TIDES: 寡核苷酸与肽的制造技术以及产品开发
CSS
寡核苷酸与肽的制造技术以及产品开发
寡核苷酸与肽的制造技术以及产品开发CMC的各课题、初期制剂开发、针对药物输送的代替投药技术相关案例研究Courses: 星期日 | Plenary Sessions: 星期一 | Main Conference: 星期二 | 星期三 CMC Challenges and Solutions
Session Sponsored by
8:15
Chairperson's Remarks
Bruce H. Morimoto, Ph.D., Vice President, Drug Development, Allon Therapeutics Inc., Canada
8:30
From QbD to Control Strategy
The development of a product control strategy is not a new concept but should be the culmination of the product development lifecycle. This talk will focus on risk management approaches used in Pfizer and how the output of this leads to definition of the initial commercial control strategy. Paul B. McCormac, Ph.D., Senior Manager, Bio-manufacturing Sciences Group, Pfizer Global Supply
9:00
Case
Continuous Chromatography for "Tides" PurificationStudy Multi-column Counter-current Solvent Gradient Purification (MCSGP) is a high-resolution chromatographic process developed for complex separations in the area of bio- and peptide-purifications. The evolution of continuous chromatography will be discussed and case studies for state-of-the-art MCSGP processes will be discussed, such as the purification of calcitonin. Massimo Morbidelli, Ph.D., Professor, Chemistry and Applied Biosciences, ETH Zurich, Switzerland
9:30
Integrating the New Process Validation Guidance into your Quality by Design Process Development Program for Peptide and Oligonucleotide Pipelines
The new Process Validation Guidance issued early in 2011 was a revelation to some and a statement of the obvious to others. However, implementing it with its many nuances can be difficult unless you take a systematic approach to underlying principles. In this presentation, learn about the mechanism to integrate it into your pre-existing development programs. Peter H. Calcott, Ph.D., President and Founder, Calcott Consulting LLC. New, Unpublished Data
10:00
First Steps for a New Validation Strategy for a Family of Oligonucleotide Sequences
Prosensa is in a unique position developing six oligonucleotide sequences for sub-populations of Duchenne Muscular Dystrophy patients, restoring the dystrophin production in muscle cells. The processing for the sequences is highly similar. A new validation strategy, creating a shared design space, will enable Prosensa to reduce validation and accelerate development of new sequences for other sub-groups of DMD patients. Charles Simons, Manufacturing Manager, Chemical Development and Production, Prosensa Therapeutics BV, The Netherlands
10:30
Networking Refreshment Break in Poster and Exhibit Hall
Strategy Discussion Forums
11:15 - 12:45
Sponsored by
Quality by Design - Revisited This session will be a follow up to the highly successful and interactive 2011 strategy discussion forum "QbD - What does it Mean in the Real World?". The session will focus on developments in use of QbD approaches in the last twelve months, and will discuss how QbD approaches may be applied to achieve efficiencies in development and validation. The panel includes both speakers from the 2011 and new speakers and promises to be a valuable follow up session. Moderator: Emma Wright, Ph.D., Senior Director, Process Development, Avecia Panelists: Mark C. Guzman, Ph.D., Principal, MG Consulting Paul B. McCormac, Ph.D., Senior Manager, Bio-manufacturing Sciences Group, Pfizer Global Supply Charles Simons, Manufacturing Manager, Chemical Development and Production, Prosensa Therapeutics BV, The Netherlands Richard W. Welch, Ph.D., Vice President, Process and Analytical Development, Emergent Biosolutions Fran Wincott, Ph.D., President, Wincott & Associates
When to Choose Recombinant vs. Synthetic Production of Peptides: The Complexities of a "Simple" Decision
As the complexity of peptides grows, the age-old question of synthetic vs. recombinant production gets more difficult to answer. In this forum, a panel of experts from industry will discuss what factors need to be part of the decision. Some of the questions we hope to probe in the discussion include:
Thomas R. Forman, BSChE, PMP, Advisor, Project Management, BioProduct Research and Development, Eli Lilly and Company Panelists: Thomas Hoeg-Jensen, Ph.D., Principal Scientist, Diabetes Protein and Peptide Chemistry, Discovery, Novo Nordisk A/S, Denmark Christopher Meenan, Associate Director, Business Development, Unigene Laboratories, Inc. Elizabeth N. Spar, Ph.D., J.D., Intellectual Property Strategist, Edwards Wildman Palmer LLP Michael H. Stowell, Ph.D., Chief Technology Officer, AmideBio Spotlight Presentations
11:15
 Primer Support™ 5G is a new solid support for synthesis of oligonucleotides that can be loaded up to 400 µmol/g. With a combination of very high synthesis efficiency and a nucleoside loading of 350 µmol/g for synthesis of DNA oligonucleotides and 300 µmol/g for RNA oligonucleotides up to 25 bases, Primer Support™ 5G will be a cost efficient solid support for scale-up and manufacturing. Anthony Scozzari, Vice President, Development Chemistry & Manufacturing, Isis Pharmaceuticals, Inc, USA Lars Holmberg, Ph.D., Director, Industrial Molecular Biology, GE Healthcare Life Sciences, Sweden
11:45
 Case
New Peptide Manufacturing Technology: Molecular HivingTM for cGMP ManufacturingStudy Molecular Hiving™ is cutting edge, hydrophobic tag-assisted liquid phase peptide synthesis (LPPS) that integrates the key advantages of solid phase peptide synthesis (SPPS). An overview of Molecular Hiving technology, including a case study that documents the synthesis and optimization of highly modified peptides is presented. Barry P. O'Connor, Ph.D., Research Scientist, R&D, Sekisui Medical Co., LTD., Japan
12:15
 Key and proprietary technologies in peptide synthesis enabling cost-effective production by increasing yield and purity, reducing the number of chemical steps and avoiding racemisation. The technologies offered by Peptisyntha are highly flexible, and are not limited to one typical product line, but can be used for a wide range of peptide APIs spanning all therapeutic areas. A review of the most innovative proprietary technologies and applications will be presented. Mimoun Ayoub, Ph.D., Vice President, Global Business, Sales and Strategic Development, Peptisyntha S.A., Member of the Solvay Group, Belgium
12:45
Networking Luncheon in Poster and Exhibit Hall
Sponsored by
|
||
|
OligonucleotidesCMC Challenges and Solutions Continued
Session Sponsored by
1:55
Chairperson's Remarks
Zhen Li, Ph.D., Associate Director, RNA Oligonucleotide Synthesis/DPC, Merck Research Laboratories
2:00
R&D Value Creation through CMC Supply Chain Management
When a lead candidate is moved towards clinical trials a reliable supply chain is needed. Synthesis and analysis are outsourced to CMOs, and a close knowledge based partnership needs to be established between sponsor and CMO. The talk will focus on the outsourcing process - what and when to outsource and is there a benefit for the research organization from the outsourcing. Michael Meldgaard, Group Leader, Oligo Production, Santaris Pharma a/s, Denmark
2:30
The Use of Custom DOE in Preparation for Process Validation
Richard W. Welch, Ph.D., Vice President, Process and Analytical Development, Emergent Biosolutions Hagen Cramer, Ph.D., Senior Manager - Oligonucleotides, Girindus Sponsored by 
Spotlight Presentation
3:00
You Have a New Impurity - So Now What?
Maintaining consistent product impurity profiles through development is a key focus; however there is the possibility that process, manufacturing site, equipment or raw material changes can lead to changed product impurity profiles or new impurities. This session will discuss the application of different experimental techniques and analytical approaches to identify the structure and route of formation of a new impurity observed during development. Presenter to be announced, Avecia Sponsored by
3:30
Networking Refreshment Break in Poster and Exhibit Hall
Strategy Discussion Forum
Sponsored by
4:00
The Oligo Supply Chain - How Strong is the Weakest Link?
A panel of supply side experts for critical raw materials will address the current status and future plans to support commercialization of oligonucleotide APIs. Questions submitted to the panelists before the show will be addressed along with those from the audience. Consideration will be given to scale, batch size, total capacity, expansion plans, supply chain risks and change management. Moderator: Paul Metz, Senior Director, Manufacturing Operations, Agilent Technologies, Inc. Panelists: John Koterba, Product Manager, Oligo Synthesis Reagents, PLS, EMD Millipore Venkatraman Mohan, Ph.D., MBA, BioPharm Technical Development Leader, Honeywell Burdick & Jackson Chris Oberle, Product Manager, NA Synthesis, Thermo Fisher Scientific Marc L. Rothstein, President, Prime Synthesis, Inc. Gaby Silver, Senior Business Development & Marketing Manager, Kinovate Life Sciences, Inc. Dr. Andreas Wolter, Site Manager, Sigma-Aldrich Biochemie GmbH, Germany Emerging Technologies Showcase - OligonucleotidesChairperson: Paul B. McCormac, Ph.D., Senior Manager, Bio-manufacturing Sciences Group, Pfizer Global Supply Spotlight Presentations
4:00
Preparation and Analysis of Conjugated Oligonucleotide Drug Candidates
Choosing a post-synthetic oligonucleotide conjugation process suitable for commercial scale production presents numerous challenges. In addressing these challenges, attention must be paid to intermediate and final product purity and impurities. This presentation will discuss various oligonucleotide conjugation reaction types along with a discussion of impurity identification approaches by LCMS. A case study is presented showing base decomposition techniques coupled with high resolution TOF MS and Ion Trap Ms(n) for identification of a novel family of conjugation related impurities. Kenneth Hill, Ph.D., Principal Investigator, Agilent Technologies Nucleic Acid Solutions Division Sponsored by 
4:30
Case
Blockmer Technology: Enabling Improved Oligonucleotide Quality and Reducing CostStudy Increasing importance of therapeutic oligonucleotides has triggered a greater demand for improved product quality while reducing the overall cost of goods. To accomplish this, we have implemented blockmer synthesis strategy. This presentation will describe the successful incorporation and recovery of Dimer Blocks during synthesis of 21-mer anticancer siRNA targeting NUAAP (noxin-like UV-induced anti-apoptotic protein). Kyeong Eun Jung, Ph.D., Director, Oligo Division, ST Pharm. Co. Ltd. (Former Samchully Pharm.), Korea Sponsored by 
5:00
Presentation to be announced
Dr. Hüseyin Aygün, CSO, Nucleic Acid Technologies, BioSpring GmbH, Germany Sponsored by 
|
PeptidesCMC Challenges and Solutions Continued
Session Sponsored by
1:55
Chairperson's Remarks
Firoz D. Antia, Ph.D., Executive Director, Product Development, Palatin Technologies, Inc. New, Unpublished Data
2:00
Solving Aggregation Aggravation: From Peptide T to Monomeric DAPTA, A Peptide HIV Antiviral that Reduces Cellular Infectious Viral Load (Reservoirs)
After several clinical trials and two decades, chemically pure formulations of the viral envelope- derived octapeptide (which appeared no more viscous than water) were discovered to have lost all bioactivity by gradual aggregation. Detecting aggregation of the octapeptide by bioassay and physical methods permitted the development of a potent, non-aggregating intranasal formulation still fully active two years out. Candace B. Pert, Ph.D., Chief Scientific Officer, RAPID Laboratories, Inc.
2:30
Synthetic Manufacturing of Icatibant (Firazyr®)
Firazyr® is approved for the treatment of acute hereditary angioedema in the US and Europe. The peptidomimetic API Icatibant is a bradykinin B2 receptor antagonist consisting of 10 amino acids (AA) including several non-proteinogenic AA. This industrial case study comprises supply chain consideration and upstream/downstream processing, demonstrating the power of state-of-the-art synthetic API manufacturing and current analytical technologies. Thomas Meier, Ph.D., Vice President, Manufacturing, Bachem AG, Switzerland
3:00
From R&D to Revolutionary Peptide ProductionSponsored by
Lonza developed and patented an evolution of conventional liquid phase peptide synthesis (LPPS) that combines the best characteristics of LPPS with the key benefits of solid phase peptide synthesis (SPPS). Lonza kept standard reagents and protected amino acids involved in SPPS for its new approach, in addition no special C-terminal anchor where found needed. The higher purity of crude peptide product created by Lonza lessens the purification load and helps reduce the development time normally associated with LPPS, while generating a greater yield of higher-purity peptides. Matthieu Giraud, Ph.D., Director, Lonza Chemicals R&D Peptides, Lonza Ltd, Switzerland Sponsored by
3:30
Networking Refreshment Break in Poster and Exhibit Hall
Emerging Technologies Showcase - PeptidesChairperson: Gary F. Musso, Ph.D., President, Musso and Associates LLC Spotlight Presentations
4:00
Application of AjiPhase™ to Large Scale of Peptide Manufacturing
AjiPhase™ is a novel liquid phase peptide synthetic methodology. AjiPhase™ overcomes the disadvantages of traditional LPPS yet retains the benefits of lower cost, higher quality and easier scale-up compared to Solid Phase Peptide Synthesis (SPPS). We have applied this technology to the synthesis of a variety of peptides including >40-mers, cyclized, and conjugated peptides in high volumes. The significant reductions in production costs and purification load, compared to SPPS have been demonstrated. Daisuke Takahashi, Chief, Research Institute for Bioscience Products and Fine Chemicals, Ajinomoto, Japan Sponsored by 
4:30
Target Peptide Optimization and Recombinant Manufacturing of an Orally Delivered Peptide for the Treatment of Obesity
Nozer Mehta, Ph.D., Vice President, R&D, Unigene Laboratories, Inc. Sponsored by 
5:00
Emergence of Cell-Free Translation as a Viable Route to Rapid Design and Production of Novel Peptide Therapeutics
Sutro has developed a scalable cell-free protein synthesis platform for the efficient production of therapeutic proteins. The platform is a powerful re-iterative design tool enabling expression of many hundreds of variants in parallel in several hours. The same system supports rapid optimization of expression and folding and can then be swiftly scaled for rapid production to support clinical studies and provide a viable manufacturing route. Trevor J. Hallam, Ph.D., Chief Scientific Officer, Sutro Biopharma Inc. |
|
|
5:30
Networking Reception and Booth Crawl in Poster and Exhibit Hall with Dedicated Poster Viewing
Poster presenters are requested to be available at their posters Courses: 星期日 | Plenary Sessions: 星期一 | Main Conference: 星期二 | 星期三 Early Drug Product Development for Oligonucleotides and Peptides
8:25
Chairperson's Remarks
Mark Francis, MRSC, CChem, Csi, Director, Formulation Process and Analysis, UK, GlaxoSmithKline, United Kingdom
8:30
Case
The Challenges of Selecting and Developing a New Route of Delivery for a Novel Osteoporosis TherapeuticStudy BA058 is a peptide analog of hPTHrP being developed to treat post-menopausal osteoporosis. BA058 is administered by daily subcutaneous injection, but a significant opportunity exists to develop a more patient convenient route of delivery. Selection and development of a new route of administration involved many considerations and challenges which will be discussed. Gary Hattersley, Ph.D., Vice President, Biology, Radius Health
9:00
Delivery Options in Peptide Development: Challenges and Opportunities
The commercial drive for long-acting therapeutic peptides creates an opportunity for novel delivery approaches. There are multiple approaches such as conjugation and depot technologies, however, many of these technologies are molecule specific. The challenge is to match the right peptide with the right delivery technology at the right time in a cost effective manner. The overview of approaches, their pros and risks, and strategy to find best fit between peptide candidates and delivery modalities will be discussed. Ramin Darvari, Ph.D., Senior Principal Scientist, Novel Delivery Technologies, BioTherapeutics PharmSci, Pfizer Inc.
9:30
Chemical Durability of Primary Packaging
As API and drug formulations become more complex there is increasing emphasis on understanding drug formulation/packaging interactions. Based on the general mechanisms of glass attack this talk will focus on the concept of stress tests to predict problems with chemical durability of primary packing like glass delamination. Data will be shown that demonstrates a container risk assessment evaluation. Daniel E. Haines, Ph.D., Scientific Advisor - Pharma Services, Pharmaceutical Systems, SCHOTT North America, Inc. New, Unpublished Data
10:00
Case
High Concentration Oligonucleotide Products: Considerations from Preformulation to DosingStudy High concentration aqueous solutions of oligonucleotides have several distinctive properties due to the polymeric nature of these molecules and the potential for both attractive and repulsive interactions. This presentation will focus on how these properties can differ with sequence and chemistry, and considerations that should be taken into account during formulation development, manufacturing process development, analytical testing, and dose administration. Andrew Dibble, Ph.D., Director, Pharmaceutical Development, Isis Pharmaceuticals, Inc.
10:30
Networking Refreshment Break in Poster and Exhibit Hall
Strategy Discussion Forums
11:15 - 12:45
What is the Appropriate Related Impurities Specification for Oligonucleotides?
The scope of the discussion may include:
Nigel Richardson, Ph.D., MRSC, CChem, Manager, API Chemistry and Analysis, GlaxoSmithKline, United Kingdom Panelists: Kathryn L. Ackley, Ph.D., Vice President, Business Development and Project Management, Girindus America, Inc. Claus Rentel, Ph.D., Director, Analytical Development Quality Control, Isis Pharmaceuticals, Inc. Brigitte E.A. Wanner-Burm, Ph.D., Manager, Analytical Chemistry and Quality Control, Prosensa Therapeutics BV, The Netherlands Introductory Presentation:
Development of Oligonucleotide Specifications from Phase I to Commercial Launch
Drug Substance and Drug Product specifications are critical components of the overall Control Strategy. In-process specifications, release specifications, analytical methodology and how to determine appropriate specification limits will be discussed. The presentation will focus on impurity limits and how these evolve as medicines progress towards commercial launch. Nigel Richardson, Ph.D., MRSC, CChem, Manager, API Chemistry and Analysis, GlaxoSmithKline, United Kingdom
Strategies for Formulation Transition
Delivery routes and modalities have significant impact on safety, efficacy, convenience and cost of biotherapeutic products. An integrated drug development strategy would allow timely identification, selection and implementation of effective delivery options. The forum will discuss the advantages and challenges in establishing an integrated strategy, and the importance of the interface between the pharmaceutical companies and delivery/device technology companies in timely development of safe, efficacious, convenient and cost effective products. Moderator: Ramin Darvari, Ph.D., Senior Principal Scientist, Novel Delivery Technologies, BioTherapeutics PharmSci, Pfizer Inc. Panelists: Andrew Dibble, Ph.D., Director, Pharmaceutical Development, Isis Pharmaceuticals, Inc. Daniel E. Haines, Ph.D., Scientific Advisor - Pharma Services, Pharmaceutical Systems, SCHOTT North America, Inc. Gary Hattersley, Ph.D., Vice President, Biology, Radius Health
Preclinical Evaluation of Immunomodulatory Effects of Oligonucleotides and Formulations: Challenges and Strategies
Oligonucleotide therapeutics fall into two categories: Those that take advantage of immunomodulatory effects and those that try to avoid them. Preclinical models of immunomodulatory effects, either beneficial or toxic, are problematic at best. This panel will discuss the practical value of preclinical models for oligonucleotide and formulation lead development, the challenges of simple versus complex formulations of oligonucleotides, the pros and cons of in vivo versus ex vivo models, the regulatory requirements for immunotoxicity testing, and the impact on chronic versus acute use and routes of administration. Key discussion points:
Bob D. Brown, Ph.D., CSO and Senior Vice President, Research, Dicerna Pharmaceuticals Panelists: Art Krieg, M.D., Entrepreneur in Residence, Atlas Ventures Arthur A. Levin, Ph.D., Chief Development Officer, Santaris Pharma A/S, USA and Denmark Dinah W.Y. Sah, Ph.D., Vice President, Research, Alnylam Pharmaceuticals, Inc.
12:45
Networking Luncheon in Poster and Exhibit Hall
Last chance to view posters and exhibits. |
||
|
OligonucleotidesCMC Aspects of Alternative Delivery Routes
1:55
Chairperson's Remarks
Doug Brooks, Ph.D., Executive Director, Chemistry, Regado Biosciences New, Unpublished Data
2:00
Moving siRNA Conjugates towards the Clinic
We have developed novel siRNA-GalNAc conjugates for hepatocyte-specific delivery of RNAi therapeutics to the liver. Subcutaneous administration of a siRNA-GalNAc conjugate targeting transthyretin results in robust gene silencing in multiple pre-clinical models at clinically relevant doses. An update on siRNA-GalNAc conjugate progress will be presented. Tracy S. Zimmermann, Ph.D., Associate Director, Research, Alnylam Pharmaceuticals, Inc.
2:30
Delivery of siRNA Therapeutics for Skin Disorders Using Dissolvable Microneedle Arrays
Although the genetic defects of many inherited skin disorders, including pachyonychia congenita, have been identified, no effective therapies exist. SiRNAs have the potential to transform treatment. We have developed dissolvable microneedle arrays that penetrate skin and deposit self-delivery siRNAs that inhibit target gene expression. These siRNAs and microneedle devices are being made under GMP conditions in preparation for clinical trials. Roger L. Kaspar, Ph.D., CEO and Scientific Founder, TransDerm, Inc.
3:00
Case
Late Stage CMC Challenges for Oligonucleotide/Adjuvant used in VaccinesStudy This session will focus on late stage CMC challenges associated with vaccines containing oligonucleotide/adjuvants including hands-on experience and the regulatory challenges this convergence represents:
William Turner, Vice President, Regulatory Affairs and Corporate Quality Systems, Dynavax Technologies |
PeptidesCMC Aspects of Alternative Delivery Routes
1:55
Chairperson's Remarks
David Litzinger, Ph.D., Director, Pharmaceutical Sciences, Amylin Pharmaceuticals, Inc. New, Unpublished Data
2:00
Case
The CovX Antibody-mAb Conjugate Platform: Development Challenges and OutcomesStudy The CovX platform has led to several candidates currently in clinical trials including bispecific conjugates. The chemistry, process and analytical challenges associated with the development of peptide mAb conjugates will be reviewed and specific challenges encountered with bispecific conjugates will be discussed. Olivier J. Marcq, Ph.D., Senior Principal Scientist, Bioconjugates and Polytides, Pfizer Biotherapeutics R&D New, Unpublished Data
2:30
Case
CMC Challenges Associated with Developing an Inhaled Dry Powder/Device Combination ProductStudy Afrezza® is an inhaled insulin product comprising a dry powder formulation and a breath-powered device. Developing combination products of this type requires an integrated approach combining formulation development and scale-up with device development and scale-up. The dry powder formulation and inhalation device are intrinsically linked and product development challenges can be simplified when these efforts are combined at an early stage. Andrea Leone-Bay, Ph.D., Vice President, Pharmaceutical R&D, MannKind Corporation New, Unpublished Data
3:00
XTEN - A Protein-Based and Biodegradable Alternative to PEGylation
Amunix developed hydrophilic unstructured polypeptides with PEG-like properties (XTEN) that can be directly fused to therapeutic peptides and proteins. XTEN fusion enables the efficient recombinant production of peptides in high yield. XTEN is stable in serum but unlike PEG it is readily degraded by intracellular proteases. Clinical studies of two XTENylated products are currently in progress. Volker Schellenberger, Ph.D., Chief Scientific Officer, Amunix Inc. |
|
|
3:30
Networking Refreshment Break
Strategy Discussion Forums
4:00 - 5:00
Alternative Delivery Platforms for Oligonucleotide and Peptide Therapeutics
Peptides and oligos are not normally amenable to oral administration due to hydrolysis by gut enzymes and poor absorption from the GI tract. As a result, administration by injection is often the default delivery route and can become a source of noncompliance. The Strategy Discussion Forum will address the advantages/disadvantages of alternative delivery platforms and their acceptability to physicians, patients and health providers. Additionally, the commercial suitability and viability of alternative delivery technologies for different types of oligo and peptide drug substances and dosages will be discussed. The forum will also examine the pros and cons of introducing alternative delivery formats during different stages of the drug development process. Moderator: Rodney Lax, Ph.D., Senior Director, Business Development, PolyPeptide Laboratories, Inc. Panelists: Ramin Darvari, Ph.D., Senior Principal Scientist, Novel Delivery Technologies, BioTherapeutics PharmSci, Pfizer Inc. Roger L. Kaspar, Ph.D., CEO and Scientific Founder, TransDerm, Inc. Andrea Leone-Bay, Ph.D., Vice President, Pharmaceutical R&D, MannKind Corporation Nozer Mehta, Ph.D., Vice President, R&D, Unigene Laboratories, Inc.
Conjugation: From a One-Off Approach to a Platform Technology - Pros and Cons
The benefits of conjugating oligonucleotides or peptides (PEGylation, mAb conjgate, etc.) will be briefly reviewed via examples. The panel will then discuss the pros and cons of a platform strategy for conjugation. For established modalities, the need to screen conjugate components in a systematic fashion and ultimately to generate candidates to feed the pipeline has led to a push in the industry for a platform approach to conjugation. Platformization can help speed development by building on lessons learned and compress overall timelines. At the same time, a too rigid strategy can hinder innovation or delay adoption of new technologies. Panelists will discuss how companies bring the necessary flexibility to their conjugates platform strategy or opt for a one-off approach. Moderator: Olivier Marcq, Ph.D., Senior Principal Scientist, Bioconjugates and Polytides, Pfizer Biotherapeutics R&D Panelists: Christopher P. Holmes, Ph.D., Executive Director, Chemistry, Affymax, Inc. Muthiah Manoharan, Ph.D., Senior Vice President Drug Discovery, Alnylam Pharmaceuticals, Inc. Lubomir V. Nechev, Ph.D., Senior Director, Process Chemistry, Alnylam Pharmaceuticals, Inc.
5:00
End of Manufacturing Sessions
|
||
