association of Bangladeshi Pharmaceutical Scientists, AABPS. No part of this printed material can be reproduced in any means without publisher’s permission. Published in Auguest, 2014. Printed in the USA. Please visit www.aabps.org for the electronic version of this brochure. Graphics Design: Mamoon Rashid, PhD 3 PRESIDENT PEOPLE’S REPUBLIC OF BANGLADESH DHAKA 5 May 2014 It gives me immense pleasure to learn that the American Association of Bangladeshi Pharmaceutical Scientists (AABPS) is going to organize its 2nd Convocation at the Buffalo Niagara Marriott in Amherst, New York, USA on August 8-9, 2014. On the occasion of this august convention, I convey my warmest greetings and felicitations to the erudite members of AABPS. Ensuring access to quality medicine is one of the most cherished goals of the Government of Bangladesh. It is on this principle that the Government always motivates and supports the pharmaceutical industry in Bangladesh to flourish this sector to a great extent. I have been informed that today pharmaceutical industry is one of the most thrust and rich sectors of the country and it is making praiseworthy contributions to the country’s socio-economic developmet by fulfilling about 97 per cent of the total domestic demand of medicine as well as by earning valuable foreign currencies through exporting medicine around the world. I am happy to note that the AABPS is working at global arena with reputation and I hope that this organization would extend its expertise in pharmaceutical developments, manufacturing, regulatory issues and pharmacy education, and thereby eventually help Bangladesh capturing more global market. I also encourage its members to work side by side with similar professional organizations in the healthcare, pharmaceutical industry and academia in Bangladesh. I wish the 2nd Convocation of the American Association of Bangladeshi Pharmaceutical Scientists a great success. Khoda Hafez. May Bangladesh Live Forever. Md. Abdul Hamid 4 CONVENTION Welcome Note AABPS Executive Committee and Organizing Chairs On behalf of American Association of Bangladeshi Pharmaceutical Scientists (AABPS), we sincerely and warm heartedly welcome our members, guests, volunteers, and family members to the 2nd AABPS Convention in Amherst, New York. We are extremely happy that you are attending the 2nd convention in this internationally acclaimed wonderful and historic Niagara Falls Area. It is truly an exciting moment for all of us to meet and exchange ideas with many members representing the field of Pharmacy and Pharmaceutical Profession from different parts of our globe. It is our continuation of journey for establishing a strong professional organization and the legacy of our successful 1st AABPS convention last year. It is our firm conviction that the commitment and dedication of our members have made AABPS evolve into a highly visible professional organization. We can proudly announce that AABPS is not only helping members in their professional enrichment, collaboration, leadership, and graduate/professional education, but is also an advocacy-group and resource for Bangladeshi-American pharmaceutical professionals. AABPS now provides a common platform for its members to work with other professional organizations in the health care, pharmacy, pharmaceutical industry, regulatory agency and academic institution to advance human health and their well-being. We understand we have a long road ahead but we are confident that our members with their excellent knowledge, expertise, vigor and courage, will establish AABPS as an effective professional organization. The field of Pharmacy and Pharmaceuticals is having a greater role in the overall global healthcare. We are confident, AABPS members with their advanced knowledge, expertise and innovations, will contribute to their fullest capability for a better global healthcare. The theme of this year’s convention is “Advancing Knowledge & Fostering Collaboration”. Through this convention, AABPS would like to advance its mission and goals, fortify professional knowledge, help young professionals succeed in their career and increase further the visibility of AABPS in the national and international arena. We are happy to see your overwhelming enthusiasm, participation and attendance in this convention. The beautiful venue, great speakers, rich professional programs, fine hospitality and excellent cultural programs are a result of the extraordinary efforts of all the Convention Committees. The determination of chairs, co-chairs and members of these committees to take their responsibilities and challenges are highly commendable. We are honored to recognize all the convention Committee members listed in the convention magazine and volunteers for their diligent work in organizing this 2nd convention. Without their vision and dedication this convention would not have been possible. We would like to specially acknowledge and thank our families for their great sacrifice, strong support and enormous patience during the countless hours for organizing this convention. We hope for a very successful convention, and an exciting and wonderful time for you and your family at Amherst and Niagara Falls Area. Best Wishes. Muhammad Delwar Hussain, Ph.D. Mohammad Hossain, Ph.D. 5 6 CONVENTION Convention Committee AABPS 2014 REGISTRATION COMMITTEE »»Saleh Hussain (Chair) »»Milad Khan (Co-Chair) »»Shahid Alam »»Anwar Hussain »»Arshad Jamil »»Mahiuddin Talukdar FUND RAISING COMMITTEE »»Mohammed Shameem (Chair) »»Naushad Islam (Co-Chair) »»Zahur Islam SITE SELECTION COMMITTEE »»Ashraf Khan (Chair) »»Mohammad Hossain (Co-Chair) »»Nahid Zaman »»Saleh Hussain »»Muhammad Delwar Hussain CONSTITUTION COMMITTEE »»Zahur Islam (Chair) »»Jamil Habib (Co-Chair) »»Mohammad Rahman »»Muhammad Delwar Hussain »»Mohammad Hossain PUBLICITY COMMITTEE »»Mamoon Rashid (Chair) »»Ahmad Abdullah (Co-Chair) »»Milad Khan »»Mohammad Hossain »»Devabrata Mondal CULTURAL COMMITTEE »»Shahid Khandker (Chair) »»Ahmad Abdullah (Co-Chair) »»Rajib Paul »»Shamsul Hoque (Tagor) »»Mortuza Bakshi SOUVENIR COMMITTEE »»Muhammad Delwar Hussain (Chair) »»Zahur Islam (Co-chair) »»Mohammad Hossain »»Nasir Uddin SPEAKER & AWARD COMMITTEE »»Jamil Habib (Chair) »»Jabed Seraj (Co-Chair) »»Murad Husain »»Muhammad Delwar Hussain »»Mohammad Hossain GRADUATE STUDENT COMMITTEE »»Nahid Kamal (Chair) »»Nahid Zaman (Co-Chair) »»Rashedul Islam »»Saifur Rahman »»Tanvirul Hye »»Ehtesham Reza 7 Sponsors of the Convention Platinum Sponsors Graduate Student Travel Award Sponsors »»Dr. Swapan Kumar Das »»Emcure Pharma »»Mr. Abdul Muktadir »»Mr. Salim Joardar »»Solco Healthcare »»Square Pharmaceuticals Ltd. Gold Sponsors »»Aristo Pharma »»Dr. Mohammed Shameem »»Dr. Rajib Paul »»Dr. Mohammed Shameem »»Dr. Saleh Hussain »»Mr. Abdul Muktadir »»Mr. Ahmad Abdullah »»Mr. Mominul Islam Souvenir Sponsor »»Dr. Zahur Islam diamond Sponsor »»Dr. Zahur Islam With Best Compliments from 8 Program Outline Friday, August 8th EVENING SESSION 5:00 PM – 5:30 PM 5:30 PM – 8:00 PM 5:30 PM – 5:45 PM CONVENTION Advancing Knowledge & Fostering Collaboration Ballroom 5 Program Committee Meeting Registration (Ballroom 5 Lobby) Reception and Welcome Address Mohammad Hossain, PhD 5:45 PM – 6:05 PM “Development of Bangladesh Pharma Sector and Its Potential as a Global Generic HUB” Mollick Mahmood Hossain, MPharm Managing Director, Novelta Bestway Pharmaceuticals, Bangladesh Ahmad Abdullah, MPharm (Moderator) 6:05 PM – 6:25 PM “Mass Spectroscopy as a Detection Technique Gaining Popularity in Analytical Assessment” Arshad Jamil, MPharm, MS, Senior Research Scientist, Emcure Pharmaceuticals Mohammad Hossain, PhD (Moderator) 6:30 PM – 8:00 PM Dinner (Sponsored by and Complements of AABPS) and Networking 8:00 PM – 8:55 PM “Inspiring Our Youth” - An Interactive Session with Our Youth & Family Shahid Rahman, Founder & President, Inspiring South Asian Youth (ISAY) Foundation Zahur Islam, PhD (Moderator) 9:00 PM Visit Niagara Falls at Night (Private arrangement) th Saturday, August 9 MORNING SESSION 7:30 AM – 6:00 PM 7:45 AM – 8:45 AM 8:30 AM – 9:30 AM 9:30 AM – 9:45 AM Ballroom 5 Registration (Ballroom 5 Lobby) Breakfast and Networking (Poster Viewing) Sunrise Session: “Applications of Statistical Concepts in Pharmaceutical Sciences” Mahmudul Huq Khan, PhD, Novartis Pharmaceuticals Zahur Islam, PhD (Moderator) Opening Remarks Muhammad Delwar Hussain, PhD 9:45 AM – 11:45 AM: Plenary Session: “Current Trends in Drug Development: Clinical, Manufacturing and Regulatory Strategies” 9:45 AM – 10:15 AM: “TAS-102: A case study in the Phase I through III clinical development of anti-cancer compound” Fabio Benedetti, MD, Senior VP Chief Medical Officer, Taiho Pharma, USA Muhammad Jamil Habib, PhD (Moderator) 10:15 AM – 10:45 AM Mid-Morning Refreshment and Networking (Poster Viewing) 10:45 AM– 11:15 AM: “Bangladesh Pharmaceutical Industries and its contribution to the health care” Tapan Chowdhury, Managing Director, Square Pharmaceuticals Ltd., Bangladesh Naushad Islam, MS (Moderator) 9 Program Outline 11:15 AM – 11:45 PM “Challenges and Opportunities of Professional Practice in North America” Ahmad Abdullah, MPharm, Proprietor, Shoppers Drug Mart, Scarborough, Ontario Saleh Hussain, PhD (Moderator) 12:00 PM– 1:00 PM Lunch and Networking (Poster Viewing) AFTERNOON SESSION Ballroom 5 1:00 PM – 2:00 PM Focus Group Discussion: “Advancing Knowledge Through Collaboration” Group I (Analytical and Formulation Development) Moderators: Enamul Kabir, MS & Shah Rashid, MS Group II (Biologics) Moderators: Muhammad Delwar Hussain, & Milad Khan, MS Group III (Clinical Research) Moderators: Jabed Seraj, MD, PhD & Mohammad Hossain, PhD Group IV (Pharmacy Practice): Moderators: Swapan Kumar Das, PharmD & Ahmad Abdullah, MPharm Group V (Regulatory Affairs) Moderators: Naushad Islam, MS & Fakrul Sayeed, PhD Group VI (Generic Product): Moderators: Anwar Hossain, PhD & Sharif Ahmed, MS 2:00 PM – 2:45 PM Focus Group Panel Updates 2:50 PM – 3:30 PM Graduate Student Forum: “Sailing to Success in Education, Research and Career” Moderators: Nahid Zaman, PharmD Candidate, SUNY Buffalo and Md. Ehtesham Reza; Formulation Scientist, Emcure Pharmaceuticals. Afternoon Refreshment and Networking (Poster Viewing) General Business Meeting: “AABPS – Achievements and Future Directions” Mohammad Hossain, PhD, Muhammad Delwar Hussain, PhD and Zahur Islam, PhD Awards & Recognitions Muhammad Jamil Habib, PhD, Muhammad Delwar Hussain, PhD and 3:30 PM – 3:45 PM 3:45 PM – 4:45 PM 4:45 PM – 5:00 PM Moderators of Each Focus Group Mohammad Hossain, PhD 5:00 pm – 5:10 PM Closing Remarks EVENING SESSION Ballroom 5: “This Moment is Ours - with Family and Friends” 6:00 PM – 7:00 PM 7:00 PM –10:30 PM Muhammad Delwar Hussain, PhD Dinner Cultural Program Songs and cultural performances by : Shikha Rouf, Sarah Naz Billah, Farhana Meer, Mohammad Mahbubul Haque & Sribash Dey Comedy by: Shamim Ahmed, PhD, MBA Emcees: Mohammad M. Haque and Rajib K. Paul, PhD 10 Convention Speakers CONVENTION Mollick Mahmood Hossain, M.Pharm Managing Director, Novelta Bestway Pharmaceuticals Ltd. Abstract: Bangladesh has all the potential to become world’s generic pharmaceutical product manufacturing hub such as it is for RMGs. With a population of 156.66 million, the country’s social development indicators are very promising. Bangladesh is enjoying a consistent GDP growth around 6.50% over last 10 years. Significant progress has been made in areas like Annual GDP growth, Per capita GDP, Population growth, Literacy rate etc. The trade deficit of the country is also coming down. Renowned Investment analysts like JP Morgan, Goldman Sachs, investor Chronicle has highly rated Bangladesh as an attractive investment destination. Pharmaceutical industry is one of the fastest growing business sectors in Bangladesh. Local market is about USD 1.51 Billion and it is the second highest contributor to national exchequer with the largest white color employment sector. Local companies largely dominate the market and the industry is almost self sufficient to meet the domestic demand. Moreover, Bangladesh is also exporting to 90 countries with a growth rate of 25%. Many local companies have achieved international regulatory certifications like TGA, UKMHRA, GCC, AGES, ANVISA, EUGMP. At least 3 local companies are in the final stage of US-FDA approval. Within next couple of years, Bangladesh Pharmaceutical industry will become stronger and play a major role in global generic market with a size of around USD 300 Billion with a CAGR of 9.7%. Asian countries like India and China are the major players in global generic and Bangladesh has all the potentials to be one of them. In last 5 years, modern, sophisticated and complaint facilities are established. The country is now producing high-tech products like biosimilars, prefilled syringe, Freeze-Dried, MDI, Hormone & steroid products. With world-class pharmaceutical production facilities, low overhead and business cost compared to other regional players like China, India, and Korea, Bangladesh is definitely an attractive destination that can be utilized as an emerging global generic HUB. Bio Profile: Mollick Mahmood Hossain completed B. Pharm (Hons) and M. Pharm from the Faculty of Pharmacy, University of Dhaka. He is the Co-founder and Managing Director of NOVELTA BESTWAY PHARMACEUTICALS LTD (NBPL). Mollick is a renowned professional with 23 years of working experience in different reputed Pharmaceutical companies like BEXIMCO Pharmaceuticals Ltd. INCEPTA Pharmaceuticals Ltd. & SILVA Pharmaceuticals Ltd. In his career, he held many vital positions like Marketing Executive, Sales Manager, Marketing Manager, Marketing Director, and Head of International Marketing to Head of operation. As a Pharmacist Mollick visited more than twenty countries. Because of his contribution to pharmaceutical sector, the Govt. of Peoples Republic of Bangladesh has appointed Mollick Mahmood as a board member of Bangladesh Council of Scientific & Industrial Research (BCSIR), the only government KPI R&D institute. He is very much involved in to equip the country people for proper employment in his home district Faridpur for last12 years. Shahid Rahman Abstract: With few exceptions most immigrants assimilate into the their host country, within one hundred years. Inspiring South Asian Youth’s (I-SAY) aim has been to create an alternative integration model by which future and current generations can remain successful as Americans (educated and civic minded), while retaining portions of their cultural identity. I-SAY’s model aims to utilize and mobilize youth in creating solutions to local issues that are both creative and attractive to other youth. The integration model is replicable and scalable. Bio Profile: The Founder and President of I-SAY (www.isay.org) has extensive experience in the non-profit sector related to the integration of South Asians in the United States. He has chaired, organized and spoke about many issues related to South Asians in the United States. He is also the President of Bangladeshi American Youth Association and is a graduate of Rutgers University with a degree in finance. 11 Convention Speakers Fabio Benedetti, MD Chief Medical Officer & Senior Vice President, Taiho Oncology, Inc., Princeton, New Jesrsey, USA TAS-102: A case study in the Phase I through III clinical development of an anti-cancer compound. Abstract: TAS-102 is an oral combination drug of trifluridine, an antineoplastic nucleoside analog, which is incorporated directly into DNA and tipiracil hydrochloride, an inhibitor of the FTDdegrading enzyme, thymidine phosphorylase, which helps maintain effective concentrations of FTD in the blood. A historical review of the clinical trial rationale, design and findings at each phase of clinical development of this compound will highlight key principles and concepts in oncology drug development. Bio Profile: Dr. Fabio Benedetti, MD, was appointed Taiho Oncology, Inc’s Senior Vice President and Chief Medical Officer in March 2010. Dr. Benedetti has extensive experience in oncology, ranging from medical practice to clinical drug development and medical affairs. Prior to joining the company, he has served in various leadership positions including Senior Vice President and Chief Medical Officer of Oncology at Geron Corporation, Vice President of Medical Affairs at Onyx as well as Millennium Pharmaceuticals, and has held Medical Director level positions at BristolMyers Squibb and Roche Laboratories. Dr. Benedetti graduated from Brown University, where he also went on to receive his medical degree in 1990. After finishing his Internal Medicine residency at Strong-Memorial Hospital in Rochester, NY, he went on to complete a Medical Oncology/ Hematology fellowship at the Memorial Sloan-Kettering Cancer Center in New York City, where he subsequently worked as an Attending Physician for the Gastrointestinal Oncology Service. Tapan Chowdhury Managing Director, Square Pharmaceuticals Ltd., Bangladesh Abstract: Not submitted. Bio Profile: Mr. Tapan Chowdhury, a leading industrialist of Bangladesh started his career in 1978 as a Marketing Officer in their family business Square Pharmaceuticals Ltd a private limited company. Today he is the Managing Director of Square Pharmaceutical, Square Textiles, Square Hospitals Ltd & few other companies of Square Group. He along with his late father Mr. Samson H Chowdhury, founder Chairman of Square Group, took Square Pharmaceuticals Ltd for Public Listing around 20 years back. Mr. Chowdhury is a Science Graduate from Dhaka University & Has a post graduation degree in Marketing from U.K. He is the President of Bangladesh Publicly Listed Companies (BAPLC), President Bangladesh Employers Federation (BEA) Incoming President of Bangladesh Textile Mills Association (BTMA ) Mr. Chowdhury is in the Board of Governors of Bangladesh Enterprise Institute (BEI). He also served as an Adviser (Minister) to the Government of Bangladesh during the last Caretaker Government & was responsible for five ministries including Power, Energy, Food & Disaster Management, Science & ICT & Youth & Sports. Mr. Chowdhury is involved with number of social & philanthropic organization. 12 CONVENTION Convention Speakers Mahmudul Khan, PhD Novartis Pharmaceuticals Applications of Statistical Concepts in Pharmaceutical Sciences Abstract: The purpose of this talk is to present applications of commonly used statistical methods, as encountered in the pharmaceutical industry. It includes types of data and their tabular and graphical representations. Application of confidence intervals and tests of hypothesis are also presented. Bio Profile: Dr. Mahmudul Khan obtained his BS and MS in Statistics from the University of Dhaka and then pursued his Ph.D. in Biostatistics from the University of Hawaii (supported by East West Center scholarship). He taught Statistics at the University of Dhaka, Jahangirnagar University and North South University at the undergraduate and graduate levels Dr. Khan imparted and continue to impart training, on statistics, in Bangladesh and in the US. He has been working in the Pharmaceutical industry in the US for the past 15 years, including J&J, Novartis, Biogen and Abbott. His hobbies include following cricket and soccer. Ahmad Abdullah, M.Pharm Proprietor, Shoppers Drug Mart, Scarborough, Ontario Challenges and opportunities in the profession of pharmacy in canada Abstract: This presentation will provide a brief overview of changes in the economic picture and government regulations which changed the landscape of pharmacy practice in Canada over the last decade. Specifically, it will discuss the impact of Bill 102 and the economic recession in the years 2008-2009 on the pharmacy profession. Some of the challenges that these changes have posed include closure of pharmacy business, reduction of hours of operation in pharmacies, withdrawal of funds for interns and students, increased number of pharmacists with a decrease in the number of jobs. Bill 102 in Ontario and similar steps taken by other provinces have negatively impacted brand manufacturing due to generic policies by the government of Canada. Other challenges include a lost revenue of 809 million dollars for the brand manufacturer, lay offs and hiring freeze for multinational companies in Canada. Introduction of registered pharmacy technicians with more responsibilities have negatively impacted pharmacist job prospects. Opportunities brought by the changes include the expanded scope of pharmacy practice approved by the government, introduction of paid services by the government (i.e. pharmaceutical opinion, medication review and injection services, more availability of support by other health care professionals of different ethnic backgrounds in order to expand collaborative pharmacy business, more job opportunities in generic manufacturer companies, stronger professional associations to provide a broader platform for professional advancement. Bio Profile: Ahmad Abdullah obtained his Bachelor of Pharmacy degree in 1975 and Masters in Pharmacy in 1977 from the University of Dhaka, Bangladesh. He immigrated to Canada in 1998. He obtained his license to practice Pharmacy in Canada in 2000. He served as a Manager of WalMart Pharmacy from 2001 to 2007. He is currently Pharmacist Owner at Shoppers Drug Mart in Scarborough, Ontario. He also works as a teaching associate to train fourth year Pharmacy Students of the University of Toronto seeking practical experience. 13 Convention Speakers Arshad Jamil, MS Senior Scientist, Emcure Pharmaceuticals, NJ Mass Spectroscopy as a Detection Technique Gaining Popularity in Analytical Assessment Abstract: HPLC Science has always been moving to more specific and more sensitive detection modes and this is where Mass Spectroscopy has become the most sought after detection Tool in Analytical Assessment. The combination of High-Performance Liquid Chromatography (HPLC) and mass spectrometry (MS) offers the analytical chemist one of the most powerful analytical techniques of modern times - it is the present and the future. LCMS is spreading widely through pharmaceutical, environmental, food, industrial materials and other fields. Mass Spectroscopy is an analytical technique used to measure the mass-to-charge ratio of ions. MS holds its popularity due to High sensitivity, High Specificity due to specific fragmentation pattern of ions and High Resolution of time. The challenge in MS is to eliminate the solvent while maintaining adequate vacuum level and to generate gas phase ions. The large majority of application in MS employs electrospray and atmospheric chemical ionization technique for the ionization and atmospheric photo ionization technique is currently emerging. Triple Quadrupole Mass Spectrometry is the method of choice for accurate quantification and confirmation of trace level analytes in complex Matrix. From the detection of drugs and metabolites in biological specimens, environmental contaminants and pesticides in food, to leachables and extractables from closure and containers and packaging systems and from in process manufacturing caveat, in Parenterals and Opthalmics, analyst all over the world are challenged with detecting an increasing number of target analytes with greater sensitivity and in more samples than ever before. FDA regulations and alertness with respect to safety of population have created more demand of MS with respect to analytical detection of the critical entities. Bio Profile: Arshad Jamil, M.S. is a Senior Research Scientist at Emcure Pharma in East Brunswick, NJ. In his role, Mr. Jamil focuses on method development and validation and is also responsible for the company’s LCMS activity performing method validation and tests for extractable and leachable components in injectables related to FDA queries and submissions. Mr. Jamil has more than 25 years of experience in drug metabolism, pharmacokinetics, bio-analytical, and analytical research and development in both brand and generic pharmaceutical industries. Prior to joining Emcure, Mr. Jamil served as a Senior Scientist at Sandoz, Inc. where he was involved with the Formulation Support Group and was responsible for analytical method development and validation of drug products on various analytical platforms including HPLC, UPLC, UPLC H-Class, GC, and UV. Earlier in his career, Mr. Jamil worked at Wyeth-Ayerst Research, Inc. (now Pfizer) where he served as senior scientist in preclinical drug metabolism and disposition research for the development of novel pharmaceutical compounds. Mr. Jamil has also worked at Barr Laboratories (now Teva), and GoldPharm Research, Inc. in Analytical R&D. Mr. Jamil earned his B.Pharm and M.Pharm degrees from the University of Dhaka, Department of Pharmacy and Later a M.S. from the Arnold Marie Schwartz College of Pharmacy with distinction from the Rho Chi Honors Society. (Biologics) Muhammad Delwar Hussain, & Milad Khan, MS GROUP III (Clinical Research) Jabed Seraj, MD, PhD & Mohammad Hossain, PhD GROUP Enamul Kabir, MS & Shah Rashid, MS IV V GROUP II (Analytical and Formulation Development) VI GROUP GROUP I GROUP Focus Group Discussion Topics (Pharmacy Practice) Swapan Kumar Das, PharmD & Ahmad Abdullah, MPharm (Regulatory Affairs) Moderators: Naushad Islam, MS & Fakrul Sayeed, PhD (Generic Product) Moderators: Anwar Hossain, PhD & Sharif Ahmed, MS CONVENTION Articles by the Members 15 Engineered Pulmonary Medicine and Appropriate Drug Delivery Technology Mohammed Ali Ph.D., MBA, CSMS. Associate Professor, Department of Technology, Jackson State University, Jackson, MS 39217 The human lung is an effective route for non-invasive drug delivery since it provides large surface area for rapid absorption, minimal physical barrier, absence of extreme pH and metabolism, no first pass liver, rich blood supply, and poor bioavailability of oral drugs. The physical and electrical properties of active pharmaceutical ingredient (API) and excipient interactively influence five electromechanical deposition mechanisms of respiratory medicinal aerosols while flowing through the airways including nose, mouth, pharynx, trachea, bronchi, bronchioles and alveoli. results using these modeling tools agreed with in-vitro study results as well. In the field of aerosol medicine there have been several methods invented and marketed to improve pharmacokinetic efficacy and effectiveness in respiratory drug delivery, and to minimize losses in the delivery devices. Examples are: nanoparticle therapeutics for reduced side effects and more targeted deposition, salt-based formulations optimized for inhalation to create a robust and flexible platform that can accommodate low or high drug loads of a range of molecule types, sustainable long pulmonary absorption achieved through tissue binding and cellular uptake in the airways, moderately lipophilic compounds with positive electrostatic charge under physiological conditions to bind preferentially lung tissues, liposomal encapsulation in controlled-release particles, and increase the molecular mass of the drug by conjugation with a water-soluble inert ligand or another protein. The therapeutic particles from a specific device during the inhalation process come out as an aerosolized form. The dispersion of these pharmaceutical powders often face difficulty since the fine powders are cohesive due to the strong inter-particle adhesion forces: van der Waals, capillary and electrostatic attractions. Typically, cohesive forces are proportional to the diameter d of the particles, whereas, the detachment forces for re-suspending the particles forming aerosol is proportional to d2 when aerodynamic shear force is used for the dispersion. Thus the smaller More examples of improved drug the diameter the higher is the shear delivery methods may include the use force needed for efficient dispersion of a valve holding chamber or spacer for forming aerosol containing the for metered dose inhalers, inlet primary API and excipient particles design change of dry powder inhalers micronized in the jet mill. A solution for less resistance to air flow and to these problems can be the Fig. 1. Respiratory therapeutic particle deposition particle de-agglomeration, facemask manufacturing of engineered API and mechanisms in the human lung. with nebulizer and spacer for infants excipient to manipulate the cohesivity, and children, charge neutralization and dispersability with necessary of nebulized aerosol before administration, non-propellant magnitudes of particle charge during the micronization inhaler with soft mist of aqueous drug solution through a process. These modifications will improve blending set of fine channels in the nozzle, enhanced condensational uniformity, and long term stability of the powder mixtures. growth of submicron particle for minimum mouth-throat The primary mechanisms of lung deposition of inhaled respirable drug aerosol particles in the human lung consist of the five electromechanical processes: impaction, diffusion, interception, gravitational settling and electrostatic effects as depicted in Fig.1. There are a number of mathematical models and computational tools developed to understand particle flow and predicting deposition patterns of particles in the whole lung or its specific region. In-silico study deposition, evaporation and condensation aerosol generator for poorly water soluble drugs suitable for pulmonary route. Studies with laboratory animals showed that antibiotic dose of nanoaerosol generated by electrospray-neutralization process for pulmonary drug delivery method requires one sixth fraction of dose for peroral treatment. The high flow nasal cannula (HFNC) therapy is currently being employed to deliver oxygen to the patients with AABPS Member’s Articles 16 CONVENTION moderate levels of hypoxemic respiratory problems. In the same fashion, this method can be used to deliver drugs to the lungs. However, it was reported that infant, pediatric and adult nasal cannula show a decrease in delivery with the increase of inspiratory flow rate which can be explained by the higher drug deposition (losses) in the device components. These losses often occurs as a result of combined effects of several issues such as inside geometry of cannula, directional change of aerosol flow in the nose, mouth, pharynx and trachea. However, the enhanced condensational growth and excipient enhanced growth showed substantial improvement (~80%) without incorporating exhalation cycle. These results may prove promising if the realistic inhalation-exhalation flows are simulated. References: 1. Ali M. Pulmonary drug delivery. In: 5. Asgharian B, Hofmann W, Bergmann 9. Onischuk AA, Tolstikova TG, Sorokina Kulkarni K. Handbook of non-invasive R. Particle deposition in a multipleIV, Zhukova NA, Baklanov AM, drug delivery systems, 1st edition. path model of the human lung. Aerosol Karasev VV et al. Anti-inflamtory Amsterdam, The Netherlands: Elsevier Sci Technol 2001;34:332-339. effect from indomethcin nanoparticles Inc; 2009:209-246. inhaled by male mice. J Aerosol Med 6. Cheng YS. Mechanisms of Pulm Drug Deliv 2008;21(3):231-243. 2. International Commission on pharmaceutical aerosol deposition in Radiological Protection Publication the respiratory tract. AAPS Pharm Sci 10. Gulshahi L, Tian G, Azimi M, Son 66; Human respiratory tract model for Tech 2014;15(3):630-640. YJ, Walenga R, Longest PW, Hindle radiological protection, New York, NY: M. The use of condensational growth 7. Patton JS, Byron PR. Inhaling Elsevier; 1994. methods for efficient drug delivery medicines: delivering drugs to the body to the lungs during noninvasive 3. Martonen T, Fleming J, Schroeter J, through the lungs. Nature Rev Drug ventilation high flow therapy. Phar Res Conway J, Hwang D. In-silico modeling Discov 2007;6:67-74. 2013;30(11):2917-2930. of asthma. Drug Del Rev 2003;55:8298. Davis ME, Chen ZG, Shin DM. 845. 11. Dhand R. Aerosol therapy in patients Nanoparticle therapeutics: an emerging receiving noninvasive positive pressure 4. Ali M, Reddy RN, Mazumder MK. treatment modality for cancer. Nat Rev ventilation. J Aerosol Med Pulm Drug Electrostatic Charge Effect on Drug Discov 2008;7:771-782. Deliv 2012;25(2):63-78. Respirable Aerosol Particle Deposition in a Cadaver Based Throat Cast Replica; J Electrostat 2008;66:401-406. NOTE: This article is part of the paper published in the Respiratory Care Journal. AABPS Member’s Articles 17 Immunomodulatory receptor (IMR) engagement – breakthrough in cancer treatment Shuangping Shi and Mohammed Shameem Biologics Bioprocess Development, Merck Research Laboratories, NJ, USA The recent cancer immunotherapy-resurgence, and inhibitory signals fine-tunes the extent of T-cell especially T-lymphocyte (T-cell) mediated therapies, activation, host defense, and “self-tolerance”. has set the stage for a revolutionary-change in cancer treatment using monoclonal antibody based therapies. Unlike traditional immunotherapy agents (e.g. Antibodies for targeting IMRs Herceptin® and Retuxin®) which target specific epitopes Monoclonal antibodies have become powerful weapons on cancer cells, T-cell mediated immunotherapies for targeting IMRs on T-cells for cancer immunity. The structural complexity of antibody CDRs allows high target surface expressed-immnunomodulatory receptors (IMRs) on T-cells (activated and regulatory). degree of specificity for target engagement, sparing Physiologically, IMRs can act either as inhibitory- the host from off-target side effects. In antagonistic fashion, the high affinity of an immune checkpoints, as in the antibody to target, often stronger maintenance of “self-tolerance” than IMRs’ natural ligands, give (e.g. CTLA-4, PD-1, LAG-3, TIMrise to potential advantages in 3, BTLA, and TIGIT), or in a completive binding to IMRs concerted co-stimulatory fashionpreventing ligand-induced as in the case of potentiated T-cell receptor activation. Conversely, activation (e.g. OX40, GITR, CD27, as an agonist, conformational 4-1BB, and ICOS) (ref 1). Preantibodies can activate a coclinical and clinical studies have stimulatory IMR in the absence validated the effectiveness of IMRs of its natural ligand. as therapeutic targets showing that blockade of inhibitory-or activation Monoclonal antibodies are highly of co-stimulatory IMRs can boost tolerated by human body with immune responses against cancer. a long half-life and predictable Targeting these IMRs on T-cells Adopted from Mellman et al (ref 1) pharmacological properties. and combining these strategies Over a quarter century of proven with other therapeutic approaches industrial record and regulatory experience makes are anticipated to transform cancer from a lethal these classes of molecules the best platform of choice disease to a chronic- more manageable condition. for T-cell mediated immunotherapies. T-cell activation and cell death Effective activation of T-cells requires two sets of signals. The first signal is delivered through the interaction between the T-cell receptor (TCR), which is the primary stimulatory receptor, and the antigen bound major histocompatibility complex (MHC) on antigen presenting cells (APCs). The second signal occurs when the B7.1 and B7.2-ligands on APCs interact with the co-stimluatory-CD28 receptor on T-cells. Upon T-cell activation, inhibitory IMRs are induced and trigger “negative” signals that dampen activation. At the same time, co-stimulatory IMRs are induced to prolong T-cell activation and prevent programmed cell death. The equilibrium between co-stimulatory- Antagonists of inhibitory IMRs Two of the best studied inhibitory-immune checkpoints are Cytotoxic T-Lymphocyte Antigen 4 (CTLA-4) and Program Death 1 (PD1). CTLA-4 is a cell surface molecule that is closely related to CD28, which is expressed constitutively on T-cells and provides the major co-stimulatory signal for T-cell activation. In contrast, CTLA-4 is transiently expressed following T-cell activation and competes with CD28 for their shared ligands B7.1 and B7.2. The competition between CD28 and CTLA-4 for B7.1 and B7.2 inhibits excessive T-cell activation through CD28 (ref 2). PD1 is another inhibitory IMR molecule that is expressed after T-cell activation. PD1 has two ligands, PDL1 and PDL2, both AABPS Member’s Articles 18 CONVENTION are B7 homologues. The interaction of PD1 with its ligands PD-L1 and PD-L2 dramatically inhibits T-cell proliferation and cytokine secretion (ref 3). It is hypothesized that cancer cells may be able to “highjack” these immune checkpoint IMRs to escape from host immune responses. By therapeutically blocking (antagonizing) the immune checkpoints or inhibitory IMRs, the “brake-signal” is essentially taken off the T-cell which then allows the immune system to mount a durable response to cancer cells. This theoretical-prolonged immune response has the potential to allow high rates of sustained tumor regression, and in-practice checkpoint-blocking antibodies such as anti-CTLA-4 (BMS Yervoy® or ipilimumab), anti-PD1 (Merck MK-3475 or pembrolizumab and BMS nivolumab) and anti-PDL1 (Roche RG7446 and Astrazeneca MEDI-4736) have demonstrated impressive clinical benefits and longterm survival in terminally ill cancer patients. In clinical studies for melanoma patients, one year survival rates for Yervoy®, MK-3475, and nivolumab were 46%, 69%, and 62%, respectively. Concurrent treatment with Yervoy and nivolumab resulted in a 1-year survival rate of 85% and 2-year survival rate of 79%. However the higher response rate is accompanied with increased toxicity (autoimmunity) compared to therapy with either single agent. Another interesting immune checkpoint inhibitor in clinical development is anti-LAG-3 (BMS BMS986016). Lymphocyte Activation Gene 3 (LAG-3) is expressed on T-cells and Natural Killer (NK) cells. Binding of LAG-3 to the MHC Class II complex on APCs blocks proliferation and effector functions of T-cells. In pre-clinical models, anti-LAG-3 worked synergistically with anti-PD1 curing mice of established tumors that were largely resistant to single antibody treatment (ref 4). Agonists of inhibitory IMRs functions upon activation (ref 5). OX40 also shuts down immunosuppressive regulatory T-cells (Treg) in tumors. The dual role makes OX40 an attractive target for cancer immunotherapy. AstraZeneca is evaluating a mouse monoclonal antibody-anti-OX40 in a Phase 1 trial. The molecule elicited tumor regression and showed increased T-cell/B-cell responses to reporter antigen immunizations (ref 6). The TNF receptor super family members 4-1BB and (Glucocorticoid-Induced TNFR family Related gene) GITR are also being investigated as cancer immunotherapeutic targets. 4-1BB is expressed on activated T-cells. An “agonist-acting” (functional accelerator)-anti-4-1BB antibody induces CD8+Tcell activation and interferon gamma secretion. Currently two 4-1BB agonist antibodies (BMS BMS663513 and Pfizer PF-05082566B) are under clinical evaluation for solid tumor and B-cell lymphoma. GITR is expressed at a significantly higher level on tumorinfiltrating Treg cells. Anti-GITR antibody was shown to promote effector activation and Treg cell depletion or inactivation at the tumor site (ref 7). TRX518 and MK-4166 are two agonist anti-GITR antibodies under early clinical development by GITR Inc. and Merck, respectively. Another stimulatory IMR worth mentioning is CD27. Unlike other TNF receptor super family members mentioned above, CD27 is constitutively expressed on naive and activated T-cells. CD27 is known to be involved in T-cell activation, effector function, maturation, and survival (ref 8). There is one antiCD27 agonist antibody (Celldex CDX-1127) in Phase 1 development for the treatment of B-cell hematologic malignancies and solid tumors. In pre-clinical studies, this antibody induces T-cell activation and tumor immunity (ref 9). Conclusions Despite the benefits that come with transforming cancer therapy, IMR-targeting agents do carry the risk of autoimmune disease. The CTLA-4-blocking Yervoy has been found to cause colitis, hepatitis, toxic epidermal necrolysis, pituitary inflammation, etc. and TGN1412, a CD28 agonist, caused life-threatening autoimmune reactions in healthy volunteers in a phase 1 study (ref 10). Nonetheless, the combination therapy that results from eliminating immune checkpoints and stimulating a positive immune response to the tumor, in conjuction with other cancer therapies, is anticipated to ultimately lead to cancer cure. As mentioned, immune checkpoints are often described as the “brake” for host immune responses. Sometimes mounting a robust and persistent immune response to cancer cells not only requires one to lift the “brake”, but also to push the “accelerator”—costimulatory IMRs. A number of co-stimulatory IMRs, most of which belong to the tumor necrosis factor (TNF) receptor family, have been-and are currently being-investigated in clinical studies. OX40, a member of TNF receptor family expressed on the surface of activated T-cells, boosts T-cell division and survival, in addition to stimulating immune effector and memory AABPS Member’s Articles 19 References and Suggested Reading 1. Mellman I, Coukos G & Dranoff G. 4. Woo ST, et al. Immune inhibitory 7. Cancer immunotherapy comes of age. molecules LAG-3 and PD-1 Nature (2011) 480 (7378): 480-9. synergistically regulate T-cell function 2. McCoy KD and Le Gros G. The role to promote tumoral immune escape. of CTLA-4 in the regulation of T cell Cancer Res. (2012) 72(4):917-27. immune responses. Immunol Cell Biol. 5. Croft M. Control of immunity by 8. (1999) 77(1):1-10. the TNFR-related molecule OX40 3. Keir ME, Butte MJ, Freeman GJ, (CD134). Annu. Rev. Immunol. (2010) Sharpe AH. PD-1 and its ligands in 28: 57–78. tolerance and immunity. Annu Rev 6. Curti BD, et al. OX40 is a potent Immunol. (2008) 26:677-704. immune-stimulating target in late9. stage cancer patients. Cancer Res. (2013) 73(24):7189-98. Bulliard Y, et al. Activating Fc γ receptors contribute to the antitumor activities of immunoregulatory receptor-targeting antibodies. J Exp. Med. (2013) 210 (9): 1685-93. Hendriks J, et al. CD27 promotes survival of activated T cells and complements CD28 in generation and establishment of the effector T cell pool. J. Exp. Med. (2003) 198: 1369-80. He JZ, et al. Agonist anti-human CD27 monoclonal antibody induces T cell activation and tumor immunity in human CD27-transgenic mice. J Immunol. (2013) 191(8):4174-83. 10. Sheridan C. TeGenero fiasco prompts regulatory rethink. Nat. Biotechnol. (2006) 24: 475–6. AABPS Member’s Articles Cultural Performers Shikha Rouf Shikha Rouf started her musical journey at a very early age of 8 with Ustad Zakir Hussain, father-in-law of the famous Niaz Mohammad Chowdhury. Five years of “Chhayanot” gave her formal lessons in Nazrul Geeti, an eastern classical base and many awards. She is also a former champion of DUCSU and “Shamsunnahar Hal” in music. Soon her achievements opened the doors in the media; she was enlisted as a grade “A” artist in both National TV and Radio. Shikha’s passion for singing made her a very popular name in the cultural shows of Dhaka, both in public and private aspects. And now she has carried her musical ventures to Toronto, and continues to perform today. Mahbubul Haque Mahbub started taking music lessons at the age of five from renowned teachers and graduated in Tagore Songs/Semi Classical from Shangeet Bhaban under the direct mentorship of Late Ustad Kalim Sharafi. In the last 20 years, he has played, performed and recorded albums with accomplished bands namely The Trap, Faith, Pentagon, Warfaze, Ark, Winning, Jahmalama (Canada), and composed original music for various artists from all over the world including Bangladeshi top celebrities. Currently Mahbub is primarily focused on fusion projects for revitalizing Bangladeshi rare root music with the blend of world music for making it more appeling to the new generation. He is also a subject matter expert in audiovisual pre/ post production technologies and event management. Mahbub has graduated in Economics from the University of Toronto, works as a Senior Business Analyst/Project Manager in the financial industry, and is happily married with Asma Anjuman Ara with one daughter, Afsheen Haque. Sarah Naz Billah Sarah Naz Billah grew up in a family of talented musicians. Sarah started her classical music lessons at the age of 5 years with Ustad Ali Imam and continued for 12 years under his guidance. After finishing college education and as a university student she joined “Chhayanot”, where she trained in Nazrul Geeti and Lalon Geeti from renowned singer Farida Parvin. She graduated with honors after five years of training at “Chayanaut” in Nazrul Geeti and joined Chayanaut as a Nazrul Sangeet teacher. She won the Gold Medal at the National Children Competition in 1989 and the National Education Week in 2001. As an enlisted artist of Bangladesh TV, she also performed in Calcutta TV in 2006 and 2008. She was the founding member of the band named, “Crimson” which was nominated as the “Best New Band” at the Citicell Channel I Music Award in 2006. Sarah is a graduate of Jahangir Nagar University with a major in English Literature. She completed a Diploma in Audio Engineering in Canada and is now working at “B4Ushowit.com” as an audio-visual technician. Her performances aired in Toronto television and her numerous on-stage performances have captivated audiences and helped her gain popularity at home and abroad. Also, Farhana Meer & Sribash Dey CONVENTION 20 Welcome To the 2nd Annual AABPS Convention From your local Bangladeshi-owned Domino’s Pizza Lumberton/Mt Holly 609-265-1300 Absecon 609-646-8808 Maple Shade 856-866-1500 Atco/Berlin 856-768-5522 Atlantic City 609-347-0303 Marlton 856-596-5900 Bayville 732-269-7800 Millville 856-327-4900 Brick 732-206-0002 Pennsauken 856-663-2522 Bridgeton 856-455-6800 Toms River 732-929-1818 Burlington 609-387-8400 Vineland 856794-3030 Camden 856-225-0400 Westmont 856-854-5600 Cape May Court House 609-465-9090 West Philadelphia 215-477-6000 Egg Harbor Township 609-646-8222 Williamstown 856-728-5533 Gibbstown 856-224-8700 Willingboro 609-871-8800 Glassboro 856-881-8100 Woodbury 856-845-6444 Hammonton 609-567-5111 Little Egg Harbor Township 609-296-2900 Call Salim Joarder, Owner, with any concerns 856-524-1200 AABPS 2014 CONVENTION First Name Ahmad Sharif Fakhruddin Shamim Mohammad Muhammad Mortuza Prosenjit Mohammad Tapan Swapan Muhammad Reza Muhammed Mohammad Mollick Saleh Muhammad Naushad Mominul Zahur Rafiqul Nasrin Arshad Enamul Mohammed Monzurul Ashrafuzzaman CONVENTION List of Registrants Middle Last Abdullah Ahmed Ahmed Ahmed S Akbar Amir Ali Bakshi Chakraborty A Chowdhury Chowdhury Kumar Das Jamil Habib M Haque Anwar Hossain Hossain Mahmood Hossain Hussain Delwar Hussain Islam Islam Islam Islam Jahan Jamil Kabir Kabir Kader Khan Shaheen Milad Mahmudul Md Saifur Mohammad Abdullah Md Habib Rajib Ayaj Shafiur Md. Bodruddoza Shaikh Mamoon Mehbuba Shah Md. Ehtesham Abdus Fakrul Jabed Syed Mahiuddin Nahid Mohibuz Mostofa Gam Huq Rahman Hasan Al K Mukidur S Khan Khan Khan Khan Miah Maruf Muniruzzaman Muntasir Paul Porosh Rahman Rafique Rahman Rashid Rashid Rashid Reza Salam Sayeed Seraj Shahriyar Talukdar Zaman Zaman Zaman Zamil 23 Dinner Buffet ÆÆ ÆÆ ÆÆ ÆÆ Food Menu Executive Continental Breakfast ÆÆ ÆÆ ÆÆ ÆÆ Assorted Naan, Rolls & Butter Mixed Field Greens tossed in a White Balsamic Vinaigrette Wild Mushroom stuffed Ravioli in Gorgonzola Sauce Grilled Halal Chicken Breast with a Lemon Herb Sauce ÆÆ ÆÆ ÆÆ ÆÆ ÆÆ ÆÆ Assorted Chilled Juices: Apple, Grapefruit, Cranberry, Oranges Juices Assorted Breakfast Bakeries Whole Fresh Fruit Coffee, Decaffeinated Coffee, Tea Saturday Assorted Freshly Baked Cookies Coffee, Decaffeinated Coffee, Tea Assorted Sodas and Bottled Water Millersport Delicatessen Lunch Buffet ÆÆ ÆÆ ÆÆ ÆÆ ÆÆ ÆÆ Chef ’s Soup of the Day Field Greens & Market Vegetables Tossed in a Balsamic Vinaigrette Tortellini Pasta Salad Potato Chips & Pretzels Roast Halal Beef, Tuna Salad, Seafood Salad & Halal Chicken Salad Sandwich Fixins Array of Whole Fruit Coffee, Decaffeinated Coffee, Tea Assorted Sodas and Bottled Water Dinner Buffet ÆÆ ÆÆ ÆÆ ÆÆ Assorted Rolls and Butter Strawberry Fields – Mixed Greens tossed with Pecans, Gorgonzola, sliced Strawberries served with Strawberry White Balsamic Vinaigrette Fresh Basil Tomato, Mozzarella and Cucumber Salad with Balsamic Drizzle Grilled Halal Chicken Breast with Pineapple and Mango topped with Rock Shrimp Relish ÆÆ ÆÆ ÆÆ ÆÆ ÆÆ Saturday Cheddar & Swiss Cheeses, Julienne Romaine, Sliced Tomatoes, Sliced Dill Pickles Appropriate Toppings & Condiments Fresh Whole Wheat Rolls & Wraps, Croissants & Assorted Deli Breads Assorted Dessert Bars Coffee, Decaffeinated Coffee, Tea and Iced Tea Saturday Afternoon Break ÆÆ ÆÆ ÆÆ Cheese Pizzas Stuffed Eggplant Rollatini in Tomato Sauce Rice with a Curry or Red Pepper Sauce Chef ’s Choice of Vegetable Plated & Served Chocolate Cake Coffee, Decaffeinated Coffee, Assorted Herbal Teas Saturday Mid-Morning Refresh ÆÆ ÆÆ ÆÆ Friday ÆÆ ÆÆ ÆÆ ÆÆ ÆÆ ÆÆ ÆÆ Saturday Cajun Seared Salmon with Cucumber Yogurt Oven Roasted Assorted Halal Chicken Pieces Herb marinated coasted with Seasoned Breadcrumbs Pasta Marinara Mashed Potatoes White and Green Asparagus with Whole Roasted Sweet Things Carrot Cake Freshly Brewed Coffee, Decaffeinated Coffee & Herbal Teas