AAPS Regulatory Sciences (RS) Section Newsletter

Transcription

1 AAPS Regulatory Sciences (RS) Section Newsletter Volume 3, Issue 2; October, Mission To be the premier organization of all regulatory scientists dedicated to the discovery, development, manufacture and life cycle management of pharmaceutical products and therapies through establishing and applying state of the art science and technology based regulatory approaches. Contents of the Issue Message from the Chair Editor s Note CMC FG Update NBC 2012 RS Election Results RS Section Awards AAPS 2012 AAPS FG Meetings QbD Survey AAPS blog Communication Committee Note Section Leadership Rajneesh Taneja Chair Ganapathy Mohan Chair elect Thirunellai Venkateshwaran Vice chair Nagesh Bandi Secretary/Treasurer Abbie Gentry Past chair Mei - Ling Chen Deepa Deshpande Kyle Hayes Lakshmi Prasanna Kolluru Marilyn Morris Maria Nadeau Edward A. Narke Umang Shah Kevin Swiss Peter Inchauteguiz Satyam Upadhrashta 1

2 Editor s Note We are targeting to issue the AAPS RS Newsletter on a semi-annual basis. The newsletter s contents focus on RS announcements, updates, and recognitions of its members. The content of the newsletter represents the views of the authors and editors and does not constitute an official position of AAPS or the RS Section. We rely heavily on electronic distribution of our newsletter to the RS community. We would greatly appreciate all your efforts in further distributing the newsletter to your colleagues in an attempt to increase membership and volunteer participation. Please send your comments and newsworthy items to the editor. We would like to hear from you! Kyle Hayes, M.S., RAC, editor AAPS RS Newsletter KyleHayes10@gmail.com 2

3 Chemistry, Manufacturing and Controls (CMC) Focus group The AAPS CMC Focus Group Face-to-Face Meeting was held on Friday, May 11, 2012 and was hosted by Pfizer at their Collegeville, Pennsylvania facility. The meeting provided a forum for discussing technical and regulatory CMC topics associated with the global development of pharmaceuticals, biopharmaceuticals, and vaccines. The topics were briefly introduced and followed by breakout sessions through which attendees in small groups rotated during the day. Each topic was co-led by Industry and FDA experts. 1. A key objective of this meeting was to generate in-depth discussion on current CMC issues leading to consensus or recommendations for further exploration of the topics. The topics relevant to both Small molecule and biologics included: Challenges and Consideration for Implementation of Q11 2. Development of Clinically Relevant Specifications 3. Experience using Control Strategies to Support Real Time Release and Design Space Proposals 4. Stability-Challenges and Considerations for Global Development There were seventy-five attendees at this meeting, which included representation from twenty-six companies and FDA. The overall feedback from attendees was that the meeting provided an excellent platform for active collaboration between industry and FDA experts. The introductory / wrap up slides from each session are attached available on the AAPS website. 3

4 RS at NBC 2012 Regulatory Sciences (RS) section played an active role in the 2012 National Biotechnology Conference held in San Diego, CA. RS organized workshops, symposiums, round tables, sunrise sessions and open forums which were appreciated by the attendees. A big thank you to our section members for their support! Deepa Deshpande, Ph.D, chair of RS section NBC Program Committee, presenting at 2012 National Biotechnology Conference AAPS 2012 Regulatory Sciences (RS) Section Election Updates We are pleased to announce that Monica Whitmire was elected as the Secretary/Treasurer of the Regulatory Sciences (RS) section. Join us in welcoming Monica to the RS leadership team. 4

5 RS Section Award Recipients RS congratulates Vijay Kumar Tammara, Ph.D from Nuron Biotech Inc for achieving the AAPS Regulatory Sciences achievement award. The award is sponsored by Novartis Vaccines and Diagnostics and is honored to a scientist in recognition to his/her contributions to regulatory sciences. Dr. Tammara will receive a $2000 honorarium, a certificate and travel expenses of $1000 to attend the conference. AAPS 2012 RS Section Travelship Ruhi Ubale from Mercer University has won RS section travelship award to present her work Novel Conjugation Free Meningococcal Polysaccharide Vaccine at AAPS, RS Reception at AAPS We would like to invite you to join us for the AAPS Regulatory Sciences (RS) Section joint membership meeting and reception at the AAPS annual meeting on Monday, October 15 th, 2012 from 5.00PM to 7.30PM at Marquette, Hilton Chicago Hotel. 5

6 RS at AAPS 2012 Annual Meeting Come join us for the 2012 AAPS Annual meeting! The meeting is scheduled for Oct 14-18, 2012 at McCormick place, Chicago, IL. The scientific programming will feature 32 symposia, 24 roundtables and mini-symposia, 15 sunrise sessions, 6 short courses, 4 hot topics, 7 open forums and 3 workshops. The RS Section will hold 5 symposia, 5 roundtables, 3 mini-symposia, 5 sunrise sessions, 2 short courses and 3 open forums during the meeting: Review session themes and find more information on the AAPS program page. AAPS is pleased to announce that we have Rebecca Skloot, author of The Immortal life of Henrietta Lacks as keynote speaker for the annual meeting. AAPS is also pleased to have three plenary speakers for the 2012 AAPS Annual Meeting: G.Michael Maddock. Michael Maddock is founding partner and CEO of Maddock Douglas, Inc. His company is an internationally recognized innovation agency and works on leading corporations invent and launch new products, services and business models. Michael Ciminera Michael Ciminera is an aerospace consultant and former Vice President of Advanced Design at Grumman. Salim Ismail. Salim Ismail is Global ambassador and founding Executive Director of Singularity University. He is a sought-after speaker, strategist and entrepreneur based in Silicon Valley. We look forward to seeing you there! 6

7 RS section Focus Groups Membership Meetings The AAPS focus group membership meetings will be held in the McCormick Place during the Annual Meeting. Please confirm the location in the final program distributed on-site. Don t miss this opportunity to share your ideas, network with colleagues, and become an active volunteer within your focus group. FOCUS GROUP DATE/TIME ROOM API Manufacturing Technology Wednesday, October 17, Noon 1:00 pm W184 Bioequivalence (with Generic Pharmaceuticals) Tuesday, October 16, Noon 1:00 pm W187 Chemistry, Manufacturing, and Controls (CMC) Monday, October 15, 12:15 pm 1:15 pm W184 CMC Statistics Tuesday, October 16, Noon 1:00 pm W196 Excipients Monday, October 15, 12:15 pm 1:15 pm W190B Generic Pharmaceuticals (with Bioequivalence) Tuesday, October 16, Noon 1:00 pm W187 In Vitro Release and Dissolution Testing Tuesday, October 16, Noon 1:00 pm W185 Non clinical Dose Formulation Analysis Monday, October 15, 12:15 pm 1:15 pm W181 Pharmaceutical Packaging Development Tuesday, October 16, Noon 1:00 pm W194 Pharmaceutical Trace Impurities Wednesday, October 17, Noon 1:00 pm W190A Pharmaceuticals in Global Health Monday, October 15, 12:15 pm 1:15 pm W194 Process Analytical Technology (with Process Development) Monday, October 15, 12:15 pm 1:15 pm W187 QbD and Product Performance Tuesday, October 16, 4:30 pm 5:30 pm W178 Stability Tuesday, October 16, 4:30 pm 5:30 pm W179 7

8 Action items: QbD survey AAPS s Quality by Design (QbD) and Product Performance Focus Group is conducting a survey of industrial, academic and regulatory colleagues to assess the current state of QbD initiatives. Specific aims of the survey will be to assess the frequency of use of QbD tools, examine the motivation for implementation of QbD principles and to judge the impact of QbD on product development, manufacturing, regulatory review and product performance in patients. The QbD and Product Performance Focus Group kindly asks for your support in completing this survey and thanks you in advance for your time and effort. Survey Link: Pen down your thoughts and experiences AAPS recently started a blog. It is a great platform to get updated on the issues affecting pharmaceutical scientists, voice our opinions and initiate discussions. If you would like to contribute, please contact Stacey May at mays@aaps.org. The AAPS blog can be accessed via the link below: 8

9 RS section leadership at AAPS 2011 annual meeting, Washington D.C. RS section leadership at AAPS 2011 annual meeting, Washington D.C. Note from the Communication Committee RS Newsletter Editors thank the leadership committee of the section and AAPS for their support and assistance. We would like to hear from you. If you haven't received the E-version of the newsletter directly from the listserv (RS Section [aaps.aaps.org]) and would like to subscribe to the biannual newsletter, forward your address to the editor. We encourage you to advise us of any changes to the addresses. If you believe you are outside the RS community or received the newsletter in error, accept our apology for the inconvenience and inform the editors to unsubscribe. If you would like to contribute or have comments/suggestions, feel free to reach us at Kyle Hayes or Lakshmi Prasanna Kolluru 9